Negotiating ‘The New Normal’
By Randy B. Hecht
April 2023
No entrepreneur entered 2022 expecting to breeze through the year. At the same time, no one could have foreseen the impact that the war in Ukraine, supply chain disruptions and skyrocketing inflation would have on business. However, three CEOs working in the therapeutics sector found ways to continue their research and build organizationally as they moved toward bringing new therapeutics to the market.
“It hasn’t been dull. I can say that,” Crystal Nyitray acknowledges. Her company, Encellin, has developed a nanotechnology-driven means of creating living medicines that delivers treatment precisely where and when it is needed. Last year, the company received regulatory approval to conduct its first clinical trials on humans.
“First in human approval is a significant milestone. And we are proud of both the quality and quantity of work that had to be done to accomplish that milestone and continue moving forward in an appropriate fashion,” Crystal says.
Jonah Sinick is another CEO pursuing the twin goals of achieving a medical breakthrough and gaining regulatory approval. His company, Equator Therapeutics, is researching a means of reversing metabolic disorders associated with obesity by unlocking natural heat production mechanisms through mitochondrial proteins. The company has worked on a series of chemical compounds that have been found to increase metabolic rates in rats and is focused on further validation of efficacy and safety.
“We’re in the stage of medicinal chemistry optimization — modifying the molecules to make them more suitable for use in humans,” Jonah says. “Among other things, we are in the process of achieving a slow and steady effect over time, which is what you want for optimal safety.”
Gen1E Lifesciences is developing novel therapies for inflammatory diseases for which there is no current treatment, such as Acute Respiratory Distress Syndrome, an inflammatory lung disease associated with COVID-19, smoke inhalation, influenza and vaping that has a 40 percent mortality rate.
Gen1E Lifesciences has harnessed artificial intelligence and machine learning to accelerate the process of creating next-generation immunomodulators.
CEO Dr. Ritu Lal has harnessed artificial intelligence and machine learning to accelerate the development of next-generation first-in-class immunomodulators. With the addition of Dr. Sham Dholakia as Chief Medical Officer, the company augments its immunology expertise and adds “a very strong foundation on the clinical side,” Ritu says. “Our goal is to file two additional INDs [Investigational New Drug applications] in the next 12 months. Having Sham on board helps us scale even faster.”
All three companies say they were tested by the economic uncertainties of 2022. After two years of supply chain issues, “all the hiccups had become our new normal,” says Crystal. “But market instability was quite jarring for us to experience. When people are waiting it out to see what happens, everything seems to move slower. And for Encellin, we weren’t waiting. We had our objectives. We wanted to get into the clinic, and we needed to get clinical approval. And with that laser focus we kept moving.”
“Market instability was quite jarring. When people are waiting it out to see what happens, everything seems to move slower.”
In 2022, Equator Therapeutics experienced supply chain-related delays related to setting up new lab equipment. “There were various parts that we needed in order to assemble certain equipment,” Jonah says. “Since then, we’ve assembled the equipment, and we’re planning ahead and obtaining goods in advance.”
Gaining maturity in the area of planning has been a priority at Gen1E Lifesciences, as well. Ritu decided to anticipate future disruptions in “the shortage economy” by hiring a systems engineer to track the company’s supply chain around the clock. “We’re using a tech approach to drive hyperefficiency,” she says. “Speed is one of the biggest differentiators for any startup. We have added a more methodical angle to the whole thing.”