LabCorp is engaged in numerous Companion Diagnostics (CDx) projects with its pharmaceutical partners; these projects span therapy areas and include platforms such as flow cytometry, ELISA, RT-PCR, and gene expression profiling.
Our unique position in the industry allows us to develop and validate novel or existing biomarkers through one of our eight Centers of Excellence, test those biomarkers in the clinical trial setting and then, contingent on intended use, submit to Regulatory authorities in tandem with the therapeutic – with the view to commercialization across our global network of laboratories.
A Regulatory app
roved LDT within the LabCorp network offers an attractive option in the reference laboratory industry and has culminated in 510(k) and pre-market approval submissions to the U.S. Food and Drug Administration (FDA).
Key Takeaway Points:
- Different models to commercialisation are available
- IVD and Regulated Laboratory Developed Test (LDT)
- Scalable commercialization pathwaysw
- Strategies to reduce CDx development timelines by up to 12 months
- Recent case studies with FDA submissions demonstrate a different approach
Speaker
Alan Wookey, Executive Director, Companion Diagnostics, LabCorp
Mr. Wookey is currently responsible for leading the Companion Diagnostics Group at LabCorp – working across the industry to develop biomarker programs with Pharma and BioTech from analytical & clinical validation through regulatory approval and commercialization.
Prior to joining LabCorp, he held leadership positions in Oncology Clinical Development at AstraZeneca including leading the Clinical Biomarker Group. During his time at AstraZeneca, Alan collected a clinical innovation award for leading the development of biomarker testing in China to support oncology clinical development programs. Alan earned his degrees in Microbiology from the University of Liverpool, UK and has been focused in Pharmacogenetics and Personalized Medicine for more than 10 years.
Message PresenterWho Should Attend?
Senior Executives, Vice Presidents, Directors of:
- Translational Medicine/Drug Development/Oncology
- Predictive Medicine
- Personalized Medicine
- Diagnostics/Companion Diagnostics
- Biomarker Development
- Molecular Profiling
- Pharmacogenomics/Pharmacogenetics
- Clinical R&D
- Regulatory Affairs
- Commercialization
- Marketing
Within large Pharmaceutical companies, all Biotechnology companies, Biomarker Discovery companies, plus Consultants, Regulators/Payors/Public Health, and Platform Providers
Xtalks Partner
LabCorp Clinical Trials
LabCorp Clinical Trials, a division of LabCorp, combines standardized international laboratory capabilities with sophisticated diagnostic technologies to provide a broad portfolio of services and clinical assays to support drug and diagnostic clinical studies.
- Full-service central laboratory support for Phase 1 through Phase IV studies
- Dedicated clinical trials laboratories in Belgium, China, Singapore and the United States
- Participation in more than 7300 clinical trials, including more than 1200 with international sites
- Scientific leadership and innovation across major therapeutic areas
- Comprehensive portfolio of clinical assays and laboratory services for accelerated drug development
- Dedicated research and development services to assist in assay development and validation, and new assay implementation
- Standardized test platforms and global reference intervals for real-time combined data
- Global proficiency testing and quality control programs
- Global courier and logistics solutions
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