Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.
Learning Objectives
Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.
Chair
Huong Huynh, PhD
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Explore strategies for high complexity projects, focusing on collaborations, regulatory submissions and asset integration. Gain insights on stakeholder management, risk mitigation, strategic planning to turn potential chaos into streamlined success.
Learning Objectives
Manage challenging biopharmaceutical collaborations and discuss efficient integration of assets; Identify effective strategies for managing complex regulatory submissions in the pharmaceutical industry; Assess risks and develop contingency plans for project timelines and budgets; Apply multiple stakeholder management techniques to ensure alignment and informed decision-making across governances.
Matt has been working in the pharmaceutical industry for more than 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →
Senior Director, Development Program Management, Genmab US, Inc., United States
Accomplished Leader with 3 decades of experience in the pharmaceutical industry, focusing on strategic initiatives, operational excellence and regulatory compliance. Adept at leading cross-functional teams and forging partnerships to execute complex projects. Passionate about optimizing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This pilot expanded PM from R&D to encompass launch activities, enhancing cross-functional collaboration and planning, stakeholder communication and alignment with country organizations. A PM covering the entire value chain drives project success.
Learning Objectives
Assess the impact of end-to-end coverage of projects, including commercialization, on project value; Integrate critical components of launch planning, including R&D, marketing, access, and medical tactics; Develop skills to enhance cross-functional collaboration among R&D and global and local commercial teams to improve project outcomes.
This session introduces the Dynamic Phased Delivery (DPD) Model, a flexible and adaptive framework that overcomes the limitations of traditional project management, enabling alignment and delivery of complex, large-scale initiatives.
Learning Objectives
Understand the limitations of traditional project management methods in delivering large-scale, strategic initiatives; Introduce the Dynamic Phased Delivery (DPD) Model as a flexible, adaptive framework for strategic project delivery; Understand how the DPD Model has been applied to date, and learn to apply DPD principles.
Business Transformation, Independent Consultant, United States
Meet Sajida Roberson, a dynamic consultant blending strategic leadership with hands-on expertise to drive impactful business transformations. With a proven track record in global pharmaceutical companies, Sajida seamlessly transitioned from corporate strategy roles to independent... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Significant business transformations can be critical to achieve organizational vision and goals in an evolving landscape. In this session we will discuss how to effectively plan, execute and monitor significant business transformations.
Learning Objectives
Discuss the importance of business transformations in defining future-states and driving organizations forward; Explain how to effectively plan, execute and monitor business transformations; Describe how to apply business transformations to drug development.
