2009 TABLE OF CONTENTS

SECTION 1: Stem Cells, Regenerative Medicine and Society

  • The NIH Guidelines for Human Stem Cell Research and the Role of Advocacy 1
    Alan Jakimo, J.D.

  • A Survey of Ethical and Legal Issues Related to Stem Cell Research 9
    Lori P. Knowles

  • Registration of Stem Cell-Based Clinical Trials: A Scientific and Ethical Imperatives 15
    Rosario M. Isasi, J.D., M.P.H.

  • Federal Funding of Stem Cell Research: Past, Present and Future 22
    Larry Soler

  • The Alliance for Regenerative Medicine: Securing Favorable Research, Regulatory and Reimbursement Policies to Advance Important Technologies 27
    Michael Werner, Esq.

  • The Thirty Year Stem Cell Debate in the United States and the Power of Advocacy 32
    Alan Jakimo, J.D.

  • 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

  • Commitment, Collaboration and Competition in States Funding to Support Stem Cell Research 105
    Dan Gincel, Ph.D.

  • 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.

  • Stem Cell Research and the Johns Hopkins Institute for Cell Engineering 117
    Chi Dang, Ph.D.

  • 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

  • Can Stem Cell Innovation Survive In The “New Normal” Economy? 127
    Peter Winter

  • Creating Partnerships With Large Pharma? Getting Ready For The Big Day 131
    Devyn Smith, Ph.D.

  • Platform Technologies in Regenerative Medicine: Maximizing the Technology Early in the Process 139
    Barbara Nelsen, Ph.D., M.B.A.

  • Stem Cell Law, Regulation and Intellectual Property: A Fundamental Pillar of Success 145
    Sam S. Woodley, Ph.D., Esq. and Peter Ludwig, Esq.

  • Commercial Manufacturing of Cell Therapy Products – Considering the Options? 150
    Scott R. Burger, M.D.

  • Creating an Effective Clinical Delivery Plan for Cell Therapies 155
    Alain Vertes, Ph.D., M.B.A.

  • From the Lab to the Market: Coverage and Reimbursement Knowledge is Critical to Stem Cell and Regenerative Medicine Technology Development 162
    Tim Hunter

  • Stem Cell Banking – the Growth of Public and Private Cord Blood Banks 168
    Toby Hamblin

  • Stem Cell Preservation and Insurance Coverage: Combining Business Leverage for the Stem Cell Industry and New Opportunities in Biobanking 173
    Amnon Pelz

  • If You're Breathing, You're in PR
    Lee Buckler 178

SECTION 5: An International Overview

  • A World of Difference: International Collaboration in Stem Cell Science 184
    Joe Sornberger