Education

February 11, 2019 - Accelerating Your Cell Therapy: A PACT Program Update

• PACT - Collaboration | Lis Welniak, PhD
• Production Assistance for Cellulary Therapies (PACT) Program | Robert Lindblad, MD
• T Cell Therapy for Viruses | Ann M. Leen, PhD
• PACT - A resource for both pre-clinical and clinical support | David H. McKenna, Jr., MD
• Web Seminar Handouts

November 8, 2018 - Issues Involbed in Starting CAR T Cell Manufacturing

• Testing CAR-T Cell Products | Adrian P. Gee, MI Biol
• Taking CAR-T Cells from the Research Laboratory to the GMP Facility | Cliona M. Rooney, PhD
• Choosing Optimal Viral Vector for T cell transduction | Maksim Mamonkin, PhD
• Web Seminar Handouts

June 19, 2018 - Development of GMP Cell Manufacturing of Cardiac Stem Cell

• Cell Combination Therapy | Joshua Hare, MD, FACC, FAHA
• Regulatory Requirements for Clinical Research Protocol Development | Aisha Khan, MSc, MBA
• Technology Transfer: The Business of Intellectual Property | Bin Yan, PhD, JD
• Web Seminar Handouts

January 16, 2018 - Early Phase Cell Therapy Product Development: Potency Assays

• Introduction  | Linda Kelley, PhD
• Examples of Applications | Emily Hopewell, PhD
• Validation | Cheryl Cox, MT ASCP
• Web Seminar Handouts

September 26, 2017 - Early Phase Cell Therapy Product Development: Quality in the Lab

• Quality Management | Rajiv Nallu, MS
• Materials Specifications | Yasmine Shad, MS
• Web Seminar Handouts

June 8, 2017 - Academic and Industry Partnerships - The Next Generation

• Contract Development | Diane Kadidlo, BS, MT(ASCP), SBB
• Academic and Industry Partnerships | Stewart Abbot, BSc, MSc, PhD
• Managing Quality Assurance Expectations | Fran Rabe, MS, ASQ CQM
• QA Agreement Basic Template
• Web Seminar Handouts

March 14, 2017 - Accelerating Your Cell Therapy

• PACT Overview | Lisbeth Welniak, PhD
• Molecular & Cellular Therapeutics | David McKenna, MD
• ISCI Cellular Manufacturing Program | Aisha Khan, PhD (candidate)
• The Center for Biomedicine and Genetics at COH | Joseph Gold, PhD
• Moffitt Cancer Center Cell Processing Faciltity | Linda Kelley, PhD
• Center for Cell & Gene Therapy cGMP Activities | Adrian Gee MI Biol, PhD
• Application Process | Deb Wood
• Web Seminar Handouts

September 25, 2014 - Challenges and Problem-Solving in Cell Therapy Product Development

• Virus-specific T cells post-transplant | Ann Leen, PhD
• Claudio Brunstein, MD, PhD - University of Minnesota (Presentation not available)
• Considerations for cGMP Production of Patient-Specific Cell Therapeutics – A PACT Case Study | Derek Hei, PhD
• Web Seminar Handouts

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

• Mesenchymal Stromal Cells Large-scale Culture | Adrian Gee, MI Biol, PhD
• Optimizing culture of suspension cells using the G-Rex | Juan Vera, MD
• Closed Culture Systems | Darin Sumstad, CLS (ASCP)
• Web Seminar Handouts
• Web Seminar Polling Questions/Results
• Question & Answer Session Transcription

November 14, 2013 - Ask the Experts

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

February 20, 2013 - Cell Therapy for Lung Indications

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

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
• Protecting Patients from Harm: Recent Responses to Marketing of Unapproved Stem Cell-Based Interventions | Leigh Turner, PhD
• Web Seminar Handouts

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
• Adverse Events associated with Cell Therapy Products | Olive Sturtevant, MT(ASCP)SBB, SLS
• Safety Reporting In Cell Therapy Clinical Trials | Robert Lindblad, MD
• Web Seminar Handouts

August 11, 2011 - Preparing for a FDA Inspection

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

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 

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
• CGMP for Phase 1 INDs | Laurie P. Norwood, MS
• Web Seminar Handouts

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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
• Web Seminar Handouts
• Question & Answer Session Transcription

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

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

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

• How to Be a Dynamic Trainer | Larry Midgett, PhD
• Effective Training for Cell Therapy Laboratories | Diane Kadidlo, MT ASCP SBB
• Web Seminar Handouts
• Question & Answer Session Transcription

July 31, 2008 - Validation Processes

• Validation Processes | Carolyn A. Keever-Taylor, PhD
• Web Seminar Handouts
• Question & Answer Session Transcription

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
• Overview of Cell Therapy in Lung Biology and Disease | Carol Blaisdell, MD
• Web Seminar Handouts

Februray 21, 2008 - Cryopreservation of Cell Therapy Products

• Cryopreservation of Cell Therapy Products | Allison Hubel, PhD
• Web Seminar Handouts
• Question & Answer Session Transcription

October 11, 2007 - Preparing for an FDA Inspection

• Preparing for an FDA Inspection
• Question & Answer Session Transcription

July 19, 2007 - Interpreting AABB & FACT Cell Therapy Standards

• Interpreting AABB & FACT Cellular Therapy Standards-FACT | Phyllis I. Warkentin, MD
• Interpreting AABB & FACT Cellular Therapy Standards-FACT | Doug Padley, MT(ASCT)
•  Question & Answer Session Transcription
• AABB's Top 10 Cell Therapy Non Conformances

February 22, 2007 - Adverse Event Reporting (Reporting Issues & Requirements)

• Adverse Event Reporting for 351 Products | Hanh M. Khuu, MD
• Adverse Event Reporting in IND Studies | Helen Heslop, MD

October 26, 2006 - Cell Therapy Data Management

• Cell Therapy Data Management | Darin Sumstad, CLS (NCA, ASCP) and Jeffrey Wilson

July 20, 2006 - Facility Master Files, SOP Development, Deviation Management System

• Facility Master Files | Adrian Gee, MIBiolo, PhD
• SOP Development | Deborah Griffin, BA
• Development & Operation of a QA System for Deviations from SOPs in a Clinical Cell Therapy Laboratory | Dave McKenna, MD

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
• Rapid Release Testing | Deborah Griffin, BA
• Packaging and Shipping of Human Cell Tissue Products | Diane Kadidlo, MT, (ASCP) SBB

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

• Biological Product Deviation Reporting | Deborah Griffin
• Chemistry, Manufacturing, and Controls Writing for Investigational New Drug Applications | Dave McKenna, MD
• Staff Training & Competency Training | Adrian Gee, MIBiolo, PhD

March 31, 2005 - Validation, equipment management and facility cleaning and disinfection

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

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