Policy Summit

Policy Summit Slides Are Now Available

ASGCT Staff - December 18, 2019

We're excited to offer presentation slides to all of our members from the 2019 ASGCT Policy Summit last month in Washington, D.C.

Our inaugural ASGCT Policy Summit last month in Washington, D.C. was a huge success with nearly 400 attendees.

Now, we're excited to offer presentation slides to all of our members from three days of robust discussions on the regulatorypayment, and ethical aspects of gene and cell therapy.

Below are the links to slides from speakers who approved the distribution of their presentations.

Adora Ndu, PharmD, J.D.—Welcome and Introduction

Martin Hernan Bonamino, Ph.D.—The Role and Contributions of the Brazilian Regulatory Agency’s Technical Advisory Board
Brazilian Health Regulatory Agency (ANVISA) Advanced Therapy Technical Committee

Liz Anne Gillham-Eisen—Health Canada: Bringing Innovation to the Regulation of Advanced Therapeutic Products
Health Products and Food Branch, Health Canada

Keynote Address: Peter Marks—The Relevance of Global Regulatory Convergence to Accelerating the Availability of Gene Therapies
Director, FDA CBER

Rune Kjeken, Ph.D.Regulatory Considerations from Europe
Norwegian Medicines Agency, European Medicines Agency’s Committee for Advanced Therapy

Kimberly Schultz, Ph.D.FDA Framework for Gene Therapy Development
Division of Cellular and Gene Therapies, FDA CBER

Megumu Mori, M.D., Ph.D.Current Status and Future Direction of the Regulatory Framework for Gene Therapy in Japan
Medical Device Evaluation Division, Ministry of Health, Labour and Welfare, Japan

Jeanette Hogan—Gene Therapy: A Lived Experience
Mother of Jack Hogan, the first post-approval recipient of Luxturna

David Barrett, J.D.Introduction and Keeping Current on the Pipeline
Executive Director, American Society of Gene & Cell Therapy

Colin Young, Ph.D.Preparing the System: Pipeline Prediction Update
Director of Drug Development Pipeline Research, MIT NEWDIGS

Jenn McNaryParent and Patient Advocate Perspective on Value for Duchenne Muscular Dystrophy
Parent and advocate for people with DMD; Manager, J McNary Consulting

Khrystal Davis, J.D.Parent and Patient Advocate Perspective on Value for Spinal Muscular Atrophy
Parent and advocate for people with SMA; Founder & President, Texas Rare Disease Alliance

Francis PangMarket Access and Value Philosophy for Gene Therapies
Vice President of Global Market Access, Orchard Therapeutics

Dan MytelkaManaging Gene Therapies: The Orphan Reinsurer and Benefit Manager (ORBM)
Director of Policy and Simulations, MIT NEWDIGS

Ross Margulies, J.D.Medicaid Landscape: A Look at State Medicaid Approaches to Gene Therapy Coverage and Reimbursement
Associate, Foley Hoag

Chethan Bachireddy, M.D.A Developing Approach to Break-through Therapies: The Virginia Medicaid Experience
Chief Medical Officer, Virginia Department of Medical Assistance Services

Jugna Shah—Proposals for CAR T-cell Therapy Reimbursement Beyond the NTAP Period
President, Nimitt Consulting

Keynote Address: Francis Collins, M.D., Ph.D.The Need for an International Moratorium on Clinical Uses of Human Germline Gene Editing
Director, NIH

Françoise Baylis, Ph.D.Broad Societal Consensus: Public Education, Engagement and Empowerment
University Research Professor, NTE Impact Ethics, Faculty of Medicine, Dalhousie University

Peter Mills, Ph.D.The Nuffield Report and UK Regulatory Pathways
Assistant Director, Nuffield Council on Bioethics

Marcy Darnovsky, Ph.D.Heritable Genome Editing: Getting Serious About Social Implications
Executive Director, Center for Genetics and Society

Neena Nizar, Ed.D.Gene Therapy: Finding Balance between Bioethical and Social Issues - A Patient Perspective
President and Founder, The Jansen’s Foundation

Andrea TaylorA Patient Perspective: Arterial Tortuosity Syndrome
President and Founder, A Twist of Fate-ATS

Julia BascomLives Worth Living: Who Decides?
Executive Director, Autistic Self Advocacy Network

Fr. Kevin FitzGerald, S.J., Ph.D.Human Germline Genetic Editing: Rapidly Advancing but Where and to What End?
Chair of the Department of Medical Humanities, School of Medicine, Creighton University 

George J. Annas, Ph.D.The Bioethics of Germline Gene Editing: Worth the Global Outcry?
Director of the Center for Health Law, Ethics & Human Rights, Boston University School of Public Health

Tina Rulli, Ph.D.Reproductive CRISPR Doesn’t Save Lives
Assistant Professor, Department of Philosophy, University of California, Davis

Keynote Address: Margaret Hamburg, M.D.—WHO Expert Advisory Group on Developing Global Standards and Oversight of Human Genome Editing: An Overview and Update
Foreign Secretary of the National Academy of Medicine​

J. Benjamin Hurlbut, Ph.D.Imperatives of Governance: Pathways for Democratic Deliberation and the Global Observatory Project
Associate Professor, School of Life Sciences, Arizona State University



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