Welcome:

• Dennis M. "Mickey" Flynn, President, Pennsylvania Bio
  
• Marcia Mellitz, President and CEO, Center for Emerging Technologies
• Morrie Ruffin, Managing Director, Adjuvant Global Advisors

Introductory Remarks:

• Lesa Mitchell, Vice President, Advancing Innovation, Ewing Marion Kauffman Foundation

Plenary Session: Road to Personalized Medicine Barriers and Opportunities

This session will be focusing on the barriers and opportunities in the area personalized medicine. What are the key challenges? What direction is the science taking? What are the patients doing? What is the impact of companion diagnostics? What is the hype versus the reality? What role does IP play and how can it be used to bring the various players together for the benefit of the patient. What are the challenges in developing a new therapy and a companion diagnostic? The experts will investigate the issues specific to large pharmaceutical companies and how these could be addressed.

Moderator: Frank Douglas, Ph.D., M.D., Senior Fellow, Ewing Marion Kauffman Foundation; Senior Partner, Pure Tech Ventures; Chief Scientific Advisor, Bayer Healthcare, AG; Founder, MIT Center for Biomedical Innovation

Panelists:

• Robert Cook-Deegan, M.D., Director, Center for Genome Ethics, Law & Policy, Institute for Genome Sciences & Policy, Duke University
• Les Paul, M.D., M.S., Vice President, Clinical & Scientific Affairs, National Pharmaceutical Council
• Wayne A. Rosenkrans, Jr., Ph.D., Chairman & President, Personalized Medicine Coalition; Distinguished Fellow, MIT Center for Biomedical Innovation; Program in Ethics and Systems Medicine, Georgetown University; Vice President, Strategic Consulting, Fuld and Co.; Chief Applications Officer, SciTech Strategies
• Dominic Spinella, Ph.D., Executive Director, Translational & Molecular Medicine, Pfizer Biotherapeutics and Bioinnovation Center, Pfizer Inc.
  

Plenary Session: Tech Transfer in the Brave New World

As university endowments have been slashed by the financial market meltdown and investors have become more risk-averse, we are in danger of losing both the societal benefits and financial rewards that new inventions coming out of academia can bring. In the face of these challenges, this panel will discuss how companies and disease foundations are finding new ways to ensure that technology transfer out of academia isn't stifled.

Moderator: Karen Bernstein, Ph.D., Chairman & Editor-in-Chief, BioCentury; Editor-in-Chief, SciBX: Science-Business eXchange

Panelists:

• Wing Delatorre, M.D., Head of Business Operations, Biogen Idec Innovation Incubator (bi3)
• Allison Formal, Vice President, Research Business Development, The Leukemia & Lymphoma Society (LLS)
• Monika Lessl, Head, Science Relations & Collaborations, Alliance Management - Collaborations GDD Berlin, Bayer Schering Pharma AG
  
• Greg Wiederrecht, Ph.D., Vice President & Head of External Scientific Affairs (ESA), Merck & Co., Inc.
• Robert A. Zivin, Ph.D., Senior Director, Corporate Office of Science and Technology, Johnson & Johnson

Roundtable Session: New Models for University Collaborations in Today's Economy

University laboratories receive a significant amount of federal, industry and philanthropic funding. Initiating and managing collaborations across all these players is complex but critical if we are to harness innovation outcomes. This panel will focus on three university models that are enabling porous boundaries and therefore accelerating innovation outcomes. In addition, the NIH will discuss the collaborative models they are instigating that will foster cross university collaborations.

Moderator: Lesa Mitchell, Vice President, Advancing Innovation, Ewing Marion Kauffman Foundation

Panelists:

• Ken Buetow, Ph.D., Associate Director for Bioinformatics and Information Technology and Director of Center for Biomedical Informatics and Information Technology, National Cancer Institute and Co-founder, caBIG and The BIG Health Consortium
• Douglas Crawford, Ph.D., Director, Industry Alliances & Associate Executive Director, California Institute for Quantitative Biosciences (QB3)
• Zishan Haroon, M.D., Ph.D., Co-Director, NC-CBIT, University of North Carolina
  
• Scott J. Weir, PharmD, Ph.D., Institute for Advancing Innovation, University of Kansas

This session will highlight some of the best research in regenerative medicine in the country.

