Vrunda Mahadevia | Associate Director, US Safety and Risk Management
Novartis

Vrunda Mahadevia, Associate Director, US Safety and Risk Management, Novartis

Vrunda Mahadevia is an accomplished Associate Director in US Safety and Risk Management at Novartis, with a proven track record of driving innovation and excellence in drug safety practices. With over a decade of experience in the pharmaceutical industry and the risk management space, Vrunda is a dynamic leader known for her strategic vision and commitment to ensuring the highest standards of safety for patients with reduced burden to the healthcare delivery system. Vrunda leads activities and strategies for US REMS programs within the patient safety and pharmacovigilance group and serves as the safety risk expert on project/product teams throughout the product's life cycle and contribute to the development and implementation of innovative, evidence-based risk management solutions, including enhanced pharmacovigilance and risk minimization activities that will ensure optimized benefit with minimized risk.  She is passionate about harnessing the power of innovation to streamline safety operations and improve decision-making within organizations. Vrunda is a strong advocate for collaboration and partnership across functions to drive performance and achieve shared safety goals.

Vrunda has the unique knowledge of US REMS, EU-RMPs, rest of the world risk management plans, and pharmacovigilance.  Throughout her career, Vrunda has demonstrated a deep understanding of regulatory requirements and industry best practices, enabling her to develop and implement robust safety strategies that align with global standards. Her strong communication skills and ability to foster relationships with key stakeholders have been instrumental in driving successful safety initiatives and ensuring compliance with evolving regulations.

As a speaker at the World Drug Safety Congress Americas 2025, Vrunda Mahadevia will share her insights on the latest trends in drug safety, highlighting the role of innovation, collaboration, and reduction of burden in empowering safety professionals and their partners. Attendees can expect to gain valuable knowledge and practical strategies from Vrunda's presentation, informed by her wealth of experience and dedication to advancing safety practices in the pharmaceutical industry.

Appearances:



Day 1 - World Drug Safety Congress Americas 2025 @ 15:40

Presentation: Release of the CAR-T REMS

Kymriah is the first approved chimeric antigen receptor T-cell (CAR-T) therapy.  Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T-cells to fight cancer. Kymriah is the first therapy based on gene transfer approved by the FDA.  Kymriah was approved with a Risk Evaluation and Mitigation Strategy (REMS) on August 30, 2017.  The REMS served to inform and educate healthcare professionals about the risks that may be associated with Kymriah treatment.  In order to support safe patient access, Novartis established a network of certified treatment centers throughout the country which were fully trained on the safe use of Kymriah and appropriate patient care.  As a part of the REMS, Kymriah was only to be administered in certified healthcare facilities.  All healthcare providers had to take a mandatory test showing adequate knowledge of CAR-T related toxicities of cytokine release syndrome (CRS) and neurological toxicities (NT) and how to manage these risks in order to prescribe, dispense, or administer Kymriah.  Subsequent to Kymriah’s approval, many other CAR-Ts emerged in the market, each having their own REMS.  Hospitals that administered various CAR-Ts had to therefore certify in multiple programs having differing CRS and NT treatment algorithms.  Novartis entered into negotiations with the FDA on streamlining and transitioning the REMS mandates into standard medical practice in 2020.  On July 26, 2025, the FDA released the entire class of BCMA and CD19 CAR-T REMS.  The presentation will cover the steps that lead up to the release of this REMS.  

last published: 12/Sep/25 14:27 GMT

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