StemCell Therapy

SAN CARLOS, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc., (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company plans to present at the following conferences in December:

Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at http://ir.iovance.com.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patients own immune cells to attack cancer. TIL cells are extracted from a patients own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the companys TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovances T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit http://www.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our). We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the U.S. and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to successfully submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates that have been granted breakthrough therapy designation (BTD) or regenerative medicine advanced therapy designation (RMAT) by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Companys product pipeline; the successful implementation of the Companys research and development programs and collaborations; the Companys ability to obtain tax incentives and credits; the guidance provided for the Companys future cash, cash equivalent, and short term investment positions; the success of the Companys manufacturing, license or development agreements; the acceptance by the market of the Companys product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Companys control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Companys business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyses of these trials or subgroups within these trials; a slower rate of enrollment may impact the Companys clinical trial timelines; enrollment may need to be adjusted for the Companys trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in the Companys cervical cancer trial may have an adverse effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient populations may result in changes in preliminary clinical results; the Companys ability or inability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical, safety, manufacturing and control requirements; the Companys interpretation of communications with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Companys ability to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development process or review of the Companys product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own facility may adversely affect the Companys potential commercial launch; and additional expenses may decrease our estimated cash balances and increase our estimated capital requirements. A further list and description of the Companys risks, uncertainties and other factors can be found in the Companys most recent Annual Report on Form 10-K and the Companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or http://www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investor Relations Contacts:Annie ChangSolebury Trout646-378-2972achang@troutgroup.com

Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com

Media Relations Contact: Rich AllanSolebury Trout646-378-2958rallan@troutgroup.com

Excerpt from:
Iovance Biotherapeutics to Present at Upcoming Investor Conferences in December - BioSpace

I recently had an experience that highlights, for me, some of what is wrong with our medical insurance system.

I love playing tennis, but my knees have been deteriorating. The cushioning material is wearing away, and there is arthritis. The increasing pain and swelling I was experiencing led me to consider knee replacement surgery, or the end of my tennis career. Neither choice was appealing.

My naturopathic doctor suggested I consider PRP therapy. Platelet-rich plasma treatment has been growing in popularity because it often provides an alternative to knee- and hip-replacement surgery. It can also help tennis tendinitis and rotator cuff injuries. Professional athletes, including Tiger Woods, use PRP therapy. Despite its successful track record, it is not covered by insurance, Medicare or otherwise.

PRP therapy involves removing a small amount of ones blood and separating out its components in a centrifuge. The concentrate is then injected into the area that needs help. The platelet-rich blood attracts stem cells, the bodys repairmen, to the area to rebuild tissue, muscles and tendons.

I love this concept because it uses the bodys own healing ability to rebuild worn-out parts. As a lifelong proponent of homeopathy and other natural healing modalities, I decided to give PRP a try. On Sept. 10, I drove to the office of Dr. John Herzog in Falmouth, Maine, to check it out, despite the fact that Medicare would not cover the cost.

Dr. Herzog is an osteopathic orthopedic surgeon who has performed thousands of surgeries to replace knees and hips over his 30-year career. In 2009 he decided to stop doing surgery and focus on PRP, after finding how much it helped his own knee condition. He has treated more than 3,000 patients since then, with an 80% success rate.

After a basic physical exam to see how well my knees flexed, we looked at them with ultrasound. It was fascinating to watch as Dr. Herzog explained the state of each knee cavity. Fortunately, I was not in a complete bone-on-bone condition; both knees were good candidates for PRP treatment.

I initially thought I would test the treatment on one knee, but opted to have both done. The cost was $600 for one knee, $1,000 for both. Despite paying for this out-of-pocket, it seemed a reasonable cost given the much more expensive alternatives. Knee and hip replacements average $30,000.

Dr. Herzog drew a cup of blood from my arm, put it in a centrifuge and injected the platelet-rich concentrate into both knees. I was out of the office on my way home in a little over an hour. I was told results were normally felt within 4 to 6 weeks, and could last up to a year or more. Every person responds differently, some return for tune-ups after a year.

The following day both knees were quite sore and swollen as blood and oxygen rushed to the area. The next day the swelling began to subside, and five days after the treatment I played tennis. Now, some two months later, the results have been remarkable. Both knees are stronger. Recovery after tennis is greatly reduced. I stopped wearing knee braces, and my movement on the court is now the best its been in years. Im considering playing three times a week instead of two. I feel a little bit like Forrest Gump!

Given the significant success rate of this treatment, the low cost, low risk and absence of side effects, why is it not covered by medical insurance? When I posed this question to a spokesperson at Concord Orthopedics, where one doctor now offers the treatment, their guess was the lack of clinical data on PRP therapy. Its clear this therapy is rapidly gaining in popularity because it is effective and inexpensive.

Dartmouth-Hitchcock offers PRP treatments. Vermont Regenerative Medicine, located in Burlington, recently ran a series of full-page ads in the Monitor advertising their services.

You would think insurance companies and the medical establishment would jump on embracing such benign treatment. I was able to afford the $1,000 fee to have both knees treated, but how about all the people who cannot?

For many years, acupuncture and chiropractic care were not covered by medical insurance. Now they are. Similar to PRP therapy, they are effective, non-invasive and low cost. All therapies that employ our bodys healing ability to recover from injury should be put at the top of the list of treatments covered by insurance. Especially when they offer a true alternative option to more expensive and invasive surgery.

(Sol Solomon lives in Sutton.)

Read more:
My Turn: The malaise of medical care - Concord Monitor

Ever since we began covering them as the first Russian bioprinting company,3D Bioprinting Solutions, or 3dbio for short, came across as more focused on raising awareness on bioprinting by conducting high profile experiments than on exploring commercial applications for the future of bioprinting. Visiting the companys lab in Moscow, and speaking with Co-founder Yusef Khesuani, we learned that it may be exactly the opposite: maybe we are not talking about 3dbio nearly as much as we should.

In fact, that may all be changing now with some more announcements coming up in the next few weeks. One of the main issues limiting 3dbios visibility in Western Europe and North America may be related to the fact that they are based in Russia. Due to generalized lack of awareness of Russian matters in the West, the way for 3dbio to get some well-deserved recognition has been to do things that are quite literally out of this world: building Russias first bioprinter (Fabion) in 2014, bioprinting and implanting a rodent thyroid gland in 2015, developing a bioprinter based on magnetic levitation and finally sending (not once but twice) said bioprinter, aptly named Organ.aut, to print in space on the ISS. That was in 2018.

Now the time has come for the bioprinting company to come back down to Earth and leverage its space-faring experience to venture into more short-term commercially viable businesses, such as bioprinting meat or in-situ bioprinting of tissue grafts. We spoke about these and the bioprinting markets status in general with Dr. Khesuani.

3D Bioprinting Solutions was founded by INVITRO, the largest private medical company in Russia, which is why the laboratory is located on one floor of the INVITRO facility in Moscow. The companys other Co-founders include INVITRO founder Alexander Ostrovsky and VIVAX BIO CEO & CFO (also INVITRO Advisory Committee Member) Yakov Balakhovsky. New York-based VIVAX BIO is actually 3D Bioprinting Solutions mother company through a complex structure that sees 3dbio as the core research lab used to fuel ideas for new, bioprinting based, commercial startups.

We hope that our R&D efforts will serve to create new spinoffs that will work as business startups, Dr. Khesuani begins. 3dbio is not a classical startup. We are here to set the foundations for science and give direction. Now we are going to launch a new startup next January, focusing on bioprinting artificial (bioficial) meat and based on the successful experiment we conducted printing meat on the ISS, together with Aleph Farms. In this case, we used the muscle cell sources supplied by Aleph Farms and combined them with our bioprinting technologies.

While artificial (or bioficial) meat may be closer to commercialization, the ultimate goal of 3dbio has been to produce human organs from the very beginning. Khesuani points out how bioprinters today are made primarily to print scientific papers rather than organs or implantable tissues. They basically combine different cells, different hydrogels and different geometries. Every different combination of one of these three factors is a basis for a new scientific paper, he says. Bioprinters are also used for drug discovery by companies like Organovo, another firm that started with the goal to print organs then moved to drug research. Khesuani believes that the drug discovery analysis process for bioprinted tissues is still too incomplete to attract big pharma companies.

