2023 ISPE International Emerging Leader Hackathon Day 1
Oct 14, 2023 8:00am ‐ Oct 14, 2023 5:00pm
Identification: NA23CEOCT1/SESHAK1
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Monday afternoon.
Volunteer Recognition Event
Oct 14, 2023 8:00am ‐ Oct 14, 2023 9:00am
Identification: NA23CEOCT1/SES_VLR
2023 ISPE International Emerging Leader Hackathon Day 2
Oct 15, 2023 8:00am ‐ Oct 15, 2023 1:00pm
Identification: NA23CEOCT1/SESSHAK2
On Sunday, each hackathon team will present to the panel of Hackathon judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best-proposed solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Monday afternoon.
Workshop: Holistic Digital Pharma 4.0 Maturity Assessment
Oct 15, 2023 9:00am ‐ Oct 15, 2023 12:00pm
Identification: NA23CEOCT1/SESWS1
The pharmaceutical industry is highly regulated due to its involvement with products that are essential to human health. The Holistic Pharma 4.0 Digital Maturity Assessment is a key step for pharmaceutical companies aiming to implement digital transformation initiatives in the framework of Industry 4.0 or Pharma 4.0. The objective of this workshop is to enable participants to apply and conduct the Holistic Pharma 4.0 Digital Maturity Assessment, evaluate the organization's status and readiness for digital transformation, identify areas for improvement and comprehend the major obstacles they may encounter the path to achieving a higher maturity level. Participants will also learn how to interpret the results of the assessment through a heatmap, which will highlight the organization's strong and weak areas of structural capability. The goal is also to get feedback from the audience of the maturity assessment for content and structure. The workshop is designed for all managers involved in a digital transformation journey like Chief Digital Officers (CDOs), Quality leads, Engineering, IT, Operations and Supply Chain of all kinds of life sciences manufacturing organizations and Service, Equipment and Software providers to assess the organization’s maturity in regard to readiness for a digital transformation.
0900 – 0915: Welcome, Announcements, Introductions by Christian Wölbeling
0915 – 0945: Presentation of Pharma 4.0 Maturity Assessment model by Daniele Iacovelli, Vincent Gerber, and Philipp Klaesle
0945 – 1015: Six Pharma 4.0 Industry Surveys – Maturity Lessons Learned by Daniele Iacovelli and Laura Kuger
1015 – 1115: Execution of assessment with participants by Vincent Gerber and Philipp Klaesle
1115 – 1145: Discussing the maturity assessment results by Vincent Gerber and Philipp Klaesle
1145 – 1200: Feedback round for the Pharma 4.0 maturity model approach with all participants
Participants are encouraged to bring their personal devices/laptops to this workshop.
Speaker(s):
- Laura Kuger, PhD Candidate, Karlsruhe Institute of Technology (KIT)
- Philipp Kläsle, VP MES & Process Management, Körber Pharma Switzerland GmbH
- Daniele Iacovelli, CDO/Global Head of Digital, Analytics & Operational Excellence, F. Hoffmann-La Roche
- Vincent Gerber, Digital Strategy Delivery Lead, F. Hoffmann-La Roche
- Christian Woelbeling, Executive Industry Advisor, Körber Pharma Software GmbH
- Teresa Minero, Founder & CEO, LifeBee - Digitalizing Life Sciences
Workshop: ICH Q9(R1) and Quality Risk Management
Oct 15, 2023 9:00am ‐ Oct 15, 2023 12:00pm
Identification: NA23CEOCT1/SESWS2
This 3-hour workshop consists of 3 plenary presentations and two breakout sessions. ICH Q9 (R1) Topic Leader, Kevin O'Donnell from EMA will summarize the rationale for and changes to the recently issued ICH Q9, Quality Risk Management revision. There will be two industry presentations summarizing ISPE activity to support the ICH Q9 Implementation Working Group with provision of case studies covering the topics of formality, subjectivity, decision-making and product availability. These will be followed by two breakout discussion sessions, each session covering two of the above topics in parallel. A participant could, therefore, attend and contribute to two out of the four breakout topic discussions. The Workshop will conclude with feedback from the breakout groups, a Q&A and closing remarks.
