Clinical Process Innovation: Driving Predictability in Clinical Development through Innovation

The biopharmaceutical industry is caught between mounting pressure to reduce development costs and the need to ensure better outcomes from clinical trials. Generics, lower approval rates, and global testing requirements have increased drug development costs to between $800 million and $1.2 billion for each successful product. Yet outcomes have remained uncertain in terms of both regulatory approval and market acceptance, and large payers continue to exert downward pressure on prices.

Although the stakes continue to increase, changing regulatory guidelines and advanced data collection methods are creating new opportunities to streamline and better focus the clinical trial process. This has the potential to reduce costs, improve trial predictability and accelerate the time it takes to bring a compound to market.

Implementing change is hard, but is necessary given the challenges we face as an industry. This webinar will explore the direction clinical research is headed and the role innovation plays in its new course. Speakers will share insights on how adapting the process of clinical development at strategic points and implementing new strategies can result in reduced cost and development time. Speakers will discuss the value of optimizing protocols against our development needs and the value of a holistic, end-to-end, approach to optimize trial delivery. Recent clarifications in the regulatory environment and the availability of near real-time data reporting and analytics have opened the door for us to be smarter about how we collect and verify the data we need. The goal is operational plans that are fit for purpose and leverage leading technology for greater efficiency, and ultimately predictability, in conducting clinical research.

Speakers

Jamie Macdonald, Chief Executive Officer, INC Research

Jamie Macdonald serves as the Chief Executive Officer at INC Research. He has more than 15 years of senior management experience in operational and financial roles in the CRO and bioPharmaceutical industries. In the CRO sector, he joined INC Research in 2011 as COO when the Company acquired Kendle, where he was also COO. Prior to Kendle, he served as Senior Vice President and Head of Global Project Management at Quintiles with direct responsibility for a team that delivered approximately $2 billion in annual service revenue. Mr. Macdonald began his career in the Pharmaceutical sector as part of Syntex/Roche. He earned a Bachelor of Arts in Economics from Heriot-Watt University in Edinburgh, Scotland and is a UK qualified Chartered Management Accountant (ACMA).

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Amy Kissam, Executive Director, Integrated Clinical Processes, INC Research

Amy Kissam, Executive Director, Integrated Clinical Processes, is a key leader in the Clinical Innovation group at INC Research. She has more than 13 years of senior level experience working in global CROs, particularly in clinical operations, quality control and clinical process integration. Most recently, she established a global multi-functional team that developed leading metrics for proactive clinical process management, which increased consistency and efficiency in reporting and improved visualization around patient safety, study performance and quality. In her role at INC Research, Ms. Kissam is focused on driving innovation across a wide array of tools, dashboards and processes to enhance quality service delivery for customers. She leads INC Research’s strategic data monitoring initiative and provides executive oversight of the ongoing development and enhancement of the Company’s Trusted Process®. Ms. Kissam earned her Bachelor of Science in Biochemistry at San Diego State University. She is a member of the Association of Clinical Research Professionals (ACRP), the Society for Clinical Data Management (SCDM), the Drug Institute of America (DIA) and a current board member of the Clinical Trials Transformation Initiative (CTTI).

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John Whitaker, Ph.D., Senior Vice President, Clinical Innovation, INC Research

As Vice President, Clinical Innovation, John A. Whitaker, Ph.D., drives the development of advanced monitoring strategy tools for INC Research. His team is focused on generating evidence-based, strategic risk-based monitoring approaches for customers that enable quicker decisions that more efficiently deliver quality, manage study performance and ensure patient safety. Dr. Whitaker has nearly two decades of experience in research and drug development. He has experience in supporting Phase I – IV clinical trials and strategic planning for programs of work. He has provided management oversight and support for regulatory submissions to both the FDA and EMEA, including representation at agency meetings. Areas of significant therapeutic experience include acute and chronic pain, HIV/AIDS, addiction, oncology, sleep, depression, and Parkinson’s disease.

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