(Part 1) Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar 2022

Part 1: Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar 2022

During this seminar, the CERSI Scholars presented the results of their regulatory science research projects, including work including work examining pharmaceutical innovation, COVID-19-related research, medical product safety, and much more. This seminar was also opened with a keynote address by Tina Morrison, PhD, Director, FDA Office of Regulatory Science and Innovation. Please see below for the full agenda.

Introduction
Molly Jeffery, PhD and Joseph Ross, MD, MHS (Yale-Mayo Clinic CERSI)

Keynote Address
“Regulatory Science at FDA” (Tina Morrison, PhD, Director, FDA Office of Regulatory Science and Innovation)

Scholar Presentations
Session 1:
Characterizing the Approvals and Supporting Evidence of Qualified Infectious Disease Products from 2012-2020 (Guneet Janda, Yale)
The Effects of Venture Capital Investment on Pharmaceutical Innovation
(Kiefer Ahn, JHU)
Biosimilar Approval Pathways: Comparing the Roles of Five Regulators
(Ryan Knox, Harvard)
Assessment of FDA Approval of Drugs Not Meeting Pivotal Study Primary Endpoints (Reshma Ramachandran, Yale)

Session 2:
Agreement of Treatment Effects from Observational Studies and Clinical Trials Evaluating Therapeutics for COVID-19: A Meta-Epidemiological Study (Osman Moneer, Yale)
Laboratory Correlates of Infectivity for SARS-CoV-2 (Vishal Shah, Mayo)
Disparities in Vaccine-Preventable Respiratory Illnesses by Race, Socioeconomic Status, and Rurality (Jamie Felzer, Mayo)
In Vitro Prediction of in Vivo Oral Drug Absorption (Asmita Adhikari, UMD)

Session 3:
Predicate Characteristics and Recalls of 510(k) Medical Devices (Alex Everhart, Harvard)
Understanding the Impact of Demographics and Socioeconomic Parameters on Treatment Selection and Utilization in Type 2 Diabetes
(Jaysón Davidson, UCSF)
Quantitative Bias Analysis Methods for Epidemiological Studies: A Systematic Review (Xiaoting Shi, Yale)

Session 4:
Assessing the Robustness of Clinical Machine Learning Models to Changes in Context of Use (Adarsh Subbaswamy, JHU)
Pharmacokinetic Insights to Improve Breast Cancer Endocrine Therapies in I-SPY 2 TRIAL (Silver Al Khafaji, UCSF)
The Utility of OCT Papillary Retinal Nerve Fiber Layer Thickness in
Differentiating Recurrent Optic Neuritis (Delaney Liskey, Mayo)
Revelations on mAb Stability using Mediated Electrochemical Probing
(Dana Motabar, UMD)