2014 Webcast

Company Presentations | 2014 Stem Cell Meeting on the Mesa

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Featured Speakers & Panels | 2014 Stem Cell Meeting on the Mesa

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DAY 1 – PARTNERING FORUM
TUESDAY – OCTOBER 7, 2014

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:
Gwendolyn Binder-Scholl, Ph.D., EVP, Head of Clinical & Regulatory Development, Adaptimmune
Christian Homsy, M.D., CEO, Cardio3 BioSciences
Jay Siegel, M.D., Chief Biotechnology Officer, Head of Scientific Strategy & Policy, Johnson & Johnson
Donna Skerrett, M.D., Chief Medical Officer, Mesoblast
Gil Van Bokkelen, Ph.D., Chairman & CEO, Athersys
9:15am FROM FIRST PRODUCT TO THERAPEUTIC PORTFOLIO – TWO CASE STUDIES
Capturing Value From a Biomaterials Platform & Building a Cell Therapy Portfolio
This session will offer perspectives from two regenerative medicine companies, one commercializing a tissue engineering platform and one developing a portfolio of cell-based products. It will focus broadly on how to leverage the role of platform technologies in the development of therapeutic applications. In addition, the session will address the strategies for portfolio expansion including the differences in building a therapeutic pipeline internally or expanding the pipeline through acquisition and/or partnership.
Chair:
Sarah Haecker, Ph.D., Director, Technology Sections, Alliance for Regenerative Medicine (ARM); Chief Scientific Officer, Adjuvant Partners
Speakers:
Eduardo Bravo, CEO, TiGenix
David Lightbody, Ph.D., CEO, Biogelx
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 Asterias Biotherapeutics Cyfuse Biomedical
11:15 am NeoStem ISTO Technologies
11:30 am Adaptimmune 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?
Chair:
Curt Herberts, Senior Director, Corporate Development, Sangamo BioSciences
Panelists:
Nicholas Anderson, Medical Technology Analyst & HEOR Consultant
Stephen Crawford, M.D., Medical Senior Director, Cigna LifeSOURCE Transplant Network
Matthew Durdy, Chief Business Officer, Cell Therapy Catapult
Stephen O’Malley, VP, Practice Head US Payer Engagement, PriceSpective
2:15pm COMPANY PRESENTATIONS
Track 1 Track 2
2:15 pm ReNeuron ViaCyte
2:30 pm Fibrocell Science 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:
Kevin Kinsella, Founder, Avalon Ventures
Daniel Menichella, VP & Chief Business Officer, AGTC
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 NexImmune
5:15 pm Osiris Therapeutics Bell Biosystems
5:30 pm TiGenix jCyte
5:45 pm Cytomedix Regenerative Patch Technologies
6:00pm PARTNERING CLOSES
6:30pm GALA RECEPTION
Open to All Regen Med Partnering Forum Attendees

 

DAY 2 – PARTNERING FORUM
WEDNESDAY – OCTOBER 8, 2014

9:20am WELCOME REMARKS
Introduction:
Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine (ARM); Managing Partner, Adjuvant Partners
Speaker:
C. Randal Mills, Ph.D., President & CEO, California Institute for Regenerative Medicine (CIRM)
9:40am JAPANESE REGULATORY FRAMEWORK & INDUSTRY INITIATIVES
Featured Speaker:
Yoshihide Esaki, Director, Ministry of Economy, Trade and Industry
Yuzo Toda, Senior VP, Fujifilm Corporation; Chairman, Forum for Innovative Regenerative Medicine (FIRM)
10:00am STEM CELLS & FDA OVERSIGHT
Featured 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 Editas Medicine NYSCF
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
Jeff Goater, VP, Business Development, Voyager Therapeutics
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 Cardio3 BioSciences Accurexa
5:00pm CLOSING REMARKS
5:00pm PARTNERING CLOSES

 

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    “Overall the Stem Cell Meeting on the Mesa has now become one of our favorite meetings in the cell therapy space. The combination of quality attendees, discussions, partnering software and venue were fantastic.”

    – Chris Moore, Global Marketing Director, Cell Processing Business Area, Terumo BCT