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Clinical Outlooks for Regenerative Medicine

June 19, 2012

The Starr Center | Schepens Eye Research institute
185 Cambridge Street, Boston, Mass

Program Overview

As many regenerative medicine and cell therapy products move into clinical trials, a clearer understanding of how these products will be administered and how they will perform clinically is critical for achieving regulatory approval and ultimately, for commercialization. This meeting will bring together leading regenerative medicine companies with clinicians and investigators from major research establishments where clinical trials are being conducted, with a goal to enhance the understanding of the key issues facing these products as they approach the marketplace.

Panels, Presenters and Select Presentations

Ophthalmology Panel

Regenerative medicine technologies are making tremendous therapeutic progress for diseases such as age-related macular degeneration, glaucoma and cornea repair. Several prominent companies and research teams have reported compelling animal data and are now reinforcing these findings with positive results from a variety early, mid and late stage clinical trials. Age-related macular degeneration alone afflicts more than 30 million people worldwide and has no cure. Will regenerative medicine transform the field of ophthalmology? This panel of leading clinicians and industry executives will discuss not only the pre-clinical success of these technologies but how they’re being implemented into the clinic and becoming the new standard of care.


Ellen Feigal, M.D., Senior Vice President, Research and Development, California Institute for Regenerative Medicine


Dennis Clegg, Ph.D., Professor, Department of Molecular, Cellular and Developmental Biology; Co-Director, Center for Stem Cell Biology and Engineering, UC Santa Barbara

Matthew Vincent, Ph.D., Director, Business Developement, Advanced Cell Technology

Jane Sowden, Ph.D., Professor in Developmental Biology and Genetics, Developmental Biology Unit, Group Leader, Eye Development and Repair Group, University College London Institute of Child Health

Michael Young, Ph.D., Associate Scientist and de Gunzburg Director, Minda de Gunzburg Research Center for Ocular Regeneration, Schepens Eye Research Institute; Associate Professor, Ophthalmology, Harvard Medical School

Metabolic Panel



Peter Lomedico, Ph.D., Director, Industry Partnerships, Cure Therapies, JDRF


Jason Gaglia, M.D., M.M.Sc., Physician Scientist, Endocrinologist, Joslin Diabetes Center, Harvard Medical School.  View Presentation

Bernhard Hering, M.D., Professor, Surgery and Medicine; Eunice L. Dwan Chair in Diabetes Research; McKnight Presidential Chair in Transplantation Science; Director, Islet Transplantation; Scientific Director, Schulze Diabetes Institute, Department of Surgery, University of Minnesota

Allan Robins, Ph.D., Acting Chief Executive Officer, Vice President and Chief Technical Officer, ViaCyte.  View Presentation

Mark Zimmerman, Ph.D., Venture Leader/Vice President, BetaLogics, a division of Janssen Pharmaceutical Companies of Johnson & Johnson.  View Presentation

Keynote speaker

George Daley, M.D., Ph.D., Director, Stem Cell Transplantation Program; HHMI/Children’s Hospital Boston; Professor, Biomedical Chemistry/Molecular Pharmacology and Pediatrics, Harvard Medical School, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Harvard Stem Cell Institute and Manton Center for Orphan Disease Research

Neurodegenerative Disease and Spinal Cord Injury Panel

One of the therapeutic areas with the greatest expectations for regenerative medicine is the field of neurodegenerative disease and spinal cord injury. This is due to the lack of significant therapeutic options given current standard of care. Many stem cell and regenerative medicine companies are developing potentially transformational therapies to stimulate neural and myelin regeneration to halt disease progression or in some cases find a permanent cure. Given the variety of indications in this field – Parkinson’s, Alzheimer’s, MS, and Spinal Cord injury, to name a few, this session will discuss how progress will be measured clinically, expectations, and the prospect for near-term successes.


Amy Comstock Rick, J.D., CEO, Parkinson’s Action Network


James Berry, M.D., Ph.D., Neurologist, Massachusetts General Hospital; Instructor, Harvard Medical School

Stephen Huhn, M.D., F.A.C.S., F.A.A.P., Vice President, Head of the CNS Program, StemCells, Inc.

Mark Noble, Ph.D., Director, Stem Cell and Regenerative Medicine Institute, Professor, Genetics, Neurobiology and Anatomy, University of Rochester Medical Center.  View Presentation

Ed Wirth, M.D., Ph.D., Chief Science Officer, InVivo Therapeutics.  View Presentation

Cardiovascular Panel

The expectation among many experts is that regenerative medicine may have its greatest impact initially in cardiovascular disease for the treatment of congestive heart failure, refractory angina and other conditions. Several potentially transformative products are already in pivotal trials and there is much discussion in the clinical community about how these products will be integrated into practice. This session will feature a discussion between some of the top corporate executives overseeing these trials and cardiologists with insight into the key clinical issues that must be addressed.


Richard T. Lee, M.D., Professor, Medicine, Harvard Medical School; Leader, Cardiovascular Program, Harvard Stem Cell Institute; Cardiologist, Brigham and Women’s Hospital


Robert Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc. and ReGenesys, BVBA.  View Presentation

Marc Penn, M.D., Ph.D., F.A.C.C., Director, Research, Summa Cardiovascular Institute; Physician, Cardiovascular, Internal Medicine, Summa Akron City Hospital; Professor, Integrative Medical Sciences; Northeast Ohio Medical University

Jonathan Sackner-Bernstein, M.D., F.A.C.C., Vice President, Clinical Development and Regulatory Affairs, NeoStem/Amorcyte

Michael Schuster, Executive Vice President, Global Therapeutic Products, Mesoblast

Wound Healing/Tissue Engineering Panel

The fields where regenerative medicine is experiencing the most significant early clinical and commercial success are the areas of wound healing, soft tissue repair and tissue engineering. The two most commercially successful regenerative medicine products to date are Dermagraft for the treatment of diabetic foot ulcers, and Apligraf for the treatment of diabetic foot ulcers and venous leg ulcers. Further, Gintuit, a product designed to form new gum tissue, was recently approved by the FDA as the first cell-based technology for use in periodontal procedures. This session will feature discussions among specialists using and prescribing these products and product development executives who interacted with them to address key clinical issues. It will also include the perspective of companies and clinicians working with the first scaffolds used to form and promote tissue growth for organ regeneration.


Skip Irving, Partner and Managing Director, Health Advances


Dolores Baksh, Ph.D., Director, Research & Development, Organogenesis

Charles Hart, Ph.D., Vice President and Chief Scientific Officer, Advanced BioHealing, a Shire Company

Ira Herman, Ph.D., Professor and Director, Program in Cellular and Molecular Physiology, Center for Innovations in Wound Healing Research, Tufts University School of Medicine

Robert Kirsner, M.D., Ph.D., Professor, Vice Chairman and Stiefel Laboratories Chair, Department of Dermatology and Cutaneous Surgery; Chief, Dermatology, University of Miami Hospital, University of Miami Miller School of Medicine.  View Presentation