A Precision for Medicine Webinar
Strategies for Immunogenicity Assays in AAV Gene Therapy: Development to CDx Approval
Date: Thursday, December 7, 2023
Time: 11am ET | 5pm CET
Duration: 45 min presentation followed by live Q&A
Learn directly from industry experts who have helped bring gene therapies to market
Immunogenicity can pose a challenge in the assessment of both the efficacy and safety of gene therapies that use adeno-associated virus (AAV) vectors. Gene therapy developers encounter a multitude of challenges, from choosing the right immunogenicity assay in the lab to regulatory approval by governing bodies. However, proven strategies can mitigate risks, reduce costs, and pave a smoother path to contemporaneous approval of Rx and companion diagnostics (CDx). In this webinar, Precision will map out a path for successful gene therapy development, CDx development, and commercialization.
By joining, you can learn about:
- Recommended best practices throughout the development lifecycle for a gene therapy CDx
- Tools for successful CDx partner assessment and selection
- Regulatory requirements of an immunogenicity clinical trial assay, based on intended use (e.g. enrollment or stratification) in US and EU
- Registration requirements and timelines for a CDx, including premarket approvals (PMAs)
Precision for Medicine Speakers:
Deb Phippard, PhD
Chief Scientific Officer
Pharma industry veteran with >25 years of biomarker-driven clinical trial design and execution expertise
Travis Harrison, PhD
VP, Bioassay Solutions
Widely-published expert on diagnostic assays for evaluating immune responses to gene therapies
Kennon Daniels, PhD
VP, IVD Regulatory Consulting
>20 years of R&D and US Regulatory Affairs experience with IVD and pharmaceutical products
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More about our speakers
Deb Phippard, Ph.D.
Chief Scientific Officer, Precision for Medicine
Long-standing pharma industry veteran and expert at biomarker-driven clinical trial design and execution with more than 25 years of biotechnology and clinical translational research experience. She is a leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. She spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.
Deb gained her PhD in Developmental Biology from the Institute of Cancer Research, London.
Kennon Daniels, Ph.D.
Vice President, IVD Regulatory Consulting, Precision for Medicine
Kennon Daniels is an accomplished regulatory professional with 20+ years of experience in IVDs, medical devices, and pharmaceuticals, specializing in molecular diagnostics, NGS, liquid biopsy, and companion diagnostics. Expert in regulatory strategy, Pre-Submissions, clinical study design, and FDA marketing submissions for 90+ IVD assays spanning various fields. Proficient in protocol development, Pre-Submissions, IDEs, de novos, 510(k)s, and EUAs for SARS-COV-2 assays.
Travis Harrison, Ph.D.
Vice President, Bioassay Solutions, Precision for Medicine
Travis Harrison is an immunologist with 20 years' experience in drug development including the design, validation and management of immunoassays, cell-based assays, and diagnostics with an emphasis on immunogenicity and gene therapy. He has successfully developed and validated GLP and cGMP assays required for IND submission of more than three dozen vaccines, gene therapies and protein therapeutics. At Precision for Medicine, he has managed development of companion diagnostics with an emphasis on gene therapies.
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