Moderator: Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine

Panelists:

• Simon Archibald, Chief Scientific Officer, Integra LifeSciences and Vice President, Integra Foundation
• Arnold I. Caplan, Ph.D., Professor of Biology & Director, Skeletal Research Center, Department of Biology, Case Western Reserve University
• Steven Nichtberger, M.D., President and CEO, Tengion, Inc.
• Marc Penn, M.D., Ph.D., Director, Experimental Animal Laboratory Department of Cell Biology, The Cleveland Clinic
• Vincent Ronfard, Ph.D., Vice President of Research, Organogenesis Inc.
  

This session examines evolving translational models for effective integration of pre-clinical safety testing and optimization in early stage life sciences technology development. Participants will discuss efforts to improve R&D efficiency through more effective pre-clinical safety testing methods and explore how these technologies can be commercialized. They will discuss efforts in California, Cambridge, North Carolina and the role of regulatory bodies such as the FDA and EMEA. They will then discuss how the biotech and pharma drug development business models can use these pre-clinical tools more effectively to enable successful translation.

Moderator: William. F. Greenlee, Ph.D., President & CEO, The Hamner Institutes for Health Sciences

Panelists:

• Drake S. Eggleston, Ph.D., Founder & Managing Partner, Innovalyst, LLC
• Michael Lawrence Greenberg, Ph.D., Vice President, Research & Development, b3 bio, inc.
• Guido Lanza, President & CEO, Numerate, Inc.
• Ed C. Saltzman, Founder & President, Defined Health
  

Universities are major innovation engines in the U.S. today. Each panelist will bring a unique perspective on how university innovation can be linked to private sector partners to enhance social good via commercialization. The session will spotlight the W. H. Coulter Foundation Translational Research Partnership Program and other private/public partnerships enabling translational research.

Panelists:

• David Chen, Director, Coulter Translational Partnership, University of Virginia
• Eric C. Leuthardt, M.D., Assistant Professor, Neurological Surgery and Biomedical Engineering; Director, Center for Innovation in Neuroscience and Technology, Washington University School of Medicine
  
• Sandy Miller, Senior Fellow, Kauffman Foundation
• Jim O'Connell, Director, Coulter Translational Partnership, University of Michigan
• Geeta Vemuri, Partner, Quaker Bioventures

Hear firsthand from non-profits who proactively work with industry and government to advance therapies in their indication. What kind of partners are these medical research organizations? Are they credible experts? How do these organizations use their resources (financial and other) differently than government, industry and VC's? Can their roles be leveraged for greater impact?

Moderator: Deborah W. Brooks, Co-Founder, The Michael J. Fox Foundation for Parkinson's Research (MJFF)

Panelists:

• Robert J. Beall, Ph.D., President and CEO, Cystic Fibrosis Foundation
• Alan J. Lewis, Ph.D., President and CEO, Juvenile Diabetes Research Foundation International
  
• Louise M. Perkins, Ph.D., Chief Scientific Officer, Multiple Myeloma Research Foundation
• Steve Perrin, Ph.D., Chief Executive Officer and Chief Scientific Officer, ALS Therapy Development Institute (ALS TDI)
  

The venture capital backed model for moving technology (medicines, diagnostics, platforms) out of academia and into commerce is dysfunctional. Emerging companies swim between islands of financing subject to market, financial, technical, and regulatory risk. What is needed is a more sustained, integrated approach that brings stakeholders and shareholders into the process to de-risk innovation. Universities, foundations, and government serve as critical sources of expertise, know-how, intellectual property and, increasingly, non-dilutive financing. Deliberate involvement of academia, foundations and government to increase the value of technology - whether at the university or in emerging companies - will contribute to greater step-ups in value, at the time of licensing and at value inflection points, along the path of development. The goal must be to create more sustainable biotechnology companies so that life saving medicines can get to patients. The panel will explore and discuss ways in which stakeholders and shareholders can work integratively to de-risk innovation and increase the likelihood of success for new medicines.

