The New York Academy of Sciences, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich Street, 40th floor New York, NY 10007-2157
2016-11-09
Wednesday, November 9, 2016 7:45 AM
Registration, Continental Breakfast, and Poster Session Setup
8:30 AM
Opening Remarks
8:45 AM
Keynote Address: In-depth Design, Characterization and Control of Liposomal Anticancer Drug Combinations Yields Favorable Clinical Outcomes Lawrence Mayer, PhD, Jazz Pharmaceuticals
Session I: The Current Landscape of Complex Drug Products Session Chair: Scott McNeil, PhD, Director of the Nanotechnology Characterization Laboratory
9:15 AM
Biologics and Non Biological Complex Drugs: Similarities and Differences / Terminology Daan Crommelin, PhD, Utrecht University
9:35 AM
FDA Perspective on Determining Equivalence of Generic Complex Drug Products Wenlei Jiang, PhD, U.S. Food and Drug Administration
9:55 AM
The CHMP/EMA Experience with Biosimilars Elena Wolff-Holz, MD, Paul Ehrlich Institute, Germany
10:15 AM
Networking Coffee Break
Session II: Hot Topic Talks from Submitted Abstracts Session Chair: Vinod Shah, PhD, Non Biological Complex Drugs Working Group
10:45 AM
Title to Be Announced Speaker to Be Selected from a Competitive Review Process
11:00 AM
Title to Be Announced Speaker to Be Selected from a Competitive Review Process
Session III: Characterization of Complex Drug Products — NBCDs and Nanosimilars Session Chair: Jon de Vlieger, PhD, Lygature
11:15 AM
Title to Be Announced Andre Raw, PhD, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
11:35 AM
Recent Development in Particle Size Measurements for Nano/Colloidal Range Wyatt Vreeland, PhD, The National Institute of Standards and Technology (NIST)
11:55 AM
NBCD Pharmacokinetics and Challenges for Bioequivalence Stephan Stern, PhD, DABT, Nanotechnology Characterization Laboratory (NCL)
12:05 PM
Panel Discussion Panelists to Be Announced
12:40 PM
Networking Lunch
Session IV: Challenges and Advances — Lessons from the Field Session Chair: Wenlei Jiang, PhD, Office of Research and Standards, Office of Generic Drugs, US Food and Drug Administration
1:50 PM
Lessons Learned for Biosimilars in the US Gillian Woollett, DPhil, MA, Avalere Health
2:10 PM
Ocular Emulsions: Challenges with In Vitro Assessments and Impact of Manufacturing Changes Chetan Pujara, PhD, Allergan
2:30 PM
Development of a Generic Doxil: A Case Study for Regulatory Harmonization Gary West, MD, Azaya Therapeutics
2:50 PM
Polymeric Micelles and Paclitaxel Kouros Motamed, PhD, NantBioScience, Inc.
3:10 PM
Speaker to be announced
3:30 PM
Networking Coffee Break
Session V: The Global Perspective Session Chair: Daan J.A. Crommelin, PhD, Utrecht University
4:00 PM
Similarity Approach of Complex Drug Products: Scientific and Regulatory Challenges Stefan Mühlebach, PhD, Vifor Pharma
4:20 PM
Speaker to Be Announced
4:40 PM
Panel Discussion Panelists to Be Announced
5:15 PM
Closing Remarks
5:20 PM
Networking Reception and Poster Session
6:30 PM
Conference Concludes
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