Dick Lancaster Email & Phone Number

I have worked in the biotechnology industry for over 25 years in product development, regulatory affairs, and manufacturing of parenteral and solid oral dosage form drug candidates in a GXP environment. My experience includes regulatory strategy, interpretation of regulatory requirements, manufacturing (in house and contract), process development, technology transfer, validation, and manufacturing scale-up to commercial production. I've been involved in the writing, editing, and review of NDA, MAA, IND, CTA, and other regulatory submissions as well as being a key subject matter expert in Pre Approval Inspections. In short, I have extensive experience in Production Development, Regulatory Affairs, and Operations of biopharmaceuticals and am flexible to meet a company’s changing strategic demands.My current role is Vice President, Product Development to manage all aspects of CMC product development of small molecule, solid oral dosage form drugs including: chemistry, API manufacturing, formulation, analytical, packaging, clinical trial labeling and distribution, and commercial labeling and serialization. I have extensive experience in third-party contract manufacturing management for all phases of development.