Workshop Materials

2013 Workshop

April 9, 2013
Developing Cellular Therapies: From Preclinical Safety To Clinical Evaluation
University of Wisconsin - Madison, Waisman Biomanufacturing (WB)
Wisconsin Institutes for Discovery
Madison, WI

April 9, 2013
  • Robert Lindblad, MD - PACT Program Overview (PDF)
  • Cliona Rooney, PhD - Manufacture of Natural Killer Cells as Treatment for Multiple Myeloma (PDF)
  • Sean Savitz, MD - Developing in-vivo Models for Stroke Indication (Presentation not available)
  • Michael Matthay, MD - Clinical Cell Therapy Experience for Acute Lung Injury (Presentation not available)
  • Timothy Hacker, PhD - In-vivo Animal Models of Heart Disease (PDF)
  • Marlowe Eldridge, MD - In-vivo Models and Cell Delivery for Lung Indications (PDF)
  • Peiman Hematti, MD - Mesenchymal Stem Cell Characterization (PDF)
  • Derek Hei, PhD - Cell Therapeutics - Process Development and Manufacturing for Human Clinical Trials (PDF)
  • John Centanni, MS - IND Application Process: For The New Clinical Investigator (PDF)
  • Christian Capitini, MD - Using Mouse Models to Optimize Cell Therapies for GVL/GVHD (Presentation not available)
  • Timothy Kamp, MD, PhD - iPS cells for Cardiac Indications (PDF)

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2012 Workshop

October 22-23, 2012
Manufacturing Cell Therapy Products: Practical Aspects
Baylor College of Medicine, Center for Cell and Gene Therapy (CAGT)
Pavilion for Women
Texas Children's Hospital
Houston, Texas

Day 1 - October 22, 2012
  • Robert Lindblad, MD - PACT Overview (PDF)
  • Adrian Gee, MI Biol, PhD - Cell Processing at CAGT (PDF)
  • Cliona Rooney, PhD - Challenges of Cell Culture in Manufacturing (PDF)
  • Juan Vera, MD - Optimization of Suspension Cell Culture (PDF)
  • Ann Leen, PhD - Generation of Antigen Specific T Cells (PDF)
  • Catherine Bollard, MD - Evaluation of T Cell Products (PDF)
  • David Spencer, PhD - Antigen Presenting Cells (PDF)
  • John Wagner, MD - Isolation and Expansion of Umbilical Cord Blood Regulatory T Cells (PDF)
  • Gianpietro Dotti, MD - Use of CARS (PDF)
  • Stephen Gottchalk, MD - Genetic Modification for Immune Evasion (PDF)
  • Bambi Grilley, RPh - Regulatory Concerns in Cellular Therapies (PDF)
Day 2 - October 23, 2012
  • Thomas Zwaka, MD - ES & IPS (PDF)
  • Natasha Lapteva, PhD - NK Cells for Therapy (PDF)
  • Peiman Hematti, PhD - Mesenchymal Stromal/Stem Cells (PDF)
  • Adrian Gee, MI Biol, PhD - Getting the Product to the Patient (PDF)
  • Helen Heslop, MD - Broadening the Application of Cellular Therapies (PDF)

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2011 Workshop

November 10, 2011
Getting to IND
City of Hope, Center for Applied Technology Development
Argyros Auditorium Duarte, CA

Day 1 - November 10, 2011
  • Larry Couture, PhD- Welcome and introductions
  • Robert Lindblad, MD - PACT, Overview Mission (PDF)
  • Tina Etcheverry PhD - Critical Considerations for Bioprocessing of Stem Cells for Clinical Use (Presentation not available)
  • Chang-Yi Chen, PhD - Scalable expansion of hES cells in suspension culture (Presentation not available)
  • Timothy Cote, MD, MPH - Regulatory considerations: Early decisions and best practices (PDF)
  • Martha Reitman, MD - Getting to IND, an Academic Industrial Perspective (Presentation not available)


September 14-15, 2011
NHLBI PACT Workshop - Cell Therapy for Pediatric Diseases: A Growing Frontier
National Library of Medicine
Lister Hill Center Auditorium
National Institutes of Health
Bethesda, Maryland

