2021 ISPE Aseptic Conference

Mar 15, 2021 ‐ Mar 17, 2021



Sessions

EXHIBIT SHOWCASE/POSTER PRESENTATIONS/LIVE DEMOS

Mar 15, 2021 7:30am ‐ Mar 15, 2021 8:30am

Identification: SESEXP01

Poster Presentations

Poster Presenter(s):
  • John O'Brien, Biotech Production Specialist, Regeneron
  • Laura Moody, PhD, Product Manager - Primary Packaging, Pharma Liquid Packaging, Syntegon

ADCs & State-Of-The-Art Fill-Finish Technology

Mar 15, 2021 7:30am ‐ Mar 15, 2021 12:00pm

Identification: SESEXP01a

When designing the manufacturing process for a new pharmaceutical, the first topic that should be considered is the potency of the product. High potent drugs are classified as drugs in the occupational exposure band (OEB) of 5 or 6, with an occupational exposure limit (OEL)

Speaker(s):
  • Laura Moody, PhD, Product Manager - Primary Packaging, Pharma Liquid Packaging, Syntegon

Opening Plenary Session Opening Plenary Session

Preview Available

Opening Plenary Session

Mar 15, 2021 8:30am ‐ Mar 15, 2021 10:00am

Identification: VL21CEMAR1/SES100

Opening Plenary Session | In this opening session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading. The COVID-19 crisis saw drastic changes in the way of working, but also tremendous efforts from the pharmaceutical industry to develop therapies and vaccines for SARS-Cov2 infections. Rapid development, commercial upscaling and distribution are needed to deliver to the patients. Ways of working need to be rethought, procedures developed and implemented at high speed.

Session Leader(s):
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
Speaker(s):

Welcome & Opening RemarksWelcome & Opening Remarks

Preview Available

Welcome & Opening Remarks

Mar 15, 2021 8:30am ‐ Mar 15, 2021 8:33am

Identification: SES100a

In this keynote session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading. The COVID-19 crisis saw drastic changes in the way of working, but also tremendous efforts from the pharmaceutical industry to develop therapies and vaccines for SARS-Cov2 infections. Rapid development, commercial upscaling and distribution are needed to deliver to the patients. Ways of working need to be rethought, procedures developed and implemented at high speed.

Speaker(s):

Welcome & Anniversary Video/Acknowledgements

Mar 15, 2021 8:33am ‐ Mar 15, 2021 8:45am

Identification: SES100b

Speaker(s):
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.

Risk Reduction, Reliability, and Sustainability: The Drivers for Modernization of Sterile Manufacturing

Mar 15, 2021 8:45am ‐ Mar 15, 2021 9:05am

Identification: SES100c

Speaker(s):
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA

Public-Private Partnership for Pandemic Preparedness and Response

Mar 15, 2021 9:05am ‐ Mar 15, 2021 9:25am

Identification: SES100d

Speaker(s):

ISPE Foundation UpdateISPE Foundation Update

Preview Available

ISPE Foundation Update

Mar 15, 2021 9:25am ‐ Mar 15, 2021 9:45am

Identification: SES100e

Speaker(s):
  • Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County
  • Joydeep Ganguly, Senior Vice President, Corporate Operations, Gilead Sciences Inc

Q&A/Discussion and Session Closing

Mar 15, 2021 9:45am ‐ Mar 15, 2021 10:00am

Identification: SES100f

Speaker(s):
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.

Intersection of ATMPs and New Technologies

Mar 15, 2021 10:15am ‐ Mar 15, 2021 11:15am

Identification: VL21CEMAR1/SES101

Intersection of ATMPs and New Technologies | Advanced Therapy Medicinal Products (ATMPs), are medicines for human use that are based on genes, tissues, or cells. ATMPs offer novel ways to treat a variety of diseases, and in some instances can be curative. As ATMPs move out of the clinic and become commercialized, manufacturers face traditional challenges of scale-up, transfer and the application of new technologies. This session will explore this intersection. You will hear from experts in the field who will provide valuable technical insight and case studies to the participants.

Session Leader(s): Speaker(s):
  • Leslie Southam, QA Manager, Vector Product Operations, Oxford Biomedica
  • James L. Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS , F. Ziel GmbH
  • Marco Fadda, ATMP Solutions Manager, Comecer, SPA
  • Rob Roman, Head of Quality Systems & Compliance, Roche / Genentech
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