Workshop

Workshop on Pharmaceutical Development Technologies

Date and Place:  March 7, 2018 in PDD 1002

Host:  Ram Mahato, Ph.D., Department of Pharmaceutical Sciences
            University of Nebraska Medical Center, Omaha, NE

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 explore the drug discovery/development interface, pre-formulation, and formulation technologies used to achieve suitable drug product process and biopharmaceutical performance.  Case studies for roller compacted drug products will be used to illustrate the concepts of formulation optimization and process development through design of experiments.  Drug product control strategies and examples of process analytical technology will be described for a product manufactured using high shear wet granulation process.  Examples more complex solid oral products such as modified release dosage forms fixed-dose combinations will be provided. An introduction to biological drug products for parenteral administration and inhaled products for pulmonary delivery will also be presented.   

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. HemenwayJeffrey Hemenway, Ph.D. is a Senior Scientist in Formulation and Process Development at Gilead Sciences Inc.  He received his bachelor’s in Chemistry from University of Missouri, Kansas City, and his doctorate in Pharmaceutical Chemistry from the University of Kansas, where he was trained in the area of prodrug design and characterization. He has over 12 year of experience in the pharmaceutical industry working for Bristol Meyers Squibb and Gilead Sciences Inc., where he has contributed to the development of several preclinical, clinical and commercially approved products.  He has published 11 research articles and book chapters and is credited to one patent as an inventor. He is a member of the AAPS and currently serves as the Past Chair of the Formulation and Dosage Design Section.  He also currently serves as a Scientific Advisor to the Editors of the Journal of Pharmaceutical Science and serves as a manuscript reviewer for several other scientific journals.  In his current position at Gilead Sciences, he leads a team of scientists responsible for discovery pharmaceutics, preformulation, formulation and manufacturing process development, clinical manufacturing, scale up, tech transfer, and CMC regulatory documentation for early and late stage programs. His areas of research interest include prodrugs, excipients and reactive impurities, degradation mechanisms, amorphous formulations, polymorphism, and physical and mechanical powder properties.

Dr. FulzeleSuniket Fulzele, Ph.D. works as Senior Manager and R&D Team leader, Formulation Development at Teva's CIMA Labs subsidiary in Brooklyn Park, Minnesota. He provides technical leadership for Formulation and Process development of complex dosage forms with Modified and Immediate Release, Abuse Deterrent, Buccal, and Orally Disintegrating properties. Suniket has contributed to several preclinical, clinical, and commercialized drug products including NDAs, and 505B2s. He is credited with over 40 peer-reviewed articles; 60 presentations/posters at various scientific meetings; book chapter; excipient monographs; patents; and invited talks. Suniket holds Ph.D degree in Pharmaceutics from Nagpur University, India; has over three years of Post-doctoral experience from Florida A&M University; and over 10 years of pharmaceutical industry experience in different capacities.

Agenda

8:45-9:00AM

Opening Remarks

Ram

9:00-9:30AM

Overview of Pharmaceutical Industry and Skills Needed to be Successful

Jeff

9:30-10:15AM 

Overview of New Drug Discovery, Development, and Commercialization Process

Ajit

10:15-10:30AM 

Break

 

10:30-11:15AM  

Discovery Pharmaceutics, Preformulation, and Form Selection

Jeff

11:15AM-12:00PM

Overview of Drug Product Technologies, Unit Operations, and Process Selection

Suniket

12:00-1:00PM  

Lunch

 

1:00-1:45PM

Formulation Optimization and Process Development with Examples in Roller Compaction

Jeff

1:45-2:30PM 

Control Strategies and Process Analytical Technologies for a Wet Granulation Process

Ajit

2:30-2:45PM

Break

 

2:45 -3:15PM

Parenteral Protein Formulations

Ajit

3:15-3:45PM

Sustained Release Formulations

Suniket

3:45-4:15PM

Combination Products

Jeff

4:15-4:45PM

Inhaled Formulations

Ajit

4:45-5:00PM

Closing Remarks

Ram