StemCell Therapy

Sigmund Freud never uttered the word neuroscience. Neither did Santiago Ramn y Cajal. It was biophysicist Francis Schmitt who grafted neuro with science in 1962 when he established the Neurosciences Research Program at MIT. The new moniker was intended to encompass a merging of relevant neuro disciplines, ranging as far afield as physiology, psychology, immunology, physics and chemistry.

Brains and behaviors have been scrutinized for millennia. But as psychology blogger Vaughn Bell has pointed out, the 1960s marked a shift in perspective. Neuroscience was the formal name given by Schmitt. But the period represented the beginnings of a neuroculture, that put brain science on a pedestal even leading to the familiar meme proclaiming my brain made me do it. One example was rooted in pharmaceutical companies development of psychiatric drugs that resulted in their investing millions both into divining the neurochemistry of experience and into massive marketing campaigns that linked brain functions to the psyche, Bell notes.

The field received an adrenaline boost precisely 50 years ago with the founding of the Society for Neuroscience, allowing Schmitts collaborative vision to be globally shared. SFNs first annual meeting in 1971 drew 1,395 attendees to Washington, D.C. This years wrapped up on October 23, bringing more than 27,500 to Chicagoand the annual numbers have occasionally topped 30,000. SFN now boasts 37,000 members from more than 95 countries.

Anything to do with the topic brain found a place among the more than 14,500 abstracts of unpublished work presented in 2019 on themes ranging from the mechanisms of sleep to cocaine craving. But the society has had to adapt its U.S.-based get-together this year to respond to a world of closing national borders.

Some members were unable to get visas to enter the U.S., in part because of the U.S. travel ban, which includes broad restrictions on visits from Iran,Libya,Syria,Yemen,Somalia,North KoreaandVenezuela. In response, SFN initiated a program called Science Knows No Borders in which would-be attendees had a PDF printed out and posted or else PowerPoints and a recorded talk proferred in their absence. An Iranian doctoral student, Shahrzad Ghazisaedi, from University of Toronto, a neuropathic pain researcher, was one among about a dozen people who took advantage of the program (not all of them necessarily subject to the travel ban). Her poster entitled Sex specific DNA methylation pattern in spinal cord and periaqueductal gray (PAG) before and after peripheral injury could be seen Monday afternoon by attendees during a session entitled Central Nervous System Mechanisms in Pain.

For those who actually were able to make it, a range of topics caught the eye: research on nervous system immune cells implicated in a range of disorders, a gene therapy for converting the brains support cells to neurons for treating Alzheimers, a prosthetic forearm that provides a sense of touch and synchronization of brain waves between two people holding hands. Also, a group of scientists got together to start planning a test in humans to determine which of two theories of consciousness is more likely to be correct.

Another theme that stood out was the challenge of working with miniaturized brain facsimiles, called organoids, that show promise of more faithfully replicating what goes on in the human organ than a mouse brain can. Organoids, though, are too close to a Mary Shelley creation for some people. At the conference, members of the Green Neuroscience Laboratory in San Diego called for a research moratorium on organoid tissue implanted into mice or other animals, a technique already in use. In an abstract for their talk, they ventured that the technology is perilously close to crossing an ethical Rubicon in which organoids may experience sentient activity and behavior. The group advocates that methods should be developed to ascertain whether any given organoid has the ability to sense and react to its surroundings.

At a press conference of scientists who grow the five-millimeter-diameter mini brains, ethical debate was welcomed, but the researchers also tried to place their work in context. Paola Arlotta from Harvard showed a video of organoids, at most the size of small peasnothing resembled an imagined brain-in-a-dish. The brain bits are also difficult to work withchallenging to grow reproducibly and their cells do not mature to become an exact replica of human cells, but instead end up with a confused identity. Researchers think the kinks can be worked out, but, even then, that may not pave the way for growing full-sized organs.

Most scientists are not interested in figuring out how to grow a human brain in a dish, says Arnold Kriegstein, of the University of California, San Francisco. They are more interested in a particular disease mechanism or a certain process they want to study. And that really requires a reductionist system. It's too complicated to study an intact human brain. What you really want are the important elements, which you can dissect and delve into in great detail in the laboratory.

Everyone agreed that discussion about mini-brain ethics is warranted. But as far as existential threats, tiny tissue nuggets run amok may not be at the top of a list that includes antibiotic resistance, climate change and self-driving cars engineered with internals that produce a loss of control that resembles a wayward 737 MAX.

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Society for Neuroscience at 50 Delves into Mini Brains, Gene Therapy, Prosthetics and All Else Related to Our Three-Pound Wonder - Scientific American

Dive Brief:

The EMA's green light for Bluebird's manufacturing removes a final hurdle standing in the way of marketing the gene therapy, which costs $1.8 million per patient.

A requirement from European authorities to narrow drug product specifications for Zynteglo forced the company to delay the gene therapy's launch later than when Wall Street analysts had expected.

In a statement, Apceth said it's ready for the challenge to bring Bluebird's treatment to market. Between 2,000 and 3,000 patients in the European Union would be eligible under the conditions approved by regulators for Zynteglo's use.

Bluebird has cautioned investors to take a long view of the new treatment's prospects, and to expect a slow start. In addition to winning approval for the new manufacturing specifications, Bluebird has to navigate through healthcare systems that aren't used to paying large sums for a one-time treatment.

In hopes to alleviating those problems, the company has offered an installment plan that would require later payments only if the treatment continues to benefit patients. The hope is that Zynteglo saves healthcare dollars by sparing beta-thalassemia patients the need for regular blood transfusions and the complications that can go along with them.

Patients with the blood disorder carry a genetic mutation that hinders the body from effectively producing the crucial oxygen-carrying protein hemoglobin. As a result, they often require transfusions every two to five weeks to fight anemia.

"This is one step along the commercial journey as we advance our ongoing launch and market access activities on a country-by-country basis," said Alison Finger, Bluebird's chief commercial officer, in the company's statement on the EMA's nod.

