Monday, April 15, 2013

Editor in Chief's Commentary: Therapeutic Innovation & Regulatory Science | March 2013

Dr. Stephen SpielbergCommentary

Dr. Stephen P. Spielberg

I’m incredibly excited to have joined the DIA at a time when medical science is advancing at an ever-increasing rate. Building on the foundation laid down by the Drug Information Journal, Therapeutic Innovation & Regulatory Science, known as TIRS, is part of DIA’s efforts to ensure the flow of information to all our members – more than 17,000 around the world. The rate of accrual of new knowledge challenges all of us to assure that the brilliance of our science is converted efficiently and effectively into new safe, effective, high quality, and sustainably available medical products.

The title of our new journal implies innovation, and we intend to publish outstanding science reflecting innovation from molecular biology, drug development and clinical trials, through real world assessment. I hope we can create a practical and impactful forum for scientific exchange. Because we live in a time of rapid change in all disciplines characterized by increasingly dense language communication within our disciplines, so too we need innovation in communication, bringing together all who share in the drug development and utilization processes.

We hope to establish a broad-based editorial board reflecting disciplines traditionally thought of as part of the drug development and evaluation processes, and expanding and integrating new areas, including patient advocacy groups and health economists. Never before has accomplishing the goals of improved therapeutics been as much of a “team sport” as it is today, and TIRS will reflect these challenges and opportunities, in print and in collaboration with DIA in multiple other formats.

The “regulatory science” part of the TIRS name reflects the increasing need of all sectors, including the regulatory community, to work at the cutting edge of innovation, being neither advocates nor impediments to innovation, but dispassionate evaluators, in the words defining the US FDA both “protectors and promoters of the public health.” Using the neutral turf of the DIA, TIRS will be an integral part of bringing together all the players needed to advance human therapeutics.

A personal reflection as I join the DIA in this effort… I entered medical school more than 45 years ago, and have been privileged to witness the most remarkable advances in science and medicine in the history of humankind. I, and I am sure all DIA members, worry about the future, the sustainable implementation of science on behalf of us all. I worry when I hear discussions that separate “patients” from the rest of us. All of us, often in the flash of seconds of time, become patients, suddenly dependent on the therapeutics about which we have just opined. It is in all our interests to work together to “get it right.” Please join us at TIRS as we navigate this process, and help create a global forum for knowledge exchange and interpretation to raise the level of health and well-being worldwide.

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