2009
TABLE OF CONTENTS
SECTION 1: Stem Cells,
Regenerative Medicine and Society
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The NIH Guidelines for Human Stem Cell Research and the
Role of Advocacy 1
Alan Jakimo, J.D.
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A Survey of Ethical and Legal Issues Related to Stem Cell
Research 9
Lori P. Knowles
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Registration of Stem Cell-Based Clinical Trials: A
Scientific and Ethical Imperatives 15
Rosario M. Isasi, J.D., M.P.H.
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Federal Funding of Stem Cell Research: Past, Present and
Future 22
Larry Soler
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The Alliance for Regenerative Medicine: Securing Favorable
Research, Regulatory and Reimbursement Policies to Advance Important
Technologies 27
Michael Werner, Esq.
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The Thirty Year Stem Cell Debate in the United States and
the Power of Advocacy 32
Alan Jakimo, J.D.
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Stem Cell Advocacy 2.0: A Blueprint for Change 41
Bernard Siegel, J.D.
SECTION 2: Road to Cures: Science,
Treatments and Economics
- The Use and Promise of Stem Cells in Drug Discovery
45
Marcie A. Glicksman, Ph.D., Kelvin Lam, Ph.D., Maria Webb, Ph.D., G.
Sitta Sittampalam, Ph.D.
- Cellular Therapy for CNS Disorders: A Translational
Perspective 50
Stephen Huhn, M.D., F.A.C.S., F.A.A.P.
- Stem Cell Retinal Replacement Therapy 57
Jeffrey H. Stern, Ph.D., M.D., Michael Radosevich, M.D., Ph.D., Sally
Temple, M.D.
- Stem Cell Therapy for Liver Disease 63
Stuart Forbes, M.D.
Orthobiologics: Early Adopters are Innovating the Regenerative
Medicine Industry with Clinical Results 67
Richard Kyle, M.D, Matthew Kyle, J.D., and Kyle Swartout
- Stem Cells and Diabetes: New Trends and Clinical Prospects
73
Juan Domínguez-Bendala, MSc, Ph.D., and Camillo Ricordi, M.D.
- Stem Cell Research in the Cardiac Field: Where Are We Now?
79
Jason Griffeth and Kristen Cornella
- Stem Cell Treatment and Models for Blood Disorders
85
Linzhao Cheng, Ph.D.
- Understanding the Role of Mutations in Stem Cells and
Cancer: An Emerging Paradigm Shift in Oncology 90
Lynn M Opdenaker, Ph.D., Jeremy
Fields, Ph.D., and Bruce M. Boman, M.D., Ph.D.
- Mimicking Extracellular Matrix to Direct Stem Cell
Differentiation 97
Jennifer Elisseeff, Ph.D. and Tara Deans, Ph.D.
- Aging: Can Piecemeal Preventative Maintenance Work?
101
Aubrey D.N.J. de Grey, Ph.D.
SECTION 3: Stem Cell Research in
Maryland
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Commitment, Collaboration and Competition in States Funding
to Support Stem Cell Research 105
Dan Gincel, Ph.D.
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Governor Martin O'Malley: Charting Maryland's Bioscience
Future 109
The University of Maryland School of Medicine Center For
Stem Cell nBiology and Regenerative Medicine: A Synergistic
Initiative to Move Stem Cells From Bench to Bedside 113
Curt I. Civin, M.D.
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Stem Cell Research and the Johns Hopkins Institute for Cell
Engineering 117
Chi Dang, Ph.D.
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Stem Cell Research at the Hugo W. Moser Research Institute at Kennedy
Krieger 122
Michael J. Shamblott, Ph.D.
SECTION 4: Building the Regenerative
Medicine (ReGEN) Industry
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Can Stem Cell Innovation Survive In The “New Normal”
Economy? 127
Peter Winter
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Creating Partnerships With Large Pharma? Getting Ready For
The Big Day 131
Devyn Smith, Ph.D.
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Platform Technologies in Regenerative Medicine: Maximizing
the Technology Early in the Process 139
Barbara Nelsen, Ph.D., M.B.A.
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Stem Cell Law, Regulation and Intellectual Property: A
Fundamental Pillar of Success 145
Sam S. Woodley, Ph.D., Esq. and Peter Ludwig,
Esq.
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Commercial Manufacturing of Cell Therapy Products –
Considering the Options? 150
Scott R. Burger, M.D.
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Creating an Effective Clinical Delivery Plan for Cell
Therapies 155
Alain Vertes, Ph.D., M.B.A.
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From the Lab to the Market: Coverage and Reimbursement
Knowledge is Critical to Stem Cell and Regenerative Medicine
Technology Development 162
Tim Hunter
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Stem Cell Banking – the Growth of Public and Private Cord
Blood Banks 168
Toby Hamblin
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Stem Cell Preservation and Insurance Coverage: Combining
Business Leverage for the Stem Cell Industry and New Opportunities
in Biobanking 173
Amnon Pelz
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If You're Breathing, You're in PR
Lee Buckler 178
SECTION 5: An International Overview
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