|A Conversation with FDA Commissioner Dr. Mark B. McClellan |
What do you see as the biggest challenge to oncology research?
Despite increasing spending on biomedical R&D, there are fewer new medical products reaching consumers than at any time in more than a decade. At the same time, we're facing unprecedented challenges involving affordability and access to the treatments that do make it to patients. The primary challenge for all of us is to speed access to safe and affordable treatments for all of our nation's patients.
What do you see as key opportunities in oncology?
From monoclonal antibodies to targeted inhibitors of cellular signals, the translation of biology into new cancer treatments is making a real difference in the lives of patients. Breakthroughs in genomics, proteomics, and other emerging fields of molecular biology have dramatically extended our understanding of what is required to turn a normal cell into a cancer cell, and these insights hold the potential for truly individualized drugs. If we can work together to find ways to make therapeutic development less costly and less uncertain, we can ensure that better treatments are available sooner for cancer patients.
How will FDA and NCI collaborate in the area of bioinformatics?
This past November, FDA and NCI announced the development of a system for submitting investigational new drug (IND) applications electronically under NCI's Cancer Biomedical Informatics Grid (caBIG) project, which will allow us to review applications faster and hopefully get new treatments to patients more quickly, and at lower cost. The eventual goal of the caBIG project is to have an entirely electronic system for the submission and evaluation of clinical trial information for cancer trials. In this digital age, we have many opportunities to expand on these initiatives to make clinical trials better and less costly.
What other joint initiatives are you planning to collaborate on in the future?
We have just announced a joint Cancer Fellowship Training Program, which will develop a corps of physicians and scientists, expert in clinical research, the regulatory process, and translation of research breakthroughs to clinical practice. New programs will make various training opportunities available for NCI researchers at the FDA, including training as product reviewers.