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David Crais of CMG Carealytics Invited to NASA Cross Industry Innovation Summit – Benzinga

Posted: November 18, 2019 at 8:46 pm

New Orleans, LA, November 18, 2019 --(PR.com)-- David Crais, CEO of CMG Carealytics, was invited to the 4th Cross-Industry Innovation Summit held at Johnson Space Center in Houston, Texas last week. An exclusive group of Chief Innovation Officers from NASA, the US Navy, Army, Columbia University Business School, Barnard College, Amazon, Google, Dow Jones, and other global organizations.

Held over three days last week at Johnson Space Center, the Cross Industry Innovation Summit is a deep dive into innovation theory and practice from venture capital, startups, and technology transfer to corporate innovation labs and research and development programs. Exploring the discovery and investigative process with manufacturing, development, and commercialization and adoption of emerging technologies, new ideas, and new program development, these business, social, and government leaders work hands on to share ideas and cultural outlook and framework to bring about advances to their domains and constituencies . This is the fourth year of the program and the fourth year David Crais was asked to participate.

CMG Carealytics, a product management and development firm specializing in scientific, medical, and complex systems and industries, is known as a leader in the innovation and commercialization field. Working with incubators, accelerators, R&D teams, tech parks, venture capital firms, and expert networks, CMG Carealytics founded and led by David Crais continues to spearhead new innovation methods and practices in quality engineering, agile, scrum, lean, buisness analysis, product management, and other sociotechnical methods and in technologies from biotech, regenerative medicine, medical device, digital medicine, personalized medicine, printed electronics, imaging, thermography, and other technologies.

Crais has been engaged in innovation theory since his university education in scientific history and social change up to his development of medical technologies and taking them to market as publicly traded companies, private placements, new product launches, non-profits, and with economic development initiatives.

His participation in the Cross-Industry Summit with NASA is in addition to his work in serving on the Master Plan Task Force with Stennis Space Center in Mississippi, as a board member on the LSU Stephenson Entrepreneurship Institute, an advisor to Nevada State College Entrepreneurship Program, UC Irvine Medical Technology Commercialization Program, and with organizations like the Urban Land Institute, Angel Capital Association, Association for Corporate Growth, and other roles.

Contact Information:CMG CarealtyicsDavid Crais773-398-4143Contact via Emailcraisgroup.comghartman1@hotmail.com

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Future Success of Regenerative Medicine Market Growth and Forecasting with Top Key Players like Acelity LP, Nuvasive, Vericel Corporation Osiris…

Posted: November 18, 2019 at 8:46 pm

The global regenerative medicine market size was estimated at USD +2 million in 2019 and is expected to witness a CAGR of +11% throughout the forecast period.

Regenerative Medicine can be defined as a process of replenishing or regenerating human cells, tissues or organs to restore or establish a normal function. This area contains a commitment to regenerate damaged tissues and organs by replacing damaged tissue or by encouraging the bodys own repair mechanisms to heal tissues or organs. Regenerative medicine may enable scientists to grow tissues and organs in the laboratory and implant them safely when the body cannot cure itself.

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Current estimates indicate that around one in three Americans could benefit from regenerative medicine. Regenerative Medicine refers to a group of biomedical approaches to clinical therapies that may involve the use of stem cells. Examples include cell therapies (injection of stem cells or progenitor cells); immune therapy and tissue engineering.

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North America, Latin America, Middle East, Africa, and Europe have been inspected to get a portfolio of the Global Regenerative Medicine Market. According to Report Consultant, the global market is expected to grow in the forecast period. The market has been elucidated with different case studies as well as feedback from various professionals. With respect to different attributes such as Importance, Development in the global market has explained in an accurate and professional manner. The progress projections for different market segments are also highlighted in the research report.

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Our research reports will give you the most realistic and incomparable experience of revolutionary market solutions. We have effectively steered businesses all over the world through our market research reports with our predictive nature and are exceptionally positioned to lead digital transformations. Thus, we craft greater value for clients by presenting progressive opportunities in the global futuristic market.

