Drug development is a global industry and all companies involved, from the smallest biotechs to the largest pharma companies, are well-advised to ensure they are collaborating with contract research organization (CRO) partners who can provide seamless global services. Harmonization of labs practices, method development, assay creation and knowledge transfer across multiple global sites is essential to building a program that will deliver the necessary flexibility, agility and speed in drug development.
A good CRO partner should have expertise in method development, which can be evaluated through incurred sample reanalysis. Incurred sample reanalysis is useful to demonstrate method robustness and analyst execution and may highlight unstable metabolites that would not be present in laboratory prepared QC samples used to validate the method.
In addition, the CRO should be able to prepare qualified Standard for Exchange of Nonclinical Data (SEND) data packages, which is a critical attributes of an effective global CRO partner. The SEND is a more recent initiative from the US Food and Drug Administration (FDA) intended to standardize nonclinical data packages based on Clinical Data Interchange Standards Consortium (CDISC). The current FDA approved SEND guidelines are required for applicable Nonclinical studies that were initiated after Dec 17, 2016.
Finally, the CRO should be a stable and reliable partner in the drug development process, from initial drug development process, through non-clinical toxicity studies, and into late-phase clinical trials.
Join this free webinar to learn how these attributes, plus having the capacity to support a full drug development program, make for a great bioanalysis CRO partner.
Dawn Moore, Director of Preclinical Business Development, QPS
Dawn Moore is a highly analytical, personable and collaborative professional with 19+ years of pharmaceutical research and development experience. She possesses scientific expertise in development drug metabolism and pharmacokinetics (DMPK) and quantitative bioanalysis in pharma (including GSK, AstraZeneca, ViroPharma and Shire where she was responsible for global nonclinical/DMPK operations, contributing to the successful submission of over 50 INDs, two BLAs and one NDA.
Eric van Ingen, MS, Director, Bioanalytical, QPS
Eric van Ingen is a director in the bioanalytical department at QPS, LLC based in Newark, Delaware. With a background in analytical chemistry, he has served the company for over 19 years in various roles including principal investigator, project manager and head of sample management and archives.
Who Should Attend?
This webinar will appeal to investigators, scientists, researchers, managers, leaders, directors, VPs, SVPs, EVPs, or heads of:
- Clinical Research
- Research and Development
- Drug Development
- Clinical Development
- Clinical Trials Management
- Clinical Trials Project Management
- Data Science
- Translational Research
What You Will Learn
Attendees will learn about:
- Critical attributes of an effective global CRO partner
- A brief overview of SEND requirements and QPS’ capabilities and experience around SEND
- Case study: QPS completed over 180 studies which contributed to a successful global drug approval
- Incurred sample reanalysis data and statistics, as well as examples of past failures and the reasons behind those failures
QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.
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