On Feb. 2, the final day of the second annual SNM Clinical Trials Network Workshop, experts working in various facets of the molecular imaging community met in Albuquerque, N.M., to discuss the nuts and bolts of using imaging in clinical trials and the challenges and opportunities ahead in the regulatory landscape.
FDA cGMP Guidelines Take Effect Dec. 12, 2011
In December 2009, the U.S. Food and Drug Administration (FDA) published a final regulation on current good manufacturing practice (cGMP) for the production of positron emission tomography (PET) drugs. At that time, FDA also published a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation. The new regulations, known as 21 CFR 212, take effect on Dec. 12, 2011.
Dr. Richard Wahl, director of nuclear medicine at Johns Hopkins University School of Medicine, presents a lecture on response criteria assessments during today’s workshop.
Preparing for New cGMPs: A Clinical Perspective
Steve Larson, M.D., chief of nuclear medicine at Memorial Sloan-Kettering Cancer Center in N.Y., gave a presentation on the use of new imaging surrogates in assessing therapeutic agents, specifically the use of bone scans in prostate cancers.
“I am happy to participate in this workshop to present the importance of developing surrogate imaging endpoints in cancer research,” said Dr. Larson. “Focusing on ‘time to event end-points,’ such as radiographic progression of disease in prostate cancer, may aid in determining which therapeutic drugs move onto Phase III development. Effectively used, this has the potential to bring the best drugs to patients more quickly.”
Discussion Critical for the Entire Molecular Imaging Community
At a concurrent session, Ravi Harapanhalli, Ph.D., former branch chief of chemistry, manufacturing and controls (CMC) at FDA and currently a principal at Parexel Consulting, talked about ways for PET radiopharmaceutical manufacturing sites for therapeutic multicenter trials to prepare for the new regulations and transition to inspections.
“The experience provided by the SNM Clinical Trials Network Workshop and other educational meetings is absolutely necessary to ensure the effective implementation of regulation 212 and its seamless transition from the existing <USP> 823 regulations,” said Dr. Harapanhalli. “Today’s presentations and workshops are critical ways to support the medical community, cyclotron manufacturers and FDA in both the current and upcoming implementation of the PET regulations for 21 CFR, part 212.”
FDA Helps the Molecular Imaging Community Transition to New PET Drug Regulations
Ravindra Kasliwal, Ph.D., a chemistry, manufacturing and controls expert at FDA, presented at the workshop as part of the FDA’s concerted efforts to educate the imaging community about the new regulations and the regulatory framework for PET drugs. In the interim, the producers of PET radiopharmaceuticals will continue to comply with USP <823>, which has provided a regulatory framework for more than a decade.
Mapping the Road Ahead: Next Steps
As the SNM Clinical Trials Workshop concludes, the molecular imaging community continues to look ahead and prepare for the positive changes that are coming in December 2011. Working with FDA, the community will continue to recognize the value of the new rules and prepare their sites for compliance.
“Helping sites to understand the complex and changing landscape is one of the key roles of the SNM Clinical Trials Network,” said John M. Hoffman, M.D., co-chair of the network and professor of radiology and neurology at the University of Utah School of Medicine. “Together, pharmaceutical companies, imaging research facilities, manufacturers and the FDA will work to ensure standardization and harmonization of molecular imaging in multicenter clinical trials.”
As next steps, SNM, FDA and the Radiological Society of North America (RSNA) will host a workshop about the new guidelines and regulations, April 13–14, 2010, at the National Institutes of Health, Bethesda, Md. Wendy Sanhai, Ph.D., M.B.A., senior scientific advisor, Office of the Commissioner, FDA, outlined the overarching objectives of the April two-day scientific workshop. In her presentation, Dr. Sanhai explained that the first day of the workshop will focus on the general issues of imaging standards in clinical trials, and the second day will address regulatory aspects of the manufacturing of PET radiopharmaceutical products. FDA representatives will also lead educational sessions at a workshop on June 5, 2010, which will take place during SNM’s 57th Annual Meeting in Salt Lake City, Utah.