Agenda

9:00 AM — Registration & Networking

10:00 AM — Opening Remarks

10:15 AM — Industry Trends: M&A, In-Licensing, Business Impacts & Company Strategies

• Hosted by Garrett Smith - Executive Director, Life Sciences Solutions, TransPerfect

Featured Speaker:

• Meraf Eyassu - Executive Director, Clinical Operations, Terns Pharmaceuticals

11:00 AM — CDISC V1, ICH E6(R3) & TMF Impact

• Presented by Gillian Gittens - Senior Director, e-Clinical Strategy & Solutions, TransPerfect

11:45 AM — TMF and M&A: Experiences and Case Studies

• Hosted by Christopher Utterback - Regional Director, Life Sciences, TransPerfect

12:15 PM — Tech Innovation Spotlight: eTMF Automation with Inspection Readiness Flags & Risk Management

12:45 PM — LUNCH

1:45 PM — AI Adoption: Successes and Struggles in R&D

• Hosted by Stacy Dagana - Senior Implementation Manager, TransPerfect

Featured Speaker:

• Ashley Bates - Managing Director, R&D Advisory, Syneos Health
• Iris Castillo - Director, Clinical Compliance, Taysha Gene Therapies
• Sarah Darnell - Director, Quality, Profound Research

2:15 PM — Quality Management, Risk-Based Oversight, and GxP

• Hosted by Christine Morris - Executive Director, TransPerfect

Featured Speakers:

• Anusha Rameshbabu - Senior Manager, TMF Systems & Operations, Moderna
• Sara Schmidt - Chief Quality & Compliance Officer, Profound Research

2:45 PM — Surviving Inspections

• Hosted by Avani Amin - Director, Client Solutions, TransPerfect

Featured Speakers:

• Ashley O'Bannon - Senior Manager, Global Records Management, Premier Research
• Jamie Toth - Senior Director, Global TMF Management & Records, BeOne Medicines
• Nikki McGuire - Director, Clinical Operations, ABK Biomedical

3:05 PM — COFFEE BREAK

3:25 PM — Tech Innovation Spotlight: CTMS Hyper-Automation and Integration

4:10 PM — OpTImizing eTMF Usage: Configurations, Essential Features, and Interoperability

• Hosted by Stacy Dagana - Senior Implementation Manager, TransPerfect

Featured Speaker:

• Kelsea Filter - Outcomes & Strategy Manager, Professional Education & Research Institute
• Brandy Ward - Associate Director, Records Management & Head of TMF, Akebia Therapeutics

4:50 PM — Closing Remarks

Please note that the agenda is subject to change, and this page will update as more details become available.

9:00 AM — Sponsor/CRO Collaboration & Technology: Best Practices, Metrics, and Resource Models

• Hosted by Laurel-Ann Schrader, Director, Client Solutions, TransPerfect

Featured Speakers:

• Jessica Barag - Executive Director, Clinical Operations, Premier Research
• Nicole Fernandez - Director of Operations, PERI
• Brandy Ward - Associate Director, Records Management & Head of TMF, Akebia Therapeutics

10:00 AM — Tech Innovation Spotlight: Country Workflows and SSU

10:20 AM — Powering Site Partnerships Through Collaboration and Tech

• Hosted by Christine Morris - Executive Director, TransPerfect

Featured Speakers:

• E.B. McLindon - CEO, Helios Clinical Research
• Sara Schmidt - Chief Quality & Compliance Officer, Profound Research
• Sarah Darnell - Director, Quality, Profound Research

11:05 AM — TMF Closeout: Accountability, Reconciliation, and Archiving

• Hosted by Gillian Gittens - Senior Director, e-Clinical Strategy & Solutions, TransPerfect

Featured Speakers:

• Ashley O'Bannon - Senior Manager, Global Records Management, Premier Research
• Robin Farmer - Senior Director, Records Management, Doc Control, and Training, GRAIL
• Iris Castillo - Director, Clinical Compliance, Taysha Gene Therapies

11:35 AM — Tech Innovation Spotlight: AI Continuous Compliance & LiveTMF

11:55 AM — From OpTImize to Action

• Hosted by Garrett Smith - Executive Director, Life Sciences Solutions, TransPerfect

Featured Speakers:

• Ashley O'Bannon - Senior Manager, Global Records Management, Premier Research
• Jamie Toth - Senior Director, Global TMF Management & Records, BeOne Medicines
• Robin Farmer - Senior Director, Records Management, Doc Control, and Training, GRAIL

12:25 PM — LUNCH

1:30 PM — Product Roadmap Updates

2:30 PM — Trial Interactive Focus Groups

4:00 PM — Networking & 1:1 Meetings

Please note that the agenda is subject to change, and this page will update as more details become available.