header logo image


Page 825«..1020..824825826827..830840..»

End of blood donor clinics in Timmins – Timmins Press

November 21st, 2019 2:44 pm

Clifford LeBrun is seen here on Tuesday donating blood for the 269th time in his life. Wednesday marks the last day the Canadian Blood Services will be holding donor clinics in Timmins.Elena De Luigi/The Daily Pressjpg, TD

For Clifford LeBrun, donating blood is personal.

On Tuesday, he donated for the 269th time at the last Canadian Blood Services donor clinic being held in Timmins.

His goal is to reach 300 though its not likely to happen at a clinic held in Timmins.

LeBrun has been giving the gift of life since he was 18. He said he remembers the first time he ever donated blood.

I had a little friend that got hit by a truck coming out in front of the bus and he died because there was a blood shortage. So I started then.

Since that first time, LeBrun always keeps his little friend in mind.

Its the gift of life. So look at it that way. Its easy. My little friend wouldnt have passed away if there would have been enough blood at St. Marys Hospital at that time.

Its rewarding. Its self-rewarding.

Jenny Fortin, territory manager in Northeastern Ontario for Canadian Blood Services, said the organization is transitioning out of whole-blood collections in the region. Residents will be able to continue to donate plasma in Sudbury once the transition is complete.

Were really thankful for the communitys support that weve received all these years and just wanted to celebrate that support and say thank you to the community, she said, adding it will be bittersweet for regular donors.

Fortin said she encourages people to donate plasma when they are in the Sudbury area, and to also visit the organizations website for more ways to contribute.

Theres a lot of ways to still be a part of Canadas lifeline moving forward, she said, adding people can join the Organs and Tissues Registry, or the Stem Cell Registry.

Fortin said the organization is hoping to collect 120 units of blood each day from residents in Timmins during the last two days of the donor clinic.

When asked if he will travel to Sudbury to donate plasma, LeBrun said he would make the trip.

Im Type O (negative). Its universal. I believe Ive helped over 600 people. I will continue.

Fortin said it is especially important to donate blood during holidays.

Typically we do see a decline in people walking through our doors, just because people are out and about a little bit more and theyre buying presents and visiting family so donating blood is not necessarily top of mind. But with an increase in the amount of people on the roads, we do see an increase in the amount of accidents (and) the need for blood actually goes up, she said, adding it can take up to 50 units of blood to help one accident victim.

One unit is equivalent to one donor, so thats 50 donors.

LeBrun, who was also a volunteer for Canadian Blood Services for 10 years, said he was on list to donate if there ever was major accident, but he has not had that chance.

It just never happened, he said.

Asked about its decision to discontinue blood donor clinics in Timmins, Canadian Blood Services offered this explanation to The Daily Press, Canadian Blood Services will be opening a proof-of-concept plasma donation centre in Sudbury in the summer of 2020. In preparation for the opening of this centre, the Sudbury whole blood donation centre will be closing in January. We are discontinuing the mobile blood donation events in the surrounding Northern Ontario communities.

While we understand this is a change for the generous blood donors in communities in Northern Ontario, we are taking steps to increase the amount of plasma collected in Canada to meet rising patient demand.

This change will not impact the availability of blood products for hospitals or patients. We operate a national inventory which ensures the quality and safety of our products and services while working efficiently to help hospitals get the right treatment to patients where and when they need them.

We are grateful for the many blood donors in Timmins, and their commitment to saving lives. There are other ways to support Canadas Lifeline, including but not limited to joining the national stem cell registry, registering your intent to become an organ and tissue donor, or making a financial donation.

With the mobile units being discontinued, the nearest location from Timmins for residents to donate blood will be Parry Sound.

We appreciate that it may be too difficult to travel a great distance to donate blood, the organization stated. When possible, many people opt to include blood donation in their travel plans in Canada.

Today is the final day of the last blood donor clinic being held in Timmins. It is being held at Paroisse St. Dominique Hall from 12:30 to 5:30 p.m.

Here is the original post:
End of blood donor clinics in Timmins - Timmins Press

Read More...

European Commission Approves Two New Regimens of Merck’s KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent…

November 21st, 2019 2:44 pm

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] 1). This approval is based on findings from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant improvement in overall survival (OS) as monotherapy (HR = 0.74 [95% CI, (0.61-0.90); p=0.00133] and in combination with chemotherapy (HR=0.65 [95% CI, 0.53-0.80]; p=0.00002), in patients whose tumors expressed PD-L1 (CPS 1).

This disease is especially debilitating since it can be highly visible and affect a patients appearance and their daily functions, such as eating and speaking, said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. Considering the great need for new treatment options, we are encouraged by todays KEYTRUDA approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.

This approval allows marketing of the KEYTRUDA monotherapy and combination regimen in all 28 EU member states plus Iceland, Lichtenstein and Norway.

KEYTRUDA is now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent head and neck cancer, a disease that has been treated the same way in the EU for more than a decade, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.

Data Supporting the European Approval

This approval is based on data from the Phase 3 KEYNOTE-048 trial, a multi-center, randomized, open-label, active-controlled trial conducted in 882 patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies. Randomization was stratified by tumor PD-L1 expression (Tumor Proportion Score [TPS] 50% or <50%), HPV status (positive or negative), and ECOG Performance Status (PS) (0 vs. 1). The dual primary endpoints were OS and progression-free survival (PFS). Patients were randomized 1:1:1 to one of the following treatment arms:

Treatment with KEYTRUDA continued until RECIST v1.1-defined progression of disease as determined by the investigator, unacceptable toxicity or a maximum of 24 months.

Efficacy Results for KEYTRUDA as Monotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA

n=257

Standard

Treatment*

n=255

OS

Number (%) of patients with event

197 (77%)

229 (90%)

Median in months (95% CI)

12.3 (10.8, 14.3)

10.3 (9.0, 11.5)

Hazard ratio (95% CI)

0.74 (0.61, 0.90)

p-Value

0.00133

PFS

Number (%) of patients with event

228 (89%)

237 (93%)

Median in months (95% CI)

3.2 (2.2, 3.4)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

1.13 (0.94, 1.36)

p-Value

0.89580

ORR

Objective response rate (95% CI)

19.1% (14.5, 24.4)

35% (29.1, 41.1)

Complete response

5%

3%

Partial response

14%

32%

p-Value

1.0000

Duration of Response

Median in months (range)

23.4 (1.5+, 43.0+)

4.5 (1.2+, 38.7+)

% with duration 6 months

81%

36%

*

Cetuximab, platinum, and 5-FU

Based on the stratified Cox proportional hazard model

Based on stratified log-rank test

Response: Best objective response as confirmed complete response or partial response

Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)

Efficacy Results for KEYTRUDA plus Chemotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA +

Platinum Chemotherapy +

5-FU

n=242

Standard

Treatment*

n=235

OS

Number (%) of patients with event

177 (73%)

213 (91%)

Median in months (95% CI)

13.6 (10.7, 15.5)

10.4 (9.1, 11.7)

Hazard ratio (95% CI)

0.65 (0.53, 0.80)

p-Value

0.00002

PFS

Number (%) of patients with event

212 (88%)

221 (94%)

Median in months (95% CI)

5.1 (4.7, 6.2)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

0.84 (0.69, 1.02)

p-Value

0.03697

ORR

Objective response rate (95% CI)

36% (30.3, 42.8)

36% (29.6, 42.2)

More here:
European Commission Approves Two New Regimens of Merck's KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent...

Read More...

Nanomedicine Market Healthy Pace throughout the Forecast by 2023 – Crypto News Byte

November 21st, 2019 2:43 pm

Overview:

Nanomedicine is an offshoot of nanotechnology, and refers to highly-specific medical intervention at the molecular scale for curing diseases or repairing damaged tissues. Nanomedicine uses nano-sized tools for the diagnosis, prevention and treatment of disease, and to gain increased understanding of the complex underlying pathophysiology of the disease. It involves three nanotechnology areas of diagnosis, imaging agents, and drug delivery with nanoparticles in the 11,000 nm range, biochips, and polymer therapeutics.

Get Sample Copy Of The Report@ https://www.trendsmarketresearch.com/report/sample/9807

Majority of nanomedicines prescribedcurrently, allow oral drug delivery and its demand is increasing significantly. Although these nanovectors are designed to translocate across the gastrointestinal tract, lung, and bloodbrain barrier, the amount of drug transferred to the organ is lower than 1%; therefore improvements are challenging. Nanomedicines are designed to maximize the benefit/risk ratio, and their toxicity must be evaluated not only by sufficiently long term in vitro and in vivo studies, but also pass multiple clinical studies.

Market Analysis:

The Global Nanomedicine Market is estimated to witness a CAGR of 17.1% during the forecast period 20172023. The nanomedicine market is analyzed based on two segments therapeutic applications and regions.

The major drivers of the nanomedicine market include its application in various therapeutic areas, increasing R&D studies about nanorobots in this segment, and significant investments in clinical trials by the government as well as private sector. The Oncology segment is the major therapeutic area for nanomedicine application, which comprised more than 35% of the total market share in 2016. A major focus in this segment is expected to drive the growth of the nanomedicine market in the future.

Regional Analysis:

The regions covered in the report are the Americas, Europe, Asia Pacific, and Rest of the World (ROW). The Americas is set to be the leading region for the nanomedicine market growth followed by Europe. The Asia Pacific and ROW are set to be the emerging regions. Japan is set to be the most attractive destination and in Africa, the popularity and the usage of various nano-drugs are expected to increase in the coming years. The major countries covered in this report are the US, Germany, Japan, and Others.

Therapeutic Application Analysis:

Nanomedicines are used as fluorescent markers for diagnostic and screening purposes. Moreover, nanomedicines are introducing new therapeutic opportunities for a large number of agents that cannot be used effectively as conventional oral formulations due to poor bioavailability. The therapeutic areas for nanomedicine application are Oncology, Cardiovascular, Neurology, Anti-inflammatory, Anti-infectives, and various other areas. Globally, the industry players are focusing significantly on R&D to gain approval for various clinical trials for future nano-drugs to be commercially available in the market. The FDA should be relatively prepared for some of the earliest and most basic applications of nanomedicine in areas such as gene therapy and tissue engineering. The more advanced applications of nanomedicine will pose unique challenges in terms of classification and maintenance of scientific expertise.

Request For Report Discount@ https://www.trendsmarketresearch.com/report/discount/9807

Key Players:

Merck & Co. Inc., Hoffmann-La Roche Ltd., Gilead Sciences Inc., Novartis AG, Amgen Inc., Pfizer Inc., Eli Lilly and Company, Sanofi, Nanobiotix SA, UCB SA and other predominate & niche players.

Competitive Analysis:

At present, the nanomedicine market is at a nascent stage but, a lot of new players are entering the market as it holds huge business opportunities. Especially, big players along with the collaboration with other SMBs for clinical trials of nanoparticles and compounds are coming with new commercial targeted drugs in the market and they are expecting a double-digit growth in the upcoming years. Significant investments in R&D in this market are expected to increase and collaborations, merger & acquisition activities are expected to continue.

Benefits:

The report provides complete details about the usage and adoption rate of nanomedicines in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, vertical players initiatives, government initiatives towards the nanomedicine adoption in the upcoming years along with the details of commercial drugs available in the market. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

Report Analysis@ https://www.trendsmarketresearch.com/report/analysis/IR/nanomedicine-market

View more :Healthcare, Pharmaceuticals, & Medical Devices Report Insights

Continue reading here:
Nanomedicine Market Healthy Pace throughout the Forecast by 2023 - Crypto News Byte

Read More...

World Pancreatic Cancer Day: increasing awareness and inspiring action – UNSW Newsroom

November 21st, 2019 2:43 pm

Pancreatic cancer is an insidious disease itis often diagnosedat an advanced stage, with about 90% of patients dying within five years of diagnosis.New projections suggest pancreatic cancer will be the second leading cause of cancer mortality by 2025.

This World Pancreatic Cancer Day, we are celebrating some of the many UNSWresearchers who are dedicated to changing those statistics. Cancers with poor outcomes like pancreatic cancer are a key focus area in UNSW Medicine's cancer theme.

Associate Professor Phillips is the Head of the Pancreatic Cancer Translational Research Group and Deputy Director of the Adult Cancer Program at the Lowy Cancer Research Centre at UNSW Medicine.

This year, A/Prof Phillips was a key driver in establishing the Pancreatic Cancer Research Hub, which aims to double the survival of patients with pancreatic cancer by 2030.

She says World Pancreatic Cancer Day is a powerful advocacy event to increase community and government awareness of pancreatic cancer.

It is also a time to reflect on the progress we have made in understanding this terrible disease and focus on the next steps to overcome current clinical challenges to ensure our research efforts bridge the gap and, as in other cancers, improve the outcomes for our patients with pancreatic cancer.

I know that we are on the brink of overturning the unacceptable statistics. Uniting researchers with the community who, unlike in other cancers, dont often get to be a strong voice advocating for themselves and Government will ensure Australian researchers continue to make positive change for pancreatic cancer patients globally.

A/Prof Phillips group has developed a novel cutting-edge way to keep pieces of human pancreatic tumours alive in the laboratory for two weeks after surgical resection.

Our capacity to grow human tumour tissue in the laboratory provides a valuable new clinical tool to test how a patients tumour responds to different chemotherapies and has the potential to immediately inform patient treatment options. Our unique tumour model is superior to other models because it is human in origin and it contains the complex tumour environment present in patients.

In 2016 A/Prof Phillips had a major breakthrough, successfully developing a novel nanomedicine a tiny drug delivery vehicle consisting of a state-of-the-art nanoparticle that can package gene therapy to inhibit any tumour-promoting gene in pancreatic cancer.

With the generous support from the Brian O'Neill Pancreatic Cancer Fundraising Dinner held last night the team will be able to perform essential preclinical studies to test the therapeutic potential of their nano-gene therapy in combination with a clinically approved drug. They also plan on using their expertise to improve the bioavailability of the clinically approved drugs using a nanomedicine approach.

Professor Minoti Apte was the first in the world to isolate and characterise pancreatic stellate cells, a cell type that is now known to play a major role in the progression of both chronic pancreatitis and pancreatic cancer. Coming up with ways to target these cells to prevent them from doing harm is now a major focus of her teams research.

The group has now shown that interrupting the cross-talk between cancer cells and surrounding cells in the microenvironment by targeting a certain signalling pathway reduces tumour growth and eliminates metastasis in early as well as advanced pre-clinical models of pancreatic cancer.

We have also shown that targeting this pathway reduces the risk of recurrence and progression after surgical resection of pancreatic cancer in a mouse model, and are currently working on possible pathways to take our laboratory findings to the clinic, Professor Apte says.

To me, World Pancreatic Cancer Day is a great opportunity to raise awareness in the community about this deadly cancer, but it is also a day to admire the courage and resilience of patients and their carers. These are the people that spur us researchers on to continue working hard to develop new therapeutic approaches to improve outcomes.

Last year, Professor Apte received the Gastroenterological Society of Australia (GESA) Distinguished Researcher Prize 2018. In 2014 she was awarded the Medal of the Order of Australia (OAM), after being named the NSW Woman of the Year in 2015. She was also the 2016 recipient of the Professor Rob Sutherland AO Make a Difference Award at the NSW Premiers Awards for Outstanding Cancer Research an award that recognises highly successful research that is actively changing cancer treatment and improving patient survival.

Dr Angelica Merlot, who is based at the Childrens Cancer Institute, focuses her research on developing new anti-cancer drugs that target drug resistance and suppress cancer spread.

This year, the cancer researcher has won the 2019 NSW Young Woman of the Year award for her achievements and research into treatments for pancreatic and brain cancer. She also won a 2019 Young Tall Poppy Science Award and the 2019 NSW Early Career Researcher of the Year (Biological Sciences) at the NSW Premiers Prizes for Science & Engineering.

Dr Merlot says today is an important day to raise awareness about one of the world's toughest cancers.

This is crucial as it broadens community knowledge, inspires action and supports further research funding for this cancer. It's also a time to remember those whom we have lost and those currently fighting this disease, she says.