One key difference between 3dbio and other bioprinting companies is that, after the Fabion and Fabion 2 systems, which are based on different types of extrusion, deposition and curing processes, they have now been working on a morevolumetric approach for bioprinting in spaces microgravity environment. While extrusion and deposition systems are considered ideal for flat, layered organs, such as cartilage and skin, more complex, tubular organs, such as, for example, a urethra, need a more tridimensional approach.

Using the Organ.aut magnetic system and further developing new acoustic means of controlling cellular materials in microgravity, 3dbios volumetric technique is able to produce more complex constructs without requiring a scaffold. The bioprinter now on the ISS uses magnetic fields to control the cellular materials. Using microgravity as a co-factor, it implements a scaffold-free, nozzle-free and label-free (no magnetic nanoparticles involved) formative approach. 3dbio researchers also showed off an early version of the acoustic system (in the video above). In theory, one could be used to distribute the material on the X and Y axes while the other could be used to control them along the Z-axis.

What feels particularly amazing is that, while visiting the 3dbio lab and speaking with Dr. Khesuani, Earths orbit, all of a sudden, seems a lot closer. Supplies from 3dbio regularly go up to (and down from) the ISS, in special containers that even have a stamp showing they transited on the ISS (seen in the photo above). In general, all of Moscow seems to have a particularly close relationship with space. When 3dbio approached Roscosmos about bioprinting in space in 2014 their proposal was met with enthusiasm. The project was conducted very rapidly, in spite of the first launch failing. Now laughing about it, Khesuani revealed that the bioprinter that fell back to Earth from a height of about 80,000 meters was actually still functional and will be exhibited at the Space Museum in Moscow in March.

Another approach to bioprinting that 3dbio is exploring is that of using a multi-axis robot for in-situ contour 3D bioprinting also considered a type of volumetric 3D printing. We have also been working with Kuka on using one of their robots to 3D printing tissue grafts directly on the body and we are soon going to announce another startup focusing on this technique, Khesuani reveals. We implemented our nozzles on the robotic arm to print directly on skin defects. One key issue that we are approaching is that our system will be able to use computer vision and machine learning algorithms in order to compensate for a living organisms body movements while breathing.

Along with the software, 3dbio developed a number of innovations for material handling in order to make the skin graft truly effective These will be officially presented next December 6th, in a joint release with Kuka. The first experiments will be conducted on small size pigs. Some experiments were already successfully conducted on rats, however, Khesuani explained that there is a significant gap between experimenting on small and large animals and an even bigger gap between large animals and humans. We expect to have the results of the tests for in-situ bioprinting on the pigs sometime next year, he said.

If bioprinting may still take years to bring real commercial applications, is bioprinted meat any closer? The answer lies in what we mean by meat. Just like industrial applications, to fully leverage the benefits of digital, additive manufacturing we need to completely reinvent food products. Thats one of the reasons why there is so much interest for bioprinting in space, where astronauts and cosmonauts already need to eat very different paste-like food products.

A lot of people think the goal is to bioprint a steak, Khesuani explains. If that is the final objective, then regenerative medicine may actually be closer. What we need to do is imagine new food products based on cellular agriculture. Even snacks such as Mars or Snickers were invented for military purposes in the 50s and 60s. We need to think of food products that do not exist today.

One of the biggest limits, in food as in medical bioprinting, is the lack of adequate cellular materials. Its almost like having Google without having the Internet, Khesuani says. We have the bioprinters to surf but we lack the materials to surf on. For in-situ medical applications, 3dbio developed the Viscoll line of collagen materials, which are suitable for any 3D bioprinter. It is aconcentrated sterile solution of highly purified Type 1 collagen which can be used to print three-dimensional scaffolds directly, or blended with cell suspensions to print cell-laden hydrogels. It was designed for the engineering of biocompatible and non-toxic, three-dimensional tissue constructs ideal for tissue engineering and regenerative medicine. A unique feature of the Viscoll hydrogel range is the use of a viscous solution of collagen with a physiological pH value, enabling the addition of living cells or spheroids without neutralization prior to 3D bioprinting. This significantly reduces the time and effort spent on conducting experiments and increases the viability of biological material.

The wide range of collagen concentration allows researches to produce designs with different mechanical densities and rates of bioresorption, depending on their biomedical purpose and the type of cells being used fibroblasts, multipotent mesenchymal stromal cells, pancreatic islet cells, and so on. The presence of any collagen Types I-V or other ECM proteins (Vitronectin, Fibronectin, Laminin) in the hydrogel determines the specific tissue type of the constructs: skin, bone or cartilage tissue, blood vessels, and parenchyma of internal organs.

Selling bioprinters is also a possible commercial business, and several FABION systems are now installed worldwide. Khesuani does not expect this to ever become a core business for 3dbio as operating these machines require engineering experience that is not often found in a scientific laboratory. The systems are generally installed in institutes that partner directly with 3dbio on developing new applications.

We have to be optimistic Khesuani says -. When we started there were maybe six bioprinting companies all over the world, now there are over 80 including companies, like CELLINK that have a great business model, although different from ours. Our goal was always to print human organs. We need to focus on that, rather than on selling more machines. He believes that other possible areas of expansion could be the development of medical devices and a new B2S business to science segment, where 3dbio could provide scientific results from experiments and help to commercialize them, as they are doing with the bioprinter in space.

One such result, also achieved in space, was growing of protein crystals, another was the development of new materials in space to use in regenerative medicine. Yet another was the production of 3D structures using bacteria, also in space, to study antibiotic resistance. 3dbio continuous to build networks with some of the most prestigious universities in the world and is entering talks with other space agencies such as ESA and JAXA. Next up will be the next generation of magnetic and acoustic bioprinters for volumetric bioassembly, as 3dbio continues to go where no other bioprinting company has ever gone before while building the bioprinting application market here on Earth.

Visit link:
The future of bioprinting is out of this world at 3D Bioprinting Solutions in Moscow - 3DPMN

Hitachi, Ltd. headquartered in Tokyo, Japan, is focusing on Social Innovation Business combining its operational technology, information technology and products, has developed a new automation technology of 3D culture, solving problems of the previous 3D culture using Hitachi's Automated Cell Culture Equipment for iPS cells.

Automation of both 2D culture and 3D culture using this equipment makes it possible to automatic massive manufacture a variety of cell types such as cardiomyocytes, meeting customer needs. The automation technology was developed by collaborative research with Myoridge Co. Ltd. which has culture technology of iPS cell-derived cardiomyocytes by the protein-free method.

Furthermore the support service to establish an automatic manufacturing process for customers who are considering automation of manufacturing regenerative medicine products will be started on December 1st, 2019. As for the service, Hitachi will examine customers' manual manufacturing process to find out the important parameters, and suggest how to optimize them by the development knowledge of automation technology of 3D culture.

Expanding the market of regenerative medicine to recover the functions of tissues and organs is expected in recent years. A large number of cells are required for regenerative medicine but it is difficult to manufacture an enough amount of cells manually. So the automation technology of mass cell culture is necessary to expand the market of regenerative medicine.

Hitachi had been developing automation technology of mass iPS cell culture, and developed the automated cell culture equipment for iPS cells for research use in June 2017. Adopting the closed flow channel for the connection of the culture vessels and the medium bottles, the equipment is capable of cell seeding, culturing, and monitoring in sterile environment and offers stable supply of high-quality mass cells. Hitachi commercialized the automated cell mass culture equipment which has the necessary functions to comply with the Japanese regulation, GCTP for the first time in Japan in March 2019.

Hitachi automated the new 3D culture (low medium cost, low shear stress, and simple medium change process) by collaborating with Myoridge, solving problems of the previous 3D culture. The previous 3D culture has problems such as using a large amount of medium because of the height of the culture reactor, the shear stress to cells from the agitating medium, and the complex process of medium change. Hitachi started the collaborative research with Myoridge in October 2018 and developed the automation technology of the new 3D culture by distributing spheroids both uniformly and densely on the cell culture vessel for 2D culture. Furthermore, Hitachi manufactured cardiomyocytes by the automation technology more effectively than by manual. The technology is probably able to be applied to a variety of cell types and make them be manufactured automatically.

