Agenda

Loading [Contrib]/a11y/accessibility-menu.js

Featured Events & Activities

Thu, 15 May 2025

Facility Tours

Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference.

Learn More & Register
Sat - Sun, 10-11 May 2025

International Hackathon

Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.

Learn More & Register
Thu - Fri, 15 - 16 May 2025

Training

Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors.

Learn More & Register
Thu, 15 May 2025

Facility Tours

Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference.

Learn More & Register
Sat - Sun, 10-11 May 2025

International Hackathon

Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.

Learn More & Register
Thu - Fri, 15 - 16 May 2025

Training

Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors.

Learn More & Register
Thu, 15 May 2025

Facility Tours

Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference.

Learn More & Register
Sat - Sun, 10-11 May 2025

International Hackathon

Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.

Learn More & Register
Thu - Fri, 15 - 16 May 2025

Training

Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors.

Learn More & Register
Thu, 15 May 2025

Facility Tours

Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference.

Learn More & Register
Sat - Sun, 10-11 May 2025

International Hackathon

Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.

Learn More & Register

All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.

Filters

Selected filters:

Good Engineering Practice - Investment Management

Tue, 13 May

Wed, 14 May

1015 – 1045

Bridging Innovation and Compliance

Good Engineering Practice - Investment Management

Florian Keferböck, Takeda

1045 – 1115

FOYA Innovation

Good Engineering Practice - Investment Management

Ryan O'Sullivan, Eli Lilly

1115 – 1145

Risk and Project Management in Pharma: Dos & Don'ts

Good Engineering Practice - Investment Management

Giulio Ripaccioli, GSK Vaccines - Rosia, IT

Leonardo Zanus, MAASI Enterprises

1315 – 1345

You are Probably Doing C&Q Wrong

Good Engineering Practice - Investment Management

Hazem Eleskandarani, CSL Behring

Mark Drinan, Takeda Pharmaceuticals International AG

1345 – 1415

Challenges and Opportunities in Multi-Product Facilities

Good Engineering Practice - Investment Management

Theresa Ahern, Eli Lilly

Nicola Powell, BioPhorum

1415 – 1445

Aligning with Annex 1: risk based room classifications and sustainable facility design

Good Engineering Practice - Investment Management

1530 – 1600

Improving Legacy Processes: A Case Study on Reducing Risks

Good Engineering Practice - Investment Management

Sebastian Scheler, Innerspace GmbH

Jeff Gensler, Kindeva Drug Delivery

Legacy facilities can pose significant risks to product quality, with hidden issues potentially leading to regulatory non-compliance. Companies operating legacy systems face the dual challenge of ensuring safe, reliable operations while adhering to increasingly stringent regulatory standards for modernization and contamination control. This presentation highlights a case study from the Kindeva Fill-Finish Facility in Brentwood, MO where advanced process modeling and risk profiling were employed to substantially reduce risks in legacy processes. For the first time, this study quantifies the risk reduction achieved through these methods, providing a robust framework for evaluating their effectiveness.

The case study features detailed hazard screening of an RABS filling line, which uncovered critical process improvements previously overlooked, resulting in a significantly safer operation. The insights gained also facilitated the technology transfer to state-of-the-art equipment, integrating Quality by Design (QbD) and Quality Risk Management (QRM) principles. A key highlight of the study is the implementation of a fully integrated QRM approach. Utilizing AI, this approach automatically generated essential manufacturing documents - such as MBR, SOPs, training materials, and process overviews - directly from the risk profiling repository. This automation enabled shop floor personnel to manage residual risks more effectively and was supported by a comprehensive surveillance program.

