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Tuesday, June 25 • 8:00am - 9:15am
#212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

This is the kickoff to a GxP series on the importance of implementing quality standards in early drug development conducted in academia and start-ups that govern how a compound is to be manufactured, tested in animals and studied in clinical trials.

Learning Objectives

Define GxP, G(R)P, GMP, GTP, GLP, and GCP; Discuss the importance of GxPs in manufacturing and translational research; Identify the challenges of implementing GxPs in an academic research and development environment.

Chair

Nancy Pire Smerkanich, DrSc

Speaker

Panelist
Eunjoo Pacifici, PharmD, PhD

Panelist
Paul W. Price, PhD, MS

Panelist
Andrew Norris, PhD

Panelist
Gary Gilleskie, PhD

Panelist
Susan E Vogel, BSN, RN



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 →
AN

Andrew Norris

Director of Research, BCN Biosciences
Dr. Andrew Norris has a varied background in both business and the technology sector. He is co-founder of The Midvale Group LLC in 2002, consulting in both the technology and biotechnology sector. Dr. Norris has also co founded BCN Biosciences, a company with principal focus in the... Read More →
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... 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 Nancy Smerkanich

Nancy Smerkanich

Assistant Professor, Department of Regulatory & Quality Sciences, USC School of, University of Southern California
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
SV

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH
Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA