2012 Agenda

DAY 1 – Investor & Partnering Forum
Monday – October 29, 2012

7:00 am
Registration and Breakfast

7:30 am
Welcome Remarks

  • Gil Van Bokkelen, Ph.D., Chairman and CEO, Athersys, Inc.; Chairman, Alliance for Regenerative Medicine
  • Greg Lucier, M.B.A., Chairman and CEO, Life Technologies

8:00 am
Plenary Panel – The Clinical Outlook for Regenerative Medicine

As many regenerative medicine and cell therapy products move into clinical trials, a clearer understanding of how these products will perform clinically is critical for achieving regulatory approval and ultimately, for commercialization.  This session will discuss the major clinical events expected to drive the regenerative medicine sector over the next 2 years, as well as address some of the key issues facing these products as they approach the marketplace.

Moderator:

  • Greg Lucier, M.B.A., Chairman and CEO, Life Technologies

Panelists:

  • Jay Siegel, M.D., Chief Biotechnology Officer and Head, Global Pharmaceutical Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
  • Paul Simmons, Ph.D., Executive Vice President, Corporate Research and Product Development, Mesoblast Limited
  • Matthias Steger, Ph.D., M.B.A., Global Head Research and Technology Partnering, Roche Ltd.
  • Dean Tozer, Vice President, Corporate Development, Shire Regenerative Medicine

9:00 am
Partnering opens // Morning Break

9:15 am
Company Presentations

  • 9:15 am: Organovo
  • 9:30 am: Aderans Research Institute
  • 9:45 am: Sangamo Biosciences
  • 10:00am: Nanofiber Solutions
  • 10:15 am: Q Therapeutics

10:30 am
Panel 1 – Ensuring Maximum Reimbursement for a Regen Med Product

How to ensure that your regenerative medicine product is appropriately reimbursed is an increasingly difficult task for company executives.  Thriving in both the private insurance and Medicare markets requires careful and long-range planning.  Using a case-study approach, these panelists will discuss reimbursement challenges, goals, and strategies.  They will discuss how to get products covered and reimbursed by payers in an environment that demands cost effectiveness and value.

Moderator:

  • Michael Werner, J.D., Executive Director, Alliance for Regenerative Medicine

Panelists:

  • Stephen Crawford, M.D., Medical Senior Director, LifeSOURCE Transplant Network, Cigna
  • Richard Maziarz, M.D., Medical Director, Adult Blood and Marrow Stem Cell Transplant Program; Professor, Medicine, Oregon Health & Science University
  • Gil Van Bokkelen, Ph.D., Chairman and CEO, Athersys, Inc.; Chairman, Alliance for Regenerative Medicine

11:30 am
Case Presentation: The Organogenesis Story

  • Geoff MacKay, President and CEO, Organogenesis Inc.

12:00 pm
Lunch

1:00 pm
Company Presentations

  • 1:00 pm: Advanced Cell Technology
  • 1:15 pm: Cellular Dynamics International
  • 1:30 pm: Cytomedix
  • 1:45 pm: MaxCyte
  • 2:00 pm: RhinoCyte
  • 2:15 pm: AlloSource

2:30 pm
Panel 2 – The Regen Med Investment Hypothesis: What is it and how does it differ based on the type of Investor?

This session will examine the regenerative medicine investment hypothesis from the perspective of the primary sources of capital at key stages in the development process from discovery to late-stage clinical development. Additionally, panelists will discuss different parts of the sector – therapeutics, devices, tools, and services — and different types of business models to explore how they evaluate risk and why some models are more compelling than others. Investor perspectives represented on the panel will include traditional venture, angels, institutional investors and corporate strategics.

Moderator:

  • Douglas Armstrong, Ph.D., Chief Business Officer, Dawson James Securities

Panelists:

  • Steve Brozak, M.B.A., President, WBB Securities
  • Fariba Ghodsian, Ph.D., M.B.A., Managing Member and Chief Investment Officer, DAFNA Capital Management
  • Paul Kim, Managing Director, POSCO Global Strategic Fund; CEO, POCASTEM
  • Edward Lanphier, President and CEO, Sangamo BioSciences
  • Devyn Smith, Ph.D., COO, Neusentis Research Unit, Pfizer Worldwide R&D

3:30 pm
Afternoon Break

3:45 pm
Company Presentations

  • 3:45 pm: DiscGenics
  • 4:00 pm: New York Stem Cell Foundation
  • 4:15 pm: UC Davis, John Laird
  • 4:30 pm: Sistemic
  • 4:45 pm: TAP Biosystems
  • 5:00 pm: StemBioSys
  • 5:15 pm: Eqalix
  • 5:30 pm: Medistem
  • 5:45 pm: Regen BioPharma

