Dainius Macikenas
About Dainius Macikenas
Dainius Macikenas serves as the Director of Formulation at both Retrophin and Travere Therapeutics, where he focuses on formulation development in rare diseases and other therapeutic areas. He holds a PhD in chemistry and has extensive experience in CMC projects, regulatory expertise, and innovative solid form strategies.
Work at Travere Therapeutics
Dainius Macikenas serves as the Director of Formulation at Travere Therapeutics, a position he has held since 2020. Based in San Diego, California, he is responsible for leading formulation development efforts within the company. His work focuses on developing drug candidates in various therapeutic areas, particularly in rare diseases. He has contributed to the formulation of both small molecules and peptides, ensuring the successful delivery of innovative therapies.
Education and Expertise
Dainius Macikenas holds a Bachelor of Science in Chemistry from Vilnius University, where he studied from 1990 to 1995. He furthered his education at Case Western Reserve University, earning a PhD in Chemistry from 1995 to 1999. Additionally, he studied at Aarhus University for one year, obtaining another Bachelor of Science in Chemistry. His academic background provides a strong foundation for his expertise in formulation development and CMC regulatory processes.
Background
Before joining Travere Therapeutics, Dainius Macikenas held various roles in the pharmaceutical industry, including his position at Retrophin, where he also serves as Director of Formulation. His extensive experience includes leading CMC projects and formulation development across multiple therapeutic areas, including antibacterial, hepatitis-C, cancer, and cystic fibrosis therapies. He has a proven track record in developing both branded and generic products.
Achievements
Dainius Macikenas has led significant initiatives in formulation development, including the establishment of a center of excellence for structural informatics and single crystal X-ray crystallography. He conceived and executed a robotic Small Scale Solid Form Screening platform, which won the Pfizer Global R&D Award and was implemented across Pfizer's R&D sites. His work has contributed to the development of various drug candidates and has had a notable impact on the field.
Regulatory Expertise
Dainius Macikenas possesses CMC regulatory expertise, particularly in pediatric development and NDA filings. He has been involved in the regulatory processes for several notable drugs, including Kalydeco™, Incivek™, Thiola EC, and Sparsentan. His knowledge of regulatory requirements enhances his ability to navigate the complexities of drug development and ensure compliance with industry standards.