In a September company presentation, Bluebird said it wants to make sure to "get the model right" as it looks toward future gene therapies it's developing in its pipeline. The company is initially planning to offer Zynteglo through treatment centers in Germany, Italy, the U.K. and France, with a drug manufacturing facility in Munich.

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Bluebird gets European green light for gene therapy production - BioPharma Dive

A gene therapy for a rare blood disorder has shown what the manufacturer calls the first evidence of long-term improvement associated with the disease.

New York-based Rocket Pharmaceuticals said Thursday that it had presented long-term follow-up data from the Phase I/II study of RP-L102, its gene therapy for Fanconi anemia, at the annual congress of the European Society of Cell and Gene Therapy in Barcelona, Spain. The company said it represented the first evidence of long-term improvement and stabilization in blood counts and durable mosaicism among patients who received the therapy without the use of the conditioning regimens normally used for allogeneic stem cell transplants, which the company calls Process A.

Shares of Rocket were up slightly on the Nasdaq following the news. RP-L102 is a lentiviral vector-based gene therapy. Most other gene therapies in development, and both of the currently marketed ones Spark Therapeutics Luxturna (voretigene neparvovec-rzyl) and Novartis Zolgensma (onasemnogene abeparvovec-xioi) are adeno-associated viral vector-based.

According to the data, representing four of nine patients, there were improved blood counts and long-term bone marrow mitomycin C (MMC) resistance, thereby indicating durable phenotypic correction. The data met or exceeded a 10 percent threshold that the company said the Food and Drug Administration and European Medicines Agency had agreed to for its upcoming Phase II registration study, for which it plans to start enrolling patients by the end of the year.

FA is a rare, genetic bone marrow failure disorder, half of whose patients are diagnosed before the age of 10, while about 10 percent of patients are diagnosed as adults, according to the National Organization for Rare Disorders. It is often associated with progressive deficiency of production of red and white blood cells and platelets in the bone marrow and can eventually lead to certain solid and liquid tumor cancers. It occurs in 1-in-136,000 births and is more common among Ashkenazi Jews, Spanish Roma and black South Africans.

These results indicate the feasibility of engraftment in FA patients using autologous, gene corrected [hematopoietic stem cells] in the absence of any conditioning regimen, said Dr. Juan Bueren, scientific director of the FA gene therapy program at Spains Center for Energy, Environmental and Technological Research, in a statement. This indicates the potential of this therapeutic approach as a definitive hematologic treatment, while avoiding the burdensome side effects associated with allogeneic transplant, including the risk of post-transplant mortality and a substantially higher risk of head and neck cancer.

Photo: virusowy, Getty Images

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Rocket's gene therapy shows long-term efficacy in rare blood disorder - MedCity News

In Junedata on three subjects in a phase II trial of Krystal Biotechsepidermolysis bullosa gene therapy sent the group's share price up 41%. Today a final update from the trial, including results from two new patients, left investors unmoved.

This might have something to do with the updated data showing that two lesions that had been successfully treated with Krystals therapy at 90 days had reopened a month later, raising questions about whether the treatment works in the long term.

The two new patients with severe recessive dystrophic epidermolysis bullosa (RDEB) had beenadded to the trial in June 2019, after the initial data release(Krystal plays down dropout to claim a mid-stage win, June 25, 2019). Bercolagene telserpavec or B-Vec for short, formerly called KB103, was administered to one wound on each patient every other day for two weeks, or until the wound closed completely. The other wound was treated with a placebo gel.

This differs slightly from the earlier phase II patients, who had B-Vec administered to two wounds each and placebo to a third.In its press release Krystal trumpeted that, of all 10 wounds treated in the phase I and phase II trials, nine had healed at 90 days.

The unhealed 90-day lesion was a chronic wound, reported to have been open for over four years, in one of the patients in the first phase II cohort. It was still only 42% closed at 90 days following the initial administration of B-Vec. The wound was re-dosed with B-Vec approximately three and a half months later, and healed within a week of this second dose.

Reopening

But the company glossed over the fact that, at four months, two of the healed B-Vec-treated wounds in cohort 1 had reopened: at 120 daysa lesion on one patients back had returned to only 77% closure, and another patient had a lesion on their left upper arm return to 85% closure.

Moreover, one of the placebo-treated wounds that had not healed at 90 days did heal at 120. At the four-month point, across both phase II cohorts, the success rates are 63% for B-Vec versus 20% for placebo not quite emphatic as the earlier 90% versus 14%.

One question iswhich time point is the more important? On clinicaltrials.gov the primary endpoint cutoff is listed as wound healing at 24 weeks a completely different point, and one that has not yet been reached, despite Krystals statement that this would be the final update from the phase II trial.

EB is a cyclical disease. Wounds open, close and reopen in the natural course of the condition even without treatment, so it can be tricky to show a drugs effect. Krystal intends to move B-Vec into phase III, and investors might want to take careful note of the time point regulators pick for the primary endpoint.

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Gene therapys duration is less than Krystal clear - Vantage

Cobra Moradian, Fatemeh Rahbarizadeh

Department of Medical Biotechnology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

Correspondence: Fatemeh RahbarizadehDepartment of Medical Biotechnology, Faculty of Medical Sciences, Tarbiat Modares University, Jalal AleAhmad Highway, Tehran 14115-111, IranTel +98 21 82883884Fax +98 21 82884555Email rahbarif@modares.ac.ir

