Small Biopharma Companies Must Wrestle With Big Safety Data Responsibilities
It used to be relatively straightforward to aggregate all safety data from a compound’s trials and send it to the FDA annually, as required. As the sponsor, you either had the data within easy reach in your files, or the one or two CROs you’d outsourced to could easily pull it together. It was simple.
But that was then in pharmacovigilance. This is now.
Now, clinical research is awash in big, unwieldy data, and studies on one compound often have multiple endpoints across multiple protocols. Also, more often than not, the studies have been outsourced to several CROs, each of which uses different databases with different data standards and different coding for pharmacovigilance.
Now, when it’s time to send in that annual safety report for a compound in trials, a sponsor can become downright flummoxed —especially so if they are a small biotech, which is where many of the industry’s promising compounds now originate.
“So many of these companies with new compounds are now just a dream and a team,” said James Bannon, president and CEO of drug safety and pharmacovigilance company Vigilare International, which was bought by WIRB-Copernicus Group last fall. “They don’t have the same safety infrastructure as the big pharma companies and they can’t divert large portions of their money away from their development projects in order to build out a safety department.”
Added Bannon, for some, the process becomes a nightmare wherein no one on the small, overworked team even remembers where all the data are or where to look.
Angus McCulloch, senior vice president of safety and regulatory solutions for the CRO Bioclinica, also a player in the space, agrees that most small sponsors don’t have the bandwidth for robust pharmacovigilance.
“Small sponsors are focused on the progression of their pipeline and would prefer to focus less management attention on aspects of their operation that can be outsourced,” he said. “Maintaining an internal safety operation and regulatory affairs group can prove unnecessarily costly.”
Vigilare, Bannon said, jumped into the market in 2014 to help these fledgling companies as safety-focused executives began seeing the shift to innovative compounds coming from small shops rather than big pharma. He added that big pharma now waits and swoops in to buy promising compounds when they’re further down the pipeline.
The sweet spot for outsourcing the pharmacovigilance burden, said Bannon, is near the end of the compound’s phase II trials, as the developer is gearing up for phase III and poised to potentially get involved with many CROs.
At that point, a pharmacovigilance-centric vendor can come in and bring a solution that “hovers above individual protocols,” with all safety data from all trials across many compounds saved in one place, since capture is begun early in the development process, said Angela Pitwood, vice president of Vigilare, formerly a pharmacovigilance exec at Pfizer.
A compound’s move into phase III is the point of no return for a sponsor company’s easy control of the safety data, said Bannon. “The larger the datasets are, the harder it is to combine and ultimately analyze, and the more difficult it is to meet the FDA reporting requirement deadline,” he said.
The industry abounds with companies willing to help sponsors big and small with the management of their drug safety universe. According to Grand View Research, the global pharmacovigilance market size has grown steadily, was estimated at $3.40 billion in 2016 and is anticipated to witness a compound annual growth rate of 13 percent through the report’s forecast period of 2025.
Increasing incidence of adverse drug reactions and the growing prevalence of chronic diseases are expected to spur the industry on.
And most of the work is being outsourced. Said the report’s authors, contract outsourcing held the dominant share of the market, while growth of in-house pharmacovigilance efforts was moderate.
The key players in the space, according to Grand View, are Accenture, Clinquest, Cognizant, Laboratory Corporation of America, IBM, ArisGlobal, ICON, Capgemini, ITClinical, iMEDGlobal, Foresight Group, TAKE Solutions, PAREXEL, Bioclinica, Wipro, and United BioSource.
Said Bart Cobert, pharmacovigilance consultant and author, many of the smaller players in the pharmacovigilance sector who market to small and medium sized sponsors are, like Vigilare, getting bought up by bigger companies. Another example is Drug Safety Alliance, which was bought by UDG Healthcare in 2012 and renamed Ashfield Pharmacovigilance.
But, Cobert added, that doesn’t mean they will get big themselves. On the contrary, it’s their small size and competitive pricing that appeal to the small sponsors, he said.
Add to that, said Cobert, the fact that much pharmacovigilance work is now done in India for a very low price, which presents another choice to small sponsors on a budget. Said Bioclinica’s McCulloch, larger CROs now outsource some of their pharmacovigilance work to companies overseas.
“The business case is compelling and if they have a direct relationship with the safety services provider, they have easier access to their consolidated safety data in the event that there is an acquisition,” said McCulloch.
“It’s a very dynamic and flamboyant market right now,” said Cobert, who blogs about issues in pharmacovigilance for C31 Solutions, a subsidiary of Merck.
What does the future hold in this space? Bannon says he expects to see more innovation in technology that can make the pharmacovigilance piece easier and more streamlined to handle. Cobert said he expects to see the smaller players in the space continue to be bought by larger companies.