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Monday, June 25 • 11:00am - 12:00pm
#115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-528-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regenerative medicine therapies include certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products, including genetically modified cellular therapies and gene therapies that produce durable effects. Challenges in the development of these products range from establishing a consistent manufacturing process to demonstrating efficacy in clinical trials. This session will address the regulatory framework for regenerative medicine products, Regenerative Medicine Advanced Therapy designation, and will also suggest potential pathways sponsors can take to address issues related to manufacturing and clinical trial design.

Learning Objectives

Describe the regulatory framework for regenerative medicine products; Identify potential pathways sponsor can take for issues related to manufacturing and clinical trial design.

Chair

Peter W. Marks

Speaker

Regenerative Medicine Advanced Therapy Designation Pathway
Tejashri Purohit-Sheth, MD

Advancements in Product Manufacturing: Lessons Learned from Developing Cellular Therapies
Robert W. Mays, PhD

Preclinical Program Development to Support Early-Phase Clinical Trials
Jane S. Lebkowski, PhD

EMA Approach to Regulating Advanced Therapies
Marie-Helene Pinheiro, PharmD

Panelist
Iwen Wu, PhD

Panelist
Donald Wright Fink, PhD

Panelist
Joshua Hare, MD, FACC



Speakers
DF

Donald Fink

Cell Therapies Branch, Division of Cellular and Gene Therapies, OTAT, CBER, FDA
Presently, Dr. Fink is engaged in overseeing an extensive portfolio of applications that includes hematopoietic, mesenchymal, cord blood, placenta-derived, and pluripotent stem cell-derived cellular products. His current appointment is as Expert Regulatory Biologist with specific... Read More →
avatar for Joshua Hare

Joshua Hare

Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine, University of Miami
Dr. Joshua Hare directs the Interdisciplinary Stem Cell Institute at the University of Miami. He is a pioneer advancing stem cell therapeutics through first-in-human clinical trials. He's published multiple clinical trials investigating mesenchymal stem cells in patients with heart... Read More →
avatar for Jane Lebkowski

Jane Lebkowski

President of Research and Technology, Regenerative Patch Technologies
Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is President of R&D at Regenerative Patch Technologies, a biotechnology firm developing composite stem cell-based implants for geographic atrophy. Jane Lebkowski also served as Chief... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
RW

Robert W. Mays

Vice President of Regenerative Medicine and Head of Neuroscience Programs, Athersys, Inc.
Dr. Mays is the Head of Neuroscience and VP of Regenerative Medicine at Athersys, Inc. He is focused on the company's proprietary stem cell product, MultiStem®, and its applications in Regenerative Medicine. Dr. Mays was the Principal Investigator of the published MASTERS clinical... Read More →
RW

Robert W. Mays

Vice President of Regenerative Medicine and Head of Neuroscience Programs, Athersys, Inc.
Dr. Mays is the Head of Neuroscience and VP of Regenerative Medicine at Athersys, Inc. He is focused on the company's proprietary stem cell product, MultiStem®, and its applications in Regenerative Medicine. Dr. Mays was the Principal Investigator of the published MASTERS clinical... Read More →
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines... Read More →
TP

Tejashri Purohit-Sheth

Director/DCEPT, Office of Tissues and Advanced Therapies, CBER, FDA
Dr. Purohit-Sheth is the Director for the Division of Clinical Evaluation and Pharmacology Toxicology (DCEPT) in CBER’s Office of Tissues and Advanced Therapies. Her division is responsible for oversight of clinical, pharmacology/toxicology, and clinical pharmacology reviews for... Read More →
IW

Iwen Wu

Branch Chief of Pharmacology and Toxicology 2, OTAT, CBER, FDA
Iwen Wu is currently Branch Chief of Pharmacology/Toxicology Branch 2 in the Office of Tissues and Advanced Therapies at CBER where she was previously a Pharmacology/Toxicology Team Lead and Reviewer. Prior to joining CBER, she was a lead reviewer in the Renal Devices Branch at the... Read More →


Monday June 25, 2018 11:00am - 12:00pm
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA