Education

Part of the PACT 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. 

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PACT Web Seminars

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2020
Thank you for joining us for the September 3 web seminar.  The Q&A session responses will be posted soon.

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:

 

 

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

2019

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

 

September 10, 2019 - Vendor Qualification

 

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

2018

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

 

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

 

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

2017

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

 

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

 

March 14, 2017 - Accelerating Your Cell Therapy

2014

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

 

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

2013

November 14, 2013 - Ask the Experts

 

February 20, 2013 - Cell Therapy for Lung Indications

2012

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

 

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

2011

August 11, 2011 - Preparing for a FDA Inspection

2010

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

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

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

 

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

 

2008

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

 

July 31, 2008 - Validation Processes

 

June 25, 2008 - NHLBI Training and Funding Opportunities & Overview of Cell Therapy in Lung Biology and Disease

 

Februray 21, 2008 - Cryopreservation of Cell Therapy Products

2007

October 11, 2007 - Preparing for an FDA Inspection

 

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

 

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

2006

October 26, 2006 - Cell Therapy Data Management

 

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

 

January 19, 2006 - Rapid Release Testing, Product Transportation, Workflow Analysis: Handling Multiple Specimens

2005

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

 

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

PACT Workshops

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Developing Cellular Therapies

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

April 9, 2013

Manufacturing Cell Therapy Products

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

Day 2 - October 23, 2012

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
  • 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)
Translational Development & Scale Up

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

Day 1 - October 26, 2010

Day 2 - October 27, 2010

NHLBI PACT Workshop - Cell Therapy for Pediatric Diseases

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

Session 1: Congenital Blood Disorders - Part 2

Session 2: Neurodegenerative Diseases and Brain Injury

Day 2 - September 15, 2011 Session 3: Regenerative Medicine

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

Session 2: Mesenchymal Stem Cells

Session 3: Antigen-Specific T Cells

Session 4: Engineered T Cells

Session 5: Natural Killer Cells

Day 2 - April 24, 2009

Session 6: Dendritic Cells

Session 7: Cell Trafficking and Imaging Techniques

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

Day 2 - May 6, 2008

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

Day 2 - April 11, 2007

Design and Operation of GMP Cell Therapy Facilities

Baylor College of Medicine
Houston, Texas

Day 1 - April 4, 2006

Day 2 - April 5, 2006

Conferences/Workshops

Preservation of Cellular Therapies
Dates: May 18 - 19, 2020**
Location:  Minneapolis, MN and simultaneous webcast
Course Home Page
Flyer

**While the dates to particpate live have passed, the recorded course lectures and packet remain available for online viewing.  Registration for the online course closes October 31st, 2020. See the Course Home Page for registration details.

Lecture topics:

  • Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
  • Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
  • Equipment, reagents and supplies used in preservation, 
  • The challenges in implementing preservation in a clinical/GMP environment,
  • Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
  • Design and operation of a storage facility for cryopreserved cells,
  • Regulatory issues associated with preservation of a therapeutic product,
  • Emerging technology and approaches for the preservation of cells.

Audience:

The course is designed for a wide range of participants.  The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example.  Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees.  The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.

Speakers:

Allison Hubel, PhD is Professor of Mechanical Engineering and Director of the Biopreservation Core Resource (BioCoR, www.biocor.umn.edu), a national resource in biopreservation. 

Diane Kadidlo received her B.S. from Iowa State University.  She has served as the Supervisor for the University of Minnesota Medical Center Clinical Cell Therapy Laboratory since 1996 overseeing the production of cell and tissue products.  

David McKenna, MD is a Professor of Laboratory Medicine & Pathology at the University of Minnesota where he holds the American Red Cross Chair in Transfusion Medicine.  He is the Scientific and Medical Director of Molecular & Cellular Therapeutics.

Ian M Pope, PhD, MBA, BSc is the Global Director of Cryo Solutions at Brooks Life Sciences. Ian has worked in the area of cryogenic systems for over 25 years, His expertise lies in the area of the practical application of cryogenics to the storage and preservation of biological materials. 

Fran Rabe has over 20 years of experience working in the areas of tissue and cell quality assurance and regulatory compliance.  She currently oversees the quality assurance aspect of operations at the University of Minnesota Molecular and Cellular Therapeutics (MCT) Facility.

Quick links:

Questions?  Contact us at biocor-pct@umn.edu