Day 1

Saturday and Sunday, August 12-13

 

Sunday, August 13

5:00-6:00 pm Early Registration

Monday, August 14

7:30 am Registration and Morning Coffee

STEM CELL CULTURE, EXPANSION, SOURCES

8:15 Chair's Opening Remarks

Plenary Keynote Presentations

8:30 Therapy with Cultured Cells: Successes, Failures, the Road to Improvement and the Future of Human Embryonic Stem Cells  Howard Green, Ph.D., George Higginson Professor of Cell Biology, Department of Cell Biology, Harvard Medical School There are few examples of successful use of cultured cells for therapeutic tissue regeneration. The first such example was the keratinocyte, which has enjoyed broad but not always successful application. It is now clear that in order to be successful, a graft must contain an adequate number of stem cells, and criteria exist for determining that number. Keratinocytes derived from human embryonic stem cells differ appreciably from post-natal keratinocytes, and these differences affect our thinking about therapeutic use of other somatic derivatives of hES cells. 9:20 Purification and Expansion of Hematopoietic Stem Cells Based on Proteins Expressed by a Novel Stromal Cell Population Harvey F. Lodish, Ph.D., Professor of Biology and Bioengineering, MIT and Member, Whitehead Institute for Biomedical Research  We uncovered a novel fetal liver CD3+Ter119- cell population that supports ex vivo expansion of hematopoietic stem cells. DNA array experiments showed that, among other proteins, insulin-like growth factor 2 (IGF-2), angiopoietin-like 2, (Angptl2) and angiopoietin-like 3 (Angptl3) are specifically expressed by these cells. When highly enriched HSCs were cultured in the presence of IGF-2, Angptl2 or Angptl3 together with saturating levels of other growth factors for 10 days, a > 25- fold net expansion of long-term HSCs was observed by long- term bone marrow reconstitution analysis. And in collaboration with members of Susan Lindquist’s laboratory we showed that all long- term repopulating HSCs express the prion protein and that HSCs from PrP null bone marrow exhibited impaired self-renewal in serial competitive transplantation experiments, and premature exhaustion when exposed to cell cycle-specific myelotoxic injury. Ongoing studies will define the precise role PrP plays in hematopoietic stem cell biology.

10:00 Is There a Conflict Between Commercial Interests and the Progress of Science? Moderator: Ann Kiessling, Ph.D., Harvard Medical School Dr. Paul J. Price, Research Fellow and Chief Scientific Officer, GIBCO Cell Culture Research and Development, Invitrogen John Biggers, D.Sc., Ph.D., Harvard Medical School Mr. John Iwanicki, Patent Attorney, Legal, Banner & Witcoff Ltd. Morey Krause, Ph.D., Founder Vice President & Chief Technology Officer, ViaCell Inc. Howard Green, Ph.D., George Higginson Professor of Cell Biology, Department of Cell Biology, Harvard Medical School Three issues plague scientists and industry today as we all strive to improve mammalian cell culture. At the core of these issues is finding the right formulation(s) and composition (supplements) to facilitate necessary troubleshooting to move through bottlenecks. They are based on the limitations regarding formulation disclosures, amplifying with differentiation and amplifying to support cell growth. Can industry and scientist work together to find common ground?

11:00 Coffee Break, Poster and Exhibit Viewing

12:00 Lunch Break -Technology Workshops (Sponsorships Available)

SUPPORTING STEM CELL RESEARCH

1:30 Chair's Remarks

1:35 Communication Issues in Stem Cell Research and Business
D. Craig Martin, Executive Vice President, COO, Feinstein Kean Healthcare
The presentation will touch on some of the unique and complex communication challenges associated with stem cell research and development, including: market/investment issues (managing expectations while attempting to recapture momentum, and the potential perils of public sector funding); policy issues (the polarizing influence of stem cells, and where the debate may be headed); public perception issues (the link to religious and ethical conflicts) - and how researchers, executives and institutions can become more effective champions for the science, its promise and potential.

2:05 One Organization’s Approach to Organizing Around the Challenges of Stem Cell Research
Brock C. Reeve, M.Phil., MBA, Executive Director, Harvard Stem Cell Institute
This presentation will discuss why Harvard created the Harvard Stem Cell Institute, what its mission and goals are, how it is structured and how it operates. With its multiple schools and multiple affiliated hospitals, Harvard has the many resources, skills and areas of domain expertise needed to address the complexity of stem cell technology across a variety of disease settings. Even so, each constituent part has its own agenda and external collaborations will be critical to success as well. The discussion will also review current and future business model options.

2:35 Technology Watch (Sponsorships Available)

3:05 Refreshment Break, Poster and Exhibit Viewing

3:45 Commercial Orthopedic Therapy of Horses with Adipose-Derived Stem Cell
Robert Harman, DVM, MPVM, CEO, Vet-Stem, Inc.
Osteoarthritis in veterinary species is both a major disease entity and also a relevant model for human osteoarthritis. Vet-Stem is commercially providing stem cell services to veterinarians. Our primary technology is autologous, fat-derived stem cell therapy applied as a service to treat equine and canine diseases including tendonitis, desmitis, and joint injuries. This talk will cover the collection, processing, dosing, safety and efficacy of adipose-derived stem cell therapy of osteoarthritis in both the canine and equine species. Data from over 150 clinical cases will be presented, including: cell characterizations, clinical research results, case studies with ultrasound, MRI and radiographic diagnostics. Implications derived from the business model and regulatory strategy and observations about public acceptance of stem cell therapy in animals will be presented. Several successful case studies to report on as well.

4:15 Clinical-Grade Cell Sorting for Stem Cell Therapy
Lydia Villa-Komaroff, Ph.D., CSO, Cytonome, Inc.
One of the bottlenecks in moving some types of cell therapy from the lab to the bedside is the difficulty of obtaining sufficient numbers of human cells with specific desired characteristics while simultaneously eliminating cells that have undesirable properties. We will describe technology that allows the sorting of cells using multiple markers at 7 to 10 times the speed of conventional sorters using a sterile disposable sorting cartridge. This technology will enable a host of new stem cell therapies that are not possible at this time and will overcome many limitations in cell processing speed, selection capability and cGMP compliance that exist when using current cell selection technologies.

4:45 Scale Up, and Manufacture of Stem Cell Products
Alan Smith, President, Cognate Therapeutics, Inc.
The proposed presentation would include information on challenges of converting a laboratory procedure for growing stem cells to production at a scale sufficient to meet human clinical trial needs. The presentation will focus on cGMP requirements, documentation, sourcing of tissue, etc. Items such as quality control testing, purity, potency, reproducibility and reliability of stem cell products will be addressed. Often overlooked items which are key from a regulatory perspective such as initiation of reagent stability studies, product stability studies, logistics of materials, manufacturing, storage and shipping related to stem cell products will be addressed. There are a number of unappreciated or at least under appreciated elements required to make stem cell products in sufficient quantity and quality to meet human clinical trial standards and considerations for commercial viability.

5:15 CELLutions SUMMIT Networking Reception

6:30 Close of Day