Food and Drug Administration Commissioner Scott Gottlieb will be the main speaker at the two-day BIO Patient and Health Advocacy Summit, a major gathering in October involving biotechnology companies, patient advocacy groups, schools and universities and regulators aimed at discussing policy issues and sharing best practices.
The October summit is being organized by the Biotechnology Innovation Organization (BIO), a trade association that represents biotechnology companies, state biotechnology centers and related organizations in the United States and in more than 30 other nations, according to its website.
Daniel Seaton, a spokesman for BIO, said his organization does not have a "wish list" ahead of the commissioner appearing at the summit. "We expect that he will focus on the patients’ voice in the FDA approval process – when is it appropriate to incorporate patient input for good medical output," Seaton told Patient Daily.
BIO is on record as being in favor of a more streamlined process in the approval of drugs.
“Dr. Gottlieb’s perspective on drug regulation is shaped by his background as a patient, a physician and as a biopharmaceutical adviser,” BIO President and CEO Jim Greenwood said in a press release. "His practical experience as a hospital physician and his many years in government overseeing how drugs are reviewed, tested and approved will inform his tenure at the FDA.
"We look forward to hearing about his approach to the FDA, particularly how the patient perspective will be incorporated into a science-based approval process,” Greenwood said.
The summit, which takes place Oct. 2 and 3 in Washington, D.C., will include workshops and panel sessions that explore the role of patients in drug development, the BIO release said. Opening day events will include a workshop described in the release as "a hands-on interactive exercise engaging participants in the intricacies of determining the value of a new medicine."
During the summit, attendees will have the opportunity to vote on and discuss key questions to consider when investing in a new therapy and bringing it to market, the BIO release said.
The second day of the summit will include a personalized medicine workshop that aims to offer an opportunity for patient groups "to engage with other stakeholders to learn more about this emerging field of medicine that aims to get the right treatment to the right patient at the right time," the release said.
BIO members are involved in the research and development of innovative health care, agricultural, industrial and environmental biotechnology products.