Category Archives: Regenerative Medicine

Pink Porcelain Anatomical Heart 3d illustration 3d render

This story on artificial hearts is part of an extended series on Regenerative Medicine. For other stories on this topic see williamhaseltine.com and search for Regenerative Medicine. My definition of Regenerative Medicine is any medical modality that returns us to normal health when we are damaged by disease, injured by trauma, disadvantaged by birth, or worn by time. Modalities include: chemicals, genes, proteins and cells used as drugs, gene editing, prosthetics, and mind-machine interfaces.

Heart disease affects approximately 82.6 million people in the United States and is a leading cause of death among both men and women. One solution for those suffering from advanced heart failure is heart transplantation. Unfortunately, there is currently a nationwide shortage of human donor hearts. Scientists have attempted to create artificial hearts or use pig organs in lieu of human hearts for transplantation surgeries. However, current methods to produce artificial hearts are generally unsuccessful and the use of pig organs for transplants can lead to serious infections.

Now, a group at Harvard University is tackling this issue through a new, innovative method of growing artificial hearts. By building an artificial structure and implanting cardiac cells, researchers were able to grow the cardiac cells in a pattern that mimicked the natural organization of muscles in the heart. This study serves as a significant stepping stone toward developing artificial hearts that are fully functional.

The heart is largely made from muscles arranged in a helical fashion. When the heart contracts, its helically-patterned muscles engage in a twisting motion to push blood out of the heart. In fact, this helical patterning is predicted to be a crucial characteristic of healthy, functioning hearts. Many individuals who suffer from cardiac dysfunction also exhibit abnormal muscular patterning.

Figure 1: Human hearts engage in a twisting motion to pump blood through the body.

In the past, several studies have attempted to grow artificial hearts with helical patterning by using 3D printers. These studies have largely been unsuccessful because 3D printers are unable to achieve the tiny details of the hearts structure within a reasonable amount of time. For instance, a 3D printer could take hundreds of years to print even a small component of the hearts structures with enough detail for cells to grow in the correct patterns.

So, how did scientists at Harvard University achieve this feat?

Knowing that a simple 3D printer has significant limitations, Chang et al. turned towards a different technique: fiber-spinning. Fiber-spinning is a method that uses similar materials to 3D printers but can produce much finer, high-resolution structures.

Traditionally, materials are heated and extruded from a tiny hole to create singular fibers at a microscopic scale. The fibers can then be collected or processed to form 3D structures.

Figure 2: Fiber-spinning involves extruding polymers from a tiny hole to create microscopic fibers.

Fiber-spinning can create structures with very high resolutions. However, traditional methods of fiber-spinning are often imprecise and would not be able to form the consistent helical patterns of the heart. This prompted Chang et al. to engineer a new method of fiber-spinning that would not only allow them to create the hearts 3D structure at a microscopic scale but would also be precise enough to form the hearts helical patterning.

Chang et al. created a new fiber-spinning device with two major design features. First, instead of simply extruding the material haphazardly in one direction, the fiber-spinning device contains a spinneret that spins at high speeds. When the heated material is pushed into the device, the fibers are then extruded through a small hole in the side of the spinneret. This causes the fibers to collect in a cloud around the device.

Chang et al.s second innovation was to include a strong stream of air at the top of the spinneret that could align the fibers to resemble the striations of muscles. From this, Chang et al. could collect the fibers at an angle, ultimately creating the helical patterns of cardiac muscle.

Figure 3: Chang et al. used a spinneret and focused airstream to create 3D structures of the heart.

Using this method, Chang et al. was able to create 3D frames that resembled human heart ventricles. When the frames were seeded with human cardiac cells, the resulting tissues maintained the helical patterning of the frame.

Surprisingly, after 3 to 5 days of growing cardiac cells on the 3D frames, Chang et al. observed spontaneous contractions that resembled the natural activity of the human heart. This indicated that Chang et al.s model ventricles could be used to study how muscle patterning affects heart function.

To investigate this question, Chang et al. created model ventricles with helically aligned cells as well as ventricles with abnormal, circumferentially aligned cells.

