Dr.
Kelly George supports clients in navigating the FDA policy environment for drugs, biologics, and medical devices. She applies scientific and regulatory understanding to overarching drug development strategies towards establishing quality, safety and efficacy for FDA products (pre/post)approval while balancing the impact on patient access, time to market entry, cost of drug development, and the creation of a sustainable market.
Prior to joining Avalere, Kelly focused on pipeline technologies in pre-FDA approval phases of development at the Innovation Institute. Before that, she worked as a scientific consultant with Fourth River Solutions where she focused on business strategy development and in-depth market analysis.
Kelly has a PhD in bioanalytical chemistry from the University of Pittsburgh, a BS in biology from James Madison University and a regulatory affairs certification.
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.
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 accelerated changes and increased uncertainties in healthcare brought on by the COVID-19 pandemic will continue into 2021, and its impacts are likely to shape healthcare for years to come. While prevalent uncertainty is a given, the broad outline of a new era is already emerging. More than ever, careful examination of healthcare stakeholder’s business models, policy developments, and data will be essential to arrive at accurate assessments of the future state. Our experts engaged in a live discussion covering critical issues facing healthcare leaders and strategies for clearing the path.
The accelerated changes and increased uncertainties in healthcare brought on by the COVID-19 pandemic will continue into 2021, and its impacts are likely to shape healthcare for years to come. While prevalent uncertainty is a given, the broad outline of a new era is already emerging. More than ever, careful examination of healthcare stakeholder’s business models, policy developments, and data will be essential to arrive at accurate assessments of the future state. Our experts engaged in a live discussion covering critical issues facing healthcare leaders and strategies for clearing the path.
For even deeper coverage, download the 2021 Healthcare Industry Outlook document below.
For even deeper coverage, download the 2021 Healthcare Industry Outlook document below.
Mitigating the public health emergency (PHE) caused by SARS-CoV-2 requires a multifaceted approach.
On July 22, Avalere experts discussed the marketplace for COVID-19 vaccines and therapeutics in the “Cutting Through the Noise: Market Evolution and Pathways to Access for COVID-19 Vaccines and Therapeutics” webinar. They examined FDA regulatory considerations, coverage and access challenges, and key pricing and distribution scenarios for optimal US market access.
Avalere experts discussed the marketplace for COVID-19 vaccines and therapeutics, including key decision points for regulatory pathways, pricing, and distribution scenarios for optimal US and EX-US market access.
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.
To protect the public’s health during the COVID-19 pandemic, the Food & Drug Administration (FDA) released guidance expanding the availability of digital health therapeutic devices and applications for psychiatric disorders by clarifying which regulatory requirements it does not plan on enforcing as well as which products do not necessitate FDA oversight. This guidance intends to limit extraneous contact between patients (users) and providers by providing regulatory flexibility for low risk products. The policies will last until the national public health emergency ends.
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.
Opportunities exist to accelerate potential vaccine development.
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.
On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.
The Food and Drug Administration’s (FDA) efforts to modernize medical device oversight in the agency’s Center for Devices and Radiological Health (CDRH) have continued with the release of multiple draft and final guidances in 2019, as well as a plan for additional releases in 2020.
A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.
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.
New call center also supports investigational requests.
On August 6, Avalere’s regulatory experts published an article in BioDrugs highlighting upcoming regulatory changes for insulin.