Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year. As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to …
Bioanalysis of Biologics: Understanding the Role of LC-MS
As biologics-based therapies have expanded, LC-MS is increasingly applied to support quantitative bioanalysis to detect diverse peptides and proteins. LC-MS can offer a few notable advantages compared to the traditional approach for quantification with ligand-binding assays (LBAs), but is typically thought of as a complementary approach.
IND-enabling Programs for Gene and Cell Therapies Webinar Questions
Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from our recent presentation. For more information on our solutions, visit our Cell & Gene Therapy Education Center here.
IND-Enabling programs for gene therapies
Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address …
IND-Enabling programs for adoptive cell therapies
Chimeric Antigen Receptor T Cells, In Vitro and In Vivo Preclinical Models, plus regulatory and safety considerations We presented on and discussed in a webinar the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.
The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions
As COVID-19 was declared a pandemic, our Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
Immunogenicity studies for the coronavirus vaccines: How to stay on track and build testing capacity even during COVID-19
As the world waits for a vaccine to protect against COVID-19, the disease caused by the novel coronavirus, it will need not only scientific excellence but also business continuity excellence to keep vital research and immunogenicity studies running. Vaccine development relies on many early, nonclinical studies; some of the earliest …
Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs
Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …
Brexit: leveraging the mutual recognition agreement to mitigate risk with commercial drug product release testing (updated 08-20)
The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit. …
Emerging immuno-oncology therapies: life after checkpoint inhibitors
The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …