PACT Web Seminars

September 3, 2020 - Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients -- What are your cells doing? Where do they go?

In this web seminar, HESI CT-TRACS* committee speakers will provide an overview of technologies currently available for use in patients, how these are relevant to evaluate safety and efficacy aspects of cellular therapies, and the importance of collaboration to address challenges and needs facing the translation of cell therapies into the clinic. The presentation will be followed by a Question and Answer Session.

*The Health and Environmental Sciences Institute (HESI) / Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) committee provides a neutral platform for cell therapy developers, researchers, regulators, imaging specialists, and other stakeholders to interact, discuss current challenges and identify best practices to improve confidence in the safety and efficacy of these therapies.

Speakers:

•  HESI CT-TRACS: a Collaborative Effort to Address Collective Challenges & Needs | Bill Shingleton, BSc, PhD
• Tracking Cells after Administration: Imaging Modalities and Probes  | Brooke Helfer, PhD
• The Need for Collaboration Across Stakeholders to Address the Challenges Facing the Translation of Cell Therapies into the Clinic  | David Morrow, PhD, MBA

• Activity Accreditation Statement Sheet
• September 3, 2020 Web Seminar Handouts
• Web Seminar Audio File

July 17, 2020 - Cell Therapy GTP and GMP Facilities: Design and Operation to Optimize Space to Meet Manufacturing Needs

• Aligning Academic Cell Therapy Manufacturing Facility Capability with FDA Requirements: Can We Increase Output as Demand Ramps Up? | Linda Kelley, PhD
• Design, Construction and Commissioning of an Academic Cellular Manufacturing Facility | Amittha Wickrema, PhD
• July 17, 2020 PACT Web Seminar Handouts
• July 17, 2020 Web Seminar Q & A
• Web Seminar Audio File

December 10, 2019 - Guidance for Submission of an Initial IND (Investigational New Drug) Application

• Planning for an IND Submission | Catherine Cortez
• Critical Components Needed for a Complete Chemistry, Manufacturing and Control (Module 3) | Carmen Netto-Merced, MS, RAC
• Preclinical Data Required for an IND | Revathiswari Tirughana-Sambandan, ACRP-CP, PMP
• Web Seminar Handouts
• Web Seminar Audio File 

September 10, 2019 - Vendor Qualification

• Vendor Qualification | F. Enrique Alvarez, BS, MLS (ASCP), CQA (ASQ)
• Establishment of an Unrelated Cord Blood Bank Qualification Program a Transplant Center/Cell Therapy Manufacturing Perspective | Fran Rabe, MS, CQM (ASQ)
• Web Seminar Handouts
• Web Seminar Q&A
• Web Seminar Audio File

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

• PACT - Collaboration | Lis Welniak, PhD
• Production Assistance for Cellular 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
• Web Seminar Audio File

November 8, 2018 - Issues Involved 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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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 Audio File
• 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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

   

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

July 31, 2008 - Validation Processes

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

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
• Web Seminar Audio File

October 11, 2007 - Preparing for an FDA Inspection

• Preparing for an FDA Inspection
• Question & Answer Session Transcription
• Web Seminar Audio File

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
• Web Seminar Audio File

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
• Web Seminar Audio File

October 26, 2006 - Cell Therapy Data Management

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

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
• Web Seminar Audio File

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
• Web Seminar Audio File

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