Emerging business models in specialty pharmaceuticals
Compliance experts talk about trending business models, including early engagement and the need to do more with less.
Pharma companies have been increasingly focused on pre-PDUFA (Prescription Drug User Fee Act) market development, according to Darren Jones, partner at Baker Tilly. He said, “I think as an industry, we always struggle with what can we engage with pre-PDUFA? What is the right level of market engagement? One of the things we’ve talked about is market access teams and others are getting engaged earlier,” he said.
Shoshanna Clark, chief compliance officer at Cerevel, agreed, noting that early market shaping has become a popular business model.
“I think one of the really prominent ones that I’ve seen is getting into shaping the market [and] prepping the market earlier and earlier where you have limited funds, and they think they can get a lot of bang for their buck if they can start talking to people early,” she said.
She shared an example: A small pharma company needed medical affairs to educate doctors around neuroscience, particularly in Parkinson’s and schizophrenia, years before product launch. Despite these being an established space, she said market research proved a gap in knowledge.
“Wanting to get out there and talk to doctors about disease state education but also a mechanism of action years before we even file. So years before PDUFA, and that’s a conversation that has to be navigated fairly carefully,” she said, emphasizing that pre-approval education carries promotional risks.
“I always take it on a case-by-case basis, a product-by-product basis,” she added.
Overall, she said this strategy could pose compliance risks, such as pre-approval promotion and potential fraud and abuse when engaging with principal investigators.
David Ryan, vice president, legal, and chief compliance officer at Ardelyx, said he would advocate a careful interrogation of what the plans would be for pre-PDUFA activities and communication.
“I do think this is an opportunity to look at your proverbial Swiss Army knife of tools that you have. And one good tool here is to speak the language of your management team, which at this stage in your development is at least keenly fixated on the cash burn and their wise use of capital,” he said.
“You can raise the question as to how much you want to invest in communicating something about a mechanism of action, about a potential therapeutic option, and how much of that do you actually know at this particular stage of communication? Because things do change depending on what phase of your trial you’re in,” he continued.
Changes in regulations, approvals, and unexpected discoveries during drug development can impact early messaging, he said, which could lead to wasted capital on communication that may not resonate with the company’s marketing strategy.
“So there’s some business reasons, in addition to the really good compliance reasons to not get too far ahead of yourself,” Ryan said.
‘Do more with less’ business model
Clark discussed another emerging business model, “do more with less,” where field team members are expected to perform different tasks, leading to a mixing of roles.
“How I’ve seen this played out in the field is they want their existing teams to do more. For instance, we’d like sales to also do some market access work,” she said. In return, this can complicate compliance, she noted, adding that compliance measures are tied to specific roles.
“I can get comfortable with certain activities, like sales reps going and selling to doctors, because they’re not doing other things. They’re not talking to patients, for instance; they’re not administering an adherence program. Shockingly, that’s not sales,” she shared with delegates.
However, she expects as financial pressure gets put on brands, especially smaller ones with fewer resources, field teams will be expected to perform more duties.
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