StemCell Therapy

The Alliance for Regenerative Medicine Outlines Recommendations on Enabling Cross-border and Regional Access to Advanced Therapy Medicinal Products (ATMPs) in Europe

BRUSSELS, BELGIUM 27 January, 2020

The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, today published a positioning paper outlining recommendations for the timely and effective access to cross-border healthcare for patients.

Todays new position paper focuses, and further elaborates, on the recommendations of ARMs July 2019 report on ensuring timely access to ATMPs in Europe (see the report here). It represents the views of the ARM members and aims to stimulate debate and reach consensus among key stakeholders, including marketing authorisation holders, payers and treatment centres, on solutions to ensure all European patients can secure access to ATMPs, irrespective of their country or region of origin.

Challenges to expanded ATMP access in Europe

ARMs key recommendations

In order to ensure that patients across Europe can access ATMPs, ARM recommends the following:

Additional recommended measures to facilitate industry engagement in existing initiatives could include: improved opportunities for cross-country collaboration, removing duplicative processes at national level, and adopting policy principles to enhance cross-country collaboration.

Janet Lambert, CEO of ARM, commented: Europe has always been a leader in ATMP innovation, both in R&D and getting products to market, however, to ensure that patients have access to these transformative treatments, there are several challenges that need to be overcome at EU, national and regional levels. This paper builds on the EU Market Access Report published in 2019 and the subsequent European stakeholder meeting in Brussels, and outlines the challenges and the recommendations that we, alongside our members, believe will most effectively get these therapies to patients in a sustainable manner.

To read the report in full, please follow this link.

Press inquiriesFor more information about the report or media requests, please contact Consilium Strategic Communications at arm@consilium-comms.com.

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. Founded in 2009, ARM 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 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.

ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidance. For more information, visit alliancerm.org.

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The Alliance for Regenerative Medicine Outlines Recommendations on Enabling Cross-border and Regional Access to Advanced Therapy Medicinal Products...

The approach builds on technology developed for regenerative medicine. I work in a lab that investigates ways to engineer tissue for the replacement or repair of human organs. We use some of these methods to grow meat.

The first step involves what I call a high-tech cotton-candy machine. The machine takes in a solution of water and gelatin, spins it at a high rate, and sends out nano- and microfibers that get woven together into a slab. The texture of the slab mimics that of an animals muscular tissuethe part that gives meat its texture. We then immerse the slab into a solution containing stem cells from a cow or a rabbit, where it acts as a scaffolding for the cells to cling to and grow. We use myoblastsstem cells that are already committed to turning into muscle cells. Once the solution has permeated the scaffolding, we turn the stem cells into muscle cells by tweaking the nutrients in the solution. Et voil, we have long, thin threads of muscle, like in real meat.

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Q&A: Growing Steaks in the Lab - Physics

The idea of scientists trying to grow brain tissue in a dish conjures up all sorts of scary mental pictures (cue the horror-movie music). But the reality of the research is quite far from that sci-fi visionand always will be, say researchers in the field. In fact, a leader in this area of research, Arnold Kriegstein of the University of California, San Francisco, says the reality does not measure up to what some scientists make it out to be.

In a paper published on January 29 in Nature, Kriegstein and his colleagues identified which genes were active in 235,000 cells extracted from 37 different organoids and compared them with 189,000 cells from normally developing brains. The organoidsat times called mini brains, to the chagrin of some scientistsare not a fully accurate representation of normal developmental processes, according to the study.

Brain organoids are made from stem cells that are transformed from one cell type to the another until they end up as neurons or other mature cells. But according to the Nature paper, they do not always fully complete this developmental process. Instead the organoids tend to end up with cells that have not fully transformed into new cell typesand they do not re-create the normal brains organizational structure. Psychiatric and neurodevelopmental conditionsincluding schizophrenia and autism, respectivelyand neurodegenerative diseases such as Alzheimers are generally specific to particular cell types and circuits.

Many of the organoid cells showed signs of metabolic stress, the study demonstrated. When the team transplanted organoid cells into mice, their identity became crisper, and they acted more like normal cells, Kriegstein says. This result suggests that the culture conditions under which such cells are grown does not match those of a normally developing brain, he adds. Cellular stress is reversible, Kriegstein says. If we can reverse it, were likely to see the identity of cells improve significantly at the same time.

Brain organoids are getting better at recapitulating the activities of small clusters of neurons, says Kriegstein, who is a professor of neurology and director of the Eli & Edythe Broad Center for Regeneration Medicine and Stem Cell Research at U.C.S.F. Scientists often make organoids from the cells of people with different medical conditions to better understand those conditions. But some scientists may have gone too far in making claims about insights they have derived from patient-specific brain organoids. Id be cautious about that, Kriegstein says. Some of those changes might reflect the abnormal gene expression of the cells and not actually reflect a true disease feature. So thats a problem for scientists to address.

A small ball of cells grown in a dish may be able to re-create some aspects of parts of the brain, but it is not intended to represent the entire brain and its complexity, several researchers have asserted. These organoids are no more sentient than brain tissue removed from a patient during an operation, one scientist has said.

Of course, models are never perfect. Although animal models have led to fundamental insights into brain development, researchers have sought out organoids, or organs-in-a-dish, precisely because of the limitations of extrapolating biological insights from another species to humans. Alzheimers has been cured hundreds of times in mice but never in us, for instance.

That said, the current models are already very useful in addressing some fundamental questions in human brain development, says Hongjun Song, a professor of neuroscience at the Perelman School of Medicine at the University of Pennsylvania, who was not involved in the new research. Using brain organoids, he adds, the Zika virus was recently shown to attack neural stem cells, causing a response that could explain why some babies exposed to Zika in utero develop unusually small brains.

Michael Nestor, a stem cell expert, who did not participate in the new study, says his own organoids are very helpful for identifying unusual activity in brain cells grown from people with autism. And he notes that they will eventually be useful for screening potential drugs.

Even though the models will always be a simplification, the organoid work remains crucial, says PaolaArlotta, chair of the department of stem cell and regenerative biology at Harvard University, who was also not involved in the Nature study. Neuropsychiatric pathologies and neurodevelopmental conditions are generally the result of a large number of genetic changes, which are too complex to be modeled in rodents, she says.

Sergiu Pasca, another leader in the field, says that the cellular stress encountered by Kriegstein and his team might actually be useful in some conditions, helping to create in a dish the kinds of conditions that lead to diseases of neurodegeneration, for instance. What I considerthe most exciting feature remains our ability to derive neural cells and glial cells in vitro, understanding their intrinsic program of maturation in a dish, says Pasca, an assistant professor at Stanford University, who was not part of the new paper.

The ability to improve cell quality when exposed to the environment of the mouse brain suggests that it may be possible to overcome some of the current limitations, Arlotta says. There is not yet a single protocol for making brain organoids in a lab, which may be for the best at this early stage of the field. Eventually, she says, scientists will optimize and standardize the conditions in which these cells are grown.

Arlotta, who is also the Golub Family Professor of Stem Cell and Regenerative Biology at Harvard, published a study last year in Nature showing that she and her colleagues canover a six-month periodmake organoids capable of reliablyincluding a diversity of cell types that are appropriate for the human cerebral cortex. She says it is crucial for organoid work to be done within an ethical framework. Arlotta is part of a federally funded team of bioethicists and scientists working together to ensure that such studies proceed ethically. The scientists educate the bioethicists on the state of the research, she says, and the ethicists inform the scientists about the implications of their work.

Nestor feels so strongly about the importance of linking science, policy and public awareness around stem cell research that he has put his own laboratory at the Hussman Institute for Autism on hold to accept a year-long science-and-technology-policyfellowship with the American Association for the Advancement of Science. He says he took the post to make sure the public and policy makers understand what they need to know about organoids and other cutting-edge science and to learn how to communicate about science with them.

