PACT Web Seminars

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2020

Coming Soon...

December 15, 2020 - Contract Manufacturing By and For Academic Institutes

In this webinar we will review how academic institutions are operationalizing their resources to offer contract manufacturing. We will also cover outsourcing of manufacturing and testing by academic institutions. The personalized nature of cellular therapy products introduces a detailed and scientific development. Academic institutes are well-equipped to develop products with scientific oversight. Their involvement also helps to accelerate their institutional ideology in furthering the growth and evolution of the field of cell therapy.

Speakers:

  •  Contracting: In and Out | Adrian Gee, MI Biol
     Director, Clinical Application Laboratory, Center for Cell and Gene Therapy, Baylor College of Medicine
  •  Contract Manufacturing at an Academic Medical Center | Allan Dietz, PhD
    Associate Professor of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine

 

Prior 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?

Speakers:

 

 

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

Speakers:

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

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