The FDA Science Forum is held biennially to inform the public about the groundbreaking science conducted at the Agency, and to show how scientific research is used in FDA's regulatory decisions to protect and promote public health. The Forum is open to the public, industry, academia, patient advocates, government agencies, and current and potential collaborators. The two-day event offers an opportunity to hear FDA scientific experts and nationally renowned scientists speak on a range of topics associated with regulatory science. The theme for the 2023 FDA Science Forum, Advancing Regulatory Science Through Innovation will highlight areas of FDA research, including: 1) improving clinical and post-market evaluation, 2) tools to effectively use big data, 3) product development tools and manufacturing, and 4) medical countermeasures (MCMs), infectious disease and pathogen reduction technologies.

• FDA's Strategic Plan for Regulatory Science. Available: https://www.fda.gov/media/161381/download

• Discuss FDA contributions to the evolving science of clinical, non-clinical, and post-market evaluation;
• Discuss how innovative approaches in evolving areas such as biomarkers, alternative methods for toxicity assessment, precision toxicology prediction, analytical chemistry, and advanced manufacturing may contribute to advances in regulatory decision making and improve product quality and timeliness;
• Discuss how FDA leverages social and behavioral sciences to empower patients and consumers;
• Explain how AI and big data together can improve public health;
• Discuss scientific advances using the One Health approach to innovative and continuous surveillance of food and cosmetic safety;
• Discuss FDA’s intramural and extramural regulatory science research to support medical countermeasures (MCMs) and emerging technologies to reduce or eliminate pathogens from medical products. The presentations will discuss the application of innovative tools and approaches to support pandemic response, development and evaluation of MCMs and the detection of emerging agents;
• Discuss how the fields of regenerative medicine and microbiome affect individual and public health;
• Describe methods that scientists at FDA are using to study and combat problems associated with substances of abuse.

