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.

Nicole Braccio

Senior Associate

Nicole
Braccio

Nicole Braccio, Senior Associate, supports clients on market access, product commercialization and reimbursement policy. She applies her background in pharmacy, patient care, and medical communications to help pharmaceutical manufacturers optimize access to their products.

Prior to joining Avalere, Nicole was a Pharmacist with Target Pharmacy, leading a team of pharmacists and technicians to ensure prescriptions were processed accurately while providing effective clinical care. She currently maintains certifications in immunizations and CPR/BLS for Healthcare Providers. She supported the launch of several pilot programs which notably included implementation of medication therapy management and Target’s Specialty Pharmacy to increase patient access to specialty drugs by incorporating community outreach.

Nicole has a Doctor of Pharmacy from Rutgers, the State University of New Jersey. She is a Registered Pharmacist in New York and New Jersey.

Jay Jackson

Manager

Jay
Jackson

Jay Jackson, Manager, supports clients on methods to optimize regulatory strategy. He applies his background in molecular biology and legislative affairs to track policy updates, strategize stakeholder engagement and analyze the regulatory environment. Jay also has experience in database analytics.

Prior to joining Avalere, Jay was a Legislative Policy Analyst in the office of Colorado Sen. Jeanne Nicholson performing research and analysis on a wide range of social and public health issues. Prior to that, he was a Professional Research Assistant at the University of Colorado, managing animal model behavioral testing and human genetic copy number assays.

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

Debleena Sengupta

Director

Debleena
Sengupta

Debleena Sengupta, PhD, RAC, Director, advises clients on FDA regulatory strategy and policy. She applies her research background in molecular biology and biochemistry, along with over ten years of regulatory experience helping clients with the development, approval and life cycle management of drug and biological products. Debleena has special expertise in both regulatory therapeutic area strategy and CMC, and has worked at brand and generic companies. She also has experience performing FDA regulatory due diligence.

Prior to joining Avalere, Debleena was an Associate Director at Forest Research Institute, providing regulatory affairs strategy and serving as the primary liaison between FDA and the company for a portfolio of CNS drugs. Prior to that, as Manager and Liaison, Global Regulatory Affairs, at Merck & Co. (formerly Schering Plough), she was responsible for the CMC content for a number of products registered in the European Union, as well as international drug filings and approvals.

Debleena has a PhD in Chemistry from Columbia University and a BS in Chemistry from Stanford. She also holds a Regulatory Affairs Certification (RAC).

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