FDA Visiting Scientist Program

Overview

UCSF-Stanford CERSI has developed a robust Visiting Scientist Program with the U.S. Food and Drug Administration in which we bring FDA scientists to the Bay Area to give talks and interact with the scientific community on the West Coast. FDA scientists typically visit for 2-5 days and participate in a number of activities, based on their interests, including but not limited to:

Meetings with UCSF and/or Stanford faculty members to discuss mutual interest areas
Initiate/discuss research collaborations at UCSF and Stanford University
Meetings with UCSF and/or Stanford trainees (graduate students, postdocs, fellows)
Give a lecture or participate in a panel discussion that is open to the public
Visit organizations/companies of interest in the Bay Area
Record lectures to be used for CERSI educational programs

Program Goals

Inform FDA visitors of cutting-edge research being performed in the Bay Area
Facilitate new scientific collaborations between UCSF/Stanford faculty and FDA scientists
Educate scientists in the Bay Area about ongoing work at various FDA offices and centers
Encourage academic trainees to consider careers in regulatory science, particularly at the FDA
Expose the public to various topics in regulatory science

Process

FDA scientists are initially identified to participate in this program by UCSF-Stanford CERSI staff or by the FDA centers through their representative on the FDA CERSI Steering Committee. The list of visitors is then finalized by UCSF-Stanford CERSI working in close collaboration with the FDA’s Office of Regulatory Science and Innovation (ORSI). Once approved by ORSI and the FDA CERSI Steering Committee, UCSF-Stanford CERSI will reach out to the FDA scientists to identify visit dates and develop the visit agenda. FDA scientists who are interested in visiting UCSF-Stanford CERSI should contact their center’s CERSI Steering Committee representative. UCSF or Stanford affiliates who are interested in hosting specific FDA scientists should contact UCSF-Stanford CERSI.

Contact

Please contact Lawrence Lin, Director of External Relations and Outreach, with any questions about the FDA Visiting Scientist Program at [email protected]

Upcoming FDA Visits

Due to the current COVID-19 situation, the in-person FDA Visiting Scientist Program has been temporarily suspended. In its place, we will have a “virtual” visiting scientist program; this page will be updated when dates are scheduled.

Public seminars and events related to upcoming FDA visits can be found on our Events page.

Past FDA Visits

2020 FDA Visitors

Dates	Topics	Visitors
January 9-10, 2020	Safety Surveillance of Biologics Using Real World Data	Steven A. Anderson, PhD, MPP \| Director, Office of Biostatistics and Epidemiology/CBER Barbee Whitaker, PhD \| Lead General Health Scientist, Office of Biostatistics and Epidemiology/CBER Hui-Lee Wong PhD \| Epidemiologist, Office of Biostatistics and Epidemiology/CBER
January 13, 2020	Regulatory Science and Innovation	Audrey Thomas, MS \| Project Manager, Office of Regulatory Science and Innovation, OCS/OC
November 4, 2020	Digital Health Recording: Bakul Patel Slides: Bakul Patel	Fraser Bocell, PhD \| Social Science Analyst, Patient Science and Engagement/CDRH Allen Chen, PhD \| Program Manager, Patient Science and Engagement/CDRH Matthew Diamond, MD, PhD \| Chief Medical Officer for Digital Health, Division of Digital Health/CDRH David Gebben, PhD \| Staff Fellow, Patient Science and Engagement/CDRH Bakul Patel, MSEE, MBA \| Director, Division of Digital Health/CDRH Anindita Saha \| Assistant Director for Partnerships to Advance Innovation and Regulatory Science/CDRH Michelle Tarver, MD, PhD \| Assistant Director for Patient Science and Engagement/CDRH Srikanth Vasudevan \| Biomedical Engineer, Division of Digital Health/CDRH
December 2, 2020	Science of Patient Input Recording: CBER SPI Team Slides: CBER Slides	Hussein Ezzeldin, PhD \| Senior Staff Fellow, Office of Biostatistics and Epidemiology/CBER Martin Ho, MS \| Associate Director of Science for Patient Input and Real-World Patient Evidence, Office of Biostatistics and Epidemiology/CBER Ting-Hsuan Lee, MHS \| Research Fellow, Office of Biostatistics and Epidemiology/CBER Xinyi Ng, PhD \| Visiting Scientist, Office of Biostatistics and Epidemiology/CBER Sarah Stothers, RN, MSN, MPH \| Research Fellow, Office of Biostatistics and Epidemiology/CBER

2019 FDA Visitors

Dates	Topics	Visitors
April 16-17, 2019	Regulatory Science in Generic Drug Product Development Slides: Lei Zhang	Lei Zhang, PhD \| Deputy Director, Office of Research and Standards, OGD/CDER
April 23-24, 2019	Regulatory Science and Innovation	Audrey Thomas, MS \| Project Manager, Office of Regulatory Science and Innovation, OCS/OC
May 6-8, 2019	Surveillance of Biologic Products Slides: Steve Anderson	Steven A. Anderson, PhD, MPP \| Director, Office of Biostatistics and Epidemiology/CBER Barbee Whitaker, PhD \| Lead General Health Scientist, Office of Biostatistics and Epidemiology/CBER Gregory Pappas, MD, PhD \| Associate Director for National Surveillance/CBER
May 15-17, 2019	Microphysiological Systems Slides: Alexandre Ribeiro	Alexandre Ribeiro, PhD \| Staff Fellow, Division of Applied Regulatory Science/CDER Ayesha Arefin, PhD \| ORISE Fellow, Division of Applied Regulatory Science/CDER
June 12-13, 2019	Advanced Patient Monitoring and Control Slides: Chris Scully	Zane Arp, PhD \| Director, Division of Biomedical Physics/CDRH Shawn Forrest, MS \| Biomedical Engineer, Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices/CDRH Christopher Scully, PhD \| Research Biomedical Engineer, Division of Biomedical Physics/CDRH
July 9-10, 2019	Digital Health	Bakul Patel, MSEE, MBA \| Director, Division of Digital Health/CDRH Srikanth Vasudevan \| Biomedical Engineer, Division of Digital Health/CDRH
July 9-12, 2019	Minority Health and Health Equity	Richardae Araojo, PharmD \| Assistant Commissioner for Minority Health Martin Mendoza, PhD \| Director of Extramural Research, Office of Minority Health and Health Equity
July 9-13, 2019	Patient Engagement	Fraser Bocell, PhD \| Social Science Analyst, Patient Science and Engagement/CDRH Brittany Caldwell, PhD \| Biomedical Engineer, Partnerships to Advance Innovation and Regulatory Science/CDRH Allen Chen, PhD \| Biomedical Engineer, Office of Product Evaluation and Quality/CDRH David Gebben, PhD \| Staff Fellow, Patient Science and Engagement/CDRH Anindita Saha \| Assistant Director for Partnerships to Advance Innovation and Regulatory Science/CDRH Michelle Tarver, MD, PhD \| Assistant Director for Patient Science and Engagement/CDRH
July 22-25, 2019	Artificial Intelligence and Data Science	Qi Liu, PhD \| Team Leader, Office of Clinical Pharmacology/CDER Rhonda Moore, PhD \| Social Scientist, Office of New Drugs/CDER Yaning Wang, PhD \| Director, Division of Pharmacometrics, Office of Clinical Pharmacology/CDER
September 24, 2019	FDA Principal Deputy Commissioner	Amy Abernethy, MD, PhD \| Principal Deputy Commissioner of Food and Drugs Joe Franklin, JD, PhD \| Policy Director for the Principal Deputy Commissioner

2018 FDA Visitors

Dates	Topics	Visitors
January 24-26, 2018	Genomic Medicine	Brittany Schuck, PhD \| Senior Staff Fellow, Division of Chemistry and Toxicology Devices, OIR/CDRH You Li, PhD \| Staff Fellow, Division of Molecular Genetics and Pathology, OIR/CDRH Soma Ghosh, PhD \| Biologist, Division of Molecular Genetics and Pathology, OIR/CDRH
May 15-17, 2018	Pediatric Medical Devices	Vasum Peiris, MD \| Chief Medical Officer – Pediatrics and Special Populations/CDRH
June 18-20, 2018	Patient Engagement	Heather Benz, PhD \| Biomedical Engineer, Office of Science and Engineering Laboratories/CDRH Fraser Bocell, PhD \| Social Science Analyst, Office of the Center Director/CDRH Brittany Caldwell, PhD \| Biomedical Engineer, Office of the Center Director/CDRH Martin Ho, MSc \| Associate Director of Quantitative Innovation, Office of Surveillance and Biometrics/CDRH Anindita Saha \| Director, External Expertise and Partnerships/CDRH Michelle Tarver, MD, PhD \| Director, Patient Science and Engagement, Office of the Center Director/CDRH
June 20, 2018	Reimagining the Medical Device Oversight Paradigm	Jeffrey Shuren, MD, JD \| Director, Center for Devices and Radiological Health
June 21-22, 2018	Blood Safety and Pathogen Detection	Sanjai Kumar, PhD \| Chief, Laboratory of Emerging Pathogens/CBER
July 30-August 1, 2018	Computational Science Slides: Lilliam Rosario	Lilliam Rosario, PhD \| Director, Office of Computational Science/CDER Kendra Worthy, PharmD, MS \| Team Leader, Tools, Technology, and Innovation, Office of Computational Science/CDER Crystal Allard \| Team Leader, Data Quality, Office of Computational Science/CDER Qais Hatim, PhD \| Computer Scientist, Office of Computational Science/CDER Matthew Steele \| Regulatory Information Specialist, Office of Computational Science/CDER
September 20-21, 2018	Viral Detection	Indira Hewlett, PhD \| Chief, Laboratory of Molecular Virology/CBER Jiangqin Zhao, PhD \| Staff Scientist, Laboratory of Molecular Virology/CBER
November 8-9, 2018	Regenerative Medicine Slides: Kyung Sung and Johnny Lam	Kyung Sung, PhD \| Principal Investigator/Reviewer, Division of Cellular and Gene Therapies/CBER Johnny Lam, PhD \| Staff Fellow, Division of Cellular and Gene Therapies/CBER

2017 FDA Visitors

Dates	Topics	Visitors
March 20-22, 2017	Trends in Regulatory Science	Frank Weichold, MD, PhD \| Director, Critical Path and Regulatory Science Initiatives, Office of the Chief Scientist
March 29, 2017	Pharmacovigilance	Robert Ball, MD \| Deputy Director, Office of Surveillance and Epidemiology, CDER
April 19-20, 2017	Rare Diseases and Gene Therapies Slides: Ilan Irony	Ilan Irony, MD \| Deputy Director, Division of Clinical Evaluation and Pharmacology/Toxicology/OTAT, CBER
May 11-12, 2017	Biostatistics	Rajeshwari Sridhara, PhD \| Director, Division of Biometrics V, Office of Biostatistics, CDER Lei Nie, PhD \| Mathematical Statistician, Office of Biostatistics, CDER
June 5-9, 2017	Medical Devices and Patient Preference	Heather Benz, PhD \| Medical Device Fellow, External Expertise and Partnerships, CDRH Martin Ho, MSc \| Associate Director of Quantitative Innovation, Office of Surveillance and Biometrics, CDRH Nicole Ibrahim, PhD \| Chief, Structural Heart Devices Branch, Division of Cardiovascular Devices, CDRH John Laschinger, MD \| Medical Officer, Structural Heart Devices Branch, Division of Cardiovascular Devices, CDRH Vasum Peiris, MD \| Chief Medical Officer – Pediatrics and Special Populations, CDRH Anindita Saha \| Director, External Expertise and Partnerships, CDRH
September 20-22, 2017	Personalized Medicine and Molecular Genetics	David Litwack, PhD \| Personalized Medicine Staff/OIR, CDRH Hisani Madison, PhD, MPH \| Biologist, Division of Molecular Genetics and Pathology/OIR, CDRH Reena Philip, PhD \| Director, Division of Molecular Genetics and Pathology/OIR, CDRH Brittany Schuck, PhD \| Senior Staff Fellow, Division of Chemistry and Toxicology Devices/OIR, CDRH
October 2-3, 2017	Gene Editing and Gene Therapy Products Slides: Jakob Reiser and Ying Huang	Ying Huang, PhD \| Pharmacologist, Division of Clinical Evaluation & Pharmacology/Toxicology/OTAT, CBER Jakob Reiser, PhD \| Principal Investigator, Division of Cellular & Gene Therapies/OTAT, CBER
November 15-16, 2017	Cellular Immunotherapies Slides: Graeme Price and Kristin Baird	Kristin Baird, MD \| Medical Officer, Division of Clinical Evaluation & Pharmacology/Toxicology/OTAT, CBER Graeme Price, PhD \| Research Microbiologist, Division of Cellular & Gene Therapies/OTAT, CBER
December 18, 2017	Regulatory Science and Innovation	Carol Linden, PhD \| Director, Office of Regulatory Science and Innovation, OCS/OC

2016 FDA Visitors

Dates	Topic	Visitors
April 18-22, 2016	Patient Preference	Heather Benz, PhD \| Medical Device Fellow, External Expertise and Partnerships, CDRH Martin Ho, MSc \| Associate Director of Quantitative Innovation, Office of Surveillance and Biometrics, CDRH Xuefeng Li, PhD \| Mathematical Statistician Team Leader, Division of Biostatistics/OSB, CDRH Anindita Saha \| Director, External Expertise and Partnerships, CDRH Million Tegenge, PhD \| Visiting Scientist, Office of Biostatistics & Epidemiology, CBER
May 10-11, 2016	Clinical Pharmacology	Issam Zineh, PharmD, MPH \| Director, Office of Clinical Pharmacology, CDER
May 19/25, 2016	FDA Commissioner	Robert Califf, MD \| FDA Commissioner
July 5-6, 2016	Next-Generation Sequencing and the FDA HIVE Architecture Recordings: Eric Donaldson and Vahan Simonyan	Eric F. Donaldson, PhD \| Virology Reviewer, Division of Antiviral Products, CDER Vahan Simonyan, PhD \| Lead Scientist, High-Performance Integrated Virtual Environment, CBER
August 1-2, 2016	App-Based Safety Surveillance for Generic Drugs Slides: Liang Zhao and John Wang	Liang Zhao, PhD \| Director, Division of Quantitative Methods and Modeling/OGD, CDER John (Zhong) Wang, PhD \| Staff Fellow, Division of Quantitative Methods and Modeling/OGD, CDER Andrew Babiskin, PhD \| Chemical Engineer, Division of Quantitative Methods and Modeling/OGD, CDER Xia Pu, PhD \| Staff Fellow, Division of Quantitative Methods and Modeling/OGD, CDER Meng Hu, PhD \| Staff Fellow, Division of Quantitative Methods and Modeling/OGD, CDER
August 23-25, 2016	Radiation Therapy and Biomedical Imaging Devices Recordings: Robert Ochs, Michael O’Hara, Nicholas Petrick and Daniel Krainak	Robert Ochs, PhD \| Director, Division of Radiological Health, CDRH Michael O’Hara, PhD \| Deputy Director, Division of Radiological Health, CDRH Nicholas Petrick, PhD \| Acting Director, Division of Imaging Diagnostics and Software Reliability, CDRH Daniel Krainak, PhD \| Biomedical Engineer, Division of Radiological Health, CDRH
September 13-14, 2016	Excipients in Generic Drugs Susie Zhang and Hong Wen	Xinyuan (Susie) Zhang, PhD \| Staff Fellow, Division of Quantitative Methods and Modeling/OGD, CDER Hong Wen, PhD \| Chemist, Division of Quantitative Methods and Modeling/OGD, CDER
September 26-27, 2016	Stem Cells and Computational Modeling Recordings: David Strauss, Wendy Wu, Zhihua Li, Ksenia Blinova, Robbert Zusterzeel, Darrell Abernethy	David Strauss, MD, PhD \| Acting Director, Division of Applied Regulatory Science/OCP, CDER Darrell Abernethy, MD, PhD \| Associate Office Director for Drug Safety, Office of Clinical Pharmacology, CDER Wendy Wu, PhD \| Staff Fellow Pharmacologist, Division of Applied Regulatory Science/OCP, CDER Zhihua Li, PhD \| Staff Fellow Computational Biologist, Office of Clinical Pharmacology, CDER Robbert Zusterzeel, MD, PhD \| Staff Fellow Medical Officer, Division of Applied Regulatory Science/OCP, CDER Ksenia Blinova, PhD \| Staff Fellow, Division of Biomedical Physics, CDRH
October 24-25, 2016	Genomics and Targeted Therapies Recording: Anuradha Ramamoorthy	Michael Pacanowski, PharmD, MPH \| Associate Director for Genomics and Targeted Therapy/OCP, CDER Anuradha Ramamoorthy, PhD \| General Health Scientist, Genomics and Targeted Therapy/OCP, CDER Oluseyi Adeniyi, PhD \| Commissioner’s Fellow, Genomics and Targeted Therapy/OCP, CDER
October 27-28, 2016	Office of the Chief Scientist	Frank Weichold, MD, PhD \| Director, Critical Path and Regulatory Science Initiatives, Office of the Chief Scientist
November 16-18, 2016	Stem-Cell Based Product Characterization and Regulatory Science	Steven R. Bauer, PhD \| Chief, Cellular and Tissue Therapy Branch, CBER Ross Marklein, PhD \| Staff Fellow, Cellular and Tissue Therapy Branch, CBER

2015 FDA Visitors

Dates	Topic	FDA Visitors
April 2-3, 2015	Characterizing Cell Populations Recordings: Carolyn Wilson, Malcolm Moos and Steven Bauer	Carolyn A. Wilson, PhD \| Associate Director for Research, CBER Malcolm Moos, MD, PhD \| Medical Officer, Office of Cellular, Tissue and Gene Therapies, CBER Steven R. Bauer, PhD \| Chief, Cellular and Tissue Therapy Branch, CBER
April 22-23, 2015	Medical Device Regulation	Elias Mallis \| Director of Industry and Consumer Outreach, CDER
May 18-19, 2015	Therapeutic Equivalence in Generic Drug Review Recordings: Robert Lionberger	Robert Lionberger, PhD \| Director, Office of Research and Standards/OGD, CDER
August 17-21, 2015	An FDA Roadmap for Medical Devices Recordings: Malvina Eydelman	Malvina B. Eydelman, MD \| Director, Division of Ophthalmic and Ear, Nose and Throat Devices, CDRH
August 26-27, 2015	Data Science	Taha Hass-Hout, MD, MS \| Chief Health Informatics Officer, Office of Informatics & Technology Innovation Amber Griffin \| Program Support Specialist, Office of Informatics and Technology Innovation Letria Hall, MS \| IT Specialist, Office of Informatics and Technology Innovation Peggy Leizear \| Program Analyst, Office of Informatics and Technology Innovation Jonathan Levine, PhD \| Senior Scientific Policy Analyst, Office of Informatics and Technology
August 25, 2015	Development & Approval of Rapid Diagnostics and Measures for Viral Outbreaks Recordings: Cynthia Kelley and Sally Hojvat	Sally A. Hojvat, PhD, MSc \| Former Director, Division of Microbiology Devices/OIR, CDRH Cynthia Kelley, MS \| Senior Advisor for Counterterrorism/Medical Countermeasures, CBER
September 3, 2015	Modeling and Simulation in the Development and Approval of Drugs Recordings: Vikram Sinha	Vikram Sinha, PhD \| Senior Advisor for Regulatory Program and Policy, Office of Clinical Pharmacology, CDER
September 23-24, 2015	Regulatory and Scientific Challenges for Drug-drug Interactions Recordings: Shiew-Mei Huang and Lei Zhang	Shiew-Mei Huang, PhD \| Deputy Director, Office of Clinical Pharmacology, CDER Lei Zhang, PhD \| Senior Advisor for Regulatory Program and Policy, Office of Clinical Pharmacology, CDER
September 24-25, 2015	Next-Generation Sequencing Recordings: Marc Salit and E. David Litwack	Elizabeth Mansfield, PhD \| Director for Personalized Medicine and Molecular Genetics, Office of In Vitro Diagnostics and Radiological Health, CDRH E. David Litwack, PhD \| Policy Advisor, Office of In Vitro Diagnostics and Radiological Health, CDRH Katherine Donigan, PhD \| Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, CDRH Eunice Lee, PhD \| Acting Branch Chief, Division of Molecular Genetics and Pathology, CDRH Sharon Liang, MD, PhD \| Expert Scientific Reviewer, Division of Molecular Genetics and Pathology, CDRH Zivana Tezak, PhD \| Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health, CDRH
September 28-30, 2015	Patient Preferences in Medical Device Approval	Anindita Saha \| Director, External Expertise and Partnerships, CDRH Kathryn O’Callaghan \| Associate Director for Science and Strategic Partnerships, CDRH Telba Irony, PhD \| Chief, General and Surgical Devices Branch, Division of Surgical Devices, CDRH Martin Ho, MSc \| Team Leader, Neurologic and Dental Biostatistics, CDRH Anton E. Dmitriev, PhD, MSc \| Director, Division of Applied Mechanics, Office of Science and Engineering Laboratories, CDRH