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Day Three: Stem Cell Research and Its Application in Therapeutics


8:30 Morning Coffee

Realizing Therapeutic Potential

8:45 Chair's Remarks
Dr. Cyndi Chen, Director of Research, US Biodefense, Inc

keynote presentation
8:50 Stem Cells and Systems Biology
Dr. Ihor Lemischka, Professor, Department of Molecular Biology, Princeton University 
Dr. Lemischka's research interests include hematopoietic stem cell biology and developmental biology. The unifying goal of his studies is a direct cellular, molecular and functional analysis of hematopoietic stem cells. Recently his laboratory has been applying genomics and functional genomics approaches to identify stem cell molecular phenotypes and to begin elucidating stem cell regulatory network and pathways.

9:35 Stem Cell-Based Therapies and the FDA: On the Critical Path to Innovative Medical Products
Dr. Donald Fink, Jr., Biologist, Office of Cellular, Tissue and Gene Therapies, US Food and Drug Administration 
Cellular biologic therapies either consisting of or derived from embryonic, fetal or adult stem cells (stem cell-based therapies) may provide effective treatments for current unmet medical needs that necessitate replacement, restoration, repair, or regeneration of damaged or diseased tissues and organ systems. The challenge of drawing upon all available scientific evidence to assess and gage the safety of biologics produced from stem cells is the responsibility of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA). The safety and efficacy review of stem cell-based therapies is the responsibility of the Office of Cellular, Tissue, and Gene Therapies (OCTGT), CBER. Regulatory expectations for the development of nascent therapies comprised of stem cells, including those derived from human embryonic stem cells, will be discussed.

10:05 Manufacturing Cell and Gene Therapy Products - Overcoming the Obstacles
Dr. Scott Burger, Managing Director, Advanced Cell & Gene Therapy, LLC 
Unprecedented numbers of cell and gene therapy products are in clinical development today, for a remarkable range of therapeutic applications. US FDA alone has over 500 INDs cell or gene therapy INDs on file; worldwide more than 300 companies are active in this area. Yet cell and gene therapies present unique challenges in process development, characterization, GMP and GTP manufacturing, and distribution. Overcoming these obstacles requires innovative strategies that blend elements of biotechnology, engineering, transplantation and transfusion medicine.

10:35 Refreshment Break, Poster and Exhibit Viewing

11:15 Transplantation to Regeneration: Industrializing Tissue and Cell Therapies through an Evolving Political and Regulatory Landscape
Mr. David Smith, Pepper Hamilton, LLP 
Clinical applications of human tissue engineering and regeneration technologies are the beneficial end result of an extended process of basic and applied research. However, that research process does not necessarily naturally anticipate and seamlessly resolve the many product development, regulatory approval and market acceptance issues encountered in the transition from bench to bedside. This presentation will provide an overview of those elements - with particular attention to tissue access and regulatory concerns -- that can have a significant impact on the economic viability of an emerging tissue and cell therapy industry.

11:45 Under the Microscope: Business and Legal Issues Directing the Evolution of Stem Cell Technologies

Sponsored by:

Dr. John Garvey, J.D, Partner, Foley & Lardner LLP
Proposition 71, California’s $3 billion stem cell research measure, has sparked national interest in the proper balance of public and private funding for stem cell research. Other states must weigh whether to follow California’s lead or to take a different course, including even to ban certain stem cell research. This policy debate in the U.S. takes place against a backdrop of overseas developments that threaten the historically strong position of American stem cell science. This presentation will consider the confluence of commercial, legal, and social factors likely to determine when or whether the clinical promise of this field will be realized.

12:15 Lunch on your own
(Technology Workshops Available)

Therapeutic Applications 

1:30 Chair's Remarks
Dr. John Garvey, Partner, Foley & Lardner LLP

Featured presentations
1:35 Advances in Tissue Engineering Related to Stem Cell Biology
Dr. Charles A. Vacanti, Leroy D. Vandam/Benjamin G. Covino Professor of Anaesthesia, Harvard Medical School; Anesthesiologist-in-Chief & Director, Laboratories for Tissue Engineering and Regenerative Medicine, Brigham and Women's Hospital
A key factor, now receiving much attention, is the source of the cells to be utilized for tissue engineering. Several studies have suggested that immature cells, as opposed to fully differentiated cells of specialized tissues, may hold greater potential for tissue engineering. Such cells may be multipotent (progenitor cells), or pluripotent (stem cells). They can be autologous (adult, mesenchymal stem cells), or from another individual (embryonic stem cells). Immature cells can be induced to differentiate after several divisions. Efforts by several groups have focused on the use of embryonic stem cells. In our laboratories, we have studied a unique adult progenitor/stem cell for Tissue Engineering applications. They appear to lie dormant in several tissues of the body, and are stimulated to proliferate and mature after an insult or injury to the tissue. We have characterized these cells in many tissues including liver, brain, kidney and pancreas and believe that they may be responsible for the natural repair of injured tissue. One area of interest in our labs is in the area of spinal cord regeneration. We have hypothesized that the potential exists to isolate neural stem cells from injured spinal cord and deliver them back into the injured area, in combination with specific polymer scaffolds and various growth factors in a manner to repair the defect. We will present data related to these studies in rats and higher animals.

