Klick Health Gathers Biotech And Pharma Luminaries To Discuss Industry Innovations, Investments And Future

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

“I hope society recognizes that the impact that disease can have, measured as it was in the pandemic in the trillions, in terms of economics – and not even able to calculate the loss of life and suffering associated,” Yancopoulos said. “I hope that makes society realize that perhaps shouldn’t we be investing more than $30 million, for example, for NIH funding, but also investing a lot more in this great industry to protect ourselves against these catastrophic losses. I think we’re not doing enough.”

He attributed Regeneron’s speed in developing its early monoclonal antibody treatment REGEN-COV — along with work by Pfizer, Moderna, AstraZeneca and Eli Lilly — building on the companies’ decades of scientific development and investing. With much more needed, he pointed out.

“We have to recognize none of the existing solutions for disease and none of the existing solutions for climate change will save us. We need new solutions,” he said, which will only come from supporting next generations of talent and with investments “at much larger scales than we are today.”

Former BARDA chief Rick Bright also talked about the need to invest and improve not only the current Covid response as it becomes endemic, but also the importance of trust and truth in those efforts. Bright headed BARDA under President Barack Obama, joining in 2016, but was removed and reassigned to a lower level NIH job by the Trump administration in April 2020. Bright subsequently filed a whistleblower complaint and testified before Congress about the government’s chaotic response to the pandemic.

“We hear a lot about the erosion of trust and to be trustworthy we have to be honest,” he said. “… From the outset of this pandemic, we didn’t have a lot of truth, honestly. So we need to make sure we’re not only getting the truth out, but make sure we’re translating the truth to something people can understand. When they see the development of a vaccine or monoclonal antibody therapeutic, as George said they don’t realize that it’s been a decade worth of work. That was skipped over for a political rhetoric to say, ‘Hey, I made a vaccine in a short period of time.’”

Also taking the stage on a panel about personalized medicine was Tal Zaks, the former chief medical officer at Moderna and Spikevax Covid vaccine developer, who is now a partner at OrbiMed.

While the ideas of personalized medicines and mass market vaccines may seem incongruent, Zaks noted that “all medicine has always been personalized. We go to the doctor for treatment for ourselves, not our neighbor.”

In Covid-19 vaccines and treatments, for example, personalization comes into play for immunocompromised people and some cancer patients who don’t respond as well and need specific, different therapies. While costs, benefits and value are familiar topics in personalized medicine discussions, Zaks said the potential size of the patient pool for personalized medicines is less important to him than what they can deliver.

“Rather than look at the rise of personalized medicine as something that pharma went to because they couldn’t make money elsewhere, I take a different view. For me, the reason we’re talking about personalized medicine is because that’s what science has uncovered,” he said. “… The world of science and the world of technology is opening up opportunities for us to understand populations better — even in prevalent diseases. If you talk to pharma today, they’re actually not shying away from cardiovascular disease or neurological disease or diabetes. What they’re bringing to the fore is a much more nuanced way of understanding those populations and an individual’s risk factor.”

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region.

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.