Expert in Cardiovascular Safety
Expert ID: 736750 California, USA
|Year: 2005||Degree: MPH||Subject: Epidemiology, Biostatistics||Institution: Harvard T.H. Chan School of Public Health|
|Year: 1984||Degree: MD||Subject: Medicine||Institution: GSVM Medical College, Kanpur, India|
|Year:||Degree: Doctor of Medicine||Subject: Doctor of Medicine||Institution: G.S.V.M. Medical College|
|Years: 2018 to Present||Employer: Undisclosed||Title: Vice President, Global Head of Safety and Pharmacovigilance||Department:||Responsibilities: ▪ Member of Senior Leadership Team, report to Chief Medical Officer.
▪ Built company's drug safety and pharmacovigilance capabilities from the ground up.
▪ Responsible for safety and pharmacovigilance division budget.
▪ A key team member for driving strategy for NDA and MAA submission. Responsible for many key submission documents, e.g., Integrated Summary of Safety (ISS), the pharmacovigilance system master file (PSMF), post-authorization safety studies (PASS), registries, Risk Evaluation and Mitigation Strategy (REMS), and Risk management Plan (RMP).
▪ Led to successful approval of Fintepla by FDA in June 2020 and by the EMA in December 2020.
▪ A key team member for due diligence and buying additional assets.
▪ Chairperson of Global Cardiovascular Advisory Board at company
▪ Had multiple in-person interactions with FDA, EMA, and PMDA.
▪ Organized four cardiovascular advisory board meetings in the US and one in Paris.
|Years: 2017 to 2018||Employer: Zogenix Inc.||Title: Executive Director, Global Head of Safety and Pharmacovigilance||Department:||Responsibilities: Leading, directing, and supporting drug safety and risk management program for rare seizure disorders. Leading the safety team for the successful submission of NDA and MAA. Guiding the cardiovascular safety strategy for the whole program
▪ Supervising the CROs who are managing the case intake and safety database.
▪ Supervising the core lab for EKG and echocardiogram
▪ Chairperson of the international cardiovascular advisory board
▪ Leading the team to the successful completion of various deliverables for MAA and NDA e.g. REMS, RMP, Integrated Summary of Safety, and Pharmacovigilance system master file.
|Years: 2012 to 2017||Employer: Gilead Sciences Inc.||Title: Therapeutic Area Director (cardiovascular/respiratory), Drug Safety and Risk Management||Department:||Responsibilities: Worked across the organization, leading, directing, and supporting drug safety and risk management programs for Cardiovascular, HIV, and respiratory products. Served as a member of Medical Surveillance and Coding (MSC) Leadership team, and Chairperson of the Risk Management Committee for assigned compounds.
▪ Worked with in-house PharMetrics database, the industry's most comprehensive and diverse integrated insurance claims database, for signal evaluation.
▪ Facilitated weekly medical review of individual case safety reports (ICSRs), leveraging full working knowledge of safety operations and medical coding.
▪ Co-chair of Safety Monitoring Task Force who is assigned to implement the FDA guidance—Safety assessment for IND safety reporting guidance for industry.
▪ Safety Lead for multiple phase I-IV cardiovascular, respiratory, HIV, and Oncology trials.
|Years: 2010 to 2012||Employer: Pfizer Inc.||Title: Director, Safety Risk Lead, Safety Strategy and Risk Management||Department:||Responsibilities: Oversaw and directed global safety strategy and provided pharmacovigilance leadership and support to the clinical development team on assigned products, including anti-inflammatory, respiratory, transplant, oncology, gastroenterology, neurology (Alzheimer's disease), and OTC products. Demonstrated expertise with Spotfire® and Empirica Signal.
▪ Served as Chairperson of the Safety Risk-Core Working Group and Risk Management Committee for the assigned compounds, and Safety Lead for one NDA, one MAA.
▪ Acted as lead physician for two monoclonal antibodies for inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
▪ Performed ad hoc special scholarly safety strategy and risk management activities to meet specific needs in the business units, such as rapid response team deliverables/emerging safety issues white papers/product due diligence assessments.
▪ Represented Pfizer at safety crisis related to InFuse® Bone Graft.
▪ Provided expertise as Lead Safety Physician for Alzheimer's disease program with responsibility for four pivotal phase III trials for bapineuzumab (the Alzheimer disease immunotherapy compound) in collaboration with Janssen.
o Chaired monthly and quarterly joint risk management team meetings; ensured that risk management activities were fully aligned with the clinical, safety, regulatory and commercial strategies for the program
o Co-chaired bapineuzumab REMS program and provided medical review of documents for planned BLA submission.
|Years: 2006 to 2010||Employer: Glaxosmithkline Pharmaceuticals Plc.||Title: Director, Cardiovascular & Metabolic, Safety Evaluation & Risk Management||Department:||Responsibilities: Provided strategic oversight of the Department of Global Clinical Safety and Pharmacovigilance, with responsibility for supporting products including Avandia diabetes franchise, Avandia Alzheimer's disease program, and a developmental compound for Alzheimer's disease.
▪ Worked with FDA on Standardized Definition for Cardiovascular Outcomes Trials initiative.
▪ Provided expert opinion to clinical development teams on cardiovascular safety issues as a member of the Internal Cardiology Safety Panel.
▪ Served as a key member of "Quantitative Benefit-Risk Evaluation" steering committee.
▪ Safety Physician for TIDE cardiovascular outcome trial
o 16,000 patient cardiovascular outcome trial conducted in collaboration with the Population Health Research Institute at McMaster University, Ontario, Canada
▪ Safety Physician for RECORD cardiovascular outcome trial
o 4, 447 patient cardiovascular outcome trial sponsored by GlaxoSmithKline
o Medical review of clinical study report and submission to FDA, EMEA, Health Canada
|Licenses / Certifications|
California License Registration
American Board of Internal Medicine
Pennsylvania License Registration
Massachusetts License Registration
American Board of Internal Medicine
Alabama License Registration
Awards and Honors:
American Heart Association Junior Fellowship Award
Gold Medal for the highest score in cardiology examination