Although we've seen a small improvement in the current survival rate, a lot of progress is still required. Further translational research means that there is a greater likelihood that the survival rates can be increased and the journey and treatment of those affected by the cancer can be improved.

Dr Merlot became focused on cancer research as an undergraduate. Her interest in aggressive cancers, such as pancreatic and brain cancer, was motivated by lack of improvement in survival rates over the past decades, largely due to late diagnosis, a lack of screening programs, low awareness of symptoms and a lack of treatment options.

After moving to UNSW Medicine as a Scientia Fellow in 2018, Dr Merlot focused on understanding the mechanisms by which cancer cells grow and adapt to their environment, why drugs become less effective and the development of nanoparticles to improve drug delivery.

Dr Merlots current projects are investigating part of a human cell called the endoplasmic reticulum (ER). The ER is a type of organelle, or subunit within a cell, that has been shown to help cancers grow, spread and develop drug resistance.

Dr Ying Zhu will lead a team of researchers from UNSW to discover much needed early detection methods for pancreatic cancer patients: the UNSW Medicine researcher today received $100,000 grant from the Avner Pancreatic Cancer Foundation. A/Prof Phillips is a co-investigator on this grant.

As current approaches to this research are time and labour intensive, the team will develop an integrated and small device based on nanotechnology for rapid and sensitive exosome analysis. The team will define a set of biomarkers that can differentiate between cancer and non-cancer subjects from cells and plasma carrying early signs of human pancreatic cancer. This novel technology will also be applicable for doctors monitoring the development and customising the treatment of a patients tumour.

Pancreatic cancer is difficult to diagnose in the early stages. Early tumour cant be observed during routine physical exams as the pancreas is deep inside the body. Most patients are diagnosed when the cancer has become very large or has spread to other organs. A method to detect pancreatic cancer early on is urgently needed, Dr Zhu said.

My project team aims to develop a blood test to detect pancreatic cancer in the early stages. The team will target exosomes, which are nanosized fragments released by cancer cells. Exosomes are important for communicating messages and transporting materials between cells. Exosomes have been identified as more accurate and promising biomarkers, or biological clues for pancreatic cancer diagnosis, Dr Zhu continued.

We are pleased to award funding to this innovative project, said Michelle Stewart, CEO of the Avner Pancreatic Cancer Foundation. We are encouraged by the high calibre of the research and believe that investment into projects like these will help us to increase survival for people diagnosed with pancreatic cancer.

Read the original post:
World Pancreatic Cancer Day: increasing awareness and inspiring action - UNSW Newsroom

Read More...

Nanomedicine Market Segmented by Applications and Geography Trends, Growth and Forecasts 2026 – The Bay State Herald

November 21st, 2019 2:43 pm

A new market assessment report on the Nanomedicine market provides a comprehensive overview of the Nanomedicine industry for the forecast period 2019 2026. The analytical study is proposed to provide immense clarity on the market size, share and growth rate across different regions. The profound knowledge and extensive examination of the trends from the yesteryear and future aims at offering the stakeholders, product owners, and marketing personnel a competitive edge over others operating in the Agricultural Tires market for the forecast period, 2019 2026.

The study will also feature the key companies operating in the industry, their product/business portfolio, market share, financial status, regional share, segment revenue, SWOT analysis, key strategies including mergers & acquisitions, product developments, joint ventures & partnerships an expansions among others, and their latest news as well. The study will also provide a list of emerging players in the Nanomedicine market.

In this report, theglobal Nanomedicine marketis valued atUSD xx million in 2019and is expected to reachUSD xx millionby the end of2026, growing at aCAGR of xx.x%between 2019 and 2026.

Download FREE Sample Brochure (Customized Sample PDF File delivered as per your specific requirement) @https://www.reportsanddata.com/sample-enquiry-form/1048

The major manufacturers covered in this report:Arrowhead Pharmaceuticals Inc. AMAG Pharmaceuticals, Bio-Gate AG, Celgene Corporation and Johnson & Johnson. Johnson & Johnson

The study is a professional probe into the revenue generated and capacity estimates for the Nanomedicine market for the forecast period 2019 2026 empower the business owners to maintain a competitive edge over their rivals.

The research further examines and provides data on the market by type, application and geography interspersed with illustrations and other graphical representations. The market analysis not only determines the attractiveness of the industry but also the evolving challenges and opportunities and their association with the weaknesses and strengths of prominent market leaders.

Other factors taken into consideration when studying the industry include profitability, manufacturing capability, distribution channels and industry cost structure and major success factors.

The industry experts have left no stone unturned to identify the major factors influencing the development rate of the Nanomedicine industry including various opportunities and gaps. A thorough analysis of the micro markets with regards to the growth trends in each category makes the overall study interesting. When studying the micro markets the researchers also dig deep into their future prospect and contribution to the Nanomedicine industry.

Product Outlook (Revenue, USD Billion, 2018-2026)

Therapeutics

Regenerative Medicine

In-vitro diagnostics

In-vivo diagnostic

Vaccines

Drug Delivery System Outlook (Revenue, USD Billion, 2018-2026)

Nanobots

Nanoghosts

Nanoclusters

Nanobubbles

Exosomes

Injectable Nanoparticle Generator

Dendrimers

Liposomes

Carbon nanotube

Graphene

Others

Application Outlook (Revenue, USD Million, 2015-2026)

Oncology

Infectious diseases

Cardiology

Orthopedics

Others

!!! Limited Time DISCOUNT Available!!! Get Your Copy at Discounted [emailprotected]https://www.reportsanddata.com/discount-enquiry-form/1048

Key Research:

The main sources are industry experts from the global Nanomedicine industry, including management organizations, processing organizations, and analytical services providers that address the value chain of industry organizations. We interviewed all major sources to collect and certify qualitative and quantitative information and to determine future prospects. Through interviews in the industry experts industry, such as CEO, vice president, marketing director, technology and innovation director, founder and key executives of key core companies.

Secondary Research:

Secondary research studies critical information about the industrial value chain, core pool of people, and applications. We also helped market segmentation based on the industrys lowest level of industry, geographical markets and key developments in market and technology-driven core development.

Geographically, this report studies the key regions, focuses on product sales, value, market share and growth opportunity in these regions, covering:

United States

Europe

China

Japan

Southeast Asia

India

Incorporated with Info-graphics, charts, 75 tables and 105 figures, this 243-page research report NanomedicineMarket Size, Type Analysis, Application Analysis, End-Use Industry Analysis, Regional Outlook, Competitive Strategies And Forecasts, 2019 2026 is based on a complete research of the entire Global market and covering all its sub-segments through comprehensively thorough classifications. Insightful analysis and assessment are created from superior primary and secondary information sources with data and information derived from industry specialists across the value chain. The report provides historical market data for 2014-2018, base year estimates for 2018, and forecasts from 2019 to 2026.

Table of Contents:

Report Overview:It includes the objectives and scope of the study and gives highlights of key market segments and players covered. It also includes years considered for the research study.

Executive Summary:It covers industry trends with high focus on market use cases and top market trends, market size by regions, and global market size. It also covers market share and growth rate by regions.

Key Players:Here, the report concentrates on mergers and acquisitions, expansions, analysis of key players, establishment date of companies, and areas served, manufacturing base, and revenue of key players.

Breakdown by Product and Application:This section provides details about market size by product and application.

Regional Analysis:All of the regions and countries analyzed in the report are studied on the basis of market size by product and application, key players, and market forecast.

Profiles of International Players:Here, players are evaluated on the basis of their gross margin, price, sales, revenue, business, products, and other company details.

Market Dynamics:It includes supply chain analysis, analysis of regional marketing, challenges, opportunities, and drivers analyzed in the report.

Appendix:It includes details about research and methodology approach, research methodology, data sources, authors of the study, and a disclaimer.

For further information on this analysis, please visit @https://www.reportsanddata.com/report-detail/nanomedicine-market

Why Choose Reports and Data?

Request customized copy of Nanomedicine report

We are grateful to you for reading our report. If you wish to find more details of the report or want a customization, contact us. You can get a detailed information of the entire research here. If you have any special requirements, please let us know and we will offer you the report as you want.

Have Any Query? Ask Our Expert @https://www.reportsanddata.com/make-enquiry-form/1048

Read more here:
Nanomedicine Market Segmented by Applications and Geography Trends, Growth and Forecasts 2026 - The Bay State Herald

Read More...

Global Next-Generation Sequencing (NGS) Market Report 2019 – World Market Projected to Surpass $25 Billion by 2026, Rising at a CAGR of 20.6% -…

November 21st, 2019 2:43 pm

DUBLIN--(BUSINESS WIRE)--The "Global Next-Generation Sequencing (NGS) Market Analysis 2019" report has been added to ResearchAndMarkets.com's offering.

The Global Next-Generation Sequencing (NGS) market is expected to reach $25.09 billion by 2026 growing at a CAGR of 20.6% from 2018 to 2026.

Low cost, high accuracy & speed, and exact outcomes even from low sample input are the fundamental advantages it offers over Sanger's sequencing technique. It is utilized to execute different applications for example, biomarker discovery, oncology studies, personalized medicine, agricultural & animal research, and others. It has streamlined nucleotide analysis and has generally replaced conventional tools of genomics, particularly microarray efficiently. Consequently, these aforementioned factors help in expanding the market share.

Factors such as rise in technological advancements and increase in partnerships & collaborations are driving the market growth. Though, lack of skilled professionals, and ethical & legal limitations are projected to inhibit the growth of the market. Moreover, cloud computing as a potential data management service and lucrative opportunities in emerging markets may provide ample opportunities for the market growth.

By end user, academic institutes & research centers segment acquired significant growth in the market owing to the increasing number of collaborations between the market players and academic & research institutions and on the account of wide usage of these methodologies in research and Ph.D. projects, on-site bioinformatics courses, and workshops across regions, and the development of cost-efficient products and services for researchers is leading to the market growth.

The key vendors mentioned are 10x Genomics, Agilent Technologies Inc, Beckman Coulter (A Subsidiary of Danaher), Becton, Dickinson and Company, BGI, Eurofins Scientific, F. Hoffmann-La Roche AG, Genewiz, Illumina Inc, Macrogen Inc, Oxford Nanopore Technologies Ltd, Pacific Biosciences of California Inc, Perkinelmer Inc, Qiagen N.V. and Thermo Fisher Scientific Inc.

Key Questions Answered in this Report

Key Topics Covered

1 Market Synopsis

2 Research Outline

3 Market Dynamics

3.1 Drivers

3.2 Restraints

4 Market Environment

4.1 Bargaining power of suppliers

4.2 Bargaining power of buyers

4.3 Threat of substitutes

4.4 Threat of new entrants

4.5 Competitive rivalry

5 Global Next-Generation Sequencing (NGS) Market, By Disease

5.1 Introduction

5.2 Rare Disease Diagnostics

5.3 Cardiovascular

5.4 Other Diseases

6 Global Next-Generation Sequencing (NGS) Market, By Service

6.1 Introduction

6.2 Sequencing Services

6.3 Animal & Plant Sequencing

6.4 Gene Regulation Services

6.5 Human Genome Sequencing Services

6.6 Microbial Genome - based Sequencing Services

6.7 Single Cell Sequencing Services

7 Global Next-Generation Sequencing (NGS) Market, By Type of Sequencing

7.1 Introduction

7.2 CHIP Sequencing

7.3 De Novo Sequencing

7.4 Illumina Sequencing

7.5 Methyl Sequencing

7.6 Pre-Sequencing

7.7 RNA Sequencing

7.8 Targeted Sequencing & Resequencing

7.9 Whole Exome Sequencing

7.10 Whole Genome Sequencing

8 Global Next-Generation Sequencing (NGS) Market, By Informatics

8.1 Introduction

8.2 Primary and Secondary Data Analysis Tools

8.3 NGS Informatics Services

8.4 Computing

8.5 Storage

8.6 LIMS (Laboratory Information Management System)

8.7 Biological Interpretation and Reporting Tools

9 Global Next-Generation Sequencing (NGS) Market, By Product

9.1 Introduction

9.2 Reagents & Consumables

9.3 Instruments

9.4 Platforms

9.5 Software

9.6 Services

10 Global Next-Generation Sequencing (NGS) Market, By Technology

10.1 Introduction

10.2 454 Technology

10.3 DNA Nano Ball Sequencing

10.4 Ion Semiconductor Sequencing

10.5 Ion Torrent Sequencing

10.6 Ion Semiconductor Sequencing

10.7 Massively Parallel Signature Sequencing (MPSS)

10.8 Nanopore Sequencing

10.9 Pyrosequencing

10.10 Reversible Terminator Sequencing

10.11 Sequencing by Ligation (SBL)

10.12 Sequencing By Synthesis

10.13 Sequencing by Synthesis (SBS)

10.14 Single Molecule Real Time (SMRT) Sequencing

10.15 Single-Molecule Real-Time Sequencing

10.16 Supported Oligonucleotide Ligation and Detection (SOLiD)

11 Global Next-Generation Sequencing (NGS) Market, By Application

11.1 Introduction

11.2 Agrigenomics & Forensics

11.3 Biomarker Discovery and Cancer

11.4 Cardiovascular

11.5 Clinical Investigation

11.6 Consumer Genomics

11.7 Drug Discovery

11.8 Emerging Application

11.9 Forensics

11.20 Genetic Analysis

11.21 Hereditary Disease Detection

11.22 HLA Typing/Immune System Monitoring

11.23 Human Leukocyte Antigen (HLA) Testing

11.24 Infectious Disease Diagnostics

11.25 Life Science

11.26 Metagenomics, Epidemiology & Drug Development

11.27 Oncology

11.28 Pharmaceuticals

11.29 Precision Medicine

11.30 Reproductive Health

12 Global Next-Generation Sequencing (NGS) Market, By End User

12.1 Introduction

12.2 Academic Institutes & Research Centers

12.3 Agriculture and Animal Research

Read more:
Global Next-Generation Sequencing (NGS) Market Report 2019 - World Market Projected to Surpass $25 Billion by 2026, Rising at a CAGR of 20.6% -...

Read More...

Bankrupt biopharmas are rare. 2019 has some worried that’s changing. – BioPharma Dive

November 21st, 2019 2:43 pm

Editors note: This is part of a series about bankruptcy in the biopharma industry. Click here to see a running list of 2019 biopharma bankruptcies, and click here to see 31 biopharmas at high risk of bankruptcy for 2020.

Six years ago, Bind Therapeutics was flying high, with little idea how hard it would soon crash.

Headed into a public stock offering in 2013, the biotech, founded by top MIT and Harvard researchers, generated buzz with its lofty scientific ambitions. Company executives believed its nanomedicine platform, while only through Phase 1 tests, represented the next advance in cancer therapies.

Those dreams came undone within three years. As its experimental therapies struggled in clinical testing, Bind was punished by the market, and debt repayments forced the company into bankruptcy in 2016.

Bind may be a cautionary story in todays life sciences ecosystem, one that features biotechs going public at earlier stages and with heightened ambitions.

While bankruptcy is a rare outcome for biopharmas, 2019 has bucked that trend with an uptick in Chapter 11 filings. Eleven companies have declared bankruptcy so far this year, compared to an average of four per year during the past decade, according to a review of data tracked by the firm BankruptcyData.

That increase may forewarn of more companies falling to zero, industry experts said in interviews with BioPharma Dive, especially at a time of rising legal and political headwinds for the sector. After a decade of booming growth, the ballooning ranks of newly public biotechs may struggle to withstand market pressures.

I think theres a turning point now, said Andrew Hirsch, the former CEO of Bind, in an interview. I think its not sustainable.

Hirsch highlighted the rising prominence of early-stage platform companies, like Bind, going public in greater numbers and at larger valuations. That can bring steeper downside, he warned.

Things arent always going to work the first time, thats just the rule in this industry. A lot of times, companies are valued for perfection, said Hirsch, now Agios Pharmaceuticals chief financial officer.

If they are lucky and it works, thats great. But if you have a setback because youre doing novel things, the public markets can be a cruel place to be.