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4th Annual Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine Congress held by MarketsandMarkets – ccsentinel.com

Posted: November 18, 2019 at 8:46 pm

Date: 10th 11th March 2020 Location: London UK

In the 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine, we would be focusing on the pre-clinical, manufacturing, clinical and regulatory aspects of cell therapies and regenerative medicine. This Congress event will be held on 10th and 11th March 2020 in London -UK

Regenerative therapies are proving its acceptance in the potential of cell-based therapies for chronic disorders. Since our past three editions, our aim through this conference is to provide an illustrative approach to recent developments in technologies of bioprocessing of cellular therapies, to process development and addressing qualitative and regulatory hurdles.

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I Got Fillers to Fix the Bump on My Noseand It Was Bizarre and Incredible – Prevention.com

Posted: November 18, 2019 at 8:46 pm

I am my own harshest critic when it comes to my physical flaws. I dont think thats uncommonwe all see parts of ourselves that others are blind to. My large, hooked nose has always bothered me. While Ive learned to appreciate its size, Ive never grown fond of the large bump. Additionally, at the ripe young age of 28, I have significantly more forehead wrinkles than anyone else my age. Yes, I wear sunscreen, but Im also a very expressive person, particularly when it comes to my eyebrows. My expressiveness has also manifested in prominent crow's feet.

While Im not opposed to aging and think wrinkles and crow's feet are attractive, its bizarre how many I have considering Im still in my twenties. I also know these things only get worse over time. I will say without shame that I dont want to have a withered and leathered face by the time Im 40. Because of this, I decided to make an appointment with Dr. Jessie Cheung, a board-certified dermatologist specializing in aesthetics, hormones and sexual health, and regenerative medicine.

When I arrived for my appointment, Dr. Cheung warmly greeted me, her face glowing like a cherub. She ushered me into her office and asked what Id like to get done. Its a bizarre question, when you think about it. The essence of what she was asking was: How can I change your face?

After explaining that Id like to get rid of my wrinkles and maybe add a little lip for fun (I have zero upper lip), she said she could do that without a problem. Then, she asked if she could make a few suggestions. This was the moment that I learned I'm actually not my own harshest critic.

It turns out, the left side of my chin is larger than the right side. My cheekbones have sunken in and my jawline could be stronger. There was more, but Ill save you from hearing it all.

Its wild: Ive looked at my face tens of thousands of times and had never noticed these things. Even when she pointed them out, I didnt really see them. Dr. Cheung then said that with a few fillers, she could straighten the bump on my noseit sounded too good to be true.

After all of her suggestions, I had a bit of an internal panic attack. It wasnt because I was becoming more aware of my flaws or, perhaps we should say, the areas of my face that could be improved upon. It was more that I was worried that my face would look completely different and I like my face. I didnt want someone elses face. I wanted mine, just a little smoother.

So, I expressed my reservation and repeatedly asked if all this work would look natural. Clearly, I wasnt the first person Dr. Cheung had seen with reservations, because she took my questions in stride. Even with her reassurance, I couldnt shake the feeling that Id come out looking like Donatella Versace. But then, when she said we could start with less and add more, I said, Screw it. Im here, load my face up. Besides, it only lasts roughly 4-6 months. So, if I didnt like it, I figured I could just become a shut-in during the cold winter months. Not the end of the world.

First, she numbed my face. Then, she started poking me with a syringe and loading me up with various fillers. Ill admit, it hurt a bit more than I thought it would. However, you can take breaks and the pain shouldnt deter you if you want to get this type of work doneits not that bad.

She stuck me for about an hour, hitting almost every part of my face. Throughout, shed stop and show me what she was doing, asking if I wanted more. Sometimes I said yes, other times I said noespecially when she worked on my lips. I knew that big, plump lips would make me look like a clown and, personally, I just dont care for that fake lip look.

Finally, I was done. When I looked in the mirror, it was scary. My face was so numb that I could barely move it. There was also some blood and injections swell for a few days before going down, so I liked really puffy. But, I will say, the bump on my nose had vanished. It was absolutely bewildering and incredible. As someone who has been self-conscious about my nose for years, it was exhilarating to see a change so quickly.

The first two days after all the injections was hard. It was tough to eat because it hurt to clench my jaw. But each day the pain lessened and by day three, nearly everything had settled. By day five, I looked how I look nowand let me tell you, Im damn stunning. Most of my wrinkles are gone and my face is far more symmetrical than it was before. When I take a photo, my cheekbones hit the light and pop. And dont even get me started on my nose!

