PACT Workshops

University of Wisconsin - Madison, Waisman Biomanufacturing (WB)
Wisconsin Institutes for Discovery
Madison, WI

April 9, 2013

• Robert Lindblad, MD - PACT Program Overview
• Cliona Rooney, PhD - Manufacture of Natural Killer Cells as Treatment for Multiple Myeloma
• 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
• Marlowe Eldridge, MD - In-vivo Models and Cell Delivery for Lung Indications
• Peiman Hematti, MD - Mesenchymal Stem Cell Characterization
• Derek Hei, PhD - Cell Therapeutics - Process Development and Manufacturing for Human Clinical Trials
• John Centanni, MS - IND Application Process: For The New Clinical Investigator
• 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

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
• Adrian Gee, MI Biol, PhD - Cell Processing at CAGT
• Cliona Rooney, PhD - Challenges of Cell Culture in Manufacturing
• Juan Vera, MD - Optimization of Suspension Cell Culture
• Ann Leen, PhD - Generation of Antigen Specific T Cells
• Catherine Bollard, MD - Evaluation of T Cell Products
• David Spencer, PhD - Antigen Presenting Cells
• John Wagner, MD - Isolation and Expansion of Umbilical Cord Blood Regulatory T Cells
• Gianpietro Dotti, MD - Use of CARS
• Stephen Gottchalk, MD - Genetic Modification for Immune Evasion
• Bambi Grilley, RPh - Regulatory Concerns in Cellular Therapies

Day 2 - October 23, 2012

• Thomas Zwaka, MD - ES & IPS
• Natasha Lapteva, PhD - NK Cells for Therapy
• Peiman Hematti, PhD - Mesenchymal Stromal/Stem Cells
• Adrian Gee, MI Biol, PhD - Getting the Product to the Patient
• Helen Heslop, MD - Broadening the Application of Cellular Therapies

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
• 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
• Martha Reitman, MD - Getting to IND, an Academic Industrial Perspective (Presentation not available)

University of Minnesota, Molecular and Cellular Therapeutics
Continuing Education & Conference Center
St. Paul, Minnesota

Day 1 - October 26, 2010

• Debbie Wood - Meeting Overview & Objectives
• John E. Wagner, MD - Clinical Trial Design - The Art of Translational Medicine
• Jeffrey S. Miller, MD - PACT: Translational Development & Scale Up NK Cells
• John R. Ohlfest, PhD - (Presentation not available)
• Claudio G. Brunstein, MD - Adoptive Transfer of Regulatory T Cells in UCB Transplantation
• David H. McKenna, Jr., MD - Development of Potency Assays for Cellular Therapies
• Keli L. Hippen, PhD - Purity and Potency Assay Development
• Julie M. Curtsinger, PhD - Immune Monitoring for Translational Clinical Trials
• Allison Hubel, PhD - Emerging Issues in Cryopreservation of Cellular Therapies
• Diane M. Kadidlo, BS, MT (ASCP), SBB - MCT Facility Overview

Day 2 - October 27, 2010

• David H. McKenna, Jr., MD - Moving from Research to Clinical Production
• Darin J. Sumstad, BS, MT (ASCP) - Cell Culture Optimization
• Adrian P. Gee, MI Biol, PhD - Equipment and Vendor Qualification
• Fran Rabe, MS, CQM, (ASQ) - FDA Inspection and Management

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

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

Session 2: Neurodegenerative Diseases and Brain Injury

• Paul J. Orchard, MD - Hematopoietic Stem Cell Transplantation for Adrenoleukodystrophy
• 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
• Joanne Kurtzberg, MD - Can Autologous Cord Blood Correct Acquired Brain Injury in Pediatric Patients?

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
• Jane S. Lebkowski, PhD - Human Embryonic Stem Cell Therapy for Spinal Cord Injury
• Jakub Tolar, MD, PhD - Transplantation for Extracellular Matrix Disorder: Problems, Premises, and Promises
• Christopher Breuer, MD - The Translation of Tissue Engineered Vascular Grafts for Use in Congenital Heart Surgery

Natcher Conference Center
National Institutes of Health
Bethesda, Maryland

Day 1 - April 23, 2009

Session 1: T-Regulatory Cells

• David H. McKenna, Jr., MD - 
• Bruce L. Levine, PhD - 
• Claudio G. Brunstein, MD - (Presentation not available)

Session 2: Mesenchymal Stem Cells

• Adrian P. Gee, MI Biol., PhD - 
• Ian K. McNiece, PhD - 
  
• Katarina Le Blanc, MD, PhD - (Presentation not available)

Session 3: Antigen-Specific T Cells

• Shelly Heimfeld, PhD - 
• Philip D. Greenberg, MD - (Presentation not available)
• Cliona M. Rooney, PhD - 

Session 4: Engineered T Cells

• Bernard A. Fox, PhD - 
• Carl H. June, MD - 
• Steven A. Rosenberg, MD, PhD - 

Session 5: Natural Killer Cells

• David Stroncek, MD - 
• Jeffery S. Miller, MD - 
• Richard W. Childs, MD - 

Day 2 - April 24, 2009

Session 6: Dendritic Cells

• Theresa L. Whiteside, PhD - 
• Sharon A. Riddler, MD, MPH - 
• Pawel Kalinski, MD, PhD - 

Session 7: Cell Trafficking and Imaging Techniques

• Marianna Sabatino, MD - 
• Erin F. Simonds, PhD Candidate - (Presentation not available)
• Zhenghong Lee, PhD - (Presentation not available)
• Eric T. Ahrens, PhD - (Presentation not available) 

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

Day 2 - May 6, 2008

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

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

Day 2 - April 11, 2007

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

Baylor College of Medicine
Houston, Texas

Day 1 - April 4, 2006

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

Day 2 - April 5, 2006

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