12 Jan 2023

Dear All,

Thank you for the good meeting we had on Thursday January 12th .

Present:

• Antonio Moreira • Ferdinando Aspesi • Darren Dasburg • Diane Tennenhouse • Jo Davisson • Joseph Sanchez • Manfred Maeder • Ranjit Deshmukh • Adam Fernier

Excused:

• Tara Stonebarger • William Clark • Meli Ratna We welcomed Adam Fernier . he is replacing Robert Famiglietti that has left J&J to a new job in the Industry.

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

• UMBC (Tony Moreira) o Tony has confirmed that a new full course on Clinical Trials has been approved and will be delivered during the 2023 Spring Semester. The course will be taught by an FDA officer from CBER. o The GMP/Regulatory class is being attended by 28 students and we expect to have additional extended learning students. Case studies have been developed by Ferdinando Aspesi and they will be presented on February 2, 2023. o The Design of GMP facilities course and practical case is led by Richard Bank (Skan). It includes the use of a 200 liters Bioreactor, Aseptic Fill and Finishing in compliance with the requirements of the PIC/S 2A and Annex 1. The outcome might become later an ISPE paper. o Chemical Engineering is interested to connect with a Company to develop a Capstone Project to involve Senior Undergraduate students. It should involve Facilities or Process Design including costing and sustainability issues. Our team members have been asked to provide any input/connection to start this initiative to Tony. o New/additional courses planned for 2023 :  Cell & Gene Therapy Course – It has been confirmed that it will be again offered as part of 2023 Spring Semester. 11 Students have already enrolled.  Viral Vector Manufacturing – Leader to be identified – Mark Schenerman is working to identify the Leader.  Vaccines Manufacturing – Leader to be identified – Ditto. • If anybody has names to suggest as leaders for the “Viral Vector Manufacturing” and for the “Vaccines Manufacturing” courses, please contact Dr. Moreira  AI & Machine and Bioinformatics – Mark Schenerman is working on a course to be launched during the Fall 2023 Semester.  A Flyer for all the above 2023 new courses will be provided to our team by Dr. Moreira o UMBC - The “Pharmaceutical Industry Speaker Series” like the Purdue one has been postponed to the 2023 Fall Semester or Spring 2024 Semester to better communicate its availability to Students.

• Purdue University (Jo Davisson, Tony Moreira) o The 2023 Spring “ Pharma industry Introduction lectures” are underway . Joe Sanchez has just delivered the “ Biopharma Industry Overview”. It has been attended by 88 students. o Prof. Davisson mentioned that Purdue has decided to start the “ Purdue Pharmaceutical Manufacturing Institute” in Indianapolis. Its funding will be dedicated 50% to Research Projects (as graduate work) and 50% to Scholarships to ensure guaranteed Scholarships to High Students to study at the Institute and later join the Industry. Jo has encouraged us to continue our initiative interaction with the Professors described here below as well as to engage with Eric Munson at the new formed PPMI. Ferdinando will discuss with Tony to decide when to meet with Eric Manson or Rex Reclaitis (Purdue) on this project. o Prof Davisson has acknowledged the receipt of the 13 Technical Profiles and 8 related Job descriptions sent by Ferdinando last month. They cover the Industry profiles not considered by Purdue yet. They could be used for future interactions with the PPMI and Purdue Faculty. o Automation & Robotics Engineer – We had the second meeting with Prof. Dr. Martin Jun last July. As agreed with Prof Jun we plan to reconnect with him soon. Dr. Moreira will follow up with Prof. Jun in February 2023. o IT & Data Management in Manufacturing Engineer – A meeting with Prof. Tim Hazbun was held on August 2. As agreed with Prof. Hazbun we plan to reconnect with him soon. Dr. Moreira will follow up with Prof. Hazbun in February 2023.
o Cold Chain Packaging Engineer course. We are waiting for Purdue feedback to understand if the lectures will be repeated in 2023. Ferdinando will follow it up with Alina Alexeenko.

• UC Davis (Meli Gallup and Tara Stonebarger)

o Ferdinando will organize in the next two weeks a UC Davis FIT meeting to refocus our activities with UC Davis. o The QbD in Biopharmaceuticals short course will be part of the Chemical Engineer Master and it will be delivered on March 1,2023 as part of the Spring Semester. The Industry Panel will need to be recontacted (Meli, a Meli’s colleague from Genentech, Nassim from AZ and a Grifols representative – Meli to follow up with these individuals) . o Combination Products course . Prof. Choi is waiting her Bioengineering colleagues’ feedback to decide the next steps. Meli will follow up this topic with Prof. Choi soon. o Short course on IT & Data Management in Manufacturing. Adam Fernier will reconnect with the UC Davis Faculty to understand the next steps. o Risk Management Short course . Tara Stonebarger (Bayer) is ready discuss the next steps with Meli and Karen McDonald. Tara would prefer to run it in person. o Phase II Profiles contacts update (Tony Moreira)  No new Info. Dr. Moreira will recontact in February Karen McDonald and Denneal Jamison McClug to discuss a new collaboration on “Biology” and “Cold Chain Engineer” Profiles

Next Meeting:

• Thursday February 16,2023 – 12 PM to 1PM US EDT • Zoom invite will be issued on January 24, 2023 • Agenda will be issued by Ferdinando Aspesi around February 9 , 2023