Overview
Alicia Whittlesey is a Principal of Porzio, Bromberg & Newman’s New England office. With over 15 years of experience working as in-house legal and compliance for multiple companies including Biogen and Sunovion (formerly Sepracor) in the life sciences industry. Ms. Whittlesey leverages her background by providing a valued business perspective guiding teams and stakeholders and offering solutions that take into account business needs while helping to move a company forward in a compliant manner. Ms. Whittlesey has experience analyzing and managing legal and commercial risks from a US perspective.
She focuses her practice on advising clients in the pharmaceutical, medical device and biotechnology space. She advises on legal, regulatory and compliance matters governing the life sciences industry. These areas include marketing, advertising & promotion including the review of marketing, medical and corporate communications, clinical research, patient recruitment, social media, field sales activities, policy development/review and training, compliance assessments, internal/external communications and interactions, patient advocacy, patient assistance & support programs. Ms. Whittlesey provides guidance related to fraud and abuse laws, Anti-Kickback legislation, PhRMA Code, Food, Drug & Cosmetics Act, and FDA guidance and regulations.
News
Articles
- Social Media: Good, Bad or Something In-Between?, 3/13/2024
- Something Old, Something New: Hot Topics and Enforcement Trends of 2023, 12/27/2023
- Navigating the New FDA Draft Guidance: Evolving Manufacturer Considerations When Providing Scientific Information for Unapproved Uses, 11/03/2023
- Should Compliance have an "on-line" or "off-line" role?, 12/16/2020
- Communication During a Pandemic, 4/27/2020
- Regulatory and Legal Roles in Promotional Review Committee Meetings: Is There Really a Difference?, 2/27/2020
Events
Speaking Engagements
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"The Intersection of Legal and Compliance – Understanding the Risks of the Federal Anti-Kickback Statute for HCP Engagements & Transparency," 2022 Transparency, Aggregate Spend & HCP Engagement Conference, 8/10/2022
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"Closing Remarks," Porzio's Ethics & Eggs 2021, 12/09/2021
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"Enforcement Action Current Trends: Compliance Takeaways from the Incyte Complaint," Porzio Life Sciences Webinar, 6/30/2021
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"Compliant Patient Interactions," CBI's 16th Annual Pharmaceutical Compliance Congress, 4/18/2019
Prior Relevant Experience
- Biogen, Weston, MA, Commercial Counsel Legal Affairs, 2013-2018
- Sunovion Pharmaceuticals Inc. (formerly sepracor Inc.), Marlborough, MA, Counsel, 2008-2010; Senior Counsel, Commercial Legal Affairs, 2010-2012
- Bristol-Myers Squibb Company, Plainsboro, NJ, Associate Counsel, 2005-2008
- Eisai Inc, Teaneck, NJ, Administrative Assistant, Paralegal, 1996-2002; Counsel, 2002-2005