Background: Breast cancer stem cells (BCSCs) are cells with a higher ability to metastasis and resistance to conventional treatments. They have a phenotype of (CD44high/CD24low) and the unlimited ability for proliferation. Development of strategies to target the BCSC population may lead to the establishment of more effective cancer therapies. Pseudomonas exotoxin A (PE) is a potent cytotoxic protein. CXCR1 promoter provides BCSC and HER2 specificity on transcription level. 5UTR of the basic fibroblast growth factor-2 (bFGF 5UTR) provides tumor specificity on translation level. Here, we utilized a mutant form of PE encoding DNA PE38, CXCR1 promoter and bFGF 5UTR to target BCSCs.Methods: The stemness of SK-BR-3, MDA-MB-231 and MCF10A cell lines were evaluated based on the expression of the CD44high/CD24low stem cell signature and the ability to form mammospheres. Then, the cell lines were transfected with constructs encoding luciferase/PE38 under the control of the CMV/CXCR1 promoter with or without bFGF 5UTR. Luciferase protein expression was evaluated using dual-luciferase reporter assay. PE38 transcript expression was measured by real-time PCR, and the cytotoxic effect of PE38 protein expression was determined by MTT assay.Results: The percentage of CD44high/CD24low population did not correlate to mammosphere forming efficiency (MFE). Given that the percentage of CD44 high/CD24 low is not a conclusive BCSC profile, we based our work on the mammosphere assay. However, in comparison with MCF10A, the two tumorigenic cell lines had higher MFE, probably due to their higher BCSC content. Reporter assay and real-time PCR results demonstrated that CXCR1 promoter combined with bFGF 5UTR increased BCSC-specific gene expression. Meanwhile, tightly regulated expression of PE38 using these two gene regulatory elements resulted in high levels of cell death in the two tumorigenic cell lines while having little toxicity toward normal MCF10A.Conclusion: Our data show that PE38, CXCR1 promoter and bFGF 5UTR in combination can be considered as a promising tool for killer gene therapy of breast cancer.

Keywords: breast cancer stem cell, PE38, CXCR1 promoter, bFGF-2, HER2, mammosphere

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Targeted Toxin Gene Therapy Of Breast Cancer Stem Cells Using CXCR1 Pr | OTT - Dove Medical Press

During the third-quarter financial call, Vasant Narasimhan, CEO of Novartis, noted that questions from European and Japanese regulators regarding chemistry, manufacturing and controls (CMC) were behind expected decision dates on Zolgensma (onasemnogene abeparvovec) being pushed back into 2020.

At present, the company expects to receive opinions from the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter and the first half of 2020, respectively.

Narasimhan revealed few other details regarding the questions, only that there were an extensive set of questions with respect to manufacturing, to which it had submitted responses. Reuters stated that he also confirmed that the decision delay was not due to the revelation of data manipulation in August.

Despite the setback on potential approval date, the company was able to confirm that the product had achieved US sales of $160m (143m), arriving higher than analyst predictions of $98m (88m).

When questioned on the patient numbers this related to, on paid programs, Narasimhan confirmed that approximately 100 patients had been treated though other patients had received the gene therapy through treatment in clinical trials.

Once approved in elsewhere in the world, Narasimhan predicted such number could increase rapidly: I think in some countries in Europe, as well in the Middle East, there could be very strong demand coming very quickly after approval.

He cited pent-up demand as a reason that sales would increase quickly, and also pointed to early access programs being made available in France, Portugal and Germany as another positive long-term sign for the product.

The company will need to see substantial return on the product, after investing $8.7bn in the AveXis acquisition to gain access to the technology.

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Novartis gene therapy held up by manufacturing questions - BioPharma-Reporter.com

PTC Therapeutics has presented new long-term outcome data from its investigational gene therapy, PTC-AADC, in patients living with aromatic L-amino acid decarboxylase (AADC) deficiency.

The one-time gene therapy was found to give patients the ability to sit, walk, and talk, from data representative of up to five years of follow up post-treatment.

The new analysis evaluated outcomes of 26 patients with AADC deficiency across three separate clinical trials, and found that 12 months post-treatment with PTC-AADC, patients mean body weight had increased from 12.0 kg to 15.2 kg, and the frequency of oculogyric crises (involuntary upward eye movement) was reduced.

The data, presented at the Child Neurology Society 48th Annual Meeting, is a result of the most comprehensive analysis of patients treated with PTC-AADC to date.

Unfortunately, there are currently no approved therapies that address the underlying cause, and as such patients with severe AADC deficiency have a high risk of death during childhood.

The company is excited to see the transformational effects in AADC deficiency patients in this long-term study as patients with severe AADC deficiency never achieve the ability to sit, walk or talk, said Stuart Peltz, chief executive officer of PTC Therapeutics.

He also announced that PTC is on track to submit a biologics license application (BLA) to the FDA by the end of the year and are proud to be on the verge of bringing the first commercial treatment for AADC deficiency patients, which is in line with our mission of bringing clinically differentiated treatments to patients with rare disorders.

AADC deficiency is a rare genetic condition caused by a mutation in the dopa decarboxylase (DDC) gene, resulting in a lack of functioning AADC enzyme, which is responsible for the final step in the synthesis of key neurotransmitters dopamine and serotonin.

It results in delays or failure to reach developmental milestones such as head control, sitting, standing, walking, or talking, low muscle tone, severe, seizure-like episodes involving involuntary eye movement, autonomic abnormalities, and the need for life-long care.

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Investigational gene therapy shows long-term success in AADC - PharmaTimes

The Centre for Process Innovation (CPI) has announced it has overcome a significant bottleneck in the development of gene therapies.

CPI said its CRD IUK project, which was launched in partnership with Cobra Biologics and GE Healthcare Life Sciences, has been successful in its aim to develop a scalable, cost-effective purification process for adeno-associated viruses (AAVs).

AAVs are a vital technology for the delivery of gene therapies into patients. By transporting genetic material into patient cells, AAVs are able to provide a cure for otherwise untreatable diseases.

However, manufacturers are currently hindered by the low efficiency of AAVs production, which slows down the overall development timescale of gene therapies, ultimately increasing the cost for payers in healthcare systems.

The CRD IUK project was funded by a 570K grant from Innovate UK and focused on optimising an AAV purification process using GE Healthcare Life Sciences Fibro chromatography material. The material is based on electrospun cellulose nanofibers that contain different chromatography functionalities, overcoming the limitations of existing chromatographic supports.

Whilst the technology was understood to be highly effective for purification of biomolecules, the CRD IUK project extended the technologys effectiveness to AAVs. After assessing the technology, a multistep purification process was developed for AAV purification.

