Dainius Macikenas Email & Phone Number

Pharmaceutical professional with strong CMC record of accomplishment: formulation development, GMP clinical supply manufacturing, biopharmaceutics, preformulation. Regulatory expertise from initial filings to NDA submissions. Strong collaborative leadership and problem-solving skills. • Head of Formulation Development in the rare disease-focused company, from preclinical/enabling formulations to late-stage development, clinical supplies manufacturing across US/EU• CMC project leader and/or formulations development lead in rare disease areas, antibacterial, hepatitis-C, cancer, and cystic fibrosis therapies across the stages of development, delivering crystalline and amorphous oral as well as IV, IM drug candidates: small molecules, combination products and peptides. defined solid forms (salts, cocrystals, polymorphs) and formulations for numbers of currently marketed medicines.• CMC regulatory expertise in IND/IMPD filings, responses, amendments; pediatric development, NDA filings of Kalydeco™, Incivek™, Thiola EC (TM), Filspari (TM); • Solid form and formulation IP strategies for branded and generic products, including Kalydeco™, Thiola™, Fosmetpantotenate; life-cycle management strategies.• Conceived and executed Pfizer Global R&D Award-winning compound-sparing 96-well based robotic Small Scale Solid Form Screening and solid-state analytics platform; implemented across Pfizer R&D sites.• Established structural informatics and single crystal X-ray crystallography center of excellence.

Listed skills include Formulation, Pharmaceutical Industry, Drug Development, Chemistry, and 14 others.