Moderator - Imran Nasrullah, M.S., J.D., CLP, Chief Business Officer, Massachusetts Biotechnology Council

Panelists:

• Timothy M. Block, Ph.D., Chairman, President & Co-Founder, Hepatitis B Foundation; Professor & Director, Drexel University College of Medicine & Drexel Institute for Biotechnology and Virology Research
• Anthony P. Green Ph.D., Vice President, Technology Commercialization Group: Life Sciences, Ben Franklin Technology Partners; Ben Franklin Director, The Nanotechnology Institute
• Andrew L. Pecora, M.D., FACP, CPE, Chairman & Executive Administrative Director, John Theurer Cancer Center, Hackensack University Medical Center; Professor of Medicine, UMDNJ
• Paul J. Schmitt, Managing Director, Novitas Capital
  
• Michael Weingarten, Director, NCI SBIR Development Center, SBIR/NIH
  

NIH CTSAs have focused on academic institutions and the life science industry on new ways of preparing students and fostering research. This roundtable will explore lessons learned in this program, emerging issues in academic/industry collaborations, and suggest new roles for CTSAs.

Moderator - Stephen S. Tang, Ph.D., President and CEO, University City Science Center

Panelists:

• Peter C. Adamson, M.D., Director, Office of Clinical and Translational Research and Chief, Division of Clinical Pharmacology & Therapeutics, The Children's Hospital of Philadelphia
• Richard Christie, Vice President, External Research & Early Development, Johnson & Johnson
• Brian Strom, M.D., M.P.H., George S. Pepper Professor of Public Health and Preventative Medicine in Biostatistics and Epidemiology, University of Pennsylvania
• Peter White, M.D., Director of Bioinformatics, Assistant Member, Joseph Stokes Research Institute, The Children's Hospital of Pennsylvania; Research Assistant Professor, Department of Pediatrics, University of Pennsylvania
  

One of the most difficult challenges in translational medicine is developing a financing model that works and incentivizes the most capable and innovative minds to participate at the earliest stages of the drug development process. The financing model must support the most innovative ideas with commercial potential and be able to adjust to clinical setbacks without jeopardizing other clinical insights and progress. This session will examine the translational financing challenges from several key perspectives looking at new ideas and models that have shown promise as a means of bridging the critical translational funding gap.

Moderator: Morrie Ruffin, Managing Director, Adjuvant Global Advisors

Panelists:

• Deborah W. Brooks, Co-Founder, The Michael J. Fox Foundation for Parkinson's Research (MJFF)
• Maggie Flanagan LeFlore, Ph.D., Managing Director, MedImmune Ventures
• Brenda D. Gavin, Founding Partner, Quaker BioVentures
• John Gill, Founder, President, CEO & Director, TetraLogic Pharmaceuticals
  
• Juan M.E. Harrison, Vice President, Takeda Research Investment, Inc.

The challenges of translational medicine knows no national boundaries. Researchers and entrepreneurs in Europe, Asia and Canada all face many of the same obstacles to funding and nuturing biomedical innovation as we face in the U.S. This session will examine some of the strategies employed outside of the U.S. and also highlight cross-border collaborative models that could provide efficiencies and risk-sharing solutions to overcome common challenges.

Moderator: Ravi Kiron, Ph.D., M.B.A., Managing Director, Adjuvant Global Advisors, LLC

Panelists:

• Kamran Alam, Director, Business Development, Centre for Drug Research and Development, University of British Columbia
• James Hallinan, Ph.D., Manager of Innovation and Commercial Development, UniQuest
• David K. Rosen, D.V.M., Head of Out Licensing, World Wide Business Development, Pfizer Inc.
• Eugene Williams, Executive Chairman, Translational Medicine India

In this period of economic uncertainty, our current healthcare system has been identified as a major component of our economic lives where fundamental change is required if we are to address our healthcare needs without bankrupting the system in the process. This session will address these challenges in the context of the drug/device discovery and development process with the help of insight provided by three industry experts possessing distinct and provocative views of what we must do differently.

• Frank Douglas, Ph.D., M.D., Senior Fellow, Ewing Marion Kauffman Foundation; Partner, Pure Tech Ventures; Chief Scientific Advisor, Bayer Healthcare, AG; Founder, MIT Center for Biomedical Innovation
• Duane J. Roth, Chief Executive Officer, CONNECT
• Ed C. Saltzman, Founder & President, Defined Health