Daniel Smith, chief scientific officer, Cobra Biologics, said:We are delighted to have been part of this collaboration working to develop robust processes for use in the development of gene therapies. This project has provided a scalable, cost-effective fibre-based chromatography method for production of AAVs that will greatly enhance development of innovative new treatments.

John Liddell, chief technologist, CPI, said: Gene therapies have the potential to be transformative for disease areas with unmet clinical need, and effective manufacturing processes are crucial for reaching the time and cost points necessary for achieving commercialisation. This was the second Innovate UK-funded project related to viral vectors for CPI and therefore further enhances the Catapult centres ability to support growth of this emerging sector, which has been confirmed in subsequent gene therapy projects.

Oliver Hardick, business leader, Puridify, GE Healthcare Life Sciences, added: This has been an excellent collaboration with Cobra Biologics and CPI. Together, we have made a big step forward in the production of viral vectors to be used in gene therapies. The success of the project will significantly reduce the cost and time associated with development and manufacturing of AAVs, helping to accelerate delivery of gene therapy products to market.

Continued here:
Industry collaboration overcomes significant bottleneck for gene therapy production - EPM Magazine

A new report has predicted that gene therapy development will pick up pace but a high price point continues to pose a challenge.

According to a new report, ongoing collaborations between different industry players and a buildup of real-world evidence establishing safety and efficacy are expected to drive the growth of gene therapies for neurology indications.

The report from GlobalData, continues that, of the 38 pipelines products that are currently in development, 45 percent are adeno-associated virus (AAV) based delivery platforms. Other types include Lentiviral, which accounts for 13 percent.

A majority of the current pipeline products are in Phase II development and the most common neurology indications for which gene therapies are currently being evaluated include Parkinsons disease, pain and amyotrophic lateral sclerosis, said Vinie Varkey, Senior Analyst at GlobalData. The dominance of viral vectors is expected to continue as such platforms account for the bulk of these pipeline products, with adeno-associated virus being the most common among the viral vectors.

A high price point poses a challenge for the development of gene therapies, Varkey says, with key opinion leaders (KOLs) interviewed by GlobalData highlighting the need to create sustainable funding solutions so that such therapies become accessible to patients everywhere irrespective of where patients are located.

While the development of gene therapies are expected to pick up pace, the next wave of such therapies are expected to be ones that target diseases that are more frequent.

While monogenic rare diseases are the obvious first-to-go choice for which gene therapies can be developed, targeting more frequent diseases will need a holistic approach in order to address a wider mechanism of action, Varkey concludes. If gene therapies for frequent diseases do become available, then that will result in a more pronounced effect on healthcare not only in terms of providing better treatment options for patients but also test the ability of healthcare organisations to adapt with high price points of these therapies.

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New report predicts growth of gene therapies for neurology indications - European Pharmaceutical Review

US researchers have highlighted the potential of using gene therapy to treat wet age-related macular degeneration (AMD) at the annual meeting of the American Academy of Ophthalmology (1215 October, San Francisco).

Dr Szilard Kiss, from Weill Cornell Medical College, shared his belief that a gene therapy for wet AMD could be available within the next three to five years.

Dr Kiss and his team developed a vector that inserts genetic material producing a molecule similar to anti-VEGF medicine aflibercept within the cells of the eye.

Once inserted, the DNA sequence begins making aflibercept protein.

Instead of taking a vile of aflibercept and injecting it into the eye, your eye makes the aflibercept, Dr Kiss highlighted.

The goal is a potentially one-and-done treatment. You may need a booster once in a while, but this gene therapy could theoretically last a lifetime, he added.

Image credit: Pixabay/PublicDomainPictures

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Using a one-and-done gene therapy to treat wet AMD - AOP

28 October 2019

The Bill and Melinda Gates Foundation has teamed up with the National Institutes of Health (NIH), the US national science funding body, to pledge US$100 million each over four years towards development of gene therapies for HIV and sickle cell anaemia. Their intention is to make gene therapies globally accessible, particularly in low resource areas in the USA and sub-Saharan Africa.

'This unprecedented collaboration focuses from the get-go on access, scalability and affordability of advanced gene-based strategies for sickle cell disease and HIV to make sure everybody, everywhere has the opportunity to be cured, not just those in high-income countries,' said Dr Francis Collins, the director of NIH. 'We aim to go big or go home.'

Significant advances have been made in gene therapy in recent years, made possible by new technologies such as CRISPR genome editing. Those techniques that are now becoming available, for example to treat inherited blindness, neuromuscular disease and leukaemia, are currently expensive and challenging to deliver.

In most cases, the approaches involve removing cells from the body, editing or removing genes, then reintroducing the cells, a risky process that requires a good medical infrastructure. The collaboration between the Gates Foundation and the NIH aims to overcome this hurdle to access in lower income countries by developing approaches that can be delivered directly into the body without the need to remove cells first.

The two diseases named in the proposal, sickle cell anaemia and HIV, are major global health burdens. Approximately 38 million people live with HIV worldwide, with 67 per cent of those sub-Saharan Africa, half of whom are living untreated. Fifteen million babies will be born with sickle cell disease globally over the next 30 years, with about 75 percent of those births in sub-Saharan Africa.

'We are losing too much of Africa's future to sickle cell disease and HIV,' said Matshidiso Rebecca Moeti, regional director for Africa at the World Health Organisation. 'Beating these diseases will take new thinking and long-term commitment. I'm very pleased to see the innovative collaboration announced today, which has a chance to help tackle two of Africa's greatest public health challenges.'

'Yes, this is audacious,' Dr Collins said. 'But if we don't put our best minds, resources, and visions together right now, we would not live up to our mandate to bring the best science to those who are suffering.'

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Gates Foundation and NIH pledge $200 million for gene therapies - BioNews

Shares of gene therapy biotech companies vaulted higher Thursday on rumors the U.S. Federal Trade Commission cleared Roche's (RHHBY) takeover of Spark Therapeutics (ONCE).

