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Wednesday, June 26 • 8:00am - 9:15am
#312: Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-653-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session will describe GLP requirements for successful translation of academic research projects. GLP requirements for toxicity studies must be met before FDA allows new therapies to proceed to human clinical trials.

Learning Objectives

Describe the characteristics GLPs; Recognize where GLP fits in the development cycle of a medical products being developed in academia; Identify how GLPs in academia can help to translate innovate therapies into products more efficiently.


Isabel Lauren Jackson, PhD


An Introduction to Good Laboratory Practice (GLP) Regulations: What Are They, and How Did We Get Here?
Jon Carl Mirsalis, PhD, MS

Translating Academic Research into Product Development: Implementation of a Quality Management System in Academic Laboratories to Improve Data Quality, Traceability, and Reproducibility.
Isabel Lauren Jackson, PhD

Translating Drug Discovery From Academia and Important Criteria for Success
Andrew Norris, PhD

Perception Versus Experience: The Advantages of Academic Research and Development Partners and Limitation of Commercial CRO's
John L McManus

avatar for Isabel Jackson

Isabel Jackson

Associate Professor, University of Maryland School of Medicine
Dr. Jackson is an Associate Professor, Dept. of Radiation Oncology and serves as Deputy Director of the Division of Translational Radiation Sciences at the University of Maryland School of Medicine (UMSOM). Her subject matter expertise is in the field of tumor and normal tissue radiobiology... Read More →

John McManus

Principal, EVS Partners
avatar for Jon Mirsalis

Jon Mirsalis

Vice President, Translational Development, SRI Biosciences
Jon C. Mirsalis, Vice President of Translational Development at SRI International, manages all regulated medical product development at SRI. His group has advanced over 175 drugs from early development into clinical trials; over 20 have reached the market. Dr. Mirsalis received his... Read More →

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 →

Wednesday June 26, 2019 8:00am - 9:15am PDT
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Session