February 9, 2009 - Presenters at the workshop stressed the need for the correct imaging biomarker available to accelerate the completion of clinical trials, as well as imaging standardization, consistent manufacturing practices and regulatory considerations, at The SNM Clinical Trials Network Community Workshop held on Feb. 8, 2009, in Clearwater, FL.
Speakers from the field of molecular imaging, regulatory agencies and pharmaceutical developers focused on the critical need to increase the use of imaging biomarkers in clinical trials and called for immediate action.
"The time to develop new imaging biomarkers is now," said Jeff Evelhoch, vice president of imaging at Merck. "We must come together as a community to make this happen, working together to facilitate the regulatory process."
Experts in oncology, cardiology, dementia and cell therapeutics discussed the important role that imaging biomarkers - indicators of a particular disease state or a particular state of an organism - can play in drug development studies. Other speakers addressed the challenges that researchers and imagers currently face in harmonizing imaging results between different locations in a multicenter trial.
“SNM’s Clinical Trials Network was conceived just for this reason: to create a standardized protocol across multiple sites in the U.S. and internationally in order to expedite the creation of new biomarkers for use in clinical trials,” said Michael Graham, M.D., Ph.D., president-elect of SNM and a chair of SNM’s Clinical Trials Network. “We are currently registering potential imaging sites, assessing their ability to participate in the Clinical Trials Network, and looking forward to announcing the first clinical trial in late 2009.”
“The role of medical imaging in clinical trials is rapidly increasing due to the ability to provide patient assessment and early drug trial results,” said Gustav K. von Schulthess, M.D., Ph.D., professor and director of nuclear medicine, University Hospital, Zurich, Switzerland, who was the keynote speaker at the workshop. “SNM’s Clinical Trials Network is expected to assist greatly by creating and enforcing standards among multiple trial sites, which, in the end, will benefit imagers, pharmaceutical manufacturers and patients.”
Pharmaceutical developer representative Diane Jorkasky, M.D., FACP, and former vice president of Global Clinical Research Operations at Pfizer, helped the audience understand the industry perspective on the use of medical scanning in drug development, how different therapeutic areas view the value of that scanning and how “go/no-go” decisions are used when employing such imaging.
"Only through partnerships comprising researchers, pharmaceutical developers and government will we be able to achieve novel approaches necessary to establishing successful clinical trials," she said. According to Dr. Jorkasky, one of the key attributes of a standardized trials protocol is that imagers and pharmaceutical developers will have insight earlier whether a drug under development shows potential for truly helping patients who can benefit from molecular imaging pharmaceuticals.
Wendy Sanhai, Ph.D., senior scientific advisor, Immediate Office of the Commissioner, U.S. Food and Drug Administration, closed the day's presentations by acknowledging the critical role of medical imaging agents in early diagnosis, as well as patient care and monitoring disease progression. "Medical imaging techniques can provide real-time feedback on drug effectiveness and separate those patients who respond from those who do not and thus allow successful clinical decisions for the most effective treatment," she said.
Dr. Sanhai described clinical studies that incorporate imaging and that are currently underway in collaboration with multiple stakeholders. Her presentation provided updates on studies being facilitated within the Biomarker Consortium--a public-private research partnership of the Foundation for the National Institutes of Health--as well as efforts underway at FDA to facilitate biomarker development.
For more information: www.snm.org/clinicaltrials