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Navigating drug and device development: VCU Bench to Community series charts a path for medical innovation

Every day, millions of people in health care, from oncologists to rehabilitation specialists to dentists, use the tools at their disposal to help patients get better.

“And everyone runs into times when they say, what if?” said L. Franklin Bost, MBA. “What if I had something better? What if I could give someone better treatment? What if I could improve this patient’s health care, or many patients’ health care?”

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L. Franklin Bost, MBA, speaks to attendees of the Bench to Community Seminar Series.

Maybe there’s a device that doesn’t quite do what a surgeon wants it to do, a machine that doesn’t fit a nurse’s needs, or a treatment that a researcher thinks a new drug formulation could improve.

In his 30-year industry career, Bost worked through many such challenges faced by medical practitioners. Later, as a VCU College of Engineering professor and co-director of the VCU Institute for Engineering and Medicine, he became a leader in medical device development and commercialization. Now his experience – and that of several other leaders in the field – is preserved in a six-part seminar series for faculty and clinicians looking for guidance in the complex process of medical device and drug development.

Hosted by the Institute for Engineering and Medicine, the Wright Center for Clinical and Translational Research and the Office of the Vice President for Research and Innovation, the Bench to Community series provides a framework and pathways for inventors whose ideas could lead to innovations in medical care that improve health care for all patients.

“It’s not a journey that you go on alone,” Bost said. “It’s a journey you go on with a multitude of partners.”

Videos of the series are open to the public and available for viewing at Kaltura. (CME credit is available for VCU physicians, surgeons and nurses who watch the recordings. They can email cmeinfo@vcuhealth.org with the course code found within the video.) Read More

Wright Center joins network to help researchers navigate drug and device regulations

Virginia Commonwealth University, via the Wright Center for Clinical and Translational Research, has joined a network of other Clinical and Translational Science Award (CTSA) hubs that will help VCU researchers navigate the complex regulatory world of drug and device development.

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VCU is the first institution outside the Carolinas to join the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) network.

With ReGARDD, a VCU researcher has a larger regulatory pool to draw from in meeting their research needs. The network has resources, training, events, templates and guidance on navigating drug and device development in the academic setting. Researchers can register to receive upcoming educational events and updates in their inboxes on their website.

ReGARDD is led by regulatory affairs specialists and experts from North and South Carolina institutions that receive funding from the National Institutes of Health’s CTSA Program. The other institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, and RTI International and the Medical University of South Carolina.

VCU staff with regulatory expertise will pool resources with the other institutions. The network enables the sharing of ideas, lessons learned and historical information, as well as the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment.

Access the ReGARDD network at their website and email indide@vcuhealth.org for guidance on drug and device development at VCU.

Find more information about VCU’s FDA regulatory program at the Office of the Vice President for Research and Innovation.