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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
2023 FDA Science Forum
June 13 - 14, 2023

Activity Coordinators:
Sharron Watson (,  Rokhsareh Shahidzadeh (

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:
Learning Objectives
  • 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.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, and nurses.
Day 1 June 13, 2023
Time Topic Speaker
9:00 - 9:05 AM EDT Introduction- Office of Scientific Professional Development (OSPD) Sharron Watson
9:05 - 9:15 AM EDT Welcome- Namandje Bumpus, PhD Namandje Bumpus, PhD
9:15 - 9:30 AM EDT Opening Remarks and Introduction of Keynote Speaker- Robert M. Califf, MD, FDA Commissioner Robert M. Califf, MD
9:30 - 10:00 AM EDT Keynote Speech- Murray Lumpkin, MD, Deputy Director of Integrated Development, Bill & Melinda Gates Foundation Murray Lumpkin, MD, MSc
10:00 - 10:30 AM EDT Break
10:30 - 10:50 AM EDT Concurrent Session 1: Clinical Evidence & Medical Devices: Generating Actionable Evidence from the Real World Mary Beth Ritchey, PhD, BSN, MSPH
10:50 - 11:10 AM EDT CDER/CBER Real-World Evidence Program John Concato, MD
11:10 - 11:30 AM EDT Real World Evidence for Vaccine Effectiveness at FDA Center for Biologics Evaluation and Research Richard Forshee, PhD
11:30 - 12:00 PM EDT Real-world evidence to provide supportive evidence for evaluating the safety and effectiveness of therapeutic products Sebastian Schneeweiss, MD, D.Sc
12:00 - 12:30 PM EDT Panel Discussion Sebastian Schneeweiss, MD, D.Sc
John Concato, MD
Richard Forshee, PhD
Mary Beth Ritchey, PhD, BSN, MSPH
Ruth Barratt, PhD DVM
10:30 - 11:00 AM EDT Concurrent Session 2: Advancing Drug Discovery with Biofabricated 3D Tissue Models Marc Ferrer, PhD
11:00 - 11:15 AM EDT Advancing Translational Models and Tools into the Drug Review Process: Opportunities for MPS Kevin Ford, PhD, DABT, DSP
11:15 - 11:30 AM EDT Opportunities and challenges in using liver microphysiological systems to study drug metabolism and hepatotoxicity Qiang Shi, PhD
11:30 - 11:45 AM EDT Advanced analytical methods for assessing the efficacy of regenerative medicine cellular products Kyung Sung, PhD
11:45 - 12:00 PM EDT Additive Manufacturing: A Case Study in Advanced Manufacturing of Medical Devices Matthew A. Di Prima, PhD
12:00 - 12:15 PM EDT Enhancing Regulatory Toxicology Decision-making for Tobacco Products: The Role of Computational Toxicology Tools Luis Valerio Jr, PhD, ATS
12:15 - 12:30 PM EDT Q&A Marc Ferrer, PhD
Kevin Ford, PhD, DABT, DSP
Qiang Shi, PhD
Kyung Sung, PhD
Matthew A. Di Prima, PhD
Luis Valerio Jr, PhD, ATS
Suzanne Fitzpatrick, PhD, DABT ERT
12:30 - 1:30 PM EDT Lunch
1:30 - 2:00 PM EDT Concurrent Session 3: Discussion on Increasing the Diversity of Patient and Caregiver Engagement with the Center for Biologics Evaluation and Research (CBER) on Food Allergy Drug Development Joey Mattingly, PhD, PharmD
2:00 - 2:15 PM EDT Providing Information Needed to Make Decisions about COVID-19 Vaccines: Qualitative Testing of Educational Materials Alexandria Smith, MSPH
2:15 - 2:30 PM EDT Amplifying Equity of Voices: Empowering patients and consumers Julie Hsieh, PhD, MPH
2:30 - 2:45 PM EDT FDA’s Closer to Zero Initiative: What Parent’s Can Do to Help Protect Children from Environmental Contaminants Kellie Casavale, PhD, RD
2:45 - 3:00 PM EDT Promoting Antimicrobial Stewardship in the Next Generation: Educational Projects Funded by the FDA’s Veterinary Laboratory Investigation and Response Network Sarah Peloquin, DVM
3:00 - 3:15 PM EDT A patient-centered approach toward the development of a patient-reported outcome measure Fraser Bocell, PhD, MEd
3:15 - 3:30 PM EDT Discussion and Q&A Alexandria Smith, MSPH
Sarah Peloquin, DVM
Joey Mattingly, PhD, PharmD
Kellie Casavale, PhD, RD
Kathryn LaRosa, MPH
Fraser Bocell, PhD, MEd
Julie Hsieh, PhD, MPH
1:30 - 2:00 PM EDT Concurrent Session 4: Securing Machine End Points in a Post Quantum operating environment Jose Arrieta, MBA
2:00 - 2:10 PM EDT Reimagining regulatory data submissions through FHIR Jose Galvez, MD
2:10 - 2:20 PM EDT Leveraging Large Datasets for the Development and Evaluation of New AI-enabled Medical Imaging Devices Frank Samuelson, PhD
2:20 - 2:30 PM EDT Using Genomic Data and Machine Learning to Study Antimicrobial Resistance in Foodborne Pathogens Amy Merrill
Chih-Hao Hsu, PhD
2:30 - 2:40 PM EDT Machine Learning and Case Identification in Claims Data Ravi Goud, MD, MPH
2:40 - 2:50 PM EDT Using machine learning to predict non-compliance in the global food supply: Improving risk-informed resource allocation and public health protection Jeffrey Chou, MSPH
2:50 - 3:30 PM EDT Panel Discussion Steve Condrey, MPS
Joshua Xu, PhD
Yu Mei, MD
Hesha Duggirala, PhD
Day 2 June 14, 2023
Time Topic Speaker
8:55 - 9:00 AM EDT Opening Remarks and Introduction Rokhsareh Shahidzadeh, RN, MSN
9:00 - 9:30 AM EDT Concurrent Session 5: ILMERAC- sharing scientific expertise in the area of methodologies for chemicals in food with national and international risk assessment agencies across the globe Antoine Keng Djien Liem, PhD
9:30 - 9:45 AM EDT Progress and Needs for New Alternative Methods (NAMs) in CFSAN’s Regulatory Mission Steven Musser, PhD
9:45 - 10:00 AM EDT Studies to Assess the Virulence of Enteric Foodborne Pathogens Steve Foley, PhD
10:00 - 10:15 AM EDT An update on NCTR and OCAC’s collaborative efforts to support cosmetics safety evaluation Luisa Camacho, PhD
10:15 - 10:30 AM EDT The US National Antimicrobial Resistance Monitoring System: Helping Ensure the Efficacy of Antibiotics Patrick McDermott, PhD
10:30 - 11:00 AM EDT Panel Discussion and Q&A Antoine Keng Djien Liem, PhD
Patrick McDermott, PhD
Steven Musser, PhD
Steve Foley, PhD
Luisa Camacho, PhD
Rajesh Nayak, PhD
9:00 - 9:05 AM EDT Concurrent Session 6: Introduction to Medical Counter Measures, Infectious Disease and Pathogen Reduction Technologies Mugimane Manjanatha, PhD
9:05 - 9:25 AM EDT Investing in the Future of Health Security Sandeep Patel, PhD
9:25 - 9:45 AM EDT FDA ARGOS: where trusted sequence data meets quality by design approach. Vahan Simonyan, PhD, D.Sc
9:45 - 10:00 AM EDT Assessing the role of T cell responses in SARS-CoV-2 protection Marian Major, PhD
10:00 - 10:15 AM EDT Development of Regulatory Science Tools to accelerate development of medical devices in public health emergencies Jenna Osborn, PhD
10:15 - 10:30 AM EDT Development of a platform approach to model neurotropic viral infections and characterize the therapeutics that target them Daniela Verthelyi, MD, PhD
10:30 - 10:45 AM EDT Evaluation of Testicular Organoids as a Model for Zika Virus Infection Dayton Petibone, PhD
10:45 - 11:00 AM EDT Panel Discussion Marian Major, PhD
Jenna Osborn, PhD
Daniela Verthelyi, MD, PhD
Dayton Petibone, PhD
Mugimane Manjanatha, PhD
Sandeep Patel, PhD
Vahan Simonyan, PhD, D.Sc
11:00 - 12:00 PM EDT Lunch
12:00 - 12:30 PM EDT Concurrent Session 7: Update on personalized cancer vaccines Catherine Wu, MD
12:30 - 12:45 PM EDT Use of NGS technologies in B-cell receptor based Immunome profiling and MRD biomarker discovery Wenming Xiao, PhD
12:45 - 1:00 PM EDT Host-Microbiome Crosstalk: Disruption of Gastrointestinal Barrier as Toxicity Assessment Tool Sangeeta Khare, PhD
1:00 - 1:15 PM EDT Regulatory Perspectives on Advancing Regenerative Medicine Products & Emerging Technologies  Carolyn Yong, PhD
1:15 - 1:30 PM EDT Dermal Drug Delivery via Dissolvable Microneedles: Formulation variables affecting CQAs Nahid Kamal, PhD
1:30 - 1:45 PM EDT Assessment of trabecular bone stiffness using radiomics and deep-learning features Qian Cao, PhD
1:45 - 2:00 PM EDT Q&A Sangeeta Khare, PhD
Mugimane Manjanatha, PhD
Catherine Wu, MD
Wenming Xiao, PhD
Carolyn Yong, PhD
Nahid Kamal, PhD
Qian Cao, PhD
12:00 - 12:05 PM EDT Concurrent Session 8: Introduction to Substance Use, Misuse, and Addiction Marta Sokolowska, PhD
12:05 - 12:35 PM EDT Abuse Liability Testing with Humans: A Review of Standard Methods and Recent Innovations Using Cigarettes Varying in Nicotine Content as an Exemplar Stephens Higgins, PhD
12:35 - 12:45 PM EDT Field deployable analytical toolkit for rapid analysis of FDA regulated products at international ports of entry Martin Kimani, PhD
12:45 - 12:55 PM EDT Blunt and Non-Blunt Cannabis Use Associated with Cigarette, E-Cigarette, and Cigar Initiation: Findings from the Population Assessment of Tobacco and Health (PATH) Study Heather Kimmel, PhD
12:55 - 1:05 PM EDT Leveraging systems modeling to inform policies on opioids Sara Eggers, PhD
1:05 - 1:15 PM EDT Public Health Harms from Prescription Stimulant Diversion and Nonmedical Use Rose Radin, PhD, MPH
1:15 - 1:25 PM EDT Barriers to Prescribing Buprenorphine as a Medication for Opioid Use Disorder: Healthcare Providers’ Practices, Perspective and Experiences. Matthew Walker, DrPH
1:25 - 1:35 PM EDT Neonatal Opioid Withdrawal Syndrome (NOWS): A Scientific and Regulatory Update An Massaro, MD
1:35 - 2:00 PM EDT Q&A Marta Sokolowska, PhD
Stephens Higgins, PhD
Martin Kimani, PhD
Sara Eggers, PhD
Heather Kimmel, PhD
Rose Radin, PhD, MPH
Matthew Walker, DrPH
An Massaro, MD
Arit Harvanko
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 9.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 9.50 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-055-L04-P, and ACPE Universal Activity Number JA0002895-0000-23-055-L04-T for 9.50 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 9.50 contact hour(s).
Requirements for Receiving CE Credit

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 ( 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.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

  • 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 (
  • 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, Steve, 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

Planning Committee
  • 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

CE Consultation and Accreditation Team
  • 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
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 70% of the activity.