Workshop Booklet Day 1 - September 14, 2011

Session 1: Congenital Blood Disorders - Part 1

  • Mark Walters, MD - Hematopoietic Stem Cell Transplantation for Hemoglobinopathies (PDF)
  • John F. Tisdale, MD - Stem Cell Gene Therapy for Hemoglobinopathies (PDF)
  • Sung-Yun Pai, MD - Stem Cell Gene Therapy for Immunodeficiency (Presentation not available)
  • M. Louise Markert, MD, PhD - Thymus Transplantation for Complete DiGeorge Anomaly (PDF)

Session 1: Congenital Blood Disorders - Part 2

  • Hans-Peter Kiem, MD, FACP - Stem Cell Gene Therapy for Franconi Anemia - (Presentation not available)
  • John E. Wagner - Hematopoietic Stem Cell Transplantation for Fanconi Anemia (PDF)
Session 2: Neurodegenerative Diseases and Brain Injury
  • Paul J. Orchard, MD - Hematopoietic Stem Cell Transplantation for Adrenoleukodystrophy (PDF)
  • David A. Williams, MD - Stem Cell Gene Therapy in Childhood Cerebral Adrenoleukodystrophy - (Presentation not available)
  • Robert D. Steiner, MD - Neural Stem Cell Transplantation for Neuronal Ceroid Lipofuscinosis (Batten Diseases): Successes and Challenges - (Presentation not available)
  • Charles S. Cox, Jr., MD - Progenitor Cell Therapies for Pediatric Traumatic Brain Injury (PDF)
  • Joanne Kurtzberg, MD - Can Autologous Cord Blood Correct Acquired Brain Injury in Pediatric Patients? (PDF)
Day 2 - September 15, 2011 Session 3: Regenerative Medicine
  • Kenneth L. Berger, PhD - Clinical Application of ESC derived Motor Neuron Progenitors (MotorGraftTM) in the Treatment of Infantile Spinal Muscular Atrophy (SMA) Type 1 (PDF)
  • Jane S. Lebkowski, PhD - Human Embryonic Stem Cell Therapy for Spinal Cord Injury (PDF)
  • Jakub Tolar, MD, PhD - Transplantation for Extracellular Matrix Disorder: Problems, Premises, and Promises (PDF)
  • Christopher Breuer, MD - The Translation of Tissue Engineered Vascular Grafts for Use in Congenital Heart Surgery (PDF)

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2010 Workshop

October 26-27, 2010
Translational Development & Scale Up: Focus on Immune Cell Populations
University of Minnesota, Molecular and Cellular Therapeutics
Continuing Education & Conference Center
St. Paul, Minnesota

Day 1 - October 26, 2010
  • Debbie Wood - Meeting Overview & Objectives (PDF)
  • John E. Wagner, MD - Clinical Trial Design - The Art of Translational Medicine (PDF)
  • Jeffrey S. Miller, MD - PACT: Translational Development & Scale Up NK Cells (PDF)
  • John R. Ohlfest, PhD - (Presentation not available)
  • Claudio G. Brunstein, MD - Adoptive Transfer of Regulatory T Cells in UCB Transplantation (PDF)
  • David H. McKenna, Jr., MD - Development of Potency Assays for Cellular Therapies (PDF)
  • Keli L. Hippen, PhD - Purity and Potency Assay Development (PDF)
  • Julie M. Curtsinger, PhD - Immune Monitoring for Translational Clinical Trials (PDF)
  • Allison Hubel, PhD - Emerging Issues in Cryopreservation of Cellular Therapies (PDF)
  • Diane M. Kadidlo, BS, MT (ASCP), SBB - MCT Facility Overview (PDF)
Day 2 - October 27, 2010
  • David H. McKenna, Jr., MD - Moving from Research to Clinical Production (PDF)
  • Darin J. Sumstad, BS, MT (ASCP) - Cell Culture Optimization (PDF)
  • Adrian P. Gee, MI Biol, PhD - Equipment and Vendor Qualification (PDF)
  • Fran Rabe, MS, CQM, (ASQ) - FDA Inspection and Management (PDF)

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Previous PACT-sponsored Workshops