Physicians, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

• Arrieta, Jose, MBA, Chief Executive Officer, Imagineeer - nothing to disclose
• Barratt, Ruth, PhD DVM, Senior Science Advisor, FDA/CDER/OTS/IO - nothing to disclose
• Bocell, Fraser, PhD, MEd, Psychometrician, FDA/CDRH - nothing to disclose
• Bumpus, Namandje, PhD, Chief Scientist, OC/OCS - nothing to disclose
• Califf, Robert M., MD, Commissioner, Food and Drug Administration - I have the following relationship(s): Various - My financial disclosure report and ethics agreement are publicly available documents (https://www.oge.gov/web/oge.nsf/home).
• Camacho, Luisa, PhD, Deputy Director, Division of Biochemical Toxicology, FDA/NCTR - nothing to disclose
• Cao, Qian, PhD, Visiting Scientist, Food and Drug Administration - nothing to disclose
• Casavale, Kellie, PhD, RD, Senior Science Advisor for Nutrition, FDA,CSFAN, OAO - nothing to disclose
• Chou, Jeffrey, MSPH, Biologist, FDA - nothing to disclose
• Concato, John, MD, Supervisory Physician, CDER-OMP - nothing to disclose
• Condrey, Steve, MPS, Program Analyst, ORA/DQMS - nothing to disclose
• Di Prima, Matthew A., PhD, Materials Scientist, US Food and Drug Administration - nothing to disclose
• Duggirala, Hesha, PhD, Epidemiologist, FDA - nothing to disclose
• Eggers, Sara, PhD, Director, Decision Support and Analysis Staff, CDER - nothing to disclose
• Ferrer, Marc, PhD, Director, NIH/NCATS - nothing to disclose
• Fitzpatrick, Suzanne, PhD, DABT ERT, Senior Science Advisor for Toxicology, Food and Drug Administration - nothing to disclose
• Foley, Steven, PhD, Division Director, FDA National Center for Toxicological Research - nothing to disclose
• Ford, Kevin, PhD, DABT, DSP, Associate Director, DARS - nothing to disclose
• Forshee, Richard, PhD, Deputy Director, Office of Biostatistics and Pharmacovigilance, FDA/CBER/OBPV - nothing to disclose
• Galvez, Jose, MD, Deputy Director, Office of Strategic Programs, FDA/CDER/OSP - nothing to disclose
• Goud, Ravi, MD, MPH, Medical Officer, CBER - nothing to disclose
• Harvanko, Arit, Health Scientist, FDA - nothing to disclose
• Higgins, Stephens, PhD, Virginia H. Donaldson Professor of Translational Science in the Depts of Psychiatry and Psychology, University of Vermont - nothing to disclose
• Hsieh, Julie, PhD, MPH, Staff Fellow, FDA - nothing to disclose
• Hsu, Chih-Hao, PhD, Computer Scientist, CVM - nothing to disclose
• Kamal, Nahid, PhD, Pharmacologist, US FDA - nothing to disclose
• Khare, Sangeeta, PhD, Research Microbiologist, US FDA - nothing to disclose
• Kimani, Martin, PhD, Senior Regulatory Research Officer, ORA/ORS/FCC - nothing to disclose
• Kimmel, Heather, PhD, Health Scientist Administrator/Project Officer, NIH/NIDA - nothing to disclose
• LaRosa, Kathryn, MPH, Program Analyst, FDA, Center for Tobacco Products - nothing to disclose
• Liem, Antoine Keng Djien, PhD, Team leader Preparedness, Methodology and Scientific Support Unit, European Food Safety Authority - nothing to disclose
• Lumpkin, Murray, MD, MSc, Deputy Director - Integrated Development, The Bill and Melinda Gates Foundation - nothing to disclose
• Major, Marian, PhD, Lab Chief, CBER - nothing to disclose
• Manjanatha, Mugimane, PhD, Deputy Director, Division of Genetic and Molecular Toxicology, National Center for Toxicological Research - nothing to disclose
• Massaro, An, MD, Supervisory Medical Officer, FDA/OCPP/OPT - nothing to disclose
• Mattingly, Joey, PhD, PharmD, Associate Professor, University of Utah College of Pharmacy - nothing to disclose
• McDermott, Patrick, PhD, Senior Science Advisor for Antimicrobial Resistance, FDA Center for Veterinary Medicine - nothing to disclose
• Mei, Yu, MD, Supervisory Regulatory Informational Specialist, FDA - nothing to disclose
• Merrill, Amy, Mathematical Statistician, FDA/CVM - nothing to disclose
• Musser, Steven, PhD, Deputy Center DIrector, FDA/CFSAN - nothing to disclose
• Nayak, Rajesh, PhD, Associate Director, FDA/NCTR - nothing to disclose
• Osborn, Jenna, PhD, Scientific Project Manager, FDA/CDRH/OSEL - nothing to disclose
• Patel, Sandeep, PhD, Director DRIVe, BARDA - nothing to disclose
• Peloquin, Sarah, DVM, Veterinary Medical Officer, FDA CVM - nothing to disclose
• Petibone, Dayton, PhD, Research Biologist, National Center for Toxicological Research US FDA - nothing to disclose
• Radin, Rose, PhD, MPH, Lead Epidemiologist, CDER/OSE/OPE/DEPI-2 - nothing to disclose
• Ritchey, Mary Beth, PhD, BSN, MSPH, Chief Epidemiologist, FDA/CDRH/OPEQ/OCEA - I have the following relationship(s): Currax Pharmaceuticals; MannKind; CERobs Consulting, LLC (consulting with AbbVie, Genmab, Gilead, Incyte, Johnson and Johnson, Kite, Passage Bio, Takeda, UCB, Urovant) - consultant, contracted research
• Samuelson, Frank, PhD, Physicist, US Food and Drug Administration - nothing to disclose
• Schneeweiss, Sebastian, MD, D.Sc, Professor, Harvard Medical School and Brigham and Women's Hospital - I have the following relationship(s): Aetion, Inc. - Shareholder and consultant; UCB pharma - Recipient of an investigator-initiated research grant; Boehringer Ingelheim - Recipient of an investigator-initiated research grant
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose
• Shi, Qiang, PhD, Visiting Scientist, FDA - nothing to disclose
• Simonyan, Vahan, PhD, D.Sc, Chief Scientist, DNAHIVE - nothing to disclose
• Smith, Alexandria, MSPH, Social Scientist, FDA - nothing to disclose
• Sokolowska, Marta, PhD, Deputy Center Director for Substance Use and Behavioral Health, FDA - nothing to disclose
• Sung, Kyung, PhD, Branch Chief (acting), Division of Cellular Therapy 1, Office of Cellular Therapy and Human Tissue CMC - nothing to disclose
• Valerio Jr, Luis, PhD, ATS, Associate Director, FDA/CTP/OS/DNCS - nothing to disclose
• Verthelyi, Daniela, MD, PhD, Supervisory Biologist, CDER/OPQ/OBP/DBRR-III - nothing to disclose
• Walker, Matthew, DrPH, Social Scientist, FDA CDER OCOMM - nothing to disclose
• Watson, Sharron, Training Specialist, OC/OCS/OSPD - nothing to disclose
• Wu, Catherine, MD, Professor of Medicine; Chief, Division of Stem Cell Transplantation and Cellular Therapies, Dana-Farber Cancer Institute - I have the following relationship(s): BioNTech - equity holder; Pharmacyclics - research funding
• Xiao, Wenming, PhD, Lead Bioinformatics Scientist, CDER/OND/OOD - nothing to disclose
• Xu, Joshua, PhD, Branch Chief, Research-to-Review, Division of Bioinformatics and Biostatistics, FDA/NCTR - nothing to disclose
• Yong, Carolyn, PhD, Associate Director for Policy, FDA/CBER/OTP - nothing to disclose

• Barratt, Ruth, PhD DVM, Senior Science Advisor, FDA/CDER/OTS/IO - nothing to disclose
• Belov, Artur, PhD, Operations Research Analyst, CBER - nothing to disclose
• Burke, Gerome, MD, PhD, SARITA Program Manager, FDA/CDER/OTS-IO - nothing to disclose
• Carranza, Dorn, PhD, Associate Director for Partnerships and Innovation, OSEL/CDRH, U.S. FDA - nothing to disclose
• Fitzpatrick, Suzanne, PhD, DABT ERT, Senior Science Advisor for Toxicology, Food and Drug Administration - nothing to disclose
• Garnett, Theodore, PhD, Health Science Administrator, FDA - nothing to disclose
• Gensheimer, Kathleen, MD, medical officer, FDA - nothing to disclose
• Harvanko, Arit, Health Scientist, FDA - nothing to disclose
• Janusziewicz, Ashlee, Pharm.D, Compounding Incidents Team Leader, FDA/CDER/OC/OUDLC - nothing to disclose
• Kwegyir-Afful , Ernest, PhD, Senior Policy Advisor, Center for Food Safety and Applied Nutrition, Food and Drug Administration - nothing to disclose
• LaRosa, Kathryn, MPH, Program Analyst, FDA, Center for Tobacco Products - nothing to disclose
• Mendrick, Donna, PhD, Associate Director, Regulatory Activities, NCTR - nothing to disclose
• Myers, Todd, PhD, Scientific Program Manager, FDA - nothing to disclose
• Sayers, Elizabeth, PhD, Social Scientist, Center for Tobacco Products - nothing to disclose
• Schneider, Julie, PhD, Associate Director for Research Strategy and Partnerships, Oncology Center of Excellence - nothing to disclose
• Shaheed, Shaila, Masters Degree, Program Manager/ Supervisory Analytics Officer, OCS - nothing to disclose
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose
• Shi, Qiang, PhD, Visiting Scientist, FDA - nothing to disclose
• Smith, Alexandria, MSPH, Social Scientist, FDA - nothing to disclose
• South, Erin, PharmD, Pharmacist, FDA - nothing to disclose
• Whetsel, Robert, DCS, Associate Director for Data Architecture, FDA/OSP/IO - nothing to disclose
• Young, Monica, Ph.D., Senior Scientific Advisor, Center for Biologics Evaluation and Research - nothing to disclose

• Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose