As the paradigm shift in drug development continues to drive unsustainable costs, biopharmaceutical companies must lift the veil on true sponsor vs. CRO operating costs. The mounting internal cost of drug development and total cost of ownership forces companies to identify and thoroughly assess core, critical, and non-core competencies. Through this process, biopharmaceutical companies will discover opportunities to lower costs and increase flexibility, while maintaining strategic control, mitigating regulatory risk, and enhancing the overall quality of their drug development pipeline.
Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts University
Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.
Samir Shah, Chief Operating Officer of Strategic Solutions division, PRA Health Sciences
Samir Shah is the Chief Operating Officer of the Strategic Solutions division of PRA Health Sciences. In this role, he is responsible for the operations, strategy, and business functions across the global division. Mr. Shah joined the legacy RPS organization nearly at its inception in 2000 before it was acquired by PRA Health Sciences in 2013. He was one of the key pioneers in the development and maturation of the Embedded sourcing model creating market differentiation in the bioPharmaceutical life science space. Mr. Shah’s expertise includes strategic sourcing, change management, and optimizing effective governance and operating structures.
Previously, Mr. Shah has held various positions across clinical operations and business enablement in the bioPharmaceutical industry at US Bioscience and Zeneca Pharmaceuticals and in the CRO sector at Theorom Clinical Research (formerly Biopharm/IBAH Clinical Services) 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 and has a BS degree from Saint Joseph’s University in Philadelphia.
Who Should Attend?
- Development Operations Leaders
- Procurement/Outsourcing Leaders
- Finance Leaders
- Compliance officers
- Academic researchers
PRA Health Sciences
At PRA Health Sciences, providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life- improving drugs. We help change people’s lives for the better every single day. It’s who we are. Innovating to help people is at the heart of our process, but it’s even more than that. It’s also our privilege.