Heres the thing: Most folks cant even tell Ive gotten work done, which is what I hoped for. Some friends who have either gotten their own work done or who want to get some done could telland they gushed over the results. And, of course, a few friends say, Why did you do that? I loved how you looked. The answer is, I didnt do it for themI did it for me. I did it to feel more comfortable in my skin.

All in all, I dont see much downside in getting fillers. I loved itwhich means I am going to have to go back to Dr. Cheung every 4-6 months. I see it as a small price to pay for the confidence it gave me.

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Organogenesis Holdings Inc. Reports Third Quarter and Nine Months of 2019 Financial Results – OrthoSpineNews

Posted: November 18, 2019 at 8:46 pm

CANTON, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for its third quarter ended September 30, 2019.

Third Quarter 2019 Financial Summary:

Third Quarter 2019 and Recent Highlights:

We delivered another quarter of significant year-over-year revenue growth across both our Advanced Wound Care and Surgical and Sports Medicine portfolios, said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. We grew our customer base across both portfolios and leveraged PuraPlys pass through advantage to gain new accounts, drive PuraPly adoption deeper into existing accounts and drive sales of our non-PuraPly products to existing PuraPly accounts. Strong execution also drove year-over-year growth of commercially available non-PuraPly products across our customer base. I am very pleased that despite amniotic capacity constraints, we successfully leveraged our diversified portfolio to deliver a solid quarter.

Mr. Gillheeney, Sr. continued: With continued execution against our PuraPly commercial strategy and improved amniotic capacity exiting Q3, we expect a strong finish to the year. We have updated our full-year 2019 revenue guidance and now expect to grow in a range of 31% to 34%. We remain committed to delivering on our mission to provide integrated healing solutions that substantially improve medical outcomes while lowering the overall cost of care.

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Todos And Amarantus JV Announces Full Enrollment For Clinical Trial Of LymPro Alzheimer’s Blood Test Relationship With Amyloid PET – Laboratory…

Posted: November 18, 2019 at 8:46 pm

Topline results expected before the end of Q1/2020

Rehovot, Israel and New York, NY (GLOBE NEWSWIRE) - Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, and Amarantus Bioscience Holdings, Inc. a US-based JLABS-alumnus biotechnology holding company developing proprietary orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, today announced that their joint venture company, Breakthrough Diagnostics, Inc. has completed enrollment of its ongoing clinical trial evaluating the relationship of Alzheimers blood diagnostic Lymphocyte Proliferation Test (LymPro Test) with amyloid PET neuroimaging at Leipzig University in Germany (the LymPro PET 2). Topline results are expected before the end of the first quarter of 2020.

Breakthrough completed a 20-subject clinical study (LymPro PET 1) in 2018 evaluating the correlation between LymPro scores and the diagnosis of Alzheimers disease, as confirmed with amyloid PET neuroimaging and other Alzheimers disease biomarkers. LymPro measures cell cycle dysregulation in peripheral lymphocytes. The top-line data, announced in July 2019, revealed a strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216). Breakthroughs academic collaborators at the Leipzig University then expanded enrollment of that study to include an additional cohort of 20 subjects (LymPro PET 2) to confirm the strong relationship seen from LymPro PET 1. The data from both LymPro 1 and LymPro 2 will be published together in a peer-reviewed journal in 2020.

LymPro is a unique immune system-based Alzheimers blood test, said Dr. Herman Weiss, President & CEO of Todos. LymPro could prove to be a major breakthrough for Alzheimers disease diagnosis by measuring cell cycle dysregulation and amyloid, together, conveniently as part of a blood workup in routine clinical practice. The therapeutic field in Alzheimers has begun to see some renewed hope based upon recent Aducanumab data announced by Biogen that is directly related to the amyloid hypothesis, as well as conditional approval by the National Medical Products Administration in China for the first new Alzheimers drug in over 20 years, called Oligomannate from Shanghai Green Valley Pharmaceuticals, that is based on gut-brain biology of the microbiome and its effects on the immune system. We believe this renewed optimism and broadening of pathophysiological hypotheses relevant to Alzheimers disease being evaluated in the clinic significantly increases the scope for LymPro pharma services collaborations and begins to refine LymPros clinical utility profile for primary care physicians as strategies to correct cell cycle dysregulation emerge.