Biotech vastly outperformed the broader stock market over the past decade, and a steady inflow of capital supported more companies going public at rich valuations.

But those tides have turned. A leading biotech index has fallen more than 15% since peaking in the summer of last year, while the S&P 500 has ticked up nearly 13% in the same timeframe. The capital required for funding biopharmas ambitions is leaving too, with one Wall Street firm calculating $8.7 billion in net capital outflows this year rivaling a stretch in late 2015 and early 2016.

After years of outperformance, biotech has lagged the market for the past year

Price per share of a leading biotech index (XBI) and the S&P 500 (SPX) from January 2018 to October 2019 (indexed)

The base value of the index is trading value on Jan. 2, 2018.

Nami Sumida/BioPharma Dive

Investor anxiety is rising at a time when more companies are fighting for funding than in past decades. Evercore ISI analyst Josh Schimmer said this year hes noticed a marked shift in investor attitudes.

When they stumble, the markets are more unforgiving than ever, Schimmer said in an interview. They arent given second chances the way they used to be given. That may be a factor that does lead to a higher rate of bankruptcies.

And small biotechs arent the only ones facing elevated bankruptcy risk. The weight of thousands of lawsuits related to opioid marketing has already taken down Purdue Pharma and Insys Therapeutics. Several others, like Teva Pharmaceutical, Mallinckrodt and Amneal, are at risk of joining them.

The legal uncertainty has made these companies perceived as uninvestable, SVB Leerink analyst Ami Fadia said in an interview. Additionally, many of these pharmas are highly leveraged and face issues in generating cash going forward, she added.

Its pretty obvious that some of these companies are at high risk of bankruptcy, said Fadia, who covers several of these drugmakers including Mallinckrodt and Amneal.

To be sure, the effect of opioid liabilities is constrained to a comparatively small set of companies. But heading into an election year with drug pricing as a top issue, worries about capital fleeing the industry and a legal crackdown on opioid makers could be exacerbated by political threats as well.

Industry lobbyists have blasted HR3, the leading Democratic drug pricing proposal, saying it would trigger a nuclear winter by eroding the upside of biopharmas high-risk, high-reward investment premise.

If HR3 becomes law, it is lights out for a lot of very small biotech companies that are pre-revenue and depend on attracting capital, PhRMA CEO Stephen Ubl said at a recent media briefing.

Industry-specific concerns, of course, come against the backdrop of fears of a broader economic slowdown. Financial analysts have flagged recession signals in the U.S., which, if materialized, would further squeeze the industry.

It may be coming, in which capital itself is scarcer for companies, said Bob Eisenbach, a lawyer at Cooley specializing in bankruptcies. And when that happens, it puts pressure even on good companies.

Biopharmas are structured to avoid bankruptcies. Pre-revenue companies typically carry little debt and have little to restructure through a bankruptcy court if their pipeline fizzles.

Privately held biotechs that suffer clinical failures can also avoid bankruptcy by having their financial backers buy them out, saving face for those venture capitalists.

It just disappears into this great maw of the biotech universe, said Kevin Kinsella, a venture capitalist and founder of Avalon Ventures, referring to distressed biotechs in an interview.

Having launched more than 100 biopharmas, including prominent names like Vertex, Neurocrine and Onyx, Kinsella said hes been lucky enough to avoid getting entangled in any bankruptcies.

Someone absolutely failing, shutting the doors and turning off the lights, you dont really see that a lot in our industry, he said.

Drug companies, both young and old, derive value from ideas and hope more than tangible assets or resources. Just last year, early-stage platform companies like Moderna Therapeutics and Rubius Therapeutics went public with multi-billion dollar valuations despite lacking profits and significant clinical data.

But investor attitudes appear to have shifted. Rubius stock, for instance, has dropped more than 70% since its IPO. While up this month, shares in Moderna are 30% off their 52-week high in May.

Speaking generally about platform companies, Binds former CEO said market sentiment has turned.

Investors have lost their appetite for companies going public with preclinical data, Hirsch said.

Youre probably going to see more of these situations going forward, where a company is preclinical, went public and is left on their own and has to raise additional money from the public markets and they flounder.

Yet even floundering biotechs can persist for years, even decades. Long-standing industry veterans like Xoma, Novavax and Geron have survived in as-yet fruitless searches for their first drugs, suffering clinical failures along the way. Despite accumulated deficits exceeding $1 billion, these companies can find the necessary capital to keep chugging along.

Theres always someone else whos willing to bet the next discovery is around the corner, or the next asset, or if we get this clinical trial enrolled and finished, all will be good, Kinsella said. Theres always hope.

Besides selling hope, biopharmas, like all businesses, have practical options to stave off bankruptcy. Restructuring and raising cash are the main focuses, turnaround experts said.

Corporate restructurings typically shrink the business, either by laying off employees, selling assets or killing off R&D projects. Raising capital can include licensing rights to experimental therapies, taking on debt or tapping the public markets for secondary stock offerings.

If those options are exhausted, M&A can be another way out for shareholders. Firms like Deerfield Management, Hercules Capital and Highbridge Capital Management often aid distressed biotechs in such endeavours.

Deerfield, for instance, reached deals to finance R&D costs for Dynavax and helped fund Melinta Therapeutics acquisition of an infectious disease business.

A last resort can be merging with another struggling biotech, or becoming the shell in a reverse merger for another company seeking an easy path to a public listing.

Both happened in just the past few weeks. Foamix Pharmaceuticals and Menlo Therapeutics merged into one dermatology company, while NewLink Genetics was the shell through which Lumos Pharma joined public markets.

These strategies act as moats that insulate a high-risk industry from bankruptcy. In recent years, they have worked tremendously well. Among the 333 biopharmas that have gone public since 2012, just 3% filed for bankruptcy while 6% became reverse merger shells and 10% exited via M&A, according to data tracked by Evercore ISI.

But with 2019 looking shaky for biopharma, some have begun to wonder how markets will respond.

The last few years have featured record levels of capital raising, according to the investment bank Jefferies, which tallied 100 initial public offerings and 270 follow-on raises in 2018 and 2019 that drummed up tens of billions in cash.

At the same time, the number of public small and mid-sized biotechs has doubled in the past decade. There arent just more of these smaller firms; they also are worth more and consume more capital on average. From 2010 to present, these companies have seen their typical market values double, R&D budgets triple and cash burn rates quadruple, Jefferies found.

The annual burn rate for these biotechs, which includes market values from $200 million to $5 billion, has increased from $20 million to $80 million. Jefferies analyst Michael Yee credited that to free-flowing capital, more platform companies and an arms race in oncology.

Biotechs impressive market performance has made that possible. A leading biotech index, for instance, outperformed the S&P 500 by 30% since the market bottomed out in March 2009.

But of late, biotech has struggled, creating a tougher environment to raise cash.

The question is whether this is sustainable if market and macro conditions get tougher and political uncertainty gets more obvious, forcing companies to tighten their belts to ride out 2020, Yee wrote.

2019 has brought an uptick in industry bankruptcy filings

Credit: Data from Bankruptcy Data

Conditions have clearly worsened by some metrics, such as the amount of money invested in healthcare- or biotech-dedicated funds. Data tracked by a Piper Jaffray found $8.7 billion in investment has left such funds in 2019. Ten of the past 12 weeks have registered net capital outflows, a streak a Piper Jaffray analyst called seemingly the new normal.

Billions of dollars flowed out of biotech in 2015 and 2016, too, at a time when many biotech shares were falling and the prospect of a Hillary Clinton presidency had raised investor fears on drug pricing.

Biotech weathered that storm, with few companies entering bankruptcy, and has grown since. Going forward, a critical question will be gauging whether the sector is on a new trajectory or if it will emerge from this period relatively unscathed.

Getting investor attention is harder than ever to begin with, said Evercores Schimmer. For a company that has faltered, even if they are doing the right thing, its a struggle.

See the rest here:
Bankrupt biopharmas are rare. 2019 has some worried that's changing. - BioPharma Dive

Read More...

Cell Separation Technology Market Growth Forecast through 2019-2027 with Upcoming Trends and Market Opportunities – Montana Ledger

November 21st, 2019 2:42 pm

Transparency Market Research (TMR)has published a new report on the globalcell separation technology marketfor the forecast period of 20192027. According to the report, the global cell separation technology market was valued at ~US$ 5 Bnin 2018, and is projected to expand at a double-digit CAGR during the forecast period.

Overview

Cell separation, also known as cell sorting or cell isolation, is the process of removing cells from biological samples such as tissue or whole blood. Cell separation is a powerful technology that assists biological research. Rising incidences of chronic illnesses across the globe are likely to boost the development of regenerative medicines or tissue engineering, which further boosts the adoption of cell separation technologies by researchers.

Expansion of the global cell separation technology market is attributed to an increase in technological advancements and surge in investments in research & development, such asstem cellresearch and cancer research. The rising geriatric population is another factor boosting the need for cell separation technologies Moreover, the geriatric population, globally, is more prone to long-term neurological and other chronic illnesses, which, in turn, is driving research to develop treatment for chronic illnesses. Furthermore, increase in the awareness about innovative technologies, such as microfluidics, fluorescent-activated cells sorting, and magnetic activated cells sorting is expected to propel the global cell separation technology market.

Request PDF Brochure of the Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=1925

North America dominated the global cell separation technology market in 2018, and the trend is anticipated to continue during the forecast period. This is attributed to technological advancements in offering cell separation solutions, presence of key players, and increased initiatives by governments for advancing the cell separation process. However, insufficient funding for the development of cell separation technologies is likely to hamper the global cell separation technology market during the forecast period. Asia Pacific is expected to be a highly lucrative market for cell separation technology during the forecast period, owing to improving healthcare infrastructure along with rising investments in research & development in the region.

Rising Incidences of Chronic Diseases, Worldwide, Boosting the Demand for Cell Therapy

Incidences of chronic diseases such as diabetes, obesity, arthritis, cardiac diseases, and cancer are increasing due to sedentary lifestyles, aging population, and increased alcohol consumption and cigarette smoking. According to the World Health Organization (WHO), by 2020, the mortality rate from chronic diseases is expected to reach73%, and in developing counties,70%deaths are estimated to be caused by chronic diseases. Southeast Asia, Eastern Mediterranean, and Africa are expected to be greatly affected by chronic diseases. Thus, the increasing burden of chronic diseases around the world is fuelling the demand for cellular therapies to treat chronic diseases. This, in turn, is driving focus and investments on research to develop effective treatments. Thus, increase in cellular research activities is boosting the global cell separation technology market.

Increase in Geriatric Population Boosting the Demand for Surgeries

The geriatric population is likely to suffer from chronic diseases such as cancer and neurological disorders more than the younger population. Moreover, the geriatric population is increasing at a rapid pace as compared to that of the younger population. Increase in the geriatric population aged above 65 years is projected to drive the incidences of Alzheimers, dementia, cancer, and immune diseases, which, in turn, is anticipated to boost the need for corrective treatment of these disorders. This is estimated to further drive the demand for clinical trials and research that require cell separation products. These factors are likely to boost the global cell separation technology market.

According to the United Nations, the geriatric population aged above 60 is expected to double by 2050 and triple by 2100, an increase from962 millionin 2017 to2.1 billionin 2050 and3.1 billionby 2100.

Productive Partnerships in Microfluidics Likely to Boost the Cell Separation Technology Market

Technological advancements are prompting companies to innovate in microfluidics cell separation technology. Strategic partnerships and collaborations is an ongoing trend, which is boosting the innovation and development of microfluidics-based products. Governments and stakeholders look upon the potential in single cell separation technology and its analysis, which drives them to invest in the development ofmicrofluidics. Companies are striving to build a platform by utilizing their expertise and experience to further offer enhanced solutions to end users.

Stem Cell Research to Account for a Prominent Share

Stem cell is a prominent cell therapy utilized in the development of regenerative medicine, which is employed in the replacement of tissues or organs, rather than treating them. Thus, stem cell accounted for a prominent share of the global market. The geriatric population is likely to increase at a rapid pace as compared to the adult population, by 2030, which is likely to attract the use of stem cell therapy for treatment. Stem cells require considerably higher number of clinical trials, which is likely to drive the demand for cell separation technology, globally. Rising stem cell research is likely to attract government and private funding, which, in turn, is estimated to offer significant opportunity for stem cell therapies.

Biotechnology & Pharmaceuticals Companies to Dominate the Market

The number of biotechnology companies operating across the globe is rising, especially in developing countries. Pharmaceutical companies are likely to use cells separation techniques to develop drugs and continue contributing through innovation. Growing research in stem cell has prompted companies to own large separate units to boost the same. Thus, advancements in developing drugs and treatments, such as CAR-T through cell separation technologies, are likely to drive the segment.

As per research, 449 public biotech companies operate in the U.S., which is expected to boost the biotechnology & pharmaceutical companies segment. In developing countries such as China, China Food and Drug Administration(CFDA) reforms pave the way for innovation to further boost biotechnology & pharmaceutical companies in the country.

Global Cell Separation Technology Market: Prominent Regions

North America to Dominate Global Market, While Asia Pacific to Offer Significant Opportunity

In terms of region, the global cell separation technology market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the global market in 2018, followed by Europe. North America accounted for a major share of the global cell separation technology market in 2018, owing to the development of cell separation advanced technologies, well-defined regulatory framework, and initiatives by governments in the region to further encourage the research industry. The U.S. is a major investor in stem cell research, which accelerates the development of regenerative medicines for the treatment of various long-term illnesses.

The cell separation technology market in Asia Pacific is projected to expand at a high CAGR from 2019 to 2027. This can be attributed to an increase in healthcare expenditure and large patient population, especially in countries such as India and China. Rising medical tourism in the region and technological advancements are likely to drive the cell separation technology market in the region.

Launching Innovative Products, and Acquisitions & Collaborations by Key Players Driving Global Cell Separation Technology Market

The global cell separation technology market is highly competitive in terms of number of players. Key players operating in the global cell separation technology market include Akadeum Life Sciences, STEMCELL Technologies, Inc., BD, Bio-Rad Laboratories, Inc., Miltenyi Biotech, 10X Genomics, Thermo Fisher Scientific, Inc., Zeiss, GE Healthcare Life Sciences, PerkinElmer, Inc., and QIAGEN.

These players have adopted various strategies such as expanding their product portfolios by launching new cell separation kits and devices, and participation in acquisitions, establishing strong distribution networks. Companies are expanding their geographic presence in order sustain in the global cell separation technology market. For instance, in May 2019, Akadeum Life Sciences launched seven new microbubble-based products at a conference. In July 2017, BD received the U.S. FDAs clearance for its BD FACS Lyric flow cytometer system, which is used in the diagnosis of immunological disorders.

Global Cell Separation Technology Market: Segmentation

Cell Separation Technology Market by Technology

Cell Separation Technology Market by Application

Cell Separation Technology Market by End User

Cell Separation Technology Market by Region

Visit link:
Cell Separation Technology Market Growth Forecast through 2019-2027 with Upcoming Trends and Market Opportunities - Montana Ledger

Read More...

Student Health Services offers preventative medical care for Aggies traveling abroad – Texas A&M The Battalion

November 21st, 2019 2:41 pm

Texas A&M Student Health Services offers preventive care to keep traveling students safe from overseas illness, while protecting their classmates from any infectious diseases they could bring back from abroad.

Preventive medicine can immunize a student from a certain disease or infection, and SHS can also provide screenings, examinations and blood work. But it is not only important for students going abroad to keep themselves safe and healthy. Taking these steps can also protect the A&M community at large from any possible diseases that may have been caught overseas and could be brought back to campus.

Claire Kolb, a physician assistant at Beutel Health Center, said SHSs goal is for students to stay well and do well, and preventive medicine does much to keep the campus community safe.

[It] helps to support that mission and increase screening and prevention of disease to keep our students and community healthy, Kolb said. We are able to do that through screening for communicable diseases, providing vaccinations, travel medicine and allergy [immunotherapy] injections.

Holly Hudson, executive director of Education Abroad, said it is not up to the students or the university whether they get any immunizations when studying abroad.

