Check this out RedThis has got to be great news for emerging...

Check this out Red
This has got to be great news for emerging Biotechs when it comes from the head of the FDA in the USA. I wonder when our TGA will catch up.
Here is a summarized transcript of the interview aired April 15, 2007, on CSPAN with Dr. Eric Von Eschenbach.

summarized version, the speech is archived on CSPAN
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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. Important 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 Woodco
*ck, 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, occuring 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.