Figure 4: Chang et al. created model ventricles with helically aligned cells and circumferentially ... [+] aligned cells.

The researchers then suspended both model ventricles in a liquid containing fluorescent beads. By tracking the displacement of the beads, Chang et al. could determine how many were pumped through the ventricles at a time. This strategy allowed the researchers to calculate the overall volume of liquid the model ventricles could pump.

After testing both the helically patterned ventricle and the abnormally patterned ventricle, Chang et al. found that the helically patterned ventricle was able to pump significantly higher volumes of liquid. This demonstrated that abnormal alignment of cardiac cells does, in fact, decrease the hearts ability to function.

Finally, not only was Chang et al. able to create model heart ventricles that could contract, but by using their innovative fiber-spinning method, the researchers were able to recreate all four chambers of the heart. These individual chambers were then assembled to ultimately create a full-sized model of the human heart.

Figure 5: Chang et al. successfully created all four chambers of the heart to assemble a full-sized ... [+] model.

Overall, this study represents significant progress in our ability to create a fully functional artificial heart. While more work must be done to expand functional model ventricles into full-scale heart models, this study demonstrates real promise for the use of innovative fiber-spinning techniques for complex whole-organ formation.

Link:
How To Mend A Broken Heart - Forbes

The first of approximately 97 patients with classical Hodgkin lymphoma (cHL) has been administered the combination of TT11 and nivolumab (Opdivo) in the phase 1b ACTION study (NCT05352828).1

TT11 is an experimental autologous CD38-chimeric antigen receptor (CAR) T-cell therapy that is being developed for the potential treatment of relapsed or refractory cHL as a single agent and in combination with other therapies. The agent had been granted a regenerative medicine advanced therapy designation by the FDA and the PRIME scheme by European Medicines Agency.

Initiation of this phase 1b clinical trial marks an important milestone for our autologous CD30- CAR T program as we now have the opportunity to evaluate TT11 in combination with nivolumab as a potential second-line treatment for relapsed or refractory classical Hodgkin lymphoma, stated John Ng, chief technology officer and acting chief operating office and of Tessa Therapeutics, in a press release.

Dosing in the study comes after single-agent results were reported from the phase 2 CHARIOT study (NCT04268706). In heavily-pretreated patients with cHL, promising efficacy and tolerable was shown with TT11 monotherapy. The overall response rate observed was 71.4% with a complete response rate of 57.1% In terms of safety, the most common toxicities were hematologic toxicities.2

Data from our ongoing clinical program investigating TT11 as a monotherapy treatment for later lines of classical Hodgkin lymphoma has demonstrated the CAR T therapy to be safe with promising measures of efficacy. We now welcome the opportunity to capitalize on this clinical progress by investigating TT11 as a second-line combination therapy, which offers the opportunity to greatly increase the patient population who could potentially benefit from this course of care, added Ng.1

In the multicenter, open-label, single arm ACTION study, patients will receive 4 cycles of TT11 at 2 x 108 cells/m2 in combination with nivolumab 480 mg or 6 mg/kg 4 times per week, fludarabine 30 mg/m2/day for 3 days, and bendamustine 70 mg/m2/day for 3 days after a successful leukapheresis to produce CD30 CAR T cells.3

The primary end point being explored in the study is the safety of autologous CD30 CAR T cells determined by dose-limiting toxicities. The secondary end points of the study include anti-tumor activity, overall response rate, duration of response, and progression-free survival. Other outcome being investigated include overall survival and pharmacokinetics.

Male or female patient aged 12 years or older are eligible to enroll if they have relapsed/refractory cHL following failure on standard frontline therapy, at least 1 measurable lesion, and adequate hematologic, renal, hepatic function and other laboratory tests. Patients are required to have an ECOG performance status of 0 or, a life expectancy of > 12 weeks, and no active infection at the time of screening.

Patients are excluded from the study if they have received prior treatment with salvage therapy for relapsed/refractory cHL, investigational CD30 CAR T cells. Moreover, patients receiving other investigational therapies, live vaccines, or immunosuppressive agents are not eligible for the study. Comorbidities that may interfere with study treatment and hypersensitivity to study drugs are also mentioned in the exclusion criteria.

