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 …
Top considerations for developing a biomarker solution and CDx strategy
When it comes to designing clinical trials with expedience and efficiency, many drug developers are choosing biomarker-driven strategies for their investigational precision medicines. As key features of developing new therapies and diagnostics, biomarkers define the disease biology, provide potential targets for new therapies and provide strong potential for market differentiation. …
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 …
Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct
The association between excessive alcohol consumption and liver disease is well documented. In fact, the effect on alcohol consumption levels during the COVID-19 pandemic has more recently been investigated. In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an …
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 …
How patient-centricity embeds value and stability in LTFU studies
Phase I-III randomized controlled trials alone are not generating enough data to extrapolate conclusions and theories about therapeutics to the global population. Not all drugs demonstrate the same efficacy in the real world as shown in the clinical trials. Because of this, we are seeing a rise in long-term follow-up …