Agenda

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

Featured Activities

2025 ISPE Hackathon

Students and recent graduates participate in the 2025 Hackathon to analyze and present solutions to a problem to expert judges.

Register Now!
Workshops

Participate in one of five interactive, hands-on learning sessions designed to guide you through processes to gain a competitive advantage

Learn More
FOYA Banquet & Awards Celebration

Join ISPE to celebrate the 2025 ISPE FOYA Banquet and Awards Celebration, where we will formally recognize and celebrate the 2025 Category

Learn More
Foundation Golf Tournament

Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back!

Learn More
2025 ISPE Hackathon

Students and recent graduates participate in the 2025 Hackathon to analyze and present solutions to a problem to expert judges.

Register Now!
Workshops

Participate in one of five interactive, hands-on learning sessions designed to guide you through processes to gain a competitive advantage

Learn More
FOYA Banquet & Awards Celebration

Join ISPE to celebrate the 2025 ISPE FOYA Banquet and Awards Celebration, where we will formally recognize and celebrate the 2025 Category

Learn More
Foundation Golf Tournament

Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back!

Learn More
2025 ISPE Hackathon

Students and recent graduates participate in the 2025 Hackathon to analyze and present solutions to a problem to expert judges.

Register Now!
Workshops

Participate in one of five interactive, hands-on learning sessions designed to guide you through processes to gain a competitive advantage

Learn More
FOYA Banquet & Awards Celebration

Join ISPE to celebrate the 2025 ISPE FOYA Banquet and Awards Celebration, where we will formally recognize and celebrate the 2025 Category

Learn More
Foundation Golf Tournament

Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back!

Learn More

View All

All session times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.

For your convenience, Registration will also be open on Saturday, 25 October 2025, from 1300-1800.

Filters

Selected filters:

Digital Transformation

Mon, 27 Oct

Tue, 28 Oct

1045 – 1115

BMS’s Journey to a Tech-Enabled Global Transformation

Digital Transformation

Terri Melzer, Bristol Myers Squibb

Pamela Paddock, JLL

This presentation will explore Bristol Myers Squibb's digital organizational transformation in partnership with JLL. Terri Melzer, Senior Director Global Facilities Services at Bristol Myers Squibb will join Pam Paddock as an expert speaker for this session. Together we will discuss how BMS is setting the foundation for future flexibility through cutting-edge technologies, AI-driven analytics, and cloud-based platforms. This organizational transformation will drive efficiency, reduce costs, and enhance compliance across their portfolio of lab, manufacturing, and office facilities.

Key focus areas include:

Implementing a modern CMMS and data backbone to consolidate systems and provide enterprise-wide visibility.

Deploying smart building technologies to enable predictive maintenance and optimize energy usage.

Utilizing AI and machine learning to drive data-driven decision-making for asset management and capital planning.

Streamlining regulatory compliance and documentation through digital tools.

Implementing reliability-centered maintenance to capture asset condition, uncovering data-driven TCO strategies for asset management

Transforming vendor relationships and contracts from task-based agreements to outcome-focused partnership agreements.

Attendees will discover how biopharma organizations can kickstart a digital transformation journey, no matter an organization’s size. Attendees will gain insights on how to leverage Industry 4.0 technologies to modernize pharma facilities management and unlock new value.

Terri Melzer

Senior Director Global Facilities Services
Bristol Myers Squibb

Pamela Paddock

Managing Director
JLL

1115 – 1145

Digital Transformation in Cell Therapy Manufacturing

Digital Transformation

Rebecca Street-Howard, RoslinCT

Keith Morris, PM Group

1145 – 1215

Trust in the Digital Age: Blockchain’s Role in Pharma

Digital Transformation

William Lichtman, Takeda Lexington MA

Tanya Sharma, Assurea, LLC

Everett Hildenbrandt, Runtime Verification

As data exchange within life sciences becomes increasingly decentralized, verifying and tracing source data within layered information systems presents a major challenge. Secure information networks and data sharing are critical. Blockchain-based technologies offer data security, transparency, and traceability. This session will explore various blockchain applications within the pharmaceutical industry, including decentralized identity, secure data storage, and formal verification. A case study will be presented on formal verification, which is a mathematically rigorous method for verifying software correctness, enhancing trust in decentralized software systems, and ensuring compliance with regulatory frameworks such as GxP and 21 CFR Part 11. As the industry moves toward more decentralized systems and emerging technologies like AI evolve rapidly, recognizing the benefits of blockchain will play a critical role in maintaining data integrity. This timely discussion emphasizes the importance of blockchain in safeguarding data in an increasingly complex landscape and with a diverse panel discussion with leaders from various domains ( quality, digital transformation, compliance).