The ACTION study is actively recruiting patients with relapsed/refractory cHL at study sites in California, Florida, North Carolina, and Texas.

REFERENCES:

1. Tessa Therapeutics doses first patient in phase 1b clinical trial investigating TT11 in combination with nivolumab for the treatment of relapsed/refractory classical hodgkin lymphoma (cHL). News release. August 17, 2022. Accessed August 18, 2022. https://bit.ly/3AteZem

2. Tessa Therapeutics announces positive data from phase 2 trial of autologous cd30-car-t therapy (TT11) in relapsed or refractory classical hodgkin lymphoma at 2021 ASH Annual Meeting. News release. August 14, 2021. Accessed August 18, 2022. https://bit.ly/3Qy0OKL

3. Phase 2 study evaluating autologous CD30.CAR-T cells in patients with relapsed/refractory hodgkin lymphoma (CHARIOT). Clinicaltrials.gov. Updated April 5, 2022. Accessed August 18, 2022.

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Dosing of Novel Autologous CAR T Cells and Nivolumab Begins in cHL Study - Targeted Oncology

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Partnering Terms and Agreements 2015 to 2022" report has been added to ResearchAndMarkets.com's offering.

This report is intended to provide the reader with an in-depth understanding and access to Regenerative Medicine trends and structure of deals entered into by leading companies worldwide.

Regenerative Medicine Partnering Terms and Agreements includes:

In Global Regenerative Medicine Partnering Terms and Agreements 2015-2022, the available deals are listed by:

Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

The Global Regenerative Medicine Partnering terms and Agreements 2015-2022 report provides comprehensive access to available deals and contract documents for over 1600 Regenerative Medicine deals.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/pu1ymr

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Regenerative Medicine Partnering 2015 to 2022: Terms and Agreements Entered Into by the Leading Companies Worldwide - ResearchAndMarkets.com -...

image:The ARDD Meeting 2022 will be hosted on August 29 - September 2, 2022 view more

Credit: Insilico Medicine Hong Kong Limited

August 18, 2022 Marco Quarta, Ph.D., will present the latest research on the topic From Single Cell AI-enabled Discovery of Cellular Senescence to Targeted Senolytic Drug Development at the worlds largest annual Aging Research and Drug Discovery conference (9th ARDD). Dr. Quarta is the CEO and Co-founder at Rubedo Life Sciences.

Marco co-founded and leads Rubedo Life Sciences driving its mission to develop treatments for age-related diseases and extend healthspan by selectively targeting pathological cells involved in the biological aging process. As a scientist, he earned a Masters degree in Biotechnology, a PhD in Neuroscience, and post-doctoral training in Aging and Stem Cells Biology in the lab of his mentor Prof. Thomas Rando at Stanford University School of Medicine. He then directed at Stanford/VA Hospital Palo Alto a research team focused on translational medical research in the fields of aging and regenerative medicine. He is backed by over 20 years of research with a track record of scientific publications in top tier journals. Marco is an inventor and entrepreneur, he co-founded and led the international biotech umbrella organization Young European Biotech Network (YEBN), and later joined the European Federation of Biotechnology (EFB) executive board.

Marco Quarta founded and led the biotech company WetWare Concepts in Europe. In California, with the Stanford colleague Prof. Vittorio Sebastiano he also co-founded Turn Biotechnologies based on their work on epigenetic reprogramming of cellular aging, where he served as CSO and he is a Board Director. Quarta sits on the advisory board of the California Institute for Regenerative Medicine (CIRM) Calpoly program in regenerative medicine. He is in the advisory and research board at the Center for Healthcare Innovation (CHI). He is a member of the Paul F Glenn Center for the Biology of Aging Studies at Stanford University. Quarta keeps fostering and championing high standards of compliance, ethics and patient safety in the development of innovative translational therapeutics, putting patients and society at the center of all actions.

The conference proceedings of the ARDD are commonly published in peer-reviewed journals with the talks openly available at http://www.agingpharma.org. Please review the conference proceedings for 2019, 2020 and 2021https://www.aging-us.com/article/203859/text .

