Endpoint Based Protocol Development: A Central Laboratory Perspective + Microbiology Case Study

The ability to ensure that relevant and accurate laboratory testing is performed, which will meet the primary and secondary endpoints in a clinical trial, is the basic expectation for any central laboratory. Pharmaceutical and biotech organizations, along with CROs continually look to those central laboratories that maintain a full continuum of testing capabilities where routine safety testing can be performed in conjunction with high complexity, esoteric and indication-specific testing. To optimally employ the myriad of laboratory methods and instrumentation available to perform seemingly identical tests, a rigorous scientific review is an essential element in clinical trials protocol design.

But what are the core principles and steps that must be taken in order to optimize the selection of the diagnostic testing to support the trial protocol?

An important step is a thorough review by experienced personnel versed in the scientific/technical and operational aspects of indication-specific laboratory testing. Additional considerations include the level of experience the laboratory has with performing testing for specific indications; how the laboratory’s current test menu aligns with the protocol requirements and the willingness of the laboratory to tailor innovative solutions to meet unique endpoints. A brief scientific dialogue to confirm the proposed approach meets with expectations should be conducted very early in the process to avoid costly amendments and delays in study starts.

Using a case-based approach, join ACM Global Central Lab for this webinar to learn about:

• Best practices for conducting a rigorous scientific review to ensure appropriate testing is utilized during the development of a protocol.
• How indication-specific quality metrics can provide assurance that test menu and corresponding results will stand up to regulatory scrutiny.
• A case study example in which the microbiology team implemented specialty techniques to ensure the appropriate tests and analysis met the needs of the clinical trial including operational procedures for specimen collection, handling and shipping to maintain sample and ultimately test result integrity.

This webinar is part of ACM Global’s “Navigating Global Clinical Trials with your Central Lab” series of informative and interactive events.

Speakers

Mark Engelhart, Chief Commercial Officer, ACM Global Central Laboratory

Mark has more than 25 years of experience within the Pharmaceutical and drug development industries, with extensive experience in sales, marketing, strategy, and global commercial operations. He has held commercial and general management roles across the continuum of drug development and commercialization, from pre-clinical and clinical development through post-approval marketing and sales. As Chief Commercial Officer at ACM, Mark manages our global business development, marketing, commercial analysis, and bids & proposals functions.

Message Presenter

Kathleen Murray, Executive Director, Scientific Affairs, ACM Global Central Laboratory

Kathy has spent more than 30 years in the clinical laboratory with experience in all areas of general laboratory testing. Kathy has been aligned with the clinical trials central laboratory division since 1997.She has been instrumental in the expansion of ACM’s global presence. A current focus is ensuring that ACM is delivering optimal testing for the indication and ensuring harmonization worldwide.

Message Presenter

Suzanne Dale, PhD, D(ABMM), Director of Microbiology and Molecular Diagnostics, ACM Global Central Laboratory

Dr. Suzanne Dale holds a PhD degree in Microbiology and Immunology from the University of Western Ontario and is board-certified in Medical and Public Health Microbiology by the American Board of Medical Microbiology. Dr. Dale has 10 years of experience within academic and private diagnostic microbiology laboratories. At ACM Global Central Laboratory, Dr. Dale oversees all Microbiology and Molecular Diagnostics activities with an emphasis on providing highly-quality, uniquely-tailored testing solutions.

Message Presenter