He will lead the firm’s Commercialization and Regulatory Team. Nancy Beck and Ernest Voyard will serve as directors in this practice, supplementing Avalere’s strong talent base. Avalere’s Commercialization and Regulatory team partners with life sciences companies, patient advocacy organizations, and a range of other customers to address market access, policy, and regulatory needs.
“FDA regulatory policy is increasingly important in the context of establishing competitive markets for medical products in the US and around the world, with the ultimate goal of delivering value for patients,” said Dan Mendelson, president at Avalere Health. “As the healthcare system moves towards quality and value-based payments, our clients are increasingly integrating analytic approaches to regulatory strategy, which is a major focus of our work.”
About Tom Kraus
During Kraus’ tenure at the FDA, he served as the principal advisor to the Commissioner for the management of the Agency, including oversight of the Agency’s budget, strategy, and operations. He oversaw the rollout of major FDA actions, including product approval decisions, enforcement actions, and new regulations. Kraus also led the Agency’s coordination with the Trump administration to ensure a smooth transition of FDA’s leadership and programs. He has also held positions at McKinsey & Company, the U.S. Senate Committee on Health, Education, Labor and Pensions, and has served as a health policy advisor to Senators Ted Kennedy and Tom Harkin.
About Nancy Beck
Prior to joining Avalere, Nancy Beck served as a program director at the Reagan-Udall Foundation (RUF) for the FDA. In her role at RUF, Beck was responsible for developing strategic partnerships to support new programs tied to current policy and regulatory priorities. She also helped raise awareness of RUF’s mission, and represented RUF with key constituencies, including the FDA, biopharmaceutical companies, and patient and advocacy groups.
About Ernest Voyard
Ernest Voyard most recently served as a senior director of regulatory affairs at the Leukemia and Lymphoma Society (LLS). During his time at LLS, Voyard developed and executed the organization’s FDA regulatory policy initiatives with a specific focus towards regulations that affect the development and approval of therapies for blood cancers. Ernest was also responsible for building and maintaining relationships with FDA staff and leading LLS’ agenda with the Agency.