More here:
Hitachi develops automation technology of 3D culture - BSA bureau

The future of innovation in the field of medical devices and regenerative medicine depends on the deep understanding of the mechanisms of interaction between biomaterials and the host biological environment. New chemistry and material engineering will need to emerge to produce biocompatible, bioactive, and bioresponsive biomaterials. The European Society for Biomaterials (ESB) offers a multidisciplinary environment where scientific knowledge is promoted, and technological solutions can be found. Speaking to ESB President Pamela Habibovic, we found out about some of the latest developments in advanced medical devices, regenerative medicine, and Biomaterials research and development.

The ESB is the oldest and one of the largest societies in the field of biomaterials. We bring together scientists in this field, in order to really stay up to date with the developments in the field. We connect with our affiliated societies in Europe and we do the same with our international sister societies. For example, every year, the presidents from each affiliated European society come together to discuss what is happening on the national level in the individual countries and how we can learn from each other and strengthen these developments.

In addition to this, we are also playing the liaison between our members and our sister societies (such as those in the US, Canada and Asia). We are trying to understand the developments in the other parts of the world in this field and communicate that to our members. Moreover, we liaise with the European Commission to both understand the European vision and priorities in research and development funding, and to inform the policy makers about developments in our field. In short, we explain how biomaterials can be used to address the societal and economical challenges we are facing.

We also try and stimulate them to open possibilities for collaboration with biomaterials societies in China or in the US for example, where sometimes research is accelerating very quickly, and so we want to stay up to speed with the societies in these countries. The ESB also has a lot of attention for the younger researchers in the field. We offer them possibilities to stay informed and educated on relevant topics such as scientific writing, grant applications, and job opportunities. An important player in these activities is the ESBs Young Scientists Forum. The ESB has a lot of really different roles; it is bringing everybody together in the biomaterial field, academic researchers, clinicians and people from the industry, and offering them a platform to exchange ideas and knowledge.

The whole biomaterials field has changed over the past couple of years and it is still changing. Before, we had the materials that were passively taking over the function of a malfunctioning organ or tissue, mainly medical devices such as hip implants and mechanical heart valves etc, and whilst these are still tremendously important and have made a difference to many patients, we are now expecting more and more from biomaterials.

We dont want them to just sit there and to perform their mechanical function. We really want them to actively interact with the body, and to instruct the body to exert a certain function. For example, to trigger the process of regeneration, or to stop infection or inflammation.

We are trying to develop materials that have an advanced interaction with the environment of the body. We also see that theres a greater need for models that are more physiologically representative than conventional systems based on cell and tissue culture in 2D. This will reduce the number of animal studies needed to test new drugs, regenerative therapies, etc. I think biomaterials are already playing a very important role in the context of creating a physiologically relevant microenvironment.

It is important to have models where we can understand diseases and develop treatments. However, current developments of new medical devices, implants and tissue engineered constructs will remain equally important.

I think the biggest challenge is the translation of research itself. We expect researchers to have all the knowledge ranging from the doing fundamental research, to doing everything that is needed to turn such an innovation into a product. Nowadays, if I look at academia, we expect researchers to actually take the initiative to translate their research findings into something that is potentially clinically or commercially relevant. However, many of us academics, we do not have the important knowledge to do that. Many researchers simply do not have the time or skills to turn our research into business plans.

What I think is one of the biggest challenges is finding a liaison between research and people who are experts in making the research translate into something clinically applicable, or even a commercial product. This includes actively helping the scientists identify the potential ideas that can then be translated into clinical applications and helping them through the process of regulation and business plan development. I think that this is missing and that many scientists are struggling with this. Many of us working in this field do have the final aim of helping a patient, but it is difficult to go from a finding in the lab to something that is commercially viable; there is still insufficient support in this process in my opinion.

What I consider important in this context is the fact that the field of biomaterials is insufficiently making use of many available technologies from other fields. For example, in terms of wearables for sports and/or monitoring our health, eventually this will start playing a more important role in medical devices and regenerative medicine as well. In order to do that, we really have to learn from other fields and integrate innovations from those fields into ours.

We have to make much more use of the fields of micro- and nanotechnology but also data science, for example. There is a lot of advanced engineering going on in other fields, but these havent yet reached our field. I think that what would be great is that if the ESB could play this role and actually monitor developments in other fields and try to bring these to our scientists and vice versa. I hope we will be able to play a more proactive role in this context in the future.

The ultimate aim of our field is to make patients quality of life better. Im hoping that in five years from now, we will have even more therapies in which biomaterials play a role, which have reached the clinic and have actually helped patients. I also believe that without a very high end fundamental research, the innovation will stop so Im also hoping that the field will continue to innovate (for example, by using tools from other fields), but there is also so much more unexplored in our field.

Im hoping that in five years from now, there will be significant progress both in the translational side of the field as well as an fundamental side and that there will be enough funding for both because we really do need both to continue to innovate.

In terms of where the ESB will be in five years from now, I think we will still be there. We will be able to even more actively monitor, influence and support the developments in the field. I find monitoring what is happening in the world, and really making sure that we stay at the highest possible level as compared to the rest of the world imperative, and in addition to that, providing support to our scientists (especially our young scientists) in these development. That is really something that I hope we will be able to achieve and in five years from now be larger and more active than ever.

Pamela Habibovic PresidentEuropean Society for Biomaterials president@esbiomaterials.euTweet @ESBPresidenthttp://www.esbiomaterials.eu/

Read the original post:
Biomaterials research and development: Welcome to the ESB - SciTech Europa

Join us! To furnish your research and ideas and to examine your interpretation at International Conference on Stem Cells and Regenerative Medicine which is scheduled on November 06 - 07, 2019 at Tokyo, Japan.

Stem Cells 2019 provides you with a unique platform to share your generous thoughts and ideas related to your research and it adds a valuable acknowledgment to your profile.

The conference is based on the theme of Novel Techniques in Stem Cells and Regenerative Medicine. Based on this, we are delighted to have your presence at our conference.

Highlights include: Stem Cells, Regenerative Medicine, Tissue Regeneration, Therapeutic Cloning, and Stem Cell Transplantation which is detailed in Stem cells

To Visit our conference webpage: http://stemcells.pulsusconference.com/

Hope you will join hands with us to encourage Stem Cells research to have a better tomorrow.

We look forward to receiving a favorable consideration from you.

Explore the evidence to make a difference!

Best Regards,

Veronica Carter

Program Manager | Stem Cells 2019

E: stemcellresearch(at)pulsusglobalevents(dot)com

Ph: 44-203-769-1778

See the original post here:
International Conference on Stem Cells and Regenerative Medicine - Hoover Sun

WASHINGTON, D.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM) today released its most recent quarterly sector report, offering an in-depth look at cell therapy, gene therapy, tissue engineering, and broader global regenerative medicine sector trends and metrics in the third quarter of 2019.

By further curating information provided by ARMs data partner Informa, the quarterly sector report details industry-specific statistics compiled from 959 cell therapy, gene therapy, tissue engineering, and other regenerative medicine therapeutic developers worldwide, including total financings, partnerships and other deals, clinical trial information, key clinical data events, and ARMs current strategic priorities.

Amanda Micklus, a senior consultant for Pharma Intelligence at Informa, provided an overview of the commercial, clinical, and regulatory environment in the third quarter of 2019. The report also features commentary from founding members of ARM in honor of the organizations 10-year anniversary. Excerpts from panels at ARMs 2019 Meeting on the Mesa included in the report highlight the continued progress and innovation in the sector.

Highlighted findings from the Q3 2019 data report include:

ARM will continue to update this information through new reports to be released after the close of each quarter, tracking sector performance, key financial information, clinical trials by phase, and significant clinical data events.

The report isavailable online here, with interactive data and downloadable graphics from the reportavailable here. For more information, please visitwww.alliancerm.orgor contact Lyndsey Scull at lscull@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

Lyndsey Scull202 213 7086lscull@alliancerm.org

Read the original:
The Alliance for Regenerative Medicine Releases Q3 2019 Sector Report, Highlighting Industry Trends and Metrics - BioSpace

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

In a recent document published by the UK government in response to the Regenerative Medicine Inquiry by the House of Commons Science and Technology Committee, policymakers stressed the importance of commercialising new therapies to meet the changing needs of the health sector.

In the UK, the Regenerative Medicine Expert Group (RMEG) has been tasked with developing an NHS regenerative medicine strategy to ensure the NHS is fully prepared to deliver innovative treatment and that regulations support and not hinder its delivery.

