From Organoids to Bloodhounds, These Teams Have Regulatory Science Talent
The eighth annual America’s Got Regulatory Science Talent student competition hosted by the UR CTSI’s Regulatory Science Program, drew the largest number of competing teams in its history. On March 4, 2021, twelve teams faced off for a chance at first prize: to present their novel regulatory science ideas to a panel of scientists from the Food and Drug Administration (FDA) in April or May.
The unprecedented field presented a full spectrum of innovative solutions to address nine priority areas outlined in the FDA Strategic Plan for Advancing Regulatory Science. Learn more about the top four projects:
Preparing for POC: A Proposed Infrastructure for 3D Printing in Hospitals
Alex McMullen, Aaron Craig, Megan Luzenski
The field of healthcare-related 3D printing has advanced by leaps and bounds in the past few years, and point-of-care (POC) printing could be right around the corner. It’s not unreasonable to think an organ or piece of tissue could be printed right in the hospital before implanting in a patient within a matter of years. The trouble is: there is currently no regulatory framework to ensure the safety and effectiveness of POC implants.
McMullen, Craig and Luzenski propose creating a database with mandatory reporting of POC-cleared implants to track their quality over time. The team also proposes a system for validating implants and the equipment used to make them. Equipment would be registered and would have to be tested and certified on a regular basis. Their plan also includes periodic in-depth training by manufacturing representatives.
Blood Contacting Device Testing Without the Bloodhound
Julia Schroth, Matt Izard
Any new medical device that will come into contact with blood must be tested to make sure it won’t cause clotting. Currently, the standard way to test this uses canines as a model. The test, which hasn't changed significantly since it was developed in 1976, is riddled with issues. It doesn't fully model how devices will be used in humans and yields poor reproducibility and statistical accuracy.
In an effort to reduce animal use in research and more closely model a devices’ use, Schroth and Izard propose a new in vitro blood flow assay. The assay would use human blood and would more easily control and monitor a host of blood and vessel characteristics like pulsatile flow, wall shear stress and heparin levels. You could do a lot more tests in a much shorter time and with less effort and money – and save a few of man’s best friend while you’re at it.
Third Place (tie):
In the era of CRISPR-based gene editing, personalized gene and cell therapies are on the rise. But these therapies come with unknown risks that can be difficult to predict and test. To bridge the gap between cell and animal models, Pang proposes using 3D organoid models to assess the safety of gene and cell-therapy products.
Organoids are model organs derived from a patient’s skin cells and grown in a dish. The patient’s skin cells are reengineered back to a stem cell, then induced to become your organ-cell-of-choice. Once the organoid is developed, it could provide a low-risk way to test toxicity of gene or cell therapies and to see how those therapies might impact that patient.
The Institute of Medicine approximates that 90 million Americans misinterpret medicine labels, and it’s easy to see why: they display a myriad of information, making it difficult for the user to discern what is and is not relevant to them. For example, Aliza Panjwani never thought to check that Tylenol contains cornstarch, to which she has a mild allergy, until she started researching for this project.
Panjwani’s fix: An FDA Drug Database extension in electronic medical record apps like MyChart. This database, appearing as a tab called MyHealth Library within MyChart, would be confidential and linked to your stored medical records to automatically highlight the information on drug labels most relevant to you. This would increase access to important information for patients and might have the added bonus of increasing MyChart use.
This year’s competition was also unique for featuring three judges from outside the Rochester area for the first time - a silver lining to our COVID-induced virtual world. Lending expertise from all corners of the regulatory science world were:
- Khaled Bouri, Ph.D., science advisor to the director of the Office of Regulatory Science & Innovation at the FDA;
- Milton Marshall, Ph.D., DABT, director of Regulatory Affairs at Protospheric Products, Inc., and president of Marshall and Associates; and
- Mary Clare McCorry, Ph.D., director for Technology and Process Development at the Advanced Regenerative Manufacturing Institute.
The America’s Got Regulatory Science Talent student competition is organized by Scott Steele, Ph.D., director of UR CTSI Regulatory Science Programs, and Joan Adamo, Ph.D., director of Regulatory Support Services at UR CTSI, and is supported by the University of Rochester CTSA award number UL1 TR002001 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Susanne Pritchard Pallo |