PRA, as the original pioneers of the embedded functional service provider (FSP) sourcing model, is now connecting these models with their project-based CRO service model to create a customized, blended delivery solution that benefits their mid-size pharma customer partners.
The PRA embedded-FSP solution enables the use of a consistent set of systems and processes across the clinical trial portfolio while allowing access to the scale economies more often reserved for larger pharmaceutical companies. Whether a company’s desire is to build a consistent, global operating model, establish a recognized global development presence or to retain accountability to deliver a clinical trial portfolio, this solution offers a model that can address each of these important priorities. It’s a model that can grow and evolve with the customer as the customer grows and evolves with PRA.
Register for this webinar to learn about the evolution of the FSP/Embedded Model, and PRA’s experiences implementing successful blended FSP and CRO project-based outsourcing strategies.
Samir Shah, Executive Vice President and President, Strategic Solutions, PRA Health Sciences
Samir Shah is the Executive Vice President and President of Strategic Solutions at PRA Health Sciences. He previously served as Chief Operating Officer of Strategic Solutions at PRA from 2013 through 2018. With over 25 years of industry and research experience, Mr. Shah is one of the key pioneers in the development and maturation of the embedded sourcing model, and has specific expertise in transformational models in the biopharmaceutical life science space.
Previously, Mr. Shah had roles of increasing responsibility at US Bioscience, Zeneca Pharmaceuticals, Theorem Clinical Research and Parexel. In addition to his experience in clinical drug development, Mr. Shah served as a Research Scientist at the University of Pennsylvania Medical Center in the Department of Psychiatry.
Cathy Lane, Executive Director, Embedded Operations, Strategic Solutions, PRA Health Sciences
Cathy Lane is an Executive Director, Embedded Operations at PRA Health Sciences, and 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. Cathy’s accomplishments include leading the implementation of a 300+ resource global blended delivery solution for a US-based biotech company transitioning from a traditional outsourced model to a blended outsourcing model. She is also responsible for leading the development of a new blended delivery solution for a biotech company with global operations in both China and the US. Cathy has a wealth of experience with the implementation of new and diverse programs, spanning all divisions of PRA.
Susan Schwarzwalder, Vice President, Biometrics Strategic Solutions, PRA Health Sciences
Susan Schwarzwalder is the Vice President of Biometrics Strategic Solutions and leads the SSD global biometrics embedded teams at PRA. She also supports the global strategic leadership team in developing customized sourcing solutions for clients’ specific needs across their pipeline.
Ms. Schwarzwalder has worked in the pharmaceutical industry for 25 years. She began her career working for a CRO as a data and quality control coordinator developing computer-aided new drug applications. She later moved into regulatory affairs, where she participated in agency, client and site audits, conducted software validation, led SOP development, and directly participated in the compilation and filing of NDAs.
Ms. Schwarzwalder came to PRA Health Sciences, Strategic Solutions division, 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 groundwork to support and build out the processes and best practices for implementing and managing embedded teams across multiple sponsors and functions. Solutions include best practices in organizational management structures, resourcing across pipelines, KPI development, proposal implementation, training/academy programs, and process and system improvement initiatives.
John Barry, SVP, Consulting Practice, and Chief Strategy Officer, Strategic Solutions, PRA Health Sciences
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 of key opportunities and customer models.
Mr. Barry 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. Prior to joining PRA, Mr. Barry was the Chief Operating Officer at a mid-size CRO after 4 years as head of portfolio sourcing and relationship management and a member of the senior leadership team for Merck Research Laboratories’ Global Clinical Trials Organization.
Mr. Barry has managed a variety of delivery models, including functional, full-service CRO, single-service and sole-source relationships. He is well versed across a variety of contract structures, including value-based contracting and has significant experience negotiating innovative commercial and capital models.
Prior to joining Merck, Mr. Barry spent over 20 years working for two of the top five global CROs.
Mr. Barry has a Bachelor of Science degree from Cornell University and an MBA from the University of North Carolina at Chapel Hill.
Who Should Attend?
This webinar will benefit professionals from emerging and mid-sized pharmaceutical companies in the following roles:
- Clinical Operations
- Data Management
- Functional Operations
- Medical Affairs
- Procurement/Outsourcing, Biostatistics
- Procurement/Outsourcing, Regulatory
What You Will Learn
- How emerging and/or mid-size companies can leverage the blended model to establish a global presence
- Considerations for using CRO project-based services as complementary to an FSP solution
- Method for implementing a single operating platform that combines both FSP and CRO project-based sourcing for trial delivery
- How to develop a collaborative partnership that optimizes a blended operating model
- The benefits of enhancing accountability, responsibility and aligning sponsor/partner goals and objectives
- Moving beyond model realization and creating a sustainable model of continuous improvement
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.
With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.
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