If the [Centers for Disease Control] requires those immunizations, then students actually have to get those in order to obtain a visa or entry into the country where they want to study, Hudson said. In any case where immunizations are required, it is not optional.

For those who study abroad, Hudson said they will be provided with a form of health insurance to be used should they get sick, injured or in any way hurt.

We enroll all our students who are studying abroad in international health insurance, Hudson said. Students are enrolled in insurance that will treat any sort of emergency situation they may have in regards to health. It will cover any medical expenses while abroad and will pay for them to come home should they require additional medical care.

Despite many students going overseas for an extended period of time, Hudson said it is not often that students get severely sick while studying abroad.

Usually, we see injuries the same way that wed see here, like a broken leg, falling or just in the wrong place at the wrong time, Hudson said. Any operational issues we may see, such as a kidney or respiratory infection, are generally treatable wherever they are. Its very rare for a student to get very sick abroad and need to return home as a result of that.

On top of medications and screenings provided for students, Kolb said there are numerous other well-being efforts students can engage in.

[Student Health Services] provides immunizations as needed, Kolb said. We also provide free STI screening at our monthly STI events. We work with our integrated behavioral health providers to assist patients with mental health awareness.

There are also other general health campaigns that SHS holds, Kolb said, which are generally inexpensive and easy to access.

We have a free flu shot campaign in early October to prevent an influenza epidemic on campus, Kolb said. Our immunizations are covered for all students with the TAMU student health insurance, and we offer low cost payment options as well.

See the original post:
Student Health Services offers preventative medical care for Aggies traveling abroad - Texas A&M The Battalion

Read More...

Chronic Inflammation Is a Huge Problem. But This Specialized CBD for Inflammation Can Help. – Futurism

November 21st, 2019 2:41 pm

Inflammation has become one of the biggest buzzwords in health and wellness circles in recent years. And while all the fuss over inflammation it may seem like yet another fad promulgated by television quacks and bloggers, its really not. Many health professionals now believe that understanding and controlling chronic inflammation is the future of preventative medicine. Thats why Mellowment CBD has specifically developed a specific type of CBD for inflammation. Its called Mellowment High Impact for Inflammation, and it combines CBD and curcumin for maximum inflammation relief, recovery, and comfort.

Inflammation is an essential survival mechanism of the human immune system. As such, its usually a good thing, a sign that the body is working to heal an injury or fight off some pathogen or disease. When cells are in distress, they release chemicals that alerts the immune system. The immune system in turn sends inflammatory cells to capture the pathogens or heal damaged tissues. Meanwhile, blood vessels in the area expand to accommodate the additional immune system traffic and bring fluid to the site of the injury or infection. This is called acute inflammation. And while it is painful and uncomfortable, its also necessary.

Unfortunately, for a variety of reasons, sometimes this natural immune system response does not get switched off. Sometimes its because the cause of the initial immune system response cannot be eliminated. Sometimes the immune system simply malfunctions. Either way, the immune system tells white blood cells to attack healthy tissues and organs, resulting in chronic inflammation.

While all adults experience some level of chronic inflammation that slowly wears down our organs and tissues, in some people this chronic inflammation is more extreme. And what scientists have finally realized is that this excessive chronic inflammation causes major damage that contributes to many of the most common degenerative diseases, including coronary artery disease, diabetes, cancer, and Alzheimers.

The good news? Numerous studies suggest that treating chronic inflammation can significantly reduce the risk for these diseases.

That brings us to Mellowment High Impact CBD for Inflammation.

Mellowment has become one of the leading names in CBD over the last few years thanks to their exacting scientific methods and rigorous quality control. With High Impact for Inflammation, theyve combined their proprietary CBD formula with and curcumin, a compound found in the spice turmeric that has been used as an herbal medicine in India for thousands of years.

CBD has long been observed to have anti-inflammatory effects. Now were finally starting to understand why. According to one study, for example, CBD reduces inflammation by modulating the endocannabinoid system and disrupting the production of cytokines, which are proteins secreted by immune cells that trigger inflammation. As for curcumin, modern science has proven it has anti-inflammatory and antioxidant properties, and numerous studies have shown it to be effective in treating inflammation and pain associated with arthritis.

One of the problems in treating inflammation with CBD and curcumin is that both compounds typically have poor bioavailability. That means they are not easily absorbed into your system due to poor absorption, rapid metabolism, and rapid elimination. However, Mellowment has solved the bioavailability problem. By subjecting CBD and curcumin to an advanced nano-emulsification process that shrinks and suspends the active ingredients microscopic droplets of oil which can easily pass through cell walls, Mellowment more than doubles their bioavailability. That means more CBD and curcumin reach systemic circulation, ensuring maximum effectiveness.

Each bottle of Mellowment High-Impact for Inflammation contains 30 softgels, with each softgel containing a 25mg dose of CBD and a 10mg dose of curcumin. Theyre formulated to be taken as needed, and most customers take one to four softgels per day. Mellowments CBD extracts are meticulously engineered from Colorado-grown hemp using an advanced chromatography process that removes all THC, eliminating the risk of failed drug tests and undesired psychoactive effects.

Whether youre looking for natural relief from discomfort caused by acute inflammation, or you want to combat chronic inflammation and reduce your risk for more serious degenerative conditions, Mellowment High Impact for Inflammation could be right for you

This supplement has not been evaluated by the FDA, and is not intended to cure or treat any ailments. Do not take CBD products if you are allergic to any of the ingredients in the product you are consuming. Tell your doctor about all medicines you may be on before consuming CBD to avoid negative reactions. Tell your doctor about all medical conditions. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. Other side effects of CBD include: dry mouth, cloudy thoughts, and wakefulness. You are encouraged to report negative side effects of any drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Continue reading here:
Chronic Inflammation Is a Huge Problem. But This Specialized CBD for Inflammation Can Help. - Futurism

Read More...

Restorative Medicine: IV Therapy in NYC Announces Partnership with Better Health Chiropractic, PC – Press Release – Digital Journal

November 21st, 2019 2:41 pm

Restorative Medicine: IV Therapy, based in New York, NY, has announced a trusted partnership with Better Health Chiropractic, PC. Restorative Medicine: IV Therapy is a provider of IV therapy nutrition New York NY services and was founded by Dr. Vladimir Alexeyenko, M.D. The practice is geared towards serving the needs of those who want a way to counteract the damage that stress and modern living have been causing. Dr. Alexeyenko wants to emphasize that people often work long hours at a desk, eat on the run, have disrupted sleep, and are exposed to environmental toxins. All of that stress can weaken the bodys immune system and make it more difficult to fight off disease.

Dr. Vladimir Alexeyenko says, We offer vitamin infusions, hydration IV therapy treatments, and other IV therapy solutions that will energize you and restore your body and mind. Our bodies need fuel, not just any fuel, but the right mix of vitamins, minerals, water, and hormones. The human form is a complex system that relies on many compounds to get up and go. There is a perfect balance that helps us feel great but, modern life, especially in urban areas, robs us of that balance.

Dr. Vladimir Alexeyenko is a licensed physician who has developed IV infusion therapy using his in-depth knowledge regarding the human body and what it requires to be able to perform at peak efficiency. He wants to point out that he established Restorative Medicine: IV Therapy based on the philosophy that preventing disease is better than cure.

He says, We can prescribe and administer any infusion that can restore your energy, increase your metabolism, rebalance levels of vitamins and minerals, and strengthen your immune system. You will see and feel the results immediately. At Restorative Medicine, your body will regain the ability to heal itself thanks to IV vitamin therapy and other IV drips that will revive your energy, restore cell function as you go back to your vibrant and busy life.

With nutrients, vitamins, minerals, and fluids being essential in helping the body function well and in flushing out toxins, these are provided in IV drips and booster form for preventative medicine. The treatments supervised by Dr. Alexeyenko can help in fighting disease, boosting energy levels, and strengthening the immune system. This allows patients to have more control over their health journey. However, this requires the guidance of an experienced physician like Dr. Alexeyenko.

Dr. Vladimir Alexeyenko also provides IV ozone therapy New York NY services. This is designed to get rid of viruses, toxins and infections from the body. Its purpose is to oxygenate the blood to create an aerobic environment, which is hostile to microbes that thrive on anaerobic metabolism. It should be noted that while ozone can be dangerous when inhaled, it is not harmful in the bloodstream. Ozone therapy may be used by people who frequently travel and breath recycled air. It may also help during the flu season as it may be able to boost the bodys immune system.

According to Dr. Alexeyenko, IV therapy may be able to provide long lasting vitality and bring back systemic balance to the human body. IV therapy has an advantage over supplements or pills because the latter are taken orally and are diluted during digestion. On the other hand, IV therapy allows the nutrients, vitamins and minerals to their work at the cellular level.

Dr. Vladimir Alexeyenko has been practicing medicine for more than 25 years. He has always sought to be up-to-date regarding the study and use of restorative, holistic treatments. He also prescribes modern medical treatments but his long term goal is to guide his patients into the use of conventional and integrative practices and treatments designed to prevent ill health.

Those interested in IV therapy NYC services can visit the Restorative Medicine: IV Therapy website or contact them on the phone or through email. They are open from Monday to Friday, 9:00 am to 6:00 pm. Saturdays and Sundays are by appointment only.

###

For more information about Restorative Medicine: IV Therapy, contact the company here:

Restorative Medicine: IV TherapyDr. Vladimir Alexeyenko(917) 994-9390doctor@vladimiralexeyenkomd.comRestorative Medicine: IV Therapy2 W 46th St Ste 806, Rm2New York, NY 10036

Read the original:
Restorative Medicine: IV Therapy in NYC Announces Partnership with Better Health Chiropractic, PC - Press Release - Digital Journal

Read More...

A guide to CBD topicals, balms, and lotions – Leafly

November 21st, 2019 2:41 pm

Rae LlandNovember 18, 2019

(Irina_Strelnikova/iStock)

CBD, or cannabidiol, is a compound produced by cannabis and hemp plants. Unlike THC, CBD doesnt produce a feeling of being high.

CBD topicals such as lotions, balms, gels, or creams are infused with CBD to produce skin-friendly products that contain the medicinal properties of CBD. In topical form, CBD is most popularly used for managing pain and inflammation.

CBD topicals penetrate the skin to provide targeted relief, without entering the bloodstream. This makes them a fantastic choice for anyone who wants to focus the healing properties in specific problem areas rather than feel the effects throughout their body. CBD topicals can potentially provide relief for a variety of pain, headache, and skin issues such as:

Lo Friesen, lead chemist for cannabis wellness company Heylo, believes CBD topicals are also a fantastic preventative medicine. She says using these topicals every day, multiple times a day allows the body to not only uptake CBD quicker, but also build a CBD level in those areas and prevent worsening inflammation.

Its just preventative maintenance, says Friesen. For example, people who have arthritis in their hands who use [CBD topicals] on their hands every day are going to have less pain, less inflammation. Theyre going to have less pain in their hands over time than people who use it to treat [the pain as it happens].

Some CBD topicals may have bases such as shea butter, or oils like coconut, avocado, jojoba, or vitamin E. These nourishing ingredients are great for the skin, providing added benefit to the medicinal properties of CBD. Its also possible to find more traditional lotions with CBD or products with an Aquaphor base.

While lotions will be water based, creams usually have a fat or oil base, and balms a thicker base such as beeswax. Water-based lotions absorb more quickly into the skin, but oil based CBD topicals are more easily absorbed and get into the skin deeper. Meanwhile, gels can be useful for easier thicker application, making them possibly preferable for those with reduced hand dexterity, such as arthritis patients.

At the end of the day however, Friesen says, Just take your favorite skin care product and find something with similar ingredients, add CBD, and youve already made it better.

Unfortunately, due to an oversaturated market and lack of regulation, not all CBD topicals will produce the desired results. CBD can be sourced from either hemp or traditional cannabis, but their resulting extracts typically have quite a few differences in terms of the diversity of compounds found within them.

CBD extracts from cannabis tend to include a wide diversity of helpful compounds whereas hemps chemical diversity is more limited. Youll also want to make sure that a hemp-derived product actually contains CBDhemp seeds or stalk dont produce CBD, so its important to understand which part of the hemp plant was used in the extraction process.

Whats more, some products claim to have an abundance of CBD in them, but the reality doesnt always match the label. So how can consumers make sure they are getting a quality product?

Dr. Jeremy Riggle, chief scientist with cannabis wellness company Marys Medicinals weighed in:

Not all CBD products are created equal, and consumers should do their research. Ask questionswhat type of CBD extract does it contain: full spectrum, broad spectrum, or isolate? Where is the raw material sourced from? Does the producer use organic and sustainable agricultural practices? Does the supplier have a Certificate of Analysis showing test results for pesticides, heavy metals, residual solvents, microbials, cannabinoid potency, and terpene profile?

Finally, its worth noting that milligram content can make a difference, and with CBD, higher is generally better. Friesen says you get what you pay for, but that this is also why some make the switch over to CBD:THC topical products. Friesen believes these 1:1 or 1:3 ratio products are more effective than CBD on its own, due to the cannabinoids tendency to amplify each others effects. As such, patients may be able to use less to achieve similar effects, than they would with a CBD only product, and save money in the process.

All in all, there are plenty of great topical CBD products on the market for those who want to try a targeted method of delivering these helpful cannabinoids to problem areas and add CBD to their wellness routine.

Rae Lland is a freelance writer, journalist, and former editor for Weedist and The Leaf Online. With a focus on culture, music, health, and wellness, in addition to her work for Leafly, she has also been featured in numerous online cannabis publications as well as print editions of Cannabis Now Magazine. Follow her on Instagram @rae.lland

By submitting this form, you will be subscribed to news and promotional emails from Leafly and you agree to Leafly's Terms of Service and Privacy Policy. You can unsubscribe from Leafly email messages anytime.

More:
A guide to CBD topicals, balms, and lotions - Leafly

Read More...

Beefing Up the East End’s Substance Abuse Treatment – East End Beacon

November 21st, 2019 2:41 pm

When Quannacut Outpatient Services substance abuse treatment center was preparing to move into its new facility across Riverhead in July, a rumor quickly spread through patients that it may be closing. But that rumor was quickly replaced with the real news, which is quite good: Not only has the facility tripled in size in its new location, but it is now better able to accommodate its mission to treat not only substance abuse, but also mental and physical health needs that are often unavailable to people in substance abuse treatment.

Stony Brook Eastern Long Island Hospital and Quannacut held a ribbon-cutting celebrating the opening of the new 1,400-square-foot offices at 905 East Main Street in Riverhead on Nov. 20, and theyre planning to open another satellite outpatient center at 291 Hampton Road in Southampton this month, which will fill a gap in outpatient substance abuse treatment on the South Fork.

The expansion was made possible by a $1.6 million grant received in 2017 from the New York State Department of Healths Statewide Health Care Facility Transformation Program. A goal of this program is to make it easier for people, especially those with Medicaid, to receive preventative medical services, in an effort to reduce emergency room visits for non-emergencies.

The new Quannacut outpatient center in Riverhead has three medical examination rooms, and is in the process of hiring medical staff under the guidance of Medical Director Dr. Jarid Pachter, said Quannacut Outpatient Services Director David Cohen on a mid-November tour of the facility. He said some of the top medical needs among patients there are infectious diseases, often related to substance use, and basic primary care needs, often longstanding chronic conditions that have gone untreated.

Theres a general rule of thumb, he said, that about 1/3 of people who visit the emergency room also have an untreated behavioral health need, while 1/3 of the people in Quannacuts program also come in with untreated medical needs.

Stony Brook Eastern Long Island Hospital, which is in Greenport, opened Quannacut as an inpatient rehabilitation program in 1989, expanding with an outpatient program that moved from Mattituck to Harrison Avenue in Riverhead in 2001. Quannacut is a Native American word that means hope.

Mr. Cohen said that, when he arrived shortly after that, the outpatient program was seeing around 70 patients at a given time. Now, he said, they have about 300 active patients, and accept walk-in patients on Mondays and Fridays from 9 a.m. to noon.

