PACT Webseminars

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2017

March 14, 2017 - Accelerating Your Cell Therapy
Web Seminar Flyer

Registration for the web seminar

A free, interactive web seminar to discuss the revised PACT Program and to answer participants’ questions about the program’s goals, the application process and criteria, and the details surrounding PACT manufacturing assistance.

Representatives from the 5 PACT Cell Processing Facilities will present on their diverse product manufacturing capabilities. NHLBI and Emmes will discuss the program’s scope and application process.

  • Joseph Gold, PhD - Center for Biomedicine and Genetics, City of Hope
    • Dr. Joseph Gold spent 16 years at Geron Corporation, leading research into therapeutic applications of embryonic stem cells.  He served for 4 years as associate director of translational research at Stanford Cardiovascular Institute, and is now Director of Manufacturing at the Center for Biomedicine and Genetics in the Beckman Research Institute at City of Hope.
  • Linda Kelley, PhD - Moffitt Cancer Center
    • Dr. Linda Kelley is a Professor of Oncological Sciences at the University of South Florida and Senior Member at Moffitt Cancer Center in Tampa, Florida. She serves as the Director of the Moffitt cGMP Cell Therapy Facility.
  • Adrian Gee MI Biol, PhD - Center for Cell and Gene Therapy, Baylor College of Medicine
    • Adrian Gee is the Director of GMP facilities at the Center for Cell & Gene Therapy, Baylor College of Medicine in Houston, Texas. He has more than 30 years experience in cellular therapies, with particular interest in regulatory aspects, facility design and manufacturing technologies. He was instrumental in the founding of the International Society for Cellular Therapy (ISCT) and the Foundation for the Accreditation of Cell Therapy (FACT).
  • Aisha Khan, PhD (candidate) - ISCI Cellular Manufacturing Program, University of Miami
    • Aisha Khan has twenty-one years of leading-edge research experience in developing cellular therapy products, mesenchymal stem cells, cardiac progenitor stem cells, and manufacturing of various other types of cells and vaccines. She manages all aspects of medical research labs that are focused on developing various types of stem cells and manufacturing a wide variety of cellular products. Ms. Khan regularly serves as the subject matter expert and consultant for many U.S. and international organizations on cell processing, development, and manufacturing. She is involved in streamlining laboratory operations and developing SOPs in order to maintain quality assurance and compliance with all requirements of FDA, FACT, AABB, CLIA, and other organizations.
  • David McKenna, MD - University of Minnesota, Molecular and Cellular Therapeutics Facility
    • David McKenna is a Professor of Laboratory Medicine & Pathology and holds the American Red Cross Chair in Transfusion Medicine at the University of Minnesota.  He serves as the Director of the Division of Transfusion Medicine and the Scientific and Medical Director of Molecular and Cellular Therapeutics (MCT), the University’s cGMP facility.

NHLBI (PACT funding institution) and Emmes (Coordinating Center for PACT) will discuss the program’s scope and application process.

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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