Aging is emerging as a druggable condition with multiple pharmaceuticals able to alter the pace of aging in model organisms. The ARDD brings together all levels of the field to discuss the most pressing obstacles in our attempt to find efficacious interventions and molecules to target aging. The 2022 conference is the best yet with top level speakers from around the globe. Im extremely excited to be able to meet them in person at the University of Copenhagen in late summer. said Morten Scheibye-Knudsen, MD, Ph.D., University of Copenhagen.

Aging research is growing faster than ever on both academia and industry fronts. The ARDD meeting unites experts from different fields and backgrounds, sharing with us their latest groundbreaking research and developments. Our last ARDD meeting took place both offline and online, and it was a great success. I am particularly excited that being a part of the ARDD2022 meeting will provide an amazing opportunity for young scientists presenting their own work as well as meeting the experts in the field. said Daniela Bakula, Ph.D., University of Copenhagen.

Many credible biopharmaceutical companies are now prioritized aging research for early-stage discovery or therapeutic pipeline development. It is only logical to prioritize therapeutic targets that are important in both aging and age-associated diseases. The patient benefits either way. The best place to learn about these targets is ARDD, which we organize for nine years in a row. This conference is now the largest in the field and is not to be missed, said Alex Zhavoronkov, Ph.D., founder and CEO of Insilico Medicine and Deep Longevity.

Building on the success of the ARDD conferences, the organizers developed the Longevity Medicine course series with some of the courses offered free of charge at Longevity.Degree covered in the recent Lanced Healthy Longevity paper titled Longevity medicine: upskilling the physicians of tomorrow.

About Aging Research for Drug Discovery Conference

At ARDD, leaders in the aging, longevity, and drug discovery field will describe the latest progress in the molecular, cellular and organismal basis of aging and the search for interventions. Furthermore, the meeting will include opinion leaders in AI to discuss the latest advances of this technology in the biopharmaceutical sector and how this can be applied to interventions. Notably, this year we are expanding with a workshop specifically for physicians where the leading-edge knowledge of clinical interventions for healthy longevity will be described. ARRD intends to bridge clinical, academic and commercial research and foster collaborations that will result in practical solutions to one of humanity's most challenging problems: aging. Our quest? To extend the healthy lifespan of everyone on the planet.

About Scheibye-Knudsen Lab

In the Scheibye-Knudsen lab we use in silico, in vitro and in vivo models to understand the cellular and organismal consequences of DNA damage with the aim of developing interventions. We have discovered that DNA damage leads to changes in certain metabolites and that replenishment of these molecules may alter the rate of aging in model organisms. These findings suggest that normal aging and age-associated diseases may be malleable to similar interventions. The hope is to develop interventions that will allow everyone to live healthier, happier and more productive lives.

About Deep Longevity

Deep Longevity has been acquired by Edurance RP (SEHK:0575.HK), a publicly-traded company. Deep Longevity is developing explainable artificial intelligence systems to track the rate of aging at the molecular, cellular, tissue, organ, system, physiological, and psychological levels. It is also developing systems for the emerging field of longevity medicine enabling physicians to make better decisions on the interventions that may slow down, or reverse the aging processes. Deep Longevity developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed "deep aging clocks" to provide a universal multifactorial measure of human biological age. Originally incubated by Insilico Medicine, Deep Longevity started its independent journey in 2020 after securing a round of funding from the most credible venture capitalists specializing in biotechnology, longevity, and artificial intelligence. ETP Ventures, Human Longevity and Performance Impact Venture Fund, BOLD Capital Partners, Longevity Vision Fund, LongeVC, co-founder of Oculus, Michael Antonov, and other expert AI and biotechnology investors supported the company. Deep Longevity established a research partnership with one of the most prominent longevity organizations, Human Longevity, Inc. to provide a range of aging clocks to the network of advanced physicians and researchers. https://longevity.ai/

About Endurance RP (SEHK:0575.HK)

Endurance RP is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering. https://www.endurancerp.com/

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Marco Quarta to present at the 9th Aging Research & Drug Discovery Meeting 2022 - EurekAlert

3D Systems announced on August 18 the appointments of Dr. Toby Cosgrove, former President and Chief Executive Officer of the Cleveland Clinic, and Dr. Bon Ku, Director of the Health Design Lab at Thomas Jefferson University.

