2020 ISPE Annual Meeting and Expo

Driving the Future of Pharma

Thank you for making this virtual conference a huge success!  Attendees access your on demand content now.

Thank you to our keynote speakers who kicked off the 2020 ISPE Annual Meeting & Expo this morning with compelling and insightful presentations:

Jeffrey Marrazzo
CEO & Co-Founder
Spark Therapeutics, Inc.
Paul F. McKenzie, PhD
Chief Operating Officer
CSL Behring
S.Joseph Tarnowski, PhD
Senior Vice President, R&D, Medicinal Science & Technology
Amy Abernethy, MD, PhD
Former Principal Deputy Commissioner, US FDA

Watch this short clip of Paul McKenzie’s presentation “Engineering and the Pandemic: Lessons for the Future of How We Work” to hear him share 1 of 5 lessons learned.

Challenges in the Pharma Industry

Watch Dr. Hahn, Commissioner USFDA, discuss challenges in pharma industry during the 2020 ISPE Annual Meeting & Expo.

FOYA Overview


    In this clip from the 2020 ISPE Annual Meeting & Expo, Ilaria Lo Presti, Civil Engineering, GSK, shares three elements that helped GSK to minimize design and construction challenges for their Attachment Inhibitor (AI) Project in Parma, Italy—Winner of the 2020 FOYA Social Impact Category.

Agile Project Deliver for Cell & Gene Therapies BLindros EPD Process

During the 2020 ISPE Annual Meeting & Expo session “Agile Project Delivery for Cell & Gene Therapy Facilities,” Byron Lindros, Director Capital Projects, Kite Pharma, and Scott Bertch, Sr. Director of Technical Operations, AveXis, Inc., walked us through project management best practices in delivering cell and gene therapy facilities.

In this clip, Byron answers the question: Why develop an engineering project delivery (EPD) model?

Thank you to Bausch+Ströbel GmbH + Co. KG, Virtual Platform Supporter for this session.

Blockchain The GAMP Aspects Panel

Is PharmaLedger the only blockchain initiative under IMI - Innovative Medicines Initiative or are there other ones?

Watch this clip to hear from Daniel Fritz, Domain Architect Supply Chain & ESO - PharmaLedger Industry Project Lead, Novartis. Plus, hear additional thoughts on blockchain from James Canterbury, Principal, Consulting, EY, and John Bass, CEO, Hashed Health, during the 2020 ISPE Annual Meeting & Expo session “Blockchain: The GAMP® Aspects.”

Combination Products

What does risk analysis and risk management look like when you’re doing the development of pre-filled syringes and pen injectors?

Johnson & Johnson, posed this question during the 2020 ISPE Annual Meeting & Expo session “Combination Products Part 1: An Industry Perspective.”

Watch this clip to hear Vetter Pharma, and Tobias Nemeth, Director Primary Packaging Service & Projects, Vetter Pharma, answer this question.

GAMP® Data Integrity by Design Part 2 

Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety.

In this clip from the 2020 ISPE Annual Meeting & Expo session “GAMP® Data Integrity by Design Part 2,” Rob Dillman, Informatics Specialist-Data Integrity, Eli Lilly and Company, highlights examples of business rules.

Flexible & Modular Manufacturing

Approximately 25% of all NCEs are classified as high-potency with OELs (occupational exposure limits) below 10ug/m3 with this number expected to grow. Typically, pharmaceutical companies will either outsource high-potency products (40% of all outsourced products are classified as high-potency) or create dedicated facilities.

In this clip of the 2020 ISPE Annual Meeting & Expo session “Flexible and Modular Manufacturing,” Emily Gullotti, Associate Principal Scientist, Merck, gives us look into Merck’s innovative strategy to build the FLEx Center (Formulation, Laboratory and Experimentation Center), a new, state-of-the-art facility with flexible, high-potency manufacturing to include both modular and podular design features.

Process to Embace Pharma 4.0™

Watch Now: During the 2020 ISPE Annual Meeting & Expo presentation “Trimming the IT Quality Management System to Do More in Pharma 4.0,” Levi Schenk, M.S., CSM, CSSBB, Manager IT Quality Governance, CSL Behring, discussed the processes to embrace Pharma 4.0™.

Conference Highlights