Brian Huber

ICON, USA

Title: Gene therapy – affordability, access, and reimbursement

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Biography

Dr. Brian Huber is based in the US with 35 years experience in the Biopharmaceutical Drug Development, CRO Service and Investment Sectors. Broad expertise from pre-IND to registration & commercialization with most forms of therapies including chemotherapies, targeted therapies, immuno-therapies, cell and gene therapies, and tumor vaccines. Expertise in innovative clinical and operational strategy to yield maximal value for patients, sponsors and investors. He is Board Certified in Clinical Pharmacology 

Abstract

In the next 15 years, it is anticipated that 1.09 million patients may be eligible for or treated with gene therapies.

The FDA anticipates over 200 cell and gene therapy (CGT) IND applications in 2021. This growth is fuelled by a robust influx of capital, driven by the potential to generate more sustainable disease-modifying clinical outcomes. The new curative therapies promise to provide a shift from long-term disease management to one-time curative therapies, which may revolutionise the practice of medicine.

Even though gene therapy is one of the most exciting new frontiers in modern medicine, significant challenges have emerged. The exciting expansion of gene therapies intensifies pressure on insurers, health systems, and BioPharma companies to develop a framework for determining value, pricing, and payment options. Two of the biggest and interrelated challenges are cost/ affordability and equity access.