Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.
Allyson also advises on development, drafting, and implementation of policies and procedures related to financial conflicts of interest, research misconduct, physician advisory board and consulting services agreements and other clinical research and commercial device compliance matters. She has advised numerous life sciences and healthcare entities, ranging in size from closely-held two employee pre-clinical start-ups, to large multinational publicly held entities with commercial products, on a variety of healthcare regulatory, privacy, and commercial matters, including various mergers, acquisitions, and private equity or venture capital investments, including IPOs, SPACs, and other corporate matters.
Allyson also provides advice to clients in the firm’s Cannabis practice, focusing on FDA and state regulation of products containing CBD, THC, & hemp, manufacturers and growers, and cannabis industry service providers, such as point of sale vendors and online marketplaces.
Prior to joining McGuireWoods, Allyson was associate general counsel and data privacy officer at a commercial-stage biopharmaceutical company and its pre-commercial subsidiary utilizing AI to identify& commercialize new drug candidates in neuroscience and immuno-oncology, and before that she served as associate general counsel & data privacy officer for a molecular diagnostics company located in New York and New Jersey. Allyson’s prior in-house experience allows her to bring a practical perspective to business and operational matters. Before moving in-house, Allyson served as senior associate in the Life Sciences-Healthcare Regulatory, Privacy & Cybersecurity, and Cannabis practices groups in the New York office of an AmLaw 50 firm.
“Spending time as in-house counsel means I have direct experience with the challenges regulated entities face. I bring a practical, business-minded perspective to the “gray areas” of regulatory compliance and risk assessment.”
Hofstra University School of LawJDCertification in Clinical Bioethics
magna cum laude, Dean’s List, Dean’s Honor Scholar, Senior Associate Editor and Staff Member, Hofstra Law Review2015
Missouri State UniversityBAEnglish, minor in Political Science
Member, American Health Law Association (AHLA)
- Panelist, "Investments in Pharma Services", 16th Annual Healthcare Finance and Growth Conference, September 28, 2023
- New York
Selected for inclusion, “Best Lawyers: Ones to Watch,” Health Care Law, Woodward/White, 2023
- Author, Homeland Security and HHS Release Interactive Healthcare Cybersecurity Toolkit, McGuireWoods Legal Alert, November 16, 2023
- Author, HHS Rescheduling, SAFER Banking Act May Change the Marijuana Landscape, McGuireWoods Legal Alert, November 14, 2023
- Author, FDA Proposes Brominated Vegetable Oil Ban, McGuireWoods Legal Alert, November 6, 2023
- Author, FDA Establishes and Solicits Nominations for Digital Health Advisory Committee, McGuireWoods Legal Alert, November 3, 2023
- Author, Pharma Services Industry Leaders Cautiously Optimistic: HCFG Conference Recap, McGuireWoods Legal Alert, October 19, 2023
- Author, HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct, McGuireWoods Legal Alert, October 18, 2023
- Author, California Bans Four Common Food Additives and 26 Chemicals Used in Cosmetics, McGuireWoods Legal Alert, October 16, 2023
- Author, FDA Publishes New Guidance on Cybersecurity in Medical Devices, McGuireWoods Legal Alert, October 2, 2023