Ted Grasela is the president and CEO of Cognigen Corporation and adjunct professor of pharmaceutics at the University at Buffalo.
All scientists share the challenge of keeping apace of new technology and innovations. No matter what your employment sector, innovation can disrupt well-worn work processes and create uncertainty in selecting a strategy for advancing a research program. As much as scientists want to advance the frontiers of knowledge, the frontier can seem a dangerous place.
Recently, the President’s Council of Advisors in Science and Technology (PCAST) released a report on the state of biomedical innovation and offered recommendations for accelerating innovation in an area that counts: the successful development and commercialization of new medicines. One recommendation directed toward the Food and Drug Administration (FDA) was the need to improve communications with industry to ensure that pharmaceutical and biotechnology development programs are kept abreast of changes in regulatory science and opportunities for innovative drug development strategies.
Toward that goal, PCAST suggested that FDA solicit public input on the most important topics requiring guidance, create a list of high priority topics, and create an accountable internal process to ensure that guidance documents are completed in a timely manner. This process should include prioritization and timely completion of guidance documents currently under development and currently in draft form. And FDA should also engage third party organizations with appropriate expertise and credibility to convene stakeholders and develop recommendations for guidance.
PCAST also recommended that FDA create web-based communication tools and a white paper process to rapidly update sponsors and other stakeholders about policy and technical standards relevant to drug development.
Accelerating the development of new drugs is not solely an FDA problem but is a worthwhile challenge for the entire community of scientists working in pharmaceutical research and development. I believe that it would be a valuable service to the scientific and medical community if we could harness the expertise of AAPS scientists to contribute to this effort. AAPS contains a diversity of research interests, reflected in its sections, focus groups, and discussion groups, and its members have much to offer the scientific and regulatory community in terms of scientific expertise and experience that could inform policy making.
A single scientist is rarely as effective in achieving change as a chorus of voices focused on understanding new developments in science and working through the implications for new processes and policies. In the current environment, it can take twenty or more years for a truly innovative idea to become commonplace. Twenty years is a generation. Think about that. Do we want our generation’s legacy to be that a good idea takes twenty years to be validated?
If we are going to live on the frontier, then let’s recognize that our neighbor’s problems are our problems. Let’s work together to clear the fields of old ideas and advance in an intelligent and disciplined way to the future. New ideas must be proven before they can replace the tried and true, but the tried and true ideas won’t give up their place without a fight.