Agenda

The Stem Cell Meeting on the Mesa is a three-day conference combining discussions between key opinion leaders, senior executives and regulatory and finance experts with 40+ presentations by the field’s most promising companies.

This agenda will be updated periodically so check back soon!


DAY 1 – PARTNERING FORUM
TUESDAY – OCTOBER 7, 2014

ESTANCIA LA JOLLA HOTEL & SPA
 

7:30am REGISTRATION & BREAKFAST
8:00am WELCOME REMARKS
Speaker:
Geoff MacKay, Chair, Alliance for Regenerative Medicine; President & CEO, Organogenesis Inc.
8:15am PLENARY SESSION: CELL THERAPY PRODUCT DEVELOPMENT
Maintaining Momentum in the Face of Expected Clinical Challenges
As more products head into later stage clinical development inevitably there will be successes and setbacks along the way. How do we educate key stakeholder groups so that expectations are realistic and informed, thus avoiding volatility and overreaction to positive and negative data events? What do we see as the key clinical issues we need to address in some of the larger indications so we can help prospective partners and investors better understand the commercial opportunities around cell therapy products? This panel of industry and clinical experts will examine these issues and offer insight into how these challenges will be addressed over the next 3-5 years.
Chair:
Mark Stevenson, EVP & President, Life Science Solutions, Life Technologies, A Thermo Fisher Brand
Panelists:
Christian Homsy, CEO, Cardio3 BioSciences
Silviu Itescu, M.B.B.S., CEO & Managing Director, Mesoblast
Jay Siegel, M.D., Chief Biotechnology Officer, Head of Scientific Strategy & Policy, Johnson & Johnson
Helen Tayton-Martin, Ph.D., Chief Operating Officer, Adaptimmune
Gil Van Bokkelen, Ph.D., Chairman & CEO, Athersys
9:15am TISSUE ENGINEERING FEATURED PRESENTATIONS
9:45am MORNING BREAK
10:15am COMPANY PRESENTATIONS
Track 1 Track 2
10:15 am Aastrom Biosciences Histogen
10:30 am Mesoblast Stanford University
10:45 am Capricor Therapeutics MEDIPOST America
11:00 am Cardio3 BioSciences Cyfuse Biomedical
11:15 am NeoStem ISTO Technologies
11:30 am Cytori Therapeutics DiscGenics
11:45 am Athersys RepliCel
12:00pm LUNCH
1:15pm PANEL I: PAYER PERSPECTIVES ON REGENERATIVE MEDICINE & ADVANCED THERAPIES
This session will explore payer views of advanced therapies such as cell therapy, gene therapy and tissue engineered products. The panel is comprised of representatives from payer organizations who will discuss issues including what is the best way to demonstrate clinical effectiveness? How should companies demonstrate the value of these new therapies? And how will new treatment paradigms fit into the reimbursement model?
Panelists:
Nicholas Anderson, Medical Technology Analyst & HEOR Consultant
Stephen Crawford, M.D., Medical Senior Director, Cigna LifeSOURCE Transplant Network
2:15pm COMPANY PRESENTATIONS
Track 1 Track 2
2:15 pm ReNeuron ViaCyte
2:30 pm Harvard Apparatus Cesca Therapeutics
2:45 pm Organovo TC Biopharm
3:00 pm InVivo Therapeutics Regeneus
3:15 pm StemCells, Inc. UCLA
3:30pm AFTERNOON BREAK
4:00pm PANEL II: COMING OF AGE: HOW DO WE SUSTAIN INVESTOR INTEREST IN ADVANCED THERAPIES OVER THE LONG TERM?
It’s not enough to simply say: “It’s all about the data, stupid.” This is no different from any new drug or therapeutic that has been developed over the last thirty years. While positive clinical results will help sustain momentum, the sector also needs to continue educating investors about the technology, demonstrating mastery or at least a sensible approach to pricing and reimbursement issues, and also showing an understanding about how the healthcare infrastructure will continue to evolve to support next-generation therapies. This panel of investors representing a cross-section of the investor community will examine these issues and speak candidly about what it will take to finance the sector over the next 5-10 years.
Chair:
Reni Benjamin, Ph.D., Managing Director & Head of Equity Research, H.C. Wainwright & Co.
Panelists:
Bong Koh, M.D., Partner, Venrock
Dennis Purcell, Founder & Senior Advisor, Aisling Capital
Brock Reeve, Executive Director, Harvard Stem Cell Institute; Portfolio Manager, Poliwogg
5:00pm COMPANY PRESENTATIONS
Track 1 Track 2
5:00 pm MiMedx Group Promethera Biosciences
5:15 pm Osiris Therapeutics Bell Biosystems
5:30 pm TiGenix jCyte
5:45 pm Cytomedix
6:00pm PARTNERING CLOSES
6:30pm GALA RECEPTION
Open to All Regen Med Partnering Forum Attendees

 

DAY 2 – PARTNERING FORUM
WEDNESDAY – OCTOBER 8, 2014
ESTANCIA LA JOLLA HOTEL & SPA

7:00am REGISTRATION & BREAKFAST
7:30am REIMBURSEMENT WORKSHOP
This “hands-on” reimbursement workshop will feature interaction with a series of experts in coding, coverage and payment who have helped companies navigate the many challenges in reimbursement and provide opportunities for specific discussions about how to address issues related to products. Attendees will learn how to incorporate successful reimbursement strategies into their business and clinical programs. Questions to be discussed will include: what are the key strategic questions for a company? Is there existing Medicare data that could support a company’s position and how can you access that data? What reimbursement is available for drugs used in clinical trials?
Chair:
Faraz Ali, VP, Commercial Development, bluebird bio
Participants:
Douglas Paul, Pharm.D., Ph.D., Partner, Medical Marketing Economics (MME)
Jayson Slotnik, Partner, Health Policy Strategies
Michael Werner, Executive Director, Alliance for Regenerative Medicine (ARM); Partner, Holland & Knight
7:30am MANUFACTURING & SCALE-UP WORKSHOP
We often hear that the field of regenerative medicine is today where the biologics industry was 10-15 years ago. With cell and gene therapy products now in commercial distribution, there is greater clarity around the remaining obstacles to completing the journey of ‘bench to beside’. The regenerative medicine industry continues to face challenges unique to its development in realizing its goals. Successful commercialization of these therapeutics requires high quality products with reasonable cost of goods in a scalable manner that can be sustained throughout the commercial life of the product. With increasing sophistication and experience, the solutions to these challenges are becoming more apparent. What lessons can we learn from those who wrote the previous chapter in medical history? In this session, we will hear experts from the biologics revolution as they provide insight as to how they overcame considerable obstacles to build a sustainable commercial pathway two decades ago. We will ask them to comment on our challenges and advise us on how to face this new frontier with practical suggestions of what pitfalls to avoid and what strengths to build around.
Chair:
Robert Preti, Ph.D., Co-Founder & President, Progenitor Cell Therapy (PCT); Chief Scientific Officer, NeoStem
Participants:
Stewart Abbot, Ph.D., Executive Director, Integrative Research, Celgene Cellular Therapeutics
Ian Harris, Ph.D., Senior Director, Janssen R&D
Stephen Ward, Ph.D., Chief Operating Officer, Cell Therapy Catapult
9:20am WELCOME REMARKS
Introduction:
Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine (ARM)
Speaker:
C. Randal Mills, Ph.D., President & CEO, California Institute for Regenerative Medicine (CIRM)
9:40am FEATURED SPEAKER
Speaker:
Yuzo Toda, Senior VP, Fujifilm Corporation; Chairman, Forum for Innovative Regenerative Medicine (FIRM)
10:00am FEATURED SPEAKER
Speaker:
Celia Witten, M.D., Ph.D., Director, Office of Cellular, Tissue, & Gene Therapy Center for Biologics Evaluation & Research, Food & Drug Administration (FDA)
10:30am MORNING BREAK
11:00am PANEL III: BRINGING INNOVATIVE PRODUCTS TO MARKET IN THE CURRENT REGULATORY ENVIRONMENT
This panel, comprised of regulators and leading experts in the field, will discuss the key US and international regulatory issues confronting advanced therapy companies. Topics to be discussed will include: clinical trial design, expedited approval programs, pre-clinical and clinical issues.
Chair:
Katherine Tsokas, Senior Director, Global Regulatory Affairs, Janssen Research & Development
Panelists:
Anne-Virginie Eggimann, VP, Regulatory Science, bluebird bio
Ellen Feigal, M.D., SVP, Research & Development, California Institute for Regenerative Medicine (CIRM)
Natalie Mount, Ph.D., Chief Clinical Officer, Cell Therapy Catapult
Robert Pietrusko, Pharm.D., SVP, Regulatory Affairs, Voyager Therapeutics
Celia Witten, M.D., Ph.D., Director, Office of Cellular, Tissue, & Gene Therapy Center for Biologics Evaluation & Research, Food & Drug Administration (FDA)
12:00pm LUNCH
1:15pm COMPANY PRESENTATIONS
Track 1 Track 2
1:15 pm Sangamo BioSciences Voyager Therapeutics
1:30 pm bluebird bio MaxCyte
1:45 pm Oxford BioMedica Juventas Therapeutics
2:00 pm Avalanche Biotechnologies Terumo BCT
2:15 pm AGTC BioLife Solutions
2:30 pm Kite Pharma Fibrocell Science
2:45pm AFTERNOON BREAK
3:15pm PLENARY SESSION: GENE THERAPY & GENE-MODIFIED CELL THERAPIES
What are the Deals and Infrastructure Requirements to Support Next-Generation Therapies?
This session will bring together several of the leading in-vivo and ex-vivo gene therapy companies in addition to pharma companies making a large bet in gene-modified cell therapy. While the interest in these technologies abounds due to recent clinical and technological advancements, we also need to understand the commercial model and how these therapies can be deployed into the healthcare system through a sustainable and cost-effective process. With single dose administration regimens and the potential for curative therapies, parts of the healthcare system will have to adapt to these new forms of treatment. This panel will discuss these issues and the unique partnerships that will be required for clinical and commercial success.
Chair:
Edward Lanphier, President & CEO, Sangamo BioSciences
Panelists:
Faraz Ali, VP, Commercial Development, bluebird bio
Hans Hull, SVP, Business Operations, Avalanche Biotechnologies
Douglas Kerr, M.D., Ph.D., Senior Medical Director, Clinical Development, Biogen Idec
4:15pm COMPANY PRESENTATIONS
Track 1 Track 2
4:15 pm Celladon Corporation RhinoCyte
4:30 pm Cellular Dynamics Cedars Sinai Medical Center
4:45 pm
5:00pm CLOSING REMARKS
5:00pm PARTNERING CLOSES

 

3rd ANNUAL PUBLIC FORUM
SANFORD CONSORTIUM FOR REGENERATIVE MEDICINE

5:30pm PUBLIC FORUM OPENS
5:45pm PUBLIC FORUM PRESENTATION
Introduction By:
Silviu Itescu, M.B.B.S., CEO & Managing Director, Mesoblast
Featured Speaker:
Carl June, M.D., Richard W. Vague Professor in Immunotherapy, Perelman School of Medicine, University of Pennsylvania
6:45pm RECEPTION & NETWORKING
Open to All Stem Cell Meeting on the Mesa Attendees
7:30pm PUBLIC FORUM CLOSES

 

DAY 3 – 9th ANNUAL SCIENTIFIC SYMPOSIUM
THURSDAY – OCTOBER 9, 2014
SALK INSTITUTE FOR BIOLOGICAL STUDIES

7:00am REGISTRATION & BREAKFAST
8:00am WELCOME REMARKS
Introduction:
Roger Bingham, Co-Founder & Director, The Science Network; Member, Computational Neurobiology Laboratory, Salk Institute for Biological Studies
Speaker:
C. Randal Mills, Ph.D., President & CEO, California Institute for Regenerative Medicine (CIRM)
8:15am MORNING KEYNOTE PRESENTATION
Speaker:
Laura Niklason, M.D., Ph.D., Professor of Anesthesiology & Biomedical Engineering, Yale University; Founder, Humacyte
8:55am PANEL I: ENGINEERING MICROENVIRONMENTS FOR STEM CELLS
Chair / Introduction By:
Karen Christman, Ph.D., Associate Professor of Bioengineering, UC San Diego
Panelists:
Shaochen Chen, Ph.D., Professor, NanoEngineering & Bioengineering; Co-Director, Biomaterials & Tissue Engineering Center, UC San Diego
Adam Engler, Ph.D., Associate Professor, Department of Bioengineering, UC San Diego
Laura Niklason, M.D., Ph.D., Professor of Anesthesiology & Biomedical Engineering, Yale University; Founder, Humacyte (discussion only)
Sharon Presnell, Ph.D., Chief Technology Officer & EVP of Research & Development, Organovo
10:15am MORNING BREAK / POSTER VIEWING
10:40am PANEL II: CLINICAL TRIALS AT THE SANFORD STEM CELL CLINICAL CENTER
Chair / Introduction By:
Lawrence Goldstein, Ph.D., Distinguished Professor, Departments of Cellular and Molecular Medicine and Neurosciences; Director, Sanford Stem Cell Clinical Center; Director, UC San Diego Stem Cell Program; Scientific Director, Sanford Consortium for Regenerative Medicine
Panelist:
Catriona Jamieson, M.D., Ph.D., Associate Professor, Division of Hematology-Oncology; Deputy Director, Sanford Stem Cell Clinical Center; Chief, Division of Regenerative Medicine, UC San Diego; Director, Stem Cell Research at Moores UC San Diego Cancer Center
12:00pm LUNCH / POSTER VIEWING
1:15pm PANEL III: EPIGENETICS & STEM CELLS IN DEVELOPMENT & REGENERATIVE MEDICINE
This panel will discuss the maintenance of pluripotency or commitment to specific cell lineages and further differentiation into specialized cell types determined by specific changes in chromatin structure that lead to unique patterns of gene expression. The speakers will explore the identification and functional characterization of the components of the chromatin-remodeling machinery that underlie the epigenetic control of stem cell fate, a fundamental task for future applications of stem cells in regenerative medicine.
Chair / Introduction By:
Luke Lairson, Ph.D., Assistant Professor, Department of Chemistry, The Scripps Research Institute; Principal Investigator, California Institute for Biomedical Research
Panelist:
Pier Lorenzo Puri, M.D., Ph.D., Associate Professor, Development, Aging & Regeneration Program, Sanford-Burnham Medical Research Institute
2:35pm AFTERNOON BREAK / POSTER VIEWING
3:00pm PANEL IV: MODELING HUMAN DISEASE
Chair / Introduction By:
Evan Snyder, M.D., Ph.D., Professor, Del E. Webb Center for Neuroscience, Aging, and Stem Cell Research; Director, Stem Cells and Regenerative Biology Program, Sanford-Burnham Medical Research Institute
Panelists:
Juan-Carlos Izpisua Belmonte, Ph.D., Professor, Gene Expression Laboratory, Salk Institute for Biological Studies
Inder Verma, Ph.D., Irwin and Joan Jacobs Chair in Exemplary Life Science, American Cancer Society Professor Molecular Biology, Laboratory of Genetics, Salk Institute for Biological Studies
Joseph Wu, M.D., Ph.D., Director, Stanford Cardiovascular Institute; Professor, Department of Medicine (Cardiology) & Radiology, Stanford University School of Medicine
4:20pm AFTERNOON KEYNOTE PRESENTATION
Speaker:
Thomas Rando, M.D., Ph.D., Director, Glenn Center for the Biology of Aging, Stanford University School of Medicine
5:00pm CLOSING REMARKS
5:00pm NETWORKING RECEPTION / POSTER VIEWING
6:30pm PROGRAM CLOSES