Over the past 20 years, I have helped innovators from Big Pharma, Biotech, large and small virtual developers and individual Pharma Entrepreneurs develop effective syntheses and manufacturing processes to supply APIs from late pre-clinical development to late clinical development and commercial manufacture.
I can provide both strategic CMC advice and hands-on implementation for the development and manufacture of your drug substance and regulatory CMC advice and support as needed. My work has included:
resolving chemistry & solid-state issues during manufacturing process development, while guiding analytical methods development to support drug substance and drug product manufacturing campaigns as well as analytical testing of intermediates and release testing of finished goods;
sourcing the most suitable CRO and CMO partners, from developing RFP’s through assembling comprehensive tech transfer packages and eventual management and oversight of R&D and manufacturing;
planning and program management for CMC activities relative to the overall drug development program and strategy, including regulatory CMC Strategy Development and Implementation Support; and
developing detailed CMC documentation to support IP development and successful regulatory filing, and subsequently liaising with regulatory agencies.
My involvement is flexible, depending on your needs and the complexity of your development program. A signature of my work is the close working relationships I develop with your internal team and external service providers, from solving problems to acting as your virtual Head of CMC.
…worked directly with the CMO…optimal process for isolation of a single polymorphic form of the drug substance…provided a unique solution…critical for our IND filing…successful development of this compound through Phase 2 clinical trials.
…consistently provided thoughtful, data-driven, and practical feedback that was critical to resolving a range of challenges on our projects. …helped to put our GMP drug substance and drug product manufacturing activities in great shape…
...far exceeded my expectations...led me through every step of the process...made sure I understood what we were doing...I felt informed and in-charge...outcome was outstanding...my strongest recommendation
…will roll up his sleeves, accomplish tasks and continually strive to advance the program. …deep knowledge of synthetic chemistry, process chemistry and drug product development. …well-connected within the CRO/CMO space
...dramatically mature and improve our synthesis...craft effective filings...create scalable processes...resulted in valuable IP...passion and commitment...