The Cell and Gene Therapy Catapult is also continuing to work to bridge the gap between translational research and commercialisation.

However, for the UK to be well-positioned to offer safe and effective regenerative therapies, a strategy is needed that covers the whole value chain from academic research, commercial development and clinical application.

The effect of Brexit on the UKs regenerative medicine sector remains unclear, but the UK has the opportunity to develop an independent framework outside the EU regulatory system to accelerate the development of new therapies and its economic potential while upholding the highest patient safety standards.

In any case, EU and UK regulators need to prioritise the standardisation of regulations governing manufacturing, quality control and the supply chain to keep up with advancements made by the FDA in the US.

Establishing an efficient supply chain for regenerative medicine

The promise of regenerative medicine requires an innovative look at the complete product life cycle, 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 3 clinical trials, including packaging, labelling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far. Regenerative medicine is either personalised or matched to the donor-recipient. They are also highly sensitive to exogenous factors like time and temperature.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability. 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.

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.

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 times and temperatures, according to cell and tissue requirements.

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 vapour phase nitrogen; however, many clinical settings remain ill-equipped to handle such equipment.

On-site 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 Good Manufacturing Practice (GMP)-licensed clean room.

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.

Read more:
Delivering the promise of regenerative medicine - PMLiVE

New York City, NY: November 05, 2019 The recent update in WorldwideRegenerative Medicine Market begins with description of the merchandise, definition, classification specifications and scope of product Regenerative Medicine market outlook. The Regenerative Medicine report provides forecast amount from 2019 to 2028. It also includes a radical analysis of worldwide market static knowledge, growth factors and geographical region-wise analysis, the highest manufacturers/major players.

It analyse historical Regenerative Medicine market values to figure on latest market wants and estimate future market propensity. It compose of development plans and policies of every and key players at the side of their producing processes and distinct approaches used throughout the method.

The report systematically specialize in competitive analysis of Regenerative Medicine market that disclose prime competitors concerned in marketing and marketing of market merchandise. This research report can provide associate degree detailed and complete info to the readers of Regenerative Medicine market. It conjointly serves a actual analysis of parent market of business with the assistance of past, gift and future market info.

To access the sample report, click here:https://marketresearch.biz/report/regenerative-medicine-market/request-sample

which can be helpful to require decisive judgement of business on Regenerative Medicine market and increase the ratio. the primary five-year accumulative revenue (20192023) of Regenerative Medicine market is projected to be US$ XX Mn, and latter 5 years (20242028) revenue is projected to be US$ XX Mn is calcualted during this report.

Vital Regions that operate Regenerative Medicine market covers geographic region (colombia, Argentina and Brazil), North America (Mexico, North American nation and also the United States), Regenerative Medicine market in Asia-Pacific (China, Japan, Korea, Republic of India and South-East Asia), (UK, Russia, FRG and Italy), the center East and continent (South Africa, UAE, Egypt and Saudi Arabia). Besides, production worth and volume, Regenerative Medicine market share, Regenerative Medicine value, import/export particularisation,SWOT analysis,Regenerative Medicine market growth analysis and price/cost.

Global Regenerative Medicine Market 2019 covers following leading manufacturers:

Organogenesis Inc, Osiris Therapeutics Inc, Pfizer Inc, Novartis AG, Vericel Corporation, NuVasive Inc, Cook Biotech Inc, GlaxoSmithKline plc., Boehringer Ingelheim GmbH, Amgen Inc

Key features of Regenerative Medicine market:

Elaborated data of Regenerative Medicine market opportunities, growth, prohibiting and risk study.

Moreover an entire analysis of existing and rising markets Regenerative Medicine market segments.

Leading market Regenerative Medicine players are present within the report.

The advance market tendencies, startegies and technologies have accelerated range of enterprise models and firms across the world.

Correct arrangement of Regenerative Medicine market is completed on the premise of segments, market size and share.

The information serves during this analysis report isnt solely descriptive in terms of amount however additionally quality.

Every and each Regenerative Medicine data collect from secondary sources are cross examined many times throughout paid primary interviews and business skilled expertize.

Enquire about our Regenerative Medicine report with our industry specialist:https://marketresearch.biz/report/regenerative-medicine-market/#inquiry

The research methodology used to obtained crucial information for Regenerative Medicine market:

1. The analysis methodology of Regenerative Medicine market includes not solely primary however additionally secondary research info sources. It perform distict factors moving business like market setting, varied government policies, historical information and latest trends, technological advancement,market restrains, market risk factors, future innovations,challenges, opportunities and any technical evolution in business.

2. Analysis analysts at first collect the data from distict trivial Regenerative Medicine info sources like monetary reports of the corporate, internet, magazines and analysis reports.

3. The fetched Regenerative Medicine market information is verified and even to assure its quality. varied quality testing techniques are accustomed guarantee its quality of Regenerative Medicine market. theyre approved by attending, conducting and direct interviews and questionnaires with Regenerative Medicine companys business executive, market main opinion leaders, market specialists and business executives.

4. At the end, the info is drawn in pictorial method within the type of tables, bar graphs, pie-charts and figures format. totally different methods are accustomed collect information concerning Regenerative Medicine market size covers high down and bottom-up approach.

5. Resulting a part of the Regenerative Medicine report provides a listing of manufacturers/distributors, information sources, analysis findings, and postscript.

This content has been distributed via WiredRelease press release distribution service. For press release service enquiry, please reach us at[emailprotected].

More here:
Regenerative Medicine Market Risk Factors, Growth Analysis, Market Size and Innovations By 2028 - 5Gigs News

HAIFA, Israel, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (ATSM), which is being held November 25-26, 2019 in Berlin. As a leading member of the large-scale research initiative, Pluristem, along with additional respected members, is committed to accelerating the availability of advanced therapies to all those in need, a main motivation standing behind RESTORE.

Led by Charit-Universittsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH-Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need. Advanced Therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health, said Prof. Volk. We are determined to translate promising research findings into safe therapies, and we are working across disciplines and national borders in order to achieve this goal. The 1st Advanced Therapies Science Meeting provides the opportunity to discuss the still numerous obstacles in the way of implementing these promising therapies in routine clinical care.

This initiative may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, said Zami Aberman, Executive Chairman of Pluristem. The European Commission is poised to make a significant investment of up to 1 billion in a consortium of companies that can drive forward the development of novel regenerative therapies, and we are pleased to be a leading part in this effort. Given our proprietary cell manufacturing technology and broad, late-stage pipeline, we believe we can play a key role toward making the transforming promise of advanced therapies into a reality.

The 1st ATSM will bring together experts from industry, patient organizations and academia to discuss the challenges within the field of advanced therapies, which include gene and cell therapies and tissue-engineering approaches. The ATSM is focused on trying to drive forward a concerted interdisciplinary effort, making use of science, infrastructure and funding within Europe to make regenerative therapies available to the broadest possible patient population.

The two-day program will include talks from Nobel Prize winner Ada Yonath (Director of Weizmann Institute of Science, Israel), Michele De Luca (University of Modena, Italy), Timothy OBrien (National University of Ireland, Galway, Ireland), Maksim Mamonkin (Baylor College of Medicine, USA), Manuela Gomes (University of Minho, Portugal) and others.

RESTORE partners include the Charit Universittsmedizin Berlin and Berlin Institute of Health (Germany), the University of Zurich (Switzerland), Cell and Gene Therapy Catapult (United Kingdom), TissUse GmbH (Germany), Pluristem (Israel), Miltenyi Biotec GmbH (Germany), INSERM Institut National de la Sant et de la Recherche (France), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal).

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the potential for the RESTORE Consortium to receive up to a 1 billion award by the European Commission and the timing of the potential award, that RESTOREs aim is to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need, that RESTORE and the 1st ATSM may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, and its belief that given its proprietary cell manufacturing technology and broad, late-stage pipeline, it believes it can play a key role toward making the transforming promise of advanced therapies into a reality. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

View post:
RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting, Aiming to Translate Promising Research into a Game Changer in Healthcare -...

Posted By MyUVicLife on Oct 30, 2019 in Hands-on learning, Student life

On the weekend of October 4th, our team participated in this years Health and Regenerative Medicine Hackathon. We thought we would give a quick recap of the event as well as share our experience with you.

By: Natalie Koehn, Jacqui Moreland, Kim Arklie and Jacky Le

The second annual Health and Regenerative Medicine Hackathon was held at FortTectoriain downtown Victoria during the first weekend of October.

Traditionally, a hackathon is a competition where people gather to tackle coding and programming related challenges in a consecutive period of 24-48 hours. However, the Health and Regenerative Medicine Hackathon is different! The challenges as its name suggests are related to health and medicine. Due to the nature of the challenges, competitors were allowed to work on their designs during the month leading up to the Hackathon weekend.

The following challenges were presented to us by various organizations involved in Victorias health industry:

As a combined team of biomedical and mechanical engineers from the University of Victoria, we are passionate about creating assistive technology to solve health-related problems. We had worked together in a school group project in the past and were looking to find another opportunity to work together and design something meaningful.

Inspired by their patient stories and their mission to provide low-cost healthcare opportunities to developing countries, we were eager to take on the Victoria Hand Projects (VHP) challenge to create an assistive device to allow children to write.

A 3D printed solution was optimal for both the rapid prototyping of the Hackathon but also was one of the design requirements for the given project.

In the two weeks leading up to the Hackathon, we came up with a general design concept consisting of two major components an attachment mechanism to the prosthetic hand and a clamping mechanism for the writing utensil. A few iterations were made as a result of tests performed on our original design.

This led us to our final product that utilizes a three-prong and elastic mechanism to grasp the pencil. The pencil is housed in a cylindrical tube, held in place at an optimal angle, that attaches to a simple support that wraps around the bottom of the hand. The hand rests on a bed of silicone at the base of the device in order to prevent unwanted movement, and tightly secured with avelcrostrap.

It was inspiring coming together on the final day of the Hackathon to see the hard work of each group come to life to create such a wide range of solutions. The panel of judges, sponsors and professionals that attended the event were just as passionate about the projects as we were. They provided feedback and support to the teams throughout the Hackathon and helped make the event possible.

All in all, it was a great opportunity and we are looking forward to participating in next years Hackathon. We encourage anyone who is interested in STEM related fields to engage in opportunities like this and explore the design world in a fun, out of school environment!

The views expressed in this blog are my own, and do not necessarily reflect the policies or views of the University of Victoria. I monitor posts and comments to ensure all content complies with the University of Victoria Guidelines on Blogging.

More:
2019 Health and Regenerative Medicine Hackathon - University of Victoria News

SELBYVILLE, Del., Nov. 5, 2019 /PRNewswire/ -- The global Cancer Gene therapy market'srevenue is expected to surpass USD $2.5 billion by 2025, according to a new research report by Global Market Insights, Inc. Rising government initiatives in emerging economies for promoting developments in gene therapies will positively impact the cancer regenerative medicine market's growth. The government often implements several laws and initiatives to motivate scientists and researchers to perform extensive analysesof gene therapies. Furthermore, the government also funds various studies that are carried out for developing molecular therapies utilized in the treatment of cancer. The aforementioned factors should escalate the industry's growth.

There have been several advancements in the biotechnology sector that have proven beneficial for the industry's growth. Several viral vectors have been introduced in the market that work efficiently for carrying out gene transfers. Researchers vigorously work on studying the efficacy and efficiency of the viral, as well as non-viral, vectors that are utilized in gene therapy. Newly developed viral vectors are capable of inhibiting the growth of tumor-inducing genes and are preferred by biopharmaceutical companies. Moreover, healthcare professionals working on gene therapy have started trusting and preferring these viral vectors for treating cancer patients. Therefore, growing advancements will ensure the availability of superior quality vectors for gene transfer, which will foster the market's growth.

Request for a sample of this research report athttps://www.gminsights.com/request-sample/detail/763

The types in the cancer gene market are categorized into in-vivo and ex-vivo. The in-vivo segment of the cancer gene therapy market was valued over USD $350 million in 2018 and will experience substantial growth throughout the analysis period. In-vivo gene therapy is a cost-effective option since it avoids the tedious process of removing cells from a patient's body. Furthermore, in-vivo cancer gene therapy is widely expected to treatcystic fibrosis, which positively influences business growth. However, in recent times, several high-profile, adverse events pertaining to gene therapies were recorded that has reduced its demand, therebylowering the pace of segmental growth.

Based on product, the global market is bifurcated into viral vectors and non-viral vectors. The viral vectors segment of cancer gene therapy is anticipated to foresee around 23% growth throughout the analysis timeframe. Adenovirus is one of the highly preferred viral vectors that has commendable transductional efficiency that raises its adoption. Moreover, theadenovirus vector reduces the risk of mutagenesis. Besides, other viral vectors are also efficient and enable long-term DNA expression, reducing the mortality rate in patients suffering from cancer. The aforementioned factors will spur the viral vectors' segment growth.

Cancer Gene Therapy Market Growth, By Product

5.1. Key segment trends

5.2. Viral vectors5.2.1. Market size, by region, 2014 2025 (USD Million)5.2.2. Adenoviruses5.2.2.1. Market size, by region, 2014 2025 (USD Million)5.2.3. Lentiviruses5.2.3.1. Market size, by region, 2014 2025 (USD Million)5.2.4. Retrovirus5.2.4.1. Market size, by region, 2014 2025 (USD Million)5.2.5. Adeno associated virus5.2.5.1. Market size, by region, 2014 2025 (USD Million)5.2.6. Herpes simplex virus5.2.6.1. Market size, by region, 2014 2025 (USD Million)5.2.7. Vaccinia virus5.2.7.1. Market size, by region, 2014 2025 (USD Million)5.2.8. Others5.2.8.1. Market size, by region, 2014 2025 (USD Million)

5.3. Non-viral vectors5.3.1. Market size, by region, 2014 2025 (USD Million)

5.4. Others5.4.1. Market size, by region, 2014 2025 (USD Million)

Browse key industry insights spread across 95 pages, with 120 market data tables and eight figures and charts from the report,Cancer Gene Therapy Market Size By Type (Ex-vivo, In-vivo), By Product (Viral Vectors {Adenoviruses, Lentiviruses, Retrovirus, Adeno Associated Virus, Herpes Simplex Virus, Vaccinia Virus}, Non-viral Vectors), By End-use (Biopharma Companies, Research Institutes), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, U.K., France, Italy, Spain, Japan, China), Price Trends, Application Potential, Competitive Market Share & Forecast, 2019 2025," in detail, along with the table of contents:

https://www.gminsights.com/industry-analysis/cancer-gene-therapy-market

The end-use segment of cancer gene therapy includes biopharmaceutical companies, research institutes and others. The research institutes segment held around a 40% revenue share in 2018. Significant segmental growth can be attributed to the increasing demand for viral vectors by research institutes that work on cancer gene therapies. Research institutes constantly focus on assessing the efficacy of gene therapies by using different vectors. Moreover, vector manufacturing companies develop superior quality viral, as well as non-viral, vectors that will positively influence the segmental growth.

The U.K. market accounted for around USD $35 million in 2018 and is projected to witness momentous growth during the analysis timeframe. The increasing adoption of cancer gene therapy due to considerably high purchasing power has augmented the cancer gene therapy market growth in the country. Furthermore, the increasing prevalence of cancer has positively influenced the industry's growth. According to a study, in 2017, around 164,901 people died from cancer in the U.K., which creates demand for advanced gene therapies for treating cancer.

Make an inquiry for purchasing this report athttps://www.gminsights.com/inquiry-before-buying/763

Browse Related Reports:

Cancer Diagnostics Market Statistics 2025: Breast cancer is one of the most frequent cancers among womenacross the globe. According to the World Health Organization (WHO), about 2.1 million women are suffering from breast cancer each year. Also, breast cancer rates are higher among women in more developed countries than in developing and under-developed economies. A few prominent players operating in the global market are Abbott, Roche, Siemens Healthcare, Danaher Corporation, Becton, GE Healthcare, Dickinson and Company (BD), Janssen Diagnostics among others.

https://www.gminsights.com/industry-analysis/cancer-diagnostics-market

About Global Market Insights

Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider, offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.

Contact Us:

Arun HegdeCorporate Sales, USAGlobal Market Insights, Inc.Phone:1-302-846-7766Toll Free:1-888-689-0688Email:sales@gminsights.com

Related Images

cancer-gene-therapy-market.jpg Cancer Gene Therapy Market Forecasts 2025 Cancer Gene Therapy Market is set to register over a 22% CAGR up to 2025, driven by the rising prevalence of cancer in developed, as well as developing, economies.

Related Links

Cancer Gene Therapy Market size

Cervical Cancer Diagnostic Market

SOURCE Global Market Insights, Inc.

https://www.gminsights.com

View post:
Cancer Gene Therapy Market Value to Hit $2.5 Billion by 2025: Global Market Insights, Inc. - PRNewswire

Toronto, ON, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Notch Therapeutics, a company in the emerging field of gene-modified T cell therapy, has been created to commercialize a revolutionary technology that creates allogeneic (donor) gene-edited T cells from stem cells on an industrial scale, efficiently making T cell therapies that are clinically robust and of a consistently high quality. Notch is actively pursuing industry partnerships.

The founders of Notch - Sunnybrook Health Sciences Centre, University of Toronto (UoT), Toronto Innovation Acceleration Partners (TIAP) and CCRM, with Lumira Ventures as an additional investor - created Notch to provide a vehicle through which to further develop and bring to market the combined pioneering research, nearly ten years underway, from the labs of Drs. Juan CarlosZiga-Pflcker,Senior Scientistin Biological Sciences atSunnybrook,and Chair of the Department of Immunology atUoT;andof Peter Zandstra,Professor, Institute of Biomaterials and Biomedical Engineering at UoTandDirector, School of Biomedical engineering and Michael Smith Laboratories at the University of British Columbia.

"This technology is very promising and might be used to create therapiesto treatsome of our greatest medical challenges,like cancer, autoimmune diseases and organ transplant rejection. Its also the first and only method that can reconstitute immune systems," says Dr. Andy Smith, President and CEO of Sunnybrook Health Sciences Centre. "Finally having optionstotarget these high-impact areasfor our patientsis what we mean when we say we are inventing the future of health care."

Jennifer Fraser, Director Innovations at the University of Toronto, comments that "Dr. Ziga-Pflckers allogeneic T cell therapy was one of the first projects I worked on when I joined UoT. Its very gratifying to see the technology move toward the clinic."

Even as the field for these therapies grows rapidly, major challenges have until now prevented wider adoption mainly due to a slow and expensive manufacturing process which yielded variable results. The Notch technology, however, shows promise for surmounting these issues cost-effectively and reliably. Notch, having been incubated at CCRM, will be able to leverage its in-house process development expertise and Good Manufacturing Practices (GMP) facility, located in downtown Toronto. It offersuniversally enhanced T cell therapies against high-impact diseases, using stem cells as a renewable source to expand treatment options and deliver cost-effective immunotherapies to patients. The aim of Notch is to generate T cells from multiple sources of stem cells and provide a platform for research and development, and a better way of manufacturing T cells and their applications for treating cancers or immune deficiencies.

"TIAP is pleased that, after many years of nurturing this research and investing in the risky early-stages with our co-founders, we are now seeing a truly ground-breaking new health science technology make its way through development in a very encouraging way. This is yet another example of what can be done through TIAPs unique ability within the community to bundle technologies across multiple institutions. This is a true collaboration which has resulted in development of a technology that will have significant impact", says Dr. Rafi Hofstein, President & CEO of TIAP.

"Notch Therapeutics is a star pupil in CCRMs incubation program," says Dr. Michael May, President and CEO of CCRM. "By de-risking the technology and designing Proof of Concept studies to appeal to investors, attracting experienced start-up management, and working with our ecosystem partners, we have collectively given Notch every opportunity to succeed."

Dr. Benjamin Rovinski, Managing Director of Lumira Ventures, states: "Early on, our team recognizedNotchs novel and differentiated platform and its potential to produce safer, more effective, and scalable allogeneic T cell therapies. We are pleased to be part of the financing syndicate. The quality and breadth of science coming out of Canadian universities is phenomenal, and important innovators like Notch are able to access capital, knowledge and the engaged support of Lumira and other investors, to enable the development and commercialization of their technology. We are excited to work with the entire Notch team."

About TIAP

TIAP is a leading provider of venture building services, early-stage funding, and deal-brokering with industry and private investors. As a member-based organization made up of 14 member institutions including University of Toronto and affiliated teaching hospitals TIAPs mandate is to drive the commercialization of their most promising research breakthroughs. TIAP has an active portfolio of more than 60 companies in sectors such as therapeutics, medical devices and IT/AI, which have raised in excess of CDN$300M from global investors, and has created more than 1000 direct/indirect jobs.

For more information, please visit http://www.tiap.ca

About University of TorontoFounded in 1827, the University of Toronto is Canadas leading institution of learning, discovery and knowledge creation. U of T is one of the worlds top research-intensive universities, driven to invent and innovate. It is also one of the top five universities in the world for its start-up incubator programs. In the last 10 years, the U of T entrepreneurship community has created over 500 companies and raised over $1.5 billion in investment capital. http://www.utoronto.ca

About Sunnybrook Health Sciences CentreSunnybrook Health Sciences Centre is inventing the future of health care for the 1.3 million patients the hospital cares for each year through the dedication of its more than 10,000 staff and volunteers. An internationally recognized leader in research and education and a full affiliation with the University of Toronto distinguishes Sunnybrook as one of Canadas premier academic health sciences centres. Sunnybrook specializes in caring for high-risk pregnancies, critically-ill newborns and adults, offering specialized rehabilitation and treating and preventing cancer, cardiovascular disease, neurological and psychiatric disorders, orthopaedic and arthritic conditions and traumatic injuries. The Hospital also has a unique and national leading program for the care of Canadas war veterans. For more information about how Sunnybrook is inventing the future of health care. Please visit us online at http://www.sunnybrook.ca

About CCRMCCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, dedicated funding, and unique infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Torontos Medicine by Design. CCRM is hosted by the University of Toronto. Visit us atccrm.ca.

About Lumira VenturesLumira Ventures isCanadasleading and most active healthcare venture capital firm. Lumira invests in best-in-class North American companies developing innovative therapeutics and medical technologies whose products offer transformative improvements to patient health outcomes and provide meaningful reductions to the overall cost of healthcare delivery. Since inception, Lumiras portfolio companies have brought 50+ new therapies to market, impacting the lives of 1+ billion patients globally, generating $65+ billion in cumulative revenue.

For more information, please visit http://www.lumiraventures.com

See the rest here:
Notch Therapeutics a new company with a revolutionary allogeneic ("off the shelf") T cell technology - GlobeNewswire

GERMANTOWN, Md., Nov. 4, 2019 /PRNewswire/ -- Intrexon Corporation(NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, today announced it will release third quarter financial results before the market opens on Tuesday, November 12th, 2019. Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients and a wholly owned subsidiary of Intrexon, will host a conference call that day at 11:00 AM ET to provide Precigen business and pipeline updates.

The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1412-317-6061(International) and providing the number 4454504 to join the Precigen Business and Pipeline Update Call. Participants may also access the live webcast through Intrexon's website in the Investors section at http://investors.dna.com/eventsor Precigen's website in the Presentations section at https://precigen.com/media/#id-presentations.

About Intrexon Corporation Intrexon Corporation (NASDAQ: XON) is Powering the Bioindustrial Revolution with Better DNA to create biologically-based products that improve the quality of life and the health of the planet through two operating units Intrexon Health and Intrexon Bioengineering. Intrexon Health is focused on addressing unmet medical needs through a diverse spectrum of therapeutic modalities, including gene and cell therapies, microbial bioproduction, and regenerative medicine. Intrexon Bioengineering seeks to address global challenges across food, agriculture, environmental, energy, and industrial fields by advancing biologically engineered solutions to improve sustainability and efficiency. Our integrated technology suite provides industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA, and we invite you to discover more at http://www.dna.comor follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.

About Precigen : Advancing Medicine with Precision Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen also follows the science opportunistically in pursuit of promising programs in emerging therapeutics. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. Precigen was founded as a wholly owned subsidiary of Intrexon Corporation(NASDAQ: XON) and leverages a diverse portfolio of technology platforms to advance human health. For more information about Precigen, visit http://www.precigen.comor follow us on Twitter @Precigenand LinkedIn.