About Alzheimer's DiseaseAccording to the Alzheimer's Association, it is estimated that over 5.4 million people in the United States suffer from Alzheimer's disease. Over 500,000 patients are diagnosed annually, with nearly one-in-eight older Americans affected by the disease. Alzheimer's disease is the third leading cause of death in the United States. The cost of unpaid care in the United States is estimated at over $210 billion annually. Total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. Alzheimer's expenditures in the United States are expected to exceed $1.2 trillion by 2050. There is no cure or effective treatment for Alzheimer's disease. Worldwide, about 35.6 million individuals have the disease and, according to the World Health Organization, the number will double every 20 years to 115.4 million people with Alzheimer's by 2050.

About Dr. Arendt's Research at Leipzig UniversityDr. Thomas Arendt is Professor of Neuroscience at Leipzig University where he runs the Paul Flechsig Institute of Brain Research. He has a 30-year record in R&D of therapeutic and diagnostic strategies of neurodegenerative disorders and made several seminal contributions to therapeutic concepts of Alzheimer's disease, including stem cell therapy and modulating tumor suppressor genes. In the early 1980's, he was involved in identifying the degeneration of the cholinergic system in Alzheimer's disease laying the basis for today's only available treatment. He is one of the pioneers of the "cell-cycle theory" of Alzheimer's disease, which he developed towards a diagnostic and therapeutic concept.

About Breakthrough Diagnostics, Inc.Breakthrough Diagnostics, Inc. is a joint venture owned by Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) (80.01%) and Todos Medical Ltd. (19.99%). Breakthrough has been assigned the intellectual property and other rights to the LymPro Test, a diagnostic blood test for Alzheimers disease, as well as rights to other neurological diagnostics testing intellectual property. Todos Medical has provided Amarantus with notice of Todos decision to exercise its exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.

The Lymphocyte Proliferation Test (LymPro Test) determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as surrogates for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

About Todos Medical Ltd.Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancers influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The companys two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test, a blood test for diagnosing Alzheimers disease.

For more information, the content of which is not part of this press release, please visit http://www.todosmedical.com

About Amarantus Bioscience Holdings, Inc.Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. The Companys 80.01%-owned subsidiary Breakthrough Diagnostics, Inc., currently a joint venture with Todos Medical, Ltd., has licensed intellectual property rights to the Alzheimers blood diagnostic LymPro Test from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise and Parkinsons diagnostic NuroPro. Amarantus entered into a joint venture agreement with Todos Medical, Ltd. to advance diagnostic screening assets and Todos has exercised its exclusive option to acquire Amarantus remaining ownership in Breakthrough in exchange for approximately 50% ownership of Todos. The transaction is expected close before the end of the first quarter of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc., a healthcare data-generating technology company that specializes in biomarker assay services that target multiple areas of oncology. Avant provides precision oncology data through its TheraLink assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders, initially for breast cancer, to over 70 FDA-approved drug treatments.

AMBS 50%-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, Alzheimers aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquired Cutanogen Corporation from Lonza Group in 2015. Cutanogen is preparing for pivotal studies with Engineered Skin Substitute (ESS) for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriners Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. AMBS wholly-owned subsidiary, MANF Therapeutics Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (MANF). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram Syndrome, Retinitis Pigmentosa and Glaucoma, as well as neurodegenerative diseases such as Parkinsons disease. MANF was discovered by the Companys Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS proprietary discovery engine PhenoGuard, and believes several other neurotrophic factors remain to be discovered. Amarantus has entered into a binding letter of intent to license the therapeutic assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald Organic Products.

Forward-looking StatementsCertain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, 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; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any 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 Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

2019 GlobeNewswire, Inc. All Rights Reserved.

SOURCE: Todos Medical Ltd.

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Personalized Stem Cells, Inc. Announces First Patients Treated in FDA Approved Clinical Trial for Treatment of Osteoarthritis with Stem Cells – PR Web

Posted: November 18, 2019 at 8:41 pm

We expect to rapidly increase enrollment in this first clinical trial as we prepare for additional clinical trials using stem cells for orthopedic injuries.

