Pamela Lapham
Vice President of Regulatory Affairs, Thymmune Therapeutics
- Role
- Vice President of Regulatory Affairs at Thymmune Therapeutics
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Pamela Lapham
Highly accomplished Regulatory Affairs professional with over 30 years experience spanning translational medicine through pivotal clinical trials-Expert in managing US FDA and EU submissions for a wide range of products, including cell and gene therapies, vaccines, antibodies, small molecule drugs, medical devices, and combinationproducts leveraging novel drug delivery systems-Adept at guiding successful regulatory and quality strategies for complex investigational products across diverse indications-Proven track record for acquiring Orphan Drug and accelerated program designations to facilitate rapid product approval pathways. Core Expertise: Extensive experience with US FDA (CBER, CDER, CDRH) and EU (EMA) regulations, with a focus on IND/IDE strategy, nonclinical and CMC modules, and protocol/ ICF/ DSUR/ CSR authoring. Key Accomplishments: Demonstrated success in securing FDA product clearances, approvals, and designations through a deep understanding of regulatory strategy, clinical execution, andquality management; managed and/or contributed to the successful acquisition of over $10M in grant funding. Publications & Presentations: Primary and/or contributing author on 25 peer-reviewed scientific publications /book chapters and 60+ scientific abstracts and presentations. Broad Experience: Proficient in applying US FDA 21 CFR, EU CTR 536/2014, and MDR/IVDR regulations, and served as a primary liaison and trusted partner for top-tier clients including Abbott, Alnylam, Eli Lilly, Exact Sciences, Novo Nordisk, Otsuka, Regeneron, Sanofi, and the US Department of Defense.
Experience
Vice President of Regulatory Affairs
Oct 2024 — Present · Cambridge, MA, US
Provides strategic guidance and comprehensive regulatory strategies across nonclinical, CMC, and clinical activities, with a primary focus on thymic-related disorders- Strategizes, leads, writes, and supervises the development and submission of documents or plans to regulatory agencies to support development goals- Serves as the primary point of contact for global regulatory authorities, leading all communications and meetings- Drives profitability and growth of Thymmune by supporting commercial teams in the development and expansion of clinical indications for innovative iPSC-derived products- As a member of the Thymmune Leadership Team, contributes to companystrategy and operations to foster a culture of excellence and continuous improvement.
Education
San Diego State University
Advanced Certification, Regulatory Affairs
2007 — 2007
University of Massachusetts Dartmouth
Bachelor of Science (BS), Biology, General
1982 — 1986
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