Consulting firm puts compliance front and center for clinical-stage drug developers


New "emergent biopharma" service combine compliance with pricing, market access

You could argue that its position is “to a hammer, every problem looks like a nail,” but CIS (Compliance Implementation Services, Philadelphia) makes a compelling case that the compliance function, broadly defined, needs to be an integral part of a clinical-stage company’s forward movement. There are compliance aspects to research and clinical trial design, of course, but CIS maintains that a well-built infrastructure around compliance will provide value for eventual co-marketing or out-licensing arrangements, as well as the valuation when and if a biopharma startup is acquired by Big Pharma.

That’s the basic message of Neil DeHenes, who is leading a new service at CIS called Emergent Biopharma Insights. “When clinical stage companies lacking a solid compliance infrastructure reach the commercialization point, there are three things that can happen with a potential partner,” he says. “The partner can walk away, saying that their risk tolerance is not that high; or it offers a lower value for the partnership or agreement; or it brings in companies like ours to do the due diligence and bring the clinical company’s programs up to par.” In all cases, he says, the company is better off with a solid program in place from an early stage. “For companies planning their own commercialization, having a compliance infrastructure built into the front end ensures that their plan won’t be derailed through missed government requirements or business process pitfalls,” he adds.

DeHenes, who previously spent a dozen years at Cardinal Health, says that clinical-stage companies generally need a broad range of consulting services and strategies, ranging from pricing and contracting, to channel marketing and distribution programs, and (of course) compliance. CIS is structured to provide many of these under its Emergent Biopharma Insights service; CIS is the company many others in the commercialization space bring in to oversee compliance/commercialization functions. As the pace quickens on drug-development and regulatory agency approvals, expect more service offerings like CIS’ to appear.

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