2021 ISPE Aseptic Conference

Mar 15, 2021 ‐ Mar 17, 2021


Devices and Decontamination—Overcoming Challenges

Mar 17, 2021 9:00am ‐ Mar 17, 2021 10:00am

Identification: VL21CEMAR1/SES110

Devices and Decontamination—Overcoming Challenges | Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment. This session will also present a unique isolator decontamination approach.

Session Leader(s): Speaker(s):

Regulatory View on ATMPs and Make vs. Buy

Mar 17, 2021 9:00am ‐ Mar 17, 2021 10:00am

Identification: VL21CEMAR1/SES111

Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs will be the topics during this ATMP Session. Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. Interview with Alyce Maksoud TGA (Therapeutic Goods Administration from Australia) and Francesco Cicirello Adaptimmune (former TGA Subject Matter Expert): Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. Alyce Maksoud, Team Leader Inspection Section, TGA MQB Australian Department of Health, PIC/S Chair of the Working Group on Tissue and Cells. The Interview with Alyce and Francesco will cover most ask questions related to Cell and Tissue Manufacturing. A must to attend for all working with ATMPs.

Session Leader(s):
  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

Regulatory and Industry Panel

Mar 17, 2021 10:15am ‐ Mar 17, 2021 12:00pm

Identification: VL21CEMAR1/SES112

Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time. You will learn the most current perspectives of thought leaders regarding your most pressing challenges. The session is completely interactive, providing for a very rich experience. You will not want to miss this session.

  • David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
  • Thomas J. Arista, Consumer Safety Officer, FDA/ORA
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
  • Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
  • Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
  • Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