Gillian Woollett

Gillian Woollett 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 DPhil in immunology from the University of Oxford and an MA and BA in the natural sciences tripos (biochemistry) from the University of Cambridge.

Authored Content

Stakeholders in the COVID-19 pandemic response face regulatory and commercial uncertainties as emergency operations transition and market access of products face both emergency use and full licensure.

Crises often drive change at a pace not thought feasible in normal times. The COVID-19 pandemic has been no exception, bringing the accelerated development and emergency approval of vaccines, the wide implementation of telehealth, and potentially permanent changes to the way that global business is conducted.

On May 5, the Biden administration announced its support for waiving World Trade Organization (WTO) intellectual property regulations with respect to COVID-19 vaccines, in an effort to increase supply and worldwide access to the vaccines.

Join Avalere’s panel of policy, public health, and regulatory experts to learn about the challenges, opportunities, and key milestones to watch.

The 351(k) biosimilars pathway was legally established under the Biologics Price Competition and Innovation Act (BPCIA) provision of the Patient Protection and Affordable Care Act (ACA) of 2010. Since the passage of the ACA, 28 biosimilars have been approved by the Food & Drug Administration (FDA) along with the promulgation of policy that also applies to all biologics, including the creation of a suffix within the nonproprietary name of these products. Additionally, substantial case law has been made with respect to intellectual property pertaining to biologics. With the legality of the ACA currently under scrutiny, the future of BPCIA and biosimilars is uncertain.

Mitigating the public health emergency (PHE) caused by SARS-CoV-2 requires a multifaceted approach.

As life sciences companies sprint toward COVID-19 vaccines and therapies, the discussion below considers who has the authority to make the call on their availability at the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS).

While the COVID-19 pandemic continues to spread around the world, FDA has been balancing taking action to accelerate development of COVID-19 therapeutics and vaccines, while concurrently maintaining day to day activities to ensure proper oversight of current and future products on the market for all other unmet medical needs.

The US market has seen a recent surge in cannabidiol (CBD) use and sales, despite many of these marketed CBD products being unregulated and untested for most of the claimed indications.

The Biologics Price Competition and Innovation Act (BPCIA) mandates that specific protein products that were approved as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) be licensed as biologics under section 351 of the Public Health Services Act (PHS Act) as of March 23, 2020.

The evolution of the US influenza vaccine market offers insights into the potential barriers and opportunities for successful rollouts of novel COVID-19 vaccines.

On April 7, Gillian Woollett authored a Health Affairs blog piece with Ge Bai from the Johns Hopkins Carey Business School and Bruce Pyenson from Milliman about the role that testing plays in recovering from the COVID-19 pandemic.

The FDA has adjusted its priorities in response to the COVID-19 pandemic and the agency is expediting decisions on testing, therapies, and vaccines on a daily basis.

In response to the COVID-19 pandemic, FDA has announced actions that may have much broader implications for drug development, lifecycle management, and oversight.

On Monday, March 23, over 90 products that had historically been regulated as drugs were deemed to be licensed as a biologic. This includes insulin products. During the past several years, the Food & Drug Administration (FDA) has released guidance about their interpretation of the provision to guide sponsors and provide information about what to expect for the transition.

Patient access to high-quality, low-cost generic drugs continues to increase, due to a record number of generic approvals by the FDA in fiscal year 2019.

On August 6, Avalere’s regulatory experts published an article in BioDrugs highlighting upcoming regulatory changes for insulin.

The US Food and Drug Administration (FDA) makes its medical product marketing approval decisions based on a risk–benefit determination of safety and effectiveness.

Earlier this week, the Food & Drug Administration (FDA) released a Part 15 public hearing announcement and request for comment on how the FDA can facilitate greater availability while balancing competition and innovation for all biologics.

Tune in to the final podcast in our series as we discuss 3 steps companies should complete now to take advantage of the FDA’s priority to advance the adoption of RWE to support agency decision-making.

Avalere evaluated payer policies for biologics when biosimilars are available.

In just two years, on March 23, 2020, biologics currently regulated as drugs will transition to being regulated as biologics. Many aspects of how FDA will implement this transition have yet to be established.

Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.

Tune in to episode 2 of our discussion covering why the FDA is so interested in real-world evidence and how they are approaching it.

In the US, an interchangeability designation by the Food & Drug Administration (FDA) is perceived as the holy grail in biosimilars development by some and yet regarded as irrelevant by others.

Tune in to our new real-world evidence podcast series, where Avalere experts explore real-world evidence as a disruptive force in healthcare. In Episode 1, we focus on why RWE is such a hot topic.

