video porno
Agenda | Stem Cell Meeting on the Mesa

Agenda

The Stem Cell Meeting on the Mesa is a three-day conference combining discussions between key opinion leaders, senior executives and top academic researchers. The program also includes 60+ presentations by the field’s most promising companies and poster abstracts by 40 leading scientists from around the globe.

This agenda will be updated continuously so please check back for added speakers.

SCMOM-Agenda-Day1-495x105

7:00am – 9:30am | REGISTRATION & BREAKFAST
7:00am – 9:00am | CONCURRENT WORKSHOPS

DOING BUSINESS IN JAPAN WORKSHOP

7:15am – 8:45am | Magnolia Room
In Partnership with the Forum for Innovative Regenerative Medicine (FIRM)

Speakers:
Hidetaka Nishimura, Director, Bio-Industry Division, Ministry of Economy, Trade & Industry (METI)
Daisaku Sato, Ph.D., Director, Office of Cellular & Tissue-based Products, Pharmaceuticals & Medical Devices Agency (PMDA)
Sachiko Yoshimura, Chief Executive Director, Japan External Trade Organization (JETRO) Los Angeles

MANUFACTURING & SCALE-UP WORKSHOP

7:15am – 8:45am | Learning Theater
Sponsored by PCT Caladrius

As practitioners in the development of the regenerative medicine industry, we are often compared to those that came before us in the biologics industry. In fact, whilst the challenges to commercial success in this industry are real, just as in the industries that we are being compared to, solutions are forming along the lines of the unique challenges presented. That being said, are we really that different than our biologics industry predecessors? What lessons can we learn from how they solved the challenges of developing novel and game changing therapeutics that didn’t quite fit their predecessors in the small molecule drug development industry? As we contend with the key issues including dose finding, optimal route of administration and frequency of administration for our therapeutics, it is often said that, in regenerative medicine, traditional drug and then biologic paradigms of pharmacokinetic (PK) and pharmacodynamics (PD) modelling are difficult, if at all possible to directly apply. This session is intended to bring experts on the topic of how PK/PD models have been adapted to biologics to describe the relation between dosing, concentration and efficacy, in an attempt to inform the practices and approaches of today’s regenerative medicine development professionals.

Chair:
Robert Preti, Ph.D., Co-Founder & President, PCT Caladrius; SVP, Development & Technical Operations & Chief Technology Officer, Caladrius Biosciences

Speakers:
Frank Borriello, M.D., Ph.D., VP, Head of Search & Evaluation, Baxalta
Olivier Danos, Ph.D., SVP, Gene Therapy, Biogen
Andreas Katopodis, Director, Novartis Institutes for BioMedical Research

