Live In-Person Event

JMP Discovery Seminar: Accelerate pharmaceutical process and analytical development

Join us for an enlightening event on the applications of machine learning in statistical analysis.

Date: February, 13, 2025
Time: Main program: 9:00 a.m.–12:00 p.m. ET
Lunch: 12:00–1:00 p.m. ET
After party and additional learning opportunities: 1:00–3:00 p.m. ET
Location: Boston Marriott Cambridge
50 Broadway
Cambridge, MA 02142
Registration: Free, but registration is required.

You’re invited to join us for this Discovery Seminar Series event in Cambridge! This event focuses on accelerating pharmaceutical process and analytical development using statistical methods and Quality by Design (QbD) principles. Participants will learn to optimize experimental designs, control variability, and enhance decision-making. Key sessions cover the practical application of statistics in implementing ICH QbD guidelines (Q8, Q9, Q10, Q14) to improve product quality. Real-world case studies provide practical examples, and the event concludes with an open forum to discuss additional topics like continuous process verification and predictive modeling.

Key learnings:

Statistical approaches to accelerate process and analytical development
A framework for Quality by Design that can streamline development and drive product quality.
Analytic methods to address ICH guidelines

Each session will be followed by live Q&A with our experts. A networking lunch and additional learning opportunities round out the program.

Attendance is limited. If you plan to join us, please register as soon as possible.

Registration

Time: 8:00–9:00 a.m. ET

Plenary: Statistics for the Bench Scientist: Practical Approaches to Accelerating Process and Analytical Development

Time: 9:15–10:00 a.m. ET

Session Presenter
Russ Wolfinger, JMP

This session introduces statistical methods to accelerate process and analytical development. Participants will learn practical approaches for optimizing experimental designs, controlling variability, and driving faster decision-making to enhance innovation in pharmaceutical development.

About Russ Wolfinger

Russ Wolfinger is the Director of Scientific Discovery and Genomics at JMP. In his role, Russ leads a team in research and development of JMP-based software solutions in the life sciences. He joined SAS in 1989 after earning a Ph.D. in Statistics from North Carolina State University (NCSU). For ten years, he devoted his efforts to developing and promoting statistical procedures for mixed models and multiple testing. In 2000 he started the Scientific Discovery department at SAS and JMP.

Russ is co-author of more than 150 publications, 4 books, and is the most cited author at SAS. He is a fellow of both the American Association for the Advancement of Science and the American Statistical Association, an adjunct faculty member at NCSU and the University of North Carolina at Chapel Hill, and a Kaggle Competition Grandmaster.

Session: Case Study

Time: 10:00-10:30 a.m. ET

Session Presenters
Bryon Wingerd and Christian Stopp, JMP

These case studies will apply statistical approaches when using donor material in cell therapy development and handling repeated measures over time.

Session: Your QbD Toolkit: Applying ICH Guidance in Process and Analytical Development

Time: 10:50—11:30 a.m. ET

Session presenter
Andrea Coombs, JMP

Explore practical tools for implementing Quality by Design (QbD) principles in both process and analytical development. Align ICH Q8, Q9, Q10, and Q14 guidelines with tools like risk management, Design of Experiments (DOE), and control strategies that can streamline development and drive product quality.

Session: Case Study

Time: 11:30 a.m.—12:00 p.m. ET

Session presenter
Greg Flexman and to-be-named customer from Waters, JMP

This case study will apply the ICH Q14 enhanced approach to analytical method development.

Networking lunch

Time: 12:00—1:00 p.m. ET

After party: Additional learning opportunities

Time: 1:00—2:00 p.m. ET

Topics of your choice such as continuous process verification, root cause analysis, equivalence testing, prediction modeling, and more.

Register now to attend

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Session: Bridging Statistics and AI: Machine Learning for Scientists and Engineers:

Time: 2:00—2:20 p.m. ET

Session presenter
Russ Wolfinger, JMP

This advanced session explores the intersection of advanced statistics and artificial intelligence (AI) tools in pharmaceutical development. We are in the midst of one of the largest surges of analytical productivity in human history, with countless new three-way interactions between statistical methods, computer science, and deep scientific and engineering domain expertise.

In this session, Russ talks through several exciting modern applications with image, text, and tabular data using JMP and JMP Pro, all while providing guiding perspectives as we shoot headlong into the new year.

Adjournment

Time: 3:00 p.m. ET