On April 15, 2007, an interview featuring Dr. Von Eschenbach, the Director of the FDA, was aired on CSPAN.
Dr. Von Eschenbach is the man who ultimately approves Dendreon's (NASDAQ:DNDN) application for Provenge.
As the interview shows, Dr. Von Eschenbach's FDA is looking to add new weapons to the arsenal in the War Against Cancer.
To wit, Dr. Von Eschenbach has given 2015 as the D-Day for cancer treatments in the United States, as in, THERE WILL BE significant strides made in treatment while he is the head of the FDA.
Below is a summarized transcript of the high points of the interview. A verbatim transcript can be found here. (While the article does not specifically mention Dendreon, it does relate to the current BLA that will be finalized by the FDA on or about May 15th. What I offer is a summarized transcript with the link to the verbatim transcript. While Dr. Von Eschenbach cannot specifically mention Dendreon's application, it is widely known that Dendreon's Provenge will be the first application in this new class of immunotherapy based treatments for cancer.)
Read and decide for yourself. Provenge will be approved now, not later. Both terminal prostate cancer patients and Dendreon win:
Thanks National Health Council for your initiative in bringing new products. We are committed to serving patients to bring them new products and a new vision. Abiltiy to bring new solutions for cancer. I saw much suffering and dying. It is important that we continue to make progress. Progress has to have a purpose. We are immersed in era of opportunity. Opening up opportunities for new solutions for cancer , diabetes, etc.
A bridge between discovery and development to delivery - rapid, translation and delivery of those interventions. Accelerate and facilitate, while we can still assure patients, not just as a bridge but to protect their health. Rapid is not reckless. Bring effective agents rapidly not less safe. Most profound transformation of what is now possible in this new era. Effectiveness and safety can go hand in hand. Profound transformation has come about because of the advancement made. Cancer is no longer a lump or a shadow, but for the first time at the genetic, molecular and cellular level. Opened up a new understanding to create new solutions.
New future, much more personalized, more predictive, participants and not passive patients. View the person, genetic and molecular. FDA is positioned to take a new view of its future, to be that bridge to bring the products to patients for safety and efficacy. FDA is going to work across the entire life cycles of those products. Total life cycle - need to ensure understanding of outcomes. Promote and protect public health. Work collaboratively and cooperatively. Enhance our understanding, to maximize their effectiveness and minimize side effects. Continuously improve our ongoing processes. Finally, once a product is approved, we will stay engaged, so that delivery becomes a learning and discovery process to inform us of changes.
FDA will be a science based and a science led agency. Embrace discovery, development and collaborative and cooperative, academic, scientific, industry etc. Align ourselves with the new regulatory analysis. Rapid and effective implementation. New Deputy Commissioner, Janet Woodcock, to work to operationalize our critical pathway. Like C Path, attempting to bridge the gap, NIH, etc, working to bring biomarkers to the forefront.
Design new trials. Allow the use of small doses in an exploratory way to see beneficial and adverse events before being used in large populations. Better diagnostics, right patient, right intervention, for the right reason. FDA science based and science led. New CEO to the FDA to moderize the structure John Dyer, rebuilding the infrastruction. Bioinformatics board to streamline the IT structure. Improving the physical structure, more dynamic integration across systems.
New Office of Integrity and Accountibility.
New strategies for aggressive post market surveillance. Mine data for greater information and create pilot programs to be proactive. Greater integration and interaction. Enhance new products effectiveness and safety. Better understand risk at the front end and monitor it after used in larger populations.
41 Initiatives, strengthen science, improve surveillance, modernize structure.
Creation of career development to bring better people to the FDA.
Ability to better understand biologics. Interest in Congress to be able to address follow on protein products. Provide solutions available and appropriate for patients.
Science led and science based.
So radical a transformation that one must think about it like a metamoprhosis. The difference between a caterpillar and a butterfly.
The change is profound, occurring as we speak.
People will no longer need to suffer from a disease. Be able to see their grandchildren grow up.
We can change the world.
FDA will fix the potholes and be the guard rail.