Sebastian Scheler

Managing Director
Innerspace GmbH

Jeff Gensler

Vice President of Quality
Kindeva Drug Delivery

1600 – 1630

The Future Role of Artificial Intelligence in Project Management

Good Engineering Practice - Investment Management

Gerhard Ortner, PhD, University of Applied Science BFI Vienna

Artificial Intelligence (AI) is transforming project management by enhancing efficiency, accuracy, and decision-making. With its ability to process vast amounts of data, recognize patterns, and generate insights, AI offers significant strengths that can address the challenges of complex projects. In project management, AI is particularly valuable in several key areas, e.g.: Resource Management: AI optimizes resource allocation by analyzing historical and real-time data to forecast personnel, materials, and equipment needs. This ensures efficient utilization and early identification of bottlenecks. Knowledge Management: AI systems streamline access to organizational knowledge by transforming static databases into dynamic, user-friendly tools like conversational AI. This facilitates the retrieval of best practices and lessons learned. Support for Repetitive Tasks: Automating routine activities, such as scheduling, data aggregation, and report generation, frees project teams to focus on strategic decision-making. AI-driven tools create real-time dashboards, offering stakeholders immediate insights into project performance. Controlling, Reporting and Risk Management: By continuously monitoring project progress, AI enhances cost control and schedule adherence through predictive analytics and anomaly detection. Instant reporting capabilities improve transparency and decision-making. AI also extends to quality assurance and communication. Its predictive capabilities enable teams to proactively address potential issues and adapt to dynamic project environments. However, integrating AI demands careful consideration of ethical implications, data privacy, and organizational culture. This presentation will explore practical applications of AI in project management, highlighting how its adoption drives transformative changes across multiple dimensions. Processes will become increasingly automated and data-driven, requiring project teams to adapt to new workflows. Employees will need to develop advanced digital literacy and analytical skills to collaborate effectively with AI systems, while traditional roles in project management will evolve to include oversight of AI tools and interpretation of their outputs. Additionally, the integration of AI will prompt shifts in organizational structures, demanding flexibility and a culture of continuous learning to fully harness the potential of these technologies.

Gerhard Ortner, PhD

University of Applied Science BFI Vienna

1630 – 1700

Revolutionizing Pharmaceutical Production: The Power of Fleet Management in Distributed Manufacturing

Good Engineering Practice - Investment Management

Ryan Farley, NovoNordisk

Christian Siegmund, PhD, F Hoffman-La Roche

Sebastian Faller, F Hoffmann-La Roche AG

Line Lundsberg-Nielsen, NNE

Revolutionizing Pharmaceutical Production: The Power of Fleet Management in Distributed Manufacturing

The pharmaceutical industry faces significant challenges in fast expanding production capacity to respond to the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to respond to the dynamic demands of modern healthcare. This paper proposes a novel regulatory framework for Distributed Manufacturing that leverages the concept of "Fleet Management" to address these challenges. Fleet Management involves creating a network of standardized manufacturing facilities that can be efficiently managed and replicated across multiple sites. This approach draws inspiration from the principles of standardization that revolutionized other industries such as automotive manufacturing.
The proposed approach offers significant benefits, including improved regulatory efficiency, reduced drug shortages, and enhanced environmental sustainability. The paper calls for collaboration between regulators and industry stakeholders to refine and implement this innovative framework, paving the way for a more resilient and responsive pharmaceutical manufacturing ecosystem.

Ryan Farley

Project Manager
NovoNordisk

Christian Siegmund, PhD

Fleet Program Owner, Drug Product Equipment
F Hoffman-La Roche

Sebastian Faller

Global Drug Product (DP) Fleet Quality Owner
F Hoffmann-La Roche AG

Line Lundsberg-Nielsen

Managing Consultant, Compliance Consulting
NNE

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.

Facility Tours

International Hackathon

Training

Facility Tours

International Hackathon

Training

Facility Tours

International Hackathon

Training

Facility Tours

International Hackathon

Filters

Selected filters:

Bridging Innovation and Compliance

FOYA Innovation

Risk and Project Management in Pharma: Dos & Don'ts

You are Probably Doing C&Q Wrong

Challenges and Opportunities in Multi-Product Facilities

Aligning with Annex 1: risk based room classifications and sustainable facility design

Improving Legacy Processes: A Case Study on Reducing Risks

The Future Role of Artificial Intelligence in Project Management

Revolutionizing Pharmaceutical Production: The Power of Fleet Management in Distributed Manufacturing

Bayer Solida 1 - Innovation in Technology, Design and Execution

Facility Design for Peptide & Oligonucleotide Manufacturing

Smart Investments, Strong Foundations

Speaker Qualifications

Agenda Changes