POWAY, Calif. (PRWEB) November 13, 2019

Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, has successfully enrolled the first patients in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. The first treatment came shortly after the one-year anniversary of the formation of the company as a subsidiary of VetStem Biopharma.

In July of 2019, PSC received FDA approval for a New Drug (IND) application to conduct clinical trials for use of a persons own adipose-derived stem cells to treat their osteoarthritis. This first clinical trial uses stem cells to treat osteoarthritis in the knee.

PSC has recruited, trained, and qualified clinical trial sites sufficient to treat up to 125 patients in this first clinical trial. Clinical trial sites are currently located in San Diego and Los Angeles California, Portland Oregon, Chicago Illinois, and New Jersey. Additional clinical trial sites are anticipated in coming months.

PSC CEO, Michael Dale, stated, We are pleased with the response from patients who suffer from knee arthritis and with the diligence and enthusiasm of the participating clinics around the country. We expect to rapidly increase enrollment in this first clinical trial as we prepare for additional clinical trials using stem cells for orthopedic injuries.

This is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA approved clinical trials starting with uses in orthopedics and expanding to other medical conditions such as trauma in the future.

PSC is working within the FDA cell therapy regulations to provide stem cell therapy for patients that follows the rules FDA has created in order to assure consistent manufacturing, quality tested cells and clinical trial and manufacturing oversite for safety and efficacy.

PSC was founded by Michael Dale, CEO, and Robert Harman, DVM, MPVM, Chief Scientific Officer, both of whom also co-founded VetStem Biopharma and are both experienced serial entrepreneurs.

About Personalized Stem Cells, Inc.Personalized Stem Cells was formed in 2018 to advance and legitimize human regenerative medicine. This privately held biopharmaceutical enterprise, based near San Diego (California), offers qualified physicians who enroll, an FDA compliant autologous stem cell product (from patients own fat tissue) for use in FDA approved clinical trials. PSC is driving development and adoption of stem cell and regenerative medicine within the FDA-IND process by providing cGMP manufactured, quality tested cells, and well-defined clinical trials. PSC has licensed a portfolio of over 70 issued patents in the field of regenerative medicine.

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New Cell Therapy Improves Memory and Stops Seizures Following TBI – University Herald

Posted: November 17, 2019 at 8:46 am

Irvine, Calif. - November 14, 2019 - Researchers from the University of California, Irvine developed a breakthrough cell therapy to improve memory and prevent seizures in mice following traumatic brain injury. The study, titled "Transplanted interneurons improve memory precision after traumatic brain injury," was published today inNature Communications.

Traumatic brain injuries affect 2 million Americans each year and cause cell death and inflammation in the brain. People who experience a head injury often suffer from lifelong memory loss and can develop epilepsy.

In the study, the UCI team transplanted embryonic progenitor cells capable of generating inhibitory interneurons, a specific type of nerve cell that controls the activity of brain circuits, into the brains of mice with traumatic brain injury. They targeted the hippocampus, a brain region responsible for learning and memory.

The researchers discovered that the transplanted neurons migrated into the injury where they formed new connections with the injured brain cells and thrived long term. Within a month after treatment, the mice showed signs of memory improvement, such as being able to tell the difference between a box where they had an unpleasant experience from one where they did not. They were able to do this just as well as mice that never had a brain injury. The cell transplants also prevented the mice from developing epilepsy, which affected more than half of the mice who were not treated with new interneurons.

"Inhibitory neurons are critically involved in many aspects of memory, and they are extremely vulnerable to dying after a brain injury," said Robert Hunt, PhD, assistant professor of anatomy and neurobiology at UCI School of Medicine who led the study. "While we cannot stop interneurons from dying, it was exciting to find that we can replace them and rebuild their circuits."

This is not the first time Hunt and his team has used interneuron transplantation therapy to restore memory in mice. In 2018, the UCI team used a similar approach, delivered the same way but to newborn mice, to improve memory of mice with a genetic disorder.

Still, this was an exciting advance for the researchers. "The idea to regrow neurons that die off after a brain injury is something that neuroscientists have been trying to do for a long time," Hunt said. "But often, the transplanted cells don't survive, or they aren't able to migrate or develop into functional neurons."