One thing all of the scientists interviewed for this article agree on is that these brain organoids are not actual mini brains, and no one is trying to build a brain in a dish. Even as researchers learn to make more cell types and grow them in more realistic conditions, they will never be able to replicate the brains structure and complexity, Kriegstein says. The exquisite organization of a normal brain is critical to its function, he adds. Brains are still the most complicated structure that nature has ever created.

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"Mini Brains" Are Not like the Real Thing - Scientific American

DUBLIN, Jan. 31, 2020 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced it will release fourth quarter and full year 2019 financial results on Monday, February 10, 2020, prior to the open of U.S. financial markets.

For additional materials related to Allergan's fourth quarter and full year 2019 financial results, please visit Allergan's Investor Relations website at https://www.allergan.com/investors.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website atwww.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences;difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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(862) 261-7488

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Allergan to Report Fourth Quarter and Full Year 2019 Financial Results - Yahoo Finance

Three-dimensional printers have now assembled candy, clothing, and even mouse ovaries. But in the next decade, specialized bioprinters could begin to build functioning human organs in space. It turns out, the minimal gravity conditions in space may provide a more ideal environment for building organs than gravity-heavy Earth.

If successful, space-printed organs could help to shorten transplant waitlists and even eliminate organ rejection. Though they still have a long way to go, researchers at the International Space Station (ISS) hope to eventually assemble organs from adult human cells, including stem cells.

The medical field has only recently embraced 3D printing in general, particularly in biomedical fields like regenerative medicine and prosthetics. So far, these printers have produced early versions of blood vessels, bones, and different types of living tissue by churning out repeated layers of bioinka substance comprised of living human cells and other tissue thats meant to mimic the natural environment that surrounds growing organs.

Recently, researchers are finding that Earth might not be the best environment for growing freestanding organs. Because gravity is constantly pushing down on these delicate structures as they grow, researchers must surround the tissues in scaffolding, which can often debilitate the delicate veins and blood vessels and prevent the soon-to-be organs from growing and functioning properly. Within microgravity, however, soft tissues hold their shape naturally, without the need for surrounding supportan observation thats driven researchers to space.

And one manufacturing lab based in Indiana thinks its tech could play a key role in space. The 3D BioFabrication Facility (BFF) is a specialized 3D printer that uses bioink to build layers several times thinner than human hair. It cost about $7 million to build and employs the smallest print tips in existence.

The brainchild of spaceflight equipment developer Techshot and 3D printer manufacturer nScrypt, the BFF headed to the ISS in July 2019 aboard the SpaceX CRS-18.

Currently, the project focuses on building increasingly thick artificial cardiac tissue and delivering it back to Earth. Once the printed cardiac tissue reaches a certain thickness, it gets harder for researchers to ensure that a printed structures layers effectively grow into one another. Ultimately, though, theyd like the organs to arrive here fully formed.

Printed organs would eventually require vasculature and nerve endings to work properly, though that technology doesnt yet exist.

The next stagetesting heart patches under microscopes and within animalscould span over the next four years. As for whole organs, Techshot claims it plans to begin production after 2025. For now, the project is still in its infancy.

If you were to look at what we printed, it looks very modest, says Techshot vice president of corporate advancement Rich Boling. Its just a cuboid-type shape, this rectangular box. Were just trying to get cells to grow one layer into the next.

Cooking organs like pancakes

Compare the manufacturing process to cooking pancakes, Boling says. The space crew first creates a custom bioink pancake mix with the cells sent from Earth, which they load with syringe-like tools into the BFF.

Researchers then insert a cassette into the BFF containing a bioreactora system that mimics the normal bodily functions essential for growing healthy tissue, like providing nutrients and flushing out waste.

Approximately 200 miles below in Greenville, Indiana, Techshot engineers connect with ISS astronauts on a NASA-enabled secure digital pathway. The linkup allows Techshot to remotely command BFF functions like pump pressure, internal temperature, lighting, and print speed.

Next, the actual printing process occurs within the bioreactor and can take anywhere from moments to hours, depending on the shapes complexity. In the final production step, the cell-culturing ADvanced Space Experiment Processor (ADSEP) cooks the theoretical pancake; essentially, the ADSEP toughens up the printed tissue for its journey back to earth. This step could take anywhere from 12 to 45 days for different tissue types. When completed and hardened, the structure heads home.

The researchers have gone through three testing processes so far, each one getting more exact. This March, theyll begin the third round of experiments.

The bioprinter space race

The BFF lab is the sole team developing this specific type of microgravity bioprinter, Boling says. Theyre not the only ones looking to print human organs in space, though.

A Russian project has also entered the bioprinting space race, however their technique highly differs. Unlike the BFFs bioink layering method, Russian biotechnology laboratory 3D Bioprinting Solutions uses magnetic nanoparticles to produce tissue. An electromagnet creates a magnetic field in which levitating tissue forms the desired structuretechnology that appears ripped from the pages of a sci-fi novel.

After their bioprinter fell victim to an October 2018 spacecraft crash, 3D Bioprinting Solutions rebounded; the team now collaborates with US and Israeli researchers at the ISS. Last month, their crew created the first space-bioprinted bone tissue. Similar to the US project, 3D Bioprinting Solutions aims to manufacture functioning human tissues and organs for transplantation and general repair.

Just because we have the technology to do it, should we do it?

If the 3D BioFabrication Facility prospers in printing working human organs, theyd be subject to thorough regulation here on Earth. The US approval process is stringent for any drug, Rich Boling says, posing a challenge for this unprecedented invention. Techshot predicts at least 10 years for space-printed organs to achieve legal approval, though its an inexact estimate.

Along with regulatory acceptance, human tissue printed in microgravity may encounter societal pushback.

Each country maintains varying laws related to medical transplants. Yet as bioengineering advances into the the final frontier, the international scientific research community may need to shape new guidelines for collaboration among the stars.

As the commercialization of low-Earth orbit continues to ramp up in the next few years, it is certainly true that were going to have to take a very close look at the regulations that apply to that, says International Space Station U.S. National Laboratory interim chief scientist Michael Roberts. And some of those regulations are going to stray into questions related to ethics: Just because we have the technology to do it, should we do it?

Niki Vermeulen, a University of Edinburgh science technology and innovation studies lecturer, has researched the social implications of 3D bioprinting experiments. Like any Earth-bound project, she urges scientists not to get peoples hopes up too early in the process; individuals seeking organ transplants could read about the BFF online and think it could soon be ready to meet their needs.

The most important thing now, I think, is expectation management, Vermeulen says. Because its really quite difficult to do this, and of course we really dont know if its going to work. If it did, it would be amazing.

Another main issue is cost. Like other cutting-edge biotechnology innovations, the organs could also pose a major affordability challenge, she says. Techshot claims that a single space-printed organ could actually cost less than one from a human donor, since some people must pay for a lifetime of anti-rejection meds and/or multiple transplants. Theres currently no telling how long the BFF process would actually take, however, compared to the conventional donor route.

Plus, theres potential health risks for recipients: Techshot chief scientist Eugene Boland says cell manipulation always presents a possibility of genetic mutation. Modified stem cells can potentially cause cancer in recipients, for example.

The team is now working to define and minimize any dangers, he says. The BFF experiment adheres to the FDAs specific regulations for human cells, tissues, and cellular and tissue-based products.

Researchers on the ground now hope to perfect human cell manipulation: Over 100 US clinical trials presently test cultured autologous human cells, and several hundred test cultured stem cells with multiple origins.

What comes next

After the next round of printing tests this March, Techshot will share the bioprinter with companies and research institutions looking to print materials like cartilage, bone, and liver tissue. Theyre currently preparing the bioprinter for these additional uses, Boling says, which could advance health care as a whole.

To speed things up for space crews, Techshot is now building a cell factory that produces multiple cell types in orbit. This technology could cut down the number of cell deliveries between Earth and space.

