Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges

This is an exciting time to be in clinical research. New tools have evolved in the imaging diagnostic and theranostic space, providing opportunities for improved ways of diagnosis and treatment of cancers and other diseases. Challenges, particularly those associated with translating preclinical research into clinical setting, remain. This presentation will discuss a few diagnostic and theranostic agents currently under development and in use from the lifecycle management perspective, discuss challenges, and the solutions to overcome them.

Key Topics:

• Regulatory expectations for imaging diagnostic and theranostic investigational products
• Innovative tools for diagnostic imaging and treatment of cancers and other diseases
• Partnership between biotechnology and diagnostic imaging agents
• Some clinical development challenges and Ideas to overcome them
• Statistical Considerations

Speakers

Prithul Bom, Senior Director of Scientific Affairs and Therapeutic Area Lead for Medical Devices & Diagnostics

Prithul Bom joined Chiltern in 2014 with 18 years of health care industry experience in medical devices and diagnostics. Bom is Chiltern’s senior director of scientific affairs and executive lead for diagnostics devices across all therapeutic areas with extensive experience in cardiovascular, dermatology, infectious disease and orthopedic medical devices. She provides strategic, scientific, clinical development, quality systems and regulatory guidance on protocols, and she designs operational solutions to support them. Bom excels at collaborating with global operations to establish and track metrics to ensure targets are consistently met for quality deliverables, sponsor satisfaction and operational profitability, and has multiple professional associations and industry qualifications.

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Lisa Moore, RN, PhD, Executive Director, Medical Devices & Diagnostics Development, Chiltern

Lisa Moore serves as Chiltern’s senior director of scientific affairs for medical devices and she is the therapeutic lead for cardiovascular trials. A registered nurse with a doctorate degree in physiology, she has more than 30 years’ experience in cardiovascular research and cardiovascular critical care nursing. Additionally, she has significant expertise in clinical trial development for devices, as well as management of data and safety monitoring boards and clinical events committees. Moore has been integrally involved in protocol development and trial management for more than 35 cardiovascular trials and has experience in multiple transplant studies and dermatology studies. An assistant professor at the Florida Institute of Technology, Moore has been active in the industry, presenting on topics such as endpoint adjudication, imaging endpoints, data mining and human factors engineering.

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Jeffrey Joseph, Executive Director, Statistics, Chiltern

Jeffrey Joseph is senior director of biostatistics at Chiltern where he leads global feasibility assessments, working with project teams and collaborating cross-functionally on global clinical trials. With master’s degrees in both human genetics and biostatistics, Joseph has significant therapeutic experience in multiple areas, particularly oncology and infectious disease. He has more than 30 years’ experience in biostatistics and biometrics working for both pharmaceutical and contract research organizations, and he is a frequent presenter at industry workshops covering such topics as the role the of the clinical statistician, common statistical issues the FDA encounters and innovative adaptive designs in early-phase oncology trials.

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