PK Assessment for Advanced Modalities (Cell and Gene Therapies)
Advanced modalities do not easily lend themselves to the standard approaches for quantitating drug product as small and large molecule therapeutics do. Technologies such as qPCR, ddPCR and flow cytometry not typically used for this purpose, must be used to support these complex drug modalities. These platforms were not previously leveraged for extensive use in the regulated space for the purpose of drug quantitation. However, the industry is rapidly adjusting to define criteria for the development, validation and implementation of assays on these platforms to support this exciting field of growth for the biotech and pharma industry. We’ll discuss these topics along with an open Q&A session with our scientists developing and implementing these assays.
What will you learn?
- Approaches used for developing assays
- Validation expectations
- Current regulatory guidance
- Current industry practices
Who may this interest?
- Bioanalytical scientists
- Clinical pharmacologists
- Nonclinical study directors
- Clinical operations
- Medical advisors
- Gene and cell therapy scientists
Speakers
Jim McNally, PhD
Chief Scientific Officer
BioAgilytix (MA, USA)
Jim McNally offers 20 years of experience in bioanalytical assay development and program leadership in pharmaceuticals and biotechnology. At BioAgilytix, he advises on emerging scientific developments and provides scientific and regulatory guidance. Prior to BioAgilytix, Dr McNally was Executive Director at CRISPR Therapeutics (MA, USA), with previous roles at Genzyme (MA, USA), Pfizer (MA, USA), EMD Serono (MA, USA) and Shire (MA, USA).
Dr McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and progression of biotherapeutics from research through clinical development. He has special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue.
Amanda L Hays, PhD
Scientific Officer
BioAgilytix (KS, USA)
Dr Hays offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR. She has particular expertise leading programs through all stages in the drug development process. In her current role, she serves as a Scientific Officer and provides global scientific leadership and technical guidance at BioAgilytix. Dr Hays is the Chair of the AAPS biomarkers and precision medicine community and the AAPS qPCR working group, among other volunteer leadership positions. She earned her PhD in Pharmacology from the University of Kansas Medical Center in Kansas City (KS, USA).
Thomas J Schneider, PhD
Associate Director of Scientific Services
BioAgilytix (MA, USA)
Dr Schneider oversees flow cytometry and biomarkers. Trained at the Boston University School of Medicine (MA, USA), his PhD work led to the cloning of a novel gene (faim) involved in immunologic and neurologic cell fate decision. At the Center for Blood Research (Vancouver, Canada), he demonstrated how receptor-editing tolerogenic mechanisms govern B-cell development. At Merrimack Pharmaceuticals (MA, USA), he developed a potency assay to assess alfa-fetoprotein function.
At STC Biologics (MA, USA), Dr Schneider correlated how molecular and formulation changes impinge upon biosimilar antibody functionality. The rigors of biophysical critical quality attribute assessment coupled with functional immunoassay readouts provided a rare perspective: even quite modest changes can dramatically effect target engagement and function.
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