2:05 Biological Opportunities and Therapeutic Limitations in the use of Stem Cells for Neurological Disease 
Dr. Ole Isacson, Professor of Neurology (Neuroscience), Harvard Medical School; Director of Center for Neuroregeneration Research at McLean Hospital/Harvard Medical School; and NINDS Morris K. Udall Parkinson's Disease Research Center of Excellence
Clinical studies using transplantation of fetal dopaminergic (DA) cells into the brains of Parkinson's disease patients have provided proof of principle that implanted immature, but well-defined post-mitotic neurons can restore function even in a progressive age-dependent neurological disease. A biotechnological and large-scale medical application of this methodology could be achieved by obtaining similar cells derived from human embryonic stem (hES) cells, or perhaps even by stimulating endogenous adult stem cells. However, while several hES cell differentiation protocols have been developed for generating DA neurons, the production of sufficient amounts of the "right" therapeutic DA cell has not yet been accomplished. To achieve this goal, specific criteria have to be fulfilled to really obtain therapeutically useful DA cells and also a clinical understanding is needed of how to accomplish sufficient cell survival, accurate integration in the brain circuitry with normal function in the absence of tumor formation or immunogenicity in patients. This presentation provides an in-depth discussion of the current state of hES cell-derived neurogenesis and necessary criteria for generating therapeutically relevant cell sources for neurological diseases.

2:35 Development and Application of Lung Progenitor Cells - State of the Art Technology
Dr. Min Wu, Assistant Professor, Department of Biochemistry and Molecular Biology, University of North Dakota
The lung possesses a myriad of cell phenotypes because of its unique function of inhaling and expiring air. Due to this structural complexity, transdifferentiation of stem cells into the lung is particularly complicated. In addition, assessing the stem cells and lung progenitor cells in the respiratory system is technically difficult. Despite these difficulties, recent studies have advanced our understanding of bone marrow stem cells differentiating into lung progenitors as well as the local progenitor cells. Our laboratory focuses on mechanistic analysis and therapeutic application of local lung progenitor cells. For analytical purposes we use alveolar epithelial type II cells as a model to define the pathogenic mechanism of P. aeruginosa infection at cellular levels. For therapeutic studies we apply the progenitor type II cells for over-expressing DNA repair genes to reduce oxidative injury. We will be presenting our updated research in lung progenitor development and application. We will also discuss obstacles that limit the use of stem cells in the lung.

3:05 Use of ESC to Treat Autoimmune Diseases
Dr. Richard K. Burt, Chief, Division of Immunotherapy, Northwestern University Feinberg School of Medicine
ESCs, (embryonic stem cells) have been the topic of much professional and lay literature, yet despite their potential, the use of ESCs to cure disease is generally lacking. Herein, we demonstrate that ESCs may be easily manipulated without adverse side effects to treat and cure type I diabetes through induction of islet cell tolerance.

3:35 Development of Unrestricted Somatic Stem Cells (USSCs) from Umbilical Cord Blood for Cardiac Regeneration after Myocardial Infarction.
Dr. Stephan Wnendt, Senior Vice President, R&D, ViaCell Inc.
Interventional cardiology and cardiac surgery have brought major therapeutic achievements to the treatment of coronary artery disease and myocardial infarction by catheter-mediated revascularization and bypass-grafting. However, even after successful restoration of coronary blood flow after acute myocardial infarction many patients suffer from chronic remodeling of the left ventricle, leading to impaired cardiac function and reduced life expectancy. Several clinical trials with catheter-based or surgical transplantation of autologous bone marrow-derived cells or skeletal myoblasts indicate that cell therapy can improve cardiac function by prevention or even reversion of left ventricular remodeling. In order to provide a pluripotent cell source of standardized quality as an off-the-shelf product we are developing our human cord-blood derived USSC for cardiac cell therapy. Pre-clinical data from small and large animal models of myocardial infarction show improvement of relevant parameters of cardiac function (e.g. ejection fraction, wall motility, stroke work) and engraftment of human cells after USSC transplantation. The presentation will provide an overview on the current cardiac cell therapy and the development of USSC as an allogeneic stem cell source for cardiac regeneration. 

4:05 Interactive Panel Discussion with Afternoon Speakers

4:30 Close of Conference


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