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Evaluation Video ViewAttendees 16

Pharmaceuticals (includes Biologics & Drugs)

Data Science and Management: Strength of Collaborations for Evidence Generation To Advance Medical Product Development

Wednesday, October 8, 2025
2:15 PM - 3:15 PM EST
Location/Room: 304
The convergence of data science and management in medical product development has created unprecedented opportunities to accelerate innovation. As regulatory agencies increasingly embrace sophisticated data approaches from synthetic data to real-world evidence and model-informed drug development, the potential for transformation and innovation in medical product development has never been greater. Through compelling use examples to demonstrate the strengths of data sharing and collaborations through public-private partnerships, this session will examine how advanced analytics and strategic management practices are revolutionizing development timelines and regulatory decision-making. Participants will discover proven strategies for success, including building data-driven cross-functional teams, leveraging real-world analytics for adaptive management, and aligning diverse stakeholder goals, including regulators, sponsors and patients, toward shared objectives.

Learning Objectives:

  • Understand data science concepts for integration of advanced data analytics. Apply adaptive management strategies that align with evolving regulatory approaches to complex data types, including synthetic data and real-world evidence.
  • Identify regulatory-ready data and use of this data as evidence to support regulatory submissions. Evaluate how the integration of advanced data analytics with management practices can accelerate medical product development through examples of successful public-private partnerships.
  • Understand how regulatory professionals can support cross-functional teams during evidence generation and analysis. Apply frameworks for establishing effective cross-functional teams that leverage data-driven objectives and analytics to improve stakeholder decision-making in product development.