This new integration of medical and psychiatric services builds on strengths already existing within ELIH and Stony Brook University Hospital.

ELIH has long had the only inpatient psychiatric facility on the East End, and the hospitals recent affiliation with Stony Brook University Hospital, which has a psychiatric emergency room, is designed to integrate mental health and substance abuse treatment throughout the continuum of care.

This is a sea change for health care, where traditionally medical, psychiatric and substance abuse professionals had worked in separate silos. Mr. Cohen said some medical and substance abuse practices dont want to deal with people with certain mental health issues or medications, he said, in part become some psychiatric medications are addictive.

Were experts here on co-occurring conditions, he said. Our staff is heavily trained. Not one thing works best for each individual.

Dr. Richard Rosenthal, director of the Division of Addiction Psychiatry at Stony Brook University, said the addition of Quannacuts services to the Stony Brook network is part of a larger endeavor integrating addiction, mental health and primary care.

Substance use disorders are classified as psychiatric disorders, but they are overseen by different regulatory agencies, said Dr. Rosenthal. The truth is a continuum is the rule rather than the exclusion.

Dr. Rosenthal added that, as part of this integration of care, the Stony Brook University Hospital network is training doctors to administer buprenorphine shots in the emergency rooms in Southampton and Greenport.

Buprenorphine has not gotten as much public attention as naloxone, better known as Narcan, an immediate opioid antidote carried by first responders to revive people from opioid overdoses. But once they survive an overdose, opioid users who want to quit will need a way to manage their withdrawal symptoms. Thats where buprenorphine, a medically administered opioid used to treat withdrawal, comes in.

Dr. Rosenthal said Dr. Kenneth Kaushansky, the dean of the Universitys Renaissance School of Medicine, has fully backed training Stony Brook doctors to administer buprenorphine, which has historically had a difficult time gaining traction with medical doctors.

To prescribe buprenorphine, you need to be trained, and its substantive training, said Dr. Rosenthal. Patients come in and agree to go into treatment, theyre given a couple doses, which they complete at home, and they get a referral and connection to outpatient treatment. They may need to stay overnight.

Its very safe, and its really no big deal, he said, adding that 130 Stony Brook doctors have been trained to administer buprenorphine. The patient feels better. It protects them from the nods and it medically stabilizes them. Its a lifesaver.

Dr. Rosenthal added that the way doctors are trained also plays a role in alleviating the opioid crisis.

Were training doctors differently regarding pain, he said. Thats a big, big shift in terms of what we were doing even five years ago.

Even primary care doctors operating in practices affiliated with Stony Brook are now giving patients screening questionnaires for substance abuse and mental health issues as soon as they walk in for routine medical appointments.

Doctors are practical people. They believe the same thing regular people do, said Dr. Rosenthal. Theres a culture change. We want to know if people are thinking of self-harm. We need to do a better job helping people when they feel desperate and hopeless.

Despite the major leap the new facility is bringing to Quannacut, the staff there arent resting on their laurels. They are currently working on an adolescent program, and they run two sober houses within 15 minutes of the Riverhead center.

But those houses, which have just 18 beds, all for male residents, are just a drop in the bucket compared with the need. Quannacut would ultimately like to add a female sober house as well.

Housing is the number one thing that undermines treatment, said Mr. Cohen. A lot of people we see are one step away from homelessness. Our houses are always filled, and theres always a waiting list.

Related

Here is the original post:
Beefing Up the East End's Substance Abuse Treatment - East End Beacon

Read More...

ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational bNAb with potential for long-acting…

November 21st, 2019 2:41 pm

LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the company will be developing the investigational broadly neutralising antibody (bNAb) N6LS for the treatment and prevention of HIV-1, as part of an exclusive licensing agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Broadly neutralising antibodies are antibodies that can recognise and block the entry of different strains of HIV into healthy cells. N6LS is an antiviral bNAb that works by binding to a specific site (gp120) on the surface of HIV that prevents its entry into uninfected immune system cells (CD4+ T-cells). By blocking HIVs entry into human CD4+ cells, HIV replication is halted, and the HIV transmission process may be prevented.1

Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: We are excited to advance N6LS from its current proof of concept stage to the next step in its development by studying this bNAb as a long-acting medicine that could potentially be used for both treatment and prevention of HIV. By continuing to research new ways that people living with HIV can reach undetectable viral loads, we build on our ten-year history of furthering innovative science in HIV and take another important step forward in ending the epidemic.

ViiV Healthcare looks forward to initiating a phase IIa study with material manufactured by the NIAID Vaccine Research Center that will evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of N6LS in adults living with HIV.

Additional details about N6LSN6LS was originally discovered and developed by scientists at NIAIDs Laboratory of Immunoregulation and VRC. NIH and GSK entered into a Cooperative Research and Development Agreement (CRADA) to jointly identify and further develop new bNAbs such as N6LS that could serve as the next generation of treatment regimens for people living with HIV and preventative options for HIV transmission. This exclusive license outlines a programme for ViiV Healthcares development of N6LS as well as milestone payments and royalties to the NIAID.

About ViiV HealthcareViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The companys aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline and commitment, please visit http://www.viivhealthcare.com.

About GSKGSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com.

_____________________1 Kumar R, Qureshi H, Deshpande S, Bhattacharya J. Broadly neutralizing antibodies in HIV-1 treatment and prevention. Ther Adv Vaccines Immunother. 2018;6(4):6168.

Continue reading here:
ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational bNAb with potential for long-acting...

Read More...

Regenerative Medicine: Overcoming The Supply Chain Challenges – Contract Pharma

November 21st, 2019 2:41 pm

Regenerative medicine is one of modern sciences most exciting developments. Defined by the Medical Research Council, regenerative medicine is an interdisciplinary field that seeks to develop the science and tools that can help repair or replace damaged or diseased human cells or tissues to restore normal function.

In the human body, the liver is the only organ capable of regenerating itself spontaneouslyeven after serious injurybut in the future, any part of the human body may be capable of doing so. Our own cells will also be able to treat and cure diseases and conditions of the blood and immune system, as well as restore the blood system after treatments for specific cancers.

Once only imaginable in science fiction, the latest applications include engineered skin tissue to treat burn victims, custom-grown bones for implants and joint replacements, personalized dietary treatments using gut bacteria and just recently, the worlds first 3D vascularized engineered heart was created using a patients own cells and biological materials.

As scientists understanding and the tools at their disposal become more advanced, the closer to the widespread commercialization of regenerative medicine the pharmaceutical industry finds itself.However, offering regenerative medicine therapies at scale requires one of the biggest shake-ups to the global pharmaceutical supply chain ever seen. Without it, the world risks missing out on the curative promises of this next-generation medical technology.

Regenerative medicine is one of, if not the most, exciting advancements in modern science which has far-reaching benefits for big pharma, healthcare systems and patient outcomes.

Regenerative medicine is a growth industry in more than one sense of the word; as a sector, its growing from strength to strength. In fact, last year the global regenerative medicine market was worth $28 billion and its expected to grow to $81 billion by 2023.

As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, established pharma companies alongside small biotech start-ups are racing to discover and bring to market medicine-based approaches that stimulate the bodys natural ability to repair itself.The cutting-edge innovations of regenerative medicine generally fall into three distinct categories:

Replenish Replace Rejuvenate

Stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system, replenishing the body. Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of aging are being better understood and delayed by using stem cells to rejuvenate the body.

Marking a new era in healthcare and one which has the promise of addressing the needs of an aging population challenged by escalating chronic diseases, regenerative medicine is certainly a game-changer. Beyond more effective medical treatments that can be applied routinely despite age, comorbidities, or disease severity, it also has the potential to cure many of todays incurable diseases and support healthcare systems to move towards a preventative model.

Today, regenerative medicine is largely confined to a research environment. In fact, according to a recent report, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.

Regenerative medicine is poised to transform healthcare as we know it, offering potential cures for deadly diseases which before would require long-term treatment to manage. However, while billions are being spent on regenerative medicine research and clinical studies, little resource has, so far, been allocated to the management and delivery of innovative medical therapies at scale.

Currently, the race appears to be on between smaller Medtech companies and large multi-national pharmaceutical companies to see who wins first-mover advantage in the regenerative medicine market. Today, many established pharmaceutical companies prefer to partner with Medtech startups to in-license products in early clinical development stages as opposed to conducting early development on their own which comes at a huge cost. This is a risk-reduction tactic, but it could mean big pharma misses the boat.

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where Medtech companieswho are in some instances one step ahead of big pharma in terms of drug developmentare happy to be a third-party provider to big pharma who have the budgets and networks to truly deliver the regenerative medicine revolution.

Regulation is, and will continue to, play a hugely important role in delivering regenerative medicines from a lab setting to a clinical setting. Only recently, the FDA announced a new policy framework for the development of regenerative medicine products, taking into account the dynamic and fast-moving nature of the field.

Ultimately, the governments aim is to protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies according to Former FDA Commissioner Dr. Scott Gottlieb. The FDA plans to achieve this over the coming years by driving stakeholder engagement with the developing regulatory framework in order to efficiently advance access to safe and effective regenerative medicine advanced therapies.

However, so far, progress by the pharma industry in coming into compliance with FDAs regulations for regenerative medicines has been slow, despite the grace period set by the FDA before it fully exercises enforcement fast approaching (ending in November 2020).

In order to speed up the process of bringing novel medicines to market, the FDA is toying with the idea of fast-tracking products that are deemed low risk to patients if sponsors have engaged with the regulatory process and demonstrated responsibility by filing Investigational New Drug Applications (INDs).

The FDA has also promised to strengthen its enforcement action against drug developers who are marketing unapproved products, prioritizing cases where the threat to patient health and safety is largest.For example, last November the FDA stepped in where a Californian business was selling stem cell products using umbilical cord blood for the treatment of arthritis and other conditions, despite this form of treatment not having FDA approval for that particular use. Several patients (at least 12) undergoing this treatment were hospitalized after developing infections of the bloodstream and joints, as well as abscesses along the spine and skull.

In summary, one of the FDAs central aims over the coming years is to drive stakeholder engagement with the developing regulatory framework for regenerative medicine advanced therapies in order to efficiently advance access to safe and effective new products.

The promise of regenerative medicine requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent. As such, information about supply chain management needs to be submitted to the regulator after the completion of phase three clinical trials, including packaging, labeling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine. Thats because, unlike many mass-market drugs, regenerative medicine is either personalized or matched to a unique donor-recipient.

The distribution of regenerative medicine therapies is further complicated by the fact they are also extremely sensitive to exogenous factors like time and temperature. Therefore, there are strict conditions under which these therapies must be transported and received.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability across the pharma supply chain. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible and avoid costly wastage.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours, making distribution a complex task. Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain time periods and temperatures, according to different cell and tissue requirements which can vary from product to product.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapor phase nitrogen, however, many clinical settings remain ill-equipped to handle such equipment.

Onsite production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells. However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a licensed clean room which may not be possible given budget restrictions and limited space onsite.As a first-generation technology, stakeholders will have a greater tolerance for higher pricing, but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time. Just like big data and artificial intelligence is transforming the practice of medicine, regenerative medicine holds the promise of extending the bodys natural ability to replenish, replace and rejuvenate itself.

If the global health industry can work collaboratively on overcoming the challenges presented by delivering safe and effective advanced therapies, a dramatic extension of the human healthspan is possible. We may even reach the point where no disease is considered incurable, transforming healthcare as we know it.

Read this article:
Regenerative Medicine: Overcoming The Supply Chain Challenges - Contract Pharma

Read More...

The Opioid Epidemic: Past and Future – Psychology Today

November 21st, 2019 2:41 pm

When I said goodbye to Dylan on November 21st, 2013, I did not think itwould bethe last time I would see him. He left me smiling, on his way to visit a friend in Long Beachfor the night.That evening, at the young age of 26, Dylan was found deceased. His cause of death was an accidental overdose on Oxycodone.

Dylan was one of over 16,000 Americans who died in prescription painkiller related deaths in 2013 (in 2017 it was 47,600).The current opioid epidemic is unprecedented. Reports state that more than 130 people die from opioid-related drug overdoses each day, with the economic cost of the opioid crisis estimated to be $504 billion.

While effective analgesics, opioids are highly addictive, and adult patients undergoing surgery who receive an opioid prescription are at an increased risk of misusing and persistently using opioids. Time and time again, America witnesses thesame story:a patient visits a doctorcomplaining about a sudden moderate pain or perhaps a chronic issue; the doctor provides the quickest solution on the market, prescription narcotic painkillers; the patient leaves satisfied and often on their way to a nasty addiction.

But whyis this story becoming more common rather than less, despite increasing awareness of the prevalence of addiction in mainstream American culture? Why havephysicians dishedoutmore of these medications in recent years,rather than refusing to provide them to patients?How and why did opioids transition from being a treatment for end of life illness and postoperative pain relief to a commonly doled out solution to headaches and back pains? Theory suggests, and research confirms, that doctors were influenced by pressure from two angles: that of the manufacturers and of the patients.

The irony is that prescription narcotics do not fit their new purpose. According to Dr. Andrew Kolodny, president of the Physicians for Responsible Opioid Prescribing, controlled narcotics such as Hydrocodone and Oxycodone are actually ineffective in treating long-term pain.However, in a culture of fast food, instant messaging, and quick results, Americans seeking pain relief are not as concerned with the long-term solution.

A lot of societys trust goes into the capabilities of modern medicine, and while the rise of prescription opioids was strongly driven by manufacturers and pharmaceutical companies, patients welcomed it.And when the patients have a demand, the pressure to fulfill these needs falls on the doctors. As Celine Gounder, physician, public-health specialist, and medical journalist wrote in the New Yorker, The promise of a set of medicines that could cure pain was appealing to many patientsand, with a customer-is-always-right mentality having pervaded the doctors office, patients were able to pressure physicians to satisfy their requests for the pain pills theyd begun hearing about. Gounder explains the difficulties for a doctor to deny the requests of their patients and send them out of their visit dissatisfied. Doctors have a hard time saying no, whether a patient is asking for a narcotic to relieve pain or an antibiotic for the common cold. We are predisposed to say yes, even if we know it isnt right.

Whats worse is the consistent consumption of drugs like Hydrocodone and Oxycodone leads to increased tolerance and a condition called hyperalgesia, which is the increased sensitivity to pain after long term intake of pain medication.These consequences, in turn, require more pain medication for the patient and dependency develops before the drugs were ever technically abused.

With such a gradual progression to reliance on drugslabeled as legal and supplied in unnecessarily high quantities by an authority figure in a lab coat, patients and drug seekers do not fear the consequences of addiction or overdose. It is difficult to believe that the doctors we trust and depend on would put us at risk with the frequency and justification of prescription, the amount of opioids per prescription, and the number of refills on each prescription. The reality is that pain medication is not meant for long term use and the amount of pain after an operation should only last up to one weekHowever, theres not enough awareness about how serious this crisis is, Kolodny said. I dont think enough doctors know that these painkiller medicines dont work for chronic pain.

The pharmaceutical companies, from the start of this painkiller epidemic,capitalized on their ability to keep doctors misinformed. Big drug manufacturers recruited attractive marketers to convince physicians that their drug was the best painkiller on the market. We had cheerleaders from Big Ten schools, with no medical background or knowledge, put into a boot camp to learn the workings of the pharmaceutical industry, the doctor they will be selling to, and the benefits of their drug. It is these businessmen and women that are going into our doctors offices and selling our health care providers on what will be best for us, our family, our friends, and our loved ones.And doctors have been temporarily pleased when their patients reportless pain, considering their job well done.

Unfortunately, once a doctor has begun prescribing these medications to the patients, it is difficult for them and their successors to cease providing these drugs. Taking that stand would lead to unhappy and dissatisfied patients, and the potential accusations against the doctors of malpractice. There are also the doctors who just dont want to take the extra time during a busy day to explain why that prescription for a narcotic isnt a good idea and those who use the promise of prescription narcotics to persuade patients to keep their medical appointments, or to take their other medications, writes Gounder.Dr. Sanjay Gupta expressed similar concerns in hisCNN article:It is easier for a doctor to write a prescription than to explore other effective options to combat pain, and it is easier for patients to take those prescription pills than to search for alternatives themselves. Both those things must absolutely change."

