AVEO Oncology appoints Nikil Mehta as SVP of Regulatory and Quality Assurance

AVEO Oncology announced the appointment of Nikhil Mehta, Ph.D., as Senior Vice President of Regulatory and Quality Assurance, effective November 20, 2017. In this role, Dr. Mehta will oversee all aspects of regulatory, quality and technical operations for the company’s portfolio. Dr. Mehta brings to AVEO more than 25 years of experience in the biotechnology and pharmaceutical industries, having played a key role in the development and approval of important therapeutic products in the areas of oncology and orphan disease.

“Dr. Mehta brings to AVEO a depth of experience in regulatory affairs and oncology that we believe will be invaluable as we plan and advance our U.S. registration strategy for tivozanib as a potential treatment for renal cell carcinoma,” said Michael Bailey, president and chief executive officer of AVEO. “Over the course of his career with companies such as Baxalta, Merck, Shire and ImClone Systems, Dr. Mehta’s experience includes the development and execution of global regulatory strategies leading to the approval of a number of important oncology therapeutics including KEYTRUDA (pembrolizumab) and ERBITUX (cetuximab). I anticipate his integration into the AVEO team will be seamless and rapidly productive. In the very near term, we look forward to working with Dr. Mehta through the announcement of topline data from the pivotal TIVO-3 trial, which we anticipate in the first quarter of 2018, potentially followed by a U.S. regulatory filing in the second half of 2018.”

“The AVEO team has made outstanding progress in advancing an important, differentiated therapeutic in tivozanib, including executing a confirmatory pivotal study, working alongside a partner to secure European marketing registration and initiating a new immunotherapy combination study,” said Dr. Mehta. “I look forward to contributing to the next stages of this progress by leveraging my expertise and experience to help ensure AVEO’s successful transition to a global commercial entity.”

Most recently, Dr. Mehta served as Executive Vice President and Chief Regulatory Strategist at Tang Capital Management, where he played a key role in the establishment of two biopharmaceutical companies, Odonate Therapeutics and Sentier Therapeutics. Prior to Tang Capital, Dr. Mehta served as Global Head of Regulatory Affairs at Baxalta, a period during which the company gained approval for ADYNOVATE, VONVENDI, and OBIZUR. Prior to Baxalta, he was Vice President, Global Regulatory Affairs, Oncology, Hematology, Immunology and Diagnostics, at Merck & Company, where, among other accomplishments, he played a key role in the rapid development and first approval of Merck’s blockbuster checkpoint inhibitor, KEYTRUDA. Prior to Merck, Dr. Mehta held positions of increasing responsibility within regulatory affairs at Shire HGT, ImClone Systems, Bristol-Myers Squibb and Hoffmann-La Roche, where he played key roles in the approvals of ELAPRASE, VPRIV, FIRAZYR and ERBITUX. Dr. Mehta holds a Ph.D. in Chemical and Biochemical Engineering from Rutgers University.