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Tuesday, June 25 • 2:00pm - 3:15pm
#267: Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-618-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session will define cGMP and describe the importance of regulatory preparedness in developing a translational program, and how academic and medical institutions are preparing the next generation work force.

Learning Objectives

Describe the basics of cGMP and the quality and regulatory requirements of drug manufacturing;. Explain how cGMP and GTP are implemented in cell and gene therapy;Discuss how academic institutions can implement programs to prepare students and support industry professionals in the area of GMP manufacturing.

Chair

Paul W. Price, PhD, MS

Speaker

The What and Why of cGMP
Paul W. Price, PhD, MS

cGMP Training in an Academic Environment: BTEC’s Program for Developing a Skilled Workforce for the Biopharmaceutical Industry
Gary Gilleskie, PhD

Overview of the Relevant Regulations Covering Human Cells, Tissues, and Cellular and Tissue-Based Products
Olive Sturtevant, MS, MT


Speakers
avatar for Gary Gilleskie

Gary Gilleskie

Acting Director, Biomanufacturing Training and Education Center, North Carolina State University
Dr. Gary Gilleskie has been with NC State’s Biomanufacturing Training and Education Center (BTEC) since 2007 and is currently BTEC’s Acting Director. Gary’s work at BTEC focuses on downstream processing of biopharmaceuticals, including protein therapeutics, vaccines, and gene... Read More →
avatar for Paul Price

Paul Price

Regulatory Officer, Office of Regulatory Affairs, DAIT, National Institute of Allergy and Infectious Diseases, NIH
Dr. Price is a Regulatory Officer with NIH, NIAID, DAIT, ORA . Paul received his Ph.D. in Biology (Immunology) from Georgetown University, and completed post doctorate training at the Department of Microbiology and Immunology, University of MD School of Medicine. Paul has over 35... Read More →
avatar for Olive Sturtevant

Olive Sturtevant

Senior Administrative Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
Olive has 30 plus years in blood banking, clinical laboratory management and cellular manufacturing. In her current role, she is directly responsible for the Financial and Administrative oversight, Regulatory Compliance, Quality Control, Quality Assurance, Materials Management and... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Session