Mark Slisz, a Senior Advisor at Pearl Pathways, will discuss why startups and independent researchers should approach the drug development process with a regulatory mindset months before their first formal interaction with FDA or other global health authorities. Mark will speak to an audience of startup pharmaceutical companies and researchers within the Fred Hutchinson Cancer Research Center (Fred Hutch).
Mark will present to Fred Hutch startups and community members on Thursday, January 16, 2020 at the Fred Hutch campus in Seattle, Washington.
This session will focus on the FDA regulatory process, which is infamous for being confusing, time consuming, and costly. Mark will walk attendees through the drug development pathway, from identifying a target and compounds to initiating a clinical trial, highlighting when and how to communicate with FDA along the way. Mark aims to make the regulatory approval process a bit less intimidating for attendees, providing practical tips and real-life scenarios for startups and independent researchers so that they may better strategize and present the story of their drug to FDA.
About Fred Hutch
“At Fred Hutch, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers — including three Nobel laureates — bring a relentless passion to their work and deliver hope to patients who come here from all over the world. We’re discovering new ways to detect cancers earlier, when cure rates are highest; developing effective treatments with fewer side effects; and learning how to prevent cancers from developing in the first place.” Learn more about Fred Hutch.