NIPTE Improving Quality Lowering Cost Enhancing Confidence The National Institute for Pharmaceutical Technology and Education 2005-2015: a decade of scientific excellence A not-for-profit academic organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing RESARCH CONFERENCE: PHARMACEUTICAL CRITICAL PATH MANUFACTURING-2015 April 30 – May 1, 2015, Rockville, MD In 2011, NIPTE was awarded an U01 Grant from the U.S. Food and Drug Administration (FDA) titled “Critical Path Manufacturing Sector Research Initiative” to conduct research in pharmaceutical technology and education. The grant is focused on the continuing need for research towards enhancing reliability and achieve better quality assurance on drug products manufactured across the entire industry. FDA believes that the shared knowledge and implementation of science- and risk-based controls will increase the likelihood of successfully manufacturing the products throughout their lifecycle. Free registration at www.nipte.org Location: Conference Center, Building 2, The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, MD 20850 CONFERENCE AGENDA Friday, May 1, 2015 Thursday, April 30, 2015 08:30 – 09:00 Registration Morning Session Chairperson: Lucinda (Cindy) Buhse, Ph.D. 09:00 – 09:15 Lucinda Buhse, Ph.D. US Food and Drug Administration Opening Remarks 09:15 – 09:45 Janet Woodcock, M.D. US Food and Drug Administration The New Office of Pharmaceutical Quality; Why, What and How? 09:45 – 10:15 Vadim Gurvich, Ph.D. NIPTE/University of Minnesota NIPTE: A Decade of Excellence in Pharmaceutical Science 10:15 – 10:45 Robert Lionberger, Ph.D. US Food and Drug Administration 10:45 – 11:00 11:00 – 11:30 11:30 – 12:00 Pharmaceutical Science for Generic Drugs 08:20 – 08:40 Ajaz Hussain, Ph.D. NIPTE Q&A and Panel Discussion NIPTE: Future Directions 03:50 – 03:05 09:00 – 09:20 Drug Delivery System Development Chairperson: Katherine Tyner, Ph.D., US Food and Drug Administration 03:05 – 03:25 Katherine Tyner, Ph.D. Introductory Remarks Stephen Hoag, Ph.D. Methods for the Assessment of Cold Flow in 03:25 – 03:45 University of Maryland - Baltimore Matrix Transdermal Drug Delivery Systems 03:45 – 04:05 Maureen Donovan, Ph.D. University of Iowa 04:05 – 04:25 Bodhi Chaudhuri, Ph.D. University of Connecticut Panel Discussion In Vitro Assessment of Nasal Deposition Patterns in the Pediatric Population Electrostatic Behavior in Granular Materials 10:25 10:45 11:05 Zoltan Nagy, Ph.D. Purdue University 12:05 – 12:20 Panel Discussion Variation in Pressure Within the Drying Chamber and Impact on Freeze-Drying Design Space Development of a Real-Time Release Continuous Crystallization System With Anti-Crust Control 12:20 – 01:15 Lunch and Poster Session Three 01:15 – 02: 15 Quality Metrics Panel (moderators Ajaz Hussain and James Drennen) Lawrence Yu, Raj Suryanarayanan, TBD (industry representatives) 02:15 02:35 02:55 03:15 Reception and Poster Session Two Organizing Committee Vadim Gurvich, Chair, NIPTE and University of Minnesota Robin Bogner, University of Connecticut Stephen Hoag, University of Maryland - Baltimore Lee Kirsch, University of Iowa Eric Munson, University of Kentucky Gintaras Reklaitis, Purdue University Robin Bogner, Ph.D. University of Connecticut IgG1 Fc Glycoforms as Model for Biosimilars Comparative Analysis Anna Schwendeman, Ph.D. Physico-Chemical Characterization of Remicade University of Michigan and its Biosimilar Remsima – 10:10 Panel Discussion – 10:25 Break and Poster Session Three Pharmaceutical Solids and Solid Manufacturing Chairperson: Larry Sau Lee, Ph.D. US Food and Drug Administration – 10:45 Larry Sau Lee, Ph.D. Introductory Remarks Lynne Taylor, Ph.D. (invited) – 11:05 TBD Purdue University Lian Yu, Ph.D. Pharmaceutical Co-Crystals and Their Anomalous – 11:25 University of Wisconsin-Madison Formation Properties 11:25 – 11:45 03:30 05:00 – 06:00 Insights from In Silico Analysis for Improved Design of Freeze-Drying Systems and Processes 09:20 – 09:40 09:40 10:10 Break and Poster Session One Alina Alexeenko, Ph.D. Purdue University Thomas J. Tolbert, Ph.D., David B. Volkin, Ph.D., and 08:40 – 09:00 Christian Schöneich, Ph.D. University of Kansas Break 12:00 – 01:00 Lunch and Poster Session One Enhancing Confidence in Therapeutic Biological and Pharmaceutical Equivalence Chairperson: Mansoor Khan, Ph.D., US Food and Drug Administration 01:00 – 01:20 Mansoor Khan, Ph.D. Introductory Remarks Gregory Amidon, Ph.D. Impact of Buffer on Dissolution: In Vivo 01:20 – 02:40 University of Michigan Relevance Initial Studies on the Use of Particle Size Lee Kirsch, Ph.D. Distribution Overlap Metrics to Evaluate 02:40 – 03:00 University of Iowa Release Rate Equivalency for Disperse System Drug Products Cory Berkland, Ph.D. 03:00 – 03:20 TBD University of Kansas 03:20 – 03:50 Panel Discussion 04:25 – 04:55 Biologicals and Biosimilars Chairperson: Steve Kozlowski, Ph.D., US Food and Drug Administration (invited) 08:00 – 08:20 Steve Kozlowski, Ph.D. Introductory Remarks 03:50 04:10 04:40 Pharmaceutical Manufacturing Chairperson: Christine Moore, Ph.D., US Food and Drug Administration – 02:35 Christine Moore, Ph.D. Introductory Remarks Mechanistic Modeling of High Shear Wet Rohit Ramachandran, Ph.D. – 02:55 Granulation Processes: Toward QbD in Rutgers University Pharmaceutical Drug Product Manufacture Peter Wildfong, Ph.D. – 03:15 Characterization of complex mixtures Duquesne University – 03:30 Break Warren Rose, Ph.D. Microbiological Assessment of Pre-operative – 03:50 University of Wisconsin-Madison Antiseptic Products Raj Suryanarayanan, Ph.D. University of Minnesota Evaluation of Polymorphic Changes During Tablet – 04:10 Manufacturing and Storage Eric Munson, Ph.D. University of Kentucky – 04:40 Panel Discussion – 05:00 Concluding Remarks Lawrence Yu and Ajaz Hussain 05:00 Meeting adjourned