Webinars

Artificial Intelligence in Drug & Biological Product Development Hybrid Public Workshop 2025

Posted on by Hannah Faulkner

Webinars | November 4, 2025

Topics Included: Artificial Intelligence

Hybrid Public Workshop Resources:

Meeting Webpage

Full agenda

Download the full PowerPoint slide set

Meeting Recordings:

Welcome & Session 1: Where Are We Now?

Session 2: Data Quality, Reliability, Representativeness, and Access in AI-Driven Drug Development

Session 3: Model Performance, Explainability, Transparency, and Interpretability in AI-Driven Drug Development

Session 4: Navigating the Future of AI in Drug Development

Discussion & Concluding Remarks

Share Your Feedback

We welcome your questions and feedback about this workshop. If you have follow-up thoughts or comments on the topics discussed, please share them using the brief form linked below. Your input will help inform future discussions and events.

Submit Your Feedback

Recent News Feed

CTTI’s Disease Progression Modeling Recommendations & Tool Launch

Webinars | July 8, 2025

Topics Included: Innovative Trials, Regulatory Submissions + Approvals

CTTI Project: Using Disease Progression Modeling to Advance Trial Design and Decision Making

Webinar Presenters

  • Sara Calvert, Clinical Trials Transformation Initiative (CTTI)
  • Lindsay Kehoe, Clinical Trials Transformation Initiative (CTTI)
  • Efthymios Manolis, European Medicines Agency (EMA)
  • CJ Musante, Pfizer
  • Karthik Venkatakrishnan, EMD Serono
  • Tiffany Westrich-Robertson, AiArthritis
  • Theo Zanos, Northwell Health

Webinar Resources

DPM Recommendations

DPM Considerations Framework

Download full slide presentation

 

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Recent Webinars

TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members


Webinar Presenters:

  • Craig Wozniak

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

CTTI and TransCelerate have been in an ongoing dialogue about their respective efforts, including, for example, how work related to risk based monitoring (RBM) may be integrated. This webinar features a presentation by TransCelerate highlighting their RBM initiative.

Translating Quality by Design Principles into Practice, Part 1

Webinars | October 10, 2024

Topics Included: Ensuring Quality

CTTI Project: Quality by Design

Webinar Objective

This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

  • CTTI Quality by Design Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience by Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience by Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q&A

Watch Translating Quality by Design Principles into Practice, Part 2

Recent Webinars

Results of National Public Poll on Clinical Trials

Webinar Presenters:

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

A few months ago, CTTI assisted with questions to include in a national poll conducted by Research!America, the nation's largest not-for-profit, membership-supported, grassroots public education and advocacy organization. They are committed to making medical and health research a higher national priority, and Woolley's review of the survey includes trust factors for clinical trial participation, as well as attitudes towards and information sources for clinical trials.

Sponsors’ Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

Download Slides

Webinar Presenters:

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Soo Bang, Sr. Director, Business Development & Global Alliances, Celgene Corporation
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences across different sponsor organizations in implementation of central IRB model for multi-centered clinical trials

Webinar Agenda

  1. Introduction: CTTI Use of Central IRBs for Multi-center Clinical Trials Project and Recommendations
  2. Sponsors’ role in choosing to use a central IRB for multi-center clinical trials
  3. One biopharmaceutical sponsor’s approach for adapting to new paradigm for IRB review in the U.S.
  4. A federal sponsor's experience of using a single central IRB for clinical trial networks
  5. Questions and Discussion