Derek MacLean

Background

About Derek MacLean

Senior chemical scientist with an unusually broad range of experience in pharmaceutical/biotech technology, research, and development. Extensive knowledge in the development of therapeutic peptide NCEs (4 invented peptides to clinic, with Parsabiv global approval in 2016/17). Significant experience in API / drug product manufacturing, process validation, CMC/Regulatory, outsourcing, and supply-chain management. Small molecule, peptide, biologic, and polymer therapeutic development. Manage CMC activities for 5 compounds up to Phase 3 and commercial readiness, including API process development, scale-up; Drug product formulation, sterile manufacturing, process validation, analytical development and validation. CMC lead for partnering activities and alliance management. Writing of regulatory documents (IND, IMPD, NDA, MAA, BLA). Outsourcing selection, negotiation, and vendor management. Lead all aspects of building chemistry capabilities, facilities and team in three start-up environments. Cost-effective chemistry implementation from empty lab to IND and beyond. Lead medicinal chemistry discovery program, and all chemistry aspects of transition into preclinical and clinical studies. Advanced delivery technology for IV, SC and transdermal administration. PET radiochemistry technology integrating advanced medical imaging and drug discovery. Strong expertise in drug discovery technology. Creative leadership and integration of chemistry, engineering, biology, and analytical tools for efficient, miniaturized small-molecule compound manufacturing and testing. Specialties: Contract Manufacturing, Parenteral Formulation Development, Oral Biologics, Medicinal Chemistry, CMC, Peptide Chemistry, Peptide Manufacturing, Molecular Imaging, Solid-Phase Chemistry, Combinatorial Strategies, Drug Delivery