Consulting

Clinical Research: Phase 1 - Phase 4

Tales from the Road – World Orphan Drug Congress

Last week, I attended World Orphan Drug Congress in Belgium. It was my first WODC, and it was a productive three days in Brussels – even if it was held at the airport hotel, and we never left the building! The congress agenda covered a wide range of topics in the rare and orphan disease...

Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Speakers:Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier ResearchTodd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis alone is tricky, given the often-delayed onset of symptoms, and optimizing study design, recruitment, event adjudication, and biomarker use complicates...

Consulting

A Premier Time with STARR Coalition at CNS Summit

As it was starting to get cold in the Northeast, a group of us snowbirded down to warm Florida for the CNS Summit. Before the conference began, we participated in STARR Coalition’s annual meeting. STARR Coalition is a remarkable group whose mission is to create meaningful change by increasing communication, partnerships, and goodwill among stakeholders...

Consulting

Success in Neurodegenerative Disease Trials: Attend Our Nov. 15 Webinar

DURHAM, N.C., November 10, 2016 — Researchers developing treatments for neurodegenerative disorders face some of the biggest hurdles in planning and conducting clinical drug trials. Get advice on navigating this difficult terrain by attending a Premier Research webinar on Tuesday, November 15. Neurodegenerative Disease Research: Steps to a Successful Clinical Trial will describe a complex...

Clinical Research: Phase 1 - Phase 4

What Does Brexit Mean for Drug Development in the U.K.?

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...

Consulting

NORD Summit, a Rare Disease Regulatory Wonderland

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...

Consulting

‘Trailblazers’ needed to combat the agonizing scourge of addiction

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...

Consulting

Developing & Negotiating a Study Budget

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...

Consulting

The Importance of Study Team Experience

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 –...