Dr. Cosgrove and Dr. Ku become the fourth and fifth members of 3D Systems recently established Medical Advisory Board (MAB). The two join former Health and Human Services Secretary Alex Azar, Dr. Stephen K. Klasko, and former U.S. Secretary of Veterans Affairs David J. Shulkin as members of the advisory board.

The primary mission of the board is to provide strategic input, guidance and recommendations for the companys expanding efforts in regenerative medicine.

Dr. Cosgrove has been affiliated with the Cleveland Clinic healthcare system for nearly 50 years. He served as President and CEO from 2004 to 2017 and is currently an Executive Advisor to the Clinic.

As President and CEO, Dr. Cosgrove oversaw a 6 billion USD annual revenue institution comprised of the Cleveland Clinic, over 20 Ohio-based hospitals, family health centres and surgical facilities, as well as Cleveland Clinic affiliates in other U.S. states and internationally.

Dr. Cosgrove was a cardiac surgeon in Cleveland and served as Chairman of the Department of Thoracic and Cardiovascular Surgery from 1989 to 2004 at the clinic. He has performed over 22,000 operations over the course of his career.

Dr. Bon Ku has enjoyed a career as both a practicing medical clinician and as a proponent of using technology-based innovations to solve pressing healthcare challenges. Dr. Ku is the Marta and Robert Adelson Professor of Medicine and Design at Thomas Jefferson University as well as an emergency physician at the Universitys Sidney Kimmel Medical College.

Dr. Ku has used modern technological tools such as virtualisation, digital modelling, prototyping and additive manufacturing. He is the co-founder and Director of Thomas Jefferson Universitys Health Design Lab. The lab works with medical students, researchers and physicians to develop new medical devices and innovative design concepts for the healthcare sector.

The Health Design Lab led by Dr. Ku features a clinical 3D printing and bioprinting lab and is home to the JeffSolves MedTech initiative. This serves as a centre for the incubation and commercialisation of new medical technologies.

Dr. Ku has written a number of peer-reviewed publications focusing on the application of 3D-printed medical devices and digital models to improve surgical outcomes, optimise treatments and make advancements in personalised medicine.

3D Systems President and CEO Dr. Jeffrey Graves said: We are exceptionally pleased to welcome Dr. Cosgrove and Dr. Ku to our Medical Advisory Board. These two professionals have impeccable track records of combining hands-on medical practise experience with a clear passion for utilising innovative approaches and modern technology to transform healthcare outcomes.

Graves continued, saying: Both Dr. Cosgrove and Dr. Ku will be uniquely positioned to advise 3D Systems as we build a world-class regenerative medicine business and pursue 3D printing-based advancements in areas such as accelerated pharmaceutical development, human tissue and organ printing, medical device innovation and personalised medicine.

There have been a lot of acquisitions from major 3D printing companies so far in 2022, with3D Systems among those to have added new strings to its bow. The company recentlyacquired material jetting firm dp polar, while taking over both Titan Robotics and Kumovis earlier in the year.

3D Systems also recently announced a partnership with Fleet Space Technologies, and produced parts for the Alpine F1 team for the 2021 and 2022 seasons.

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3D Systems announces appointment of Dr. Toby Cosgrove and Dr. Bon Ku as members of its Medical Advisory Board - TCT Magazine

Most of us wish we could turn back the clock in some way, to retain or reclaim some of the benefits of youth, whether it's looking younger or regaining some element of youthful prowess. Researchers say they've discovered a way to do just that in skin cells: to reverse their age so they look and behave like cells that are 30 years younger. Read on to find out how they did itand how Dolly the sheep is involvedand what the implications could be for the future of aging.

