By: Julia Tobacyk, BS; Myrtle Davis, DVM, PhD; James L. Stevens, PhD; and Natalie Holman, PhD
Adverse events remain a significant contributor to drug attrition during clinical trials. Thus, it comes as no surprise that improving drug safety sciences is imperative for improving patient outcomes. The application of emerging technologies to improving drug safety science is the theme of the Gordon Research Conference (GRC) on Drug Safety, chaired by SOT members James L. Stevens, Eli Lilly and Company, and Myrtle Davis, Bristol-Myers Squibb, which will be held June 10–15, 2018, at Stonehill College, Easton, MA, and the Gordon Research Seminar (GRS) on Drug Safety, chaired by SOT members Natalie Holman, Roivant Sciences, and Julia Tobacyk, University of Arkansas for Medical Sciences, to be held June 9–10 at the same venue.
The conference will take scientists on a journey through the modern drug discovery and development landscape—from the lab (preclinical research) through clinical trials in humans and ending with post-marketing surveillance (monitoring drug safety once a drug is on the market). The scientific program mirrors the discovery and development pipeline by merging stage-appropriate session topics with presentations from leading researchers on a spectrum of approaches, ranging from computational and systems toxicology, tissue engineering, microphysiological systems, and immunotherapy through big data application to pharmacovigilance and translational safety. The main conference topics are listed in the graphic below.
The Drug Safety GRC will bring together an international gathering of scientists from diverse sectors, including academic institutions and biopharmaceutical and government organizations to discuss different approaches to tackling safety challenges in drug discovery and development. They all share the same goal: to make medicines safer and available for the patient. Thus, for students and trainees, the conference is an important career development opportunity and a chance to share their research results with experts in various fields through poster sessions and short talks. Social gatherings each evening allow time for in-depth and informal interactions with leading research scientists.
Sessions during the 2018 GRC on Drug Safety include:
- Opening Keynotes
Gunter Wagner, Yale University (United States), “Network Biology and the Evolution of Complex Biological Systems"
Patrick Cahan, Johns Hopkins University (United States), "Gene Regulatory Networks and Computational Approaches to Stem Cell Differentiation"
- Quantitative and Systems Toxicology
Nicolas Le Novere, Babraham Institute (United Kingdom), “Computational Systems Models of Cell Signaling Networks”
Jason Papin, University of Virginia (United States), “Reconciling Rat and Human Genome Scale Metabolic Networks”
Doug Lauffenburger, Massachusetts Institute of Technology (United States), "Computational Modeling of Inflammation and Immunity"
- Application of Systems Models in Drug Safety Assessment
Blanca Rodriguez, University of Oxford (United Kingdom), “Computational Modeling of Cardiac Adverse Events"
Cindy Afshari, Amgen Inc. (United States), “Integrative Biology Provides a Model for Evolving Drug Safety Assessment"
- Microphysiological Systems—Engineering Human Biology
D. Lansing Taylor, Drug Discovery Institute, University of Pittsburgh (United States), "Functional Coupling of Liver Microphysiological Systems"
Christopher Hughes, University of California, Irvine (United States), "Tissue Engineering of Functional Vascular Networks"
Sarah Blutt, Baylor College of Medicine (United States), “Gastrointestinal Microphysiological Systems: Opportunities and Challenges”
- Stem Cells in Health and Disease
Jorge Nieva, University of Southern California (United States), "Host Factors in Drug Toxicity"
Joseph Wu, Stanford Cardiovascular Institute, Stanford University School of Medicine (United States), "Cardiomyocytes in Microphysiological Systems: Application for Safety and Efficacy"
- Challenges and Opportunities for Immunomodulator Development
Laura Johnson, GlaxoSmithKline (United States), “Engineering T-Cells for Immunotherapy in Cancer”
Jeffrey Ravetch, Rockefeller University (United States), "Impact of the Fc in Efficacy and Safety of Immunomodulatory Agents and Translation Across Species"
Karen Price, Bristol-Myers Squibb (United States), “Balancing Safety and Activity of CTLA4-Targeted Therapy with Second-Generation Antibodies in a Non-Human Primate Model"
- Patient Safety and Immunomodulators in Clinical Development
Agne Taraseviciute, Seattle Children's Hospital (United States), “Nonhuman Primate Models for CAR-T Cell Therapy"
Amy Rosenberg, US Food and Drug Administration (United States), "Understanding and Monitoring Adverse Event in Clinical Trials of Novel Immune Modulators"
- Pharmacovigilence and Adverse Effects Monitoring
Robert Ball, US Food and Drug Administration (United States), “Data Mining and Pharmacovigilance in Regulatory Practice”
Nicholas Tatonetti, Columbia University (United States), “Data Science and Mapping Health Care Outcomes”
David Hong, University of Texas MD Anderson Cancer Center (United States), "Monitoring Adverse Events in Treatment of Cancer"
- Closing Keynote "Modulating the Immune Systems for Therapeutic Benefit"
Alan Korman, Bristol-Myers Squibb (United States)
To further enhance the experience for students and postdoctoral fellows, a GRS will be held in conjunction with the GRC. This seminar is being led by and organized for young scientists with a focus on their scientific presentations. A Career Development Panel will include Alison Harrill, National Institute of Environmental Health Science (United States); Remi Villenave, Emulate, Inc. (United States); David Watson, Eli Lilly and Company (United States); Shraddha Thakkar, National Center for Toxicological Research, US Food and Drug Administration (United States); and Vishal Vaidya, Pfizer (United States), who will offer career advice and draw from their life experiences on how to succeed as a student and early-career scientist.
The GRC registration fee ($1,070) includes the cost of registration, all meals, and accommodations for the duration of the meeting. Accommodations begin on Sunday evening with a Friday morning check out. Registration for the GRS is $275.
If you are interested in attending the Drug Safety GRC/GRS, review the full conference program on the GRC and GRS websites and apply at the link provided! We are looking forward to having you attend and participate in these exciting meetings.