Achieving Technological Leadership in Advanced Pharmaceutical Manufacturing

Held in Washington, DC; November 13-15, 2023

8:00 am	Welcome and Introductions	Dr. Vadim Gurvich, PhD, Executive Director, NIPTE
8:10 am	Keynote Address 1	James Coburn (FDA/OSTP)
8:55 am	Q&A
9:05 am	Keynote Address 2	Ranjani Prabhakara (FDA) – Advanced Mfg Technologies
9:50 am	Q&A
10:00 am	Keynote Address 3	Eric Edwards (Phlow)
10:45 am	Q&A
10:55 am	SESSION END

11:00 am – 12:40 pm EST

NIPTE DISTINGUISHED SCHOLARS

	Introduction and Presentation of 2023 Awards	Dr. Vadim Gurvich, PhD, Executive Director, NIPTE
11:10 am		Dr. Mansoor Khan, Texan A&M University Michael J. Pikal Distinguished Scholar in Pharmaceutical Processing
11:40 am		Chaowang Zeng, University of Minnesota 2023 NIPTE – Rigaku Fellowship
12:10 pm		Mustafa Bookwala, Duquesne University 2023 Outstanding Student Researcher
12:40 pm	SESSION END

1:15 pm – 2:15 pm EST

Presentations: Student Research Poster Session

1:15 pm	Student from NIPTE Institutions will present posters of their research work.
2:15 pm	SESSION END

2:30 pm – 5:30 pm EST

5:30 pm – 7:00 pm EST

Closed Working Session

SPECIAL SESSION: Steve Byrn Career Celebration

5:30 pm	Welcome, Tribute & Introductions	Dr. Vadim Gurvich, PhD, Executive Director, NIPTE
5:40 pm	Tribute 1
5:55 pm	Tribute 2
6:10 pm	Tribute 3
6:20 pm	Remarks	Steve Byrn, Purdue University
6:40 pm	Memory Sharing/Toasts/Open Dialogue	All Participants
7:00 pm	SESSION END

*Subject to Change*

8:00 am – 10:30 am EST

Talks (NIPTE Faculty Research Spotlights on Achieving Technological Leadership in Advanced Pharmaceutical Manufacturing)

8:00 am	Session & Speaker introduction	Dr. Vadim Gurvich, PhD, Executive Director, NIPTE
8:05 am	Keynote Speaker 4	Eyal Barash
8:50 am	Q&A
9:00 am		Speaker 1
9:30 am		Seongkyu Yoon, University of Massachusetts Lowell
10:00 am		Speaker 3
10:30 am	SESSION END

10:45 am – 12:50 pm EST

SPECIAL SESSION: Updates from Major Projects (Knowledge Management Project/USP System AND Biologics/Biosimilars Project AND BAAs)

10:45 am	Session & Speaker introduction	Dr. Vadim Gurvich, PhD, Executive Director, NIPTEiversity
10:50 am	Update on Knowledge Management Project/USP System	Gerardo Callegari, Katie Baumer (USP)
11:20 am	Update on Biologics/Biosimilars Project	Sury, Anurag, Reza
11:50 am	BAA 1: Continuous Drug Substance Manufacturing from Biomass Derived Building Blocks	Torsten Stelzer
12:20 pm	BAA 2: End-to-End Continuous Manufacturing	James Ferri and Ravendra Singh
12:50 pm	SESSION END

1:30 pm – 5:00 pm EST

Closed Working Session

8:00 am – 10:15 am EST

10:15 am – 10:30 am EST

Closed Working Session

Break

10:30 am -12:00pm EST

SPOTLIGHT SESSION: New NIPTE Schools and the Center of Excellence Initiative

10:30 am	Summary of Roadmap Initiative	Peter Wildfong
10:40 am	Injectables Workshop
11:00 am	Drug Development Process – Moving on from Workshop January 2023	Xiuling Lu
11:20 am	Opportunities for Academia to Address Drug Development, Distribution & Disparities	Michael Kinch
11:40 am	Conference Closing Thoughts	Rodolfo Romanach, NIPTE Chair of the Faculty
12:00 pm	SESSION END