Anthony Mack is no stranger to navigating a setback. In 2008, he was sent adrift after losing a national sales director position in pharma.  

“Obama was sworn into office, and I got laid off the next day. I thought, ‘This guy got in, and now I’m out,’” he recalls with a laugh.

He didn’t know it then, but that downturn was actually an opportunity that would put Mack on course to find his true calling — rethinking how to optimize the delivery of pharmaceutical molecules and move them through accelerated FDA regulatory pathways toward approval.

At the time, finding a new job in the industry would have likely meant relocating from his home in Florida — a move he thought his family wouldn’t have the appetite for. So instead of taking a job with another company, he launched his own: Florida-based, ProSolus Inc., which specializes in researching and manufacturing transdermal drug delivery systems. With his partners, the team built an FDA-approved R&D and manufacturing facility from the ground up and created a state-of-the-art line of topical and transdermal solutions. The company took off and Mack eventually sold it to Mission Pharmacal, a privately held pharmaceutical company in San Antonio in 2015.

His winning streak continued at his next venture, Scilex Pharmaceuticals, which made a name for itself focusing on non-opioid pain-relieving solutions. Scilex was also sold — the $47.6 million acquisition by Sorrento Therapeutics was announced in 2016 — and its product, a lidocaine patch, was approved under Mack’s direction in 2018.

Now the CEO of Virpax Pharmaceuticals, Mack is applying all this experience to guide the company to its own commercial success.

The five products in Virpax’s pipeline are right up Mack’s alley. They all use less traditional delivery systems — including intranasal sprays and a hydrogel — and three are aimed at non-addictive pain management. And despite the fact that they’re all in preclinical development, the publicly held company has raised $60 million to date through a public stock offering, indicating that investors see promise in their market potential.

Of course, getting a pharma product across the regulatory finish line can be an arduous process, and there’s always pressure to move fast. Here, Mack shares the lessons he’s learned on what it takes to make it — from strategically selecting assets to navigating accelerated regulatory pathways.

Keep an eye out for promising candidates: After founding Virpax in 2017, Mack says his team didn’t have the funds to start from scratch with developing a new product. Instead, Mack says he had to “kiss a lot of frogs” in search of a prince.

To find promising candidates, Mack studied research posted at industry trade shows, met with new product developers, and over time, found two of the first three products for Virpax’s pipeline. The pipeline includes a topical spray, an intranasal spray for pain and a hydrogel — all aimed at treating different types of pain.

Leverage grants: After licensing the first three assets between 2018-2019, Mack says the company scored an in-kind grant from the National Center for Advancing Translational Sciences (NCATS), a division of the National Institutes of Health. The grant has supported preclinical development of Envelta, Virpax’s intranasal spray for acute and chronic pain, including cancer pain.

The financial backing has helped move Envelta more quickly toward an IND filing, which Mack says the company expects to make near the beginning of 2023.

“We have a team of folks who help us to look for the grants,” Mack says. “As a new company, this has helped us because this kind of development is a very expensive proposition.”

Reimagine existing products to tap accelerated clinical pathways: For Virpax’s Probudur, a hydrogel for post-operative pain, and Epoladerm, a topical spray film targeting pain associated with osteoarthritis of the knee, the company will be able to leverage accelerated regulatory pathways because the medications have already been approved in other formulations.

“As a result of our pre-IND review, the FDA has indicated that it is reasonable for Virpax to pursue an accelerated 505(b)(2) NDA for Epoladerm and Probudur,” Mack explains. “The 505(b)(2) regulatory pathway is a type of NDA submission that encourages further innovation of drugs that have already received approval from the FDA. This pathway allows for faster approval times as it can avoid unnecessary duplication of studies that were already performed on approved drugs.”

To pursue the accelerated pathway, Mack says the company had to demonstrate that its products improved drug delivery. Now, the pathway has allowed the company to skip some of the clinical study steps because they can use existing clinical data.

For example, Mack explains, once Epoladerm enters into human trials, Virpax might be able to skip from a successful phase 1 study to a phase 3 before it files an NDA. With Probudur, Virpax might be able to bypass a phase 1 study altogether and start with a phase 2.

“For a company that wants to go commercial, this is a good option — but it has to show it has a product that is better than what exists on the market,” Mack says. “We have been able to show that, and that we fulfill an unmet need.”

Try to kill your darlings: Before Virpax proceeds with investing in any new product, Mack says he brings his team together and they first try to kill it. To get a well-rounded assessment, Mack’s team includes input from regulatory, medical, drug development, marketing and market access experts.

“We make these products pass a lot of tests,” he explains. “Basically, we ask: ‘Is this a viable commercial product?’”

Because Virpax is not currently developing medications with traditional modalities — such as oral solid dose — the company takes a close look at the cost of materials needed for production and the manufacturing landscape for  finished products. In addition, Virpax’s team studies the payer landscape to determine if insurance providers will cover the product. And of course, they weigh the odds of approval.

“The last person we have look at the products is Dr. Eric Floyd [chairman of Virpax’s Science and Technology Committee and a member of its board],” Mack says. “He has 30-35 approvals under his belt and an extensive background with the pain division of the FDA. So, he knows how to package products and get them approved. He’s the last person who looks at a product before we submit it to the FDA.”

Have a timely angle: When it comes to getting the final approval, Mack says it helps to have a product with key advantages over other options on the market.

With the company’s hydrogel that targets post-operative pain management, Virpax showed the FDA animal-study data suggesting that it works for a longer duration than the product it would compete with on the market — that improvement could help speed its eventual approval.

“We met with the FDA and presented these data, and the agency said if we are able to reduce the amount of opioid needed by patients in the first 72 hours after a surgery, considering successful phase 3 trials, Probudur may receive an opioid-sparing label,” Mack says. “This is the kind of asset the agency wants to bring to the market.”

Virpax will take a similar approach with one of its newer products called VRP324, an intranasal spray for pharmaceutical-grade cannabidiol (CBD), which is being developed to treat epilepsy.

In 2018, GW Pharmaceuticals, which was purchased by Jazz Pharmaceuticals in 2021, scored the first-ever FDA approval for a CBD-based drug for the management of rare epilepsy in children. Mack says Virpax's intranasal nose-to-brain delivery will have several advantages over GW’s oral-based drug.

“The oral formulation gets metabolized in the liver and may cause drug-to-drug interactions,” he says. “We avoid this first pass effect … and deliver the cannabidiol directly to the brain. Our formulation will use significantly less cannabidiol dosing…so we can reduce the amount of active ingredient that it takes to get to the same therapeutic benefit of the approved oral formulation required to manage seizures.”

Although sprays and gels have been around years in pharma, Mack says Virpax’s patented formulations are showing how they can be used to develop a next-generation approach to existing medications.

“I think pharma is going to focus on targeted drug delivery in the future,” he says. “The most unique thing about drug delivery platforms is their ability to target pain and CNS disorders at the source, making them competitive options if approved. Our preclinical studies are showing proprietary drug delivery can provide a significantly better option than what’s on the market today.”