Collaborative Innovations in Pharmaceutical Product Development
October 2 – 4, 2019
Hyatt Regency Crystal City at Reagan National Airport
SCHEDULE
October 2 | 5 – 8 PM | Potomac V, VI – Ballroom Level
| ❯ | 5:00 | Dinner reception and NIPTE Awards presentation |
October 3 | 8 AM – 4 PM | Potomac Foyer and Conference Theater – Ballroom Level
| | Poster sessions will be in the Regency E. Foyer
| ❯ | 8:00 | Breakfast and poster session |
| SESSION 1: CONFERENCE WELCOME AND KEYNOTE | ||
|---|---|---|
| ❯ | 8:30 | Conference overview and welcome – Dr. Vadim J. Gurvich, Executive Director, NIPTE |
| ❯ | 8:45 | What do we see when we look at NIPTE as a Community of Knowledge? – Dr. Ajaz Hussain, President, NIPTE |
| ❯ | 9:15 | Advancing Drug Product Quality – Dr. Susan Rosencrance, Director, OPQ’s Office of Lifecycle Drug Products (OLDP), FDA |
| ❯ | 9:45 | Driving Innovation in Biomanufacturing Through Measurement Science – Dr. Michael Tarlov, Chief, Biomolecular Measurement Division, NIST |
| ❯ | 10:15 | Refreshments and poster session |
| SESSION 2: BIOLOGICS AND BIOSIMILARS | ||
| ❯ | 11:00 | Session and speaker introductions – Dr. Bruce Yu, University of Maryland |
| ❯ | 11:10 | Advanced Manufacturing of Complex Biologics: A CBER Perspective – Dr. Manuel Osorio, Senior Scientist for Emerging Technologies and Medical Countermeasures, FDA/CBER |
| ❯ | 11:30 | Analytical Comparability Strategies for Biosimilars – Dr. Anna Schwendeman, University of Michigan |
| ❯ | 11:50 | Multiscale PK Modeling of Local Absorption and
Systemic Exposure of Biotherapeutic Formulations Injected in Human Subcutaneous (SC) Tissue – Dr. Tonglei Li, Allen Chao Chair and Professor of Industrial and Physical Pharmacy, Purdue University |
| ❯ | 12:10 | Panel introductions and moderator – Dr. Anna Schwendeman, University of Michigan |
| ❯ | 12:20 | Panel / Q&A |
| ❯ | 12:50 | Lunch and poster session |
| NEW INITIATIVE — TRANSLATIONAL BIOMARKERS | ||
| ❯ | 1:50 | Emerging ideas, latest innovations, and the new Translational Biomarkers focus group – Dr. Jeff Idle, Director and Endowed Professor, Arthur G. Zupko’s Systems Pharmacology and Pharmacogenomics, Long Island University |
| ❯ | 2:20 | Break |
| SESSION 3: NANOTECHNOLOGY | ||
| ❯ | 2:40 | Session and speaker introductions – Dr. Aliasger Salem, University of Iowa |
| ❯ | 2:50 | Regulatory Research Supporting the Development of Drug Products Containing Nanomaterials — a US FDA Perspective – Dr. Katherine Tyner, Associate Director for Science (acting), Office of Pharmaceutical Quality, CDER/FDA |
| ❯ | 3:10 | Nanotechnology Standards for Medical Products – Dr. Anil Patri, Director, Nanotechnology Core Facility, Office of Scientific Coordination, FDA |
| ❯ | 3:30 | Synthetically lethal nanoparticles that treat endometrial cancer – Dr. Aliasger Salem, University of Iowa |
| ❯ | 3:50 | Panel introductions and moderator – Dr. Xiuling Lu, University of Connecticut |
| ❯ | 4:00 | Panel / Q&A |
| ❯ | 4:30 | Networking and poster session |
| ❯ | 5:00 | Adjourn |
| October 4 | 8 AM – 2 PM | Potomac Foyer and Conference Theater – Ballroom Level | ||
| | Poster sessions will be in the Regency E. Foyer | ||
| BREAKFAST SPECIAL SESSION | ||
| ❯ | 8:00 | Intellectual Property in Pharma: General Principles for the Research Scientist – Eyal H. Barash, Barash Law LLC |
| SESSION 4: ADVANCED MANUFACTURING | ||
| ❯ | 8:45 | Session and speaker introductions – Dr. Ira Buckner, Duquesne University |
| ❯ | 8:55 | Advances in Regulatory Science and Emerging Technologies – Dr. Jason Rodriquez,Laboratory Branch Chief, St. Louis, MO, US FDA |
| ❯ | 9:15 | Advanced Manufacturing Technologies for Sustained Release Implants – Dr. Athanas Koynov, Merck |
| ❯ | 9:35 | Implications of Industry 4.0 for Continuous Pharmaceutical Manufacturing – Dr. Gintaras V. (Rex) Reklaitis, Edward W. Comings Professor of Chemical Engineering, Purdue University |
| ❯ | 9:55 | Panel introductions and moderator – Dr. Michael Repka, University of Mississippi |
| Special guest panelist – Dr. Fernando Muzzio, Rutgers University | ||
| ❯ | 10:05 | Panel / Q&A |
| ❯ | 10:35 | Refreshments and poster session |
| SESSION 5: ABUSE DETERRENT FORMULATIONS | ||
| ❯ | 11:00 | Session and speaker introductions – Dr. Stephen Hoag, Charles B. Jordan Professor of Medicinal Chemistry, Purdue University |
| ❯ | 11:10 | Regulatory Consideration and Research to Evaluate Abuse Deterrence (AD) Properties of Opioid Drug Products – Dr. Xiaoming Xu, Senior Staff Fellow, Office of Testing and Research/Office of Pharmaceutical Quality, CDER |
| ❯ | 11:30 | Transdermal Patch Design for Fixed-Dose Combination Drug Delivery – Dr. Zachary Warnken, University of Texas at Austin |
| ❯ | 11:50 | Experimental Considerations in the Evaluation of
Abuse Deterrent Formulations (ADF) – Dr. Stephen Hoag, University of Maryland |
| ❯ | 12:10 | Panel introductions and moderator – Dr. Stephen Hoag, University of Maryland |
| ❯ | 12:20 | Panel / Q&A |
| CLOSING SESSION: PHARMACEUTICAL INNOVATIONS LUNCH & LEARN | ||
| ❯ | 1:00 | Lunch and closing remarks – Dr. Ajaz Hussain, President, NIPTE |
| ❯ | 2:00 | Adjourn |