News
Theorem Expert to Speak on Combination Trials at Partnerships in Clinical Trials
Drug-device combination products present promising new treatment options, and attendees at Partnerships in Clinical Trials will have the opportunity to hear one of the industry’s leading experts on the subject. D. Lee Spurgin Jr., Ph.D., senior vice president and general manager of medical device and diagnostic development for Theorem Clinical Research, will be a panelist for a discussion on “Bridging the Gap Between Drugs and Devices: Differences, Takeaways and Lessons Learned.”
“We have made drug-device combination trials a focal point of our services,” Spurgin said. “These are complex and demanding studies, and overcoming the unique regulatory and study management challenges have taught us much that will be of value for future projects.”
Theorem has been performing drug-device combination trials since the 1990s and was one of the first CROs managing combination device programs for the development of drug-eluting cardiovascular stents.
“Bridging the Gap Between Drugs and Devices” will be presented at 11:30 a.m., Wednesday, April 24, as part of the medical device trial optimization track.
Visitors to the Theorem booth at Partnerships in Clinical Trials will have the opportunity to register to win an adaptive study design consultation with prominent regulatory expert Brian Bollwage. Bollwage, vice president of global regulatory affairs at Theorem Clinical Research, has managed the submission and associated FDA liaison activities for more than 150 INDs and 25 successful NDAs or BLAs.
Partnerships in Clinical Trials will be held April 21-24 in Orlando, Fla. Theorem Clinical Research will be in Booth #533 and will have a professional caricature artist on hand providing individual portraits for guests.
About Theorem Clinical Research
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world’s leading pharmaceutical, biotech and medical device companies. A leader in medical device and drug-device combination trials in addition to a notable capability in pharmaceuticals and biologics, Theorem has deep expertise in a broad range of therapeutic areas and in all phases of development. Some of the industry’s top scientists and most advanced clinical analytics capabilities help ensure smooth-running, successful trials. For a full-service, right-size global research partner, don’t think twice. THINK THEOREM.
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