The ISS has taken in plenty of commercial ventures in recent years, Michael Roberts says, and its getting crowded up there. Space-based experiments ramped up between 40 and 50 years ago, though until recently they mostly prioritized satellite communications and remote observation technology. Since then, satellites have shrunk from bus-sized to smaller than a shoebox.

Roberts has witnessed the scientific areas of interest broaden over the past decade to include medicine. Organizations like the National Institutes of Health are now looking to space to improve treatments, and everything from large pharmaceutical companies to small-scale startups want in.

Theyve got something stuck on every surface up there, he says.

As the ISS runs out of space and exterior attachment points, Roberts predicts that commercial ventures will build new facilities built for specific activities like manufacturing and plant growth. He sees it as a good opportunity for further innovation, since the ISS was originally designed for far more general purposes.

Space, as a whole, may start to look quite different from the first exploration age.

Baby boomers may remember glimpsing at a grainy, black-and-white moon landing five decades ago. Within the same lifetime, they could potentially observe the introduction of space-printed organs.

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Space might be the perfect place to grow human organs - Popular Science

Hitachi Chemical Advanced Therapeutics Solutions (HCATS), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemicals Regenerative Medicine Business Sector (RMBS) in North America, has opened its new cell and gene therapy manufacturing facility in Allendale, NJ. The new facility is the companys first to be designed from the ground up to meet the needs of commercial cell and gene therapy products and more than doubles HCATS existing manufacturing capacity in New Jersey.The facility currently includes six classified environment rooms, with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The companys ongoing investment in facility expansion complements ongoing investments in the companys quality systems and commercial expertise, all with the aim of meeting its commitments to existing clients with near-term expectations for commercial product manufacturing.The opening of this new facility marks an important milestone for HCATS and will offer a state-of-the-art resource for our clients as they commercialize cell and gene therapies, said Robert Preti, president and chief executive officer, HCATS, and general manager, RMBS. Access to this type of manufacturing space is needed across the industry to ensure the continued growth and momentum of these promising therapeutics. This facility will require up to 500 more employees to reach full operational capacity over the next several years, supporting our growing roster of clients.Governor Phil Murphy of New Jersey, said, I am excited for Hitachi Chemical Advanced Therapeutics Solutions future in New Jersey, and I have no doubt that their new, state-of-the-art facility will not only help New Jersey residents, but also contribute to expanding the innovation economy by bringing up to 500 new jobs to our state. With our highly educated and diverse workforce, New Jersey is the perfect location for expanding biotech firms like Hitachi Chemical.The leadership and employees of HCATS, along with officials of Hitachi Chemical and local dignitaries, commemorated the milestone with a ribbon cutting ceremony on January 29 at the new facility.

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Hitachi Opens Cell And Gene Therapy Facility In NJ - Contract Pharma

In what is a world-first and potentially the dawn of a new medical technology to treat damaged hearts, scientists in Japan have succeeded in transplanting lab-grown heart cells into a human patient for the first time ever. The procedure is part of a cutting-edge clinical trial hoped to open up new avenues in regenerative medicine, with the treatment to be given to a further nine patients over the coming years.

The clinical trial harnesses the incredible potential of induced pluripotent stem cells (IPSCs), a Nobel Prize-winning technology developed at Kyoto University in 2006. These are created by first harvesting cells from donor tissues and returning them to their immature state by exposing them to a virus. From there, they can develop into essentially any cell type in the body.

Professor Yoshiki Sawa is a cardiac surgeon at Osaka University in Japan, who has been developing a technique to turn IPSCs into sheets of 100 million heart muscle cells, which can be grafted onto the heart to promote regeneration of damaged muscles. This was first tested on pigs and was shown to improve organ function, which led Japans health ministry to conditionally approve a research plan involving human subjects.

The first transplantation of these cells is a huge milestone for the researchers, with the operation taking place earlier this month and the patient now recovering in the general ward of the hospital. The sheets are biodegradable, and once implanted on the surface of the heart are designed to release growth factors that encourage new formation of healthy vessels and boost cardiac function.

The team will continue to monitor the first patient over the coming year, and over the next three years aims to carry out the procedure on a total of 10 patients suffering from ischemic cardiomyopathy, a condition caused by a heart attack or coronary disease that has left the muscles severely weakened.

I hope that [the transplant] will become a medical technology that will save as many people as possible, as Ive seen many lives that I couldnt save, Sawa said at a news conference on Tuesday, according to The Japan Times.

Source: The Japan Times

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Lab-grown heart cells implanted into human patient for the first time - New Atlas

Company Expects to Add Up to 500 Employees in New Jersey

Hitachi Chemical Advanced Therapeutics Solutions, LLC ("HCATS"), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemicals Regenerative Medicine Business Sector ("RMBS") in North America, today announced the opening of its new cell and gene therapy manufacturing facility in Allendale, New Jersey. The new facility is the companys first to be designed from the ground up to meet the unique needs of commercial cell and gene therapy products and more than doubles HCATS existing manufacturing capacity in New Jersey.

The facility ("75 Commerce") currently includes six classified environment rooms, with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The companys ongoing investment in facility expansion complements ongoing investments in the companys Quality Systems and commercial expertise, all with the aim of meeting its commitments to existing clients with near-term expectations for commercial product manufacturing.

"The opening of this new facility marks an important milestone for HCATS and will offer a state-of-the-art resource for our clients as they commercialize cell and gene therapies. Access to this type of manufacturing space is needed across the industry to ensure the continued growth and momentum of these promising therapeutics," said Robert Preti, Ph.D., President and CEO, HCATS, and General Manager, RMBS. "This facility will require up to 500 more employees to reach full operational capacity over the next several years, supporting our growing roster of clients."

"I am excited for Hitachi Chemical Advanced Therapeutics Solutions future in New Jersey, and I have no doubt that their new, state-of-the-art facility will not only help New Jersey residents, but also contribute to expanding the innovation economy by bringing up to 500 new jobs to our state," said Governor Phil Murphy of New Jersey. "With our highly educated and diverse workforce, New Jersey is the perfect location for expanding biotech firms like Hitachi Chemical."

The leadership and employees of HCATS, along with officials of Hitachi Chemical and local dignitaries, commemorated the milestone with a ribbon cutting ceremony on January 29 at the new facility. For a selection of images from the ceremony please visit https://www.pctcelltherapy.com/pct-pulse/HCATS-Opens-Second-New-Jersey-Facility

About the Hitachi Chemical Regenerative Medicine Business Sector

The Hitachi Chemicals Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.

For more information on North America services, please visit http://www.pctcelltherapy.com.

For more information on Europe services, please visit http://www.apceth.com.

For more information on Japan services, please visit http://www.hitachi-chem.co.jp/english/

View source version on businesswire.com: https://www.businesswire.com/news/home/20200130005221/en/

Contacts

Hitachi Chemical Advanced Therapeutics Solutions, LLC Gregory Johnsongregory.johnson.jt@hitachi-chem.com Tel: +1 201 515 2153

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Hitachi Chemical Advanced Therapeutics Solutions Announces Opening of Its New Facility Designed to Manufacture Commercial Cell and Gene Therapies -...

Six patients with a rare blood disease are now in remission thanks to a new gene therapy. The condition, known as X-CGD, weakens the immune system leaving the body vulnerable to a range of nasty infections and shortens a persons lifespan. It is normally treated using bone marrow transplants, but matching donors to patients can be tricky and time-consuming and the procedure comes with risks.

A team led by UCLA recently treated nine people with the disease and six successfully went into remission, allowing them to stop other treatments. All six patients are doing well and havent suffered any adverse effects.

X-CGD is a form of chronic granulomatous disease (CGD). People with CGD have an inherited mutation in one of five genes involved in helping their immune system attack invading microbes with a burst of chemicals. This means that CGD sufferers have weaker immune systems than healthy people, so they have a greater risk of getting infections. These infections can be life-threatening, particularly if they affect the bones or cause abscesses in vital organs.