6:00 pm
Partnering Closes for the Day // Day 1 Program Close

6:30 pm
Gala Reception @ Estancia La Jolla Resort & Spa

  • Open to All Investor & Partnering Forum Attendees

 

DAY 2 – Investor & Partnering Forum
Tuesday – October 30, 2012

7:30 am
Registration and Breakfast

8:00 am
Welcome remarks

  • Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine
  • Jonathan Thomas, Ph.D., J.D., Chair, Governing Board, CIRM (Independent Citizens Oversight Committee)

8:30 am
Panel 3 – Navigating the Commercialization Pathway

Profitable commercialization is a key goal for all cell based therapeutic biotech and pharmaceutical companies: however, moving through the clinical phases to commercialization has many challenges. This panel will provide insight into several of these challenges including manufacturing and cost hurdles, regulatory obstacles, channel partner difficulties and funding needs, among others.  Further, it will provide both an overview of these challenges as well as practical approaches towards addressing them.

Moderator:

  • David Smith, Head, Cell Therapy, Lonza

Panelists:

  • Kimberly Benton, Ph.D., Deputy Director, Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, CBER/FDA
  • Eduardo Bravo, M.B.A., Managing Director and CEO, TiGenix
  • Timothy Fong, Ph.D., M.B.A., Vice President, Technology and Product Development, PCT
  • Samer Kaba, M.D., Vice President, Neuroscience, Medpace; Clinical Assistant, Professor, Neurology, Emory University

9:00 am
Partnering opens for the day

9:30 am
Case Presentation: The Pervasis Acquisition

  • Dean Tozer, Vice President, Corporate Development, Shire Regenerative Medicine

10:00 am
Morning Break

10:15 am
Company Presentations

  • 10:15 am: StemCells, Inc.
  • 10:30 am: UC Davis, Vicki Wheelock
  • 10:45 am: Regenerative Patch Technologies
  • 11:00 am: ViaCyte
  • 11:15 am: TheraBiologics
  • 11:30 am: Stanford Cardiovascular Institute
  • 11:45 am: Cedars-Sinai Regenerative Medicine Institute

12:00 pm
Lunch

1:00 pm
Company Presentations

  • 1:00 pm: NeoStem
  • 1:15 pm: Athersys
  • 1:30 pm: Juventas Therapeutics
  • 1:45 pm: Cytori

2:00 pm
Panel 4 – Getting to Market:  Keys to Regulatory Success

This session will examine the regulatory challenges facing regenerative medicine companies and the strategies they employ to reach the market.  Panelists will range from companies with clinical programs at all stages of development and will discuss FDA regulations and policies, how to work within the existing regulatory structure, and will propose ways to increase the certainty of the regulatory approval pathway in the US and elsewhere.

Moderator:

  • Robert Preti, Ph.D., Co-founder, President and CSO, PCT

Panelists:

  • Karen Aboody, M.D., Associate Professor, Department of Neurosciences and Division of Neurosurgery, City of Hope Comprehensive Cancer Center and Beckman Research Institute; Founder, CSO and Director, TheraBiologics, Inc.
  • Kimberly Benton, Ph.D., Deputy Director, Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, CBER/FDA
  • Patrick Bilbo, M.B.A., Vice President, Regulatory Affairs and Government Relations, Organogenesis Inc.
  • Ellen Feigal, M.D., Senior Vice President, Research and Development, California Institute for Regenerative Medicine (CIRM)
  • Ed Field, M.B.A., Chief Operating Officer, Cytomedix

3:00 pm
Afternoon Break

3:15 pm
Case Presentation: The GE-Karolinska Partnership

  • Firman Ghouze, Ph.D., Director, Cell Therapy, GE Healthcare
  • Rolf Hultcrantz, M.D., Professor, Gastroenterology and Hepatology, Karolinska Institutet, Karolinska University Hospital
  • Johan Permert, M.D., Professor, Chairman, Development and Innovation, Karolinska University Hospital

3:45 pm
Company Presentations

  • 3:45 pm: Healthpoint Therapeutics
  • 4:00 pm: Capricor
  • 4:15 pm: TiGenix
  • 4:30 pm: Owl Biomedical

4:50 pm
Closing Remarks

5:00 pm
Investor & Partnering Forum Program Close

6:00 pm
Partnering Closes

 

DAY 2 – PUBLIC Forum
Tuesday – October 30, 2012

5:30 pm
Registration

5:45 pm
Introductory Remarks:

  • Larry Goldstein, Ph.D., Director, UC San Diego Stem Cell Program; Scientific Director, Sanford Consortium for Regenerative Medicine

Featured Speaker:

  • J. Craig Venter, Founder, Chairman & President, J. Craig Venter Institute

6:30 pm
Sunset Reception @ Sanford Consortium for Regenerative Medicine

  • Open to All Stem Cell Meeting on the Mesa Attendees

7:30 pm
Reception Concludes