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Roundtable/Forum

Forum on Regenerative Medicine

The Forum on Regenerative Medicine provides a convening mechanism for interested parties from academia, industry, government, patient and provider organizations, regulators, foundations, and others to engage in discussions that address the challenges facing the application of, and the opportunities for, regenerative medicine to improve health through the development of effective new therapies. The Forum identifies potential barriers to scientific advances; examines the impact of current policies on discovery, development, and translation of regenerative medicine therapies; considers unique challenges of identifying, validating, and bringing regenerative medicine applications to market; and explores ethical, legal, and social issues posed by regenerative medicine advances.

In progress

Any project, supported or not by a committee, that is currently being worked on or is considered active, and will have an end date.

"We convene a variety of interested parties to spark exchange and inspire action to advance regenerative medicine for the benefit of all."

Core Themes
Clinical Translation and Implementation

The forum’s Clinical Translation and Implementation working group considers the obstacles and opportunities to improve clinical translation, implementation, and access to regenerative medicine therapies for all. Through their activities, this working group aims to highlight the perspectives of patients, clinicians, and payers in the clinical translation and implementation of cell, gene, and tissue-based therapies.

Examples of forum activities:

•  The Intersection of Regenerative Medicine and Women’s Health: A Workshop

•  Understanding the Role of the Immune System in Improving Tissue Regeneration: A Workshop

•  Exploring Novel Clinical Trial Designs for Gene-Based Therapies: A Workshop

•  Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - A Workshop

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Innovation and Emerging Technologies

The forum’s Innovation and Emerging Technologies working group aims to explore the innovations and emerging technologies that enable the development and delivery of safe and effective regenerative medicine products to patients faster, at scale, and more efficiently. 

Examples of forum activities:

•  Developing Regenerative Medicine Therapies with Artificial Intelligence: A Workshop

•  Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies: A Workshop

•  Applying Systems Thinking to Regenerative Medicine: A Workshop

•  Navigating the Manufacturing Process and Assuring the Quality of Regenerative Medicine Therapies: A Workshop

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Workforce Development

The forum’s Workforce Development working group examines incentives and disincentives for the expansion and retention of the regenerative medicine workforce. Members examine the increasingly interdisciplinary nature of the field of regenerative medicine to better understand gaps in training and development for creating a workforce that is knowledgeable in data science, mathematics, modelling, and informatics.

Example of forum activity:

   Training the Regenerative Medicine Workforce for the Future: A Workshop

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Core Group


The forum’s Core Group consists of co-leads from each of the working groups. In alignment with the forum’s purpose and strategic plan, the group coordinates activities across the forum, identifies topics and speakers of interest for upcoming forum meetings, and monitors scientific and technological advancements in regenerative medicine and develops sessions on updates in policies and ethics surrounding the field. They also stay abreast of current regulatory developments, including standards and the roles of various regulatory bodies in enforcing regulations and policies related to regenerative medicine products, policy changes, and issues related to cost of therapies.
 

Examples:

•  Reducing Risks and Delays in the Translation of Cell and Gene Therapy Innovations into Regulated Products

•  In 2019, Google released a new advertising policy to describe a category of "speculative and experimental medical treatments." Google's decision to explore its advertising policy was informed by its participation in the forum's February 2019 meeting and subsequently through individual follow-up discussions with several forum members.

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Our mission

The work of the forum engages interested parties to explore:

  • existing and potential barriers to scientific and therapeutic advances;

  • the impact of current policies on the discovery, development, and translation of regenerative medicine therapies;

  • the challenges of identifying, validating, and bringing regenerative medicine applications to market;

  • and the ethical, legal, and social issues posed by regenerative medicine advances.

Forum activities—including public workshops, membership meetings, and other information-gathering activities—provide opportunities to discuss important questions and challenges in the field of regenerative medicine and foster the advancement of high-quality science toward safe and effective therapies for patients. 

Influential Leadership

The forum membership includes leaders from government, academia, pharmaceutical and biotechnology companies, professional groups and associations, and patient advocacy organizations. Forum members work together to illuminate critical issues and challenges facing the application of, and the opportunities for, regenerative medicine to improve health through the development of effective new therapies. View committee.

