Cambridge, Massachusetts, United States
President and Principal Consultant at Windshire Group, LLC, a premier biotech and pharmaceutical industry consultancy in existence for over 12 years. Our core competency is providing expert teams to provide comprehensive CMC and management consulting for biopharmaceutical, pharmaceutical, biome, and cell and gene therapy (CGT) therapy development by covering all aspects of process development, quality, regulatory, operations, and supply chain. We have extensive experience in product and process development, CDMO oversight, IND/BLA filings, data analysis, and investor due diligence. Our mission is to accelerate therapeutic development and commercialization for our clients, ranging from start-ups to multi-national corporations. We leverage our expertise, network, and services to provide solutions that address the complex and evolving challenges of the biotech and pharmaceutical industry. Our services include Stabilityshire (data analysis and management), and Assurashire (QA support). We are passionate about helping our clients succeed and improving the lives of patients. I have led Manufacturing and Technical Operations for MedTherapy and Shore Therapeutics. I have authored several publications, and regularly speak and teach at industry events and conferences. I enjoy sailing! #biotechnology #FDA #biologics #pharmaceuticals #laboratory #quality #processdevelopment #manufacturing #CDMO #CMO #IND #BLA #NDA My academic credentials include a PhD in Chemical Engineering, an MBA/MS in Business Administration and Technology Management, and an MS in Microbiology.
Biologics, Pharmaceuticals, Vaccines, Cell Therapy, and Biome CMC, Due Diligence and Strategic Consulting Services. "Our experts and teams accelerate therapeutic development"sm through comprehensive CMC "chemistry manufacturing controls" consulting, including quality support. Interim head of manufacturing and technical operations for MedTherapy, a Boston-based global biotechnology corporation manufacturing cell, gene and immunological therapies for the treatment of cancer to make them accessible and affordable for every cancer patient in the world. On founding management team and led manufacturing and technical operations for Shore Therapeutics in the successful re-commercialization of Fenoglide.
Process development, technical operations and business consulting to the biopharmaceutical industry with specific expertise in cell culture and fermentation process development, manufacturing, regulatory and GMP compliance and auditing, product commercialization, CMO oversight, IND/BLA filings, cost modeling, data analysis, and due diligence on products, technologies and company CMC programs. Engagement lead for a BLA CMC filing- No "Refusal to File" and product was approved.
Led technical operations for Humira manufacturing. Served on site validation review board and quality management teams. Pivotal role in successful PAI and launch of Humira. Served on Global Technical Operations project team for Abbott's global reorganization and operational excellence effort.
Provided technical support to Cerezyme, and several other commercial and late stage products, including both mammalian and microbial processes.
Developed and scaled-up manufacturing processes for recombinant products produced in E. coli and mammalian cell culture.