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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.

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Workshops

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

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ISPE 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

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Annual ISPE 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
ISPE 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
Annual ISPE 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
ISPE 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
Annual ISPE 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

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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.

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Workshops

Sun, 26 Oct

1300 – 1600

Facilitating Analytical Procedure Changes via ICH Q14

Workshops

Timothy Graul, PhD, Pfizer, Inc.

Mary Beth Pelletier, PhD, Apogee Therapeutics

Mark Milford, PhD, Eli Lilly

Nina Cauchon, PhD, Amgen Inc.

The ICH Q14 guideline provides a science- and risk-based approach to developing and maintaining analytical procedures, ensuring they remain fit for purpose throughout a drug’s lifecycle. However, implementing changes to analytical procedures remains complex due to regulatory variations across global markets. The adoption of ICH Q14, alongside principles from ICH Q12, offers the promise of a streamlined postapproval change management process that reduces regulatory burden while maintaining compliance. This interactive workshop organized by the ISPE PQLI ICH Q2(R2)/Q14 Analytical Method Strategy team will explore how analytical procedure changes can be facilitated through case studies on method changes, column and instrument transitions, platform method adaptations, and the utilization of established conditions (ECs) and post-approval change management protocols (PACMPs). These examples highlight how the use of risk assessment and performance-based criteria streamline post-approval changes while ensuring robust product control. By leveraging ICH Q14’s flexible framework, companies can integrate new technologies, improve laboratory efficiency, and ensure pharmaceutical quality in an efficient manner. The ultimate goal is to enhance innovation, optimize supply chains, and deliver safe, effective products to patients faster.

Timothy Graul, PhD

Senior Director, CMC Advisory Office
Pfizer, Inc.

Mary Beth Pelletier, PhD

VP, Quality Control
Apogee Therapeutics

Mark Milford, PhD

Director - Analytical
Eli Lilly

Nina Cauchon, PhD

Director Regulatory Affairs - CMC
Amgen Inc.

1300 – 1600

Integrated Process for Drug-Device Combination Products

Workshops

James Wabby, AbbVie, Inc.

Kent Abrahamson, AbbVie

Fubin Wu, GessNet

Juan Cheng, Merck

This workshop provides an integrated view of the essential processes needed for the development of safe, effective, and reliable combination products. It encompasses Design Controls, Drug Development, Risk Management, Safety Assurance, and Reliability processes, highlighting their interrelations and dependencies. By incorporating this structured approach, organizations can improve efficiencies and reduce regulatory risks while ensuring safety and effectiveness. The complexity of drug-device combination products introduces unique challenges compared to standalone drugs or medical devices. Existing regulatory frameworks such as Quality by Design (QbD), design controls, and risk management were developed separately and may not fully address the integration required for combination products. This class will demonstrate how a holistic and structured approach enhances these frameworks to define, implement, verify, validate, and maintain product safety and effectiveness across the lifecycle.

This workshop will explore:

The benefits of proactive modeling in streamlining the integrated approach to combination products, focusing on safety, reliability, and effectiveness.
The role of digital traceability in QbD, design controls, risk management, and lifecycle management.
How to effectively leverage the large amounts of data generated during testing and manufacturing to identify and refine specifications and integrate them into risk management processes.

Additionally, model-based systems engineering (MBSE) will be introduced as a digital framework to systematically manage safety- and effectiveness-critical functions, ensuring a proactive and data-driven approach to combination product development. Attendees will explore key concepts through a combination of lectures, real-world case studies, and hands-on activities, equipping them with practical strategies to address the unique challenges of combination products, navigate evolving regulatory expectations, and foster innovation while ensuring compliance.

James Wabby

Global Head, Regulatory Affairs
AbbVie, Inc.

