Workshop

Workshop on Pharmaceutical Development Technologies

Date and Place
March 13-14, 2019
Truhlsen Events Center
619 South 42nd Street, Omaha, NE

Organizers
Program Chair:  Aaron Mohs, PhD, Department of Pharmaceutical Sciences, University of Nebraska Medical Center
Members:  Ajit Narang, PhD, Small Molecule Pharmaceutical Sciences, Genentech, Inc., One DNA Way, South San Francisco, CA 94080
Ram Mahato, PhD, Department of Pharmaceutical Sciences, University of Nebraska Medical Center

Objectives
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 panel/small group sessions directly related to career development that is essential to the pharmaceutical industry.

Speakers

Dr. Narang

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.

Dr. Erinc SahinTitle: 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.

Dr. Joseph LubachTitle: 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.

Dr. Bei Chen

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.

Dr. Rebecca Nofsinger

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.
Picture: attached.

Dr. Jerry TsoTitle: 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.

Jonathan CheongTitle: In Vitro Permeability Assays for Drug Discovery and Development

Jonathan Cheong, Senior Scientific Researcher, Genentech, received his BSc degree in Biochemistry from the University of Kansas. He started his scientific research on developing high throughput assays for optimization of absorption and metabolism properties of lead compounds from combinatorial chemistry. With more than 20 years of research experience in Drug Metabolism and Pharmacokinetics, his current research continues to develop absorption models and in vitro assays to predict in vivo drug concentrations for efficacy and toxicity and to apply in silico approaches in support of drug design.

March 13, 2019
7:30-8:30 Check-in and breakfast
8:30-8:45 Welcome and introduction to the workshop
Aaron Mohs, PhD, Director, Pharmaceutical Sciences Graduate Program, UNMC
8:45-9:35 Combination Product Design
Ajit Narang, PhD, Senior Investigator, Genentech, Inc.
9:35-9:45 Break
9:45-10:35 Inventing for Life
Becky Nofsinger, PhD, Associate Principle Scientist, Merck
10:45-11:45 Interview skills/Soft skills for working in industry/Technical skills valued for work in the industry
11:45-12:00 Group Photo, all
12:00-1:00 Boxed lunch, all
1:00-1:50

Pharmaceutical Solid-State Chemistry & Characterization in Drug Discovery and Development
Joe Lubach, PhD, Senior Scientist, Genentech Inc.

2:00-2:50 Analytical methods and challenges supporting early phase inhaled drug product Development
Jerry Tso, PhD, Scientist, Genentech Inc.
3:00-4:00 Interview skills/Soft skills for working in industry/Technical skills valued for work in the industry
4:00-4:30

In Vitro Permeability Assays for Drug Discovery and Development
Jonathan Cheong, Senior Scientific Researcher, Genentech

4:30-4:35

Day 1 Closing Remarks
Ram Mahato, PhD, Chair, Pharmaceutical Sciences, UNMC

4:35-4:40 H. Dele Davies, M.D., Senior Vice Chancellor for Academic Affairs
4:40-5:30 Attendee Social – Soft drinks, light snack
March 14, 2019
8:00-8:30 Breakfast
8:30-9:20 Risks at the interface of development and manufacturing of parenteral drug products
Erinc Sahin, PhD, Principle Scientist, Bristol-Myers Squibb
9:20-9:30 Break
9:30-10:20 Extrusion Applications in Manufacturing Pharmaceutical Oral Drug Products
Bei Chen, PhD, Principle Research Engineer, Abbvie
10:20-11:20 Interview skills/Soft skills for working in industry/Technical skills valued for work in the industry
11:20-11:30 Closing Remarks