To further test their observations, Hunt and his team silenced the transplanted neurons with a drug, which caused the memory problems to return.

"It was exciting to see the animals' memory problems come back after we silenced the transplanted cells, because it showed that the new neurons really were the reason for the memory improvement," said Bingyao Zhu, a junior specialist and first author of the study.

Currently, there are no treatments for people who experience a head injury. If the results in mice can be replicated in humans, it could have a tremendous impact for patients. The next step is to create interneurons from human stem cells.

"So far, nobody has been able to convincingly create the same types of interneurons from human pluripotent stem cells," Hunt said. "But I think we're close to being able to do this."

Jisu Eom, an undergraduate researcher, also contributed to this study. Funding was provided by the National Institutes of Health.

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New Weill Neurohub will unite UCSF, UC Berkeley, UW in race to find new treatments for brain diseases – UW Today

Posted: November 17, 2019 at 8:46 am

Engineering | Health and medicine | News releases | Population Health | Research | Science | Technology

November 12, 2019

Microscopy image showing the cytoskeleton within neurons, which are differentiating from induced pluripotent stem cells.UC San Francisco

With a $106 million gift from the Weill Family Foundation, UC Berkeley, UC San Francisco and the University of Washington have launched the Weill Neurohub, an innovative research network that will forge and nurture new collaborations between neuroscientists and researchers working in an array of other disciplines including engineering, computer science, physics, chemistry and mathematics to speed the development of new therapies for diseases and disorders that affect the brain and nervous system.

A 2016 study by the Information Technology & Innovation Foundation estimated that, in the U.S. alone, neurological and psychiatric disorders and diseases including Alzheimers; Parkinsons; anxiety and depression; traumatic brain injury and spinal cord injury; multiple sclerosis; ALS; and schizophrenia carry an economic cost of more than $1.5 trillion per year, nearly 9 percent of GDP.

The gains in knowledge amassed by neuroscientists over the past few decades can now be brought to the next level with supercomputers, electronic braincomputer interfaces, nanotechnology, robotics and powerful imaging tools, said philanthropist Sanford I. Sandy Weill, chairman of the Weill Family Foundation. The Neurohub will seize this opportunity by building bridges between people with diverse talents and training and bringing them together in a common cause: discovering new treatments to help the millions of patients with such conditions as Alzheimers disease and mental illness.

Complementing the strengths of UCSF, Berkeley and the UW, the Weill Neurohub will draw on the expertise and resources of the 17 National Laboratories overseen by the Department of Energy, which excel in bioengineering, imaging, and data science. In August 2019, the Weill Family Foundation and the DOE signed a Memorandum of Understanding creating a new publicprivate partnership. The partnership is exploring the use of the Departments artificial intelligence and supercomputing capabilities, in conjunction with Bay Area universities and the private sector, to advance the study of traumatic brain injury, or TBI, and neurodegenerative diseases.

Secretary of Energy Rick Perry, who has spearheaded the creation of an AI and Technology Office during his tenure at DOE, said that the vision for the Weill Neurohub dovetails with his own mission to make publicly funded AI and supercomputing resources more widely accessible to advance scientific discovery. We are on the cusp of great discoveries that could transform our approach to TBI, Alzheimers disease and other neurological and psychiatric disorders, and easing access to the world-class computational power of our National Laboratories to initiatives like the Weill Neurohub is a win-win for science and the public sector and, eventually, for patients.

As many neurological disorders, such as dementia, are associated with aging, the costs of these unmet medical needs are expected to increase significantly in the coming years. California, with the largest aging population in the U.S., with one in five residents reaching age 65 or older in the next decade, faces particularly formidable challenges, said Gov. Gavin Newsom.

Every day, millions of people in California, the nation, and the world are facing the uncertainty of neuro-related diseases, mental illness and brain injuries, and collaboration between different disciplines in science, academia, government and philanthropy is critical to meet this challenge. Together, we must accelerate the development and use cutting-edge technology, innovation and tools that will advance research and practical application that will benefit people across the world and for generations to come, said Newsom. I want to thank Sandy Weill and his wife, Joan, for their amazing work, kindness, dedication and commitment to philanthropic causes, especially when they open doors, bridge gaps, and make innovation and collaboration possible to advance causes that can truly have an impact on peoples quality of life.

