06Jun

Before the discovery of antibiotics, tuberculosis was the second most common cause of death in the US. Today, thanks to antibiotics, the few who contract the disease rarely die.

But as TB and other once-easily cured diseases grow increasingly antibiotic resistant, the very real fear is that medicine may run out of treatment options, leading to epidemics dwarfing COVID-19.

To head-off that kind of future, two dozen pharmaceutical firms have invested nearly $1 billion creating the AMR Action Fund with the goal of developing 2-4 new antibiotics by 2030.

AMR – antimicrobial resistance – arises when infectious disease pathogens become resistant to existing medicines. Tuberculosis is one of them, as are several others including the much publicized MRSA.

“AMR has the potential to render diseases that are relatively easy to treat today virtually incurable,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

“Left unchecked, AMR could significantly eclipse the global health challenge that the world is facing currently with COVID-19,” he said in a statement announcing the launch of the AMR Action Fund.

The initial funding pledges from the bioscience and drug firms – including $100 million pledged each by Johnson & Johnson and Pfizer – will be supplemented by non-industry partners, the Fund says on its website.

Explaining that “drug resistant bacteria are developing faster than new antibiotics can reach the market,” the Fund says there are few antibiotics in clinical development to meet current and anticipated needs. The reason is that the market for antibiotics “doesn’t support the level of investment needed to maintain a robust antibiotic pipeline.”

The website goes on to explain that smaller biotech firms have trouble financing trials of the antibiotics they do develop. Some that have developed new antibiotics “have declared bankruptcy or exited this space,” cautions the Fund, “Due to the lack of commercial sustainability, resulting in the loss of valuable expertise and resources.”

To achieve its goal of bringing to market the new antibiotics in a decade, the Fund said it “will invest in smaller biotech companies focused on developing new antibiotics that address the highest priority public health needs.”

Specifically, the AMR Action Fund will:

  1. “Invest based on the WHO/CDC priority lists of pathogens, with the goal to address major unmet needs and maximize public health impact.
  2. “Prioritize novel antibacterial treatments, as recognized by leading public health agencies, with significant and differentiated clinical utility and that reduces patient mortality.
  3. “Invest across all stages of clinical development.”

[bdp_post_carousel]

Jun 6, 2023

COVID Has Forever Changed How Vaccines Are Developed

The vaccine rollout may be progressing too slowly, but that there’s a vaccine so soon at all is a tribute to the single-focus of scientists and the biotech industry.

The way the Pfizer and Moderna vaccines were developed “are revolutionary,” says Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization.

In a wide-ranging interview with Steve Forbes and published on Forbes online, she said, “The platforms that have shown success — for example, the MRNA platform that has been used in both the Pfizer and Moderna vaccine — are revolutionary in that they will forever change how we think about developing new vaccines.”

Because of what scientists have learned, “When it comes to preventing the next pandemic — when it comes to even preventing the next iteration of Covid, because we know it’s constantly mutating and evolving — we are incredibly prepared.”

The breakdown in getting a vaccine, she says, is not the development. “We have seen that the science is not our barrier; that often it’s the bureaucracy, it’s the miscommunication and misalignment, and it’s the lack of resources.”

McMurry-Heath laments the lack of effective planning for the distribution of the vaccines and the therapeutics that have been shown effective in treating patients. “There’s no excuse for this. This is not rocket science. We’ve done mass vaccination programs before,” she said.

Michelle Mcmurry Heath.jpg

The pandemic and how the nation responded to it have shown us, she says, that, “The things I think we’ve learned that are most impactful don’t even have to do with infectious diseases.”

Looking ahead, she told Forbes, it’s important the “high-touch-and-rapid-response approach” of the Food & Drug Administration continues. Another lesson is “that we need a new approach to clinical trials.”

“We need to look at our national clinical trial networks and ask ourselves, why are they not more easily mobilized for these massive public health concerns? And why is it so hard to get diverse patient populations through them?”

Says McMurry-Heath, “These are critically important questions that we are just starting to ask. But they’ll be very important, not just for infectious diseases, but for every disease out there that’s awaiting a cure.”

Photo by Macau Photo Agency

[bdp_post_carousel]