9:00 AM — Registration & Networking
11:00 AM — Opening Remarks
11:05 AM — Rapid Fire Innovation Spotlight - eTMF: Automate with Inspection Readiness Flags & Risk Management
- Presented by Jay Smith - Vice President, Product Management, TransPerfect
11:20 AM — AI Adoption: Successes and Struggles in R&D
- Hosted by Christopher Utterback - Life Sciences Regional Director, 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
- Jordan Ellington - CEO & Founder, Virtual Data Corp
12:20 PM — OpTImizing eTMF Usage: Configurations, Essential Features, and Interoperability
- Hosted by Stacy Dagana - Senior Implementation Manager, TransPerfect
Featured Speaker:
- Kelsea Filter - Outcomes & Strategy Manager, PERI
- Brandy Ward - Associate Director, Records Management & Head of TMF, Akebia Therapeutics
12:50 PM — Rapid Fire Innovation Spotlight - Simplified Study and Site Training
- Presented by Christine Morris - Executive Director, Life Sciences Solutions, TransPerfect
1:05 PM — LUNCH
2:05 PM — Inspection Survival Stories: Tales from the Front Line
- 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
2:50 PM — TMF Closeout: Accountability, Reconciliation, and Archiving
- Hosted by John Merkel, Director, Business Development, TransPerfect
Featured Speakers:
- Robin Farmer - Senior Director, Records Management, Doc Control, and Training, GRAIL
- Ashley O'Bannon - Senior Manager, Global Records Management, Premier Research
- Iris Castillo - Director, Clinical Compliance, Taysha Gene Therapies
3:20 PM — Rapid Fire Innovation Spotlight - Country Workflows and SSU
- Presented by Tami Bruin - Solutions Consultant, TransPerfect
3:45 PM — COFFEE BREAK
4:05 PM — TMF and M&A: Experiences and Case Studies
- Hosted by Garrett Smith - Executive Director, Life Sciences Solutions, TransPerfect
Featured Speakers:
- Shyanne Ali - Senior Vice President, Quality Assurance, Aditum Bio
- Meraf Eyassu - Executive Director, Clinical Operations, Terns Pharmaceuticals
4:35 PM — 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
- Erin O'Boyle - Senior Vice President, Clinical Operations, Rezolute
- Princess Barcelona-Martin - Senior Clinical Documentation Manager, Beacon Therapeutics
5:15 PM — Closing Remarks
6:15 PM — Networking Cocktail at the W Hotel
7:30 PM — Social Event: Food, drinks, and live entertainment at 25 Lusk
