May 7, 2019-Clinical Wanderlust: Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data?

Date
8am - 10am
Location
Biocom: McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121

Clinical Wanderlust: Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data?
Exploring the viability of Eastern Europe & Australia for First-in-Human Trials

US life science companies embarking on global clinical trials must consider how the FDA will handle foreign data generated. This discussion will introduce the FDA’s guidance on Acceptance of Foreign Clinical Studies, and how the FDA is addressing the challenge of processing the sheer volume of data and breadth of international inspections. The presenters will also present clinical, regulatory, import/export, and logistical benefits and challenges that you need to be aware of for your clinical trials in Australia, Czech Republic, Poland, and Slovakia.

Speakers:
Cameron Johnson, CEO, Nucleus Network
Jamie Weishaar, Business Development Executive, PCI Pharma Services
Mary Nguyen, PhD, Business Development Manager, Neox Clinical Research

June 18, 2019- Designing Clinical Trials From the Patient’s Point of View

Date
8am - 10am
Location
Biocom: McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121

Speakers:
Katie Croskrey – Executive Director, Alzheimer’s Association
Josh Bohannan – Public Policy Manager, Alzheimer’s Association
Tracy Dixon-Salazar, PhD - Director of Research & Strategy, LGS Foundation (Lennox-Gastaut Syndrome)

June 25, 2019: Imaging Techniques in Pre-Clinical Research

Date
8am - 10am
Location
Biocom: McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121

July 16, 2019- Formulation

Date
8am - 10am
Location
Biocom: McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121

Quotient: Nikki Whitfield, Vice President of CDMO Services
Catalent: TBD