Chapter -20230330

30 March 2023

We have welcomed Brad Beach. He is added as Purdue University Representative representing the Purdue “ Advanced Pharmaceutical Manufacturing Institute” project.

We have covered the Status of the activities at the three FIT’s (UMBC, Purdue, UC Davis)

Purdue University (Jo Davisson, Brad Beach)

  • Brad has covered the “Institute for Advanced Manufacturing of Pharmaceuticals” Project and the opportunity to work together with the “Workforce of the Future” to define the courses to offer to Students to reach a “Certification” in Pharmaceutical Manufacturing and potential Master Programs/Degrees in Advanced Pharmaceutical Manufacturing.
  • The current thought is to organize “Job Profile” Teams led by a Faculty Lead and an Industry Team Lead. This approach and feasibility need to be confirmed in the next weeks as well as identify which Profiles to pursue first.
  • A shorter version of Brad’s presentation is attached for your perusal and comments.

UMBC (Tony Moreira)

  • During the Fall Semester four new courses will be offered: -Pharmaceutical Career Course – 16 Industry lectures – The lectures will be offered on Monday evenings. -Clinical Trial course and Intro to Statistics – The course will be delivered by the former FDA OTAT (office of Tissues and Advanced Therapies) Director -Vaccines Development & Manufacturing including Clinical Trials and Continuous Manufacturing -Summer Course: mAbs Analytical Testing – The course is being developed in collaboration with NIST.

UC Davis (Meli Gallup and Tara Stonebarger)

  • The QbD in Biopharmaceuticals short course is now part of the Chemical Engineer Master curriculum and it has been delivered on March 1,2023 as part of the Spring Semester. The Industry Panel was in attendance.
  • Short course on IT & Data Management in Manufacturing. Adam Fernier will reconnect with the UC Davis Faculty to understand the next steps.
  • Risk Management Short course . Tara Stonebarger (Bayer) is ready discuss the next steps Karen McDonald. Tara would prefer to run it in person.
  • Phase II Profiles contacts update (Tony Moreira)
    • Following the meeting with Karen McDonald, Ferdinando will organize a meeting with Denneal Jamison McClug to assess UC Davis interest in a new collaboration on various Technical profiles.

Next Meeting:

• Wednesday May 3 – 12 PM to 1 PM US EDT • Zoom invite was issued on March 31, 2023 • Agenda will be issued by Ferdinando Aspesi around April 25th .

Best,

FERDINANDO ASPESI