2022 Winners of the America's Got Regulatory Science Talent Competition Present at FDA
Due to the COVID-19 pandemic, this event was pre-recorded and online only
Since 2013, the University of Maryland CERSI, an FDA grant recipient, and the University of Rochester CTSI have held their annual America’s Got Regulatory Science Talent Competition to foster student interest in the pioneering field of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA‐regulated products. Each competing student team presented a proposed solution to a current challenge in regulatory science, aligned with the FDA Center/Office Regulatory Science Research Priority Areas for CERSI Program and Focus Areas of Regulatory Science (FARS). The winning teams are listed below for both universities.
FDA's Centers of Excellence in Regulatory Science and Innovation (CERSIs) housed in Office of Regulatory Science and Innovation (ORSI) are cooperative agreement grants between FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges. This year for the first time, the Office of Data, Analytics, and Research (ODAR) joined ORSI to coordinate mentors for students who were encouraged to use data science techniques in their proposed solutions. The CERSI Steering Committee, which consists of representatives from the Centers & Offices that participate in the CERSI program, and CFSAN were also engaged in recommending judges and mentors. A panel of judges evaluated each student team presentation for the quality, novelty, potential significance and feasibility of the students’ proposed solutions. Thank you to the below FDA judges and mentors who volunteered to assist with the University of Maryland and University of Rochester Regulatory Science Competitions!
Judges:
- Roberta Glass, MD, Senior Medical Officer, Center for Drug Evaluation and Research (CDER), Office of New Drugs-1, Division of Psychiatry, FDA
- Albert Rodriguez, Assistant Director, Clinical Evidence Quality Team 1, DCEA1: Division of Clinical Policy and Quality | OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
- Benjamin Sommerkorn, PhD, Lead Engineering Reviewer, DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality, CDRH, FDA
Mentors:
- Michael Folkendt, MS, Associate Director for Regulatory Affairs, Office of Program and Regulatory Operations (OPRO), Office of Pharmaceutical Quality (OPQ), CDER, FDA
- Omnia A. Ismaiel, PhD, Pharmacologist/Bioanalytical Lead, Division of Applied Regulatory Science (DARS), Office of Clinical Pharmacology (OCP), Office of Translational Science (OTS), CDER, FDA
- Sandy Weininger, PhD, Senior Electrical Engineer – electrical safety gatekeeper, Acting Deputy Director – DBP, Co-chair AAMI Interoperability WG, ISO TC 121/SC3 JWG10 – Oximeters, Division of Biomedical Physics (DBP), Office of Science and Engineering Laboratories (OSEL), CDRH, FDA
- Erin L. Wood, PhD, Senior Research Scientist, OPQ, Immediate Office, Scientific Staff, CDER, FDA
- Dumitru Macarisin, PhD, Research Microbiologist, Molecular Methods and Subtyping Branch, Division of Microbiology, Office of Regulatory Science, CFSAN, FDA
- Vinay Pai, PhD, MBA, Digital Health Specialist, Digital Health Center of Excellence, Office of Strategic Partnerships and Technology Innovation (OST), CDRH, FDA
- Tyler Peryea, Data Scientist, Health Informatics Staff (HIS), Office of Data, Analytics, and Research (ODAR), Office of Digital Transformation (ODT), Office of the Commissioner, FDA
- Kevin Snyder, PhD, Associate Director of Nonclinical Informatics, Immediate Office, Office of New Drugs, CDER, FDA
- Stephen Walker, PhD, PE, Engineer, Division of Dairy Egg and Meat Products, Office of Food Safety, CFSAN, FDA
- Betsy Yakes, PhD, Research Chemist, Office of Regulatory Science, CFSAN, FDA
Due to the COVID-19 pandemic, all the presentations were pre-recorded virtually – see below links to view the recordings and presenter slides. To learn more about the students on the winning teams and their proposed solutions to a regulatory science challenge, see the University of Maryland and University of Rochester “Talent Competition Abstracts and Bios” documents found in the below links. Send questions for the winning teams to their email address hyperlinks associated with winning team member names shown below.
Recordings:
Note: After clicking on recording links, when a pop-up box appears with the label “Switch to Classic View,” click on the “Close” button.
Presentations:
Introductory Remarks
– Dr. Tina Morrison, Director, FDA Office of Regulatory Science and Innovation
Recording
Welcome Remarks
– Ram Iyer, Director & FDA Chief Data Officer, Office of Data Analytics and Research, Office of Digital Transformation
Recording
Overview of Competitions and Introduction of University of Maryland Talent Competition
– Dr. William E. Bentley, University of Maryland
Recording and Slides
University of Maryland Talent Competition Abstracts and Bios
First Place Team: “AcetaSAFE”
Team: Iulia Opran, Chenchu Vignesh Pernati, and Belinda Tamrakar
Brief description of proposed solution: The team presented their idea to develop a QR code for over-the-counter (OTC) acetaminophen and prescription medications. The aim is to improve patient knowledge of acetaminophen dosing. The group found that patients often lack clear understanding of their appropriate acetaminophen dosing for different health needs, which can put consumers at risk of an overdose. When acetaminophen is taken in excess, it can cause long-term effects on the liver, the group said. Given this, the team believes that a QR code will help improve patient education, raise awareness of OTC and prescription drug toxicity, and decrease hospitalization costs. The AcetaSAFE team was awarded first place for their presentation, which the judges described as interactive and transformative.
Recording and Slides
Second Place Team: “Keeping Blood Glucose SweetNLow”
Team: Joanna Shaju, Rebecca Faulkner, Sumbel Malik, Ivan Jay Bauzon, and Sabrina Wang
Brief description of proposed solution: The team presented their idea for optimizing continuous glucose monitoring (CGM) devices by incorporating patient-centered outcomes (PCO) as research prompts for diabetes patients. There is currently no one-size-fits-all solution for diabetes patients. Recognizing this, the team proposes a standard interface via which a patient could monitor subjective data – including symptoms, daily activity, and/or health complications. The platform would also offer prompts that would appear when a patient’s glucose levels are outside their target range. In this way, Team “Keeping Blood Glucose SweetNLow” aims to make diabetes care more personalized and easier for patients to manage. Team SweetNLow was awarded second place for their idea, which the judges noted to be interesting and innovative.
Recording and Slides
University of Rochester Talent Competition and Introduction
– Drs. Scott Steele and Joan Adamo, University of Rochester
Recording and Slides
University of Rochester Talent Competition Abstracts and Bios
First Place Team: “Smart Health Event Evaluation and Reporting (SHEER)”
Team: Warish Zaman Orko, Mark Truskinovsky
Brief description of proposed solution: The FDA and medical product developers and manufacturers have a rich source of information made available to them through many diverse adverse event reporting platforms, but this wide selection results in a large quantity of data to parse through. This team outlined a regulatory initiative to make use of the data by passing it through a machine learning algorithm, SEER, that is designed to identify trends in the data throughout both the pre- and post-market timelines.
Recording and Slides
Second Place Team: “COVIDeo App Uniters” ”
Team: Nandita Bhowmik, Katarina Lichak, Bahie Ezzat, Ejiroghene Davies-Okarevu
For details, please refer to University of Rochester website.
Third Place Team: “Allergen Hunters: Empowering Consumers to Make Safer Choices”
Team: Yuthika Shekhar, Abhijeet Talaulikar
For details, please refer to University of Rochester website.
For additional information of America’s Got Regulatory Science Talent competitions, see the University of Maryland and University of Rochester websites.
For questions:
Please contact Dr. Tracy Chen, ORSI, at [email protected]
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