Past FDA Visitors

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

 

 

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 | Commissioner of Food and Drugs

 

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

 

Please contact Lawrence Lin to learn more about any of the past FDA visits.