Last week, a Food and Drug Administration (FDA) advisory committee

 a Biologics License Application (BLA) for RBX2660, a treatment for recurrent 

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 13 to 4 in favor of the efficacy of RBX2660 and 12 to 4 in favor of the safety of RBX2660 (with 1 abstention).

, about what the VRBPAC vote means and the promise of RBX2660 therapy for this vulnerable patient population.

 is an investigational microbiota-based live therapy. It combats the dangerous cycle of C diff recurrence by restoring the gut microbiome.

Approximately half a million Americans are diagnosed with CDI each year. Of these patients, Feuerstadt says, 25-35% will have an initial recurrence, 40-50% will have a second recurrence, and up to 60% will have a third recurrence.

Feuerstadt says that the “rudimentary” solution for recurrent CDI is a fecal microbiota transplant (FMT). “RBX2660 is a much more sophisticated approach,” he explained, citing the broader screening approach for both the donor and donor specimen.

The RBX2660 administration takes the form of an enema, Feuerstadt says, and is a pre-packaged single dose of 150 mL microbiota suspension from individual human stool donation.

Feuerstadt describes how tragically easy it is for CDI patients to get trapped in the vicious cycle of recurrence. Not only are recurrences a drain on patient health and hospital resources, but there is psychological damage as well.

“The effect on patients is so profound,” said Feuerstadt. “Believe it or not, there’s a post-traumatic stress disorder that comes with this…We have seen that impact last years into the future.” Patients live in fear of an embarrassing and debilitating recurrence, he said, long after being cured.

“The future is incredibly bright for the treatment of C difficile,” Feuerstadt said, “and that’s something I can’t understate.”

RBX2660 is a biotherapeutic developed by Ferring Pharmaceuticals. Before the positive VRBPAC vote, RBX2660 was granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA.

 is an assistant clinical professor of medicine at the Yale School of Medicine in New Haven, Connecticut, and an attending gastroenterologist at the Physicians Alliance of Connecticut (PACT) gastroenterology center.

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C diff patients live in fear of a recurrence, says gastroenterologist Paul Feuerstadt, MD. RBX2660 has entered the FDA pipeline and looks to end this vicious cycle.

RBX2660 Could Heal Recurrent C Diff Patients, Physically and Psychologically

In a paper written this year, researchers reported that antigens close to SARS CoV-2 proteins which would confer a potential natural immunity were found in greater frequency in tropical areas of Asia and Africa, compared to areas of high incidence rates, like North America and Europe.

In the paper, Jean-Paul Gonzalez, MD, PhD, Department of Microbiology & Immunology, Georgetown University and colleagues hypothesize that tropical areas of Asia and Africa have a natural exposure to coronaviruses and thus have lower transmission rates of COVID-19.

“There is still a huge disparity between the Asia and Africa tropical zone (lower incidence) and northern temperate zones (high incidence). This observation favored the existence of human or environmental factors that would prevent in some place’s transmission and/or clinical manifestations of the infection,” Gonzalez et al wrote. “The hypothesis we retained in our study would be that of a natural exposure, of the population with low COVID19 incidence rate, to antigens close to SARS CoV-2 proteins which would confer a natural potential preventing immunity. The hypothesis we retained in our study would be that of a natural exposure, of the population with low COVID19 incidence rate, to antigens close to SARS CoV-2 proteins which would confer a natural potential preventing immunity.”

Gonzalez et al looked at bats and exposure to them as related to coronaviruses. Specifically, they tested the presence of SARS-CoV-2 antibodies in human samples collected in the Central African region prior to the emergence of SARS-CoV-2.

“Coronaviruses genome encodes four major structural proteins: spike (S); envelope (E); membrane (M); nucleocapsid (N). The spike-shaped transmembrane S plays an essential role for the host immune response. The S structure comprises two functional subunits: the S1, comprising an N-terminal domain (NTD) and a receptor binding domain (RBD), directed to bind to the host cell receptor (Angiotensin-converting enzyme 2, ACE2); and the S2 that allows the fusion of the virus through the cellular membrane. There is a strong correlation between RBD antibodies and the neutralizing antibodies to SARS-CoV-2 in humans,” the authors wrote.

“Among the 1655 tested samples from Central African populations tested 38.1% and 12.4%, [and] of them presented respectively reacting antibodies against 1 or 2 as compared to 9.5% and 0% for the controls. The S1 antigen shows the highest percentage of positives: 19.64% for African samples versus 2.11% for the controls. Globally, all antigens considered, there is a high significant difference (p- value<10-6) with control samples.”