X-CGD is the most common type of CGD and only affects males. It is caused by a mutation in a gene on the X-chromosome. Current treatments are limited to targeting the actual infections with antibiotics as well as bone marrow transplants. Bone marrow contains stem cells that develop into white blood cells, so bone barrow from a healthy donor can provide a CGD patient with healthy white blood cells that can help their body to fend off disease.

However, bone marrow transplants are far from ideal. The patient has to be matched to a specific donor, and the body can reject the implanted bone marrow. That means that following a transplant, the patient needs to take anti-rejection drugs for at least six months.

For their new treatment, researchers removed blood cell-forming stem cells from the patients themselves and genetically modified them so that they no longer carried the unwanted mutation. Then, the edited stem cells were returned to their bodies, ready to produce healthy new infection-fighting white blood cells.

This is the first time this treatment has been used to try to correct X-CGD. The researchers followed up with the nine patients but sadly, two passed away within three months of the treatment. Its important to note that their deaths were not a result of the treatment but of rather severe infections that they had been suffering from for a long time. The remaining seven were followed for 12 to 36 months all remain free from infections related to their condition, and six have been able to stop taking preventative antibiotics entirely. The results are reported in Nature Medicine.

None of the patients had complications that you might normally see from donor cells and the results were as good as youd get from a donor transplant or better, said Dr Donald Kohn, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAand a senior author of the paper.

Whats more, four new patients have also been treated since the initial research was conducted. None experienced any adverse reactions and all remain infection-free. Now, the team plans to conduct a bigger clinical trial to further test the safety and efficacy of their new treatment, with the hopes that it may one day become available to the masses.

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New Gene Therapy Successfully Sends Six Patients With Rare Blood Disorder Into Remission - IFLScience

WASHINGTON, D.C. This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. To date, the FDA has approved four gene therapy products, which insert new genetic material into a patients cells.

The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.

In that spirit, the FDA announced the release of a number of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators, said FDA Commissioner Stephen M. Hahn, M.D. We understand and appreciate the tremendous impact that gene therapies can have on patients by potentially reversing the debilitating trajectory of diseases. These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.

As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review; including how these products work, how to administer them safely, and whether they will continue to achieve a therapeutic effect in the body without causing adverse side effects over a long period of time.

One of the most important steps the FDA can take to support safe innovation in this field is to create policies that provide product developers with meaningful guidance to answer critical questions as they research and design their gene therapy products.

The six final guidances issued today provide the agencys recommendations for product developers on manufacturing issues and recommendations for those focusing on gene therapy products to address specific disease areas.

The six guidance documents incorporate input from many stakeholders and take a significant step toward helping to shape the modern structure for the development and manufacture of gene therapies.

The agency is issuing this suite of documents to help advance the field of gene therapy while providing recommendations to help ensure that these innovative products meet the FDAs standards for safety and effectiveness.

The scientific review of gene therapies includes the need to evaluate highly complex information on product manufacturing and quality. In addition, the clinical review of these products frequently poses more challenging questions to regulators than reviews of more conventional drugs, such as questions about the durability of response, and these questions often cant be fully answered in pre-market trials of reasonable size and duration.

For some gene therapy products, therefore, although they have met the FDAs standards for approval, the agency may need to accept some level of uncertainty around questions of the duration of the response at the time of marketing authorization.

Effective tools for reliable post-market follow up, such as post-market clinical trials, are going to be key to advancing this field and helping to ensure that the agencys approach fosters safe and innovative treatments.

The draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations provides the FDAs proposed current thinking on an interpretation of sameness between gene therapy products for the purposes of obtaining orphan-drug designation and eligibility for orphan-drug exclusivity.

The draft guidance focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease. As laid out in the FDAs draft guidance and regulations, the agencys determination will consider the principal molecular structural features of the gene therapy products, which includes transgenes (the transferred gene) and vectors (the vehicle for delivering the transgene to a cell).

With the large volume of products currently being studied, gene therapy product developers have asked the agency important questions about orphan-drug designation incentives to develop products for rare diseases with very small patient populations.

The draft guidance has potential positive implications both for product developers and patients by providing insight into the agencys most current thinking on the sameness of products, and thus, not discourage the development of multiple gene therapy products to treat the same disease or condition.

For patients, this policy could help lead to the development and approval of multiple treatments, creating a more competitive market with choices. The FDA encourages stakeholders to provide their comments.

In sum, these policy documents are representative of efforts to help advance product development in the field of gene therapy. The FDA will continue to work with product innovators, sponsors, researchers, patients, and other stakeholders to help make the development and review of these products more efficient, while putting in place the regulatory controls needed to ensure that the resulting therapies are both safe and effective.

The agency also encourages developers of new gene therapy products to make full use of FDAs expedited programs available for products intended to address unmet medical needs in the treatment of serious or life-threatening conditions.

These programs include breakthrough therapy designation, regenerative medicine advanced therapy designation, and fast track designation, as well as priority review and accelerated approval. Developers should pursue these programs whenever possible to help bring the benefits of important advances to patients as soon as possible.

The FDA believes their work will help advance innovations in a way that assures their safety and effectiveness, provides new therapeutic choices to patients and providers and continues to build confidence in this novel and emerging area of medicine.

Source: Food and Drug Administration

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FDA Continues Strong Support of Innovation in Development of Gene Therapy Products - MyChesCo

Image: Nur Yucer, PhD, a project scientist, and Clive Svendsen, PhD, director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute and Professor of Biomedical Sciences and Medicine at Cedars-Sinai. Photo by Cedars-Sinai.

Parkinson's disease is a neurodegenerative disorder that affects predominately dopamine-producing neurons in the brain. Nearly one million will be living with Parkinson's disease in the US this year, according to the Parkinson's Foundation. This is more than the number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig's diseasecombined.

About 60,000 Americans are diagnosed with Parkinson's disease each year, and more than 10 million people worldwide are living with it. Incidence of Parkinsons disease increases with age, but an estimated 10 percent of people with Parkinson's disease are diagnosed before age 50. This is called young-onset Parkinson's.

Researchers at Cedars-Sinai, led by Clive Svendsen, PhD, director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute and Professor of Biomedical Sciences and Medicine at Cedars-Sinai, reported in a study published in Nature Medicine that they found that patients who develop young-onset Parkinsons disease may have been born with dysfunctional brain cells that go undetected for decades.

The research team generated special stem cells, known as induced pluripotent stem cells (iPSCs), from cells of patients suffering from young-onset Parkinsons disease. These iPSCswhich can produce any cell type of the human body, all genetically identical to the patients own cellswere used to produce dopamine neurons from each patient to analyze their functions.

Two key abnormalities were observed in these neurons:

- Dr. Clive Svendsen

After testing a number of drugs on the abnormal dopamine neurons, the researchers discovered that a drug called PEP005 (ingenol mebutate) reduced the elevated levels of alpha-synuclein in both the dopamine neurons in the dish and in laboratory mice. A gel formulation of PEP005 is marketed by LEO Pharma as Picato and is FDA-approved for the treatment of actinic keratosis, a scaly skin patch that develops from years of exposure to the sun. According to the Mayo Clinic, a small percentage of actinic keratosis lesions can eventually become skin cancer.

Michele Tagliati, PhD, Director of the Movement Disorders Program and Vice Chair and Professor in the Department of Neurology at Cedars-Sinai, said the research team next will study how PEP005 might be delivered to the brain and whether or not the abnormalities found in young-onset Parkinson's patients also exist in other forms of Parkinsons.

- Dr. Michele Tagliati.

Edward Kim is Managing Editor of Equities.com.

_____

Sources: Equities News, Cedars-Sinai

DISCLOSURE:The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer.

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Cedars-Sinai Study Indicates That Parkinson's Disease May Start Before Birth - Equities.com

New Delhi [India], Jan 23 (ANI/Business Wire India): On Saturday, January 18 2020, the Advancells Group and the International Fertility Center together ended their first workshop - Sub-Specialty Training in Application of Regenerative Medicine (STAR 2020).