In its new regulatory framework for regenerative medicines released in November 2017, FDA takes a flexible approach, creating opportunity for manufacturers.

The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, calls on FDA to examine underlying barriers to access to investigational drugs.

Today, the Senate voted to pass H.R.2430, the FDA Reauthorization Act of 2017.

New research from Avalere finds that most health plans are covering at least one of the two biosimilar products currently on the market.

The 21st Century Cures Act presents medical product manufacturers, patient groups, and advocacy organizations with a unique opportunity to plan for upcoming policy changes that are aimed at accelerating the pace of development and approval of new therapies.

Biosimilars have the opportunity to foster competition, but policy and market barriers limit the growth of a functioning market.

The 21st Century Cures Act requirement to post compassionate use policies may explain increase.

Extension of the Sunset Clause provides additional opportunity for the FDA to award vouchers and for transference of vouchers from recipients to other sponsors.

The final signing of the 21st Century Cures Act is the culmination of 3 years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. In the final episode in our series, Jay Jackson discusses what changes are on the horizon for products under The Cures Act.

The final signing of the 21st Century Cures Act is the culmination of three years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. Listen to Cara Kelly break down the impacts in episode 1 of our series on 21st Cures.

Today, the House will vote on the updated version of the 21st Century Cures Act, H.R. 34.

Proposed Requirements in 21st Century Cures Act Would Increase Transparency Requirements

Since 1992, the Food and Drug Administration (FDA) has collected $7.67 billion in user fees from pharmaceutical manufacturers to fund drug reviews based on an Avalere analysis of FDA data.

With the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance of a submission for approval of a second biosimilar to Remicade (infliximab), questions remain for biologics manufacturers, payers, prescribers, and others as to how a mature biosimilars pipeline will begin to evolve in the United States and whether a sustainable competitive specialty market will develop.

Two Potential Policy Changes Would Reduce Out-of-Pocket Costs for Consumers

Almost every state has introduced Right-to-Try bills to try to offer patients another avenue to access investigational drugs outside of the Food and Drug Administration's (FDA) expanded access program. However, it is unclear whether these laws will impact patient access given their questionable legal standing, reduced patient protections due to lack of FDA oversight, and the risks to manufacturers of providing products under Right-to-Try laws.

In recent years, stakeholders have increasingly become aware of the potential opportunities surrounding incorporation of the patient perspective into early stages of drug development. Listen to Debleena Sengupta discuss how patient input is evaluated and incorporated into the FDA's decision-making process.

User fees are increasingly central to the funding of the drug and device review programs, and in some cases these fees account for a larger proportion of the Food and Drug Administration's (FDA) budget than congressionally-appropriated monies. For example, user fees account for 68 percent of the FDA's review budget for prescription drugs, while 58 percent of the review budget for generic drugs comes from user fees.

In Biosimilars, Avalere's Gillian Woollett shares commentary on future considerations for the role of clinical trials in the development of biosimilars.

The U.S. Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (C.F.R.)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.

When life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.

A new analysis from the National Health Council (NHC) and Genetic Alliance, with research and analytic support from Avalere Health, identifies critical barriers hindering the advancement of meaningful patient engagement and outlines tactical next steps for actionable solutions.

On June 30, 2015, Gayatri R. Rao, M.D., J.D., of the FDA's Office of Orphan Products Development (OOPD) presented an overview on the Rare Pediatric Disease Priority Review Voucher Program. Dr. Rao discussed the background and purpose of the program, application and review process, sunset provision, and what's next for the program followed by a short question and answer session.

Need to Know: On June 10, Friends of Cancer Research held a public meeting to discuss how sponsors and FDA may be able to expedite rate-limiting steps in Chemistry, Manufacturing, and Controls (CMC) and current Good Manufacturing Practices (cGMPs) for breakthrough therapy designated products, while ensuring an adequate supply of safe and efficacious product at the time of approval.

New research from Avalere Health finds that 86% of pharmaceutical companies would invest more in studies to support the development of healthcare economic information if provided additional guidance on their ability to use this evidence with external audiences.

Even during these gridlocked times in Congress, certain healthcare initiatives are getting through the cracks; one of these such initiatives is 21st Century Cures.

On Aug. 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).

Avalere impressions on the first FDA biosimilar filing.

On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.

Avalere is pleased to announce a new formalized collaboration with Michael “Buz” Waitzkin.

An Avalere analysis found that Medicare prescription drug plans (PDPs) had lower levels of coverage and fewer medicines on less expensive formulary tiers than commercial health insurance plans, potentially impacting patients' access to anticonvulsants.

Recent FDA decisions should act as a blueprint for generic and brand manufacturers of innovator products.