The ongoing challenge is what can be done to mitigate the emergence of zoonotic viruses? Developing countries are where many of the zoonotic viruses emerge, and in these locations people have much more contact with the natural world. As someone who has spent time internationally studying viruses and involved in trying to control and prevent highly pathogenic infectious disease, Gonzalez sees an interconnection between humans, animals and the environment. He has spent a good portion of his career working in low- and middle-income countries (LMIC) performing research projects in life sciences and medicine and focusing on studying diverse and complex pathologies. He has also taught the 

For example, Gonzalez studied Rift Valley Fever (RVF) in sub-Saharan Africa, where the viral disease is most prevalent. In that region, RVF is found in livestock including cattle buffalo, sheep, goats, and camels. People can get RVF through infected mosquito bites or blood, body fluids, or tissues of infected animals.

Typically, RVF is more severe in animals than humans. People will often be asymptomatic or may experience a milder case that might include a fever, weakness, back pain, and dizziness.

Although in an estimated 8-10% of people with RVF they can suffer a severe form of the disease that can include symptoms such as eye disease, hemorrhage with excessive bleeding, and encephalitis.

While in Africa, Gonzalez and colleagues did animal biosurveillance on cattle and other livestock. When they found animals were infected with RVF they took steps to ensure the livestock were isolated from the herd and looked to stop the spread of the virus. 

In terms of solutions, Gonzalez believes improved technologies for biosurveillance, a better understanding of how humans, animals, environment interact, and new vaccines and therapies can help mitigate zoonotic spread. The foundational biosurveillance work Gonzalez was doing back in the 1980s is still applicable today.



 spoke to Gonzalez about climate change and how it might be exacerbating emerging infectious diseases and human health as well as his work in biosurveillance.

1. Rift Valley Fever. Centers for Disease Control and Prevention. Updated February 25, 2020. Accessed September 11, 2022. https://www.cdc.gov/vhf/rvf/index.html

Investigators surmise a natural bat exposure within certain areas of the world may correspond with lower COVID-19 incidence rates.

Can Zoonotic Exposure Predict COVID-19 Prevalence?

 updated their hepatitis C clinical treatment guidance and said they have a global goal of reaching 90% testing and 80% treatment by 2030. Just three years ago only 21% of the 58 million persons with chronic HCV had actually been diagnosed, and 13% treated, according to WHO.

In their discussion, WHO acknowledged they are making inroads with HCV testing and treatment, but are still far below optimal levels. The WHO has made some recommendations to increase both.

And although these statistics seems rather disturbing there are ongoing efforts being made on the aforementioned global level with WHO as well as in the US. The Centers for Disease Control and Prevention (CDC) has also updated its clinical guidance.

CDC has set up its Division of Viral Hepatitis (DVH) 2025 Strategic Plan. Within this plan they set out to achieve four major goals by 2025.

The goals are:

Reduce viral hepatitis-related morbidity and mortality

Reduce viral hepatitis-related disparities

Establish comprehensive national viral hepatitis surveillance for public health action

Michael Houghton, PhD, Li ka Shing professor and holder of the Canada Excellence in Research chair (CERC) in Virology within the Li Ka Shing Institute of Virology at the University of Alberta, is intimately involved in HCV research. He won the Nobel Prize for being a co-discoverer of the virus. For the last several years he and a team of researchers have been working to develop a HCV vaccine. They have created an investigational vaccine that Houghton predicts will go into clinical trials next year. In the first part of our 

 with Houghton he spoke about the work in discovering the virus and their subsequent vaccine.

Houghton has been working on the science portion of it, but sees the value of public education as being an equal part of helping to reduce HCV. “…We can educate people, especially young people, about the risks to their livers from intravenous drug use, sharing needles and syringes—that’s a huge risk factor for hep C and HIV,” Houghton explained.

Houghton is a board member for the Liver Health Initiative (LHI). This organization is a national nonprofit organization dedicated to promoting liver health education and disease prevention. Houghton along with the LHI are working together in trying to bring the science and the education along.

In this second installment of the interview, Houghton talks about how these aforementioned goals can be worked on as well as the use of antivirals in patients who get reinfected with a different strain of HCV.

WHO and CDC have laid out some ambitious goals for the treatment of hepatitis C, and HCV co-discoverer and vaccine developer Michael Houghton, PhD, offers some insights and commentary on whether he feels it is realistic to consider the eradication of this stubborn and subtle virus.