Trademarks Intrexon, Powering the Bioindustrial Revolution with Better DNA,and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

For more information contact:

Intrexon Investor Contact:

Steven Harasym

Vice President, Investor Relations

Tel: +1 (301) 556-9850

investors@dna.com

Intrexon Corporate Contact:

Marie Rossi, PhD

Vice President, Communications

Tel: +1 (301) 556-9850

publicrelations@dna.com

Precigen Media Contact:

Donelle M. Gregory

press@precigen.com

Continued here:
Intrexon to Announce Third Quarter Financial Results on November 12th - Herald-Mail Media

- Cryoport as a preferred partner for Lonza in the transport and delivery of patient tissues on a global basis

- Partnership incorporates Cryoport's Cryoportal Logistics Management Platform, SmartPak II Condition Monitoring System and Cryoport's unique Chain of Compliance for regulatory solutions.

- Partnership builds on the recently announced partnership between Lonza and Vineti with an aim to provide cell and gene therapy developers with a fully integrated delivery solutions including manufacturing, supply chain orchestration and logistics, globally

BASEL, Switzerland and IRVINE, Calif., Nov. 5, 2019 /PRNewswire/ --

Quote from Alberto Santagostino, SVP Head of Cell & Gene Technologies, Lonza Pharma & Biotech:"The Lonza-Cryoport collaboration is an enabling part of a wider goal for Lonza to create a network of strategic partnerships and capabilities that enable seamless vein-to-vein delivery of cell and gene therapies for its customers and their patients. There is no doubt that this partnership enables us to provide a best-in-class solution to cell and gene therapy companies for manufacturing and supply chain services, allowing us to provide a fully integrated solution that reduces risk and increases transparency."

Quote from Jerrell Shelton, CEO, Cryoport:"Clinical trial activity in the cell and gene therapy sector is rapidly growing as biopharmaceutical companies discover new ways to harness regenerative therapies and combat illnesses. As more and more of these therapies approach commercialization, there is strengthening demand for reliable, integrated outsourced manufacturing and distribution solutions. Our partnership agreement with Lonza, an internationally-renowned supplier to the pharma and biotech markets, will improve effectiveness, efficiency and safety throughout the cell and gene therapy manufacturing process by integrating our temperature-controlled supply chain solutions with Lonza's manufacturing services."

Lonza (LONN.SW) and Cryoport, Inc. (CYRX) ("Cryoport"),announced today their partnership in the cell and gene therapy field and across Lonza's 'vein-to-vein' delivery network. As a part of this commitment, Lonza announced Cryoport as its preferred partner in the transport and delivery of patient tissues on a global basis, with the continued goal of seamless service for Lonza's customers and their patients. Lonza and Cryoport will work to remove the supply chain hurdles faced by developers of personalized therapeutics -- including autologous therapies, matched-allogeneic therapies, and personalized cancer vaccines -- as they prepare for the commercial launch of their respective therapies.

Lonza's network of cell and gene therapy facilities spans the US, Europe and Asia and serves both clinical and commercial customers globally. Cryoport currently supports over 413 clinical trials and 3 commercial therapies in the regenerative medicine space and operates in over 100 countries around the world. Integrating Cryoport's logistics andbioservices solutions with Lonza's manufacturing services and expertise will ensure a trusted and seamless supply chain and drive efficiencies in delivering innovative medicines to patients.

The goal of the partnership is to provide fully integrated solutions including, but not limited to, co-location of manufacturing, bioservices and distribution facilities to improve and enhance responsiveness and optimized product workflow, automated data management providing integrated data entry, and process optimization that reduces risk, increases transparency and improves certainty.

Story continues

Cryoport's logistics system aims to provide Lonza's clients with reliable and comprehensive delivery solutions through its advanced technologies, Global Supply Chain Network and dedicated scientists, technicians and supporting teams of professionals. Beyond Cryoport's proprietary Cryoport Express Shippers, this partnership incorporates Cryoport's Cryoportal Logistics Management Platform and SmartPak II Condition Monitoring System, which brings to the market an integrated IT solution that provides risk mitigation and Cryoport's unique Chain of Compliance for regulatory solutions.

About Lonza Lonza is an integrated solutions provider that creates value along the Healthcare Continuum. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found atwww.lonza.com.

About CryoportCryoport, Inc. (CYRX) is the world'spremier provider of temperature-controlled supply chain solutions for the life sciences industry,serving the Biopharma, Human Reproductive, and Animal Health markets. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences through our advanced technologies, Global Supply Chain Network and dedicated scientists, technicians and supporting team of professionals. Through purpose-built proprietary packaging; information technology; smart, sustainable cold chain logistics; and biostorage/biobanking services, Cryoport helps its customers advance life sciences research, support life-saving advanced therapies and deliver vaccines, protein producing materials, and IVF treatments in over 100 countries around the world. For more information, visit http://www.cryoport.com or follow @cryoport on Twitter atwww.twitter.com/cryoport for live updates.

Additional Information and Disclaimer (Lonza)Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

Forward Looking Statements (Cryoport)Statements in this news release which are not purely historical, including statements regarding Cryoport, Inc.'s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the Company's cash flow, market acceptance risks, and technical development risks. The Company's business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the Company's 10-K for the year ended December 31, 2018 filed with the SEC. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Cryoport, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

View original content to download multimedia:http://www.prnewswire.com/news-releases/lonza-partners-with-cryoport-and-strengthens-its-vein-to-vein-delivery-network-in-cell--gene-therapy-300950920.html

Read the original:
Lonza Partners with Cryoport and Strengthens its 'Vein-to-vein' Delivery Network in Cell & Gene Therapy - Yahoo Finance

As a member of the daytime community for many years, Don Diamont has seen soaps tackle important social issues. Now, the star of The Bold and the Beautiful is lending his name to a topical and vital concern.

The actor was invited recently to speak at the annual ISSCR (International Society for Stem Cell Research Conference) in Los Angeles. He accepted to show his support for a dear pal, who is battling ALS.

I was touched, and humbled to be asked to speak for, and about my beloved friend Nanci Ryder at this years ISSCR Conference, Diamont posted on his Instagram account. The event is the largest gathering of stem cell scientists and clinicians in the world. Nancis story is a powerful one, and I was honored to have an opportunity to share it with those on the front lines in the battle to find a cure for ALS.

Yesterday, at The Walk to Defeat ALS, I was with Nanci and the group of wonderful souls that make up TEAM NANCI, Diamont continued. Thank you to the @alsagoldenwest chapter for all that you do! Thank you to Dr. Justin Ichida! Justin is the Assistant Professor of Stem Cell and Regenerative Medicine at the Keck School of Medicine USC. Hes making significant strides in moving toward a cure for ALS. Finally, to anybody out there whos helping in any way to fight the good fight in eliminating this horrible illness, thank you!

Diamont concluded his post with words of encouragement for his friend: Nanci, you are the bravest of the brave! I, and we LOVE YOU

Soap fans may recall that the late Michael Zaslow (ex-Roger, Guiding Light; ex-David, One Life to Live) had been diagnosed with the disease. He passed away in 1998. For more information on ALS, click here. The Bold and the Beautiful airs weekdays on CBS. Check local listings for air times.