2009 Workshop

April 23-24, 2009
NHLBI PACT Workshop "Converging Concepts in Cell Therapy"
Natcher Conference Center
National Institutes of Health
Bethesda, Maryland

Day 1 - April 23, 2009

Session 1: T-Regulatory Cells

  • David H. McKenna, Jr., MD - Considerations for Clinical Manufacture of T Regulatory Cells (PDF)
  • Bruce L. Levine, PhD - Engineering Artificial Antigen Presenting Cells for Efficient Expansion of Regulatory T Cells (PDF)
  • Claudio G. Brunstein, MD - (Presentation not available)
Session 2: Mesenchymal Stem Cells
  • Adrian P. Gee, MI Biol., PhD - Opening Presentation (PDF)
  • Ian K. McNiece, PhD - Mesenchymal Stem Cells (PDF)
    Mesenchymal Stem Cell Transplantation for Heart Failure (PDF)
  • Katarina Le Blanc, MD, PhD - (Presentation not available)
Session 3: Antigen-Specific T Cells
  • Shelly Heimfeld, PhD - Banking and Qualification of Feeder Cells for Clinical Production of Antigen-Specific T Cells (PDF)
  • Philip D. Greenberg, MD - (Presentation not available)
  • Cliona M. Rooney, PhD - Antigen-Presenting Cells (APCs) for T Cell Activation (PDF)
Session 4: Engineered T Cells
  • Bernard A. Fox, PhD - Cell Processing Related Issues: Adoptive T Cell Immunotherapy (PDF)
  • Carl H. June, MD - Engineered T Cells for HIV/AIDS (PDF)
  • Steven A. Rosenberg, MD, PhD - Cell Transfer Therapy for Patients with Cancer (PDF)
Session 5: Natural Killer Cells
  • David Stroncek, MD - NK Cell Therapy: Cell Processing Considerations (PDF)
  • Jeffery S. Miller, MD - The Role of Haploidentical NK Cells in Cancer and Transplantation (PDF)
  • Richard W. Childs, MD - In Vitro Expansion of Human NK Cells for Adoptive Cancer Immunotherapy (PDF)
Day 2 - April 24, 2009 Session 6: Dendritic Cells
  • Theresa L. Whiteside, PhD - Dendritic Cells for Therapy: Production, Maturation and Potency (PDF)
  • Sharon A. Riddler, MD, MPH - Therapeutic Vaccination with Autologous Dendritic Cells in HIV Infection (PDF)
  • Pawel Kalinski, MD, PhD - Dendritic Cells in Cancer Immunotherapy: Induction of Tumor-homing Effector-type T cells (PDF)
Session 7: Cell Trafficking and Imaging Techniques
  • Marianna Sabatino, MD - Imaging and Cell Therapy (PDF)
  • Erin F. Simonds, PhD Candidate - (Presentation not available)
  • Zhenghong Lee, PhD - (Presentation not available)
  • Eric T. Ahrens, PhD - (Presentation not available)

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2008 Workshop

May 5-6, 2008
Innovative Cellular Therapies and Methods at GMP Cell Therapy Facilities
University of Pittsburgh Cancer Institute
Immunological Monitoring and Cellular Products Laboratory
Hematopoietic Stem Cell Laboratory
Herberman Conference Center
Pittsburgh, Pennsylvania

Day 1 - May 5, 2008

  • Meeting Objectives | Debbie Wood, BS, MT(ASCP) - (PDF)
  • Facility Design - University of Pittsburgh | Theresa L. Whiteside, PhD - (PDF)
  • Facility Design - University of Minnesota | Diane Kadidlo, MT (ASCP) - (PDF)
  • Facility Design - Baylor College of Medicine | Adrian Gee, MIBiol, PhD - (PDF)
  • Consideration for Optimization of Culture Conditions for Various Cell Types | Darin Sumstad, CLS - (PDF)
  • Flow Cytometric Analysis of Cell Therapy Products | Albert Donnenberg, PhD - (PDF)
  • Umbilical Cord Blood-Dervived T-Regulatory Cells | David McKenna, MD - (PDF)
  • Assessments of Regulatory T cells and Other Monitoring Assays | Theresa Whiteside, PhD - (PDF)
  • DC-based Vaccine with Autologous Inactivated HIV-1 | Sharon Riddler, MD, MPH - (PDF)
  • Clinical-Scale Production of Natural Killer Cells for Immunotherapy | David McKenna, MD - (PDF)
  • T Cell Therapies: The What, The Why and The How | Cliona Rooney, PhD - (PDF)
  • CTLs for Therapy of Post-Transplant Malignancies | Diana Metes, MD - (PDF)

