Workshop on Pharmaceutical Development Technologies
Date and Place
March 13-14, 2019
Truhlsen Events Center
619 South 42nd Street, Omaha, NE
Ram Mahato, Ph.D., Department of Pharmaceutical Sciences, UNMC
Aaron Mohs, Ph.D., Department of Pharmaceutical Sciences, UNMC
Ajit S. Narang, Genentech, Inc., South San Francisco, CA
This workshop will provide an introduction to pharmaceutical industries and an overview of the function of formulation and process development scientists in the discovery, development and commercialization of safe and efficacious drug products. Sessions will include an introduction to oral biopharmaceutical development, process development for oral drug products, chromatographic and solid phase analytical methods, and considerations for development versus manufacturing in the drug development process. Attendees will also be able to participate in sessions related to soft skills that are essential in the pharmaceutical industry.
Ajit S. Narang, Ph.D. is a senior investigator at Genentech, Inc. South San Francisco and adjunct faculty at UNMC College of Pharmacy. Dr. Narang is responsible for the pharmaceutics and biopharmaceutics of small molecules in preclinical and early clinical development of various dosage forms. He earned his Ph.D. from the University of Tennessee in Memphis, Masters in Pharmaceutics from the Banaras Hindu University in India, and Bachelors in Pharmaceutical Sciences from the University of Delhi in India. He has over 15 years of drug product development experience working for Bristol-Myers Squibb, Co. (BMS) in New Jersey, Wockhardt Pharmaceuticals (ex-Morton Grove Pharmaceuticals) in Illinois, and Ranbaxy Research Labs in India in different capacities. Ajit has contributed to several preclinical, clinical, and commercialized drug products including NDAs, ANDAs, and 505B2s. He is credited with over 74 peer-reviewed articles; 4 books; 9 issued patents/patent applications; 43 invited talks; and 83 presentations at various scientific meetings.
Title: Risks at the interface of development and manufacturing of parenteral drug products
Erinc Sahin, Ph.D., Principal Scientist, Drug Product Science & Technology, Bristol-Myers Squibb. Dr. Sahin received his B.Sc. in Molecular Biology and Genetics in METU (Turkey); M.Sc. on a joint program between Bioengineering and Materials Science & Engineering departments in Sabanci University (Turkey); and his Ph.D. on a joint program between Biochemistry and Materials Science & Engineering departments in University of Delaware. Prior to joining BMS in 2011, Dr Sahin worked on aggregation of therapeutically relevant proteins as a post-doctoral fellow in Roberts group in Department of Chemical and Biomolecular Engineering in University of Delaware. Since 2011, Dr Sahin has taken roles with increasing complexities and responsibilities in a group that develops formulations, manufacturing processes, and patient-centric product presentations for parenteral drug products, from their discovery to commercialization.
Title: Pharmaceutical Solid-State Chemistry & Characterization in Drug Discovery and Development
Joe Lubach, Ph.D., is a Senior Scientist in the Small Molecule Pharmaceutical Sciences department at Genentech, Inc., where he has been since 2007. In his current role, he leads the Solid-State Chemistry group within the Pharmaceutics department, working on physical form screening and solid-state characterization of small molecule drug substances and drug products. His personal research interests revolve around expanding applications of solid-state NMR spectroscopy across the pharmaceutical discovery and development landscape, and he has authored or co-authored thirty-five peer-reviewed publications and three reference chapters stemming from his work. Joe holds a Ph.D. in Pharmaceutical Chemistry from the University of Kansas (2007), where he worked with Prof. Eric Munson.
Title: Extrusion Applications in Manufacturing Pharmaceutical Oral Drug Products
Bei Chen, Ph.D. is currently a Principle Research Engineer in AbbVie. She joined Abbott/AbbVie in 2007 and has more than 10 years’ experience in both brand-name and generic drug companies. Bei has extensive experience in process development and scale-up of oral dosage forms. Dr. Chen has served as a lead process engineer for multiple development and marketed products, as well as CMC team lead for products in virology and oncology, representing drug substance, analytical and drug product development functions interfacing with R&D, Regulatory, commercial plants and TPMs. Dr. Chen received BS in chemical engineering from East China University of Science and Technology and Ph.D. in Chemical Engineering from Akron University. She is a certified statistics Black Belt.
Title: Inventing for Life
Rebecca "Becky" Nofsinger, Ph.D. is currently an Associate Principle Scientist in the Biopharmaceutics and Specialty Dosage Form group at Merck. Her main work activities relate to oral biopharmaceutics focusing on supporting oral formulation development across various clinical development stages with an expertise at the discovery/development interface, oral peptide permeation, and prodrug development. Becky obtained her PhD degree in Pharmaceutical Chemistry from the University of Kansas under Dr. Ron Borchardt. She has presented at various conferences and authored/co-authored several research and review articles.
Title: Analytical methods and challenges supporting early phase inhaled drug product development.
Jerry Tso, Ph.D. is a Scientist at Genentech in the Small Molecule Analytical Chemistry group at South San Francisco, CA. He currently supports the analytical development of inhaled drug product from preclinical to phase 2 clinical studies. He earned his B.S. in Applied Ecology at the University of California, Irvine and a Ph.D in Analytical Chemistry at The State University of New York, Buffalo with Professor Diana Aga. His research focused on the separations and mass spectrometry. He has held previous positions at W.L. Gore and Associates in Flagstaff, AZ as the lead scientist in the R&D analytical and bio-analytical lab for combination drug products, and as Principal Scientist and Analytical Lab Manager at Novartis in the Manufacturing Science and Technology group in Emeryville, CA.
Finalized agenda is in development.