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Essential strategies for gene therapy - from assay development to CDx commercialization

Innovators developing gene therapies face a multitude of challenges, from the lab to the FDA. Yet a number of successful strategies are emerging that are mitigating the risks, reducing costs and smoothing out the road to approval. Listen to a panel of gene therapy experts with unique perspectives and real-world experiences share successful approaches in gene therapy development, CDx development and commercialization.

Attendees will hear:
  • Factors in the NAb vs. TAb assay choice, including respective assay development challenges and agency outlooks
  • How to make the most of early engagement and collaboration with regulatory agencies
  • How to plan and prepare for CDx development from the beginning of assay development
  • New approaches for CDx regulatory approval and commercialization
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Eugen (Gene) Koren

Eugen (Gene) Koren

Senior Scientific Advisor, Immunology, Precision for Medicine

Eugen Koren, M.D., Ph.D over the last twenty-five years, has led immunogenicity assessment teams for therapeutic proteins at Genentech, Amgen, Biomarin, J&J, Abbott Vascular and Applied Immunology as well as gene therapy products at Precision for Medicine. As a senior author and coauthor, he participated in writing and publishing white papers on recommendations for binding and neutralizing anti-drug and anti-vector antibody assays.

Markus Peters

Markus Peters

President and CEO, Aevitas Therapeutics

Markus Peters, Ph.D. M.Sc. is President and Chief Executive Officer of Aevitas Therapeutics, a biopharmaceutical company developing AAV gene therapies for complement-mediated diseases, including age-related macular degeneration (AMD) and atypical hemolytic uremic syndrome (aHUS). Most recently, Dr. Peters was the Chief Operating Officer of Gemini Therapeutics, developing precision medicines for complement-mediated diseases, and Chief Commercial Officer of Agilis Biotherapeutics, advancing AAV gene therapies for rare diseases of the CNS. Before that, Dr. Peters was Vice President at Synageva BioPharma through its $8.4 Billion acquisition by Alexion Pharmaceuticals, and at Alexion where he served as Head of Global Marketing for the launch of the Soliris® aHUS franchise and Head of New Product Planning for Nephrology and Transplant. Markus received his Master of Science in Chemistry and Ph.D. in Biochemistry from Heinrich-Heine University in Düsseldorf, Germany.

Deborah Phippard

Deborah Phippard

Global Head, Research, Precision for Medicine

Deborah Phippard, Ph.D is a pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy. Currently, working on developing, validating and implementing companion diagnostic assays for neutralizing and total antibodies for multiple gene therapies.

Karen Richards

Karen Richards

Senior Vice President, IVD Regulatory & Quality Consulting, Precision for Medicine

Karen Richards, RAC is a leader and innovator in the GMP/ISO/FDA/EU-regulated in vitro diagnostic (IVD) industry. Spearheads regulatory approvals worldwide for both novel and traditional IVD assays and products, including companion diagnostics. Builds ground-up quality systems, meeting the requirements of US FDA, ISO 13485, CLIA, and CAP.

Maritza McIntyre

Maritza McIntyre

Chief Development Officer, StrideBio

Maritza McIntyre, PhD is Chief Development Officer at StrideBio, a gene therapy company developing AAV gene therapies based on its proprietary structure-inspired AAV vector engineering (STRIVE™) platform, genetic construct design expertise, and in-house manufacturing capability to create novel, best-in-class therapies for patients with rare diseases and beyond. Prior to joining StrideBio she worked as an independent consultant devising product development and regulatory strategies for gene and cell therapies, oncolytic viruses, and other complex biological products. She led the early translational and regulatory development strategies for the DMD gene therapy program at Bamboo Therapeutics prior to its acquisition by Pfizer and the CHF gene therapy program at NanoCor Therapeutics. She was part of the early management team at REGENX Bio, where she contributed to the development of the LDLR, OTC, AMD, and MPS I & II gene therapies. Prior to her industry career, she was product reviewer and then Branch Chief in the Division of Cell and Gene Therapies at FDA. She earned her PhD in Virology from the University of Chicago.

Arsalan Arif
moderator

arsalan arif

Founder & CEO, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.