“We are very fortunate to have Kay join the BIO team,” said Jim Greenwood, President and CEO of BIO. “In addition to her extraordinarily substantive experience and knowledge based on a long and distinguished career in Washington, Kay is well-known throughout the industry and will be an excellent addition to our staff.”
Holcombe comes to BIO from Sanofi, where she most recently served as Vice President, FDA Alliances and Federal Agency Relations.
Prior to joining Sanofi, she served nine years as Vice President, Government Relations and Senior Policy Advisor at Genzyme and eight years as Executive Vice President of Policy at Directions Inc., a government relations consulting firm, where she provided strategic planning, legislative, regulatory and policy advice to a variety of clients in the health care industry and academia.
She was professional health legislative staff and senior health policy advisor to the House Commerce Committee (under Representative John Dingell) and health staff to the Senate Labor and Human Resources Committees (under Senator Orrin Hatch).
She served as FDA Deputy Associate Commissioner for Legislative Affairs, and has held multiple other legislative, policy, and science positions in various public health agencies.
In these positions, she worked on the Hatch-Waxman amendments to the Food, Drug, & Cosmetic Act, and has engaged in every reauthorization cycle of the Prescription Drug User Fee Act. Kay helped represent industry in negotiations that led to enactment of biosimilars legislation as part of the Affordable Care Act, and serves as Secretary of the Board of the Reagan-Udall Foundation for the FDA.
She has also served as an advocate for patients, and in particular patients with rare disorders.
She serves as a Board member of the National Capitol Chapter of the National Multiple Sclerosis Society and The National Blood Clot Alliance.
Holcombe will join BIO in early April.
BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.” Subscribe to the BIO Newsletter.