Phase to Phase - The Guide to Drug Development
Sponsored by Thermo Fisher Scientific and PPD, experts will present innovative strategies in outsourcing discovery that allows small companies to focus on their core discovery needs and frees them up from both a capital and manpower investment.
Navigating Early Phase Clinical Trials – Design, Oversight, Guidance & Examples
Phase I and Ib trials represent the first practical tests of your compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.
Maximizing success in early phase development requires a highly coordinated effort to anticipate potential challenges, recruit the right patients, engage top investigators and design a trial that will build a platform for later-stage success.
Perform a critical assessment of your compound’s unique attributes to identify areas of strength and potential weakness that could impact the outcome of your current and subsequent trials. An integrated, early-phase program must leverage fit for purpose facilities, sites, operational expertise and development experience to execute your trial in patients and/or healthy volunteers. Each step of this process is conducted with an eye toward supporting later-phase programs and regulatory submissions.
Speaker: Darin Brimhall, DO, FACP, Strategic Medical Director, PPD Early Development, part of Thermo Fisher Scientific
- Board Certified Internist with 20+ years Internal Medicine and clinical research experience including outpatient, inpatient, acute & chronic care, hospice and palliative medicine. 15+ years experience as Principal Investigator on ~680 clinical studies (Phase 0 - 4): FIH, proof of concept, pilot & pivotal studies, BE/BA, lactation, ethno-bridging. Multiple indications including rare disease; all dosing formulations, small and large molecule, biologics. Expertise in study design, feasibility, operations, study & safety oversight as PI. Experience as medical monitor.
Moderator: Tim Peters-Strickland, MD, Vice President, Global Medical Officer, Biotech Solutions, PPD, part of Thermo Fisher Scientific
Refund/cancellation policy: This program is offered free of charge. As such refunds are not applicable. Questions: Contact Lauren Boyle, [email protected]
