ISCT 2009 Corporate Tutorials and Symposia

Here is a listing of the corporate tutorial and symposia sessions being held at the International Society for Cellular Therapy conference Sunday-Wednesday in San Diego. For more information see www.celltherapy.org.

	ISCT 2009 Corporate Tutorial and Symposium Listing

			Sunday May 3, 2009 Time: 3:00pm – 5:00pm / Grand Ballroom B Miltenyi Biotec
			Emerging treatments enabled by cellular therapy ……………………………………………………………………………………………………………… Chairperson: Shelly Heimfeld, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA, USA Topics and Speakers: Notch-mediated expansion of human cord blood stem/progenitor cells: cell processing and translation to the bedside ……………………………………………………………………………………………………………… Shelly Heimfeld, PhD / Colleen Delaney, MD, MSc, Fred Hutchinson Cancer Research Center, Seattle, WA, USA NK cell therapy in the pediatric leukemia ……………………………………………………………………………………………………………… Wing H. Leung, MD, PhD, St. Jude Children's Research Hospital Memphis, Memphis, TN, USA Antiviral T cell immunotherapy—present and future perspectives ……………………………………………………………………………………………………………… Mark W. Lowdell, PhD, FRCPath, MICR, Royal Free & University College London, London, UK The role of cell processing in the emerging regenerative medicine applications ……………………………………………………………………………………………………………… Denis-Claude Roy, MD, FRCP(C), Hopital Maisonneuve-Rosemont, University of Montreal, Canada

Monday May 4, 2009 Time: 7:30am – 8:30am / Nautilus 4 WuXi AppTec

Topics and Speakers: Validation of a rapid PCR method for the detection of mycoplasma contaminants according to European Pharmacopoiea 5.8, 2.6.7, 2007. Use in release testing of cell therapy products. ……………………………………………………………………………………………………………… Garry B. Takle, Ph.D. Vice President, Operations. WuXi AppTec Philadelphia. Recent publication of a revised section for mycoplasma testing in the European Pharmacopoeia (5.8, section 2.6.7) has led to interest in validating a nucleic acid amplification technique for use in detection of mycoplasma contaminants in cellular therapies. The replacement or supplementation of the existing culture based methods with a PCR-based method has several advantages for the biopharmaceutical industry, mainly with respect to turnaround time for results, and cost. Replacement or substitution of existing methods by a PCR method requires the demonstration of equivalent assay LOD and specificity. The experimental requirements for this comparability validation have been spelled out in detail in the EP section referenced above. In this presentation, we describe the validation and comparability analysis of a PCR method exactly according to the EP guidance. Completion of this validation activity has resulted in the availability of an assay that meets or exceeds EP compliance requirements for a mycoplasma detection method. Comprehensive testing panels for cellular therapeutics. ……………………………………………………………………………………………………………… Chris Larson, MS., Lab Manager, Cell Biology and Flow Cytometry. WuXi AppTec, Philadelphia. In this presentation WuXi AppTec will describe the current regulatory landscape for appropriate testing programs for cellular therapies, focusing on safety and identity assays. A multiuse contract manufacturing facility for the production and release of cellular therapies. ……………………………………………………………………………………………………………… John Bermel, Sr Manager, Cell banking/Cell therapy. WuXi AppTec, Philadelphia. WuXi AppTec will present a summary of the design and operation of the contract GMP cell therapy and cell banking facility located within the Philadelphia site. Design, start up and validation activities will be discussed with reference to specific projects and case studies.

Monday May 4, 2009 Time: 12:15pm - 1:30pm/ Nautilus 2 CellGenix Technologie Transfer GmbH and American Fluoroseal Corporation

Topics and Speakers Application of DC Maturation and T Cell Expansion in a Clinical Setting ……………………………………………………………………………………………………………… Dr. Gunnar Kvalheim, Radium Hospital - Oslo, Norway Purpose: Description of methods and materials for DC maturation and autologous T cell expansion in cancer therapy and a report of clinical outcomes. Expansion of Young Tumor Infiltrating Lymphocytes (Y-TIL) as a Therapeutic Agent in Cancer Treatment ……………………………………………………………………………………………………………… Dr Nina Garlie, Aurora-St. Lukes Medical Center - Milwaukee, WI. Purpose: Description of materials and methods used for a therapeutic Y-TIL expansion protocol Description of Materials and Methods for Cord Blood Expansion with Clinical Outcomes ……………………………………………………………………………………………………………… Dr. Colleen Delaney, Fred Hutchinson Cancer Center - Seattle, WA Purpose: The application of double cord transplants with one expanded cord using cytokines and notch ligand, and one cord left unmanipulated in cancer therapy.

