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The Evolution of FSP: Not Just for Large Pharma - How all Sponsors can Benefit from a Synchronized Outsourcing Strategy


Presenters

  • Samir  Shah

    Samir Shah

    • Executive Vice President and President, Strategic Solutions
    • PRA Health Sciences, United States

    As Executive Vice President of PRA Health Sciences and President of PRA’s Strategic Solutions Division and Global Regulatory Affairs, Mr Shah is responsible for each units global operations, strategy, and business functions. He has more than 25 years of industry experience. He joined the (legacy) RPS organization at its inception in 2000 before it was acquired by PRA in 2013. Mr Shah is one of the pioneers and a leader in the development and maturation of the embedded sourcing model and has specific expertise in transformation models in the biopharmaceutical life science space including strategic sourcing, change management, and optimizing effective governance and operating structures.

  • Cathy  Lane

    Cathy Lane

    • Executive Director & General Manager,Embedded Clinical Operations
    • Strategic Solutions, PRA Health Sciences, United States

    Cathy Lane is responsible for the operational delivery of global transformational partnerships and relationship management. She has 30+ years of CRO industry experience, holding a variety of distinct roles across clinical operations, business development, and alliance management. This includes roles across clinical development ranging from project management, line and functional management, and as a global operations director. Ms. Lane joined PRA in 2015 as a Senior Director, and has been instrumental in developing PRA’s global blended delivery solutions.She is responsible for leading the development of a new blended delivery solution for a biotech company with global operations in both China & US.

  • Susan  Schwarzwalder

    Susan Schwarzwalder

    • Vice President, Biometrics Strategic Solutions
    • PRA Health Sciences, United States

    Susan Schwarzwalder is the Vice President of Biometrics Strategic Solutions and leads the SSD global Biometrics embedded teams as well as supports global strategic leadership team in developing customized sourcing solutions for clients specific needs across their pipeline.She joined PRA Health Sciences in 2000 to work on a rescue project for a large non-small cell lung cancer study for a major pharmaceutical company. In 2002, she moved from a field assignment to manage a large embedded data management team for another major pharmaceutical company through PRA.This laid the ground work to support and build out the processes and best practices for implementing and managing Embedded teams across multiple sponsors and functions.

  • John  Barry

    John Barry

    • SVP, Consulting Practice and Chief Strategy Officer Strategic Solutions
    • PRA Health Sciences, United States

    John Barry joined PRA Health Sciences in 2020 and serves as the SVP and Chief Strategy Officer for the company’s Strategic Solutions Division. In this role, Mr. Barry is responsible for managing the division’s consulting practice and providing strategic oversight one key opportunities and customer models. He has extensive experience in the drug development industry and has worked as an executive leader in a variety of functions including alliance management, business development, clinical operations, contracts, proposals and legal.