9:00am | GENERAL SESSION
9:00am – 9:15am WELCOME REMARKS
Speaker:
Edward Lanphier, Chairman, Alliance for Regenerative Medicine; President & CEO, Sangamo BioSciences
9:15am – 10:15am PLENARY SESSION: PEERING BEYOND CLINICAL PROOF OF CONCEPT
What Types of Partnerships & Practices Will be Required for Commercial Success?
Given the unique development challenges for gene and cell therapy where a number of technology and process breakthroughs are occurring outside of traditional corporate structures — it is clear that strategic partnerships will play a significant role in moving beyond early clinical signals of efficacy towards versatile and robust models that can support treatment on a larger scale. This panel of pharma and biotech leaders will discuss the large volume of deals in the sector, what is driving them and how these new types of collaborations with non-traditional partners will lead to successful commercial models.
Chair:
Amy Butler, Ph.D., VP & General Manager, Cell Biology, Thermo Fisher Scientific
Panelists:
Usman Azam, M.D., Global Head, Cell & Gene Therapies Unit, Novartis
Frank Borriello, M.D., Ph.D., VP, Head of Search & Evaluation, Baxalta
Olivier Danos, Ph.D., SVP, Gene Therapy, Biogen
Perry Karsen, CEO, Celgene Cellular Therapeutics
B.G. Rhee, President, Green Cross Holdings
10:15am | PARTNERING OPENS
10:15am – 10:45am | MORNING BREAK
10:45am – 12:00pm | CONCURRENT TRACKS
COMPANY PRESENTATIONS {Ballroom 1}
10:45am – 11:00am Pluristem Therapeutics
11:00am – 11:15am Caladrius Biosciences
11:15am – 11:30am Celyad
11:30am – 11:45am Mesoblast
11:45am – 12:00pm Capricor Therapeutics
COMPANY PRESENTATIONS {Ballroom 2}
10:45am – 11:00am Editas Medicine
11:00am – 11:15am InVivo Therapeutics
11:15am – 11:30am Asterias Biotherapeutics
11:30am – 11:45am StemCells, Inc.
11:45am – 12:00pm ViaCyte
12:00pm – 1:15pm | LUNCH
1:15pm – 3:30pm | CONCURRENT TRACKS
PANEL: COMMERCIAL SCALE {Ballroom 1}
Innovation in Process Development & Manufacturing of Gene Therapeutics
1:15pm – 2:15pm
With commercial scale requirements on the not too distant horizon, this panel will examine recent advances in process development and the key features and benefits of different manufacturing approaches of viral vector based gene therapeutics. The discussion will include discourse on the factors influencing and rationale for contracted product manufacturing versus the development of in-house capabilities.
Chair:
Ryan Scanlon, Director Commercial Development, Viral Therapy, Lonza
Panelists:
John Gray, Ph.D., VP, R&D, Audentes Therapeutics
David Kirn, M.D., CEO & Co-Founder, 4D Molecular Therapeutics
Rob Kotin, Ph.D., VP of Production, Voyager Therapeutics
Alan Moore, VP, Strategic Accounts & Cell Manufacturing, WuXi AppTec
Richard Snyder, Ph.D., Director of Biotherapeutic Programs, University of Florida
COMPANY PRESENTATIONS {Ballroom 2}
1:15pm – 1:30pm Accurexa
1:30pm – 1:45pm BioCardia
1:45pm – 2:00pm StemBioSys
2:00pm – 2:15pm DiscGenics
COMPANY PRESENTATIONS {Ballroom 1}
2:15pm – 2:30pm MiMedx
2:30pm – 2:45pm Sangamo BioSciences
2:45am – 3:00pm
3:00pm – 3:15pm Oxford BioMedica
3:15pm – 3:30pm Avalanche Biotechnologies
COMPANY PRESENTATIONS {Ballroom 2}
2:15pm – 2:30pm Juventas Therapeutics
2:30pm – 2:45pm Hemostemix
2:45am – 3:00pm Cell Therapy Ltd.
3:00pm – 3:15pm ReNeuron
3:15pm – 3:30pm Kiadis Pharma
3:30pm – 4:00pm | AFTERNOON BREAK
4:00pm – 6:00pm | CONCURRENT TRACKS
PANEL: PAYER PERSPECTIVES ON REGENERATIVE MEDICINE & ADVANCED THERAPIES {Ballroom 1}
4:00pm – 5:00pm
This session will explore payer views on advanced therapies including cell therapy, gene therapy and tissue engineered products. The panel is comprised of medical coverage and policy decision-makers from private and public payer organizations who will discuss key issues to help ensure a favorable reimbursement climate for regenerative medicine.
Chair:
Arturo Araya, Global Head of Commercial, Cell & Gene Therapies Unit, Novartis
Speakers:
Donald Balfour, M.D., Former President & Medical Director, Sharp Rees-Stealy Medical Group
Michael Fine, M.D., Medical Director, Health Net
Shlomo Melmed, M.D., SVP, Academic Affairs & Dean of the Medical Facility, Cedars-Sinai Medical Center
COMPANY PRESENTATIONS {Ballroom 2}
4:00pm – 4:15pm BioLife Solutions
4:15pm – 4:30pm Terumo BCT
4:30pm – 4:45pm MaxCyte
4:45pm – 5:00pm TaiwanBio
COMPANY PRESENTATIONS {Ballroom 1}
5:00pm – 5:15pm Osiris Therapeutics
5:15pm – 5:30pm Athersys
5:30pm – 5:45pm Organovo
5:45pm – 6:00pm Vericel
COMPANY PRESENTATIONS {Ballroom 2}
5:00pm – 5:15pm BrainStorm Cell Therapeutics
5:15pm – 5:30pm GenVec
5:30pm – 5:45pm REGENXBIO
5:45pm – 6:00pm
6:00pm | PARTNERING CLOSES
6:30pm – 9:30pm | GALA RECEPTION