The three-day workshop had specialized doctors, medical practitioners, learned scientists of Advancells, the leaders in cell manufacturing and processes and IFC, one of India's most prestigious Fertility institutes who were joined by candidates with MBBS/BAMS/BHMS/BPharma and Master's degree in Life Sciences.

The key-note speaker of the workshop was Dr Rita Bakshi, founder and chairperson of International Fertility Centre, the oldest fertility clinic and one of the most renowned IVF clinics in India, one of the organizers of the event.

Participants also had a privilege to listen to Dr Sachin Kadam, CTO, Advancells and gain hands-on experience in the preparation of PRP; Liposuction method; and Bone Marrow aspiration. All these techniques were talked about at length and demonstrated in the form of manual and kit-based models to help the candidates gain exposure.

Dr Punit Prabha, Head of Clinical Research and Dr Shradha Singh Gautam, Head of Lab Operations at Advancells successfully set the base of stem cell biology for the participants who were experts in gynecology field, stem cell research and pain specialist.

With the help of detailed analysis of 'Application of PRP for Skin rejuvenation'; 'Preparation of Micro-fragmented Adipose Tissue and Nano Fat & SVF (Stromal Vascular Fraction) from Adipose Tissue'; and 'Cell Culturing and Expansion in a Laboratory', applicants understood the application of stem cells in aesthetics, cosmetology, and anti-ageing.

"Educating young scientists about stem cells is important for us. With this workshop, we wanted to discuss and share the challenges and lessons we have learned in our journey of curing our customers," said Vipul Jain, founder and CEO of Advancells Group.

"We wanted to establish a more concrete knowledge base in the presence of subject matter experts and help our attendees in more possible ways. We are hopeful to have successfully achieved what we claimed with this workshop," he added.

Given the resounding success of the Sub-Specialty Training in Application of Regenerative Medicine (STAR 2020), it's hoped that the future events shall offer even greater wisdom to the participants by helping them improve and the lead the community into the age of greater awareness.

This story is provided by BusinessWire India. ANI will not be responsible in any way for the content of this article. (ANI/BusinessWire India)

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Advancells Group, IFC concluded their three-day workshop on Regenerative Medicine - Yahoo India News

What: LDUNA Aesthetics and Wellness Center, designed to explore and introduce the future of advance treatments for the purposes of anti-aging, wellness, and aesthetics, is hosting a grand opening celebration on Jan. 22. Recognized astheCenter of Excellence for Merakris Therapeutics, a biotechnology company that focuses on cellular regeneration, Ldunasprocess will help to empower a healthier, happier, and improved quality of life.The event will feature jazz entertainment byNieve Malandra, delicious bites by Chef Anthony Vidal, 30-40% off treatments booked that evening, and raffle prizes.

Our centers approach to non-surgical procedures and regenerative treatments to enhance and restore youthfulness will not only change the way others see you, but the way you see yourself. says Byron Brooks,Director of Operations at Lduna Aesthetics and Wellness Center. We are grateful to the Henderson community for welcoming us and look forward to working with Henderson Leadership and community members to sponsor and support community activities and initiatives.

The med spas aesthetics category provides the most innovative, non-surgical methods of skin tightening for both the face and body. These services include Botox, Kybella, Juvederm, and other known fillers, Plasma Pen, as well as, fat cell reduction body contouring, laserskin improvement treatments, micro-needling with exosomes, and other technological skin related services. The anti-aging services offered are genetic testing and bio-identical hormone replacement therapy, to ensure peak biological performance, while Ldunasregenerative medicine category includes the following treatments: Platelet Rich Plasma (PRP), exosome therapy, and joint mobility injections.

Additionally, LDUNAs line of featured luxury products include: Cosmedix, Lucrece, Valmont, GM Collin, NeoCutis, and Jan Marini.

When: Wednesday, January 22

Time: 5:30pm

Address: 10521 Jeffreys Street, Henderson, Suite 220, 89052

Who: Byron Brooks, Director of Operations

Dr. Bonnie Fraser, and Dr. Abraham Fakhouri, Medical Directors

Debra Newell,Celebrity Interior Designer, Featured on Netflix and Bravo

Nieve Malandra, Entertainment/Singer

Chef Anthony Vidal

Zach Zoufaly,Chippendales Performer

For more information, please visit:https://lduna.com/(in development) or like and share on Facebook atLduna Aesthetics and Wellness Center.

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LDUNA Aesthetics and Wellness Center Grand Opening Celebration, Jan. 22 - Nevada Business Magazine

Global Field Service Management Software Market report 2020 offers a professional and in-depth study on the current state of the global Field Service Management Software industry along with competitive landscape, Market share and revenue forecast 2026. The report firstly introduced the basics: definitions, classifications, applications, and industry chain overview; industry policies and plans; product specifications; manufacturing processes; cost structures and so on.

Statistical forecasts in the research study are available for the total Field Service Management Software market along with its key segments and development policy. The key segments, their growth prospects, and the new opportunities they present to market players have been mentioned in the report. Moreover, the impact analysis of the latest mergers and acquisition and joint ventures has been included in the report. The report also provides valuable proposals for new project development that can help companies optimize their operations and revenue structure.

The main sources are industry experts from the Field Service Management Software industry, including management organizations, processing organizations, and analytical services providers that address the value chain of industry organizations. We interviewed all major sources to collect and certify qualitative and quantitative information and to determine future prospects. The qualities of this study in the industry experts industry, such as CEO, Vice President, Marketing Director, Technology and Innovation Director, Founder and Key Executives of key core companies and institutions in major Field Service Management Software around the world in the extensive primary research conducted for this study we interviewed to acquire and verify both sides and quantitative aspects.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry [emailprotected] https://www.prominentmarketresearch.com/inquiry-report/103296

On the basis of types, the Field Service Management Software market is primarily split into:Cloud-basedOn-premises

On the basis of applications, the market covers:BFSIHealthcareEnergy and UtilitiesTelecom and ITConstruction and Real EstateTransportation and Logistics

The Field Service Management Software market can be split based on product types, major applications, and important regions. From raw materials to downstream buyers of this industry will be analyzed scientifically, the feature of product circulation and sales channel will be presented as well. In a word, this report will help you to establish a panorama of industrial development and characteristics of the Field Service Management Software market.

Get Complete Report in your Inbox within 24 hours @ https://www.prominentmarketresearch.com/checkout/103296

Key Points Table of Content:

Chapter 1: Field Service Management Software Market Overview, Product Overview, Market Segmentation, Market Overview of Regions, Market Dynamics, Limitations, Opportunities and Industry News and Policies.

Chapter 2: Field Service Management Software Industry Chain Analysis, Upstream Raw Material Suppliers, Major Players, Production Process Analysis, Cost Analysis, Market Channels and Major Downstream Buyers.

Chapter 3: Value Analysis, Production, Growth Rate and Price Analysis by Type of Field Service Management Software.

Chapter 4: Downstream Characteristics, Consumption and Market Share by Application of Field Service Management Software.

Chapter 5: Production Volume, Price, Gross Margin, and Revenue ($) of Field Service Management Software by Regions (2014-2020).

Chapter 6: Field Service Management Software Production, Consumption, Export and Import by Regions (2014-2020).

Chapter 7: Field Service Management Software Market Status and SWOT Analysis by Regions.

Chapter 8: Competitive Landscape, Product Introduction, Company Profiles, Market Distribution Status by Players of Field Service Management Software.

Chapter 9: Field Service Management Software Market Analysis and Forecast by Type and Application (2020-2026).

Chapter 10: Market Analysis and Forecast by Regions (2020-2026).

Chapter 11: Industry Characteristics, Key Factors, New Entrants SWOT Analysis, Investment Feasibility Analysis.

Chapter 12: Market Conclusion of the Whole Report.

Chapter 13: Appendix Such as Methodology and Data Resources of This Research.