So how can the methodology of doctors treating pain be improved? Just as important, how can the patients understanding of a doctors decision to deny narcotics in certain circumstances be improved? The work must be done on multiple levels.Primarily, between the physicians and the FDA, there needs to be a relabeling of painkillers. Currently, the labeling on narcotics has no suggested maximum dose or duration of use by the FDA. Kolodny describes this as being very broad. He insists thatthe way to turn this epidemic around is for doctors to prescribe painkillers more cautiously." And according to Kolodny, the FDA must change the labeling requirements on prescription painkillers so that it is easier for medical schools and the larger medical community to prescribe these meds more cautiously."

The next step would be providing education to healthcare providers from sources other than the pharmaceutical companies. While doctors, for the most part, have good intentions when prescribing medication, they receive no more than a week's worth of education on pain and pain management. Education on addiction, predispositions to addiction, and abuse of medication could help doctors better identify at-risk patients and take preventative measures or connect those suffering to treatment.

As patients of our doctors and consumers of the pharmaceutical industrys products,we must also take some action. With the knowledge that these medications could lead to negative consequences, we have the choice to seek other forms of pain management. Further, there are DNA tests available to see if you are predisposed to addiction. As a society, it is important that we know our own bodies and takesteps to put an end to this pill epidemic.

Dylans death isjust one of the countless lives lost. When we receive a prescription, we never think it could change our lives or the lives of others. Dylan did not get his first pain killer prescription with the intention to abuse the medication. However, as the refills were readily available, so was the opportunity to develop what turned out to be adeadlydependency. In a society where we are addicted to relief, a small prescription needs a big warning.

This blog has been written by Dina Khoury and Dr. Zeev Kain. Khouryisa medical student who is planning a career in psychiatry,UC Irvine School of Medicine.

Read more:
The Opioid Epidemic: Past and Future - Psychology Today

Read More...

Smart toilets could turn your pee into research gold – Mashable

November 21st, 2019 2:41 pm

Pee could be a health goldmine. And to make the most of it, the world needs smart toilets.

That's what a new, small-scale study published in Nature this month seeks to establish: whether regular urine collection and analysis of the thousands of telling, changing indicators in our pee can reliably serve up information about a person's health.

The study's University of Wisconsin authors, Dr. Joshua Coon and Dr. Ian Miller, say more research is still needed as the 10-day experiment only had two subjects: Coon and Miller themselves. However, they also think that a non-invasive device that could collect and analyze a person's urine like, say, a smart toilet could work as a revolutionary tool for personalized, predictive health care.

Oh, and wouldn't you know it, they're making one such smart toilet themselves. But they're not the only ones.

How Coon and Miller envision the smart toilet of the future.

Image: Dasom (Somi) Hwang

Recently, health-tech companies and even big tech players like Apple and Google have gotten into the business of harvesting health data, mostly from AI assistants, fitness trackers, smartwatches and even the smartphone in your hand. The current drumbeat in healthcare is that big data will be able to help us monitor our health in real time, as well as predict disease and health trends at a societal level in the future. And in this coming era of data-driven medicine, the study's authors think that urine is an untapped resource.

Coon and Miller research metabolic systems at the University of Wisconsin and Morgridge Institute for Research (with work partially funded by the National Institute for General Medical Sciences). They analyze the molecules that reflect what our body has metabolized (called "metabolites"), whether that's something we ingest, or is the consequence of an internal bodily process.

Researchers have already established that there are thousands of metabolites in urine, with many of them linked to our own habits like smoking, drinking, sleep, exercise, and even disease. As our habits change, so do the levels of these metabolites.

"There aren't that many bodily fluids that you can get access to that have a window into health," Dr. Michael Snyder, a Stanford University professor who studies biomedical data for healthcare, and is not involved in the study, said. "Urine is just one of those that it makes sense to be monitoring."

The theory is that, on an individual level, regularly keeping track of your urine could give you information you can act on. For example, it could eventually tell if you have a urinary tract infection brewing before you even display symptoms, or if you're getting enough exercise, drinking too much alcohol, or are registering inflammation that could cause disease down the line.

It could also serve as a compliment to the sort of digital healthcare many people are already doing, such as monitoring heartbeats with Apple Watches. Coon says that analyzing urine for lifestyle information could give a person a fuller vision of the why behind having heart troubles something an Apple Watch alone can't do.

Your pee could turn out to be somewhat of a "fingerprint."

Even beyond what this data can tell about an individual, Coon says we don't yet know what a large batch of this data from many people could tell us about disease outbreak, or other types of medical predictions down the line.

To tap into this potential, Coon and Miller tried to see if they could measure how information in urine corresponds with lifestyle choices, such as sleep or alcohol consumption. By keeping track of their habits, they were able to establish that specific metabolites do fluctuate based on lifestyle.

Your pee could also turn out to be somewhat of a "fingerprint." The metabolic makeup of our urine varies from person to person it looked different even just between the study's two subjects! Knowing a person's "baseline" levels could make personalized healthcare more precise. For example, if a person's baseline changes, Miller says that that could serve as a warning sign, enabling "preventative treatment, instead of dealing with symptoms as they show up."

Regularly comparing that baseline to changes is what particularly intrigues Snyder.

"This frequent measurement lets you really follow changes in [a person's] health state, and that's rarely done in medicine," Snyder said. "Knowing your own personal health state is very, very important. And then finding shifts from that is the key to early detection of disease long before it's symptomatic."

The study presented a third finding: Collecting pee is not only time-consuming and resource-intensive it's annoying. Which is why they say the technology needs to catch up.

"It turns out its not convenient to collect every urine sample you make we found that out," Coon said. "But if you had a toilet that did that for you, that would make a difference."

Coon's research group is working on a smart toilet that does just that. They say they will have a prototype to demonstrate their ideas in Spring 2020, though they declined to share any preliminary images with Mashable. After that, it will be about getting funding, conducting clinical trials, and bringing it to market. It may sound like a long way off, but their vision is clear.

"The device that we are working toward is just the toilet," Coon said. "It looks like a toilet, and it samples [urine] without you having to do anything. That is a way I think to be able to acquire data that will be helpful to people."

Coons' device would sample urine every time an individual uses the toilet, and has a built-in lab tool (called a mass spectrometer) to measure samples. That reading would go to a patient's smartphone, where they could monitor their health in real time, or even send that info to doctors, or healthcare analysis companies.

An early model of Toto's discontinued smart toilet.

Image: YOSHIKAZU TSUNO / AFP via Getty Images

Another company, Toto, built a smart toilet in the early 2000s that would allegedly "analyze sugar levels in urine, check blood pressure, body weight and even measure body temperature and hormone balance." However, Toto discontinued it, owing to low demand.

Other companies including Panasonic and even Google have made moves to develop smart toilets. But they were all limited in function, collecting measurements like blood pressure, body fat, and blood in the urine. Coon sees his device as more far-reaching, with consequences for both the individual and society.

"The fascinating thing for me about this is that there are so many possibilities that one could imagine," Coon said. "It really comes down to if one could build this device, and make these measurements on a large population, it would really, we think, open the doors to changing how we think about tracking health and lifestyle."

Is Coon's vision for his smart toilet realistic?

While Snyder agrees with the theory that regularly monitoring metabolites in urine can deliver health insights, he is skeptical that Coon's 10-day, two-person study lays sufficient groundwork.

"I think we need larger studies to demonstrate utility," Snyder said. "I don't doubt in the long run they will be useful. The question is just how quickly, and I don't know the answer to that."

Other experts (and competitors) are even less gung-ho.

"I just dont think its very practical," Vik Kashyap, the founder of human waste analysis company Toi Labs, said. "They're exploring interesting things, but I dont know if theyre ever going to make their way into the real world."

At Toi Labs, Kashyap and his team have been studying the best way to bring health tech into the bathroom for years. His company is currently conducting clinical trials for their own smart toilet product, True Loo. It uses AI to analyze pictures of stool and urine for health insights (what your poo looks like can apparently tell you a lot about your health!). Kashyap said that the choice to use photography instead of the "mass spectrometer" lab tools like Coon was intentional because he says that the tools and science Coon is relying upon have some major flaws in a commercial setting.

"Weve been working on a smart toilet for more than a couple decades combined," Kashyap said. "For this kind of approach to reach the market, it would be a very slim chance."

Kashyap views mass spectrometers as large, expensive tools that work in the lab, "but don't necessarily work in an everyday toilet environment."

Kashyap is also not sold on Coon's science. He says that mass spectrometers are good at looking for specific things, like in drug testing. But does not believe they are proven as well as they need to be for a true at-home smart toilet.

Other competitors and experts share that skepticism. Raja Dhir, the co-founderand co-CEO of microbiome research company Seed Health, doesn't see the potential for urine testing without also testing blood and poop.

"The concept of continuous measurement of biological data is intriguing," Dhir told Mashable. However, he's not convinced that people will actually get much use of out of it in the real world.

Still, Coon, Miller, and even Snyder are optimistic that, with enough study, time, and investment they can prevent the future of healthcare from just being flushed down the drain.

"Ive been saying that someday, we need a smart toilet," Snyder said. "I think the day is here."

Here is the original post:
Smart toilets could turn your pee into research gold - Mashable

Read More...

Breaking Down The Invitae Short (Podcast Transcript) – Seeking Alpha

November 21st, 2019 2:41 pm

Editors' Note: This is the transcript of the podcast we published last week on Invitae (NYSE:NVTA). We hope you enjoy.

Daniel Shvartsman: Welcome to the Razor's Edge. I'm Daniel Shvartsman. I'm joined by Seeking Alpha author Akram's Razor on this show. Each episode we take an investing idea or theme that Akram has been looking at for his personal investing as well as the Seeking Alpha marketplace service he runs, also called The Razor's Edge. We look at the ideas themselves, stress test them, try to figure out where they might go right or wrong, talk about what's been going on, and talk about the research and analysis that led to this take.

The idea to share some current investing ideas here into consideration, but also get the ins and outs of deep fundamental market research today. This week's topic has a lot behind it. The ticker symbol is NVTA. The stock is Invitae. Akram released a short case on the company on Seeking Alpha on October 11th, that went long in terms of breaking down why the genetic testing company was more like a WeWork than an Amazon. In other words, the company has had prodigious revenue growth, but it's come at a cost of increasingly negative cash flows and limited competitive advantage, in Akram's view. Was a thoroughly researched short case and as is often the case it's attracted a lot of attention, both positive and negative.

On today's Razor's Edge, we're going to talk about what brought Akram to this case, what investors are missing, and some of the reactions since he went public on Invitae. We're also joined by a colleague of Akram's, James who can add some insight on this topic based on research he's done on the stock as well.

Before we begin a quick disclaimer and disclosure; The Razor's Edge is a podcast on Seeking Alpha's The Investing Edge channel. The views discussed belong to either Akram, James in this case, or me respectively, and nothing on this podcast should be taken as investment advice. We'll disclose any positions in any stocks discussed at the end of the podcast, though upfront I can say I have no positions in any of the stocks we plan to discuss, Akram is short Invitae and long Myriad Genetics, and James is short, Invitae. We're recording this on the morning of November 4th.

Listen to or subscribe to The Investing Edge on these podcast platforms:

All right, guys. Good morning. Welcome.

Akram Razor: Good morning.

James: Good morning. Thanks.

DS: So let's just go really basic, why Invitae? What brought -- why does your radar get on this stock? Where did they come up?

AR: That's definitely an interesting part of the story. I guess the starting point was, there was people shorting Myriad. So I follow the Southern Investigative Reporter. And they've done a couple short pieces on that. And I kind of have taken a look at it briefly, which caused me to take a brief look at Invitae, and that was probably like, May or June. And then Ilumina missed big time on earnings, and I've traded Ilumina several times of the year. I've never traded any of these other stocks in terms of that. But it kind of got me interested in the space. And I guess what kind of, I mean, like, I think I had pinged James on it a couple times being like this is like this is worth looking into, but like neither of us had really gotten that excited about it.

And then there was a report that came out by a short seller, recommending the stock is an amazing long idea, which I read, because I know the short seller and his work. Once I read that, I was like, I need to look at this company a little closer. And then just the typical process, like pulling up their filings, seeing exactly what's going on financially, and I was just like, wow, this is just an incinerator. What are they doing? Why is -- like, what's the business model?

And that brought me to, there's an author on Seeking Alpha who had published a lot on this over the years, capital markets, laboratories and read their work, and they made these Amazon compares where, obviously, that's where you get a little bit of a heightened radar, when a laboratory diagnostic company is being compared to Amazon, which I mean, I don't know also if you know -- and I had like a brief experience with Theranos in 2000 it was say like, early 2014, like back when it was like -- I was picking on the Decacorns then, my favorite, like when I used to write my market commentary and I'd have a little bit of fun with it.

At the time, the two I was having fun with were Zenefits and Theranos. But I mean in Theranos' case, like I was just curious as far as what like -- I mean, it was a private company, $10 billion, obviously a lot of hype. I was like, wow, do I short Quest and LabCorp, right? I mean, I can't make -- I can't invest in Theranos. But if this company is so revolutionary like it, there's this pretty simple thesis out there in the public markets where I mean, if they're going to stick a lab in a box, I should go short Quest Diagnostics and LabCorp.

And I have, on the medical side, an extensive network of friends and family. So I ended up doing just one call with someone who'd been at Quest and in the laboratory diagnostic space, pretty senior for about 20 years. And like, I mean, it was like a 30 minute conversation. I felt stupid by the time it was over. It was just like, he's like, are you an idiot, you can't stick a Lab-in-a-Box. It was like -- it was literally like that, after like being very polite for a little while. So that type of stuff kind of intrigued me. And Theranos ended up being Theranos. I never really did much more with it after that. And then Wall Street Journal came after it, and it became this cautionary tale. I don't know if James -- did you follow Theranos very closely, I don't even know if we really discussed that?

J: No, I had heard from some VC friends who were very skeptical of it all the way through. But I wasn't that close to the name myself.

AR: Yeah, I mean, neither of us I would say, I would characterize myself as close to it. But I mean, I did take the time to literally be like, hey, do I short these stocks because of Theranos, right? It was like an investment idea at the time.

So yeah, I mean, I guess that's what started it, right. I mean, like Theranos had this -- and then the message was just kind of just like affordable blood testing for all, a social cause being compared more to, like technology differentiating companies and I mean, Elizabeth Holmes like to associate herself when she talked about things, when she compared herself to the Google Founders and Facebook and like, I mean, if you saw the documentaries like here we were at, in Brazil, and this is where we -- who was sitting there, and the Google guys, and the Amazon and Facebook, and we are the stars of the show, right?

And if you look at Invitae, I mean, like on the surface, it's like there's a social enterprise element to it, right? Where it's just like, we have a mission, and this mission is to make genetic testing affordable for all. I mean, like, they don't care, they don't describe themselves as like a laboratory diagnostics company, right?

DS: Well, they --

AR: That was a genetic information company. Go ahead.

DS: Yeah. I mean, if you look, I have got their 10-K open, their last one and it's -- our goal is to aggregate a majority of the world's genetic information into a comprehensive network that enables sharing of data among network participants to improve healthcare and clinical outcomes. So it's this.

AR: Yeah, so what does that mean?

DS: Right. You know, it is this very -- it is very big mission, right. It is very big.

AR: Yeah, I mean, James, obviously has some views on this. Like, I mean, what do you think of that part?

J: Well, I think that really comes down to the crux of the investment case here, which is, just because something sounds good as a sound bite doesn't mean that it actually makes sense in business. And so the idea of accumulating the world's genetic information, you would argue, seems like if you could do that would allow you to capture rents on that database. But there are very real issues with that. Namely the company has said that they won't do that. And then when they're pressed about how -- whether or not they will do that, they kind of seem to give non answers what I can tell.

