Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar 2021

During this seminar, the CERSI Scholars presented the results of their regulatory science research projects, including work examining new drug approvals, artificial intelligence software, regenerative medicine, and much more. This seminar was also opened with a keynote address by Dr. Joe Franklin and Dr. Sean Tunis from the FDA Office of the Commissioner. Please see below for the timestamps of the various presentations.

Chapters
00:00 "Real World Data to Inform FDA's COVID-19 Response" - Keynote address by Joe Franklin and Sean Tunis
38:11 "Physical Activity, Patient-Reported Symptoms, and Clinical Events: Insight into Post-Procedural Recovery from Personal Digital Devices" - Victoria Bartlett, Yale
50:01 "Reimagining Real-World Clinical Trials to Increase Participation of African Americans for Patients, Sponsors, and Regulators" - Christopher Cross, Yale
1:06:32 "Blockchain Application Feasibility in Telehealth for DSCSA Compliance" - Stephanie Zawada, Mayo Clinic
1:23:27 1st Session Q&A
1:35:00 "Transcriptomic and Metabolomic Effects of Acetaminophen Exposure in Human Stem Cells: Potential Mechanisms Explaining Epidemiological Associations Between Prenatal Acetaminophen Exposure and Autism Spectrum Disorder" - Tristan Furnary, Yale
1:48:34 "A Computational Study of Induced SAR Values at 7T Compared to Lower Fields Near an Orthopedic Implant" - Paul Jacobs, Mayo Clinic
2:01:11 "Enhancing FDA Regulation of Artificial Intelligence / Machine Learning Algorithms" - David Jiang, Mayo Clinic
2:15:17 2nd Session Q&A
2:22:44 "SERPINA3: A Key Player in Glioblastoma Malignancy and a Potential Biomarker for the Disease" - Montserrat Lara-Velazquesz, Mayo Clinic
2:38:00 "Evaluating Clinical Trial Evidence for Single-Enantiomer Drugs Based on Existing Racemic Drugs: A Systematic Review" - Aaron Long, Yale
2:49:46 "Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019" - Meera Dhodapkhar, Yale
3:00:23 3rd Session Q&A