We can also customize this report and provide individual chapters or a region-wise breakdown report such as North America, Europe or Asia. Also, if you have any special requirements, please let us know and we will offer you the report as you want.

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Field Service Management Software Market by Key Manufacturers, Regions, Risk Analysis, Industry Share, Driving Factors, Deployment Policy, Innovative...

With so many groundbreaking medical advances being revealed to the world every single day, you would imagine there would be some advancement on the plethora of many female-prevalent diseases (think female cancers, Alzheimer's, depression, heart conditions etc.) that women are fighting every single day.

For Anna Villarreal and her team, there frankly wasn't enough being done. In turn, she developed a method that diagnoses these diseases earlier than traditional methods, using a pretty untraditional method in itself: through your menstrual blood.

Getting from point A to point B wasn't so easy though. Villarreal was battling a disease herself and through that experience. I wondered if there was a way to test menstrual blood for female specific diseases," she says. "Perhaps my situation could have been prevented or at least better managed. This led me to begin researching menstrual blood as a diagnostic source. For reasons the scientific and medical community do not fully understand, certain diseases impact women differently than men. The research shows that clinical trials have a disproportionate focus on male research subjects despite clear evidence that many diseases impact more women than men."

There's also no denying that gap in women's healthcare in clinical research involving female subjects - which is exactly what inspired Villarreal to launch her company, LifeStory Health. She says that, with my personal experience everything was brought full circle."

There is a challenge and a need in the medical community for more sex-specific research. I believe the omission of females as research subjects is putting women's health at risk and we need to fuel a conversation that will improve women's healthcare.,"

-Anna Villarreal

Her brand new biotech company is committed to changing the women's healthcare market through technology, innovation and vocalization and through extensive research and testing. She is working to develop the first ever, non-invasive, menstrual blood diagnostic and has partnered with a top Boston-area University on research and has won awards from The International Society for Pharmaceutical Engineering and Northeastern University's RISE.

How does it work exactly? Proteins are discovered in menstrual blood that can quickly and easily detect, manage and track diseases in women, resulting in diseases that can be earlier detected, treated and even prevented in the first place. The menstrual blood is easy to collect and since it's a relatively unexplored diagnostic it's honestly a really revolutionary concept, too.

So far, the reactions of this innovative research has been nothing but excitement. The reactions have been incredibly positive." she shares with SWAAY. Currently, menstrual blood is discarded as bio waste, but it could carry the potential for new breakthroughs in diagnosis. When I educate women on the lack of female subjects used in research and clinical trials, they are surprised and very excited at the prospect that LifeStory Health may provide a solution and the key to early detection."

To give a doctor's input, and a little bit more of an explanation as to why this really works, Dr. Pat Salber, MD, and Founder of The Doctor Weighs In comments: researchers have been studying stem cells derived from menstrual blood for more than a decade. Stem cells are cells that have the capability of differentiating into different types of tissues. There are two major types of stem cells, embryonic and adult. Adult stem cells have a more limited differentiation potential, but avoid the ethical issues that have surrounded research with embryonic stem cells. Stem cells from menstrual blood are adult stem cells."

These stem cells are so important when it comes to new findings. Stem cells serve as the backbone of research in the field of regenerative medicine the focus which is to grow tissues, such as skin, to repair burn and other types of serious skin wounds.

A certain type of stem cell, known as mesenchymal stem cells (MenSCs) derived from menstrual blood has been found to both grow well in the lab and have the capability to differentiate in various cell types, including skin. In addition to being used to grow tissues, their properties can be studied that will elucidate many different aspects of cell function," Dr. Salber explains.

To show the outpour of support for her efforts and this major girl power research, Villarreal remarks, women are volunteering their samples happily report the arrival of their periods by giving samples to our lab announcing de-identified sample number XXX arrived today!" It's a far cry from the stereotype of when it's that time of the month."

How are these collections being done? Although it might sound odd to collect menstrual blood, plastic cups have been developed to use in the collection process. This is similar to menstrual products, called menstrual cups, that have been on the market for many years," Dr. Salber says.

Equally shocking and innovative, this might be something that becomes more common practice in the future. And according to Dr. Salber, women may be able to not only use the menstrual blood for early detection, but be able to store the stem cells from it to help treat future diseases. Companies are working to commercialize the use of menstrual blood stem cells. One company, for example, is offering a patented service to store menstrual blood stem cells for use in tissue generation if the need arises."

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How I Went From Managing Complexity to Becoming a U.S. Ambassador and CEO - SWAAY

MIAMI, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Organicell Regenerative Medicine Inc. (BPSR) (the Company) is pleased to provide shareholders and the investment community with an update on operations since its filing on November 1, 2018 of the Companys Annual Report on Form filing of Form 10-K for the year ended October 31, 2017, as well as the status of becoming fully compliant with SEC reporting obligations.

The Company is diligently working to complete its Quarterly Reports on Form 10-Q for the quarters ended January 31, 2018, April 30, 2018 and July 31, 2018 and its Annual Report on Form 10-K for the year ended October 31, 2018. In August 2019, the Company engaged Marcum LLP as its independent registered public accounting firm. The Company expects these reports to be completed and filed during the first calendar quarter of 2020. Following completion and filing of these reports, the Company expects to promptly proceed to preparation and filing of its Quarterly and Annual Reports for the fiscal year ended October 31, 2019, with the objective of becoming current in its SEC reporting requirements as soon as possible.

Since November 2018, the Company has remained focused on research and development activities and sale and distribution of anti-aging and cellular therapy derived products.

In February 2019, the Company recommenced its efforts to once again operate a perinatal tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and processing of anti-aging and cellular therapy derived products. This new laboratory facility became operational in May 2019 and during the same period, the Company began producing products that are now being sold and distributed to its customers.

In addition, the Company has created what it believes is a world class research, medical and scientific advisory team. We believe that our team is one of the most qualified and industry reputable teams assembled to adequately address the current and expected future medical and regulatory challenges facing the Company and overall industry and to provide leadership in the ongoing development of superior quality products for use in the health care industry.

The Company has actively taken steps to assure that it meets compliance with current and anticipated United States Food and Drug Administration (FDA) regulations expected to be enforced beginning in November 2020 requiring that the sale of products that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products (HCT/Ps) can only be sold pursuant to an approved biologics license application (BLA). On July 14, 2019, the Company received Institutional Review Board (IRB) approval to proceed with two pilot studies in connection with the Companys efforts to obtain Investigation New Drug (IND) approval from the FDA and commence clinical trials in connection with the use of the Companys products and related treatment protocols for specific indications. The Company is aggressively pursuing efforts to obtain the aforementioned IND approvals and commence and complete those clinical studies as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available.

In an effort to increase sales and mitigate anticipated near future restrictions expected to be imposed by the FDA with respect to the use and distribution of Section 351 designated biologics, the Company is seeking to develop sales and distribution channels outside of the United States. In addition, the Company is focusing its efforts on developing other leading edge product offerings that would not fall within the FDA regulations for requiring a BLA license for U.S. manufacture and sale.

As a result of the Companys expected future increase in processing requirements and to enable it to perform certain advanced research and development activities, the Company is currently in negotiations to relocate its laboratory facility during the second calendar quarter of 2020 to a larger ISO 7 classified research and development and processing facility.

Story continues

The Company has also been actively developing and expanding its sales, marketing and distribution network which it believes that based on the quality of the Companys existing products, the Companys commitment to regulatory compliance and superior research and development resources, the Company believes that it will be able to achieve desired growth during 2020.

The Company expects to provide periodic updates on operational and financial reporting developments as warranted.

For more information regarding the Company please visit our website at http://www.organicell.com.

About Organicell Regenerative Medicine, Inc.

