Paul E. Luner, PhD — Oral Formulation Development & Physical Pharmaceutics

Dr. Luner’s background brings together cross-disciplinary experience in oral formulation development and deep technical understanding of drug substance form, solid state characterization and physical pharmaceutics. With proficiency in rapid formulation development and risk mitigation for solid form, he has over 25 years’ contribution in large pharma as a deep subject matter expert in small molecule development, always maintaining close continuity to the laboratory and data generation, he is adept at providing scientific leadership, applying fundamental based approaches and collaborating to accelerate compound development or innovative value-added methodologies.

Following on from positions at Parke-Davis/Warner Lambert and then serving as Assistant Professor of Pharmaceutics at The University of Iowa, College of Pharmacy, he joined Pfizer R&D in 2002 where he oversaw IR tablet formulation development for Phase I through commercial image projects, including the early clinical formulation development of Xeljanz® (Tofacitinib) and applied material characterization/API sparing techniques for rapid drug product development. Later in Pfizer’s Material Science Group he conducted form screening, selection and solid-state characterization, including an in-depth solid state integrity assessment for Inlyta® (Axitinib). In 2010, Dr. Luner joined Boehringer Ingelheim Pharmaceuticals supervising preformulation, toxicology formulation and material property characterization, along with CMC team lead roles in Product Development. Following the formation Material and Analytical Sciences (MAS), he then supported form selection/characterization and directed the GMP/GLP drug substance characterization testing supporting the pilot plant. Dr. Luner transitioned to consulting in Nov 2019.

Dr. Luner received his Ph.D. (1990) in Pharmaceutics from The University of Michigan, College of Pharmacy under Prof. Gordon Amidon.  He has published over 30 refereed articles and presented invited lectures at leading academic institutions, scientific conferences and FDA (ONDQA). He has served as vice-chair and chair for the Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR) an NSF I/UCRC, is a member of the International Steering Committee for the Handbook of Pharmaceutical Excipients and a long-time member of AAPS and ACS.