Tuesday May 5, 2009 Time: 7:30am – 8:30am / Nautilus 5 Invitrogen

Come join the leading innovators in cell therapy for a breakfast session on safer cell therapies. One of the key concerns of regulatory agencies around the world is ensuring that candidate cell therapies for clinical trials and ultimate approval have adequate safety profiles. During this session, four leading industry experts will share the technologies and strategies they have identified and employed at different stages of cell therapy development to ensure phase-appropriate safety profiles and streamlined regulatory review of their clinical products. Chair Eric Roos, Business Development Leader, Stem Cell Therapy, Life Technologies Corporation Panelists Leslie Wolfe, PhD, VP, Technology Development, Cellular Therapies, Genzyme Biosurgery Patricia Whelton, Senior Director, Regulatory and Process Development, Osiris Therapeutics, Inc. John T. Kemshead, PhD, Director, Clinical Affairs, Baxter Cellular Therapies For more information on the session: www.invitrogen.com/isctmeeting Register for the breakfast session: www.invitrogen.com/isct-register

Tuesday May 5, 2009 Time: 12:30pm – 1:30pm / Nautilus 1 Pall Medical

Culture and expansion of cord blood MNCs enriched by the Pall Purecell Select System, a new alternative to density gradient Description Enriched MNCs are used for variety of research and clinical applications. The new Pall Purecell™ Select System is a rapid, easy to use, single use disposable for the isolation of Mononuclear cells (MNC) from whole blood and other samples. Purecell Select System was evaluated for enrichment of MNCs from cord blood samples in two different research studies with direct comparison to cells isolated by density gradient method. In one study, enriched cells were subsequently used for CD34+ cell selection followed by hematopoietic progenitor cell expansion. In the second study, MNC enriched cells were used for production of Endothelial Colony Forming Cells (ECFCs®). Results of these studies will be presented and participants will walk away from the tutorial with an awareness of how the Purecell Select System can be suitable for certain research applications and it’s potential future use in clinical cell manufacturing processes. Speaker Christine Smith-Steinhart, PhD EndGenitor Technologies, Inc.

Tuesday May 5, 2009 Time: 12:30pm – 1:30pm / Nautilus 2 Biosafe SA

From Stem Cell Banking to Bedside Biosafe is honoured to have 2 renowned experts presenting some of the leading advances in the field of cellular therapy. Topics and Speakers Dr. Joanne Kurtzberg, Chief of Pediatrics and Blood & Marrow Transplantation at Duke University, NC, USA will provide an overview of the Carolinas Cord Blood Bank, one of the world’s largest and most respected public cord blood banks, before presenting recent developments in the use of cord blood to treat non-haematopoietic diseases. Dr. Riccardo Saccardi from the Haematology Department, Careggi University Hospital, Florence, Italy, will present the different work performed by his laboratory in the study and therapeutic use of cellular products. Careggi is Europe’s leading transplant centre for autoimmune diseases and Dr. Saccardi will go on to discuss the use of stem cells in the treatment of such diseases.

Tuesday May 5, 2009
Time: 12:30pm – 1:30pm / Nautilus 3


BioLife Solutions Inc.

Biopreservation Yield in Cell Therapy: Process Optimization From Source Material to Finished Product Description Participants in the Biopreservation Yield in Cell Therapy: Process Optimization workshop will experience presentation and discussion of a new class of preservation media products which result in the optimization of supply chain logistics and biopreservation processes in hypothermic storage and cryopreservation of various biologic source materials and manufactured cell therapy products. In addition, this workshop will provide a new and detailed understanding of preservation induced cellular injuries and the resultant impact on functional yield of source material and clinical therapeutic yield of manipulated cell therapy products. Critical analysis of traditional post-preservation assay type and timing and how the status quo impacts therapeutic effectiveness of cell therapy products will be introduced through the review of scientific data and selected case studies. This data will support cumulative yield improvements of source material and manufactured cell therapy products using BioLife Solutions’ HypoThermosol® and CryoStor™ products. Speaker Ian B. Nicoud, Ph.D., Director of Technology & Business Development Bio Dr. Nicoud served as an intellectual property and technology consultant for BioLife and joined the Company in September 2007. He has a strong background in transplantation medicine and preservation biology and holds a Ph.D. in Cancer Biology from Vanderbilt University and a B.S. in Biology from Saint Norbert College. He is a co-author of several of the Company’s recent patent applications and manages BioLife’s intellectual property portfolio and technology licensing activities.

Wednesday May 6, 2009 Time: 12:00pm – 1:00pm / Grand Ballroom B STEMCELL Technologies Inc.

Topics and Speakers Expansion of Mesenchymal Progenitor Cells (MPCs) in a Novel Serum- and Animal Component-Free Culture Medium ………………………………………………………………………………………………………………. Ravenska Wagey, PhD Senior Scientist, STEMCELL Technologies Inc. To address the need for serum-free MPC culture, STEMCELL Technologies has developed a novel serum- and animal component-free culture medium which promotes superior clonogenic growth and long-term expansion whilst maintaining multi-lineage differentiation potential of human bone marrow-derived MPCs. Dr. Ravenska Wagey will present performance characteristics of the medium as well as optimal procedures for the isolation, characterization and expansion of MPCs. A Rapid Hematopoietic Colony Assay for Measuring the Potency of Umbilical Cord Blood Grafts ………………………………………………………………………………………………………………. Michelle Bowie, PhD Global Product Manager, STEMCELL Technologies Inc. To meet the need for rapid and easy-to-use potency assays, STEMCELL Technologies has developed a new hematopoietic colony assay that can be completed in 7 days, is easier to score than standard CFU-assays and provides accurate measurement of hematopoietic progenitor cell frequencies in cord blood units that correlate well with results of standard CFU-assay formats. Dr. Michelle Bowie will present an overview of the hematopoietic CFU assay as well as the performance characteristics of STEMCELL’s 7-day CFU-assay.