Cell and gene therapy answers: Assessing the critical quality attributes, challenges and importance of CMC

Your source for answers to the complex challenges of cell and gene therapy development.

Connecting diagnostic and drug development expertise around the world: Meet Claudine

As the drug development and diagnostic businesses of Labcorp strengthen their combined capabilities, Claudine Rigal, PharmD, Clinical Biologist, Head of Asia Pacific Laboratory Operations and Global Head of Anatomic Pathology Operations for Labcorp Drug Development, is excited about the opportunity to improve service delivery for biotech and pharma clients.

Technologies, tools and processes to support patient-centric oncology trials

There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites. DCTs provide an opportunity to remove some of the burdens associated with in-clinic visits, allowing participants to take part in trials from their own homes and/or community healthcare setting, with fewer visits to hospital/trial site. Key to the delivery of DCTs is a suite of tools and technologies that support near real-time review of clinical data from multiple sources. This article looks at some of the technologies, tools and processes that can support more patient-centric oncology trials.

Meeting an Unprecedented Surge in Demand for Kit Production

Supply chain disruptions and manufacturing shortages have significantly affected the clinical trial industry, an issue exacerbated by an unprecedented demand for clinical trial kits. To help maintain business continuity, the Labcorp Central Laboratories team had to develop creative operational solutions at every step of production and quickly accelerate the launch of their new automated kit production facility in Europe.

Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015.

Cell and Gene Therapy Answers: Advancing treatments for pediatric patients with rare diseases

Labcorp’s cell and gene therapy scientific leaders shared their insights on the factors that make rare and pediatric diseases a good fit for cell and gene therapy, along with the key challenges and best practices in this innovative space.

Cell and gene therapy answers: Overcoming challenges for rare disease in pediatrics

Your source for answers to the complex challenges of cell and gene therapy development.

Three healthy habits to fight cardiovascular disease

February is American Heart Month and, perhaps more famously, home to Valentine’s Day. This makes it an ideal time for you to start loving your heart.

Improving diagnostic efficiencies in histology with artificial intelligence and digital scoring

Digital analysis and artificial intelligence (AI) are not novel in anatomic pathology and histology, but the technology continues to evolve as it supports clinical trial enrollment as well as routine work in pathology.

Optimizing success in application for US EPA registration of conventional new plant protection active substances under FIFRA

To open up the US crop protection market for an active substance you have already registered elsewhere, you will need to compare your existing data against the regulatory requirements of the US Environmental Protection Agency (EPA). In this blog, we outline the US regulatory landscape and suggest ways of optimizing registration success within it.