Sanford and Joan Weill.UC San Francisco

The Weill Neurohub will enable the three universities to work together on these pressing problems. For example, the UW and UCSF, renowned research universities with long traditions of excellence in basic neuroscience research, also have federally sponsored Alzheimers Disease Research Centers, or ADRCs. Through the Weill Neurohub, members of the UWs ARDC, part of the UW Medicine Memory and Brain Wellness Center, and UCSFs ADRC, led by the UCSF Memory and Aging Center, will collaborate with top neurodegeneration researchers at Berkeley.

The Weill Neurohub will provide funding for faculty, postdoctoral fellows, and graduate students at the UW, Berkeley and UCSF working on cross-disciplinary projects, including funding for high-risk/high-reward proposals that are particularly innovative and less likely to find support through conventional funding sources. But the bulk of the Weill Neurohubs funding will support highly novel cross-institutional projects built on one or more of four scientific pillars that Weill Neurohub leaders have deemed priority areas for answering the toughest questions about the brain and discovering new approaches to disease: imaging; engineering; genomics and molecular therapeutics; and computation and data analytics.

The Weill Neurohub may seek additional academic, corporate and philanthropic partners to harness resources collaboratively, better scale research and development efforts, share information and data and create partnerships to make breakthroughs faster and at a lower cost than the current paradigm allows.

Relevant examples of interdisciplinary or cross-institutional neuroscience projects now underway at UCSF, Berkeley and/or the UW include:

This gift expands on the unique vision and mission of the UCSF Weill Institute for Neurosciences, established in 2016 with a $185 million gift from the Weill Family Foundation and Joan and Sandy Weill whose giving to the neuroscience community now exceeds $300 million said UCSFs Dr. Stephen Hauser, the Robert A. Fishman Distinguished Professor of Neurology and Weill Institute director.

The UCSF Weill Institute set out to break down walls between the clinical disciplines of neurology, neurosurgery and psychiatry, and also bring these clinical specialties together with the basic neurosciences, said Hauser. Now, with the Weill Neurohub, were going even further: eliminating institutional boundaries between three great public research universities, and also other disciplinary walls between traditional neuroscience and non-traditional approaches to understanding the brain. By embracing engineering, data analysis and imaging science at this dramatically higher level areas in which both Berkeley and the UW are among the best in the world neuroscientists on all three campuses will gain crucial tools and insights that will bring us closer to our shared goal of reducing suffering from brain diseases.

Hauser will serve as one of two co-directors of the new Weill Neurohub along with Berkeleys Ehud Udi Isacoff, the Evan Rauch Chair of Neuroscience. Together with Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the UW, they will serve on the Weill Neurohubs Leadership Committee.

In the Weill Neurohub, the emphasis will be on technology to enable discovery of disease mechanisms, and thus development of novel treatments and early detection of neurologic diseases, to allow intervention before conditions become severe, said Isacoff, who heads Berkeleys Helen Wills Neuroscience Institute. The technologies include next-generation neuroimaging and therapeutic manipulations ranging from brain implants to CRISPR gene editing, with major efforts in machine learning and high-speed computation. I think these three campuses can succeed in this joint mission in a way that no others can the combined expertise this group brings to the table, especially when you bring in the National Labs, really is unparalleled.

Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the University of Washington.University of Washington

The UWs Daniel added, The Weill Neurohub brings together three outstanding public institutions, each with a deep commitment to bridge boundaries between science, engineering, computer science and data science to address fundamental problems in neuroscience and neural disorders. To my knowledge, this is a nationally unique enterprise drawing on diverse approaches to accomplish goals no single institution could reach alone, as well as seeding and accelerating research and discovery.

Neuroscientists have made huge strides in understanding the brain in the 30 years since President George H. W. Bush designated the 1990s as the Decade of the Brain, and subsequently through the National Institute of Healths ongoing BRAIN Initiative, first announced by President Obama in 2013. But treatments for neurological and psychiatric diseases have lagged far behind those for other common afflictions, such as cardiovascular disease and cancer.

Much of the lack of progress on neurological and psychiatric disease is due to the unparalleled complexity of the nervous system, in which hundreds of billions of nerve cells and support cells form as many as 100 trillion connections in intricate three-dimensional networks throughout the brain and spinal cord. The Weill Neurohubs leaders believe reaching beyond conventional approaches is essential to grappling with this complexity.

