Bridging the Translational Divide for Clinical and Commercial Success
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While the three platform technologies supporting health care today (pharmaceuticals, biologics and medical devices) have made great strides over the past decades, there are still unmet medical needs. Cell therapy represents a disruptive technology that already reached a billion-dollar market. With thousands of clinical trials in progress, cell-based therapy promises to tackle heart disease, diabetes, neurodegenerative and musculoskeletal diseases, spinal cord injuries, autoimmune diseases and stroke. CHI's Inaugural Cell Therapy conference will focus on translational strategies to bring emerging cell therapies to clinical adoption, including clinical development approaches, regulatory strategies, reimbursement schemes, manufacturing and QC, and business models.
Wednesday, February 13
7:00 am Registration and Morning Coffee
8:00 – 9:40 am Plenary Keynote Presentation - Personalized Oncology – Fulfilling the Promise for Today's Patients
In honor of the 20th anniversary of the Molecular Medicine Tri-Conference, CHI and Cancer Commons will present a plenary panel on Personalized Oncology. Innovations such as NGS and The Cancer Genome Atlas have revealed that cancer comprises hundreds of distinct molecular diseases. Early clinical successes with targeted therapies suggest that cancer might one day be managed as a chronic disease using an evolving cocktail of drugs.Representing all five conference channels, Diagnostics, Therapeutics, Clinical, Informatics, and Cancer, a panel of experts will lead a highly interactive exploration of what it will take to realize this vision in the near future.
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson’s Opening Remarks
11:10 Funding and Commercialization Strategies for Cell Therapy Companies
Greg Bonfiglio, Founder and Managing Partner, Proteus Venture Partners
11:40 Mesenchymal Stem Cells: The New Medicine
Arnold I. Caplan, Ph.D., Professor, Biology and Director, Skeletal Research Center, Case Western Reserve University
The use of exogenously supplied mesenchymal stem cells (MSCs) is the “new medicine” now being tested in over 200 clinical trials. The focus of the lecture will be to discuss both the science and medical use of MSCs.
12:10 pm Perspective of Cell Therapy Development in Academia
Leslie Silberstein, M.D., Director, Boston Center for Human Cell Therapy, Translational Research Program, Harvard Stem Cell Institute
The Center for Human Cell Therapy Boston was established with a long-term objective to further broaden the scope of cellular therapies beyond bone marrow and peripheral blood stem cell transplantation. The scope and challenges of on-going projects will be discussed.
12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
1:45 20th Anniversary Cake in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
2:20 Predicting the Future Cell Therapy Market Based on a Decade of Clinical Trials Data and FDA-Approved Product Revenues
Chris Mason, Ph.D., Professor and Chair, Regenerative Medicine Bioprocessing, Advanced Centre for Biochemical Engineering, University College London
Today the cell therapy industry is starting to grow and mature. Will this growth accelerate over the coming decade? By examining clinical trials and industry metrics it is possible to predict the future size and infrastructure requirements for the sector.
2:50 Strategies for Successful Clinical Trial Approvals in Autologous Cell Therapies
Ken K. Kleinhenz, Vice President, Reg Affairs & Quality Assurance, Cytori Therapeutics
The success of a clinical trial approval is highly dependent on the geographical region. Europe and the United States have similar regulations; however, each region differs significantly in clinical trial requirements, policies, and procedures.
3:20 Designing In-Human Clinical Studies for Cellular Therapy Applications
Robert J. Sexauer, Executive Vice President, Intellicell Biosciences
The talk will focus on the need to harmonize all of the stakeholder groups involved in clinical studies and what type of issues and challenges to expect. I will discuss clinical studies that have been completed and newer trials in development.
3:50 Development of a Translational Pipeline for Mesenchymal Stem Cell Therapy in Trauma Patients
Kim Nguyen, Ph.D., Head, Research, Quantum Cell Expansion System, Terumo BCT
Trauma remains the leading cause of death and disability in adults, eclipsing ischemic heart disease, cerebrovascular disease and HIV/AIDS. Hemorrhage is the major mechanism responsible for most trauma deaths and efforts to control hemorrhage and restore circulatory homeostasis form the core of the therapeutic approach to traumatic injuries. As a result there is a clear unmet need for the development of novel targeted therapeutics that can address issues such as uncontrolled bleeding, acute traumatic coagulopathy, multi-organ failure and ALI-ARDS. Mesenchymal stem cell (MSC) transplantation has been shown to be a promising therapeutic modality in the treatment of several disorders characterized by vascular instability including acute lung injury and acute renal failure. This presentation will describe the efforts of an industry-academic consortium aimed at translating MSC preclinical basic science research into clinical development in a population mimicking military grade trauma injuries at a world class Level 1 trauma center.
4:05 Sponsored Presentation (Opportunity Available)
4:20 Networking Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunities Available)
5:20 Breakout Discussions in the Exhibit Hall
6:20 Close of Day
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