Can We Eliminate Hepatitis C?


For scientists trying to identify viruses, it can be a long and laborious process. It took Michael Houghton, PhD, and his fellow researchers over 7 years to discover the hepatitis C virus. Houghton says you typically need to have a “critical observation” in order to discover infectious pathogens like they did for both HBV and HIV.

“Once you can observe a protein, a virus, or a cell culture system associated with the pathogen, that gives you the molecular tool to lead to a full characterization of the virus,” Houghton said.

However, for Houghton and his colleagues they ended up not finding success going those routes and instead used a novel proteomics approach to discover HCV. The cloning process proved challenging, and during this time in the 1980s, proteomics was very early in the field, and Houghton used recombinant bacteria to clone everything and “taking the calculated gamble that there would be antibodies circulating. When you put the two together you get a lot of positives and have to sift through those positives to find one that you can convince yourselves is from hepatitis C.”

The arduous process was worth it as Houghton who is Li ka Shing professor and holder of the Canada Excellence in Research chair (CERC) in Virology within the Li Ka Shing Institute of Virology at the University of Alberta, codiscovered the hepatitis C virus along with Qui-Lim Choo, PhD, George Kuo, PhD, and Daniel W. Bradley, PhD. For the HCV discovery, Houghton was awarded the 2020 Nobel Prize in Physiology or Medicine and shared the honor with Harvey J. Alter, MD, and Charles M. Rice, PhD. 

Along with the HCV discovery, Houghton and co-investigators performed studies that identified hepatitis C antibodies in the blood, which led to the development of subsequent blood tests for the virus, identified new drug targets and were also able to link HCV to liver cancer.



Vaccine Development: An Equally Difficult Path to Discovery


More recently, Houghton and a team of scientists developed a HCV vaccine which will be going into clinical trials in 2023.

The path from virus discovery to vaccine development was not any easier. For the vaccine, he encountered a number of issues including the lack of animal models, the challenge of growing cell cultures, and limited interest from biopharmaceutical companies on developing it.

Despite these challenges and shortcomings, Houghton and colleagues pushed on. After more than 10 years, he and his team at the University of Alberta developed what he calls a second generation vaccine. “We know it can elicit cross-neutralizing antibodies across most of the strains seen around the world…And then we have also dialed in cellular immune responses rather like the COVID-19 vaccines that do both—antibodies and cellular T-cell responses.” The last thing he points out is that they did some earlier vaccine studies in chimpanzees years ago which showed animal efficacy, and that no other HCV investigational vaccine has done testing in animal models.




“There is a collective consensus we need to speed up the clinical development of hepatitis c vaccines,” Houghton explained. As such, they have developed a plan to perform a human challenge trial assuming they are able to get through phase 1 trials. They are speaking with regulatory agencies around the world including Health Canada and the FDA and discussing the potential human challenge trial.

“If we show a vaccine candidate is safe in a phase 1 clinical trial, and it induces the kinds of responses we are looking for—cross neutralizing antibodies against most of the world’s strains, cellular immune responses to most of the strains—then what we would like to do to accelerate clinical development and delivery to the people that need this, we want to vaccinate volunteers and challenge them with the virus itself,” Houghton explained. “In the event those people become infected we can treat them with antivirals and cure them.”

Houghton is optimistic about the chances of their investigational vaccine getting approved. “I’m very encouraged that we can make a vaccine to the Hep C virus.”

In part one of a two-part interview with 

, Houghton discusses how they went about discovering the hepatitis C virus, the development of their vaccine, and the possibility of a human challenge trial and the potential timeline for it.



For those who are interested, the second part of the interview can be viewed 

Nobel Prize Laureate Michael Houghton, PhD, discusses the arduous journey to find the virus and a subsequent investigational vaccine designed to prevent hepatitis C (HCV).

Finding the Path Forward: HCV Co-Discoverer Has Developed Investigational Vaccine


This year marks the 10 year anniversary since the FDA approved emtricitabine-tenofovir (Truvada) for 

 thus sparking the beginning of a daily pill designed to prevent new HIV infections. This was seen as a breakthrough for trying to stem the tide of new infections.

PrEP continues to be a highly efficacious treatment strategy in HIV prevention. According to the Centers for Disease Control and Prevention (CDC), PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed.

