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those side-by-side trials in Alzheimer’s and schizophrenia were for a biotech startup to run. As Dunsire says, even a publicly traded biotech with access to the Wall Street ATM might not do that on its own—or, if it does, only with the intent of selling itself afterwards. “But the intent here was to go on, and finish the clinical program,” she says.
That meant even larger bills. Been says as the bet got bigger and bigger, with Phase 3 trials looming, the risk astronomical, Fidelity wanted a leader in place with experience commercializing a drug. Been was let go in February 2013. Dunsire, who ran the launch of bortezomib for Millennium and the successful cancer drug imatinib (Gleevec) at Novartis before that replaced him five months later.
Despite that experience, Dunsire describes her time at Forum as a crash course. She spent much of her professional life in large organizations and with companies focused on oncology, not neuroscience. She’s never taken a company public before. After eight years at Millennium, including four after Takeda Pharmaceuticals bought the company for $8.8 billion in May 2008, Dunsire stepped down in May 2013 amidst R&D cuts. She resurfaced only two months later as the CEO of EnVivo.
Dunsire told Xconomy in July 2013 she was intrigued by the challenge of studying a new field while building a company with a drug deep into development. But she had to conquer “a whole slew of learning curves,” from the science behind the company, to the competitive landscape, to developing a clinical and commercial strategy, and a pipeline—and figure out how EnVivo was going to pay for all of it. When Dunsire came aboard, the company had already started one Phase 3 trial, in schizophrenia, and was gearing up for another in Alzheimer’s. Each are massive undertakings, with thousands of patients apiece. Yet when she started, she knew the mandate from the top: think big, and think long-term. When I interviewed her in Boston recently, for instance, she pointed to a slide the company is now showing investors, which included a slew of potential diseases encenicline might affect, if it works the way she hopes—among them ADHD, depression, and traumatic brain injury.
“I’ve only had to do 20 year planning at two places,” she says. “Takeda, because the Japanese plan for 20 years, and Forum, because the investor is thinking about how the cash flow evolves from this asset over the period to patent expiry.”
Dunsire has already put her stamp on the company, starting with the new name: EnVivo was ditched because of other companies with similar names, like publicly traded Invivo Therapeutics. (“We’d sometimes get their mail,” she says.) Though encenicline is meant for big, broad populations, Dunsire envisions a more targeted, rare disease-type approach for other drugs in the Forum pipeline. One drug, FRM-0334, is being tested in a genetic subset of patients with frontotemporal dementia. Then there’s a preclinical drug for familial Alzheimer’s disease caused by a specific genetic mutation. “We’re trying to think about populations where we can identify the mutation, [where] we know the patients to select,” she says. “A precision medicine approach.”
As more private investors join, Dunsire will look for a partner to help sell encenicline in Alzheimer’s, if it comes to market, and shoulder some of the massive commercialization costs.
There’s a tricky dynamic in play, though. Forum is backed by a titanic, experienced investor that’s already poured hundreds of millions of dollars into the company (Dunsire won’t say exactly how much; Been estimates it’s at least $200 million to $300 million). Will others value Forum similarly given the risk remaining? Will they buy that encenicline is a better, different compound than the failed alpha 7 drugs of the past; a drug poised for billions in sales?
That’s Dunsire’s challenge. It’s ironic that for the journey she chose the name Forum, the place Roman senators went to debate and discuss important matters of the day. She’s trying to put a different type of Forum together now.
“We want it to be a place where not only we discuss among ourselves at Forum, but there’s input from patients, academics, basic researchers, and regulators,” she says. “So the forum was that coming together of ideas.”