Waltham, Massachusetts, United States
A drug product development leader with a track record combining strategic clinical operations and CMC planning with rapid product delivery. Experienced program manager guiding both in-house and out-sourced drug product development teams through successful Phase 1 to Phase 3 stage clinical trials. Established and built out program management group to support company portfolio of clinical programs. Focused expertise in combination drug and respiratory drug development. Strong understanding of intellectual property portfolio development and strategy. Hands-on leadership with a proven ability to manage multiple programs and groups.
Established and built out Program Management Office to support company portfolio of programs. Drove completion of successful Phase 2 and Phase 3 clinical trials and preparation for BLA submission as program leader for lead product in Selecta's ImmTOR platform.
Management of the lead clinical stage biopharmaceutical combination drug program. Led successful filing of first-in-human IND and Phase I clinical trial.
Strategic and operational combination drug product consulting services to the pharmaceutical, biotech, and medical device industries
• Concurrently directed two separate groups of research associates, scientists and IP professionals • Program leader for a clinical stage proprietary development program • Guided and managed company intellectual property portfolio of >25 patent families • Performed lead role during technical and IP diligence activities • Authored sections of regulatory submissions for IB, IMPD, CTA, and briefing documents in multiple jurisdictions • Participated in meetings with regulators in multiple countries • Managed external contractors and attorneys activities and budgets to accomplish company goals
• Guided inhaler selection and development for all liquid and dry powder aerosol programs • Co-managed successful clinical material supply for multiple clinical trials • Responsible for in-vitro aerosol characterization and in-vivo dose prediction • Customized aerosol dosing and measurement equipment for five pre-clinical species • Delivered aerosol method development, qualification and transfer for successful release and stability of clinical trial material • Coordinated multiple research studies with academic experts across countries • Designed, programmed, and deployed a novel diagnostic instrument into multiple research trials in hundreds of human subjects • Designed and developed two high dose nebulizers from original concept through prototypes, testing, and CAD models
Designed and developed dry powder inhalers for clinical stage programs