So that's one of the questions right that that I think would be very helpful for the company to lay out there, very specifically, which is, if we gather all this data up, and specifically what data is being gathered? Are they -- is that data, they've also released to a common database, like they say they have been doing, is there additional data that they're not releasing?

AR: Well, I mean, the data that they're sharing with the common database is the variant of unknown significance data, right? So I mean, that's what they're contributing to Clinvar. We don't really know. But like, I mean, I'll be honest, like if I was to go in and have hereditary cancer test, I would have never thought once about, like, who the lab doing the test is or ask the oncologist anything, but like literally now knowing this business, I mean like, make sure you're not using Invitae, because I have no clue what they're going to do with that data.

Like my DNA is a product for them to figure out somewhere down the road just to do something with it, I mean, it's so -- like James just said, it's very bizarrely unclear, which is decidedly convenient when you're running a business model like this.

DS: So step back for a second. So the thesis -- the company's thesis is that they're providing genetic tests. And then they're aggregating that, they provide it at -- arguments are they providing it for below the cost that they actually have to pay to their providers to actually deliver the test but low cost testing that they can then -- if we're going to use the Silicon Valley jargon, that they get the flywheel of more genetic data and improve, they get a lot of volume, and eventually, that's both going to give them scale to lower the costs, but then also they're aggregating this huge genetic database, which as you kind of point out, Akram, they're going to have to do something with to make it reasonable, which raises concerns in of itself. But the idea is that eventually they'll get scale from offering at cost that will allow them to become a profitable business, I think. That's how I understood the company's take and the company's argument.

AR: I mean, like James just said the company hasn't explained that. So if you look at this company's history, this isn't like a startup, number one, right. So this company was founded in 2009. They've been at this for a decade, okay. Initially, they were kind of rare disease focused, right?

Like where they're deriving the revenue, if they were to actually describe themselves accurately, they would be like, we do hereditary cancer testing far cheaper than Myriad, right? And I mean, like, I think that's an important thing to look at this. I mean, there are sources of revenue, which is generally speaking what has attracted people to the stock, it's not science, right. It's not like you've developed a test or you're like Foundation Medicine and you've got this companion diagnostic clinical trials and you are about to do something where you're going to earn a high margin, because you've developed something nobody else has. That's typically, what people get excited about in science and biotechnology, right?

You get rewarded for R&D, okay. These guys have approached the market that Myriad discovered the BRCA mutation in 1994, okay. That's like what the indication of hereditary cancer right? I understand cancer, 90% of it is not hereditary. So you're looking -- when you talk hereditary, there's a less than 10% chance that it's something hereditary. That's helpful from a clinical standpoint, as far as your treatment for cancer diagnosis, whether it's early or late stage or whatnot.

So this company came into this space in the sense that Myriad had a monopoly on this gene, right? They started doing their first BRCA testing lab kit was like 1996. They had the patent on that gene till 2013 when the Supreme Court struck it down, right. So these guys entered this space, essentially, from that standpoint as a competitor against Myriad. And once that space kind of opened up in hereditary cancer testing, I mean like, well, you can't patent these genes, right? Which is great for competition, but what's the flip side of it?

If I make a major discovery on gene X correlates to disease Y, right? And I can't patent it and I'm running like a test that kind of identifies that historically, kind of tough to build a very profitable business around it. So when we go back to like what you were saying about like this whole genetic information and whatnot, the most interesting thing about this business is look at the rest of the landscape. Nobody's selling the story, like Myriad's still the revenue leader in hereditary cancer testing.

The other space the company is in deriving revenue from is reproductive health, carrier screening, non-invasive prenatal screens. And that's the most crowded market ever. It's got Ilumina and Sequenom, which is owned by LabCorp, like pretty much, they control the IP there. And then there's like a half a dozen other competitors owned by large companies.

So like, in hereditary cancer, you've got Myriad. And then you kind of have this like at a huge, huge, huge discount to Myriad prices, Invitae, right? I mean, like now they're running what, $99 tests, okay? So you look at it and you can sit here we can just, like figuring out what they want to do data wise and the fact that it's Vegas kind of important. It's also important in the context of -- well, there's a whole industry here, right? I mean, this is at least what -- we got some heat when we cautioned this like, some of this has attracted obviously a lot of retail investors by using the Amazon compare. And, in the initial thesis it was like a cautionary mention at the end, like that the laboratory diagnostic space doesn't need another Theranos.

And at least in Theranos' case, what they were selling to investors was we're building a better mousetrap essentially, right? Like we've got -- we've engineered something that's going to change the way we are able to do testing. And that's not the story here. The story here, I mean, if you go back to the founder in 2016, there's a couple of interviews with him. And he literally says like, we're providing the same test that everyone else is providing, we're just making them more affordable. That was that's their initial story, right.

So I mean, you do kind of run into something like that, which is where, like some people may think it like, you know, oh, it's very, self-serving or opportunistic to compare this to WeWork. It is, exactly like WeWork from a business standpoint. Like you can't get around that fact. And I think the Amazon like -- and this is not like some guy writing a really bullish Seeking Alpha article and using hyperbole, the management sticks to compares. I mean, they -- literally they have a slide in their investor deck, what we can learn from Amazon, and they make statements like our competitors -- what did they say, James, is like the competitors margin is our opportunity or

J: Yeah, something that effect. Yeah, you've heard a lot of ground there, Akram. I think the important aspect of what you've said and the commonality among all those points is that the management team has made some very high level statements about the promise of this industry and the promise of their company. And they could really answer a lot of these questions if they wanted to, right? They could say, okay, here is our revenue breakdown from cancer or nips [ph], kind of other panels, which don't have necessarily the clinical efficacy.

Or they could say, here's our -- here's what we're getting from the various cost cutting or network effects or economies of scale that we promised. And here's how this is going to develop, but they don't they just say, trust us, it's all going to work out. And the way that it's not [ph] going to work out is that it worked out for Amazon. So it's there's not much transparency, there's a lot of just kind of big picture verbiage I would say.

AR: Yeah. I mean, 100% and like, I mean, you get the Amazon story, Daniel, right. I mean, if you look at it, people like, if you look, well, come on, Amazon was losing money. No, Amazon was improving operating cash flow from literally from day one. I mean, people forget, like, you make money selling DVDs and books online, particularly if you don't pay your suppliers for 100 days, right? I mean, like, where was Amazon after a decade? It was already a behemoth, right?

So when you look at it, Amazon had someone else, i.e., their suppliers funding their growth. It's free, cheap capital. This company went and IPOed in 2015, at $16 a share, had like 25 million shares outstanding. They're at 100 now, four years later, right? I mean, it's like, they keep going back to the well. So if you're an investor and you're looking at it from a return on investment on money, you're giving them. I mean, you have a serious problem. And if you look at it, and you say, hey, I'm going to compare myself to Amazon. Well, Amazon had a cost structure that attacked this cost structure of brick and mortar, okay?

They benefited from so many things. We didn't have sales taxes, if you were paying on Amazon as a consumer. They benefited from the fact that they went into markets with huge existing volume already, books and DVDs. They didn't have to convince people to buy X, Y and Z. They were already huge volume markets. I mean, I'm sorry, but like hereditary cancer testing. It's not something people get excited about to go online or buy as a gift for a friend.

I mean, like, we get the DTC space, and even that has already slowed down drastically, and that's Ancestry. And if Ancestry slowed down at like 30 million tests, right, like, you really think people are going to be super excited as individual consumers to be like, I really need to figure out whether I have a history of cancer right now. I mean

J: Well, and more importantly, more importantly, I think there's a healthy amount of skepticism in the medical community whether or not these tests are useful, right? Like the issue with any test is, if you find something, an indicator of a disease. Does that help you catch the disease? Does it help you catch it earlier than existing testing or physical exams, or other ways of seeing the diseases there? And then can you do anything about it?

So, I think one of the issues here is even if you were to send your saliva [ph] sample out, and you came back with saying indication that you might have liver cancer potentially. A, you wouldn't know, if that were real, because it's really just a correlation at this point. There's not enough data. B, even if you knew, it was real, there's really not much to do except worry about it. And so you have a lot of additional burdens on the patient and the healthcare system in terms of emotional and financial burdens, without any clear benefit.

And so I think within -- as I'm saying, within breast cancer, that there is a clear benefit in terms of efficacy and outcomes. But for the rest of the space, it's really not clear. And that's why, if you look at the treatment protocols for most of the commercial payers, they don't pay for all these tests, because the research doesn't demonstrate that they should.

DS: So one of the things I'm -- as we're throwing around these comparisons. I'm thinking about the -- there's a notion in Silicon Valley and sort of abroad, the market, the idea of tech, tech as a category is becoming less and less meaningful, because companies are adopting online models or tech models to different verticals. And what I think about with Theranos and Invitae, specifically, healthcare is a very complicated sector, both in terms of the way payers work and we can get into Medicare in a little bit, but the way the payment system works.

And I'm not talking even about what might or might not happen in the future with changes to insurance. But just -- that's, I think, always been fairly -- you have to really work through it. And the articles for example, there's looking at the different reimbursement codes and that sort of thing. Like, it's more than you have to do to figure out, well, are they going to buy this software tool or not?

And then also, Theranos is a problem, because they were actually -- there were issues of fraud around people, things that were supposed to help people's health. And so I guess I'm just kind of, I guess, I wanted to hear a little bit more about like, because -- a lot of the response.

AR: Well, I mean, look -- let's, I mean, if you think about Theranos, where really was the fraud. The fraud like, I mean, if you read the indictment, what she's really on the hook for the biggest time is misleading investors, okay. I mean, that's the biggest part.

Yes, correct, like at the end, there was issues with the lab testing and they were getting inaccurate results because by the time she did that deal with Walgreens, and clearly they were at a point where they were desperate for showing meaningful revenue, because they need to raise more cash, right? Because they still haven't made the Edison work, right? They're trying to engineer a problem. They're working on it.

She didn't set out to commit fraud, right? She set out to build -- to stick a Lab-in-a-Box, right? But she had bigger aspirations. She wanted to take -- that she wanted to aggregate your data. She wanted to stick it in this cloud called Yoda, right? I mean, if you look today, you still have people who defend -- I mean, what's his name?

DS: Yeah.

AR: Tim Draper has really defended her. And what does he defend her on the point, and his point is that look, she had this vision to give you a movie of your health, i.e. like look, I get my blood work once a month, and that goes into a cloud, right? And my physician can track it. And I'm building a historical picture of a trend, by having more real time information on my blood work, cholesterol, everything right? So that creates preventative medicine in their view, right? Like your ability to have an earlier and more accurate versus a snapshot, right?

So he's like, look, she had that and was great and I genuinely have discussed this with James. I believe if she had IPOed this company and the company had started out as like, hey, she's got this Edison and this finger stick. It would have been just like binary tech play, right? She either makes it or she doesn't. And people would have debated that and thought that out there would been the believers. And then there would have been the skeptics, but she would have had plenty of time, as she gauged how that was working, okay?

To find something that generates revenue, which investors are willing to pay for, like with her inflated market cap on the Edison optimism, where she could just do regular lab testing like Quest and like LabCorp, but she would obviously do it at a lower price, right? But she would sell you the story that I'm going to stick this in the cloud, and you're going to pay a subscription fee, right? And that subscription fee to that cloud, Yoda, where all your information is and your general practitioner can access it and whatnot, that's the business. That's where I make money.

Of course, what's the problem with that business? And that business is -- well, I mean, that you're going to be like, well, you're losing a lot of money per test, doing your tests at a lower price than Quest and LabCorp or whatever to provide this back end service, why can't they do that, right? I mean, like, that becomes the same thing because you're going to need the same infrastructure. That's where she ran into issues. She's collecting data and she doesn't have the lab infrastructure to do it at the scale that these guys are doing.

If she'd been like these DTC companies, 23AndMe ancestry, she could have actually struck a deal, which is like, I'll be the cloud and I'll outsource the testing to them. And I will take a loss on the tests, because my investors are going to subsidize it, right? I mean, there was -- there would have been many Ways, but of course, she was also trying to kill their businesses. So it didn't work, right, with her engineering. but like, I mean, the bottom-line is, is if you look at it, like, it's something where you had a potential business model in that sense, where we would be asking the same questions that you'd ask about in detail, right? Like what are you doing that's different?

If you look at them today, Quest and LabCorp, they've entered into direct-to-consumer testing. I can go online and order my own tests and schedule the appointment and go pick them up, right? I'd like it's really, like, it's something where I don't even need to go through my medical practitioner if I want to get tested. And I don't know, to the degree I mean, I've discussed this with other people in the medical community on the testing side and I'm just, why isn't there a VIP service like, if I'm an extremely wealthy individual, where they come to my house, do the work, store in a cloud. And there's access to my blood work, on let's say -- but we don't have to do a monthly but let's say every three months, right?

These -- I mean like these are obviously options. So when you look at something like that and you see what went wrong with this company, her biggest mistake was being private. It's like -- because with her turtlenecks and Steve Jobs and Stanford dropout, I mean, the benefit of doubt, she would have gotten, if you look at the benefit of doubt, for example, that this company, Invitae has gotten. I mean, their CEO says one thing, and then he does the other three months later and nobody has cared like, at all. No one's asking questions. I mean, I don't know if you -- have you watched the CNBC, the Invitae interview with him on CNBC, Daniel?

DS: No. No, I haven't pulled that up.

AR: If you watch that, you would not understand what the company does. It's like we are the company the key opinion leaders turn to and this -- like, he does not say I'm a laboratory diagnostics genetic testing company, who derives primarily its revenue from doing these types of tests. And we're doing them at a significant discount to a competitor, who has had a monopoly in the space for ages. And we're using that to generate volume and we're hoping to parlay that into other sectors. And this is like -- this is our business model. Because to be -- to tell you the truth, if you look at this closely, I don't think they figured it out. They are trying to figure it out as they go along and that's part of the problem here.

DS: Isn't -- you said, if Theranos that they could have arguably sold tests below costs, but then put the -- like, isn't that essentially what the Invitae has? They haven't maybe laid out that vision but they're essentially selling below cost to get into -- like they could build that into the cloud sort of approach like?

AR: Okay. No, let's not make that mistake, okay? I'm saying that Theranos, if they wanted to, okay, and wanted to pivot for a story to sell, that sells well, when you're dressed like Steve Jobs, and you dropped out of Stanford, and you're a unique character and you're -- you've got a Board that has these people on it. And you've convinced Tim Draper and Larry Ellison to invest in you and whatnot, right? When you've dressed something like that, and you've ticked all those boxes, okay, you could just be like, hey, I'm going to do the same blood work everyone else is doing, I'm going to do it cheaper. So come to me. And how I'm going to make money off of it down the road, is I'm going to store that data, and it's going to give you a real time picture.

Now if you were to compare this on genetic information, my DNA isn't constantly changing, right? So if I'm doing -- if my focus is hereditary screening, i.e., what's been passed on to me, and what does that indicate?

What is the usefulness of that sitting there, right? Number one. And number two, in her case, it would be like, well, you still need to build the lab infrastructure to do the tests. You're going to have to do huge volume. So any business that -- like I mean, if you listen to the CEO, he literally sits on conference calls. And he's like, we hope to do half a million tests this year and reach a million people next year, and on our way to billions across the world. Well, what kind of infrastructure, you need Amazon infrastructure for that, right? I mean, how many geneticists do you need, genetic counselors? The industry doesn't even have the employees. I mean, we were discussing this, like, how big is that industry James.

J: It's well smaller than then I thought it was. I think it's in the thousands of genetic counselors. I forget it, 10,000 or 15,000.

AR: So you're going to need lab technicians, genetic counselors, you're going to need the physical footprint. You're going to need logistics. I mean have you looked -- like part of the thing that like -- we found kind of interesting is just look at Quest Diagnostics. I mean, there was a $100 price target slapped on this thing. That's the market cap of Quest, okay? They have 3,500 trucks like 26 planes, 6,000 patient access points, right? They have infrastructure to test everybody.

