The 14th WRIB Virtual meeting kicked off this week, and I’m excited to be joining the event for the first time as Chief Commercial Officer of BioAgilytix. WRIB marks a time for collaboration and discussion on the latest developments in bioanalysis from both a scientific and regulatory perspective, and this year in particular will focus on key topics related to biomarkers, immunogenicity, and gene therapy. Our scientists have been invited to help lead several of those discussions which we’ve highlighted below. We also invite you to set up a time to chat with them individually (with coffee on us!) any time during the event which runs through June 29th.
A Look at Best Practices Using ELISpot for Gene Therapies | June 29th at 11:50am
BioAgilytix’s PD Dr. Arno Kromminga, Chief Scientific Advisor, will be presenting a session entitled “ELISpot Method Development & Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt, Evolving Trends” in which he will discuss the applications of ELISpot assays to detect cellular immune responses to specific antigens associated with viral vector-based gene therapies.
Unlike ADA- or NAb-detecting protocols, there is no regulatory guidance currently for how to develop and validate ELISpot methods. The recommendations in the 2019 WRIB white paper outlining ELISpot assay expectations and performance criteria are therefore meant to harmonize practices and standardize approaches, especially in light of the fact that ELISpot assays require a complex workflow from sample collection to testing. Dr. Kromminga will take a closer look at how to minimize the variability of ELISpot results by controlling the sample collection and handling process as well as by standardizing the peripheral blood mononuclear cells (PBMC) preparations. He’ll also step through a real-world case study discussing the process of validating an ELISpot assay for the qualitative assessment of cellular immune responses against a virus-based gene therapy.
ELISpot & Western Blotting Panel Discussion | June 29th at 12:40pm
Dr. Kromminga will also join Mr. Jason DelCarpini, Sr. Manager, Biomarkers and Clinical Assay Development at bluebird bio and Dr. Lisa Kierstead, Executive Director, Vaccine Sciences at PPD in a panel to discuss the strategies behind using the ELISpot platform with the single cell western blot assay.
To add these events to your calendar, click here.
New Thoughts on Applying Immunogenicity Guidance to Gene & Cell Therapies | June 29th at 1:10pm
Dr. Jim McNally, BioAgilytix’s Chief Scientific Officer – North America, will also be giving a presentation entitled “Application of Current Immunogenicity Guidance/Guideline (FDA/EMA) to Gene/Cell Therapy: Parallels and New Thoughts”. Unlike the typical biotherapeutic which is one molecule, gene and cell therapies have the potential to deliver many foreign proteins to the patient. Dr. McNally will address the importance of early risk assessment and how to apply validation parameters for ADA assays to gene and cell therapies, with the understanding that the “D” in ADA can represent a number of antibodies including anti-capsid, anti-transgene, anti-Chimeric Antigen Receptor (CAR), and anti-Cas9 antibodies. He will also cover bioanalytical testing strategies specific to gene therapy (including vector-specific and transgene-specific assays) and CAR-T therapy.
Gene Therapy Immunogenicity Panel Discussion | June 29th at 2:10pm
Dr. McNally will additionally be joining a panel with Dr. John Kamerud, Director, BioMedicine Design at Pfizer and Dr. Swati Gupta, Director, Immunology at Allergan to discuss the evolution of immunogenicity assessments and considerations specific to gene therapy bioanalysis. They will discuss how to develop and validate assays with the appropriate sensitivity, specificity, and selectivity to detect immune responses to different vectors used for gene therapy delivery and to evaluate their clinical implications.
To add these events to your calendar, click here.
“The Gene Therapy Roundtable” with Our Bioanalytical Experts | Held June 19th, 2020
This Gene Therapy Roundtable gave attendees direct access to BioAgilytix’s gene therapy experts Dr. McNally as well as Dr. Mike Nicholson, our Vice President of Operations who leads BioAgilytix’s gene and cell therapy bioanalytical services, for a live Q&A. They fielded diverse audience questions related to the development and validation of assays for gene-based therapeutic candidates and gene editing platforms.
You can still catch the Roundtable discussion in an on-demand now recording available at our Virtual Booth! Click here to log into the WRIB Meeting and access our booth.
Schedule a Coffee Chat with Our Scientists – Our Treat!
While we can’t meet in person, we’re still making it easy for you to collaborate with BioAgilytix’s scientists on your large molecule programs. Schedule a Virtual Coffee Chat any time during WRIB for a one-on-one experience with our experts. We’ll even treat you to coffee on us with a Starbucks gift card!