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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Advanced Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 6, Track 3: How to Make the Most of an Evolving Tech Landscape Crowded with Competing Solutions: Survival of the Fittest vs Symbiosis?

Session Chair(s)

Matthias  Sijtstra

Matthias Sijtstra

Senior Consultant

Main5 GmbH & Co. KGaA, Netherlands

This session will describe, differentiate and discuss the distinct approaches life sciences regulatory organizations have taken in acquiring, combining, and eliminating new innovative capabilities to optimize their digitalization journey. This session will include use cases from three different Life Sciences Companies of various sizes and illustrate their decision-making processes in evaluating, deploying, and managing digital capabilities. They will share their business needs, technical and process issues, design and decision-making frameworks, results, and key learnings.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Differentiate and assess strategic approaches for digitalization in life sciences
  • Apply decision-making frameworks to tech evaluation
  • Address challenges in digital adoption with limited resources

Speaker(s)

Salim  Saglam, MBA

A Tale of Two Use Cases: Lessons Learned and Way Forward in Combining Digital Capabilities Effectively

Salim Saglam, MBA

Genentech, Inc., United States

Business Transformation Lead, Product Development

Jason  Moyer, MBA

Digital Navigation: Selecting the Optimal Solution for Business Success

Jason Moyer, MBA

Gilead, United States

Executive Director Reg Affairs Innovation, Digital & External Partnerships

Jessica  Romero

Decision-Making Frameworks for Digital Capability Integration at Sarepta

Jessica Romero

Sarepta Therapeutics, United States

Director, Global Regulatory Operations, Global Regulatory Affairs

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