Organicell is a leading, fully integrated Company focused in the field of regenerative medicine. Our world class research, technology, manufacturing and clinical development team is focused on creating new biologic medicines to revolutionize the field of regenerative medicine. We believe that our ground-breaking research in the field of nanotechnology, specifically exosome enrichments and other micro vesicles, is the next frontier of stem cell-based therapeutics. Organicell is committed to creating life changing and lifesaving therapies for patients.

Our mission is to transform regenerative medicine by continuing to combine exosome technology with other synergistic therapies and become the healthcare technology incubator for biologic medicine.

CAUTIONARY COMMENT REGARDING FORWARD-LOOKING STATEMENTS

The foregoing contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements. This release contains forward-looking statements that reflect Organicell Regenerative Medicine Inc., and its subsidiaries, plans and expectations, financial situation, the ability to retain key personnel, product acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, ability to expand sales and channels, and legislation or regulations affecting our operations and the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties. You are cautioned not to rely on these forward-looking statements. In this press release and related comments by Company management, words like "expect," "anticipate," "estimate," "intend", believes and similar expressions are used to identify forward-looking statements, representing management's current judgment and expectations about possible future events.

Management believes these forward-looking statements and the judgments upon which they are based to be reasonable, but they are not guarantees of future performance and involve numerous known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance, achievements or financial position to be materially different from any expressed or implied by these forward-looking statements. Important factors that could cause actual results to differ materially from the forward-looking statements are set forth in our Form 10-K and other filings with the SEC. Other information can be obtained at http://www.organicell.com. The contents of the Companys website are not incorporated by reference in this Press Release.

Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press releases.

CONTACT:Organicell Regenerative Medicine Inc.4045 Sheridan Ave.Suite 239Miami Beach, FL 33140Website:http: http://www.organicell.comPhone: (888) 963-7881Email: info@organicell.com

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Organicell Regenerative Medicine Inc. Provides Update On Operations and Financial Reporting Status - Yahoo Finance

LAS VEGAS, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Zhittya Genesis Medicine, Inc. (a private company) (Zhittya or the Company), has signed a $151.5 million USD international marketing partnership agreement with Regenerative Medicine of Latin America, Inc. for the exclusive rights to market and sell all biological drugs developed by Zhittya during a 30-year time period. The payments include an initial upfront payment valued at $76.5 million with the additional $75 million to be amortized through future milestone payments.

Zhittya is developing a family of biological drugs to treat diseases which are characterized by diminished blood flow, or perfusion, to specific tissues or organs. The diseases Zhittyas drugs are intended to treat address a variety of disorders and diseases, including: coronary heart disease, diabetic foot ulcers, stroke recovery, Parkinsons disease (PD), Alzheimers disease, and 14 additional major medical disorders characterized by insufficient blood perfusion.

According to the American Heart Associations 2019 Statistics at a Glance, heart disease is responsible for the death of approximately one out of three U.S. adults. In a U.S. Food and Drug Administration (FDA) clinical trial, Zhittyas heart-specific drug treatment demonstrated a successful triggering of new blood vessel growth in a diseased heart. According to a 2017 report by the World Health Organization, there are an estimated 20 million people who suffer from heart disorders in Latin America alone, 80% of which suffer from a particularly notorious form called small vessel disease, a disease that only Zhittyas drug has been able to address; the standard forms of treatment for coronary artery disease, including bypass and stenting procedures, can only be performed on larger arteries.

Our portfolio of drugs seeks to address diseases which directly cause the suffering and even death of over 50% of all adults, said Zhittya CEO Daniel C. Montano. In addition to the territories covered by our existing partnerships in North America, Europe and China, Latin America is particularly impacted by heart disease due to a variety of health and environmental concerns in the region. This agreement with Regenerative Medicine of Latin America is another major step forward to treating heart disease in Latin America and globally. Going forward, we believe we are on the path to a number of other major medical breakthroughs to address even more diseases caused by a lack of blood perfusion.

Dr. Jack Jacobs, President of Zhittya Genesis Medicine, stated, Our drug currently being developed to treat Parkinsons disease has demonstrated encouraging results with impressive outcomes in preclinical models of Parkinsons disease in rodents and primates. This drug has the potential to be a disease modifying agent; in preclinical studies it was shown to reverse the decline and actually stimulate the regeneration of dopamine-producing neurons, the root cause of Parkinsons disease in patients. According to a recent report from the Cleveland Clinic, the incidence rate of Parkinsons disease per 100,000 people was highest in Hispanics. We believe our drug can have a tremendous impact in this region in addition to our existing partnerships both domestically and internationally.

Dr. Jacobs added, We have filed applications and are advancing through the approval process to initiate Phase I clinical trials in Mexico for Parkinsons disease. We are also pursuing a second medical indication for patients with amyotrophic lateral sclerosis (ALS). It is our goal to be in a position to begin dosing patients with Parkinsons disease and ALS by early 2020, which should enable us to learn if our drug has the same beneficial effects in humans as it demonstrated in animals. These clinical trials that will hopefully begin very soon in Mexico will drive intense attention and interest to Regenerative Medicine of Latin America.

About Zhittya Genesis MedicineZhittya Genesis Medicine, Inc. is advancing a group of drugs which trigger the human bodys natural regeneration process. Our medicine initiates a biological response in the human body referred to as therapeutic angiogenesis, which will only occur in diseased tissues that become ischemic due to a lack of blood flow. In those areas with insufficient blood flow, the drug stimulates growth of new blood vessels, providing nourishment and removing metabolic waste products, thereby re-establishing normal cellular functions. Heart disease, stroke, peripheral artery disease (PAD) and diabetic foot ulcers are just some of the disorders the drugs can treat. Currently, over 75 human diseases are known to be caused by lack of blood flow to a tissue or organ. The Companys management has been working to advance its proprietary medicines for over 21 years and has expended in excess of $140 million USD to date in support of these efforts. To learn more, please visitzhittyaregenerativemedicine.com

About Regenerative Medicine of Latin AmericaRegenerative Medicine of Latin America, Inc. owns the 30-year exclusive rights to market and sell all drugs developed by Zhittya for the territories of Mexico and all Latin American countries south of Mexico. These areas encompass a population of over 600 million people. In addition to its vast population, Latin America also has some of the worlds highest rates of diabetes, heart disease, strokes and other diseases brought on by vascular dysfunction.

Zhittya Contact:

Daniel C. Montano, CEOZhittya Genesis Medicine, Inc.702-790-9980dan@zhittyamedicine.com

Investor Relations Contact:

Matt Glover and Tom ColtonGateway Investor Relations949-574-3860zhittya@gatewayir.com

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Zhittya Genesis Medicine Signs $151.5 Million Biopharmaceutical Marketing Partnership Agreement with Regenerative Medicine of Latin America - BioSpace

Transaction Accelerates Anikas Revenue Growth, Broadens Joint Preservation and Restoration Product Portfolio, Enhances Commercial Capabilities and Expands Pipeline

BEDFORD, Mass., Jan. 24, 2020 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc.(ANIK), a global, integrated joint preservation and regenerative therapies company with products leveraging its proprietaryhyaluronic acid (HA) technology platform, today announced it has closed its acquisition of Parcus Medical, a leading, privately held sports medicine company.

Under the previously disclosed terms of the agreement, Anika acquired all outstanding membership interests of Parcus Medical in exchange for an upfront payment of approximately$35 millionin cash from the companys existing balance sheet, subject to customary closing adjustments. Parcus Medical unitholders will be eligible to receive an additional$60 millioncontingent upon the achievement of certain commercial milestones.

I want to congratulate our team on closing the Parcus Medical transaction and officially welcome the Parcus Medical team to the Anika family, said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. This acquisition immediately adds a diverse base of high-growth revenue and will help us achieve the objectives we set forth in our five-year strategic plan. We can now turn our attention to executing our integration plan and continuing to transform Anika into a leading global sports and regenerative medicine company.