Day 2 - May 6, 2008

  • Improving your Preservation Practice | Allison Hubel, PhD - (PDF)
  • Adipose-Derived Stem Cells: Phenotype, Function, and Clinical Targets | Albert Donnenberg, PhD - (PDF)
  • Lab Practical - CD34 Single Platform Enumeration | Deborah Griffin, MS - (PDF)
  • Lab Practical - Endotoxin and Mycoplasma | Joanna Stanson, MS - (PDF)

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2007 Workshop

April 10-11, 2007
Design and Operation of GMP Cell Therapy Facilities University of Minnesota
Molecular and Cellular Therapeutics
Earle Browne Continuing Education and Conference Center
St. Paul, Minnesota

Day 1 - April 10, 2007

  • Meeting Objectives | Debbie Wood, BS, MT(ASCP) - (PDF)
  • Facility Design-University of Minnesota | Diane Kadidlo, MT(ASCP), SBB - (PDF)
  • Facility Design-University of Pittsburgh | Deborah Griffin, BA - (PDF)
  • Facility Design-Baylor College of Medicine | Adrian Gee, MIBiolo, PhD - (PDF)
  • Facility Design-Mayo Clinic | Doug Padley, MT(ASCP) - (PDF)
  • Facility Cleaning & Environmental Monitoring | Adrian Gee, MIBiolo, PhD - (PDF)
  • Supplies and Reagents | Lisa Van Orsow, BS - (PDF)
  • Staff Training | Deborah Griffin, BA - (PDF)
  • Documentation and Batch Records | Joanna Stanson, MS - (PDF)
  • CMC Writing | Dave McKenna Jr., MD - (PDF)
  • Product Development | Karen Prezioso, MS - (PDF)

Day 2 - April 11, 2007

  • Cryopreservation | Allison Hubel, PhD - (PDF)
  • Data Management - Deviations & Processing | Darin Sumstad, CLS (NCA, ASCP) - (PDF)
  • Lot Release | Diane Kadidlo, MT(ASCP), SBB - (PDF)
  • IND - Cell Therapy | Robert Lindblad, MD, FACEP - (PDF)

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2006 Workshop

April 4-5, 2006
Design and Operation of GMP Cell Therapy Facilities
Baylor College of Medicine
Houston, Texas

Day 1 - April 4, 2006

  • Meeting Introduction & Objectives | Debbie Wood, BS, MT(ASCP) - (PDF)
  • Facility Design-University of Pittsburgh | Deborah Griffin, BA - (PDF)
  • Facility Design-University of Minnesota | Diane Kadidlo, MT(ASCP), SBB - (PDF)
  • Facility Design-Baylor College of Medicine | Adrian Gee, MIBiolo, PhD - (PDF)
  • Facility Design-MD Anderson Cancer Center | John McMannis, PhD - (PDF)
  • Facility Cleaning & Monitoring | Adrian Gee, MIBiolo, PhD - (PDF)
  • Facility and Equipment Maintenance | Deborah Griffin, BA - (PDF)
  • Supplies and Reagents | Lisa Van Orsow, BS - (PDF)
  • Documentation | Adrian Gee, MIBiolo, PhD - (PDF)
  • Labeling | Jeff Wilson, BS - (PDF)
  • Databases | Darin Sumstad, CLS (NCA, ASCP) and Jeff Wilson, BS - (PDF)

Day 2 - April 5, 2006

  • Production Records & Documentation | Diane Kadidlo, MT(ASCP), SBB and Joanna Stanson, MS - (PDF)
  • Product Testing & Release | Diane Kadidlo, MT(ASCP), SBB - (PDF)
  • Staff Training | John McMannis, PhD - (PDF)

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