William Lichtman

Director, Manufacturing
Takeda Lexington MA

Tanya Sharma

Cofounder
Assurea, LLC

Everett Hildenbrandt

CEO
Runtime Verification

1345 – 1415

Designing for Pharma 4.0 - The Practical Considerations

Digital Transformation

Mags Dalton, PM Group

Philip Ceary, AstraZeneca

1415 – 1445

Modular Plants: A New ISPE Pharma 4.0 Concept Paper

Digital Transformation

Rod Hoffman, AstraZeneca

Giuseppe Menin, Ing. Punzenberger COPA-DATA GmbH

Modular plant projects for the process industry are currently not only being discussed in academia but also tested in industrial applications. These innovative plants are designed to provide flexibility that allows manufacturers to quickly respond to changing market conditions. Conventional large-scale, custom-built, single or multi-product plants no longer seem suitable for addressing strategic challenges such as reduced product lifecycles, increasing product differentiation, and heightened competitive pressures in highly volatile markets. Modular plants with a high degree of flexibility pose various challenges for those involved in automation and digitalization. Traditional approaches using hierarchical and monolithic architectures are not suitable for modular approaches. A concrete response to these needs is represented by the MTP (Module Type Package VDI/VDE/NAMUR 2658) standard originally developed by NAMUR now on the way to becoming an international standard IEC 63280. MTP4ISPE working group, part of the "Plug & Produce" initiative within ISPE Pharma 4.0's Community of Practice (CoP), aims to analyze and evaluate MTP applicability within pharmaceuticals. This contribution intends to publicly present the content of a new ISPE concept paper about the digitalization of Modular Plants according to MTP resulting from contributions made by experts from life sciences involved in the digitalization of manufacturing lines.

Rod Hoffman

IT/OT Connected Factory Business Partner
AstraZeneca

Giuseppe Menin

Director Life Sciences & Process Industry
Ing. Punzenberger COPA-DATA GmbH

1445 – 1515

Reinventing Machines: Shaping the Backbone of Pharma 4.0

Digital Transformation

Philipp Bayer, Rommelag ILabs GmbH

1615 – 1645

Digital Vision Twin - Cut Downtime, Boost Productivity

Digital Transformation

Steffen Münzer, Johnson & Johnson Innovative Medicine

Anuschka Störmer, Körber Pharma Inspection

1645 – 1715

NextGen R&D Laboratories: Strategy and Execution

Digital Transformation

Robert Guenard, PhD, Pfizer

Brian Eden, Capgemini

1715 – 1745

Maturity Assessments: Your Catalyst for Transformation

Digital Transformation

Ryan Thompson, CRB

Alan Bateman, Johnson & Johnson Innovative Medicines

Yvonne Duckworth, CRB

Pharma’s digital transformation is no longer a question of "if" but "how fast" - yet securing buy-in, funding, and stakeholder alignment remains a challenge. Digital Maturity Assessments are proving to be a game-changer, offering a standardized, data-driven approach to measure readiness, justify investments, and drive enterprise-wide digital strategies for brownfield and greenfield facilities. In this engaging and dynamic panel discussion, leaders from J&J, along with Digital Technology SMEs, will share how they’ve leveraged Digital Maturity Assessments to break down silos, gain executive support, and move beyond scattered digital initiatives to cohesive, high-impact transformation efforts that provide concrete value as well as a strong foundation for their Digital Transformation initiative. This session will also actively involve the audience, encouraging interactive discussions and fostering a collaborative exchange of ideas. Join us to gain actionable insights on using Digital Maturity Assessments as a strategic catalyst to see your digital transformation to fruition.

Ryan Thompson

Senior Specialist, Industry 4.0
CRB

Alan Bateman

Director, Systems Architecture, Digital and Execution
Johnson & Johnson Innovative Medicines

Yvonne Duckworth

Fellow - Digital Technology, Associate
CRB

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.

2025 ISPE Hackathon

Workshops

FOYA Banquet & Awards Celebration

Foundation Golf Tournament

2025 ISPE Hackathon

Workshops

FOYA Banquet & Awards Celebration

Foundation Golf Tournament

2025 ISPE Hackathon

Workshops

FOYA Banquet & Awards Celebration

Foundation Golf Tournament

For your convenience, Registration will also be open on Saturday, 25 October 2025, from 1300-1800.

Filters

Selected filters:

BMS’s Journey to a Tech-Enabled Global Transformation

Digital Transformation in Cell Therapy Manufacturing

Trust in the Digital Age: Blockchain’s Role in Pharma

Designing for Pharma 4.0 - The Practical Considerations

Modular Plants: A New ISPE Pharma 4.0 Concept Paper

Reinventing Machines: Shaping the Backbone of Pharma 4.0

Digital Vision Twin - Cut Downtime, Boost Productivity

NextGen R&D Laboratories: Strategy and Execution

Maturity Assessments: Your Catalyst for Transformation

Future-Proof QA: From Documentation to Control Objective

Leadership Strategies and Approaches to Transform CSV

Regulatory Impact on Digital Health Technologies in DCT

New GAMP AI Guide Overview and Key Concepts

Beyond the Pilot: The AI Adoption Playbook

Speaker Qualifications

Agenda Changes