Finding safe and effective therapies remains challenging. Drugs and biologics benefit patients and improve lives, but adverse events remain a significant issue. Safety is a major cause of termination during development, contributing to the high cost of new drugs, and limits effectiveness if the drugs aren’t well-tolerated. Opportunity to improve safety in the post-genome era is unparalleled; yet, the path from promising technology to application and impact is difficult. Despite advances, safety testing continues to employ a standard paradigm of nonclinical and clinical tests. The popular and technical literature is rife with articles on poor translation from nonclinical testing to safer clinical outcomes.
What is the path forward and how can the paradigm change? To advance drug safety science and the safety testing paradigm, one thing is clear: Progress requires not only technical advances, but also collaborations—it takes a village. Scientific meetings bring scientists together to discuss new approaches and fertilize across disciplines. However, most national meetings are hectic with little time for discussion, let alone to develop effective collaboration. Discussion at a focused meeting can seed ideas and collaborations that help break out of the standard paradigm. However, there are few, if any, focused meeting on this important topic.
Gordon Research Conferences (GRCs) stand out not just for the science, but for the unique opportunity offered by the communal nature of the conferences around shared meals and social activities. Students interact with internationally recognized scientists from academia, industry, and government in a casual setting over breakfast, at dinner, and during social activities. Discussions spill over after sessions into meaningful dialogue. The agenda for 2018 Drug Safety Conferences (June 10–15, 2018, at Stonehill College in Easton, Massachusetts) brings together a cross-disciplinary group of speakers focused on key questions relevant to drug safety, including:
- Can conservation of networks across evolution improve safety translation across species?
- Do transcriptional networks in stem cell development inform model systems?
- Will computational approaches enable safer target selection?
- How can microphysiological systems and tissue engineering be deployed in safety testing?
- What safety challenges face immune modulation-based therapies in clinical trials?
- Where will “big data” inform adverse event detection?
- How does basic science interface with regulatory demands in taking a drug to registration?
As Chair of the 2018 Drug Safety Gordon Research Conference, I invite you to attend and experience an extraordinary meeting focused on safety science. A modest $1,070 fee covers registration, room, and board—you just need to show up. Please join us and share in the science!