PharmApprove Expands Consultancy Team with Addition of New Clinical Regulatory Advisor

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Leading strategic, regulatory and scientific communication consultancy welcomes Renu Gupta, MD

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"I am excited to have the opportunity to use my experience with top life sciences companies, to help others succeed in bringing new treatments and cures to the patients who need them.” -- Dr. Renu Gupta, PharmApprove Clinical Regulatory Advisor

PharmApprove announced today the addition of Renu Gupta, MD to its consulting team. As a Clinical Regulatory Advisor, she joins a senior team of advisors with drug development and regulatory expertise. These advisors complement the more than 25 consultants who provide pharmaceutical and biotech companies with regulatory strategy, scientific communications, and market access support.

“Dr. Renu Gupta is a wonderful addition to PharmApprove,” said President and Chief Scientific Officer Dr. Laurie Smaldone. “She has spent over 25 years working in the pharmaceutical industry and has extensive experience leading global research and development programs in infectious diseases, pulmonology, immunology, and oncology among other areas. Her vast expertise certainly makes her an asset to our team.”

Before becoming a consultant for PharmApprove, Dr. Gupta was a Special Advisor to the CEO of Insmed Incorporated, where she advised the CEO on new business strategy, portfolio assessment, acquisition targets, and due diligence. Prior to that, she was Executive Vice President of Development and the Chief Medical Officer at Insmed, and also served as Director of the UK subsidiary of Insmed Limited. Dr. Gupta’s past experience also includes Antigenics, Inc; Novartis; Covance; and Bristol-Myers Squibb.

Dr. Gupta has been credited with leading a fully funded RSV research laboratory to examine host immune responses to viral infections and partnering with the National Institutes of Health to test RSV proteins in vaccinia expression vector. She has also advised Merck on vaccine portfolio and development strategies and led a study evaluating long-term immunity. Additionally, Dr. Gupta advised Bristol-Myers Squibb on drug discovery targets for in-house programs and for in-licensing in Infectious Diseases and Immunology therapeutic areas. She has also been an invited speaker and panelist at FDA and EMA workshops, and at the IOM.

Dr. Gupta is also a longtime member of many industry-related organizations, including the American Association for Advancement of Science, the American Thoracic Society, American Society of Microbiology, American Society of Clinical Oncology, and the Infectious Disease Society of America.

“I am impressed with PharmApprove’s growing worldwide reputation for strategic, regulatory, and scientific communication expertise,” said Dr. Gupta. “I am excited to have the opportunity to use my experience with top life sciences companies to help others succeed in bringing new treatments and cures to the patients who need them.”

About PharmApprove: PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at and follow them socially at and

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