Historically, any CRO that registers to attend the annual WRIB meeting automatically qualifies for one seat or two seats (if you qualify by having both LBA and LCMS services) on the GCC (Global CRO Council), then for each additional site a CRO has, you are allowed an additional representative. With our acquisition in France too recent to be registered for this year’s event, KCAS will have 3 representatives on the GCC this month when they meet on September 30 in Atlanta, GA.
Every year, the GCC is a very important time for CROs to gather and discuss the year’s findings and it becomes a safe place for us to share our experiences amongst our peers. Typically, there are attendees who are asked to present about topics ranging from the latest findings on large molecules to recent changes in guidance and regulations. In years past, KCAS has presented on discoveries in Ligand Binding Assays and new Hybrid LC-MS/MS technologies. The organization allows CROs to really learn how to improve the quality of our work in the bioanalytical space by listening to our colleagues and other leaders in the field.
This year, we are proud to have three of KCAS’s leading experts representing us at the GCC.
First, we will have Dawn Dufield, PhD, who is the Senior Director overseeing Biopharmaceutical LC-MS/MS services, bridging the gap between LBA and LC-MS/MS needs for customers at KCAS. During GCC this year, she will be able to share the experiences KCAS has had with recent issues like those resulting from the 2018 FDA BMV guidance on ICH M10 and other regulatory inputs. Dr. Dufield has over 25 years of experience and has been part of GCC discussions a number of times in the past. While the group has not met while WRIB was virtual, Dufield is very much looking forward to getting back together with colleagues to discuss the changes within the biopharmaceutical industry.
Then we have Marsha Luna, who will be representing KCAS in the pharma space. There are constantly updates around the regulatory space for LCMS methods – a lot of which revolves around sensitivity and the improvement in LCMS technologies. The need for more sensitive methods is nothing new and is needed for PK analysis for pediatric studies, low dosage, ocular studies, pre-clinical studies, and other matrices/tissues that have limited volume. Additionally, KCAS is one of the leading laboratories for validation of biopharmaceutical LC-MS/MS methods and Marsha’s team is producing a number of those methods. At GCC this year, she will be able to share her experiences dealing with anything related to the affinity capture step and the performance characteristics related to how that step will perform – in addition to the LC-MS aspects.
Finally, Lawrence Goodwin will be representing KCAS to discuss the increasingly important field of Cell and Gene Therapies. This is an emerging market and our expertise and knowledge of flow cytometry, ElISpot, and molecular services put KCAS in a perfect position to help serve the needs of the industry and speak to the advances we’ve seen take place. Lawrence will be able to discuss with the GCC how KCAS and others are validating these types of methods. In previous years, Cell and Gene Therapies have been a smaller topic, we expect it to be more of a focus this year. KCAS has leading experts who specialize in supporting humoral and cellular immunogenicity for CGTs, flow cytometry and PCR based methods for PK/PD measurements, biodistribution and viral shedding for safety assessments, and nine platforms for the support of Biomarkers.
KCAS is looking forward to this important meeting again with the GCC.
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