SCMOM-Agenda-Day2-495x105

7:00am – 9:30am | REGISTRATION & BREAKFAST
7:30am – 9:00am | CONCURRENT WORKSHOPS

REIMBURSEMENT STRATEGIES WORKSHOP

7:30am – 9:00am | Magnolia Room
Sponsored by 1798 Consultants

The biotech and pharmaceutical industry has been changing rapidly over the last decade, with market access and reimbursement strategy and planning assuming a greater role in ensuring commercial success. Novel and complex regenerative therapies currently under development representing new modes of treatment will be faced with even greater challenges in navigating the reimbursement and economic landscape likely to impact their launch.

The reimbursement strategies workshop will provide an overview of the current reimbursement landscape, primarily in the U.S., but also touching on other markets as well. Attendees will learn of different frameworks to analyze the reimbursement landscape their products will face and how the analysis may be used to inform the product value proposition for different stakeholders. Attendees will benefit from an exploration of the following questions:

Key Questions That This Workshop Will Address:
• Who are the important stakeholders that will impact commercial success of my product portfolio?
• What are the current trends in payers’ utilization management and coverage policies for high cost therapies?
• How do I best position my product to healthcare insurance providers, both public and commercial payers?
• What are the main considerations of the type of benefit design(s) that will reimburse my product?
• How do provider payments vary by setting of care, and what challenges are inherent within each setting of care?

o How do the payment differences influence access to our products?
o What will be the impact of the recent shift towards value based and integrated healthcare payment systems on our market access approach?
o What are the current barriers to alternative payment models such as fixed payment or periodic payment for gene therapies?

• How do I build my commercial framework to help optimize patient access and gross to net?

o Which factors will most affect our gross to net calculations and how should we verify whether discounts or other pricing strategies will impact our pricing in other channels?
o What are the key patient support considerations to mitigate potentially prohibitive patient out of pocket barriers?

Speakers:
Roshawn Blunt, Managing Director, 1798 Consultants
Mary Roberts, VP, 1798 Consultants

INTERNATIONAL REGULATORY WORKSHOP

7:30am – 9:00am | Learning Theater
Sponsored by Cell Therapy Catapult & Janssen R&D

This workshop will include three in-depth case study presentations, each examining a specific hypothetical product in the cell and gene therapy space. Regulators from across the globe will provide feedback on options for licensure in their region and how they would recommend a development plan should be approached in each scenario.

Speaker:
Daisaku Sato, Ph.D., Director, Office of Cellular & Tissue-based Products, Pharmaceuticals & Medical Devices Agency (PMDA)

