Education

The PACT Education Committee mission is to promote interest in cellular therapy/engineering among physicians and scientists-in-training and to prepare interested individuals for academic careers in cellular therapy/engineering.

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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Help PACT provide interesting and beneficial web seminars. Please provide your feedback on topics that you would like presented on future web seminars by filling out a brief survey using the link provided below:

Survey: PACT Web Seminar Topics

2014 Web Seminars

May 8, 2014 - Scaling Up Cell Culture: Application of Closed Cell Culture Systems in Clinical Research

Registration Now Open Click here to register for the PACT Web Seminar: Scaling Up Cell Culture: Application of Closed Cell Culture Systems in Clinical Research on May 8, 2014 at 11:00 am ET.

PACT Web Seminar Flyer
  • Adrian Gee, MI Biol, PhD - Center for Cell and Gene Therapy, Baylor College of Medicine
  • Juan Vera, MD - Center for Cell and Gene Therapy, Baylor College of Medicine
  • Darin Sumstad, CLS (ASCP) - Fairview Clinical Cell Therapy Laboratory, University of Minnesota




2013 Web Seminars

November 14, 2013 - Ask the Experts

  • Cellular Therapy Clinical Research Roadmap | Myriam Armant, PhD - Slides - (PDF)
  • Translational Research | Catherine Matsumoto, BS - Slides - (PDF)
  • Resource Development | David H. McKenna Jr., MD - Slides - (PDF)
  • Preclinical Studies | Adrian Gee, MI Biol, PhD - Slides - (PDF)
  • IND Filing | John M. Centanni, MS - Slides - (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File - (WMV)



February 20, 2013 - Cell Therapy for Lung Indications

  • Cell Therapy for Lung Disease | Carol Blaisdell, MD - Slides - (PDF)
  • Mesenchymal Stem (Stromal) Cells & Acute Lung Injury & ARDS: Biology and Translational Objectives | Michael Matthay, MD - Slides - (PDF)
  • Developing Cell Therapeutics for Lung Diseases | Derek Hei, PhD - Slides - (PDF)
  • Cell Therapy for Lung Indications: Choosing the appropriate IND Enabling Animal Model | Marlowe Eldridge, MD - Slides - (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File - (WMV)




2012 Web Seminars

September 27, 2012 - Protecting Patients from Harm: Ethical, Legal & Policy Responses to Domestic and International Marketing of Clinically Unproven Stem Cell Interventions

  • Stem Cells and Regenerative Medicine: Myth vs. Reality | George Daley, MD, PhD - Slides (PDF)
  • Protecting Patients from Harm: Recent Responses to Marketing of Unapproved Stem Cell-Based Interventions | Leigh Turner, PhD - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File - (WMV)



February 23, 2012 - Adverse Events and Reactions In Cellular Therapy

  • Adverse Event Reporting in Cellular Therapy: Putting the Pieces Together | Karen Snow,BS(ASCP)BB - Slides (PDF)
  • Adverse Events associated with Cell Therapy Products | Olive Sturtevant, MT(ASCP)SBB, SLS - Slides (PDF)
  • Safety Reporting In Cell Therapy Clinical Trials | Robert Lindblad, MD - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File - (WMV)



2011 Web Seminars

August 11, 2011 - Preparing for a FDA Inspection

  • FDA Inspections: An Overview | Robert Lindblad, MD - Slides (PDF)
  • FDA Inspection/Facility Notification Case Studies | Fran Rabe, MS, CQM (ASQ) - Slides (PDF)
  • Preparing for an FDA Inspection | Kip J. Hanks - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File - (WMV)




2010 Web Seminars

May 4, 2010 - PACT Web Seminar

The NHLBI and EMMES (PACT Coordinating Center) presentations are available for viewing and printing using the link below. The 5 PACT facility speaker presentations are not available on our website. Please contact the speakers regarding their presentations. Speaker contact information can be found in the Webcast Overview Document embedded in the link below:

May 4, 2010 PACT Webcast Presentation Overview



2009 Web Seminars

October 15, 2009 - Interpretation of the Final Rule: cGMP and Investigational New Drugs Intended for Use in Phase 1 Clinical Trials

  • CGMP for Phase 1 INDs: Manufacturing Cell Therapy Products | Scott Burger, MD - Slides (PDF)
  • CGMP for Phase 1 INDs | Laurie P. Norwood, MS - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Web Seminar Audio File -(WMV)

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July 16, 2009 - Deviation Management of Type 351 and 361 Cell Products

  • Reporting Deviations of Biological Products and HCT/Ps | Ellen Areman - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Question & Answer Session Transcription - (PDF)
  • Web Seminar Audio File - (WMV)

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January 29, 2009 - Qualification: Vendor, Equipment and Supplies

  • Vendor Qualification | Fran Rabe, BA - Slides (PDF)
  • Equipment Qualification | Adrian P. Gee, MI Biol., PhD - Slides (PDF)
  • Supply Qualification | Chris Chun, MT (ASCP) HP Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Question & Answer Session Transcription (PDF)
  • Web Seminar Audio File - (WMV)
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2008 Web Seminars

November 6, 2008 - Delivering Effective and Result-based Training

  • How to Be a Dynamic Trainer | Larry Midgett, PhD - Slides (PDF)
  • Effective Training for Cell Therapy Laboratories | Diane Kadidlo, MT ASCP SBB - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Question & Answer Session Transcription (PDF)
  • Web Seminar Audio File - (WMV)
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July 31, 2008 - Validation Processes