The internet bull on this stock, he's been close to management. He's done a lot of write ups on it. One of his write ups was just recently, and I read it and he's like, I visited the company and the CEO told me that they're actually paying for the trucks to go to FedEx, to pick up the samples and bring them back instead of waiting for FedEx to bring them to the lab. And he's like, I've never seen a company who cares about the customer so much. And I am like -- I mean, sorry, logistics are part of his business. Collecting the samples and the turnaround time and what the infrastructure you need to do it, right?

Like that's not something of like, hey, I really care about my customer. It's something you have to do and unfortunately, Quest and LabCorp are sitting there with huge economies of scale and scope and infrastructure and the same machines available to them, and the lab technicians and the geneticists and everything to flip this switch on, and they're not flipping it on. Why?

DS: Right.

AR: It doesn't make money, because the volume isn't significant enough and the cost isn't at that point. So when this company talks about driving down costs, no, they're not driving down costs. Everyone else has a lower cost per test already established, because they have higher volumes in the space, right? If you look at it Myriad's cost per sample is in the $140, $150 range. If you look across all these other labs, who are doing the stuff and the testing on the reproductive health they're all far lower, right?

So this is a last person in the space coming and trying to get to the volume, trying to get to the economies of scale and trying to drive it down, right? But they still are subject to the same cost infrastructure limits. It's not amazon.com. They haven't eliminated the blockbuster employees sitting, that when they're competing against in DVDs like a Netflix or an Amazon or whatnot, they haven't eliminated the huge physical retail footprint that a Barnes & Noble needed, right? Like, they still have the same limitations, from a cost standpoint. They're relying on Ilumina machines, consumables, Agilent, Read [ph] everybody -- like it's the vials from, what's the company that sells the vials?

J: OraSure

AR: OraSure, right, like you're buying the same stuff from the same people. So it's when you look at it from that standpoint, like if they were to sell you a story about data or whatever, it's like, well, everybody else can sell us a story about data. Why are they selling it to us?

J: It's an interesting dynamic here, because when there was the rebuttal by this bullish commentator/endorsed analyst of the company, there was a comment that, hey, it's not just the raw data, it's not just the genetic information that is useful, because genetic information in and of itself doesn't tell you enough about the disease. And I think that's a partial indictment of the whole process. But more importantly, what the analyst said is, what the company does is they take that information and they combine it with a patient's medical record. That includes all of their scans, their CTs, their MRIs, all their historical blood tests, all their physical exams, and then it takes that data. And if you get enough of that data, then you can start running effectively very large statistical relationships and figure out, okay, which genetic mutations might be associated with which diseases.

The problem with that is, as far as we know, that's not what's happening. And yet the company, again, they've kind of endorsed this, this guy is an analyst of record, the company hasn't come out and said that. But that's not what's happening. Because if it is what is happening, I think they're serious privacy concerns. So I think it's very different, if you as patients and [indiscernible] into 23AndMe, you might sign a paper, some paperwork somewhere, but if they're actually signing away the rights to all their medical records. Again, I don't believe they are, but again, this is what would need to happen in order for this data to be proprietary and useful. Then I would imagine the consumers are not aware of that.

And so you kind of have this catch 22, if you're getting the data, whatever, this guy refers to it as the golden data, whatever it is, if you're getting that data, such that it's useful, you're probably in violation of some privacy laws, whether or not you are in terms of you're covered legally, I think just patients don't understand that's what's happening. And if you're not getting that data, then there's a very real question as to what exactly is the use of just this genetic information without putting it into -- in context without kind of correlating it to these other disease markers?

And again, this is a question that could -- that's very answerable by the company as far as we know, has decided not to answer.

J: I mean, look, there's also two elements of that, right. If you remember also, in his rebuttal, he pointed out to a subscription model, right ,where he was even saying that this should be looked at from a dollar-based retention standpoint like a SaaS company. So I mean, again, if he's saying this, it's something that well was spoon fed to him, okay? And that's part of the element here, when you're dealing with something like this, and you look at that, it's like, all right, so like, I go in, I do a test for cancer, but you know, a BRCA screen. And you're saying -- are you essentially saying that, in year one, you generated revenue off of the actual testing, but then in year two, and year three, supposedly, my DNA is something that just sits there, and they can find ways to make money off of, by farming it for some sort of data that they can sell to pharma.

And it's tenuous at best to even understand how that model would work, because if you look at the rest of the industry, you just have to assume, they're all idiots. I mean, how many tests has Myriad done? I mean, look, when you go back to this thesis, Daniel, one of the most important things here is, when I put this on, this company was bigger than Myriad, literally in enterprise value, it was bigger than a company with $850 million in revenue, 20 years of testing. They've done 6 million tests through some -- to that effect I think it is at this point.

They have a database that they've made a trade secret since 2004, as far as variant data. They have four times the employees of Invitae. I mean, if you were to look at this company from there -- one notable institutional bull in the space, like this bull doesn't own any Myriad, okay. And they have a genetic spawn, and they did like kind of throw like a little bit of a shade at this thesis when it came out. And I mean, I can imagine they got a lot of questions because they own a lot of the stock and they were like, these are the companies leading in AI.

And then they like -- they listed Invitae like two other names. And then they put in their tweet, which was almost essentially directed, not my gen [ph], which I mean, for someone like me, I just -- I didn't even really spend much time getting into the AI nonsense. But if you look at Myriad how many people with machine learning backgrounds and data scientists do they employ, plenty.

You could just go on LinkedIn, look at it, and draw your conclusion. But they're not out running around saying, hey, we got AI, we're doing stuff. We're literally running machine learning models on your DNA. We're figuring out better ways, a secret sauce. Like who would advertise that? If you actually have made the data a trade secret, and you refuse to share it and they've gotten a lot of heat for it, literally the whole industry had to band together to contribute data freely to Clinvar, because Myriad won't share, because they're like, hey, fine, you took away our patent, but who cares about that. Our ability to interpret this is better than everybody else at this juncture.

So again, you look at it, at something like that, and you're just like, well, there's companies who've been doing this for decades. And you're just supposed to assume that like data science is completely irrelevant to them. But the company that acquired an AI startup in July, by September is a leader in this space. I mean what, you know.

DS: Solet me -- so there are a few directions to go here. But let's quickly touch on Myriad. It's -- you're using it as a payer here, as I think you mentioned, it's -- short sellers have kind of had their eyes on it. Somebody like Southern Investigative Reporting Foundation has reported about it. Why are you comfortable with that as the other side of this trade given the fact that they've also come under fire?

AR: I mean, I don't know James, you want to tackle this? I'm obviously a lot more bullish on Myriad then most people. I would say, like, I can't really get my head around the short thesis, and I can't get my head around the short thesis in a relative context. I mean, if you've looked at the space there are some companies with some pretty crazy valuations. Myriad is not a hard business to understand. They have a cash cow in hereditary cancer. They've used that to diversify into companion diagnostics, into carrier screening, now into these pharmaco-genetic tests, psychotropic like for depression, which is a very controversial area.

A lot of a lot of volatility around Myriad lately, let's say the last six months, has been tied to this gene site division, and the way the FDA wants to treat these tests, where I get a DNA test that like tells me, I'm more tolerant for Zoloft over Prozac. And no science has shown any clinical efficacy yet, and it's a controversial area, because there's obviously some doctors, and they've been doing -- they've been running clinical studies to try to get this approved. And they missed the primary endpoints on it. But there's also an argument that in depression, which is like opioids, a national crisis, essentially speaking, and it's not going to get better, that there's nothing, and something is better than nothing. I mean, two-thirds of antidepressants are prescribed by general practitioners. Not -- you're not talking about the psychiatry side here. These are not experts on these drugs or on mental health.

And the argument is that maybe you give them something that starts this out with a little bit more direction, however little incremental it is. Now when the stock got hammered in the summer, on its last earnings, was because they said the FDA is pushing back on them on the labeling. And then recently, there was another genetic psychotropic-related test company where the FDA allowed them to resume sending the test information, but to the doctors. So the patient just gets this, like here's what your genetics say, but nothing about the drugs. But the doctor actually gets the drug indications. And then that doctor can see that and that doctor can use that as part -- like as a helpful part of his treatment.

But again, you go back to -- they haven't been able to show scientifically and it's hotly debated. I mean, there was just recently something in -- two Harvard doctors had published something in one of the big journals on mental health, same thing with oncology, like outside of BRCA, like there was a recent paper basically like these other genes are like no better than a placebo.

So this is part of the problem in the space but I mean, I haven't -- I don't have the numbers in front of me. I mean, James do you remember off the top of your head, but I mean, I think it's like $850 million in revenue and like $150 million in EBITDA, something like that against a company with -- that did what, like $144 million in revenue last year and lost what $100 million.

J: Yeah, but larger now.

DS: Yeah, $850 million, trailing 12 months revenue, looks like EBITDA of over $100 million at least.

AR: Yeah. So like, you can look at that, I mean, and this is something when you look at stocks, I mean I was long, some Pinterest against the Snapchat short. And I thought about closing it before earnings. And the reason I thought about closing it is that you know, Snap is $16 billion and Pinterest is 15 billion and Twitter after its 35% decline is 18.2 billion AV. Yeah, Twitter's growing slower than the other two. But it's like three to four times the revenue base. And you got to kind of adjust for that, when you get to that point.

And you're like, this is a company that is in the advertising space, and it's doing -- it's going to do whatever issues its got, it's going to do 3.5 times what this is going to do and their enterprise values are a hair apart. So when you -- like this wasn't -- this is a case where if you would look at an Invitae, you'd be like, this has got to be like a quarter a fifth of the size of like, even if you are a believer and you're willing to buy into the speculation of a Myriad.

And then the other problem you have with it is that they're interrelated. All the revenue growth that is coming for Invitae is coming because Myriad hasn't come down in pricing. They've been fighting this price decline, because they've had the luxury to fight it as the leader in the space and they're extracting a premium for their testing, because they -- like there's a compelling argument, at least from their end, that based on the data we have in the history, our tests can more accurately predict what you have, as far as a likelihood of a hereditary cancer and indication reliably.

And it's ironic, and we were discussing this when we were working on this, like this company throw shade at who -- I mean, they throw shade at the DTC companies. Like they literally just gave a scientific presentation at this Houston Cancer Conference with Genetics or whatever, just like two weeks ago, where they were like, here's 23andMe's tests, okay, and this is what's wrong with it. Like 23AndMe gives you a BRCA test, that only is designed to detect three variants. Basically, if you're not an Ashkenazi Jew, it's useless.

But it's literally a report that is bundled in with the ancestry, with the health with the 50, 60, 70 reports, you get for $100 okay. It's not like you're going into buy this or you're going to your doctor and you're like, okay, I had breast cancer, I'm worried about a potential recurrence. Let's see family history. Do I need to get a mastectomy early because I have this mutation and that's a good preventative measure, et cetera, et cetera. They're not looking at 23AndMe. Like, it's -- you're competing in the clinical grade medical diagnostics market. But here's this company attacking the DTC companies who are not really their competitors.

Read this article:
Breaking Down The Invitae Short (Podcast Transcript) - Seeking Alpha

Read More...

Sidestepping danger in the biotech sector – Investment Week

November 20th, 2019 4:46 am

Ailsa Craig of the International Biotechnology Trust

Passive equity products have become popular over the past decade as it has become easier and cheaper to track the performance of an index.

While this is a relatively low cost and straightforward way to access stocks and shares, active management remains the preferred choice for certain sectors.

We believe biotechnology is one such example. This industry often experiences high levels of binary risk.

Polar Capital: Healthcare headwinds short term in the US

The value of a biotechnology company can be significantly affected by the results of a single clinical trial or regulatory decision.

For example, in March 2019 Biogen announced it was halting the final phase of clinical trial for a drug known as aducanumab, which was designed to slow the progress of Alzheimer's disease. The share price fell 30% on the news.

If an investor buys a passive product that tracks a biotechnology index, there is no way to mitigate this type of individual stock risk.

An active manager can, however, sidestep this danger by selling out of the stock before the results of the trial are announced, therefore preserving capital.

The manager can then decide whether to reinvest or to allocate elsewhere once the results have been announced.

The biotechnology index is weighted by market capitalisation, giving it a significant exposure to the larger, well-established companies.

These firms are, however, often growing more slowly than smaller, more innovative companies.

Understanding the 'technological revolution in healthcare'

As an active manager does not have to mirror the reference benchmark, they can build a portfolio with a greater exposure to these faster growing firms.

It is also easier to implement an ethical investment strategy through an active manager.

For example, many investors want to avoid those companies that have profited from the opioid crisis.

Unless exchanged-traded fund providers exclude these firms from their benchmark index, this is impossible to do using a passive product.

Managing binary event risk and allocating a higher proportion of the portfolio to faster-growing biotechnology stocks has enabled active managers to outperform the benchmark.

Ailsa Craig is investment manager of the International Biotechnology Trust

Active management allows a manager to allocate a greater proportion of their portfolio to faster growing companies

It's easier for active managers to exclude stocks which do not match investors' ethical considerations.

Actively managed funds cost more than passively managed products, but the difference in price is not that significant

Actively managed funds come with manager risk

Excerpt from:
Sidestepping danger in the biotech sector - Investment Week

Read More...

Immunic, Inc. Expands Board of Directors with Appointment of Biotechnology Executive Barclay A. Phillips – P&T Community

November 20th, 2019 4:46 am

NEW YORK, Nov. 19, 2019 /PRNewswire/ --Immunic, Inc. (Nasdaq: IMUX),a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced the appointment of Barclay "Buck" A. Phillips, an established life sciences executive, investor and entrepreneur, to its Board of Directors, effective November 14, 2019. With this addition, Immunic's Board will total seven members.

"Buck's decades of relevant experience in the biotechnology sector, both as a Chief Financial Officer and investor, will add a unique perspective to our Board," stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic. "We look forward to leveraging his significant expertise in the areas of financing strategy, capital markets, business development, and others, which he has garnered during his successful career as an executive and board member for multiple, Nasdaq-listed life science companies. Buck's addition to our team reflects our desire to build the Board during a time of continued clinical progress and we look forward to his contributions."

Until recently, Mr. Phillips was Chief Financial Officer and Senior Vice President of Corporate Development at G1 Therapeutics, Inc., where, among other achievements, he was instrumental in raising over USD 300 million in multiple equity financings. Before that, he served as Senior Vice President, Chief Financial Officer and Treasurer of vaccine company, Novavax, Inc., where he helped to raise more than USD 850 million in various financings to support the company's late-stage clinical programs. Prior, Mr. Phillips was Senior Vice President and Chief Financial Officer of Micromet, Inc., which, during his tenure, was acquired by Amgen Inc. for approximately USD 1.2 billion. Mr. Phillips's exposure to venture capital came earlier, while serving as a Managing Director at Vector Fund Management, focused on investments in late-stage life sciences companies, and during his time as Biotechnology Analyst and Director of Venture Investments at Invesco, where he held primary coverage responsibility for the universe of publicly traded biotechnology companies, while managing the firm's private equity investing, with a focus on life sciences.

Mr. Phillips has served on the boards of over a dozen public and private life sciences companies. He earned a Bachelor of Arts in economics from the University of Colorado at Boulder.

About Immunic, Inc.Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. The company is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic's lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial planned in Crohn's disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: http://www.immunic-therapeutics.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's clinical and preclinical pipeline activities and the structure and composition of its board. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Item 1A. Risk Factors," in the company's Current Report on Form 8-K filed on July 17, 2019, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or ir.immunic-therapeutics.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

Immunic, Inc.Jessica BreuManager IR and Communications+49 89 250 0794 69jessica.breu@immunic.de

Or

Rx Communications GroupMelody Carey+1-917-322-2571immunic@rxir.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/immunic-inc-expands-board-of-directors-with-appointment-of-biotechnology-executive-barclay-a-phillips-300960819.html

SOURCE Immunic, Inc.

Read more from the original source:
Immunic, Inc. Expands Board of Directors with Appointment of Biotechnology Executive Barclay A. Phillips - P&T Community

Read More...

Page 825«..1020..824825826827..830840..»


2025 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick