Advancing the Development and Implementation of Analysis Data Standards
Public discussion of analysis data standards. Featured segment: 30:00–1:13:00.
LIFE SCIENCES CONSULTING · CLINICAL TRIAL NAVIGATION
Scientific depth.
Clinical perspective.
Clearer decisions.
Connecting regulatory experience, clinical research, and biomedical informatics to help life sciences teams move forward—and patients explore research opportunities.
Founded by Vaishali Popat, MD, MPH
FOR PHARMA, BIOTECH & RESEARCH TEAMS
Expertise for the questions
that shape development.
Independent scientific and strategic consulting grounded in experience evaluating medical products and building the systems used to review their evidence.
MEET THE FOUNDER
Vaishali Popat,
MD, MPH
A career connecting patients, research, and regulatory science.
View LinkedIn profileDr. Popat is an endocrinologist and former FDA leader with experience spanning NIH clinical investigation, public health, and clinical informatics. She retired from the FDA on December 31, 2025. Her work brings together the clinical context of disease, the rigor of research, and the practical challenge of turning complex data into useful evidence.
FDA leadership & clinical evaluation
She served as Branch Chief in General Medical Evaluation within the Office of Therapeutic Products at CBER, overseeing clinical regulatory activities for cell and gene therapies across development, review, and postmarketing stages.
Building biomedical informatics capability
During her tenure as Associate Director of Biomedical Informatics in the Office of New Drugs, she established a program to incorporate new tools and technologies into review. Her work included safety analytics governance, reviewer education, and initiatives involving distributed data networks.
NIH clinical research
At the NIH, she served as a clinical investigator, led a team conducting a randomized, double-blind, placebo-controlled trial in primary ovarian insufficiency, and coordinated a rare-disease natural history dataset spanning 30 years of experience. She was principal investigator on an estradiol and ovulation protocol and co-investigator on additional protocols.
Selected honors & awards
- FDA Commissioner’s Special Citation · 2018Biomedical Informatics Interest Group; recognized for professional development and clinical informatics training.
- Dr. Frances O. Kelsey Drug Safety Excellence Award · 2012MedDRA Adverse Events Diagnostics Program Development Team.
- CDER Team Excellence Award · 2017Recognition for excellence in regulatory science.
Endocrinology fellowship, NIH · MPH in Epidemiology, Johns Hopkins University · Clinical Informatics board certification listed on LinkedIn (2021)
SELECTED SCHOLARSHIP
Experience reflected
in published work.
Selected publications spanning lupus and cell therapy, drug safety, informatics, clinical trial design, and NIH research.
Advancing CAR T-cell therapy for systemic lupus
Read publication ↗Custom Medical Queries for safety analysis
Read publication ↗Informatics in medical product regulation
Read publication ↗Adopting decentralized clinical trials
Read publication ↗Bone density in POI: a three-year randomized trial
Read publication ↗The menstrual cycle as a marker of adolescent health
Read publication ↗PRESENTATIONS & PUBLIC CONVERSATIONS
Sharing insight.
Advancing the discussion.
Selected talks, workshop recordings, and slides featuring Dr. Popat’s work in regulatory science, safety analytics, and clinical informatics.
Cell Therapies and Tissue-Based Products
Public workshop on generating scientific evidence to facilitate development. Featured segment begins at 6:09:03.
Regulatory Perspectives
Dr. Popat’s presentation on gene therapy development, regulatory challenges, and genome editing.
Advancing Premarket Safety Analytics
Workshop resources covering FDA Medical Queries and the Standard Safety Tables and Figures Integrated Guide.
Clinical Informatics: Empowering Physicians to Participate in the Data Revolution
A conversation with Dr. Popat on the role of physicians and health professionals in clinical informatics.
Biomedical Informatics and Safety Analytics
An update from the Office of New Drugs, CDER/FDA, presented by Dr. Popat.
START A CONVERSATION
What question are
you working through?
For consulting opportunities or trial-navigation inquiries, reach Dr. Popat by email, phone, or LinkedIn.
Please keep initial messages general and omit medical records or sensitive health information.