On the stock market today, Spark stock rocketed 7.5%, to 108.64, in huge volume, after Twitter exploded with rumors the deal had passed FTC muster. Shares of Uniqure (QURE), often seen as a prime takeover candidate among gene therapybiotech companies, popped 8.3%, to 46.02.

Roche announced its $4.8 billion takeover of Spark in February. The deal was expected to close in the second quarter, but has since been mired in regulatory discussions.

In June, Roche said it and Spark received requests for additional information regarding the proposed transaction from the FTC and the U.K. Competition and Markets Authority. At the time, most believed the deal would close in July.

Earlier this month, the Swiss drugmaker confirmed its plan to buy Spark before year's end.

Representatives of Roche and Spark declined to comment in emails to Investor's Business Daily.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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Biotech Companies In Gene Therapy Launch On Rumors Roche Clinched Takeover Of Spark - Investor's Business Daily

This article, written byRuanne Vent-Schmidt, University of British Columbia, originally appeared on The Conversation and has been republished here with permission:

Blind and partially sighted people no longer have to wait passively for a research breakthrough in hope of treatment options. In fact, people living with genetic eye conditions can now actively drive vision research forward by enrolling in a patient registry and getting their genes tested.

There are 2.2 billion people living with visual impairment globally. Some are living with inherited retinal diseases that are progressive and can lead to complete blindness. Up until recent years, blind and visually impaired people were told that no treatment is available. This is changing as genetic testing is paving the way for a surge of gene therapies.

My passion for vision research is personal

My doctoral dissertation at the University of British Columbia was on drug therapy for retinitis pigmentosa. This progressive, blinding eye condition is the most common type of inherited retinal disease.

In people affected by retinitis pigmentosa, the light sensing cells in their retina photoreceptors die early. Unlike skin cells that regenerate, the body does not make more photoreceptors once they are damaged.

As a vision scientist affected by retinitis pigmentosa, I am passionate about finding the truth about the disease. Why do photoreceptors die? How can we stop it? How can science and medicine help?

When I was 12 years old, I realized while at summer camp that my night vision was disappearing. In the last two decades, I lost my peripheral vision, contrast sensitivity and depth perception.

I worked in Dr. Orson Moritzs lab at the UBC department of ophthalmology and visual sciences, which focuses on research using tadpoles that contain known human mutations for retinitis pigmentosa to understand the disease.

I made an alarming discovery in our animal model: knowing the genetic cause of retinitis pigmentosa is vital for treatment with one class of drugs histone deacetylase inhibitors. These determine how genes are switched on or off.

A similar study in mice showed that the same drug reacted differently to variations in a single mutant gene that also causes retinitis pigmentosa.

Treating retinitis pigmentosa is like extinguishing fire. To stop a fire, you need to know whether its water-based or grease-based. If you try to use water to stop a grease fire, the damage gets worse.

Enrol in a patient registry

Blind and visually impaired people can advocate for eye health by enrolling in a patient registry. Participation in a registry benefits researchers by offering more information about the disease.

In Canada, individuals can self-refer to Fighting Blindness Canadas secure, clinical patient registry. This database is dedicated to connecting people living with retinal eye diseases to clinical trials and research.

When a gene therapy trial arises, researchers draw participants from this database. Since gene therapy aims to correct an underlying genetic mistake in DNA that causes disease, knowing the genetic cause of a disease is a criteria for most gene therapy trials.

Globally, other registries include My Retina Tracker in the United States, Target 5000 in Ireland, MyEyeSite in the United Kingdom, the Australian Inherited Retinal Disease Registry and Japan Eye Genetics Consortium. In New Zealand, Dr. Andrea Vincent has established the Genetic Eye Disease Investigation Unit. There is even a Blue Cone Monochromacy Patient Registry for one rare eye condition.

Blossoming gene therapy trials

In the last two decades, the number of gene therapy trials has blossomed. Currently, 250 genes on inherited retinal diseases have been identified. In 2017, the first gene therapy for inherited retinal disease Luxturna was approved by the United States Federal Drug Administration.

To date, there are trials for: retinitis pigmentosa; Usher syndrome, a condition that involves hearing and vision loss; achromatopsia, a disease that causes colour blindness; X-linked retinoschisis, a dystrophy that causes splitting of the retina and affects mostly in males; and age-related macular degeneration, the third-largest cause of vision loss worldwide, caused by the interplay between genetics and environment.

Enrolment in a patient registry and genetic testing advance the design of gene therapy trials. This in turn benefits blind and visually impaired people.

Research advancement is a concerted effort across the globe blind and partially sighted people should know they have the power to push it forward.

Ruanne Vent-Schmidt, PhD Candidate, Cell & Developmental Biology, University of British Columbia

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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BEYOND LOCAL: How people living with genetic eye conditions can drive vision research forward - TimminsToday

Catalent (stand 121A82), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced a busy conference program at the forthcoming CPhI Worldwide annual conference, being held at the Messe Frankfurt, Frankfurt, Germany, on Nov. 5 - 7, 2019.

SOMESET, N.J., Oct. 29, 2019 /PRNewswire-PRWeb/ -- Catalent (stand 121A82), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced a busy conference program at the forthcoming CPhI Worldwide annual conference, being held at the Messe Frankfurt, Frankfurt, Germany, on Nov. 5 7, 2019.

On Tuesday, Nov. 5 at 10:30 a.m., Jeremie Trochu, Vice President, Operations, Oral Drug Delivery, will participate in a panel session titled "Exploring Trends in Contract Manufacturing". Panelists will discuss market trends that are currently impacting contract development and manufacturing organizations (CDMOs), and how CDMOs have evolved their strategies to meet the unmet needs of the industry, as well as drive growth.

On Wednesday, Nov. 6 at 10:30 a.m., during the "Understanding the Cell & Gene Technology Opportunity" panel session, Thomas VanCott, Ph.D., Chief Technology & Strategy Officer, Paragon Gene Therapy (part of Catalent Biologics), will discuss ways in which CDMOs can create the correct infrastructure to support innovation, and the sector's commercialization and pricing challenges. Dr. VanCott will also discuss the various investment opportunities offered by the cell and gene therapy sector.

