Brochure - National Institute for Pharmaceutical Technology and

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
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
Location: Conference Center, Building 2, The Universities at Shady Grove,
9630 Gudelsky Drive, Rockville, MD 20850
Friday, May 1, 2015
Thursday, April 30, 2015
08:30 – 09:00
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.
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
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)
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
Purdue University
Lian Yu, Ph.D.
Pharmaceutical Co-Crystals and Their Anomalous
– 11:25
University of Wisconsin-Madison Formation Properties
11:25 – 11:45
05:00 – 06:00
Insights from In Silico Analysis for Improved
Design of Freeze-Drying Systems and Processes
09:20 – 09:40
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
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
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
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
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
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
Meeting adjourned