9:00am | GENERAL SESSION & PARTNERING OPENS
9:00am – 9:15am WELCOME REMARKS
Speaker:
C. Randal Mills, Ph.D., President & CEO, California Institute for Regenerative Medicine (CIRM)
9:15am – 9:25am GLOBAL COLLABORATION STRATEGY FOR THE FORUM FOR INNOVATIVE REGENERATIVE MEDICINE (FIRM)
Featured Speaker:
Yuzo Toda, Director EVP, FUJIFILM Corporation; Chairman, Forum for Innovative Regenerative Medicine (FIRM)
9:25am – 9:45am AN UPDATE ON THE SECTOR IN JAPAN
Chair:
Firman Ghouze, Ph.D., Director, Cell Therapy, GE Healthcare
9:45am – 10:15am STATE OF THE CELL & GENE THERAPY SECTOR IN EUROPE
Chair:
Keith Thompson, CEO, Cell Therapy Catapult
Speakers:
Christian Homsy, M.D., CEO, Celyad
Jörn Aldag, CEO, uniQure
10:15am – 10:45am | MORNING BREAK
10:45am – 11:45am | CONCURRENT TRACKS
PANEL: REGULATORY CONVERGENCE & ACCELERATED PATHWAYS {Ballroom 1}
Accelerated Development Challenges & Opportunities
10:45am – 11:45am
The objective of this international regulatory session is to explore opportunities in various regions to accelerate development and approval for regenerative medicines. The panel will focus on challenges to developers wishing to license their product using accelerated pathways and will focus specifically on the similarities and differences of the schemes in various regions.
Chair:
Michael Werner, Executive Director, Alliance for Regenerative Medicine; Partner, Holland & Knight
Speaker:
Daisaku Sato, Ph.D., Director, Office of Cellular & Tissue-based Products, Pharmaceuticals & Medical Devices Agency (PMDA)
COMPANY PRESENTATIONS {Ballroom 2}
10:45am – 11:00am Videregen
11:00am – 11:15am SCM Lifescience
11:15am – 11:30am jCyte
11:30am – 11:45am Cellular Dynamics International
11:45am – 1:00pm | LUNCH
1:00pm – 2:45pm | CONCURRENT TRACKS
COMPANY PRESENTATIONS {Ballroom 1}
1:00pm – 1:15pm Healios
1:15pm – 1:30pm Fate Therapeutics
1:30pm – 1:45pm bluebird bio
1:45pm – 2:00pm Cellectis
2:00pm – 2:15pm uniQure
2:15pm – 2:30pm Inovio Pharmaceuticals
2:30pm – 2:45pm Voyager Therapeutics
COMPANY PRESENTATIONS {Ballroom 2}
1:00pm – 1:15pm MEDIPOST America
1:15pm – 1:30pm TiGenix
1:30pm – 1:45pm Histogenics
1:45pm – 2:00pm TissueGene
2:00pm – 2:15pm OrthoCell
2:15pm – 2:30pm Cesca Therapeutics
2:30pm – 2:45pm RepliCel
2:45pm – 3:15pm | AFTERNOON BREAK
3:15pm – 4:15pm | CONCURRENT TRACKS
PANEL: THE GENE THERAPY FINANCING WINDOW {Ballroom 1}
Why is the Sector so Tempting for Investors?
3:15pm – 4:15pm
Twenty years ago it was impossible to get any investor, venture or otherwise, to take a serious look at a gene therapy company. What is the difference between today’s environment and where we were in the mid-1990s? What are the key technology breakthroughs and clinical insights that have led to this resurgence in interest? No doubt there are challenges to successful commercialization, but why do investors believe these hurdles can be overcome and that valuations will remain strong? This panel of venture and institutional investors will discuss the current financing environment for gene therapy companies and how access to capital can be maintained over the long term.
Chair:
Joseph Pantginis, Ph.D., Head of Biotechnology Research & Senior Research Analyst, ROTH Capital Partners
Speaker:
Daniel Krizek, Director, Brookside Capital
Kush Parmar, M.D., Ph.D., Partner, 5AM Ventures
COMPANY PRESENTATIONS {Ballroom 2}
3:15pm – 3:30pm The J. David Gladstone Institutes
3:30pm – 3:45pm Stanford University
3:45pm – 4:00pm TC BioPharm
4:00pm – 4:15pm Regenerative Patch
COMPANY PRESENTATIONS {Ballroom 1}
4:15pm – 4:30pm MolMed
4:30pm – 4:45pm Argos Therapeutics
4:45pm – 5:00pm Fibrocell Science
COMPANY PRESENTATIONS {Ballroom 2}
4:15pm – 4:30pm Abeona Therapeutics
4:30pm – 4:45pm Cyfuse Biomedical
4:45pm – 5:00pm Cynata Therapeutics
5:00pm | PARTNERING CLOSES

SCMOM-Agenda-Day2-PF-592x105

5:30pm | PUBLIC FORUM OPENS
5:45pm – 6:45pm FEATURED PRESENTATION
Introduction By:
Donna Skerrett, M.D., Chief Medical Officer, Mesoblast
Featured Speaker:
Jennifer Elisseeff, Ph.D., Professor, Jules Stein Chair in Ophthalmology, Wilmer Eye Institute; Director, Translational Tissue Engineering Center, Johns Hopkins University
6:45pm – 7:30pm | RECEPTION & NETWORKING
7:30pm | PUBLIC FORUM CLOSES

