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

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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

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

CTTI Project: Patient Group Engagement

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Webinar Presenters

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

*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

Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

Webinar Presenters:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*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:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

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.