During the BioProduction conference, on Thursday, Nov. 7 at 12:20 p.m., Melanie Lasher, Manager, Project Management, Catalent Biologics will present "Beating the Clock: Case Studies in Accelerating Biologic Development" in the conference's "Manufacturing Strategies & Bioprocessing 4.0" stream. Using case studies, Ms. Lasher will highlight and discuss how previous challenges to reduce scheduling delays and accelerate timelines were overcome in projects progressing from cell line development to clinical trial supply.

Mr. Trochu joined Catalent in 2012, following 10 years at General Electric where he held several commercial leadership positions within its healthcare division. His current role sees him lead Catalent's global oral solid pharmaceutical development services. Mr. Trochu received a master's degree in international management from Emlyon Business School, cully, France.

Dr. VanCott joined Paragon following 14 years as the President and CEO of Advanced Bioscience Laboratories, Inc. (ABL). Before joining ABL, he held several positions at the Henry M. Jackson Foundation for the Advancement of Military Medicine. Dr. VanCott received a doctorate in physical chemistry from the University of Virginia, Charlottesville, Virginia, and a bachelor's degree in chemistry from Dickinson College, Carlisle, Pennsylvania.

Ms. Lasher has more than 10 years' experience in the biopharma industry. She has managed a variety of clinical, process and performance qualification, and commercial projects, supporting drug substance manufacturing, drug product filing, and packaging. Ms. Lasher received a bachelor's degree in management from Indiana Wesleyan University, Marion, Indiana, and is a certified Project Management Professional.

At the conference, Catalent will also be exhibiting and showcasing its multiple innovative technologies, including its OneBio platform, which has been shortlisted for a CPhI Excellence in Pharma Award, in the "Contract Services and Outsourcing" category. The winners will be announced at a gala dinner on Tuesday, Nov. 5.

Earlier that day and on Wednesday Nov. 6 at 4 p.m., Catalent will host a networking reception on their stand. For more information visit stand 121A82 or http://www.catalent.com.

To arrange a meeting with any of the attending Catalent experts at the event, contact Richard Kerns at NEPR - richard@nepr.agency.

About Catalent Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com More products. Better treatments. Reliably supplied.

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Catalent to Discuss Accelerating Development in Biologics and Gene Therapies as well as Oral Outsourcing Market Trends at CPhI Worldwide - Yahoo...

Deepak Chopra, Special to SFGate

By Deepak Chopra, MD

Most people have mixed feelings about how their lives are going, which seems inevitable. Taking the bitter with the sweet is an old saying dating back to the 13th century, but it expresses a universal experience. In the face of lifes mixed blessings, however, there runs a deep yearning for transformation. It is expressed through visons of heaven where eternal bliss is gained, in romantic literature where a perfect life is attained here on earth, and in utopian visions of every kind, including worldwide myths of a lost Eden or a Golden Age.

Is this yearning for transformation mere wish fulfillment, like dreaming of what youd do if you won the lottery? If you are totally pragmatic, the answer is yes, and having abandoned such fantasies you can productively direct your energies to becoming better off by inches and degrees. Even then, modest goals arent always achievable. We settle for half a loaf, or less, because common sense tells us to.

But I think the issue runs deeper than pragmatism. In my new book Metahuman: Unleashing Your Infinite Potential, I propose that the desire for transformation is not only realistic but totally necessary. Transformation is like the total change of state when two invisible combustible gases, oxygen and hydrogen, combine to form a liquid, water, that puts out fires. The essential nature of the two gases give no hint that they could be transformed so completely. But that is what transformation means, as opposed to gradual stepwise change.

What would it mean to totally transform a human being? Despite the stubborn way that people resist change, clinging to beliefs, fears, biases, and personal tastes for no rational reason, we are transformative beings. This can be evidenced in everyday experience.

None of these experiences is alien, yet we dont usually label them transformative. Why not? Because the setup for being human is drastically tilted toward conformity, normality, and conventionality.Every child absorbs, as if by osmosis, that life is a struggle between good and bad, light and dark, desire and frustration, success and failure.

This condition, generally known as duality, is what Metahuman tries to overturn. Duality condemns us to a lifetime of either/or choices. We identify with the choices we make, and then we cling to the identity that results. We shake our heads when we encounter people who have made bad choices, turning for example into racists or xenophobes, but at bottom the problem isnt bad choices and the solution isnt good choices. Either side of the coin keeps you trapped in duality.

Transformation provides an escape route from what is otherwise an all-embracing worldview. All visions of transformation have in common a desire to be liberated, set free from some kind of personal limitation. In exceptional cases, such as the life of the Buddha or Jesus, the vision of transformation renounces everything duality holds out as the good life.To be in the world but not of it is as radical as seeking to escape the eternal cycle of pleasure and pain.

In Metahuman I dont argue for radical transformation in that way. Instead of presenting transformation as a far-away goal, I argue that it should be a starting point. The common experiences cited earlier give a clue to what the transformed life is like. It is open to change because change is always with us. It allows rather than resists, because no one can predict where any situation might go.

But the biggest shift occurs in a persons identity. Instead of identifying with all the choices youve made in your life, you identify with the state of awareness you are in. Consciousness becomes your identity. I can illustrate what that means with a simple example. Imagine that you are on a debating team, and the question is Does God exist?In this debate the two teams will draw lots to determine who take which side of the question. As a debater you are prepared to argue for total faith in God or total atheism.

Clearly a good debater can do this, and in our legal system, defense lawyers are often asked to mount an argument for indefensible clients. In everyday life we identify with one viewpoint or the other, faith versus atheism, but in reality we are set up to rise above either position, simply because we can instantly change our perspective. This is more basic than any single perspective, yet we live as if the opposite is true. Every -ism is just a perspective somebody wants to defend and cling to.Nazism is dire while pacifism is benign, but each concept limits your unconditioned consciousness, depriving you of the power of transformation.

