Hillary Stires

Hillary Stires supports clients in navigating the regulatory strategy and FDA policy environment.

Trained as a comprehensive cancer biologist and endocrinologist, Hillary provides her clinical expertise of cancer diagnosis and treatment from a multifaceted approach including translating technical information.

Prior to joining Avalere, Hillary was a postdoctoral fellow at Georgetown University’s Lombardi Comprehensive Cancer Center where she studied endocrine resistance in breast cancer. Currently, Hillary helps clients develop market access strategies including scientific and regulatory requirements for FDA approval and success in public and private reimbursement.

Hillary has a BS in behavioral neuroscience from Lehigh University and a PhD in endocrinology and animal biosciences from Rutgers University.

Authored Content

Liquid biopsies test blood samples for circulating tumor DNA (tumor derived cell-free DNA), circulating tumor cells, cell-free tumor DNA, proteins, metabolites, exosomes, messenger RNA, and microRNAs. The promise of liquid biopsies is a new modality that screens for cancer in ways that complement and, in some cases, improve existing tests, and allow testing for early detection, cancer diagnosis, and monitoring of minimum residual disease and recurrence, without the need for invasive biopsies.

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.

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 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.

Globally, the need to flatten the epidemic curve of COVID-19 cases has become the top public health priority to save lives and minimize the burden on the health care system. In the absence of treatments and prophylactics for the novel coronavirus, social distancing and quarantine strategies continue to be implemented in the US.

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.

As the Coronavirus Disease 2019 (COVID-19), caused by the novel SARS-CoV-2 virus, rapidly spreads through the US, media and public scrutiny over the current diagnostic testing landscape has increased, given that the US lags behind other countries in the number of tests performed and turnaround time for results reported.

Announced this past August, the US Preventive Services Task Force (USPSTF) expanded risk assessment and genetic testing recommendations for BRCA-related cancers and recommendations for risk-reducing therapies. This expansion marks the growing importance of genetic literacy in the healthcare system.