Gain a deeper understanding of the implications of the Regenerative Medicine Advanced Therapies (RMAT) designation and the Expediting Drug Development: FDA's New Regenerative Medicine
LyGenesis CEO Michael Hufford joins Prime Movers Lab Partner Gavin Mathis to discuss Michael's extensive background in drug Dr Stephen Badylak, Mcgowan Institute For Regenerative Medicine at The Advanced Therapies Congress The Promise of Regenerative Medicine & Advanced Therapies in Oncology
Suzanne Ildstad, M.D., CEO Louisville, KY (Private) Regenerex, an innovative, late clinical-stage cellular therapy company, Panel: Overcoming Challenges with the Development and Translation of a Therapeutic From Academia to Industry Some of the Jessica Carmen, Vice President Gaithersburg, MD (Private)
At Cellstime Clinic, we combine science and care to help you feel and look your best. Discover cutting-edge treatments with real FDA's Efforts to Facilitate the Development of Safe & Effective Regenerative Medicine Products
A-Cell: Regulatory Considerations Cell & Gene Exchange, May 2017: Alliance for Regenerative Medicine Annual Dinner and Program Advanced Regenerative Medicine | Wellness | Aesthetics
Geoff MacKay, president and CEO of Avrobio, a gene therapy company focused on lysosomal diseases talks about the FDA's Panel: Overcoming Challenges with the Development and Translation of a Therapeutic
Standards Coordinating Body for Regenerative Medicine Are the FDA's Gene Therapy Guidances Good for Business? Stem Cells and Next Generation Regenerative Medicine Therapies
FEATURED TALK: FDA'S EFFORTS TO ADVANCE THE DEVELOPMENT AND APPROVAL OF CELLULAR AND GENE AskBio Receives FDA Regenerative Medicine Advanced Therapy
Peter Marks, MD, PhD, Director of the Center for #Biologics Evaluation and Research will deliver a presentation to help you Financing Regenerative Medicine & Advanced Therapies - Panel Presentation
In March 2017, the US FDA introduced the new Regenerative Medicine Advanced Therapy (RMAT) designation thus recognizing the enormous Advancing Regenerative Medicine: FDA's Role in Accelerating Approvals for Innovative Therapies
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes Why the FDA May Need to Rethink Its Approach to Gene and Cell Therapy
FDA refers to such designation as "regenerative medicine advanced therapy" (RMAT) designation. (See section III.C of this document). This guidance describes the Investigational gene therapy AB-1005 for the treatment of Parkinson's disease (PD) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation. Atsena Therapeutics Granted U.S. FDA Regenerative Medicine
This session will explore payer views of advanced therapies such as cell therapy, gene therapy and tissue engineered products. Chair: Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM) Speaker: Peter Marks, M.D., Ph.D., Director, Center for
What types of investors will fund late-stage development? As more products continue to enter late-stage clinical development and Featured Speaker: Advancing Gene Therapies Great and Small
Richard McFarland, M.D., Ph.D., President Gaithersburg, MD (Private) Longeveron® Announces U.S. FDA Grants Lomecel-B Regenerative medicine advanced therapy - Wikipedia
Hear about cutting-edge advances in regenerative medicine, from lab breakthroughs to patient impact. Catriona Jamieson, MD Payer Perspectives on Regenerative Medicine & Advanced Therapies
A panel of experts in regenerative medicine join moderator, Dena Ladd, to talk about advances in medical research using cutting Future of Regenerative Medicine w/ LyGenesis CEO Michael Hufford
This in-depth session will examine the progress of regenerative medicine and advanced therapies specifically as the field relates Dr. Maria Millan: California's Role in Making Regenerative Medicine a Reality (Salvatierra '21) How FDA's Breakthrough Therapy Designation Program Changed the Rare Disease Space
Dr Stephen Badylak, Deputy Director, Mcgowan Institute For Regenerative Medicine at The Advanced Therapies Congress 2019 Regenerex Speakers: Morrie Ruffin, Managing Partner, Alliance for Regenerative Medicine Michael Werner, Executive Director, Alliance for
Regenerative medicine is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, AskBio Receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson's
Have you wondered why some therapies are swiftly approved by the FDA while others are not? Why does the development of Under section 506(g) of the FD&C Act, a regenerative medicine therapy can be designated as a regenerative advanced therapy if it meets certain
From major pharma collaborations to pivotal trial milestones, this week's episode covers the most important developments How Do Regulations Impact New Regenerative Therapies? Have you ever wondered how new regenerative therapies are
Dr. Maria Millan, President and CEO of the California Institute for Regenerative Medicine presents "California's Role in Making Introduction & 2017 Industry Update
Regenerative Medicine Advanced Therapy Webinar Recording Orchard Therapeutics Announces OTL-200 Granted Regenerative Regnerative Medicine
Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there Regenerative Medicine and Technologies Graduate Program ARM's Annual Dinner is one of the regenerative medicine and advanced therapies sector's premier events. This intimate dinner
What Are The Biggest Regulatory Hurdles For Regenerative Medicine? - The Operating Table Retinal Progenitor Cells for Treatment of Retinitis Pigmentosa - Henry Klassen
The cost of living with a rare disease is often overlooked when weighing the impact of cell and gene therapies. Stephen Majors What Are The Biggest Regulatory Hurdles For Regenerative Medicine? Are you curious about the challenges faced in bringing
Why Are Regenerative Medicine Treatments Slow To Get Approved? - The Operating Table Caladrius Biosciences This webinar covers the pathways for regulatory review and approval for cell and gene therapies in the United States and Europe.
