As the biopharma industry continues its global quest for treatments for COVID-19, don’t count the Garden State out. A good number of COVID-19 projects are already underway locally, according to BioNJ CEO and President Debbie Hart.
So, Hart is rooting for the home team.
“I’ve been so proud of this industry’s immediate response to a disease that we didn’t even know existed a few months ago,” she said. “I hope it’ll be a New Jersey company, and it’s very possible it will be. But, of course, we’ll be happy with it wherever it comes from.”
Everyone’s hoping for the silver bullet for COVID-19, but there are some caveats that make it unlikely any one place will be able to call an effective therapy its own. Because, as Hart herself knows, there’s no guarantee there will be a singular silver bullet.
Patrick Smith of the local biopharma support firm Certara said what’s seeming likelier by the day — and what a lot of researchers are now focusing on — is a cocktail approach to treatment for the illness that has now claimed more than 600,000 lives worldwide.
“I think we’ve come to the realization that monotherapy with some of these drugs may not be ideal,” Smith said. “Especially for drugs not developed to treat COVID-19, but instead developed for some other purpose, we’re thinking mostly about combination therapies now.”
Princeton-based Certara is working directly with the Bill & Melinda Gates Foundation on repurposing existing drugs, likely in combination, to fight the illness. The company optimizes the productivity of various research efforts through its modeling and simulation platforms. Ninety percent of drug approvals by the FDA since 2014 have been supported by the firm in some form.
Smith, who serves as senior vice president of integrated drug development strategy at the firm, said no one was quite ready for this massive reprioritization of the life science industry, but he’s impressed with the amount of collaboration that’s now guiding the sector’s research endeavors.
Reynold Panettieri, vice chancellor for translational medicine and science at Rutgers Biomedical and Health Sciences, likened it to “building an airplane as it’s going down a runway, taking off.”
Panettieri, like Smith, believes what will end up being effective in the treatment of COVID-19 is something akin to the “triple therapy” regimen HIV researchers arrived at to “hit the virus at several different points of its life cycle.”
Of course, it might not come across as an encouraging sign that it took well over a decade to come up with the right mix of drugs to sufficiently suppress HIV.
“Partly, that’s because we were naive about the underlying disease process, but we now have the knowledge base,” Panettieri said. “I think we’re all hoping for that one drug that will be a magic bullet for COVID-19, but that might be naive as well.”
A word of caution from those in the industry: The hunger for early updates from researchers and the proliferation of preprint academic papers has led to maybe misplaced excitement about the true potential of individual COVID-19 therapeutics or even drug combinations.
An early offender might have been hydroxychloroquine, although there are still debates surrounding its efficacy in the research community. Other drugs currently being tested in combination therapies today, such as the Gilead Sciences’ antiviral drug Remdesivir, so far appear to be what Smith calls “base hits, not home runs.”
Because there’s such an appetite for fast-tracking the trials of many different drugs, it might take quite a bit longer than some might hope for the medical community’s consensus to get behind one particular treatment plan.
After that still-theoretical horizon in medicine, Panettieri expects there might be a need for biopharma researchers’ approach to the novel coronavirus to take a new angle.
“Understandably, the focus in drug development has been on saving lives,” Panettieri said “But we’ve ignored the asymptomatic person. Not everyone develops (acute respiratory distress syndrome, or ARDS). However, the asymptotic carrier can be infecting other people and others could get ARDS based on that infection. So, to slow replication of the virus, you’ll need to account for those infections, too.”
Restarting ‘regular’ research
Leaders from New Jersey’s research outfits share the same reaction when asked what the long-term impact may be from the pause put on clinical research that wasn’t life-saving.
It lands somewhere between “perhaps science will pick right up where it left off” and … “yikes.”
Reynold Panettieri of Rutgers University’s medical research arm, one of the state’s several public research institutions, speculates that the research hold will have lasting consequences, such as delays for the approval of non-oncology drugs.
His institution and others are now restarting clinical trials in once-shuttered labs, as long as they meet certain criteria laid out by health officials.
“But, with a lot of these studies having been put on hiatus, a certain amount of clinical development on new therapies has been deferred,” he said. “And, as we’re approaching almost half a year of this, that delay may be substantial.”
Carl E. Hock, professor at Rowan University’s Graduate School of Biomedical Sciences and senior associate dean for research, said the impact has been uniform across all of the state’s research institutions, as well as academic research labs across the country.
Even now that institutions such as his have restarted lab activities, Hock said there’s a lot of work entailed in ensuring the equipment and compounds in these spaces are still in working order after not being touched for several months. There’s also had to be an embrace of staggered work schedules and other social distancing arrangements during the repopulation of labs.
“So, I expect there’s going to be some slowdown of research productivity as things restart,” Hock said.