Centralized multiple myeloma service delivers on a global scale

As the volume of multiple myeloma clinical trials continues to grow, additional tests are being validated in an effort to benefit patients who typically have a five-year survival rate. These dynamics are driving strategies to address variability in testing procedures and data analysis. We recently met with our dedicated Multiple Myeloma Team to learn more.

Decentralized Clinical Trials (DCT) Monthly Blog – January 2021

In the aftermath of a turbulent 2020, in which the overall industry perception of the decentralized clinical trial (DCT) approach transitioned from being “promising but still largely experimental” to “a new-normal paradigm for the industry to adopt,” we have been considering “what’s next?”

Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook

The Relative Potency Assay for a typical biologic is usually the most complex assay in the release and stability specification. Relative Potency methods should be designed to be as simple as possible but should still reflect the mechanism of action (MOA) that is linked to the relevant biological properties of the molecule, as is required in the regulations. The more steps in an assay presents more opportunity for variation and the less precise the ultimate result may be. In some cases, multiple potency assays may be required if there are multiple MOAs of a molecule or if a full understanding of the relevant biological properties is not fully understood, as might be the case with complex cellular therapeutics.

Assessing Immunotoxicology During Drug Development: Highlights from a Webinar

Immunotoxicology assessment plays a large role in the drug development pipeline, especially for large molecules and biologics. Researchers in early drug development have a wide variety of immunologic assay methods available that can support research endpoints and offer opportunities for much clearer views into the efficacy and safety of a compound.

Decentralized Clinical Trials (DCT) Monthly Blog – February 2021

Most of our blogs focus on interesting things we hear from sponsors, new company developments, or interesting challenges we encounter as we partner with sponsors. This month, however, we want to take a look at it from the patient perspective. The changes of the past year have resulted in a shift in perception on the part of potential participants about their willingness to participate in DCTs.

Future-proofing Idiopathic Pulmonary Fibrosis (IPF) Studies in Light of COVID-19

As the COVID-19 pandemic impacted many clinical trials, sponsors were forced to quickly re-evaluate potential solutions to mitigate risks and keep trial participants safe. Continuing trials in Idiopathic Pulmonary Fibrosis (IPF) research was especially difficult as patients living with chronic lung diseases may face a greater likelihood of complications if infected with SARS-CoV-2.To help sponsors understand the strategies for ensuring research continuity, protecting patients and “future-proofing” upcoming studies from similar unanticipated disruptions, Veerle Van De Velde, Senior Medical Director, Infectious Disease & General Medicine (iiGM) and Mark Dowling, Senior Director, Strategy & Planning, iiGM, shared their recent experiences in a presentation at the 4th Annual IPF Summit in 2020.

Innovation in Plasma Cell Enrichment for Multiple Myeloma Studies

Syndecan-1 (SDC1), also known as CD138, is a well-known and specific plasma cell marker that is highly expressed on the surface of multiple myeloma plasma cells. As it can be a challenge detecting the small number of malignant plasma cells within the large proportion of cells obtained from a bone marrow (BM) aspirate, CD138 plasma cell enrichment is key to isolating plasma cells from bone marrow aspirates. We recently sat down with Janelle Salkowitz-Bokal, PhD, Maria Coronesi, and Lucas Rifkin, MD, to explore how CD138 plasma enrichment enhances the sensitivity of downstream analysis for multiple myeloma testing.

Pesticide active ingredient renewal: how to negotiate the EU endocrine disruptor requirements

ED assessment of active substances in PPPs came into effect in November 2018 in the EU. Insights from EFSA’s assessment of the first 65 actives shows how guidance is applied and how waivers are being used. Read on to find out how to negotiate the ED assessment process and when to consider derogations for active substances with ED potential.

Decentralized Clinical Trials (DCT) Monthly Blog – March 2021

This month, we want to highlight the growing connections between decentralized clinical trials (DCTs) and the critical therapeutic area of oncology.

Expanding clinical trial support in Europe, the Middle East and Africa with a new automated kit production line

As part of a global growth and expansion strategy, we’re announcing the spring opening of a new kit production line at our European Operations Center (EOC). Based in Mechelen, Belgium, the EOC is a multi-use facility that handles dry ice production and distribution for the EU, as well as study and logistics support. This new automated kit production line will produce industry-leading specimen collection kits for investigator sites in Europe, the Middle East and Africa (EMEA).