My way or the highway has become a noxious trend in todays divisive world, by which polarization has become the status quo. But at a subtler level we all cling to our point of view, having forgotten that to be human is never a point of view. To be human is to go beyond any fixed belief, conditioning, bias, or fixed assumptions. What would it be like to live as if transformation is your true essence? Thats the real issue we should be discussing, because the future of humanity and of the planet depends on the answer we arrive at.

Deepak Chopra MD, FACP, founder ofThe Chopra Foundationand founder of Chopra Global and co-founder of Jiyo, is a world-renowned pioneer in integrative medicine and personal transformation, and is Board Certified in Internal Medicine, Endocrinology and Metabolism. He is a Fellow of the American College of Physicians and a member of the American Association of Clinical Endocrinologists and Clinical Professor of Family Medicine and Public Health at the University of California, San Diego. Chopra is the author of more than 85 books translated into over 43 languages, including numerous New York Times bestsellers. His latest book is Metahuman: Unleashing Your Infinite Potential. Chopra hosts a new podcast Infinite Potential and Daily Breath available on iTunes or Spotifywww.deepakchopra.com

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Personal Transformation - What It Really Means - SFGate

Daily Inter Lake - Local News, Health providers see hope on the horizon with integrated approach '); $(this).addClass('expanded'); $(this).animate({ height: imgHeight + 'px' }); } } }); }); function closeExpand(element) { $(element).parent('.expand-ad').animate({ height: '30px' }, function () { $(element).parent('.expand-ad').removeClass('expanded'); $(element).remove(); }); } function runExpandableAd() { setTimeout(function() { $('.expand-ad').animate({ height: $('.expand-ad img').height() + 'px' }); }, 2000); setTimeout(function() { $('.expand-ad').animate({ height: '30px' }); }, 4000); } function customPencilSize(size) { var ratio = 960/size; var screenWidth = $('body').width(); if (screenWidth > 960) screenWidth = 960; $('.expand-ad__holder').parent('.ad').css('padding-bottom', (screenWidth / ratio) + 'px'); $('.expand-ad__holder').css({ height: (screenWidth / ratio) + 'px' }); $('.expand-ad').css({ height: (screenWidth / ratio) + 'px' }); $('.expand-ad img').css('height', 'auto'); $('.expand-ad embed').css('height', 'auto'); $('.expand-ad embed').css('width', '100%'); $('.expand-ad embed').css('max-width', '960px'); } function customSize(size, id) { var element = jQuery('script#' + id).siblings('a').children('img'); if (element.length 960) screenWidth = 960; element.css('height', (screenWidth / ratio) + 'px'); } (function () { window.addEventListener('message', function (event) { $(document).ready(function() { var expand = event.data.expand; if (expand == 'false') { $('.expand-ad__holder').removeClass('expand-ad__holder'); $('.expand-ad').removeClass('expand-ad'); } }); }, false); function loadIframe(size, id) { $('.ad').each(function () { var iframeId = $(this).children('ins').children('iframe').attr('name'); var element = $(this).children('ins').children('iframe'); if (element.length > 0) { var ratio = 960 / size; var screenWidth = $('body').width(); if (screenWidth > 960) screenWidth = 960; element.css('height', (screenWidth / ratio) + 'px'); } }); } })();

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It is the mission of the NJ Center for the Healing Arts, Inc. to provide access to opportunities for the integration of mind, body, emotions and spirit through counseling, medicine, complementary healing arts, educational resources, cultural and artistic expression, and the celebration of community.

NJCHA was one of the first integrated mental health and wellness centers in the country and has been offering a multidisciplinary approach to healing since 1987. Understanding that each person is a biopsychosocial being, influenced by many factors (including genetics, behavior and the environment), the emphasis at NJCHA is health of body, mind and spirit.

Creative Expressive Therapies and Art Therapy

Creative Expressive Therapies use techniques that help clients explore feelings, dreams, memories and ideas and to provide a means of creative expression for that which has no words. No artistic skill is necessary. The goal is to resolve conflict. Though a non-threatening form of therapy for children, creative expressive techniques are for people of all ages. They are especially effective when dealing with trauma, depression, and loss, recovering from abuse and for management of anger.

Sand Tray Therapy

Sand Tray Therapy is a symbolic process that has the power to reach deep unconscious content without words or analysis. It works on the premise that the human psyche is capable of healing itself when given the opportunity and the right conditions. Using a tray filled with sand, participants are given minimal instructions. They select from numerous objects and then arrange their selections in the tray. The therapist is a witness to the creation of the world in sand as the process unfolds and the story is told.

Mandala Assessment (MARI Cards)With the use of mandala drawings, symbols, colors and some dialogue, the MARI Card process can assist individuals in understanding their present states of being. An assessment and research instrument developed by Joan Kellogg, MA, ATR, it is grounded in Jungian theory and cross-cultural studies. This process can assist in understanding life issues that are seeking immediate attention. The process begins with a mandala drawing. This is a drawing in a circle, which is a universal symbol of self and wholeness. It represents the totality of the world -- one's individual world. Then, cards with symbols are selected and colors cards are chosen that help to reveal the essence of a story that is primary in the immediate moment to the individual engaged in the process. The MARI CARDS provide an experiential way to access wholeness and give focus so that action can be taken. This self discovery process is not covered by insurance.

Halloween

Visit our center on Halloween to learn more about our not-so-spooky approach to mental health and wellness! We'll have treats for children and adults alike, as well as a fun Halloween craft!

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Counseling Center Gives Treats (No Tricks) on Halloween - Patch.com

Return-to-sport protocols are integral in ensuring athletes are healthy and capable of safely performing at the highest level.

Sports medicine staff as well as strength and conditioning coaches commonly agree on what athletes need prior to reengaging in sport, but rarely are they on the same page regarding the optimal methodologies.

Some believe that when a previously repaired joint is structurally sound and capable of moving through every range of motion, they are ready.

Others, however, believe an athlete must be at or above the level they were at prior to the injury to truly be "ready."