“All of us who have been doing this for so long were able to exhale a little bit as a way to get ahead of this pandemic, because we have not gotten far enough with the vaccine,” Emily Rymland, DNP FNP-C, AAHIVS-certified HIV specialist and director of Clinical Services at 

, said of the introduction of PrEP. “This is our alternative to a vaccine, which has been super exciting and wonderful.”

Along with the intended HIV prophylaxis element, PrEP may offer other peripheral benefits. The results from 

 showed that rates of bacterial sexually transmissible infections stabilized among gay and bisexual men in Australia who received PrEP. The incidence of chlamydia fell from 48.7 cases per 100 person-years in July-December, 2016, to 42 cases per 100 person-years in July-December, 2019. Incidence of gonorrhea fell from 45.5 to 37.2 cases per 100 person-years.

In the ensuing years since PrEP’s approval, it has seen an increase in the number of prescriptions but it still remains underutilized. In the United States, there is a regional component to whether people are taking it. Rymland says there is a large issue in the south. “In southern states especially in Georgia…in Atlanta [HIV transmission rates] are huge, but no one has every spoken to them [patients] about it,” Rymland said.

The southern US continues to lead the country in transmission rates and is the lowest in PrEP utilization. According to 

, the south accounted for more than half of all new HIV diagnoses in the US in the 2016 yet only 30% of all PrEP users in the country. AIDSVu also reported the statistics of PrEP usage throughout the US. The northeast has 47.4 PrEP users per 100,000 population; the west has 28.1 PrEP users per 100,000 population; the midwest has 23.5 PrEP users per 100,000 population; and the south has 22.6 PrEP users per 100,000 population.

As outliers, both Texas and Florida are included in the top five states using PrEP. Collectively, those five states accounted for nearly 50% of all PrEP users in the country.

As an HIV specialist, Rymland is on the frontlines often telling young people under the age of 25 that they are HIV-positive. Rymland sees a big part of the underutilization problem as a lack of communication between primary care providers and patients. “They don’t feel that sexual health is part of their primary care…We [need to] change that dynamic with health care providers really jumping in and saying, ‘you don’t have to tell me what types of sex you are having, if you feel you need PrEP, I’m going to give it to you.’”

Another issue she sees is general awareness about PrEP. She says men who have sex with men (MSM) have a tendency to know about PrEP, but many others do not. Rymland sees the underutilization challenges in layers with multiple components to it. These issues include the aforementioned lack of education and awareness about PrEP, as well as accessibility to it, and insurance and financial shortcomings.



 spoke to Rymland about PrEP’s anniversary and the utilization challenges that remain.

Taking into account the first PrEP pill was FDA approved in 2012, a clinician reflects on its significance and where the shortcomings of education and utility of it needs to be fortified.

PrEP at 10: Prescriptions Have Increased but Underutilization Remains a Challenge

For the uninitiated, gene (genome) editing “is the process of modify genes of living organisms to improve our understanding of gene function and develop ways to use it to treat genetic or acquired diseases.”

Currently, gene editing therapies are being studied for a whole host of diseases and chronic conditions including cancer, diabetes, AIDS, hemophilia, and others. This type of therapy has not been FDA approved yet for any diseases, but for all involved or understand the technology, there is a great deal of promise.

Looking at chronic conditions, people are often being treated with multiple therapies and have to deal with side effects and other quality of life issues that could lead to more severe health issues because of the nature of living with such conditions over many years. For example, chronic hepatitis B can require indefinite treatment, and some people do have medication side effects, or in severe cases, the condition can lead to liver issues.

Some in the medical industry believe chronic HBV would be an ideal target for gene editing therapies.

“A number of genetic conditions or even infectious diseases like hepatitis B [have] the root cause within your DNA,” Cassandra Gorsuch, PhD, head of Gene Therapy Discovery, Precision BioSciences, said. "And most of our treatment options across the board treat symptoms of diseases but not the actual causes of diseases. The idea of gene editing approach is to use different types of technologies to permanently alter the DNA sequence, which is the underlying cause of disease.”



The Precision BioSciences gene editing candidate, PBGENE-HBV.

Gorsuch’s company is a clinical stage biotechnology company that has created its novel and proprietary genome editing platform, ARCUS. This platform is being developed for use in DNA genome insertion, deletion, and repair. Specifically, their PBGENE-HBV product gene editing candidate uses a lipid nanoparticle (LNP) delivery of ARCUS mRNA. 



Data from Precision’s preclinical study demonstrated ARCUS targeted and degraded HBV covalently closed circular (cccDNA) by 85% and reduced expression of HBV’s Surface Antigen (HBsAg) by 77% in HBV-infected primary human hepatocytes (PHH). The cccDNA plays a central role in chronic HBV. 

Similar levels of editing were achieved in novel mouse and NHP models following its LNP delivery resulting in a 96% reduction in HBsAg.

Although this is early in the development process, the company plans to move forward with PBGENE-HBV, and they will file for an FDA investigational new drug application in 2024.

Gorsuch spoke to 

 about this gene editing candidate, how their platform differs from other technologies such as CRISPR/Cas9, and the company’s hopes for its potential place in the market for HBV treatment.




1. Gene Editing – Digital Media Kit. National Institutes of Health. Updated November 5, 2020. Accessed August 29, 2022. 

https://www.nih.gov/news-events/gene-editing-digital-press-kit 

A biotech company is utilizing this platform to rid people of the virus using a technology that differs from CRISPR-Cas9. 

Applying a Novel Gene Editing Therapy for Chronic Hepatitis B Treatment

), preventative medication that can reduce the risk of contracting HIV by over 99%, is the single greatest reducer of HIV infection.

Now, a decade past the initial approval of PrEP in 2012, Emory University professor Dr. Patrick Sullivan is studying whether the populations most at risk of HIV infection are utilizing PrEP.

 conducted by AIDSVu and presented this week at the 24th International AIDS Conference (

), Sullivan and his team found gaping, systemic PrEP usage disparities in the US.

Sullivan originally came into the medical field as a veterinarian, but after completing an outbreak investigation training through the Centers for Disease Control and Prevention (CDC), Sullivan found he “liked the problem-solving aspect of public health epidemiology.”

For the past 20 years, he has been invested in HIV prevention research, specifically focusing on HIV infection inequities.

When it comes to PrEP, Sullivan says, “We’re really making sure that there’s adequate access and use, and that’s high in the populations where risk is high.”

PrEP use has grown exponentially, but Sullivan and his team found statistically significant disparities between the populations most at risk for HIV infection and the populations taking PrEP.

“Black Americans represented 42% of all new HIV diagnoses,” Sullivan said, but only 14% of PrEP users are Black Americans. Similarly, Hispanic Americans made up 27% of new HIV diagnoses but only 17% of PrEP users.

In addition to calculating what they termed the “PrEP-to-need ratio” by race and ethnicity, Sullivan and his team determined PrEP uptake by US region as well. They found that equitable PrEP use was highest in the US Northeast, and lowest in the South.

Sullivan emphasizes one “stark” finding was, “As PrEP use has increased, year over year, which is what we wanna see, we also see the inequity increasing.”

“Meaning,” he explained, “the increases that happen year over year are mostly happening in White Americans, and we know that the epidemic and new diagnoses are mostly made up of Black and Brown people.”

video interview with Dr. Sullivan to hear him break down these HIV PrEP disparities, why they persist, and what must be done to end them.

Expanding Medicaid and reducing stigma can bolster equitable HIV PrEP access, Dr. Patrick Sullivan says.

10 Years After HIV PrEP Approval, Uptake Lowest Among Highest Risk Groups

The term food desert is a way to describe areas in the inner cities and low-income communities where there is limited access to affordable or nutritious foods. Instead of having nearby supermarkets, these areas are often served by fast food restaurants and small corner stores. These “deserts” leave people without easy access to fresh produce and healthy foods options.

These same areas are often underserved by limited health care options as well, according to a study published in the 

Journal of the American Pharmacists Association

. The study’s investigators found that in communities with a poverty rate of at least 30 percent, the number of pharmacies was 15 percent higher than the number of physician offices.

With a dwindling number of physician practices, this can limit access to care and necessary health services such as vaccines.

“I think the data is unequivocal; lower income patients have poorer health care experiences at all aspects including access and quality of care,” Robert Popovian, PharmD, MS, chief science policy officer at the 

, senior health policy fellow at the Progressive Policy Institute, and visiting health policy fellow at the Pioneer Institute, said. ”Regarding immunization, the majority of the studies demonstrate a strong correlation between higher income levels and higher immunizations. We also know that minorities are over representing low-income communities.” 

Although these inequities exist, the silver lining may come in the form of the pharmacies and pharmacists who are serving these communities.