Despite amazing advances in neuroscience, new therapies are not reaching patients with mental illness and neurological disorders nearly as quickly as they have for heart disease and cancer. And in addition to the terrible personal toll these illnesses exact on patients and their families, they also have a massive impact on our healthcare system and on the global economy, said Joan Weill, president of the Weill Family Foundation. Our goal, through the broad and multifaceted approach of the Weill Neurohub, is to begin to change that.

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New Weill Neurohub will unite UCSF, UC Berkeley, UW in race to find new treatments for brain diseases - UW Today

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Gene Therapy Production and Quality Control – Genetic Engineering & Biotechnology News

Posted: November 17, 2019 at 8:45 am

Gene therapy is an emerging field and industry is yet to work out how best to manufacture these life-saving products says expert. Interest in gene therapy is growing, says Andrew Powaleny, public affairs director at the Pharmaceutical Research and Manufacturers of America (PhRMA).

As of December 2018, the last time we did our analysis, there were 289 cell and gene therapies in development either in clinical trials or awaiting FDA approval, he adds.

And the interest is understandable. Gene therapies let doctors treat the root causes of disease, potentially curing patients. Also judging by products like Zynteglo and Zolgensma, which cost $1.7m and $2.1m, respectively, gene therapies will generate significant revenue for firms able to commercialize them successfully.

But manufacturing a gene therapy remains a complex technical challenge. Just ask Zynteglo developer, Bluebird Bio.

Zynteglo is designed to treat patients with transfusion-dependent -thalassemia (TDT). Development has not always been smooth. For example, in 2017 Bluebird announced it had made manufacturing process improvements for Zynteglo after the product disappointed in an earlier trial. However, in June this year it appeared Bluebird had turned things around when the EMA granted Zynteglo conditional clearance. But, in the approval presentation Bluebird announced it would not be able to launch the product until 2020.

Bluebird explained the delay was to allow it to work with the EMA to finalize commercial drug product specifications and manufacturing parameters. The situation changed again last month. The EMA accepted refined commercial drug product manufacturing specifications for Zynteglo. And Bluebird now expects the therapy to launch this year.

Similarly, Novartis, owner of the spinal muscular atrophy therapy Zolgensma, has encountered manufacturing issues. In October the firm said the EMA and Japans PMDA had extended their assessments of Zolgensma and asked for more CMC information.

Bluebird and Novartis travails are the high-profile examples, but the wider gene therapy sector faces manufacturing challenges according to Ashleigh Wake, laboratory director, Intertek Pharma Services Manchester.

Given the newness of medicines of this type there is limited historic information available on which to build strategy and as such adds extra uncertainty to any regulatory submission, says Wake. When considering how to build an effective CMC for a gene therapy IND, selection of critical assays will depend on the specific product but may include assays for concentration, purity such as determination of residual cellular DNA or empty viral particles, identity, activity, potency and stability.

Understanding which tests are critical to determining product quality is a key part of winning approval, continues Wake. From a regulatory perspective, an understanding of the critical quality attributes (CQAs) which impact product safety, purity, and potency are required. For gene therapy products this means developing and validating analytical assays to assess, vector productivity, vector purity, biological activity and safety.

With this in mind Intertek recently announced plans to expand its service center in Manchester in the UK.

Our expansion in laboratory footprint and recruitment of specialists in gene therapy analytics coupled with our integrated approach to analytical method lifecycle will mean we can develop methods which are best suited for the intended use at the various clinical stages on the way to commercialization, he points out.

The challenges will keep coming, according to Wake. She says therapies that use viral vectors will increase demand for quality control expertise and analytical technology.The inherent complexity of viral vector-based products makes physical and biological characterization highly challenging, she explains, citing the ability to differentiate between full capsids and empty ones as an example. In order to provide a complete quality control package, a range of analytical methods and technology are required, which incorporate instrumentation such as cryoelectron microscopy, qPCR or DDPCR which are not commonly associated with pharmaceutical quality control, in addition to techniques such as HPLC or analytical ultracentrifugation.

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Gene Therapy Production and Quality Control - Genetic Engineering & Biotechnology News

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