Featured Talk: Regenerative Medicine Advanced Therapy (RMAT) Designation The Future of Precision Medicine: Stem Cells, Gene Therapy, and AI FDA Guidance for Cell and Gene Therapy: Insights from Peter Marks at CGT Summit 2023
Retinal Progenitor Cells for Treatment of Retinitis Pigmentosa - Henry Klassen Scientific Symposium from the American Society of Lunch with a Researcher: Regenerative Medicine Shirley Bartido, Director, Regulatory Affairs, Cellectis sits down with us at The Advanced Therapies Congress.
Track 3: How a Therapy Gets Developed and Approved The R&D Roadmap and the Growing Role of Patients MDA Advocacy Institute: Unlocking Treatment Development for Rare Neuromuscular Diseases
Meeting on the Med Highlights Orchard Therapeutics Announces OTL-200 Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by FDA for the Treatment of Expedited Programs for Regenerative Medicine Therapies for
Featured Fireside Chat: FDA Perspective Speaker: Scott Gottlieb, M.D., Commissioner, FDA U.S. Food & Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb
Learn about advancements in precision medicine, particularly the role of AI, stem cell research, and gene therapy. Experts Suzanne Ildstad, M.D., CEO Louisville, KY (Private) Regenerex is an innovative, late clinical-stage cellular therapy company
Advanced Therapies and the FDA's RMAT Designation with Julie Allickson from Wake Forest Institute A regenerative approach to Alzheimer's treatment, with Dr. Joshua Hare
Regenerative Medicine Advanced Therapy Designation | FDA Summer Series on Accelerated Approval and the Breakthrough Therapy Designation
Why Are Regenerative Medicine Treatments Slow To Get Approved? Have you ever wondered why some medical treatments take REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION Speaker: Wilson W. Bryan, M.D., Director, Office of
Panel: Payer Perspectives on Regenerative Medicine & Advanced Therapies The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ATSN-201 for the treatment of X-linked Accelerating cell and gene therapies for rare diseases: ARM Studios interview with Julia Jenkins
Speaker: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Longeveron® Announces U.S. FDA Grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer's
As described in Section 3033 of the 21 st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation. RMAT Policy Briefing with FDA Commissioner
Douglas Losordo, M.D., Chief Medical Officer Basking Ridge, NJ (NASDAQ: CLBS) Caladrius Biosciences is a clinical-stage RMAT is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions 2022 WMIF | The Dr. Is In | The Road Ahead: Regulatory Challenges for Gene and Cell Therapy
FDA's Efforts to Advance the Development and Approval of Cellular and Gene Therapies In this keynote from the 2023 CGT Summit hosted by Charles River Laboratories, Dr. Peter Marks, Director of the FDA's Center for
How Do Regulations Impact New Regenerative Therapies? - The Operating Table Immatics Receives FDA Regenerative Medicine Advanced Therapy
Shirley Bartido, Cellectis at The Advanced Therapies Congress Gene & Cell Therapy Update – September 11, 2025: Lilly Obesity Deal, RMAT for Stargardt and More
While a lot of work in Alzheimer's is focused on the amyloid cascade hypothesis, it's not the only one. And recent research The Road Ahead: Regulatory Challenges for Gene and Cell Therapy In this session, Dr. Marks will discuss the ins and outs of
Ellen Sigal, PhD, the chair and founder of Friends for Cancer Research, discusses how she helped make the concept of the An introduction to the FDA's RMAT designation with Dr Julie Allickson, Director, Regenerative Medicine Clinical Center at Wake AskBio, a Bayer AG subsidiary, announced that its investigational gene therapy AB-1005 for Parkinson's disease received
This session will explore payer views on advanced therapies including cell therapy, gene therapy and tissue engineered products Indiana University School of Medicine has created an interdisciplinary Regenerative Medicine and Technologies Graduate