🔒Valisure capitalizes on growing demand for drug quality checks

You've seen the headlines. The debate over transparency issues in health care and drug manufacturing isn't going away anytime soon.

However, where many see challenges, the leaders at New Haven-based analytical pharmacy Valisure see opportunities to help make impactful changes to established paradigms.

"I think there is minimal incentive for making a quality product these days, unfortunately, especially with generic drugs, as long as the factories approve them, they are all considered the same, and that's obviously not true," said David Light, co-founder and CEO of Valisure, which has been capturing headlines by discovering hazardous ingredients in drug and consumer products.

Since launching as a digital pharmacy in New Haven’s Science Park in 2018, Valisure has grown to a 20-person team and raised more than $10 million in funding — primarily from local investors like Greenwich-based Realist Ventures.

Now, the company has its sights on expanding its reach in the healthcare sector, collaborating with major pharmaceutical and healthcare companies to help verify and certify that medications heading out to consumers are safe to use.

Starting out

The origin of Valisure is grounded in a frightening experience that one of Light's longtime friends and co-founder, Adam Clark-Joseph, had with seizure medication.

"He realized that every once in a while, he'd have a refill of his meds and would feel terrible that month with bad side effects," Light said, adding that Clark-Joseph confided in him after lackluster responses from his doctors.

At the time, Light, whose background is in biotech tool development, worked at Guilford-based DNA sequencing system developer Ion Torrent.

"We put our heads together and started realizing how deep the problems go and how complicated the issues are, but the overall solutions were pretty straightforward," Light said.

Along with fellow co-founders Robert Cunningham and Wolfgang Hinz, the duo opened Valisure's laboratory in 2015. Years later, the startup launched commercially, attaching itself to a pharmacy where they verified the quality of each batch of medicine they dispensed.

It’s been full steam ahead for the company since then, according to Light, who indicated that he and his team have stayed especially busy in recent years, spearheading research that led to recalls of batches of Zantac and Metformin.

He declined to disclose the company’s annual revenues, but it makes money through its drug product certification and data index subscription services.

Most recently, Valisure made national news in May with its release of a report finding benzene in 78 different sunscreens and after-sun products. The highest levels of the industrial chemical were found in Neutrogena spray sunscreens, with some batches containing up to three times the Food and Drug Administration concentration limit for benzene.

"This is a compound that has been banned in the industry for decades," Light said. "The last time there was ever a recall for benzene was in 1990 when Perrier water had parts per billion of benzene found in it. We were finding it now at many parts per million."

Emerging popularity

Valisure's work in drug quality assurance has gained praise from pharmaceutical experts and educators, who commend the company's contribution to a growing demand for independent testing.

"It's important to know that there are options for those who are willing to invest the time and effort into a second validation of what they are providing their patients," said Arash Dabrstani, dean of pharmacy at Long Island University. "That's the niche that Valisure has been able to fill within the drug quality sector."

A growing focus and prioritization of drug quality among healthcare stakeholders has also created a wellspring of opportunities for Valisure to partner with different drug manufacturers and healthcare entities.

Cabinet Health, a New York-based over-the-counter medicine and health essentials company, focused on environmental sustainability, is among the collaborating companies.

Cabinet contracts Valisure to test its products for carcinogens, toxic metals and allergens.

"Given our intimate connection with the world of [over-the-counter] manufacturing, we learned about Valisure when their research sparked the recall of Zantac," said Achel Patel, co-founder and CEO of Cabinet.

According to Patel, Valisure's analytical testing acts as a second set of eyes for Cabinet Health’s supply chain.

"It's helpful to build another layer of testing into products before customers receive them," he said.

Valisure has also teamed up with companies like Gojo — the manufacturers of Purell — and Medley Pharmacy, where Light said they help provide "Valisure certified" products to the New York-based digital pharmacy's national network of consumers.

"As a company, we've really focused on working with the healthcare ecosystem, and we are even working with large healthcare systems that are now requiring independent certification before they buy certain generic drug products, and we see this growing dramatically by working with these kinds of large partners," Light said.