OR WAIT null SECS
Bridging science and business with the end user in mind.
John Hoekman, PhD, is co-founder and chief scientific officer at Impel NeuroPharma, which submitted its first new drug application (NDA) for migraine drug INP104 in November 2020; FDA accepted it for formal review in January. INP104, and indeed the Precision Olfactory Delivery (or POD®) technology, is the product of Hoekman’s graduate work on a novel nasal delivery system. With a PDUFA date of Sept. 6, Hoekman could realize the first milestone of an already 13-year journey.
Thirteen years might sound like a long time, but to Hoekman, it eclipsed the alternative. His original undergrad choice of physics and astrophysics (major and minor) left him conflicted.
“I’ve always been interested in science and being a scientist,” he says. “But toward the end [of his undergraduate years], I started to get uncomfortable with the idea of working in a physics lab. I wanted to work in a field where I could see the results of my work a little bit quicker than 30 to 50 years.”
Though Hoekman describes his journey to drug development as winding, it’s more of a patient, pragmatic progression. Studying abroad, a neuroscience class piqued his interest, so back at the University of Minnesota, Twin Cities, he loaded up on life sciences classes.
After graduating, he started working in a biodistribution and drug delivery pharmacokinetic lab. Here, Hoekman conducted lab work for pharma companies, and on the advice of his supervisor, a professor in pharmacokinetics, made a course correction into a more industry-focused PhD program. He pursued his thesis work in nasal drug delivery at the University of Washington, leading to his PhD in pharmaceutics.
In the second year of his PhD program, Hoekman began looking for grants to push along his project. The first application he submitted was for a technology transfer grant, which led to the tech transfer office suggesting he enter a business plan competition, which he did and won. “From there, I received a lot of encouragement to start a company,” says Hoekman, and thus the genesis of Impel.
The organization, headquartered in Seattle, WA, was founded in 2008, two months before the financial crash.
“It wasn’t a great time to start a company…we almost went under before we started,” recalls Hoekman.
But an NIH grant allowed a small lab to do part-time work as he finished his PhD in 2010. Another grant helped Impel continue, along with its first angel investments, which supported additional contract work for pharma clients.
Exposure to the pharma industry was beneficial, but in 2015, Hoekman saw the writing on the wall. Contract work could be cancelled at a moment’s notice and had already adversely affected the company a number of times. Hoekman says, “It wasn’t sustainable, and I thought that we needed to raise VC money to find a molecule and develop it ourselves, as a combination product that could be approved as a prescription product.”
In the summer of 2016, Hoekman took over the role of CEO and raised Impel’s first VC financing, transforming it to a drug-device combination product development company and laying the foundation of its pipeline.
Five years later, the company employs 58 highly motivated people, many at Impel NeuroPharma’s labs based in Seattle. The Seattle-Tacoma-Bellevue metro area was recently named as the No. 2 spot for emerging life sciences potential by JLL, which means competition for talent is on the rise.
However, Hoekman says that the company’s culture, which is built around motivation of success in and building out its products, has led to a very committed community.
“We’ve had plenty of bumps in the road and people have stayed,” he says. “I’ve had people stay on unpaid for months when we were going through financially hard times in the early days. We have people consistently working way more than I would imagine that they would be comfortable with. We’ve had people flying around the world at the last minute to go to a clinical trial site or a manufacturer and be away for two weeks on very short notice. But they go and finish the job and make sure it goes well. We enjoy our successes, but I think more than anything, we have a very determined working group.”
As the company prepares for its PDUFA date—with a hopeful eye on a positive outcome for its nasal drug delivery technology for the acute treatment of migraine headaches with or without aura in adults, conditionally named TRUDHESA™—a new CEO with successful product launch experience and commercial focus was brought in last summer.
TRUDHESA™aims to optimize dihydroergotamine mesylate (DHE) for fast and lasting whole migraine relief, regardless of when in the migraine attack it is administered, without an injection. Importantly, the drug is designed to deliver a lower dose of DHE compared to other nasally administered, FDA-approved and investigational products. This may enable patients to benefit from the established efficacy of DHE, without the undesired side effects that may be experienced with delivery to the lower nasal space.
The NDA for TRUDHESA™ is supported by safety results from the pivotal Phase III STOP 301 open-label study, in which more than 5,650 migraine attacks were treated over 24 or 52 weeks. The study met its primary objectives, with no new safety signals or concerning trends in nasal safety findings observed.
The commercial side at Impel is now expanding with a new chief commercial officer, VP of marketing, and a build-out of the company’s medical affairs department.
Though Hoekman knows the commercial decisions are imperative to Impel’s future, he views his role squarely in drug development, focusing on improving a person’s fundamental day-to-day life. And his value is to focus his team on the vision and the end goal.
“It’s very critical to create a vision for the product that makes sense and has sufficient potential to gather your team around it,” explains Hoekman. “I bring to my company the consistent push to focus on the end user. Who is using it? What is their disease burden? How do they incorporate medicine into their everyday life? Is our product going to help? If it’s not, then it’s certainly not worth the time.”
While building his company, Hoekman has also been raising two now elementary school-age children. Outside of his clear work/life time commitments, he is an amateur woodworker. He likes building tables and cabinets, and is currently working on a set of stairs, an hour at a time. He anticipates being completed within a couple of months.
At some future point, Hoekman can see himself taking the lessons learned with Impel and starting another company. But for now, this young scientist/entrepreneur is most proud of getting its lead program to where it is today, followed closely by completely transforming Impel’s business model.
He says, “To take Impel from kind of a bootstrap company collaborating with pharma to getting VC investment, and to make that pivot to transform our business and not only keep it alive but make it thrive—that was a big career event for me.”
To read the profiles of all 2021 EPL winners, click here.
Lisa Henderson is Pharm Exec’s Editor-in-Chief. She can be reached at email@example.com.