Introduction and U.K.’s exit from the EU On leaving the EU, EU-REACH legislation was copied over into UK-REACH as of 01 January 2020. Applying to only England, Wales and Scotland (collectively referred to as Great Britain or GB), Northern Ireland continues to be regulated by EU-REACH. The UK-REACH transitional arrangements …
How to de-risk OECD 443 studies through optimized dose level selections
The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently …
What does a central lab do? 4 core services to know
Every clinical trial relies on data from its study participants to inform decisions regarding the safety and efficacy of a potential new treatment. Clinical trial sponsors rely on the data from laboratory tests to bring clear insights that advance studies. Labcorp Central Laboratory Services generates more clinical trial data than …
Faster access to biopesticide alternatives to conventional pesticides under the U.S. BPPD regulatory framework
There is pressure worldwide for better, faster access to biological alternatives to conventional crop protection chemicals (CPCs). The U.S. Environmental Protection Agency (EPA) is ahead of regions such as the European Union (EU) in revising its regulatory approaches for biopesticides and in having a division dedicated to them, namely, the …
Program management services are now offered as part of Labcorp’s Preclinical Oncology Services
When it comes to discoveries in oncology, cancer patients can’t wait, which means neither can you. At Labcorp Preclinical Oncology, we understand there are many steps, phases and regulations to wade through to get to a lead drug candidate—all while time is of the utmost importance. We are excited to …
Innovative collaboration between Biomakers and Labcorp to provide greater access to oncology patients in Latin America
In December 2022, Labcorp and Biomakers signed an agreement that will positively impact thousands of cancer patients in Latin America through greater access to diagnostic molecular profiling and participation in clinical trials. We recently asked Nicolas Kirchuk (NK), CEO and co-founder of Biomakers, and Isagani Chico (IC), MD, VP, global …
4 emerging trends to watch in immunotherapy clinical trials
Approaches to systemic anticancer therapy have shifted in recent decades. The nonspecific cytotoxic agents that once dominated the oncotherapy space first gave way to more targeted agents in the 1980s and 1990s, after which advanced, novel immunotherapeutic strategies took center stage. The potential of such immunotherapies to address untreatable malignancies …
What the latest changes to EU regulations and data requirements mean for your microbial biopesticide registrations and renewals
Despite perceptions that biopesticides are inherently less dangerous, the EU regulates them as stringently as conventional, potentially highly hazardous, synthetic plant protection chemicals (Regulation [EC] No. 1107/2009). This has made approvals costly and slow. Recent regulatory revisions intended to redress this—to give EU farmers better and faster access to biological …
Biomarker Q&A: The landscape and outlook for precision medicine in neurology
Labcorp Drug Development has continued to invest in the technology, innovation and expertise globally to support clients focused on bringing life-changing treatments to patients with neurological diseases. We recently spoke with Robert Martone, Associate Director, Neurology Biomarkers with the Biomarker Solution Center, to learn about the acceleration and expansion of …
Biomarker Q&A: The power of precision medicine for kidney disease
Labcorp Drug Development has continued to invest in the technology, capacity and expertise globally to support the evolving and complex analytical needs of our clients. We recently spoke with Katherine T Landschulz, PhD, Sr. Director and Lead Scientist, Cardiovascular and Metabolic Disease, Neurodegeneration at Labcorp Drug Development, to learn about …