Britain’s plans to leave the European Union could profoundly affect clinical drug research in the U.K. The impact spans a broad range of unknowns, from where the London-based EMA will put down roots to Brexit’s influence on trial regulations, cost, funding, and recruiting of scientific talent. Our Chief Medical Officer, Dr. Colin Hayward, addressed these...
Rare disease is one of our main areas of focus here at Premier, so you’ll often see my colleagues and me talking about rare, through our webinars and white papers, and basically, almost any phone conversation with us. Last week, I attended the NORD Summit in Arlington, VA, and as usual, I found myself inspired...
This week, we get a Tales from the Road two-for-one, from Dr. Colin Hayward, our Chief Medical Officer, who went to the Oxford Biotech Network Awards one week, and the ESMO Conference the next. Have a look: OBN Premier Research had the opportunity once again to support the Oxford Biotech Network (OBN) awards night. That...
Rising addiction rates are adding to already huge unmet needs in treating drug dependence, but big pharmaceutical companies show little interest in developing medications for common dependencies such as cannabis and methamphetamine. This volatile environment begs for trailblazers who can fill the void, but inconsistent patient behavior, lack of clear regulatory pathways, and other factors...
Introducing Tales from the Road, a series of blog shorts, where our Premier People report in from their travels outside the office. Because sometimes, not everything that happens on the road stays on the road! Today’s inaugural post comes from Juliet Moritz, Executive Director, Strategic Development Department, Rare Diseases, reporting back on her trip to Amsterdam...
Over the course of more than 20 years in clinical research, I’ve sat in on more study budget development and negotiations meetings than I can count. What I’ve learned from those many thousands of hours of discussion is, whether you’re working with a global pharma company or a biotech start-up, the ultimate success of a...
There are more than 7,000 known rare diseases, and these conditions afflict an estimated 30 million Americans (almost one in 10). Worldwide, some 350 million are living with a rare disease. But for 95 percent of these conditions, there are no FDA-approved treatments — not one. Conventional wisdom holds that innovation follows need: that if...
When selecting a CRO partner, sponsors usually focus on organizational experience – how long the company has been in business, its areas of therapeutic expertise and the breadth and depth of its service offerings. But, sponsors sometimes forget to ask about specific team experience. What do you know about the core study team members –...
Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate clinical trial results. It’s as if the phrase “get it right the first time” had...
The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...