View this post on Instagram

I was touched, and humbled to be asked to speak for, and about my beloved friend Nanci Ryder at this years ISSCR Conference. The event is the largest gathering of stem cell scientists and clinicians in the world. Nancis story is a powerful one, and I was honored to have an opportunity to share it with those on the front lines in the battle to find a cure for ALS. Yesterday, at The Walk to Defeat ALS, I was with Nanci and the group of wonderful souls that make up TEAM NANCI. Thank you to the @alsagoldenwest chapter for all that you do! Thank you to Dr. Justin Ichida! Justin is the Assistant Professor of Stem Cell and Regenerative Medicine at the Keck School of Medicine USC. Hes making significant strides in moving toward a cure for ALS. Finally, to anybody out there whos helping in anyway to fight the good fight in eliminating this horrible illness, thank you! Nanci, you are the bravest of the brave! I, and we LOVE YOU

A post shared by Don Diamont (@dondiamont) on Nov 4, 2019 at 4:15pm PST

03:31

Dollar Bill Tribute

Video Credit: SunRiseIta

See original here:
The Bold and the Beautiful Star Don Diamont Supports ALS Research - Soap Hub

Masume Bayat,1 Seyed Ahmad Raeissadat,2 Maryam Mortazavian Babaki,3 Shahram Rahimi-Dehgolan4

1Physical Medicine and Rehabilitation Department of Mahdiyeh Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; 2Clinical Development Research Center of Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; 3Physical Medicine and Rehabilitation Department & Research Center, Shohada-E-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; 4Physical Medicine and Rehabilitation Department of Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran

Correspondence: Maryam Mortazavian BabakiNo. 1989934148, Shohada-e-Tajrish Hospital, Tehran, IranTel +982122731112Fax +982122724210Email maryam_m.babaky@sbmu.ac.ir

Purpose: To compare the efficacy of dextrose prolotherapy versus steroid injection in the treatment of patients with chronic lateral epicondylitis.Methods: Thirty subjects with chronic lateral epicondylitis were randomly assigned into two groups of hypertonic dextrose or methylprednisolone injection. Participants were assessed through Quick DASH and VAS scores, once before injection, and then after 1- and 3-months follow-up. Two patients were excluded due to not completing the follow-up timepoints.Results: In both groups VAS scores revealed significant improvement during the first month follow-up [mean difference (MD) = 1.93.3, versus 1.51.9 for the prolotherapy and steroid groups, respectively]. This declining trajectory continued at the third month visit in the prolotherapy group and MD reached 4.42.9, while it did not change remarkably in the steroid group (MD=1.93.4). In fact, comparing VAS scores between the 1st- and 3rd-month time points did not reveal a significant improvement in the steroid group (p=0.6). Also, the Quick DASH index showed a similar pattern and improved remarkably in both groups during the first visit. However, only the efficacy in the prolotherapy group persisted after 3-month follow-up (MD = 9.521.6, p=0.044). One month after injections no preference between the two interventions was observed (p=0.74 for VAS and 0.14 for Quick DASH score). However, the 3rd-month follow-up revealed a meaningful superiority (p=0.03 for VAS and p=0.01 for Quick DASH score) favoring the prolotherapy method.Conclusion: Both methods were proven to be effective in the short-term treatment of chronic lateral epicondylitis, but dextrose prolotherapy seems to be slightly more efficacious than steroid injection over a longer period.Clinical trial registration: Iranian Registry of Clinical Trials Database: IRCT20170311033000N3.

Keywords: regenerative medicine, tennis elbow, methylprednisolone, prolotherapy

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.

Go here to see the original:
Is Dextrose Prolotherapy Superior To Corticosteroid Injection In Patie | ORR - Dove Medical Press

Last week, the Cystic Fibrosis Foundation launched a new initiative called Path to a Cure. A press release called it an ambitious research agenda to deliver treatments for the underlying cause of the disease and a cure for every person with cystic fibrosis (CF).

It added: The Foundation is challenging potential collaborators to submit proposals that will accelerate the pace of progress in CF drug discovery and development and intends to allocate half a billion dollars to the effort through 2025.

News of the initiative comes nine days after an announcement by the U.S. Food and Drug Administration that it has approved the highly anticipated treatment Trikafta, a triple combination therapy of ivacaftor, tezacaftor, and the new elexacaftor (VX-445). Trikaftas clinical trial outcomes were remarkable and on par with the early clinical results from the highly effective Kalydeco several years ago, especially when compared with the outcomes of the not very robust but efficacious Orkambi and Symdeko.

The foundations strategic plan for the next five years is audacious, but I think its an honest pursuit. A year ago, I wrote about what a cure for CF might look like, and I discussed how the progressive and chronic nature of CF makes curing it a sort of nebulous concept.

In CF, the broken protein that is the underlying cause of the disease isnt the killer. The killers are the recurring infections, the inflammation, and the downstream effects of the broken cystic fibrosis transmembrane conductance regulator (CFTR) protein. Due to recurring infections, the lungs become damaged, and endemic bacteria become more resistant to traditional antibiotics.

For someone with moderate lung disease, fixing the underlying issue wont heal the scar tissue or reconstruct damaged airways. Most people with CF are pancreatic insufficient. Theoretically, an embryonic cure would prevent sustained damage to any part of the body. Once birth occurs, however, a cure would be too late to prevent even the slightest damage.

In the column from last year, I also wrote: Im not saying a cure is impossible or undesirable. Rather, there are multiple pillars to ultimately curing all the ills that deeply affect our lives. I think looking at a cure in this way is a reason to be hopeful. I added that I didnt believe this change of perspective about what a cure looks like should be a reason for discouragement.

What I like about the CF Foundations Path to a Cure is how theyre discussing what the different paths look like. Current therapies are modulators. At best, they repair CFTR protein, which is different than fixing or replacing it. This initiative also emphasizes the most important tenet of all CF therapies: It is intended to help everyone with CF. Complicated mutations will require different strategies.

A cure for cystic fibrosis is a complicated endeavor. CF is a particularly interesting genetic disease for many reasons, not least of which is that the pathway to curing it could be extrapolated to other diseases with genetic causes or predispositions. I do believe a cure is possible, though Im usually cautious to offer my commentary on the word cure.

Many subpopulations exist in the CF community. Thousands of people in the world have CF. A percentage of that population doesnt have access to the most basic CF treatments. Many people in the United States dont even have good access or care. Modulators arent approved for transplant patients.

Its not for nothing that the CF Foundation and the community itself must ask one important question: What does life look like for someone with feeble lung function that is cured of CF? If other treatment plans arent in place such as better transplant strategies utilizing stem cells, or using stem cells for lung regeneration a cure may not prolong life, but rather prolong the misery of end-stage disease.

Part of planning for the future is predicting the effects of that plan. But we must ask: How are we giving everyone with CF the chance to live well into their 70s and 80s? I think the important discoveries made along the way will be instrumental in learning if its possible to repair diseased lungs through regenerative medicine.

Path to a Cure is one of the most exciting research agendas weve seen. Im looking forward to the day when the CF Foundation announces that a cure has been found.

Follow along with my other writings on my humbly named site, http://www.trelarosa.com.

***

Note: Cystic Fibrosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Cystic Fibrosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to cystic fibrosis.

Read this article:
What We Should Expect from the CF Foundation's 'Path to a Cure' - Cystic Fibrosis News Today

A huge leap could be made with bioprinting the 3D printing of tissue and organs thanks to an innovative idea which proposes to use aqueous architectures, or in other words, printing in a specially made fluid.

As Science magazine reports, human tissue and organs are very tricky to make using traditional 3D printing methods without putting support scaffolding in place and that scaffolding can later be very difficult (or indeed impossible) to remove.

So the idea as advanced by Chinese researchers is to move away from a solid support structure, and instead use liquid. Specifically, this would be a fluid matrix into which the liquid design for an organ could be injected, and the surrounding fluid then drained away after the organ has set.

This kind of approach has previously been attempted, except the fluid matrix hasnt proven stable enough, and the whole thing has simply collapsed. So instead these researchers from China have used hydrophilic (attracted to water molecules) liquid polymers which are capable of creating a stable membrane.

Using this method, the liquid structure is far more robust and is even capable of holding its shape for as long as 10 days. A further benefit is that during the process of pumping the ink into the fluid membrane, if mistakes are made, the nozzle can actually extract and rewrite the ink as needed.

The researchers believe that this advance in the field of bioprinting will help greatly with the production of complex tissue-like constructs including arteries and tracheae.

And this could have a major impact in terms of regenerative medicine, the scientists say, as well as producing in-vitro tissue models for studies and the likes of disease modeling, or potential applications like drug screening or development.

The researchers note that a commercially available 3D printer has been used in their early experiments thus far, albeit when printing multiple cells, a homemade microuidic nozzle head was employed instead.

See the original post here:
3D printing could have cracked the problem of making human organs - TechRadar

NEW YORK, Nov. 05, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2019, and provide a corporate update, at 8:00 a.m., Eastern Standard Time, on Thursday, November 14, 2019.

BrainStorms President & CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com; Questions should be submitted by 5:00 p.m., Eastern Standard Time, Tuesday, November 12.

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the Investors & Media page of BrainStorms website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

Excerpt from:
BrainStorm Cell Therapeutics to Announce Third Quarter Financial Results and Provide a Comprehensive Corporate Update - GlobeNewswire