Accelerating the Drug Development Process
Free conference featuring:
- Guest speakers from government, industry and academia
- Special sessions on a wide range of topics
- Awardee presentations
- Student research virtual posters
Please register by November 28 to receive updates and access links.
Agenda
❯❯❯❯❯ All times are Eastern Standard Time (EST)
Tuesday, November 30
| 8:45 – 10:50 a.m. | CONFERENCE OPEN & KEYNOTES | ||
| 8:45 a.m. | Welcome and introduction | Vadim Gurvich, PhD, Executive Director, NIPTE | |
| 9:05 a.m. | Keynote: Using Predictive Tools to Accelerate Drug Product Development | Bruno Hancock, PhD, Global Head of Materials Science, Pfizer | |
| 9:35 a.m. |  | Keynote: Cell Therapy Technologies | Michael Caligiuri, MD, CEO, City of Hope and CytoImmune Therapeutics, Inc. |
| 10:05 a.m. | | Keynote: Ensuring the supply of quality medicines | Ronald Piervincenzi, PhD, CEO, US Pharmacopeia |
| 10:35 a.m. | Panel / Q&A | With Drs. Hancock, Caligiuri and Piervincenzi | |
| 11:00 – 12:40 p.m. | NIPTE DISTINGUISHED SCHOLARS — 2021 AWARDEES | ||
| 11:00 a.m. | Session & speaker introductions | Vadim Gurvich, PhD, Executive Director, NIPTE | |
| 11:20 a.m. | | Role of excipients in frozen and freeze-dried protein formulations – Q&A to follow | Raj Suryanarayanan, PhD, Professor and William & Mildred Peters Endowed Chair, Department of Pharmaceutics, University of MInnesota, 2021 NIPTE Michael J. Pikal Distinguished Scholar |
| 11:45 a.m. | | Developing next-generation RNA-Targeted Precision Therapeutics – Q&A to follow | Raman Bahal, PhD, Assistant Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut, 2021 NIPTE Rising Star Scholar |
| 12:10 p.m. | | Novel 3D Printing Technologies to Advance Drug Delivery – Q&A to follow | Mohammed Maniruzzaman, PhD, Assistant Professor in Pharmaceutics and Drug Delivery, University of Texas at Austin, 2021 NIPTE Rising Star Scholar |
| 12:35 p.m. | | Novel Manufacturing Strategies for Poorly Soluble Drugs – Q&A to follow | Rishi Thakkar, University of Texas at Austin, Outstanding Student Researcher |
| 1:00 – 2:30 p.m. | NANOTECHNOLOGY | ||
| 1:00 p.m. | Session & speaker introductions | NIPTE Nanotechnology Focus Group Chair, Devika Manickam, PhD, Duquesne University | |
| 1:05 p.m. | | Delivery of cellular overlords (a.k.a. mitochondria) using microvesicles | Devika Manickam, PhD, Duquesne University |
| 1:35 p.m. | | Boosting Intracellular Delivery of mRNA | Gaurav Sahay, PhD, Associate Professor, Oregon State University |
| 1:55 p.m. | | Lessons Learned From the Immunological Characterization of Nanoparticles at the NCL | Marina Dobrovolskaia, PhD, Laboratory Co-Director, Director of Operations, NIH |
| 2:15 p.m. | Panel / Q&A | Moderator: Devika Manickam, PhD, Duquesne University | |
| 3:00 – 4:30 p.m. | BIOLOGICS, BIOSIMILARS & BIOMARKERS | ||
| 3:00 p.m. | | Session & speaker introductions | NIPTE Biologics, Biosimilars & Biomarkers Focus Group Chair, Mahua Choudhury, PhD, Associate Professor, Department of Pharmaceutical Sciences, Texas A&M University |
| 3:10 p.m. | | Developing NMR as a Precision Tool for Assessment of Biotherapeutic Structure | John Marino, PhD, Leader, Biomolecular Structure & Function Group at the National Institute of Standards and Technology (NIST) |
| 3:30 p.m. | | Current Challenges and Advances in Biologics and Gene Therapy Development | Anurag Khetan, PhD, Bristol Myers Squibb |
| 3:50 p.m. | | Future of Epigenetic Biomarkers in Drug Development | Mahua Choudhury, PhD, Associate Professor, Pharmaceutical Sciences, Texas A&M University |
| 4:10 p.m. | Panel / Q&A | Moderator: Shishir Chundawat, PhD, Associate Professor, Department of Chemical and Biochemical Engineering (CBE), Rutgers University | |
Wednesday, December 1
| 8:30 – 10:00 a.m. | ADVANCED MANUFACTURING | ||
| 8:30 a.m. | Session & speaker introductions | NIPTE Advanced Manufacturing Focus Group Chair, Rodolfo Romañach, Professor of Chemistry, University of Puerto Rico | |
| 8:40 a.m. | | CBER Advanced Technologies Program: Promoting the Development and Adoption of Advanced Manufacturing Technologies | Manuel Osorio, PhD, Senior Scientist CBER/FDA |
