ICON, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has announced that, together with Pfizer, it has won the Clinical Research Team of the Year award at the inaugural Clinical and Research Excellence (CARE) Awards.
The award honored the achievements of the team that has made the most difference to a pharmaceutical or biotechnology company’s research program, and has made great strides on its core project through exemplary team-working.
ICON and Pfizer won the award for their achievements in 2015 on two ongoing parallel cardiovascular outcome studies, which will involve approximately 26,000 patients at 3,000 sites in 35 countries. Through close collaboration and by adopting a single team approach, ICON and Pfizer designed a framework that re-engineered the site start-up process and enabled them to meet or exceed the studies’ site activation and patient enrolment targets for 2015.
Pfizer has created SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events), an extensive research program to study bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The SPIRE phase III global clinical development program consists of six lipid-lowering studies (SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL) as well as two cardiovascular outcome studies (SPIRE-1 and SPIRE-2).
The two cardiovascular outcome studies are investigating the ability of bococizumab to reduce the risk of cardiovascular events in a broad range of high-risk primary and secondary prevention patients, including those with diabetes, chronic kidney disease, peripheral vascular disease or familial hypercholesterolemia, in addition to those with previous cardiovascular events such as heart attack, stroke, or cardiovascular revascularization procedures.
ICON’s Chief Executive Ciaran Murray said, “We are proud that the expertise of our clinical research teams and our partnership approach with clients have been recognized as the industry’s best. Site activation and patient recruitment are two of the most challenging aspects of managing clinical studies and it was particularly pleasing that all timelines in these studies were either met or exceeded, thanks to the hard work of the combined Pfizer and ICON team. Building strong teams that have the knowledge and experience to act as trusted partners to our clients is a key focus at ICON and I’m delighted that one of our teams has been honored by the industry.”
Pfizer’s Vice President for Clinical Operations Bill Erhardt said, “The SPIRE program for bococizumab is the only PCSK9i research program assessing cardiovascular outcomes in a broad range of high-risk primary and secondary prevention patients. It is only through a close partnership, innovative problem solving and teamwork that landmark trials of this magnitude can be completed efficiently in order to completely characterize this important potential new medicine. Pfizer is very pleased that this team has been recognized with the CARE award.”
Bococizumab is an investigational compound and has not received regulatory approval in any country.
The inaugural CARE Awards celebrate the outstanding clinical research achievements from 2015. The awards showcase excellence in clinical trial design, technological advancements within the industry, outstanding research results, as well as achievements of individuals, departments, teams, or organizations. Award winners have contributed to the advancement of therapies for unmet medical needs, undertaken ground-breaking collaborations, and contributed to positive clinical outcomes while demonstrating best practices and innovation.