Super Advisory Board Series
Shepherding the Development of a New Drug
A U.S. pharmaceutical company was developing a second-generation therapy for preventing and treating venous thrombosis and pulmonary embolism. Having satisfactorily demonstrated proof-of-concept through a Phase 2 study, the company was now looking to move forward with other various clinical studies and a major Phase 3 clinical trial. The company acknowledged that it needed ongoing expert guidance from international thought leaders on the lifecycle development of the drug as well as many preparatory steps in advance of the product's launch.
With the company’s continuous involvement, 14 renowned experts in the field (clinicians and academic researchers) were identified and recruited to join a 3-year Super Advisory Board. The mandate was to advise the company through a series of meetings and work products. The experts would meet twice a year face-to-face for a 1½ day meeting, and 4 times per year in 3-hour virtual meetings via video-conferencing. These distinguished key opinion leaders included 3 hematologists, 2 cardiologists, 2 emergency medicine specialists, 3 orthopedic surgeons, 1 pulmonologist, 1 neurologist specializing in stroke; and 2 PhD researchers from academia. The clinicians specialized in deep-vein thrombosis, pulmonary embolism, atrial fibrillation and stroke, acute coronary syndrome (including PCI), and emergency medicine. Participants were from the U.S., Canada, France, the UK, Germany, Spain, Brazil and Australia.
In consultation with the company, a professional health and biological sciences moderator was trained in the area of thrombosis management. This same moderator would facilitate all proceedings of the face-to-face and virtual meetings. The Super Advisory Board ultimately informed:
- Clinical studies; Analysis of clinical trial results
- Thresholds of evidence re efficacy and safety needed to achieve regulatory approval and ‘make a market’
- Appropriate clinical role for the company's new agent
- Elucidation of the Mechanism-of-Action
- FDA and EMA submissions
- MSL and rep training
- HTA initiatives pertaining to "effectiveness"
- Physician, nurse, pharmacist, and patient education
- Market Access and payer-reimbursement strategies
- Rollout strategies and marketing messages
From the input and work product of the Super Advisory Board, and importantly, from the ongoing detailed meeting Reports and Analyses provided to the company, the pharmaceutical corporation availed itself of the best international expert guidance available.