Avalere Health
An Inovalon Company
Services

Regulatory Strategy

Navigate Complexity

While some uncertainty is inevitable, understanding the regulatory and policy environment with up-to-date, relevant information can help mitigate risks. Increasing regulatory predictability and ensuring a more timely approval can impact commercial success. An appropriate regulatory strategy reduces time and cost to market entry and, if handled concurrently, can help optimize reimbursement, market exclusivity, and other aspects of life cycle management. Avalere empowers companies with the knowledge and insights needed to negotiate effectively with the FDA on what ultimately matters for product value. We provide scientific, legal, and regulatory perspectives and connect these drivers to the changing payment landscape so our clients know what to prioritize and can minimize uncertainly throughout the approval process.

What's Your Challenge?

  • ​Regulatory Strategy Assessments
  • ​Market Access through FDA Pathways
  • Coverage and Reimbursement Risk Analysis
  • ​Key Policy Issue Tracking

Complementary Products

Team

Meet a few of our experts ready to partner with you.

All Staff

Gillian Woollett

Senior Vice President

Gillian
Woollett

Gillian Woollett, Senior Vice President, leads our FDA Practice. She provides the "prequel" of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate Centers for Medicare & Medicaid Services and healthcare policy/business world.

Prior to joining Avalere, Gillian was Chief Scientist at Engel & Novitt, LLP, and was Vice President, Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO). She joined BIO after being Associate Vice President at the Pharmaceutical Research and Manufacturers of America. She has been an appointee on federal advisory committees to the CDC and the Department of Commerce. Trained as a molecular biologist/immunologist, Gillian publishes in peer-reviewed literature on biotechnology topics, and is a frequent speaker on emerging biosciences and their ability to support better and more focused therapies.

Gillian has a BA, MA in the Natural Sciences Tripos (Biochemistry) from the University of Cambridge, and a DPhil in Immunology from the University of Oxford.

Jay Jackson

Senior Manager

Jay
Jackson

Jay Jackson, Senior Manager, conducts evidence-based assessments of the regulatory and policy environments for approval of medical products and market access. 

Prior to joining Avalere, Jay performed research and analysis on legislative and public health issues in the Colorado Senate. Prior to that, he conducted human genomic research at the University of Colorado. Jay currently focuses on conducting healthcare clinical and economic research, analysis of legislation, federal policy and regulations, and engagement with healthcare payers and providers. Jay’s areas of expertise include market access, reimbursement, and FDA regulation, with special expertise in devices, diagnostics, and value-based evidence communication.

Jay holds an MPH in Health Systems Management and Policy from the University of Colorado School of Public Health, a BS in Microbiology and Cell Science from the University of Florida, and a Regulatory Affairs Certification.

Brenda Huneycutt

Vice President

Brenda
Huneycutt

Brenda Huneycutt, PhD, JD, MPH, Vice President in Avalere’s FDA Strategy and Regulatory Policy practice, advises clients on regulatory strategy and policy spanning drugs, biologics, and diagnostics and conducts due diligence assessments for clients looking to acquire or in-license products. Using her molecular biology research background, combined with her legal and public health policy training, Brenda helps clients translate technical information into clear descriptions for various audiences and offers special expertise in regulatory strategy for FDA approval strategies involving accelerated and new pathways, including breakthrough therapy and orphan designations, biosimilars, and interchangeable biologics. 

Prior to joining Avalere, Brenda conducted research at the Genetics and Public Policy Center at Johns Hopkins University and was a Patent Attorney for Finnegan, LLP.

Brenda has a PhD in Molecular, Cellular, and Developmental Biology from the University of Colorado at Boulder, a JD from the George Washington University School of Law, an MPH from Johns Hopkins Bloomberg School of Public Health, and a BA in Biology from the University of Delaware.

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