Kent Abrahamson

Director, Combination Product Development
AbbVie

Fubin Wu

Co-founder & President
GessNet

Juan Cheng

Principle Scientist
Merck

1300 – 1600

The Decision Process for Continuous Biomanufacturing

Workshops

Sharyn Farnsworth, Fujifilm Diosynth Biotechnologies

Robert Dream, HDR COMPANY LLC

Jeffery Odum, Genesis AEC

Andrew Sinclair, Biopharm Services Ltd

The growing number of potential high-volume molecules being evaluated to determine a manufacturing strategy is moving companies to investigate CBM as an alternative to batch-based platforms. Faced with making this choice between a traditional fed-batch manufacturing platform and moving to a continuous/perfusion-based process, what are the sourcing decisions that must be addressed? Workshop attendees will be provided with process, equipment, and operational information to identify the KPIs for driving the sourcing decision and to create options that identify the advantages and disadvantages of moving to a CBM platform. The Workshop will address risk identification, CBM vs. Batch-based pros/cons, COGs analysis, regulatory considerations, and the impacts on Capital Investment. Using recent ISPE publications and the new ISPE Guide for Continuous Biomanufacturing of Large Molecule Drugs as references, Attendees of this workshop will use case study examples to define key decision parameters for making go/no-go choices to implement CBM that invokes smart manufacturing, data integration, and real-time monitoring, and enhanced QbD attributes.

Sharyn Farnsworth

Director, Upstream Process Development
Fujifilm Diosynth Biotechnologies

Robert Dream

Managing Director
HDR COMPANY LLC

Jeffery Odum

Practice Leader: ATMPs & Biologics
Genesis AEC

Andrew Sinclair

President & Founder
Biopharm Services Ltd

1300 – 1600

Implementing an AI Solution in a Pharma 4.0 Context

Workshops

Carsten Jasper, Charles River Laboratories Inc

Frank Henrichmann, Q-FINITY Quality Management

1300 – 1600

From Imposter to Impact: Reinventing Your Career with Confidence

Workshops

Thomas Carganico, PQE Group

Jessica Bronzert, The Sparks Group

Powered and Led by Women in Pharma®

In an industry driven by innovation and precision, many people struggle with self-doubt, career transitions, and the quiet assumption that great work should speak for itself. This transformational Women in Pharma Workshop will help participants challenge imposter syndrome, reflect on personal and professional identity, and gain tools to confidently navigate career evolution.

Led by Charlotte-based executive coach and leadership expert Jessica Bronzert of The Sparks Group, the session will draw on insights from the acclaimed books Working Identity by Herminia Ibarra and Finding Your Own North Star by Martha Beck. Through a dynamic blend of keynote insights, interactive discussion, and a powerful panel of leaders, attendees will be inspired to own their voice, reimagine success, and take strategic action in their careers. Whether you're facing a crossroads or simply seeking greater alignment between your passion and your profession, this workshop is your starting point for purposeful progress.

What You'll Gain:

A deeper understanding of imposter syndrome—what it is, how it manifests, and strategies to overcome it
A framework for making confident, values-based career shifts
Insights into self-promotion and visibility from a gender-lens perspective
Stories of real women navigating career pivots successfully
Community connection and inspiration to take your next bold step

Thomas Carganico

Vice President Strategic Development, Marketing & Communication - Partner
PQE Group

Jessica Bronzert

The Sparks Group

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

ISPE FOYA Banquet & Awards Celebration

Annual ISPE Foundation Golf Tournament

2025 ISPE Hackathon

Workshops

ISPE FOYA Banquet & Awards Celebration

Annual ISPE Foundation Golf Tournament

2025 ISPE Hackathon

Workshops

ISPE FOYA Banquet & Awards Celebration

Annual ISPE Foundation Golf Tournament

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

Filters

Selected filters:

Facilitating Analytical Procedure Changes via ICH Q14

Integrated Process for Drug-Device Combination Products

The Decision Process for Continuous Biomanufacturing

Implementing an AI Solution in a Pharma 4.0 Context

From Imposter to Impact: Reinventing Your Career with Confidence

Speaker Qualifications

Agenda Changes