CDRH, NHLBI Discuss Achievements and Initiatives
Personalized imaging and gene research are in the pipeline.
Virtual clinical trial subjects, improved regulatory procedures, and new gene therapy research programs were among the topics of discussion at Wednesday’s Health and Human Services Town Hall Meeting.
Representatives from the FDA’s Center for Devices and Radiological Health (CDRH) and the National Heart Lung and Blood Institute (NHLBI) discussed their accomplishments, goals and ongoing projects.
CDRH: benefits and risks
Dan Schultz, MD, director of the CDRH, discussed some of his organization’s achievements and goals. He discussed the development of a Critical Path Plan, which is designed to develop biomarkers and clinical trial designs, promote bioinformatics and manufacturing, and address public and pediatric health needs.
Schultz also addressed the possible development of a “virtual clinical trial subject,” which would be a computer model able to mimic all physical and physiological responses of a human being to a medical device. The CDRH also is exploring the concept of personalized coronary imaging, which would consist of a virtual catheterization lab that selects the best imaging parameters for a specific imaging task for a specific patient.
The CDRH aims to focus on guidance and standards in the future. Improved guidance will be achieved through prioritization, use of industry drafts and the use of performance metrics.
Schultz said the CDRH also intends to work with colleagues in
Japan in the areas of premarket reviews, good clinical practices, and post-market safety.
The organization also plans to continue the success of the Medical Device User Fee and Modernization Act.
NHLBI: new initiatives
Susan B. Shurin, MD, from the NHLBI, outlined the institute’s Cardiovascular Reorganization (Figure). Through this reorganization, the Division of Heart and Vascular Diseases will become the Division of Cardiovascular Diseases, and the Division of Epidemiology and Clinical Applications will become the Division of Prevention and Population Sciences.
Shurin also discussed the NHLBI’s latest projects and initiatives. She first discussed the Cardiovascular Cell Therapy Research Network, which is designed to promote and expedite clinical research in the assessment of novel cell therapy strategies for individuals with cardiovascular disease. The Gene Therapy Resource Program (GTRP) will translate basic research in gene therapy into clinical applications in heart, lung and blood diseases. The GTRP will also provide resources to conduct gene therapy clinical trials and provide assistance with regulatory issues.
Shurin asked for physician feedback and ideas regarding a proposed policy of data-sharing in NIH’s Genome-Wide Association Studies.
“This has become very important, in that the cost of genome-wide studies has plummeted,” Shurin said. “The cost now puts this within reach, and what we are seeing is a tremendous number of applications. The amount of data that is generated is absolutely staggering.”
Shurin said this proliferation of genome-wide data should be made available to the research community.
“We want to do this while maximizing the public benefit,” she said.
Other elements of the proposed policy will include data management, publication, and encouragement of patent development.
Shurin also discussed the
NHLBI’s Center for Fetal Monkey Gene Transfer for Heart Lung and Blood Diseases, which will use established monkey models to explore fetal approaches to treating these diseases.
In the Q&A session, David Miller, MD from St. Jude Medical Center, asked about the status of an anticipated guidance document regarding flow charts.
“We know this is one of the most important guidance documents, and there has been a hiatus between the old document and this one. It is very close [to completion]. By the time I come back next year, that document will be out,” Schultz said.