Addressing Clinical Trials during COVID-19 & the Dialogue with Regulatory Agency
Friday, November 06, 2020
Addressing Clinical Trials during COVID-19 & the Dialogue with Regulatory Agency?
The schedule is in EST Time Zone. To check your local time, click here.
11:30 AM Speed Networking Session
Please come camera ready for effective speed networking! You will have a few minutes to interact with attendees in your room before being directed to another room. Be ready to drop your LinkedIn profile or your email address in the chatbox for further follow-up.
11:45 AM Organizer’s Opening Remarks
Emily Le, PhD, Founder & CEO, Bioinsider
11:50 AM Sponsorship Opportunity Available
12:00 PM Roundtable Discussion: Addressing Clinical Trials during COVID-19 & the Dialogue with Regulatory Agency? (Part 2)
Co-Moderator: Mohamed Hassanein, PhD, Associate Director, Clinical Assay Lead, Pfizer
Co-Moderator: Michael Partridge, PhD, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
- Rethink the traditional workflows for sample collection (patient-centric), shipment and analysis
- Regulatory expectations for EUA or BLA during the pandemic, especially for COVID-19 therapeutics
- What is the FDA position on using non-validated PK/ADA assays for EUA submission package for COVID-19 therapeutics?
- Is banking samples and testing later acceptable for EUA?
- Are we prepared for the next wave or future pandemics?
1:00 PM End of Friday Roundtable
Meet Our Moderators
Mohamed Hassanein, PhD, Associate Director, Clinical Assay Lead, Pfizer
Mohamed Hassanein has a combined academic and industry experience of more than 12 years in oncology, translational medicine, and regulated bioanalysis. Dr. Hassanein received his Masters in Biological Sciences from Delaware State University and PhD in Molecular Biology and Genetics from the University of Delaware. He completed his post-doctoral training at Vanderbilt Ingram Cancer Center where he later became a Research Assistant Professor. At Vanderbilt, his research focused on developing and validating blood-based biomarkers for early detection of lung cancer. He then moved to Covance Laboratories where he served as a Principal Investigator, overseeing the bioanalytical development and validation of PK, immunogenicity, and biomarker assays in support of preclinical and clinical development of biologics. He served as Staff Scientist/Principal Scientist overseeing the bioanalytical strategy in support of clinical development of therapeutic mAbs at Regeneron Pharmaceuticals. Currently, he is the associate director in clinical assay lead at Pfizer.
Michael Partridge, PhD, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
Born and raised in Australia, Michael received his Ph.D. from Sydney University (CSIRO). He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling, tumorigenesis and biomarkers of radiation exposure. Michael left academia to work at Regeneron where he led a group of scientists developing and validating PK, ADA, NAb and biomarker immunoassays. His current role is the bioanalytical strategic lead for multiple therapeutic areas, interacting directly with clinical teams including physicians, clinical pharmacology and regulatory departments.