UCSF

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

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

Dates

Topics

Visitors

TBD Pediatric Drug Development Jian Wang, PhD | Associate Director for Regulatory Science, Office of Drug Evaluation IV/CDER
TBD Quality Attributes of Cellular and Tissue Products Malcolm Moos, MD, PhD | Senior Investigator, Office of Tissues and Advanced Therapies/CBER
TBD Immunogenicity of Protein-based Therapeutics Zuben E. Sauna, PhD | Principal Investigator, Office of Tissues and Advanced Therapies/CBER
TBD Biostatistics and Clinical Trials Telba Irony, PhD | Deputy Director, Office of Biostatistics and Epidemiology/CBER
TBD Biomarker Development, Precision Medicine and Emerging Technologies William Slikker, Jr, PhD | National Center for Toxicological Research
TBD Genomics and Targeted Therapies TBD
TBD Electronic Study Data TBD
TBD Drug-Induced Cardiovascular Effects TBD

 

Past FDA Visits

2019 FDA Visitors

Dates

Topics

Visitors

 
April 16-17, 2019

Regulatory Science in Generic Drug Product Development

Slides: PDF iconLei 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: PDF iconSteve 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: PDF iconAlexandre 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: PDF iconChris 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

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: PDF iconLilliam 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: PDF iconKyung 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

Pharmacovigilence

Robert Ball, MD | Deputy Director, Office of Surveillance and Epidemiology, CDER

April 19-20, 2017

Rare Diseases and Gene Therapies

Slides: PDF iconIlan 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: PDF iconJakob Reiser and PDF iconYing 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: PDF iconGraeme 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: PDF iconLiang Zhao and PDF iconJohn 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

PDF iconSusie 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