Operations

Observations from GCP Sponsor Inspections

When it comes to GCP sponsor inspections there are numerous agencies throughout the world that may review your organizational practices.…

Is the GAIN Act Stimulating Antibiotic R&D?

In July 2012, the Generating Antibiotic Incentives Now (GAIN) Act was signed into law by the Obama administration as part…

The Future of Pfizer’s $5B Brand is in Jeopardy

Lyrica (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved…

The Top 5: November 2018

There were numerous articles in November 2018 that covered a wide range of topical issues. Here are five of the…

Expert Insights: Abbvie’s EU Outlook Dims as Discounts Deepen on Humira Biosimilars

In October, five biosimilar versions of AbbVie’s blockbuster Humira were given the green light to launch in the EU. Humira…

The Ongoing Fight Against Diabetes

A question for you: Did you know half of all people living with diabetes are undiagnosed? The International Diabetes Federation…

How to Conduct a Diabetes Trial – Lessons Learned

Type 2 diabetes mellitus (T2DM) is increasingly causing alarm among epidemiologists and diabetologists around the world, according to the American…

Surveying the Challenges of Preclinical Development

The Preclinical Development Operations Summit launched in 2016 in the East Coast, where a hub of preclinical development companies have…

Industry Viewpoints: The Continual Rise of Direct-to-Patient

The rise of direct-to-patient (DtP) shipping seems to know no bounds. The opportunities afforded by DtP means processes can be…

Patient-Centric Trials of the Future

The way clinical trials are being conducted needs to change. If the patient’s perspectives, expectations, fears and doubts are not…