In a study recently published in the journal eLife, researchers said they had discovered a way to reverse aging in human skin cells by 30 years. Their process, called "maturation phase transient reprogramming," refreshes older cells to partly restore their function and to renew their biological age, while maintaining the cells' specific type and function.

In their experiments, the BBC reports, the scientists rejuvenated a 53-year-old woman's skin cells so they looked and behaved like those of a 23-year-old. Their technique evolved from the technology that was used to create Dolly the cloned sheep in 2007the process used to create stem cells, in which normal cells of a specific function are erased and rebooted to become cells of any type.

The scientists subjected cells to that process, but stopped halfway through. So instead of becoming stem cellsinfant blank slates, so to speakthey became younger versions of themselves.

Although the research is only in its early stages, if the findings hold up, they could revolutionize regenerative medicinea field that aims to repair or replace cells, including old ones. Successful regenerative medicine depends on cells not just looking younger, but functioning like young cells too. The researchers found that the functionally younger skin cells they created were better able to produce collagen, and better responded to wound healing sites.

If those results can be replicated in other kinds of cells, a similar process might be able to rejuvenate aging bones, muscles, and tendons, or forestall the diseases of an aging brain, including dementia and Alzheimer's.

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"This work has very exciting implications," said Wolf Reik, a molecular biologist with Altos Labs Cambridge Institute. "Eventually, we may be able to identify genes that rejuvenate without reprogramming, and specifically target those to reduce the effects of aging. This approach holds promise for valuable discoveries that could open up an amazing therapeutic horizon."

"Our results represent a big step forward in our understanding of cell reprogramming," said Dr. Diljeet Gill, a postdoctoral researcher in Reik's lab. "We have proved that cells can be rejuvenated without losing their function and that rejuvenation looks to restore some function to old cells. The fact that we also saw a reverse of aging indicators in genes associated with diseases is particularly promising for the future of this work."

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These Scientists Say They've Reversed Aging in Human Cells by 30 Years - Best Life

PRINCETON, N.J., Aug. 16, 2022 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced that Dr. Richard Caruso, founder and former chairman and CEO of Integra LifeSciences passed away over the past weekend.

Dr. Richard Caruso made an impact on not only the medical technology industry, but more importantly, on the countless lives around the world who have benefited from the products and technologies that Integra LifeSciences has today, said Stuart Essig, chairman of the board at Integra LifeSciences. His vision, transformative ideas and entrepreneurial spirit have revolutionized the way surgeons treat their patients in the field of regenerative medicine.

Dr. Caruso founded Integra LifeSciences in 1989 with a vision that the human body could be enabled to regenerate many of its own damaged or diseased tissues, paving the way for a new discipline back then known as regenerative medicine. Through his vision, Integra became the first company to develop and bring to market a tissue regeneration product, Integra Dermal Regeneration Template, which was approved by the FDA in 1996 as a skin replacement system with a claim for regeneration of dermal tissue for the treatment of life-threatening burns and repair of scar contractures. That technology led to the development of DuraGen Dural Graft Matrix, for repair of the dura mater, the protective covering of the brain after cranial and spine surgery, and NeuraGen Nerve Guide, which creates a conduit for axonal growth across a severed nerve.

Dr. Caruso served as Integra's chairman from 1992 until 2011, and served as CEO from 1992 to 1997. In addition, he served on the Board of Susquehanna University and the Baum School of Art. Dr. Caruso received his B.S. degree from Susquehanna University, an M.S.B.A. degree from Bucknell University, and a Ph.D. degree from the London School of Economics, University of London. He was also the founder and director of The Uncommon Individual Foundation, a non-profit foundation that encourages individuals to form and follow their dreams of personal success and become the entrepreneurs of their personal lives.

About Integra LifeSciencesIntegra LifeSciences is a global leader in regenerative tissue technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel, Aurora, Bactiseal,BioD, CerebroFlo, CereLinkCertasPlus, Codman, CUSA, Cytal, DuraGen, DuraSeal, Gentrix, ICP Express, Integra, Licox, MAYFIELD, MediHoney, MicroFrance, MicroMatrix, NeuraGen, NeuraWrap, PriMatrix, SurgiMend, TCC-EZand VersaTru. For the latest news and information about Integra and its products, please visitwww.integralife.com.