| 9:00 a.m. | Advanced Manufacturing of Biologics | Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi | |
| 9:20 a.m. | | All vials are not the same: potential role of vaccine quality in vaccine adverse reactions | Bruce Yu, PhD, Professor of Pharmaceutical Sciences, University of Maryland |
| 9:40 a.m. | Panel / Q&A | Moderator: Bruce Yu, PhD, Professor of Pharmaceutical Sciences, University of Maryland | |
| 10:30 – 11:40 a.m. | EDUCATION CENTER SESSION | ||
| 10:30 a.m. | Session & speaker introductions | Center Co-Director, Carl Anderson, PhD, Associate Professor, School of Pharmacy and Graduate School of Pharmaceutical Sciences; Assistant Dean for Graduate Programs and Research, Duquesne University | |
| 10:40 am. | | Complexity of Hiring & Retaining Technical talents | Christian Airiau, Global Head Data Sciences, Biologics Development, Sanofi |
| 11:00 a.m. | Design of a pilot course for a post-baccalaureate certificate in industrial pharmacy, drug formulations, and drug quality | Kari Clase, PhD, Professor, Agricultural & Biological Engineering, Purdue University | |
| 11:20 a.m. | Panel / Q&A | Moderator: Steve Hoag, PhD, Professor, Department of Pharmaceutical Sciences | |
| 12:00 – 1:00 p.m. | STUDENT VIRTUAL POSTER SESSION | ||
| 12 p.m. | Virtual poster viewing | ||
| 12:30 p.m. | | Q&A with student researchers | |
| 3 – 4:45 p.m. | TRIBUTE TO PROFESSOR KENNETH MORRIS | ||
| 3:00 p.m. | Welcome, tribute & introductions | Vadim Gurvich, PhD, Executive Director, NIPTE | |
| 3:20 p.m. | | Reflections on My Time in the Morris Group at Purdue | Peter Wildfong, PhD, Duquesne University |
| 3:35 p.m. | | Hawaiian Days with Dr. Morris | Rahul Haware, PhD, Natoli |
| 3:50 p.m. | | Last Stop before Retirement – Long Island University | Harsh Shah, PhD, J-Star Research |
| 4:05 p.m. | | Memory sharing & toast | All participants |
| 4:30 p.m. | | Closing thoughts | Ken Morris, PhD |
Thursday, December 2
| 8:30 – 9:30 a.m. | SPECIAL SESSION: ADVANCED MANUFACTURING — INCREASING MOMENTUM | ||
| 8:30 a.m. | Session & speaker introductions | Vadim Gurvich, PhD, Executive Director, NIPTE | |
| 8:40 a.m. | | Keynote Presentation | Eric Edwards, MD, PhD, President & CEO, Phlow Corp |
| 9:00 a.m. | Q&A | ||
| 9:30 – 10 a.m. | SPECIAL SESSION: IN VITRO RELEASE TEST FOR COMPLEX DRUG PRODUCTS — START WITH WHY | ||
| 9:30 a.m. | Introduction | NIPTE Faculty Committee Past Chair, Xiuling Lu, PhD, Associate Professor, School of Pharmacy, Department of Pharmaceutical Sciences, University of Connecticut | |
| 9:40 a.m. | | Keynote Presentation | Xiaoming Xu, PhD, CDER, FDA |
| 10:00 a.m. | Q&A | ||
| 10:30 – 11:40 a.m. | INTRODUCTION TO NEW FOCUS AREAS | ||
| 10:30 a.m. | Introduction | NIPTE Faculty Committee Chair-Elect, Peter Wildfong, PhD, Duquesne University | |
| 10:40 a.m. | | Analytical Testing & Stability | Eric Munson, PhD, Purdue University, Dane O. Kildsig Chair in Industrial and Physical Pharmacy, Department Head, Purdue University |
| 11:00 a.m. | | Material Sciences & Formulation | Ira Buckner, PhD, Associate Professor, School of Pharmacy and Graduate School of Pharmaceutical Sciences, Duquesne University; Director, Duquesne Center for Pharmaceutical Technology |
| 11:20 a.m. | Knowledge Management & New Prior Knowledge | Stephen Byrn, PhD, Charles B. Jordan Professor of Medicinal Chemistry, Purdue University | |
| 11:40 a.m. | Panel / Q&A | Moderator | |
| 12:30 – 1:30 p.m. | STUDENT RESEARCH VIRTUAL POSTER SESSION | ||
| 12:30 p.m. | Virtual poster viewing | ||
| 1:00 p.m. | | Q&A with student researchers | |
| 1:45 – 3:00 p.m. | CLOSING SESSION | ||
| 1:45 p.m. | | Introduction and closing remarks | NIPTE Faculty Committee Chair-Elect, Peter Wildfong, PhD, Duquesne University |
| 1:55 p.m. | | Panel / Q&A | Panelists: NIPTE Faculty Committee Chair, Fernando Muzzio; NIPTE Faculty Chair-Elect, Peter Wildfong; and, NIPTE Board of Directors Vice Chair, James Drennen, PhD, Dean, School of Pharmacy, Duquesne University |
| 2:30 p.m. | | Perspective / Thanks / Next steps | NIPTE Faculty Committee Chair, Fernando Muzzio, PhD, Distinguished Professor, Chemical and Biochemical Engineering, Rutgers University |