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Events, News, and Funding Opportunities

EVENTS

I-Corps@NCATS Regional Short Course

We are excited to share with you that the University of Rochester (UR) is hosting the I-Corps@NCATS Regional Short Course this fall, which is specifically designed for biomedical scientists, clinician scientists, and engineers to provide them with a new approach to accelerate the translation of their discoveries from the lab to clinical practice. This program, supported by the NIH National Center for Advancing Translational Sciences (NCATS), is based on National Science Foundation’s Innovation Corps (I-Corps™) program which is the premier federally funded innovation and commercialization training in the U.S.

The program will kick off with orientation the week of October 17^th and will run for 5 weeks. All sessions will be held virtually over zoom. The attached flyer provides the program details. Apply online by October 3^rd at https://redcap.link/UR_NCATS_I-Corps_2022

The I-Corps@NCATS Regional Short Course is meant for teams of faculty, postdocs, and students with biomedical innovations or ideas and is free to participants. Course graduates receive National Science Foundation (NSF) lineage and can apply to other NSF grant awards, including the National I-Corps Team program, which carries a grant award up to $50,000. Previous NSF funding is not required to apply.

Contact Karen Grabowski, Karen_Grabowski@URMC.Rochester.edu with questions. Additional background information about the program can be found at: https://www.uab.edu/ccts/training-academy/trainings/innovation-and-entrepreneurship/i-corp

This program is being hosted by the Ain Center for Entrepreneurship and Innovation and the UR Clinical and Translational Science Institute.
Please feel free to forward this information to anyone in your network who might be interested in attending.

Global Summit on Regulatory Science, October 19-21, 2022 -The 12th annual Global Summit on Regulatory Science (GSRS22) will be held October 19-21, 2022, in Singapore and virtually. It is being co-hosted by the Singapore Food Agency (SFA) and the Global Coalition of Regulatory Science and Research. The theme for this year’s Global Summit is “Advances in Nanotechnology for Food and Medical Products: Innovations, Safety, and Standards.” There is no registration fee; however, registration is required to attend External Link Disclaimer the GSRS22.

Information from Previous Global Summits

A manuscript titled “Emerging Technologies and Their Impact on Regulatory Science External Link Disclaimer” that summarized the 2020 Global Summit on Regulatory Science (GSRS) was published in the journal Experimental Biology and Medicine. The publication represents many of the presentations made by scientists from NCTR and other research entities at the virtual GSRS20. There were 48 co-authors from 27 different research institutes representing 13 countries that contributed to the publication.

2022 Scientific Computing Days, September 7-8, 2022 (Hosted by FDA), The FDA Scientific Computing Board is a group of scientists and IT specialists at FDA who advocate for scientific computing needs, and requirements to advance FDA’s scientific and regulatory mission. The 10th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies. This year’s theme is “Scientific Computing: In the Field, Around the World, and On the Edge.” The event’s goal is to help FDA improve the application of technology, and scientific computing in support of the FDA’s public health mission. Registration opens August 2022.

FDA GRAND ROUNDS - Thursday, July 14, 2022, 12:00 p.m. - 1:00 p.m. EST - (Webcast only) CAPT Brianna Skinner from the Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia from the Center of Veterinary Medicine (CVM) will be presenting on One Health at FDA: From Concept to Application This presentation will describe the One Health concept and how it applies to FDA's regulatory mission. It will also explain FDA's application of the One Health concept in its regulatory activities. Register here

FDA GRAND ROUNDS - Thursday, June 9, 2022, 12:00 p.m. - 1:00 p.m. EST - (Webcast only) Dr. Seshadri S. Vasan, a COVID-19 Science Leader for Australia’s science agency CSIRO, and one of the successful applicants for the FDA’s Medical Countermeasures Initiative (MCMi) regulatory science presented on Some Perspectives on Data Science and Coronaviruses This lecture covered some perspectives, illustrated with recent COVID-19 experience and examples, on how in silico modelling and data science techniques could strengthen nonclinical (in vitro and animal) models for existing and emerging coronaviral diseases. Webcast Recording, Meeting Information and Event Materials

FDA GRAND ROUNDS - Thursday, May 12, 2022, 12:00 p.m. - 1:00 p.m. EST - (Webcast only) Nicholas Richardson, DO, MPH and Yvette Kasamon, MD from the Office of Oncologic Diseases (OOD) presented on The Saga of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Information on the PI3K inhibitor drug class was discussed and how it impacts future PI3K inhibitors developed for patients with cancer. Broader considerations in clinical trial design and endpoints for cancer drugs were discussed, using this drug class as an example. Webcast Recording, Meeting Information, Event Materials

FDA GRAND ROUNDS - Thursday, April 14, 2022, 12:00 p.m. - 1:00 p.m. EST - (Webcast only) Dr. Jason Neal-McKinney is a research microbiologist in the Applied Technology Branch at the Pacific Northwest Food and Feed Laboratory and presented on MinION Sequencing of Foodborne Pathogens This seminar focused on bacterial genome sequencing using the MinION from Oxford Nanopore Technologies, an inexpensive and portable sequencer that can be used to complement current sequencing strategies. Webcast Recording, Meeting Information, and Event Materials

