DIA today announced the arrival of Stephen P. Spielberg, M.D., Ph.D., as editor-in-chief of the newly launched, official DIA peer-reviewed scientific journal, Therapeutic Innovation & Regulatory Science (TIRS). Spielberg comes to DIA on the heels of his tenure at the US Food & Drug Administration (USFDA), where he has served as deputy commissioner for medical products and tobacco. Under Spielberg’s seasoned, distinguished guidance, TIRS is slated to become the premiere guide for professionals involved in the worldwide discovery, development, regulation, monitoring and marketing of medicine, medical devices and diagnostic products.
“We are immensely excited to have such a respected, celebrated and influential leader in the pharmaceutical industry to guide TIRS in becoming the foremost trusted resource for understanding and advancing the drug development industry and regulatory affairs,” said DIA Worldwide Executive Director Paul Pomerantz. “Dr. Spielberg’s commitment to fostering innovation and collaboration across all pillars of the industry will drive conversations that enable our members and partners to share knowledge and work together as never before.”
FDA Commissioner Margaret Hamburg, who announced today that Spielberg will depart FDA on Feb. 15 and assume his DIA role in March, said Spielberg's leadership and wise counsel will be missed. He has been a key member of her senior management team and a terrific spokesman for FDA, supporting invaluable work performed for drugs, biologics, medical devices and tobacco products, Hamburg said.
"He has been an important partner in helping the agency toward a more integrated approach to medical product evaluation ... working together with center leadership to address the rapid changes in human biology and therapeutic interventions, and in helping optimize FDA's approach to evolving areas such as personalized medicine," Hamburg said.
With a career spanning more than 35 years in medicine, academia, the pharmaceutical industry and regulatory affairs, Spielberg brings remarkable experience and leadership to DIA’s journal. At FDA, Spielberg was integral to advancing regulatory science through esteemed leadership and determined collaboration. Spielberg formerly served as executive director of exploratory biochemical toxicology and of clinical and regulatory development at Merck Research Laboratories, and was vice president for pediatric drug development at Johnson & Johnson. While at Johnson & Johnson, he chaired the Pediatric Task Force for PhRMA, represented the pharmaceutical industry on the FDA Pediatric Advisory Subcommittee and on pediatric legislative initiatives in the United States and European Union, and was the rapporteur for the Pediatric ICH Initiative to harmonize pediatric drug development regulations among Europe, Japan and the United States.
More recently, he was the chair in pediatric pharmacogenomics and director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital, Kansas City, Mo., as well as the dean of Dartmouth Medical School and vice president for health affairs at Dartmouth College. Spielberg also served on the board of directors of the Foundation for the National Institutes of Health, the FDA science board advisory committee and the executive board of Observational Medical Outcomes Partnership.
“We have a challenge of determining how best to inform one another about science and how that converts into the discovery, development, regulation and use of new medical products,” Spielberg said. “My vision for TIRS will bring together members of all sectors that have a stake in the future of human health to discuss key issues facing the industry and regulatory affairs—and to translate human brilliance and discovery into real products.”
Watch Dr. Spielberg's full interview.
Spielberg also brings a wealth of editorial experience to DIA. He previously was associate editor of Drug Metabolism and Disposition and serves on the editorial boards of multiple pediatric and pharmacology journals. DIA is honored to welcome such a distinguished leader to help facilitate knowledge exchange and collaboration to advance the drug development industry worldwide.
Spielberg received a bachelor’s degree in biology from Princeton University and a doctorate in pharmacology from the University of Chicago. He graduated with honors from the University of Chicago Pritzker School of Medicine.
Issues of the new journal are available online at dij.sagepub.com/content/current. For more information about Spielberg and TIRS, visit www.diahome.org
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org