I had the opportunity to attend the SCOPE Summit for Clinical Ops Executives in Orlando, February 12-15. It’s been a few years since I last attended a SCOPE Summit, so it was interesting to see that some clinical research issues have evolved, while others persist…
You’ve done all the background work. You’ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You’ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company – entering the clinic.…
Planning to export an ancillary supply or a medical device? Get ready for some bureaucratic red tape. Country governments take compliance with their import and export laws and regulations seriously. If a violation occurs, the in-country importer of record could find itself facing fines, penalties,…
The drug discovery and development process is a complex and challenging landscape, especially for the majority of small biopharmaceutical and medical device companies. It’s truly a survival of the fittest environment, fraught with potential pitfalls and company killers. For every Kite Pharma (acquired by Gilead…
Each year I take time to put forth my observations about the year ahead. From a geopolitical perspective, I will not enter the fray, except to say as business leaders, the need exists to navigate a variety of waters. One positive event is the improving…