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

You’re invited to join us for this JMP 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 learn how to optimize experimental designs, control variability, and enhanced decision making. 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 such as 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 improve product quality.
Analytic methods to address ICH guidelines.

Each session is 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.

Plenary

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

Time: 9:15–10:00 a.m.

Presenter
Russ Wolfinger, JMP

This session introduces statistical methods to accelerate process and analytical development. Participants 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, Wolfinger leads a team in research and development of JMP solutions for 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.

Wolfinger is co-author of more than 150 publications and four books; he 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.

Case study

Time: 10:00–10:30 a.m.

Presenters: Bryon Wingerd and Christian Stopp, JMP

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

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

Time: 10:50–11:30 a.m.

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 – such as risk management, design of experiments (DOE), and control strategies – that can streamline development and drive product quality.

Case study

Time: 11:30 a.m.–12:00 p.m. ET

Presenters: Greg Flexman, JMP; Margaret Maziarz, Waters Corp.

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

Networking lunch

Time: 12:00–1:00 p.m.

After party: Additional learning opportunities

Time: 1:00–1:50 p.m.

You don’t have to go home, but you can stick around here, too! The official agenda is over but we’re going to be hanging out to talk about root cause analysis, machine learning, and discussing the new environmental monitoring capabilities coming in JMP 19!

Panel Discussion (Optional)

Join us for a discussion with JMP and industry experts as we share our practical experiences with root cause analysis and environmental monitoring and take your questions.

Panel Members

Michelle Ricci, Takeda Global Applied Statistics Lead
Valérie Nedbal, Senior Product Manager
Andrea Coombs, Principal Systems Engineer, JMP
Byron Wingerd, Principal Systems Engineer, JMP
Greg Flexman, Senior Systems Engineer, JMP
Mike Anderson, Principal Systems Engineer, JMP

Register now to attend

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

Time: 2:00–3:00 p.m.

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 Statistically Speaking, Russ Wolfinger, a seasoned statistical expert and Director of Scientific Discovery and Genomics at JMP, 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 2025.

Mingle with JMP Experts

Stick around and ask a question or two or just hang out with the JMP experts and fellow users.

Mike Anderson
Principal Systems Engineer

Andrea Coombs
Principal Systems Engineer

Greg Flexman
Senior Engineer

Christian Stopp
Systems Engineer

Valérie Nedbal
Senior Product Manager

Byron Wingerd
Principal Systems Engineer

Adjournment

Time: 3:00 p.m.