Gene Therapy Trials and Tribulations
This article was originally published in Start Up
Executive Summary
The increased scrutiny of gene therapy by the National Institutes of Health and the Food and Drug Administration hasn't, to date, affected companies' clinical trials or long-term strategies, say executives of companies working in the field. This is partly because the NIH and FDA have yet to announce what new requirements, if any, companies must meet. Another reason is that few companies are working with adenoviral vectors--the focus of much attention following the death in September of an 18-year-old patient while in a gene therapy experiment.
You may also be interested in...
Cardiac Gene Therapy: Combination Products' Next Frontier?
Orthopedic biomaterials and drug-eluting stents are only the first hint at the potentially transforming nature of combination products: device/biologic combination products that may bring a revolution to clinical therapy and to the device industry. In vascular medicine, catheter-based delivery of cardiac gene therapy may become a significant advance, yet with scant clinical evidence of efficacy and only anecdotal physician experience using catheter delivery systems, the field remains all promise. Many device executives think they see a path emerging, largely due to fundamental changes in the dynamics of their industry that are moving device business models closer to that of their pharma industry cousins.
Making The Most Of ACOs: How Biopharma Is Adapting To New Customer Segment
ACOs have been one of the most hyped innovations in the US health care sector this decade. The buzz may be overdone, but ACOs are now established as a different—and confusing—new customer segment for pharma. How is industry adjusting?