Investor Relations Contact:Chris Ward(609) 772-7736chris.ward@integralife.com

Media Contact:Laurene Isip(609) 208-8121laurene.isip@integralife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fe4238dd-d2f8-487f-8f14-19e855e9b041.

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Integra LifeSciences Announces the Passing of Dr. Richard Caruso, Founder and Former Chairman and CEO - GlobeNewswire

Andre Terzic, M.D., Ph.D.

Center for Regenerative Medicine, Mayo Clinic

Andre Terzic, M.D., Ph.D.: Regenerative medicine is an exciting component of modern health care. It harnesses breakthroughs in technologies to address major unmet needs of the population, both nationally but also globally. With the successes of traditional medicine, we'll live longer. And aging has been viewed as a major triumph of humanity. At the same time, unfortunately, with aging, we are facing with a growing pandemic of so-called chronic diseases diseases that live with us throughout our lifespan, heart disease, cancer, diabetes and so on.

So regenerative medicine comes with this new ability to understand how our body can heal and to harness its innate ability, that self-ability to heal, to actually provide new solutions to these patients in need. So the Center for Regenerative Medicine at Mayo Clinic has been built to address the unmet needs of patients. It builds on our new knowledge, bringing new ways to promote the self-repair ability of our body.

There have been magic moments during these few decades that we have built the regenerative medicine field. One such moment was when we saw, for the first time, how out of a stem cell, we can create new beating heart tissue. It was a revolution for us.

We would like to bring now this knowledge that may have started in one field to build it across fields as the new science allows, essentially, for learning between fields. We need true, radical innovation to move the current knowledge into new solutions. That is where regenerative medicine has a unique role. It changes the way we treat patients.

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About Regenerative Medicine - Center for Regenerative Medicine - Mayo ...

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022,1which provides that the agency plans to issue 18 guidance documents in 2022, including eight guidance documents on tissues and advanced therapies. In this alert, we highlight some key considerations from three draft guidance documents on human gene therapy products that incorporate gene editing (GE) components, chimeric antigen receptor (CAR) T cell products, and regenerative medicine therapies that can benefit biopharmaceutical developers and sponsors. Recognizing the challenges of developing such complex, multi-component biologic drug products, including unanticipated risks associated with on-target and off-target activities, these draft guidance documents describe the FDA's recommendations for preclinical and clinical testing, chemistry, manufacturing, and controls (CMC), as well as information that should be included in investigational new drug (IND) applications to ensure proper identity, potency/strength, quality, and purity of the investigational drug products. FDA recommends sponsors of such complex products to communicate with the Office of Tissues and Advanced Therapies (OTAT) in CBER early in product development before submission of an IND, to discuss the product-specific considerations in preparation for transitioning to the clinical phase.

FDA expects detailed information and data IND applications before sponsors can transition to clinical testing. We recommend biopharmaceutical developers and sponsors review the applicable FDA draft guidance documents early in their product development process to identify these needs. Work closely with both FDA regulatory counsel and intellectual property/patent counsel to ensure there is sufficient data to support an IND application, including adequate testing and quality control measures, and that CMC, preclinical, and clinical development plans are coordinated with intellectual property and patent strategies to ensure robust protection of their intellectual property and to maximize the benefits of their patents and FDA regulatory exclusivities. We also encourage interested persons to submit comments to shape the policies proposed in FDA's draft guidance documents prior to finalization.

Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing2

Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products3

Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies4

Stakeholders have until September 14, 2022, to submit comments to this draft guidance to ensure they are considered by FDA before finalization of the guidance.

For More Information

For questions regarding FDA strategy, approval, and regulatory compliance, please contact any member of Wilson Sonsini'sFDA regulatory, healthcare, and consumer productspractice. For questions regarding intellectual property and patent counseling, please contact any member of Wilson Sonsini'spatents and innovationspractice.

Andrea Chamblee,Paul Gadiock, andEva Yincontributed to the preparation of this Wilson Sonsini Alert.

