February 28 is Rare Disease Day, a day dear to the hearts of many at Labcorp. The day is observed to raise awareness and give support to the more than 300 million people worldwide living with rare diseases, as well as their family members and caretakers. At the heart of …
Cell and gene therapy answers: Overcoming challenges for rare disease in pediatrics (part two)
Your source for answers to the complex challenges of cell and gene therapy development. Building on the topic of rare diseases in our earlier blog, Labcorp cell and gene therapy leadership shared their insights on strategies for overcoming key challenges in rare disease studies in pediatric populations along with their …
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 …
TSCA and US state legislation: Navigating your chemical or agrochemical through the federal and state regulatory landscape in the USA
Registering your chemical or crop protection product with the US EPA under TSCA or FIFRA is the first and biggest step in its regulatory journey in the USA. But you will also need to navigate state-specific legislation and regulations, and for crop chemicals this includes registering in every state where …
Cell and Gene Therapy Answers: Advancing treatments for pediatric patients with rare diseases
Your source for answers to the complex challenges of cell and gene therapy development. 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 …
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. Paul Mesange, PhD, Principal Scientist, Histology, recently shared how Labcorp Drug Development (formerly known as Covance) has …
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. In July 2021, an evaluation of 12 test cases of …
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 …
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. Labcorp shares an introduction to CMC, key analytical methods used in assessing the Critical Quality Attributes, challenges in developing these assays and thoughts on the road ahead over the next 5-10 years. What is CMC and …
A macro investment in micro science
The science behind the development of gene- and cell-based therapies is as granular as it gets. Research at this level of precision requires the latest technology, state-of-the-art facilities and expert staff to produce optimal outcomes. In order to schedule more of your cell and gene studies and help you create …