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Process

Forums create communal environments to foster dialogue across sectors and institutions. Although forums do not produce solutions themselves, they illuminate issues that need to be resolved, and opportunities for further work are often developed from meetings, workshops, and publications. For example, the activities of a forum may result in the establishment of a separate consensus study committee. Unlike a consensus study committee, which publishes a report with conclusions and recommendations, a forum may not issue work with such advice.

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Work with Us

The forum brings together leaders across federal agencies, the private sector, patient advocacy, and academia, and in doing so, serves to help advance the field and facilitate the discovery, development, and translation of regenerative medicine findings into therapies.

Contact us to learn more about how to engage with the forum:

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Description

The Institute of Medicine’s Board on Health Sciences Policy and the National Research Council's Board on Life Sciences will establish a Forum on Regenerative Medicine. The purpose of the Forum is to explore strategies for advancing the field of regenerative medicine and facilitating the discovery, development, and translation of regenerative medicine findings into therapies for medicine, public health initiatives, education, and policy. The Forum will bring together leaders from academia, industry, government, patient and provider organizations, regulators, payers, and foundations to engage in dialogue and discussions that address the challenges facing the application of and the opportunities for regenerative medicine to advance public health. The Forum will identify existing and potential barriers to scientific and therapeutic advances; identify and discuss opportunities to assist in facilitating more effective partnerships among key stakeholders; examine the impact that current policies have on the discovery, development, and translation of regenerative medicine therapies; examine the unique challenges of identifying, validating, and bringing regenerative medicine applications to market; and explore the ethical, legal, and social issues posed by regenerative medicine advances. The Forum membership will determine agenda topics, which will likely span a broad range of issues, and use public workshops, discussions, and commissioned papers to inform its future activities. All activities of the Forum will be conducted in accordance with institutional guidelines described in "Roundtables: Policy and Procedures."

Collaborators

Committee

Krishnendu Roy

Co-Chair

Katherine Tsokas

Co-Chair

Ginny Beakes-Read

Ex Officio Member

Tammy R.L. Collins

Ex Officio Member

Uta Grieshammer

Ex Officio Member

Albert Hwa

Ex Officio Member

Aron Marquitz

Ex Officio Member

Michael H. May

Ex Officio Member

Richard McFarland

Ex Officio Member

Jack Mosher

Ex Officio Member

Lisa A. Neuhold

Ex Officio Member

Amy Patterson

Ex Officio Member

Thomas Petersen

Ex Officio Member

Kimberlee Potter

Ex Officio Member

David Rampulla

Ex Officio Member

Derek Robertson

Ex Officio Member

Derrick Rossi

Ex Officio Member

Nabiha Saklayen

Ex Officio Member

Rachel Salzman

Ex Officio Member

Sumona Sarkar

Ex Officio Member

Eric Sid

Ex Officio Member

Scott Steele

Ex Officio Member

Fei Wang

Ex Officio Member

Daniel Weiss

Ex Officio Member

Michael Werner

Ex Officio Member

Kathleen Zackowski

Ex Officio Member

Karen Christman

Member-at-Large

Constance Chu

Member-at-Large

Cato T. Laurencin

Member-at-Large

Erika Moore

Member-at-Large

Krishanu Saha

Member-at-Large

Jessica Weaver

Member-at-Large

Sponsors

Advanced Regenerative Manufacturing Institute

Alliance for Regenerative Medicine

American Society of Gene & Cell Therapy

Burroughs Wellcome Fund

California Institute for Regenerative Medicine

Cellino

Centre for Commercialization of Regenerative Medicine

Department of Veterans Affairs

Food and Drug Administration

International Society for Cellular Therapy

International Society for Stem Cell Research

Johnson & Johnson

National Institute of Standards and Technology

National Institutes of Health

New York Stem Cell Foundation

United Therapeutics

Staff

Sarah Beachy

Lead

SBeachy@nas.edu

Michelle Drewry

MDrewry@nas.edu

Ashley Pitt

APitt@nas.edu

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