The energy felt every year at the annual J.P. Morgan Healthcare Conference is palpable — and the buzz is likely to be amped higher this year as the industry reconvenes on location in San Francisco for the first time since the pandemic. News will be made. Deals will be inked. Money will be invested in the companies that have strong stories — and data — to share.
Neurological disease is one of the therapeutic areas expected to play an important role in 2023, said Dr. Marcelo Bigal, CEO of Ventus Therapeutics, a biopharma using computational chemistry to develop small molecule therapeutics.
“As disease biology becomes clearer, surrogate endpoints more readily accepted by regulators, precision approaches more viable, and an increasing universe of relevant disease targets accessible by small molecules, there will likely be more investment in therapies for neurological diseases,” he said. “In addition, we predict NASH will be of focus for both strategics and investors given the recent clinical success from Madrigal and the clear unmet need for this patient population.”
Last year at JPM, we conducted several virtual interviews with biopharma execs as part of our conference coverage. One of the questions we asked was: “What’s hot?” Now, we’ve tapped a few of these thought leaders again to see if their trending predictions played out and what they’re tracking for the coming year.
Small molecules getting buzz
When we checked in with PharmaVoice 100 honoree Raymond Stevens, CEO of Structure Therapeutics (formerly ShouTi), he predicted that a major trend for 2022 would be the re-emergence of orally available small molecule drugs, something he expects to continue in 2023.
“Accessibility to medicines remains a problem in global healthcare, including in the United States,” he said. “This is a problem that is not going away anytime soon, and we need to parallel track policy and technology solutions that includes cost, stability and administration route.”
As Stevens and his colleagues head to San Francisco, he also believes access to capital remains key.
“Strong and unique companies with solid business plans will do well in this market. Access to capital to power the discovery of new medicines, capital is a requirement,” he said.
Déborah Heintze, co-founder and chief medical officer of Lunaphore, noted last year that one of the trends for 2022 would be a focus on spatial biology and a move toward translational clinical research, which she expects to address advanced clinical trials and diagnostics beyond 2023.
“We have seen an encouraging and growing body of evidence to suggest that the prevalence of spatial biology will continue to expand, moving this revolutionary field and the insights it provides into clinical use, where it can benefit patients’ lives in the future,” she said. “We believe that, from discovery to translational research, from an academic lab to a core facility or in a pharmaceutical or CRO setting, the versatility of spatial biology is unmatched. Existing automated solutions can answer a wide variety of biological questions with more insights, and we think that any area of research in which tissue is used is a potential application for spatial biology.”
She added that the movement is being driven by spatial biology’s hypothesis-based dimensions as opposed to just confirming assumptions.
“By providing tissue maps at a single-cell level we can identify and characterize biomarkers,” Heintze said. “Such molecular profiles help clinicians specify precise and predictive biomarkers to create individualized treatment plans and pave the way for new areas of drug discovery. By harnessing its full potential, researchers can advance biomarker discovery and, ultimately, develop the next generation of personalized medicine.”
Women’s health makes gains
PharmaVoice 100 honoree Sabrina Martucci Johnson, president and CEO of Daré Bioscience, is riding high on the rising tide of interest around femtech. In August 2022, the company inked a deal with Organon potentially worth $182.5 million for its lead product Xaciato.
Her enthusiasm around the progress being made in women’s reproductive health has become even more robust despite the Supreme Court’s rollback of Roe v. Wade.
“We believe investment in women’s health has been disproportionately impactful and, given the market conditions, investors are looking for disproportionately impactful investment opportunities,” Johnson said. “Approximately 1% of healthcare research is invested in female-specific conditions beyond oncology. Women’s health conditions outside of oncology comprise less than 2% of the current healthcare pipeline. Women’s health products make up 27% of total blockbuster products and contribute to 35% of total blockbuster sales. That’s impressive. Products that have generated meaningful improvements in outcomes, convenience or side effects have seen meaningful commercial adoption.”
She noted that as differentiated product candidates in women’s health continue to advance into late-stage development, the stage is set for near-term value creation.
Like her industry peers, she also expects the market outlook to be top of mind going into JPM this year.
“Global uncertainties, lingering COVID concerns and rising interest rates led many investors to shift to investments with less perceived risk and more predictable outcomes,” she said. “The uncertain capital markets that followed hurt emerging companies and their development plans across the board during 2022. Adding to these complexities, across therapeutic categories there were product launches that failed to meet expectations and several candidates failed in clinical development. So, as we start 2023 everyone is hoping for improvement compared with 2022 in terms of general market outlook.”
The benefits of radiotherapeutics
Late last year, Plus Therapeutics’ ReSPECT-GBM clinical trial for rhenium obisbemeda, a radiotherapeutic being evaluated against recurrent glioblastoma, showed positive safety results along with dose-related outcomes. This news correlates directly to president and CEO Dr. Marc Hedrick’s bullish outlook on the future of radiotherapeutics and their comeback as a viable option to treat rare and difficult cancers.
Going into 2023, Hedrick predicts significant interest in targeted radiopharmaceuticals related to new and innovative delivery methodologies and targets, new emerging isotopes, expansion of manufacturing infrastructure and new data showing safety and efficacy for unmet medical needs.
As for 2023, Hedrick anticipates speculation around the reversal of a challenging macroeconomic picture.
“The greater macroenvironment is currently a drag on corporate financing, balance sheets and growth plans, so many investors and industry players alike will be closely following in anticipation of a potential positive shift,” he said.