Speaker(s):
- Christine M. Moore, PhD, Executive Director, Quality Systems & Compliance, Organon LLC
- Jessica L. Hale, PharmD, Associate Director-US & Global Regulatory Affairs, Merck & Co Inc
- Alice Redmond, PhD, Chief Strategy Officer, CAI
- Jean Francois Duliere, Reg Advisor, ISPE
- Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority (HPRA)
- Christopher J. Potter, PhD, CMC Pharmaceutical Consultant
- John G. Groskoph, Executive Director, Global CMC, Pfizer
- Maurice B. Parlane, B Tech MIT, Principal/Director, New Wayz Consulting Ltd/CBE Pty Ltd
- Diane L. Hustead, Executive Director, Regulatory Affairs, Merck & Co., Inc.
Workshop: Development of a Contamination Control Strategy
Oct 15, 2023 9:00am ‐ Oct 15, 2023 12:00pm
Identification: NA23CEOCT1/SESWS3
According to Annex 1, Contamination Control Strategy (CCS) is referred to as a family of documents that unite, evaluate, and record the adequacy of tools used to assure the purity and quality of drug products. The heightened focus on the CCS is centered around not only physical mechanisms to control contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. This workshop will engage attendees in the development of a CCS using a case study and supporting documentation from an existing cGMP facility. Attendees will be exposed to a methodology to develop a CCS that was performed for the actual facility that is used for the case study. Attendees will interact with different procedures and design documents and see how the documents support each other and work together to ensure that the facility operates in a way to prevent contamination of drug products. Attendees will be exposed to the use of Layers of Protection Analysis (LOPA) for the CCS. Lastly, attendees will experience realistic challenges during the creation of the CCS and gain valuable lessons learned from the actual team that executed the same CCS methodology.
Speaker(s):
- David Raab, Senior Process Engineer, Genesis AEC
- Jose A. Caraballo, VP Quality Systems, Compliance, and Quality Engineering, Kite Pharma, Inc.
- Jeffery N. Odum, CPIP, Practice Leader: ATMPs & Biologics, Genesis AEC
- Norman A. Goldschmidt, President, Genesis AEC
- Stephen M. Hall, Chief Process Engineer, Genesis AEC
Workshop: Designing & Operations of a Flexible Mfg Facility
Oct 15, 2023 1:00pm ‐ Oct 15, 2023 4:00pm
Identification: NA23CEOCT1/SESWS4
Designing and Operations of a Flexible Manufacturing Facility Workshop. The first presentation will focus on the importance of facility programming to develop a thorough conceptual design that sets the project on the right path of an efficient design that meets schedule and cost targets. The programming approach will walk-through the development of a layout and challenges of defining criteria for a flexible facility.
•Identifying facility requirements and prioritizing needs vs. wants
•Progression of a conceptual layout
•Defining flexibility to provide a basis for the design
The second presentation will be a case study of a CTDMO that will discuss the overall facility and it’s approach to the facility designed for Multi-products, Multi- clients, and muliti-manufacturing and testing areas to provide a facility that provides end to end capabilities for ATMP drug products. The presentation will demonstrate the approach and key drivers for the facility design focused on a flexible suite for multiple products, multiple clients and accommodation of all levels of therapy life cycle including clinical and commercial production considerations.
•Room layout for flexibility in current and future process operations
•Suites designed for ease of change-over and reconfiguration
•Multiple floors with differing room arrangement options
•Understanding challenges of facility retrofit and renovation
Speaker(s):
- Timothy W. Lisle, Sr. Director of Process Architecture, Precis Engineering, Inc.
- Christine Holbrook, Senior Process Engineer, Center for Breakthrough Medicines
- Matthew H. Snyder, Director, Engineering & Facilities, Center for Breakthrough Medicines
- Kristina Pumphrey, PE, Director of Process Engineering, Precis Engineering + Architecture