H-D BioPharma Information

WHO I WORK WITH • Companies (established and startup) seeking unbiased evaluations and guidance. • Investors seeking objective evaluations. • Academic Centers with Assets to evaluate and partner. HOW I CAN HELP YOU I guide companies seeking help with biologics manufacturing and groups/individuals evaluating companies they are considering for investment. Biologics: • CMC expertise: examples include process descriptions, development data, safety data, validation, all aspects of filing • Process variability: CQAs or yield Due Diligence: • Scientific understanding and practical feasibility of your asset • Target patient population size and needs • Landscape of competing therapies and differentiating factors for your asset • Initial valuation Strategic Guidance: • Roadmap to asset development • Overall timeline with potential critical points and roadblocks • Contacts with expert consultants to accelerate your program HOW WE WORK TOGETHER • Contact me and we can discuss your goals and needs • We work together to build an approach that works for your needs • If I am not the right fit, I can refer you to colleagues who have the expertise you need