[1] FDA, Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022 (Updated June 2022), available at https://www.fda.gov/media/120341/download.

[2] FDA, Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing (March 2022), available at https://www.fda.gov/media/156894/download.

[3] FDA, Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, available at https://www.fda.gov/media/156896/download.

[4] FDA, Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (June 2022), available at https://www.fda.gov/media/159237/download.

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FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products - Wilson Sonsini Goodrich...

The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer

WASHINGTON, D.C. August 10, 2022

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the cell and gene therapy sector, today formally announced that its Board of Directors has appointed Timothy D. Hunt as the organizations next Chief Executive Officer. Hunt will succeed Janet Lynch Lambert, who announced in April her plan to step down as CEO and who served on the Boards Search Committee. Hunt will start at ARM on September 6.

We are excited to welcome Tim to the ARM team at such a pivotal moment for our sector, said Emile Nuwaysir, Chair of the ARM Board and Search Committee,and President and Chief Executive Officer of Ensoma, an in vivo genomic medicines company. Tims two decades of experience advocating for biotechnology companies, knowledge of the key issues facing the cell and gene therapy field, and expertise in leading teams make him the ideal choice to guide ARM in building the future of medicine. Tim has a deep philosophy of engagement with major stakeholders that will support ARM members and help bring cell and gene therapies into mainstream medical practice.

Hunt was most recently the Chief Culture and Corporate Affairs Officer at Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer. Prior to that, he was the Chief Corporate Affairs Officer at CRISPR gene-editing pioneer Editas Medicine, where he led the companys global policy and government affairs, bioethics, communications, market development and human resources initiatives. He also served in executive public affairs roles at Cubist Pharmaceuticals and Biogen.

Hunt was an Advisory Group member of the Value-Based Payments for Medical Products consortium at the Duke-Margolis Center for Health Policy. He also has been a member of the Board of Directors of the non-profit organization Life Science Cares and has chaired the Ethics Committee of the American Society of Gene and Cell Therapy (ASGCT). Hunt previously served as a member of ARMs Gene Editing Task Force and on the Biotechnology Innovation Organizations Gene Editing Working Group. He received a B.A. in history and philosophy from Boston College and a J.D. from the Columbus School of Law at the Catholic University of America.

I am honored to succeed Janet as Chief Executive Officer of the Alliance for Regenerative Medicine and for the tremendous opportunity to build upon her legacy of developing ARM into the leading sector advocate and resource for the industry, said Hunt. Cell and gene therapies are already transforming patients lives, and we are on the cusp of even more breakthroughs in both rare and prevalent diseases. Our mission is both urgent and clear: to engage all our major stakeholders to ensure the patients we serve have access to the durable and potentially curative therapies of the present and future.

Tim is an excellent choice to continue to grow and strengthen this amazing organization and help realize the potential of regenerative medicine, said Lambert, whose tenure includes doubling ARMs global membership to 425 members, strengthening the organizations advocacy in the US and Europe, and building the ARM team.

Cell and gene therapies to treat blood cancers, spinal muscular atrophy, and an inherited form of blindness are approved in the US and Europe. 2022 could be a record year for new gene therapy approvals for rare disease, and regulators in the US and Europe could approve the first such therapies for hemophilia and sickle cell disease in late 2022 and 2023. More than 2,400 regenerative medicine clinical trials 60% of which targeted prevalent diseases including diabetes and cardiovascular disease were active globally at the end of 2021. ARM is committed to working with stakeholders to ensure that patients benefit from this rapidly advancing pipeline of transformative therapies.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs).ARMpromotes legislative, regulatory, reimbursement and manufacturing initiativesin Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies.Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs.In its 12-year history,ARMhas become the global voice of the sector, representing the interests of 425+ members worldwide and 80+ members across 15 Europeancountries, including small and large companies, academic research institutions, major medical centres and patient groups.To learn more aboutARMor to become a member, visithttp://www.alliancerm.org.

Media inquiries

For more information or for media requests, please contact Stephen Majors, Senior Director of Public Affairs for ARM, atsmajors@alliancerm.org.

Original post:
The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer - GlobeNewswire