“The translational pathway from concept to marketing is complex and challenged by several necessary barriers relating to safety, efficacy, regulatory and manufacturing requirements, as well as physician education, awareness and acceptance. Our intent in developing this course is to expedite scientific discovery to clinical applications.” — Robert Roberts, MD, chair of the International Society for Cardiovascular Translational Research (ISCTR)
The current average time for regulatory approval and reimbursement of a new cardiovascular drug is 12 years, and the cost can be upwards of $2 billion. Those numbers alone are intimidating, which is why the goal of this online program is to help scientists, researchers and academics simultaneously — instead of sequentially — consider the steps of bringing a device or therapeutic to market.
By aligning its structure with that of the FDA, the course allows its students to follow a designated path — Medical Devices, Drugs or Biologics. Along that path, students will also receive dedicated instruction, through the use of modules, on nearly every important step in the process it will take to get their device from conceptualization to clinical application. These include:
To request an appointment to discuss the course with Dr. Roberts, please complete this online form.