| Labcorp

September 1, 2022

A first-in-class drug's journey to market

A leading cause of blindness, GA affects more than 5 million people worldwide and 1 million in the United States alone. This investigational targeted C3 therapy helps regulate excessive activation of the complement cascade within the immune system, a known contributor to the progression of many serious diseases.

September 2, 2022

Flexibly integrating multidisciplinary expertise in an innovative program to achieve regulatory success for complex food flavorings

Labcorp was approached by the manufacturer of three closely related flavorings due for renewal of authorization. Part of the reauthorization required a new updated suite of studies.

September 7, 2022

Causes of Mortality and Profile of Spontaneous Tumors in Young CD-1 Mice

ESVP-ECVP 2022 -- CD-1 mice are the strain of mouse most commonly used for chronic studies in Europe. Knowledge of the profile of spontaneously occurring neoplasms of rodents is essential for differentiating spontaneous and test item-related tumor patterns.

September 12, 2022

Comprehensive analysis of the association between RAS mutation and immune checkpoint marker expression

ESMO 2022 -- Revealing the relationship between RAS mutation and the expression level of the immune checkpoint molecules can guide potential combinations of treatments.

September 13, 2022

Spontaneous Neoplasms in the Uterus, Vagina and Cervix of Mice from Carcinogenicity Studies

ESTP Congress 2022 -- Carcinogenicity studies are important in identifying tumorigenic potential in animals as part of the risk assessment for new drugs. Historical control data incidences can be useful when selecting and assessing the suitability of an animal model.

September 13, 2022

Spontaneous Neoplasms in the Uterus, Vagina and Cervix of Rats from 104-Week Carcinogenicity Studies

ESTP Congress 2022 -- Carcinogenicity studies are important in identifying tumorigenic potential in animals as part of the risk assessment for new drugs. Historical control incidences are important considerations when interpreting data and useful when selecting and assessing the suitability of an animal model.

September 16, 2022

Using telemedicine and local treatment to avoid Australian interstate travel quarantines

A China-based biotech company with a Phase Ia/Ib solid tumor oncology trial running in Australia needed a creative solution to maintain study participant engagement. One participant needed to travel from their home state (Tasmania) to another state (Victoria) where the investigator site was located.

September 19, 2022

Cell and Gene Therapy - High Quality and Safety from Vein to Vein: CMC Testing for CAR T-Cell Therapies

Chemistry, Manufacturing and Control (CMC) testing is an integral part of the CAR T-cell clinical journey during vector production and T-cell modification. These tests, mandated by the FDA and other regulatory agencies, uphold the safety, purity and potency of the product before being administered to the patient.

September 20, 2022

Utilizing health economic insights to inform product development and secure market access

We are your source for strategic HEOR services to support successful market access activities. A winning market access strategy requires early and ongoing consideration of the health economic and outcomes research (HEOR) needs for your product.

September 22, 2022

Characterizing the effector functions of therapeutic antibodies

Understand the Fc region of your antibody product, so that you can assess the impact on immunology, safety and efficacy. Using a risk-based approach, find out the most efficient way to test functionality relevant to the stage of drug development.

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