NEWS

FDA VOICES - Insights from FDA leadership and experts into the agency's work to protect public health. Interested in receiving notification as FDA Voices articles are published? Register here

FDA VOICES - FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions - May 31, 2022 -We look forward to our continued interactions with device submission sponsors and appreciate your patience and understanding as we work to return to normal operations while continuing to respond to the public health emergency.
FDA VOICES - FDA's “All-in” Approach to Enterprise Transformation - May 19, 2022 - The Enterprise Modernization Action Plan is the next phase of FDA’s data and technology transformation and describes our plans to shape the agency’s future by delivering successful cross-agency efforts that optimize common and essential business processes.
FDA VOICES - FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program - May 17, 2022 - Program Aims to Improve Drug Supply Chain, Mitigate Shortages
FDA VOICES - Give Your Community a Boost: Combatting Misinformation Through Communication and Research - April 1, 2022 - During National Minority Health Month, we highlight the ways in which we are working to improve minority health and health equity.

Roswell Park and URMC to Create $19 Million Research Program Focused on Flavored Tobacco.

Prestigious federal grant funds effort to understand fast-growing but under-explored trend in tobacco use. The WNY Center for Research on Flavored Tobacco Products, or CRoFT, will unite teams from Roswell Park Comprehensive Cancer Center and the University of Rochester Medical Center in an effort to better document and understand one of the fastest-growing trends in tobacco use. This CRoFT team will pursue projects in four main areas: 1) Assessing Flavorant Toxicity; 2) Characterizing Flavors and Their Impact on Behavior; 3) Determining Respiratory health Effects of Flavors; 4) Evaluating the Effects of Product Marketing.

FDA Expert Commentary and Interview Series
A series of interviews and commentaries are available to communicate safety information to clinicians as part of a collaboration between the FDA and Medscape.

Scott Steele selected to serve on FDA's Science Board
Scott Steele, PhD, has been selected to serve on the Food and Drug Administration's Science Board. Dr. Steele is director of the Regulatory Science Core at the UR CTSI, director of the Rochester Center of Excellence in Data Science at the Goergen Institute for Data Science and Artificial Intelligence, and an associate professor of Public Health Sciences at the UR. He is one of the 21 voting members of the Science Board.

8th Annual “America’s Got Regulatory Science Talent” Student Competition
The winners of the annual “America’s Got Regulatory Science Talent Competition” from the University of Rochester presented their winning ideas to the FDA on May 21, 2021.

Congratulations to the winning teams:

1st Place - Preparing for POC: A Proposed Infrastructure for 3D Printing in Hospitals (Aaron Craig, Megan Luzenski, Alex McMullen)

2nd Place - Blood Contacting Device Testing without the Bloodhound (Julia Schroth and Matthew Izard)

3rd Place Tie - My Health (Aliza Panjwani)

3rd Place Tie - Team Organoid (Yunpeng Pang)

Archives

FUNDING OPPORTUNITIES

FDA Commissioner's Fellowship Program
Each class of fellows in the FDA Commissioner's Fellowship Program consists of outstanding health care professionals, scientists, and engineers who receive regulatory science training and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of FDA senior scientists. Please visit the FDA Student, Fellowship and Senior Scientist Programs website for available programs.

2022 PhRMA Foundation Awards
The 2022 PhRMA Foundation Awards include three award programs and they are currently requesting applications:

Health outcomes program offers pre- and post-doctoral fellowships and research starter grants.
Translational Medicine and Therapeutics program offers post-doctoral fellowships and research starter grants.

Submissions are due by Thursday, February 10, 2022. For more information or to apply, visit the PhRMA Foundation website, www.phrmafoundation.org. You may also call 202-572-7756.

Beginning with the 2021 award cycle, the PhRMA Foundation is no longer providing funding in Pharmacology/Toxicology, Pharmaceutics and Informatics. The PhRMA Foundation is providing funding in new programs for young researchers with innovative projects in Drug Delivery and Drug Discovery, along with Health Outcomes Research, Translational Medicine and Value Assessment. The PhRMA Foundation is using a new application portal, proposalCENTRAL. This system requires registration. https://proposalcentral.com/. All applicants must attend a U.S. university or research institution based in the United States. Brochures can be found here.

UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) offers a Postdoctoral Fellowship in Regulatory Science. Request for applications is closed for this year. Please visit the website for more information and application deadlines.

Regulatory Science Initiatives at the Burroughs Wellcome Fund – BWF's Innovation in Regulatory Science Awards provide up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform regulatory decisions. Start by reviewing the request for proposal. Not Open to Applications at this time. More information can be found on the BWF's Innovation in Regulatory Science webpage.

FDA Tobacco Regulatory Science Fellowship
This fellowship is for mid-career professionals to gain expertise in the field of regulatory science as it relates to the regulation of tobacco products and FDA's authorities under the Family Smoking Prevention and Tobacco Control Act. Fellows will be placed in one of six areas within the CTP: Compliance and Enforcement; Health Communication and Education; Management; Policy; Regulations; or Science. Applications are taken from January - March every year. This is a 12-month, multidisciplinary residential program in Maryland which begins in September each year. CONTACT: FDA Tobacco Regulatory Science Fellowship, NAM/HPFLP, 500 Fifth Street, NW, Keck WS 838, Washington, DC 20001, Phone: (202) 334-1506