2023 NIPTE Research Conference

Achieving Technological Leadership in Advanced Pharmaceutical Manufacturing

Held in Washington, DC; November 13-15, 2023
Texas A& M – Bush School for Government & Public Service, 1620 L Street NW, Washington, DC 20036


CONFERENCE AGENDA

Monday, November 13

8:00 amWelcome and IntroductionsVadim Gurvich, Ph.D
Executive Director, NIPTE
8:10 amKeynote Address 1James Coburn CDR
Manufacturing Innovation Lead for Pandemic Preparedness, Office of Science and Technology
White House
8:55 amQ&A
9:05 amThe Advanced Manufacturing Technologies Designation ProgramRanjani Prabhakara, Ph.D
Policy Lead
CDER/FDA
9:50 amQ&A
10:00 amAdvanced Manufacturing: Translating Promise to ProgressEric Edwards, MD, Ph.D
Chief Executive Officer
Phlow USA
10:45 amQ&A
10:55 amSESSION END

11:00 am – 12:40 pm EST

NIPTE DISTINGUISHED SCHOLARS

Introduction and Presentation of 2023 AwardsVadim Gurvich, Ph.D
Executive Director, NIPTE
11:10 amAdvances in Pharmaceutical ManufacturingMansoor Khan, Ph.D
Texas A&M University
Michael J. Pikal Distinguished Scholar in Pharmaceutical Processing
11:40 amEffect of Processing and Cosolutes on Mannitol Phase Behavior in Frozen SolutionsChaowang Zeng
University of Minnesota
2023 NIPTE – Rigaku Scholar
12:10 pmThe Implications of the Halogen Atom on the Physical Stability of Amorphous Solid DispersionsMustafa Bookwala, Ph.D
Senior Scientist, Materials and Biophysical Characterization Group, Merck
2023 Outstanding Student Researcher
12:40 pmSESSION END

1:15 pm – 2:15 pm EST

1:15 pmStudents from NIPTE Institutions – Poster Presentations
2:15 pmSESSION END

2:30 pm – 5:30 pm EST

5:30 pm – 7:00 pm EST

Closed Working Session

SPECIAL SESSION: Stephen R. Byrn Career Celebration

5:30 pmWelcome, Tribute & IntroductionsVadim Gurvich, Ph.D
Executive Director, NIPTE
5:40 pmTributesMansoor Khan, Ph.D
Texas A&M University
5:55 pmTributesKenneth Morris, Ph.D
6:10 pmTributesEyal Barash
Barash Law LLC
6:20 pmRemarksStephen R. Byrn, Ph.D
Purdue University
6:40 pmMemory Sharing/Toasts/Open DialogueAll Participants
7:00 pmSESSION END

Tuesday, November 14

8:00 am – 10:30 am EST

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

8:00 amSession & Speaker introductionPeter Wildfong, Ph.D
NIPTE – Immediate Past Chair of the Faculty
Duquesne University
8:05 amKeynote: Patents and Pharmaceutical Innovation – the Special Case of Solid Form PatentsEyal Barash
Barash Law LLC
8:50 amQ&A
9:00 amAn Integrated Workflow using Continuous Manufacturing for Nanoparticle TherapeuticsAntonio Costa, Ph.D
University of Connecticut
9:30 amChallenges and advances in gene therapy BiomanufacturingSeongkyu Yoon, Ph.D, MBA
University of Massachusetts Lowell
10:00 am3D and 4D Printing to Advance Drug DeliveryMo Maniruzzaman, Ph.D
University of Mississippi
10:30 amSESSION 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 amSession & Speaker introductionRodolfo Romanach, Ph.D
University of Puerto Rico
NIPTE Chair of the Faculty
10:50 amA NIPTE-USP Knowledge Center: Project Overview and UpdateGerardo Callegari, Ph.D
Rutgers University
Kaitlin Baumer, CAE, PMP
USP
11:20 am



Platform for Reliable Characterization and Evaluation of Comparability of Biosimilar
Drug Products in Lyophilized and Liquid Formulations




Raj Suryanarayanan, Ph.D
University of Minnesota

Anurag Rathore, Ph.D
Indian Institute of Technology, Delhi

Reza Nejadnik, Ph.D
University of Iowa
11:50 amPharmaceutical Manufacturing and SustainabilityTorsten Stelzer, Ph.D
University of Puerto Rico, Crystallization Design Institute
12:20 pmBAA 2: End-to-End Continuous ManufacturingJames Ferri, Ph.D
Virginia Commonwealth University
Ravendra Singh, Ph.D
NSF-ERC, USA, Rutgers University
12:50 pmSESSION END

1:30 pm – 5:00 pm EST

Closed Working Session


Wednesday, November 15

8:00 am – 10:15 am EST

10:15 am – 10:30 am EST

Closed Working Session

Break

10:40 am -12:00pm EST

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

10:40 amInjectables Workshop 2024Eric Munson, Ph.D
Purdue University
11:00 amDrug Development Process – Moving on from Workshop January 2023Xiuling Lu, Ph.D
University of Connecticut
11:20 amOpportunities for Academia to Address Drug Development, Distribution & DisparitiesMichael Kinch, Ph.D
Long Island University
11:40 amConference Closing ThoughtsRodolfo Romanach, Ph.D
University of Puerto Rico
NIPTE Chair of the Faculty
12:00 pmSESSION END