The methods used for rehabilitation vary depending on therapists, doctors and strength coach's individual beliefs. An integrative approach that allows one to seamlessly transition from doctor to physical therapist to strength coach with matching beliefs and congruent systems is what yields optimal results!

Admittedly, the biggest fallacy has traditionally been between physical therapists and strength coaches (like myself).

Doctors and physical therapists work extremely well together, particularly post-surgery. Patients typically have a precise protocol and adhere to it with ease, getting themselves out of the "pain stage."

From there, physical therapists do a wonderful job of restoring basic neuromuscular coordination as well as joint range of motion to their clients.

The biggest hurdle from there is when a client/athlete decides they are ready to regain full strength and get back to the activities they love.

Many physical therapists are capable of carrying out such a task, however they are often limited to the clinical space they work in where sports performance is not the primary concern.

This is where strength and conditioning professionals like myself often enter the picture and assist individuals with integration into a training routine.

Unfortunately, some people will try to bypass this stage because they believe that with no pain and a largely restored range of motion, they are essentially fully healed and ready for sport.

This could not be further from the truth! They might be ready to train, but they're likely not ready to perform.

Why?

Because they likely haven't begun proper plyometric progressions, re-trained in power and speed exercises, increased their maximal strength, or even addressed the asymmetries that originally contributed to the injury or the asymmetries that likely developed during the rehab process.

Does that sound like someone who's really ready to return to sport to you?

Strength and conditioning professionals must do a better job of communicating with physical therapists.

They must consistently communicate where the athlete is in their progress and where it is they need to go.

Programs we provide must be able to bridge the gap between athletes ready to train, and athletes ready to perform. Not all athletes will arrive at the gym healthy and ready to go. Some assessments, critical thinking, and integrative programming are required.

Perhaps one of the biggest roles a strength coach can play after that is providing training that reduces future injury risk. Preventative maintenance is key, and the number one rule of any coach is do no harm.

Properly planning and understanding that not every person will train the same based on their injury profile and history is key. My advice to anybody reading this article is to find the right coach and training program for you.

There are alternatives to nearly every training approach, and most goals can be met in a multitude of ways. Take initiative and help bridge the communication between your doctors, therapists and trainers.

Most athletes will perform a variation of a sport test with sports medicine staff prior to being cleared for sport.

Typically, that is where things get most blurry. Getting "cleared" to ski, for example, doesn't mean one is ready to do six giant slalom practice runs at their previous intensity right away.

Strength and conditioning staff can aid in this process by regularly testing all healthy athletes in a number of performance parameters (e.g., Vertical Jump, Broad Jump, 40-Yard Dash, etc.) so there's a baseline to compare if they do indeed get injured.

Taken one step further, athletes can inquire with qualified exercise physiologists to perform basic symmetry testing on them such as force plate jumps. Power, symmetry and performance numbers can be derived from such data and will allow intelligent coaches to program accordingly for athletes in their unique situation.

Last but not least, one key piece that must be discussed is a coach's own intuition.

Over years of training and coaching, one will ideally develop a high level of intuition or a keen "coach's eye."

Watching an athlete jump, run, or cut and noticing a slight movement deficiency, despite all of their numbers checking out, is a huge piece to consider. If a mechanic handed you your car back and gave you the green light to drive it but you saw a deflated tire, you wouldn't just ignore it. The same goes for an injured athlete.

Just because all of the tests have been passed and all of the numbers check out doesn't necessarily mean they are completely ready. They must be physically, mentally and psychologically ready to return.

Consider all of these points and remember that returning to sport after injury is comprehensive and requires special attention to detail. The value of a heart-to-heart conversation with an athlete about their injury and their mental and physical progress is also extremely valuable!

Many times, an athlete will simply insist that they're "ready." But if there are things that don't feel quite right and they're willing to speak with you about that, that's another piece of extremely valuable info that can further inform your approach.

Photo Credit: FG Trade/iStock

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Crucial Steps Injured Athletes Often Overlook as They Rush Back to Action - STACK News

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Sports Medicine Market witness highest growth in near future described in a new market report - Health News Office

The Council of Scientific & Industrial Research (CSIR) in India has conducted Whole Genome Sequencing of 1,008 Indians from different populations across the country.

Announcing details of the IndiGen Genome project, the Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare, Government of India, Dr Harsh Vardhan said that the whole genome data will be important for building the knowhow, baseline data and indigenous capacity in the emerging area of Precision Medicine. The outcomes of the IndiGen will have applications in a number of areas including predictive and preventive medicine with faster and efficient diagnosis of rare genetic diseases, he added.

The IndiGen initiative was undertaken by CSIR in April 2019, which was implemented by the CSIR-Institute of Genomics and Integrative Biology (IGIB), Delhi and CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad. This has enabled benchmarking the scalability of genome sequencing and computational analysis at population scale in a defined timeline. The ability to decode the genetic blueprint of humans through whole genome sequencing will be a major driver for biomedical science.

Dr Harsh Vardhan said that the benefits of this initiative include epidemiology of genetic diseases to enable cost effective genetic tests, carrier screening applications for expectant couples, enabling efficient diagnosis of heritable cancers and pharmacogenetic tests to prevent adverse drug reactions.

On the occasion, Dr Harsh Vardhan unveiled the IndiGenome card and accompanying IndiGen mobile application that enables participants and clinicians to access clinically actionable information in their genomes. He emphasized that it ensures privacy and data security, which is vital for personal genomics to be implemented at scale. Dr Harsh Vardhan elaborated that this is being pilot tested in individuals across India and has evinced interest from several Indian commercial organisations.

The outcomes of the IndiGen will be utilized towards understanding the genetic diversity on a population scale, make available genetic variant frequencies for clinical applications and enable genetic epidemiology of diseases. The whole genome data and knowhow for the analysis of largescale genomic data is expected to enable evidence and aid in the development of technologies for clinical and biomedical applications in India.

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India conducts whole genomic sequencing for Biomed applications - BSA bureau