For their study, Popovian and his fellow study investigators assessed the number of hours of pharmacies vs physician practices and the ability to offer vaccines for seniors on Medicare Part D. They found the former offered greater hours to provide vaccines. “Pharmacies can play an invaluable role in expanding immunization access.”

Still, Popovian acknowledges the need for physician services within these communities and points to the example of a local hybrid pharmacy and health center in one low-income neighborhood in Southern Los Angeles, which was built by the University of Southern California.

 spoke to Popovian who offered insights into his study, discussed incentives to reduce inequities, and how the hybrid pharmacy and health center serves as an example of overcoming these inequities.

A new study finds there are more pharmacies than physician practices in these areas; however, these inequities offer an opportunity for pharmacists to step-in and provide vaccine education and administration.  

In Low-Income Communities, Pharmacists Can Play a Critical Role in Vaccine Access


Some people with COVID-19 taking Paxlovid (nirmatrelvir/ritonavir, NM/R) have been experiencing a “rebound” of symptoms and testing positive for COVID-19 after a regimen of the antiviral. President Joe Biden was recently diagnosed with COVID-19, was treated with Paxlovid, and had the “Paxlovid rebound” phenomenon. He has had to quarantine for a few extra days until symptoms subside and he tests negative.

Davey Smith, MD, MAS, head, Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, and a team of investigators studied Paxlovid in a small study published in 

 looking at the Paxlovid rebound and if resistance was taking place.

“This study found that neither development of NM resistance or absence of neutralizing antibody were likely causes of the recrudescence,” the investigators wrote in their study.

Although they were not able to measure treatment levels and T cell responses, Smith et al felt the most likely possibility for the observed recrudescence was insufficient drug exposure.

In thinking about strategies to avoid the recrudescence, one potential idea has been to consider changing the dosing schedule from 5 to 10 days.

“I think we should do studies on that particular option,” Smith stated. “The original study was great. It showed for 5 days of Paxlovid, it prevented people from having to go to the hospital or dying by over 80%. That was amazing compared to those who got placebo. So we know that 5 days works to do what we want it to do in terms of decreasing disease severity.”

He also points out that in that study people did rebound but it "did not greatly increase the need for hospitalization or having people die.”

He says studies looking at a 10 day regimen are important to identify the benefits and risks. Smith is candid in saying they are not sure why this phenomenon is happening, but believes the clinical benefits far outweigh the potential recrudescence.

“Nobody should be scared of a Paxlovid rebound for prescribing this medication," Smith said.



spoke to Smith about his study, the efficacy of Paxlovid, and why clinicians should consider prescribing the antiviral.

The benefits outweigh the possible rebound of symptoms, according to an investigator who studied the antiviral. 



Infectious Disease Virologist: “Nobody Should be Scared of Paxlovid Rebound”


Antimicrobial resistance (AMR) remains a paramount concern within medicine. In fact, in an analysis published in 

 back in January, investigators estimated that antimicrobial resistance was the leading cause of death worldwide in 2019. Investigators estimated that resistance itself caused 1.27 million deaths that same year, and that antimicrobial-resistant infections played a role in 4.95 million deaths.

One strategy in trying to stay ahead of AMR is to develop new and novel antibiotics. Part of the existing challenge here has been that the larger pharmaceutical companies have exited this space and the development of these life-saving therapies. It has become the domain of much smaller companies. Developing antibiotics is an expensive, lengthy process, and it remains very difficult to get these medicines to market. This can put financial stress on these smaller companies who may have limited or no revenue from other medicines in their portfolio.

“Over 80% of R&D in this area is being conducted by small biotechs,” Emily Wheeler, director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO) said. “Overall we have seen a very small and waning investment in this critical sector, which is really concerning given the growing threat of resistant infections.”

One way to address these financial inequities is to offer incentives through the federal government. As such, there are organizations and campaigns aiding in trying to get legislative policies passed in Congress to help pharmaceutical companies to incentivize them to complete making antibiotics.

For example, the Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act, is a bipartisan, bicameral piece of legislation aimed to incentivize innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability when needed.

In addition to her work at BIO, Wheeler is also the director of the 

 coalition. According to its website, Working to Fight AMR, “seeks to combat this public health crisis by stimulating the production of new antimicrobial medicines.” 

 spoke to Wheeler who provided an overview of Working to Fight AMR, the challenges of the existing market, an explanation of push incentives, and some of the prospective legislation in Congress.

Working to Fight AMR is working in Washington DC to help pass policies in Congress to help alleviate this significant issue. 

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