  • Validation Processes | Carolyn A. Keever-Taylor, PhD - Slides (PDF)
  • Web Seminar Handouts - (PDF)
  • Question & Answer Session Transcription (PDF)
  • Web Seminar Audio File - (WMV)
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June 25, 2008 - NHLBI Training and Funding Opportunities & Overview of Cell Therapy in Lung Biology and Disease

  • NHLBI Training and Funding Opportunities | Traci Mondoro, PhD - Slides (PDF)
  • Overview of Cell Therapy in Lung Biology and Disease | Carol Blaisdell, MD - Slides (PDF)
  • Web Seminar Handouts - (PDF)
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Februray 21, 2008 - Cryopreservation of Cell Therapy Products

  • Cryopreservation of Cell Therapy Products | Allison Hubel, PhD - Slides (PDF)
  • Web Seminar Handouts (PDF)
  • Question & Answer Session Transcription (PDF)
  • Web Seminar Audio File - (WMV)
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2007 Web Seminars

October 11, 2007 - Preparing for an FDA Inspection

  • Preparing for an FDA Inspection – (PDF)
  • Question & Answer Session Transcription (PDF)
  • Web Seminar Audio File - (WMV)
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July 19, 2007 - Interpreting AABB & FACT Cell Therapy Standards

  • Interpreting AABB & FACT Cellular Therapy Standards-FACT | Phyllis I. Warkentin, MD - (PDF)
  • Interpreting AABB & FACT Cellular Therapy Standards-FACT | Doug Padley, MT(ASCT) - (PDF)
  • Question & Answer Session Transcription (PDF)
  • AABB's Top 10 Cell Therapy Non Conformances - (PDF)
  • Web Seminar Audio File - (WMV)
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February 22, 2007 - Adverse Event Reporting (Reporting Issues & Requirements)

  • Adverse Event Reporting for 351 Products | Hanh M. Khuu, MD - (PDF)
  • Adverse Event Reporting in IND Studies | Helen Heslop, MD - (PDF)
  • Web Seminar Audio File - (WMV)
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2006 Web Seminars

October 26, 2006 - Cell Therapy Data Management

  • Cell Therapy Data Management | Darin Sumstad, CLS (NCA, ASCP) and Jeffrey Wilson - (PDF)
  • Web Seminar Audio File - (WMV)
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July 20, 2006 - Facility Master Files, SOP Development, Deviation Management System

  • Facility Master Files | Adrian Gee, MIBiolo, PhD - (PDF)
  • SOP Development | Deborah Griffin, BA - (PDF)
  • Development & Operation of a QA System for Deviations from SOPs in a Clinical Cell Therapy Laboratory | Dave McKenna, MD - (PDF)
  • Web Seminar Audio File - (WMV)
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January 19, 2006 - Rapid Release Testing, Product Transportation, Workflow Analysis: Handling Multiple Specimens

  • Managing Multiple Specimens in a Cell Processing Facility | Adrian Gee, MIBiolo, PhD - (PDF)
  • Rapid Release Testing | Deborah Griffin, BA - (PDF)
  • Packaging and Shipping of Human Cell Tissue Products | Diane Kadidlo, MT, (ASCP) SBB - (PDF)
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2005 Web Seminars

July 14, 2005 - CMC Writing, Biological Product Deviation Reporting and Staff Training & Competency Testing

  • Biological Product Deviation Reporting | Deborah Griffin - (PDF)
  • Chemistry, Manufacturing, and Controls Writing for Investigational New Drug Applications | Dave McKenna, MD - (PDF)
  • Staff Training & Competency Training | Adrian Gee, MIBiolo, PhD - (PDF)
  • Web Seminar Audio File - (WMV)
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March 31, 2005 - Validation, equipment management and facility cleaning and disinfection

  • Facility Cleaning and Disinfection | Adrian Gee, MIBiolo, PhD - (PDF)
  • Cell Processing: Validation and Performance Qualification | Dave McKenna, MD and Diane Kadidlo, MT (ASCP) SBB - (PDF)
  • Equipment Qualification | Deborah Griffin - (PDF)
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Cell Therapy Presentations

Overview of CGTP Requirements Relevant to Human Cells, Tissues and Cellular & Tissue-based Products [HCT/Ps] - (PDF)

Aseptic Technique: A GMP/GTP Training Module - (PDF)

An Introduction to GMP and GTP - (PDF)

FDA Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products
March 31, 2014
8:30 am - 4:30 pm

Workshop Goals and Objectives

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products.

Standardization efforts concerning the clinical development of cellular therapies and regenerative medicine products have generated a great deal of interest. These efforts include standards development, expert opinion position papers, and professional practice guidelines. However, relatively little is done to coordinate the various existing efforts. In the public workshop, FDA hopes to bring together a broad range of stakeholders of cellular therapies and regenerative medicine products in order to:

  • Inform stakeholders about the types of standards and standards organizations that are available currently, the role that the Federal Agencies play in standards development, and the potential role that stakeholders can play in standards development.
  • Provide a high-level overview of current standards development activities in the fields of cellular therapy and regenerative medicine and the regulatory application of standards.
  • Provide opportunity for discussion of areas of high interest for current or future standards development in the fields of cellular therapy and regenerative medicine and to explore ways to minimize redundancy and maximize collaboration.
  • We encourage all who have an interest in the development of cellular therapies and regenerative medicine products to attend the public workshop.

Location

The public workshop will be held at the following location:
FDA White Oak Campus
The Great Room, Bldg. 31, Room 1503A
10903 New Hampshire Ave
Silver Spring, MD 20993

Registration
Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Sherri Revell (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (Subject line: SESDCTRMP Workshop Registration) by March 24, 2014. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.