Insights

Former Senior FDA Leader Julie Tierney Joins Leavitt Partners

Leavitt Partners, an HMA Company, is pleased to announce that Julie Tierney has joined the company’s team of health policy experts as a principal, located in Washington, D.C.

Tierney is a proven executive with more than 20 years of FDA legal, policy, and operational experience. She held a number of senior roles at FDA, including FDA chief of staff, overseeing more than 19,000 staff and a budget of more than $7 billion, and most recently served as deputy of the FDA’s Center for Biologics Evaluation and Research. She is an attorney with professional experience working in the FDA Chief Counsel’s office, on Capitol Hill and private legal practice.

During her career, Tierney has advanced novel policy solutions for regulatory challenges associated with cutting edge technologies, such as overseeing the development of new regulatory pathways for cell and tissue-based products and for genome editing products using a platform approach. She coordinated FDA responses to multiple public health crises and led several initiatives to help accelerate the development of therapies for patients with rare diseases, including the launch of the FDA Rare Disease Innovation Hub.

At Leavitt Partners, Tierney will help life sciences companies, patient organizations, and others understand and develop regulatory strategies and advance policy solutions for complex issues throughout the product life cycle. Her focus on FDA regulatory strategy and policy builds on a decade of Leavitt Partners’ work helping clients drive FDA policy solutions to put safe and effective medicines into the hands of patients.

“We are excited to have Julie bring her deep expertise in food and drug law and policy, FDA agency experience, and strong stakeholder relationships to our team at Leavitt Partners,” said Josh Trent, chief executive officer of Leavitt Partners. “While we live in an era of increasingly personalized medicine and medical breakthroughs, the life sciences sector is facing a wide range of nuanced and interconnected policy, regulatory, and stakeholder complexities. The potential to build a healthier and stronger future for Americans through biomedical innovations, cutting-edge science, and technology has never been greater. Julie is uniquely equipped to enhance our FDA-related services to help clients navigate the pre- and post-market complexities of the evolving FDA policy and regulatory landscape.”

Tierney joins a team of highly experienced, bipartisan health policy and government affairs consultants, many with significant experience drafting and implementing FDA laws and regulations, and leading private sector life sciences solutions. The Leavitt Partners team includes former health policy directors and FDA subject matter experts from the U.S. Senate Budget Committee, the Senate HELP Committee, the U.S. House Energy and Commerce Committee, and other senior congressional offices. Leavitt Partners, founded by former HHS Secretary Michael O. Leavitt, features former senior political appointees in Democratic and Republican presidential administrations, leaders formerly serving in several U.S. Department of Health and Human Services agencies, and former leaders in the nonprofit and corporate health sectors.

About Leavitt Partners

Leavitt Partners, an HMA Company, is a premier health policy and government affairs firm in Washington, D.C., that has been at the forefront of health policy development for decades. Leavitt Partners helps clients understand and navigate the legislative and regulatory environments to create opportunities, resolve problems, direct action, and build and maintain positive interactions with key federal policymakers. Leavitt Partners is home to expert conveners with decades of experience in the private sector and government who have spent years fine-tuning the process for building successful alliances that bring multi-sector stakeholders to the table with a commitment to reaching consensus, real-world solutions.

About HMA

HMA is an independent, national research and consulting firm specializing in publicly funded healthcare and human services policy, programs, financing, and evaluation. We serve government, public and private providers, health systems, health plans, community-based organizations, institutional investors, foundations, and associations. With over 700 multidisciplinary consultants coast to coast, HMA’s expertise, services, and team are always within client reach. Our team of life sciences consultants are experts in federal and state policy, reimbursement strategy, actuarial services, medical coding support, public affairs, investment strategy, and corporate development. From early steps of research and development to product-specific communications and commercial and reimbursement strategies, we guide life sciences companies at every stage.