Based in Frederick, Maryland, ClinicalRM employs 500 people and provides full service and functional services to many U.S. government agencies and private sector sponsors. Their scope of reach is across basic and applied research, infectious diseases, vaccine development and testing and in response to bio-threats and global viral epidemics.
“The market for government-sponsored research is significant, with over 1,500 active clinical studies being funded by the National Institutes of Health (NIH) or other federal agencies,” said Icon CEO Ciaran Murray in a release.
Murray added that ClinicalRM, founded 22 years ago, has strong relationships and a deep understanding of what is required to partner successfully with government sponsors, and will provide Icon a platform to further penetrate this large market segment.
This purchase allows Icon entry into a huge market, said Neal McCarthy, managing partner of investment firm Fairmount Partners, which focuses heavily on the life sciences. “The U.S. federal government budget for healthcare R&D is over $31 billion—that’s more than the R&D spending of the three largest drug companies in the world combined,” he said.
McCarthy explained that working as a primary contractor with the U.S. government requires special accounting systems, a stellar track record of prior performance with each of the dozens of government entities that outsource pharmaceutical research and the expertise to maneuver through federal regulations in order to emerge victorious from the complicated bidding process. ClinicalRM has all of these, McCarthy said.
“ClinicalRM has been working almost exclusively with the U.S. government for more than 20 years. It has a tremendous track record with very difficult research projects, including vaccines and infectious diseases such as the Ebola virus and more recently the Zika virus,” McCarthy said. “This acquisition provides ICON with a great opportunity to expand its share of the government market.”
Victoria Tifft, the founder and CEO of ClinicalRM, served in the U.S. Peace Corps in Togo, West Africa, as an infectious disease biologist. According to the ClinicalRM website, in her work to improve health conditions in Togo, she contracted malaria three times and came back to the U.S. committed to working to provide treatments for devastating diseases. To that end, she worked on-site at the Walter Reed Army Institute of Research and the U.S. Army Medical Research Institute for Infectious Disease, which played a large role in establishing the WRAIR Clinical Trials Center more than 20 years ago. ClinicalRM has been honored by the Bill and Melinda Gates Foundation for its work with Ebola in Africa.
Said Tifft in a release, “By combining ClinicalRM’s expertise in government-sponsored research with Icon’s breadth of services and global footprint, we will be able to bring additional services and thought leadership to our customers. We are also excited about the potential the combination has to further innovate drug development in the area of vaccines and infectious diseases, important areas of focus for both government and commercial customers.”
William Schaffner, professor of preventive medicine and infectious diseases at the Vanderbilt University School of Medicine, said the area of infectious diseases and vaccines is poised to boom.
“Traditionally, vaccines had been principally about newborns and children,” said Schaffner. “In more recent years, though, the vaccine industry has expanded to adolescents. There’s a lot of research being conducted to bring more vaccines than the flu vaccine to the adult population.”
The timeline is still early, in the U.S., for adult vaccines. Health insurance plans generally aren’t accepting schedules for adult vaccines, outside of the flu vaccine, or providing coverage, said Schaffner. Thus, if an adult is in need of a vaccine, they often must pay for it out-of-pocket. Since most adults don’t think about getting vaccines other than the flu vaccine, they aren’t yet willing to pay. But all of this is slowly morphing as more research is done and the field evolves, he said.
Infectious diseases are a much bigger problem in the developing world than they are in the U.S. Schaffner explained that pharma companies producing vaccines make money based on volume, so they charge less per dose. Fewer vaccines for infectious diseases are needed in the developed world, so the companies charge more per dose, because people in the developed world have more of an ability to pay for them, said Schaffner.
We may now be on the cusp of vaccines moving away from being merely preventive. Said Darin Seehafer, clinical scientist, vaccines, at the CRO PRA, designer vaccines are on the horizon.
“The whole market is starting to gain momentum. The technology is moving very rapidly in the area of personal vaccines,” said Seehafer. “The treatment arm is becoming huge, not just for infectious diseases, but for areas like cancer. Some in the field are adamant that in 10 or 20 years, you’ll have vaccines designed around our DNA.”
This article was reprinted from Volume 20, Issue 27, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »