<span>Aligning Core Values to Advance an Oncology Program</span>
February 11, 2022

Aligning Core Values to Advance an Oncology Program

Drug development sponsors often seek the support of a clinical research organization (CRO), but today's partnerships depend on more than capabilities. Sponsors need to ensure that the CRO can align with their culture and values throughout the development process and work collaboratively with their existing partners.
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<span>Nonclinical Considerations for Cell & Gene Therapies</span>
February 22, 2022

Nonclinical Considerations for Cell & Gene Therapies

SOT 2019 -- Brian and Paul explore advanced therapies definitions, preclinical study and regulatory safety considerations, analytical design and validation strategies, biodistribution studies and data integrity, titre assays, CMC considerations and phase-appropriate validations for preclinical cell and gene therapies.
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<span>Advancing inhalation toxicology capabilities to support chemical testing</span>
March 9, 2022

Advancing inhalation toxicology capabilities to support chemical testing

Respiratory exposure to chemicals or agrochemicals poses potential risk to human health, especially to workers handling these products. Whether preparing a solution, dusting or spraying crops, or cleaning equipment, opportunities for inadvertent inhalation is a risk that can potentially lead to toxic effects, both acute and chronic.
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<span>Postharvest Ethylene Treatment - Crop Protection Case Study</span>
March 22, 2022

Postharvest Ethylene Treatment - Crop Protection Case Study

Labcorp was approached by consultants compiling a dossier for registration renewal (registration review) of commercial gas formulations of ethylene. Ethylene is naturally produced by some fruit and vegetables during ripening and is a promoter of ripening and senescence in many crop species.
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<span>De-Risk Your Drug Development: CMC Manufacturing</span>
March 24, 2022

De-Risk Your Drug Development: CMC Manufacturing

This brochure introduces the potential for problems at BLA submission where a recent analysis of FDA complete response letters showed that 47% of the products that received them had CMC analytical issues. In many cases the drug had shown sufficient evidence of clinical efficacy but was delayed entering the market due to issues with the CMC package.

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<span>Achieving Sponsor Goals with Efficient End-to-End Solutions</span>
March 29, 2022

Achieving Sponsor Goals with Efficient End-to-End Solutions

Through a comprehensive range of solutions, efficient end-to-end services and connections with international regulatory agencies, we help build your program with a sound regulatory strategy, optimal trial design and compliance with global submission requirements.
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