Zachary Zalewski’s education and experience have brought him to Avalere to stand at the intersection of science and law.

As a member of Avalere’s team, Zach brings a holistic perspective in supporting clients through the FDA regulatory and policy environments. Trained in genetics, he has broad technical knowledge and expertise in molecular biology and related disciplines. From his legal studies, he has experience with statutory interpretation, regulatory analysis, and case law.

Zach has a JD from Case Western Reserve University with a health law concentration, a PhD in molecular and human genetics from Baylor College of Medicine, and a dual major BS in microbiology and history from Michigan State University. Prior to joining Avalere and while in law school, Zach clerked at a Cleveland intellectual property law firm and spent a semester at The Hastings Center, a nonpartisan bioethics research institute.

Authored Content

The COVID-19 pandemic identified gaps in US public health infrastructure and resources, prompting policy proposals and opportunities for stakeholder engagement.

The digital health technologies (DHTs) market is projected to grow from $3.5 billion in 2020 to $23.5 billion by 2030. Stakeholders must navigate complex pathways as the FDA develops regulatory frameworks for DHTs.

The first Congressional hearings for user fee reauthorization begin on February 3, 2022, and current legislative authority for UFAs will expire in September 2022.

Amid recent policy focus on the accelerated approval pathway and questions regarding the pathway’s evidentiary standards and decision framework, Avalere reviewed the history, process, and use of this pathway to date and the potential future use of accelerated approval for pipeline products.

A recent Pear Therapeutics–Avalere survey of 30 payers and 10 employer self-insured groups identified numerous insights to direct future efforts for broader adoption and coverage of prescription digital therapeutics (PDTs).

Prescription Digital Therapeutics (PDTs) are a growing and unique treatment modality that can provide expanded options for treatment to patients. As the landscape for these treatments develop across multiple therapeutic areas, challenges related to coverage, reimbursement, and access will need to be solved to advance broader adoption and utilization across key stakeholders.

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.

Beginning July 1, 2021, average sales price (ASP) calculations for Part B drugs with an additional non-covered self-administered formulation could alter Medicare reimbursement.

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.

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).

The CMS proposes to define line extension under the MDRP to broadly include any product that has at least one ingredient in common with the original drug, even if it is a different dosage form. If finalized, this change would have significant implications on classification and rebate liability for a wide set of current and future products.

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.

As the novel coronavirus (COVID-19) spreads throughout the United States, media and policy focus on the rollout of diagnostic testing for the disease has greatly increased. Understanding the role of testing and screening is key to the control of this outbreak.

As the novel coronavirus disease (COVID-19) continues to change daily life, concerns about the impact on global supply chains and possible drug shortages have increased. Additionally, changes to FDA processes may limit its ability to perform essential drug related activities.

The replacement to North American Free Trade Agreement (NAFTA), the United States-Mexico-Canada Agreement, was originally proposed to increase biologics exclusivity in Mexico and Canada to 10 years. As part of the Administration’s compromise with the House of Representatives, these provisions have been removed from the amended version that was recently agreed to by the US, Mexico, and Canada. While exclusivity in the US remains unchanged at 12 years, that it is not increased for Canada and Mexico may impact market entry for biologics ex-US.

The USMCA’s intellectual property provisions add additional layers of ambiguity to the already complex issues surrounding biological product exclusivity and its future in US law.

While precision medicine is expected to revolutionize patient therapy, the increasing complexity of diagnostics is leading policymakers to revamp the way these tests are regulated and paid for.