SCMOM-Agenda-Day3-530x105

7:00am – 8:00am | REGISTRATION & BREAKFAST
8:00am | GENERAL SESSION
8:00am – 8:15am 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 – 8:55am STEM CELLS IN SILENCE, ACTION & CANCER
Keynote Speaker:
Elaine Fuchs, Ph.D., Investigator, Howard Hughes Medical Institute; Rebecca C. Lancefield Professor, Robin Chemers Neustein Laboratory of Mammalian Cell Biology & Development, Rockefeller University
8:55am – 10:15am PANEL I: TRIALS AT THE SANFORD STEM CELL CLINICAL CENTER
This panel will describe new data and design for upcoming and ongoing cell-therapy clinical trials of the Sanford Stem Cell Clinical Center. The Sanford Stem Cell Clinical Center supports ethically conducted stem cell-based and stem-cell targeted clinical trials that are strongly based on evidence and have rigorous trial design. These two elements are essential for the conduct of Phase I stem cell trials. The third essential element is strong collaboration among many scientific and medical partners. The CIRM Alpha Stem Cell Clinic at UC San Diego provides infrastructural strength to enable the complex interaction required for success.
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
Speakers:
Joseph Ciacci, M.D., Clinical Professor of Surgery, UC San Diego; Chief of Neurosurgery, VA San Diego Healthcare System
Eric Ahrens, Ph.D., Professor of Radiology, UC San Diego
Stephanie Cherqui, Ph.D., Assistant Professor in Residence, of Pediatrics, UC San Diego
10:15am – 10:40am | MORNING BREAK / POSTER VIEWING – EVEN NUMBER ABSTRACTS
10:40am – 12:00pm PANEL II: NEURONAL DIVERSIFICATION USING SPINAL NEURONS AS A MODEL
Chair / Introduction By:
Samuel Pfaff, Ph.D., Benjamin H. Lewis Chair, Professor, Gene Expression Laboratory, Salk Institute for Biological Studies
Speakers:
Henk Roelink, Ph.D., Associate Professor of Genetics, Genomics & Development, UC Berkeley
Todd Macfarlan, Ph.D., Earl Stadtman Investigator, The Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), National Institutes of Health
Ben Novitch, Ph.D., Associate Professor, Neurobiology; Eli & Edythe Broad Center of Regenerative Medicine & Stem Cell Research; UCLA
Samuel Pfaff, Ph.D., Benjamin H. Lewis Chair, Professor, Gene Expression Laboratory, Salk Institute for Biological Studies
12:00pm – 12:10pm HERTZBERG-SCHECHTER PRIZE FOR STEM CELL RESEARCH
Presented By:
Alysson Muotri, Ph.D., Associate Director, Stem Cell Program; Associate Professor, Department of Pediatrics & Cellular Molecular Medicine, UC San Diego/td>
12:10pm – 1:15pm | LUNCH / POSTER VIEWING – ODD NUMBER ABSTRACTS
1:15pm – 2:35pm PANEL III: IMMUNOLOGY
Chair / Introduction By:
Mitchell Kronenberg, Ph.D., President & Chief Scientific Officer, La Jolla Institute for Allergy & Immunology
Speakers:
Donald Kohn, M.D., Professor, Department of Microbiology, Immunology & Molecular Genetics (MIMG) & Department of Pediatrics, UCLA
Stephen Schoenberger, Ph.D., Professor, Division of Developmental Immunology, La Jolla Institute for Allergy & Immunology
Stephen Forman, M.D., Francis & Kathleen McNamara Distinguished Chair in Hematology & Hematopoietic Cell Transplantation, City of Hope
2:35pm – 3:00pm | AFTERNOON BREAK / POSTER VIEWING – EVEN NUMBER ABSTRACTS
3:00pm – 4:20pm PANEL IV: TISSUE ENGINEERING
Co-Chairs / Introduction By:
Shaochen Chen, Ph.D., Founding Director, Biomaterials & Tissue Engineering Center, UC San Diego
Mark Mercola, Ph.D., Professor, Department of Bioengineering, Jacobs School of Engineering, UC San Diego; Professor & Director, Muscle Development & Regeneration Program, Sanford-Burnham Medical Research Institute (SBMRI)
Speakers:
Shyni Varghese, Ph.D., Director, Bio-Inspired Materials & Stem Cell Engineering Laboratory, UC San Diego
Pilar Ruiz-Lozano, Ph.D., Associate Professor, Pediatrics – Cardiology, Stanford University
Joseph Metzger, Ph.D., Professor & Chair, Department of Integrative Biology & Physiology, University of Minnesota
4:20pm – 5:00pm AFTERNOON KEYNOTE
5:00pm – 6:30pm | NETWORKING RECEPTION / POSTER VIEWING
6:30pm | SCIENTIFIC SYMPOSIUM CLOSES