Parcus Medical has a diverse product family that helps facilitate surgical procedures on the shoulder, knee, hip and distal extremities. The acquisition significantly expands Anikas offerings into the fast-growing ambulatory surgical center market. The Parcus Medical executive team, led by PresidentMark Brunsvold, will join Anika and continue to lead the Parcus Medical business.

SVB Leerink LLCacted as exclusive financial advisor to Anika andSullivan & Cromwell LLPacted as Anikas legal counsel in connection with the Parcus Medical transaction.

AboutAnika Therapeutics, Inc.Anika Therapeutics, Inc.(ANIK) is a global, integrated joint preservation and regenerative therapies company based inBedford, Mass.Anika is committed to delivering therapies to improve the lives of patients across a continuum of care from osteoarthritis pain management to joint preservation and restoration. The company has more than two decades of global expertise commercializing more than 20 products based on its proprietaryhyaluronic acid (HA) technology platform. For more information about Anika, please visitwww.anikatherapeutics.com.

Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, concerning, but not limited to, the acquisition of Parcus Medical and the effects of the acquisition.The Securities and Exchange Commission("SEC") encourages companies to disclose forward-looking statements so that investors can better understand a companys future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements.

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Celavie Biosciences, LLC, a company working to improve lives and restore hope by advancing innovations in CNS diseases with regenerative stem cell-based therapies, today announced their presentation of a poster, titled Five year follow-up on the first-in-human transplantation of undifferentiated stem cells into Parkinsonian patients reveals no adverse effects with improvement in motor function or arrest of the disease progression in five out of seven patients, at the Phacilitate Leaders World and World Stem Cell Summit, held January 21-24 in Miami, Florida.

The poster shows five-year follow-up data that expands on the exploratory clinical data in 7 PD patients with four-year follow-up published in Cell Transplantation in 2018. Oleg Kopyov, Executive Vice President and Chief Scientific Officer at Celavie, presented the poster on-site at the Miami Hyatt Regency.

In the results at one year after cell grafting, all but two of the seven patients completing the study showed various degrees of motor improvement, and five of them showed better response to medication. At five-year evaluation, Unified Parkinsons Disease Rating Scale III (UPDRS III) scores remained better than at baseline in 4/7 patients in the OFF condition and in 5/7 patients in the ON condition. None of the patients showed unwanted motor disturbances (dyskinesias), tumor formation, or any detectable immune responses to the grafted cells.

We are excited that the five-year data for our exploratory clinical trial suggest that the neural progenitor cells are able to stop or slow down the motor deterioration in Parkinsons patients that one would expect to see in this timespan, showing continued improvement even compared to the fourth year, said Oleg Kopyov. We anticipate filing an IND with the FDA for a Phase I U.S. trial in patients with moderate to advanced Parkinsons disease this year.

In addition, Sandy Solmon, Celavies CEO, will deliver presentations at two upcoming international industry conferences:

Ms. Solmon will discuss Celavies application of the companys human undifferentiated allogeneic pluripotent stem cells in Parkinsons disease, as well as pre-clinical data in cerebellar ataxia and upcoming milestones. To schedule a meeting with Celavie Biosciences at these conferences, please contact: Mary Beth Cicero at mbcicero@lavoiehealthscience.com.

About the World Stem Cell Summit

Produced by the non-profit Regenerative Medicine Foundation (RMF), and in its 15th year, the World Stem Cell Summit will take place January 21-24, 2020, in Miami, Florida in partnership with Phacilitate Leaders World, as part of Advanced Therapies Week. The Summit is the most inclusive and expansive interdisciplinary, networking, and partnering meeting in the stem cell science and regenerative medicine field. With the overarching purpose of fostering translation of biomedical research, funding, and investments targeting cures, the Summit and co-located conferences serve a diverse ecosystem of stakeholders. For more information about the upcoming World Stem Cell Summit in Miami, please visit: http://www.worldstemcellsummit.com.

About Celavie Biosciences

Celavie Biosciences is a privately-held company whose mission is to improve lives and restore hope by advancing regenerative stem cell therapies for the treatment of Parkinsons disease and other disorders of the central nervous system (CNS). The company develops undifferentiated, unmodified allogeneic pluripotent stem cell-based therapies, holds a strong IP portfolio, including 18 issued patents, and has an experienced management team blending expertise in concept and cell technology, product scalability and entrepreneurship. Celavet, a subsidiary, applies the same proprietary technologies for the treatment and prevention of serious veterinary diseases. More information is available at https://www.celavie.com/.

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Manufacturing issues and a scarcity of new commercial products leave predictions that 10-20 cell and gene therapy approvals each year by 2025 somewhat fanciful, says Dark Horse Consulting.

In his plenary address at the Phacilitate conference yesterday, Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, reflected on the difficulties the sector has faced since the high of 2017 when three products achieved US Food and Drug Administration (FDA) approval: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), and gene therapy Luxturna (voretigene neparvovec).

A few years ago, I introduced this evening by saying: Finally the field has had the year that weve been saying we are going to have for years. That was a great year, he told the packed room in Miami, Florida.

Dark Horses Anthony Davies opened the Phacilitate conference in Miami, Florida

The CAR-T therapies Kymriah and Yescarta gave hope to patients who previously could measure their life expectancy in a small number of months, while gene therapy Luxturna offered hope to children whose ophthalmic deterioration was a statistical certainty, he added.

With these breakthroughs, positivity was high and in January 2019 then FDA Commissioner Scott Gottlieb predicted in an agency statement that there will be upwards of 200 regenerative medicine IND submissions from 2020, and by 2025 the agency will be approving 10 to 20 cell and gene therapy products a year.

I think 200 INDs is doable this year, but INDs do not cure patients, Davies said. And I think if weve struggled with getting three commercial approvals in the years after that first year when three commercial approvals were made, so getting 10-20 in five years from now is going to be extremely challenging.

Since that breakthrough year, the industry has been hot by bad news and a lack of commercial products. Novartis/AveXis Zolgensma (onasemnogene abeparvovec) and bluebirds Zynteglo (autologous CD34+ cells encoding A-T87Q-globin gene) were approved by the FDA last year, while Takedas allogeneic cell therapy Alofisel (darvadstrocel) has been approved to a certain extent in Europe.

While Davies described the approval of Zolgensma, at a cost of $2.1 million, as groundbreaking, he noted it has been overshadowed by a scandal involving data falsification during the approval process.

He also noted that Zynteglos success has been muted by multiple manufacturing problems which has delayed launch.

Meanwhile, pioneer product Kymriah continues to suffer from manufacturing difficulties, and Novartis seems to be struggling with fixing them, Davies suggested.

At JP Morgan [Healthcare Conference] it was announced that for 10% of patients no shipment of drug is made, and for a very significant minority of patients shipment is made with out-of-spec product for which Novartis cannot charge, he told the conference

He added that at the investor conference last week, Novartis CEO Vasant Narasimhan said that they had made great process in identifying the manufacturing issues and were negotiating their resolution with the FDA.

This was exactly the same statement he made at JP Morgan the year before that.

But despite the slowdown in commercialization and industrys challenges, Davies said there remains a lot to be positive about.

Everything that I said reflects the extreme difficulty in bringing this class of therapeutics to market. If these therapeutics were easy to develop,p they would have been developed. If diseases were easy to cure, we wouldnt need new therapeutics.

Let us just use these good pieces of news and these bad pieces of news as inspiration, lets continually remind ourselves that what we do is one of the hardest things in science or medicine at this time.

Davies was not alone in his views.

Speaking Wednesday, Robert Preti, CEO of Hitachi Chem Advanced Therapeutic Solutions, admitted the industry is behind where he thought it would be when he began his career 37 years ago, but said he was not too worried.

I want to commend this industry on what we have achieved for patients, he said, noting the difficulty in developing and making these therapies. He also highlighted that with over 1,000 regenerative therapies in development, problems will eventually be ironed out and cell and gene therapies will make the widespread impact intended.

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FDA cell and gene therapy forecast 'unlikely' - Bioprocess Insider - BioProcess Insider