Antibiotic Biotech Execs Share Their Concerns
Antibiotics | The Perfect Storm
by David Shlaes
1y ago
 Since the vast majority of products in the antibiotic pipeline, from early discovery through late-stage clinical development, comes from biotech, According to the 2021 WHO analysis, 84% of pre-clinical antibacterial projects come from companies with under 50 employees. 79% of clinical stage (phase I and beyond) come from biotech. Given these observations, I thought it would be worth exploring the health of antibiotic biotech in today's depressing environment. Originally, one of the questions I wanted to explore was the effect of rising interest rates on their ability to raise funds. To d ..read more
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The Fate of Another Antibiotic Biotech - Nabriva
Antibiotics | The Perfect Storm
by David Shlaes
1y ago
 Last week, a small, publicly held antibiotic biotech, Nabriva, announced that they would wind down their operations. Everyone still there lost their jobs. This occurred just a few years after getting approval for Lefamulin, an antibiotic available both orally and by injection that was active against MRSA and, mostly, shared no cross resistance with other antibiotics. Was this the inevitable result of a biotech with another drug that did not meet medical needs, or one that followed a deluded strategy, or is this just another tale of a broken antibiotic market?  Whatever the caus ..read more
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The Grinch Stole PASTEUR
Antibiotics | The Perfect Storm
by David Shlaes
1y ago
 Antibiotic resistant infections are rising.  Deaths from these infections are rising.  The US is no exception. The dwindling antibiotic pipeline is almost uniformly filled with products from small biotechs whose financial status is never secure. The antibiotic market has failed. Most companies that have brought a new antibiotic to the market over the last decade have gone bankrupt. Investors, having lost money in the area, continue their flight. Government and other support for research and development of new antibiotics has increased, but these funds cannot compensat ..read more
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ASM Microbe - Antimicrobial Agents and Resistance
Antibiotics | The Perfect Storm
by David Shlaes
2y ago
 Guest Blogger Krisztina M. Papp-Wallace   Introducing the ASM Microbe 2022 Antimicrobial Agents and Resistance Program   Dear AAR community,   As an AAR track member of the ASM Microbe 2022 program committee, I would like you introduce you to this year's AAR programming of sessions and our speakers from around the world (see Tables below).  We have an amazing meeting planned for you with cutting-edge science and the latest developments in the field. We look forward to seeing you in-person from June 9th-June13th in Washington, D.C.!   Please register today:  ..read more
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To have functioning public health in the US, we must first have national healthcare.
Antibiotics | The Perfect Storm
by David Shlaes
2y ago
  A recent report by the US Government Accountability Office (GAO) highlights risks associated with the response to pandemics at the US Department for Health and Human Services (HHS) (1,2). These critiques go back the through several administrations and include the response to Zika, Ebola, H1N1 flu and others. They mainly involve issues around the national stockpile, strategy for testing and surveillance. While these critiques are clearly valid, I would like to add some perspective from someone (me) who has interacted with the various agencies of HHS over many years.   The ..read more
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Covid - Thank you to industry - Please do the same for AMR.
Antibiotics | The Perfect Storm
by David Shlaes
2y ago
  To all those who are skeptical because they worry that a government sponsored investment in the broken antibiotic marketplace is a give-away to the pharmaceutical industry, I have one word for you – covid!  I would like to begin and end this blog with a big THANK YOU to everyone, in industry and outside industry, who have contributed to providing the tools we need to defeat this covid pandemic! The Pasteur Act, currently before the US congress, will provide an advance payment for critical new antibiotics – a so-called subscription. This will de-link (mostly) sales volume ..read more
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Pull Incentives for AMR - Where is Biden?
Antibiotics | The Perfect Storm
by David Shlaes
2y ago
 This will be a short note . . . We are about to dedicate an entire ASM/ESCMID session to planning for the implementation of forthcoming pull incentives.  We do this because we all agree that without significant pull incentives to address the broken antibiotics market we will all pay a high price later. But where are these pull incentives and will they arrive in time?   We just celebrated (if you say that) Antibiotics Awareness Week around the world.  The White House in the US released a statement that said nothing about pull incentives at all. It ref ..read more
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Pull Incentives at ASM/ESCMID
Antibiotics | The Perfect Storm
by David Shlaes
2y ago
  On a personal note, as I grow older, I find I am likely to be more dependent on physicians and caregivers.  I am grateful to have a truly talented, kind and smart team of physicians, nurses, family and friends to provide care and support if needed.  As I contemplate this universal issue of aging, given my training and history, I can’t help but reflect on the state of antimicrobial resistance and the antibiotic pipeline designed to meet this challenge. I hope, that should the need arise, my care team will have access to antibiotics that are both safe and effective a ..read more
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Europe, Antibacterials, Pull Incentives and Access
Antibiotics | The Perfect Storm
by David Shlaes
3y ago
     Without a significant pull incentive, our pipeline of new antibacterials is doomed. This must be our top priority. If a significant pull incentive for new antibacterial research and development is to occur, there must be a mechanism for choosing which products and sponsors will be its beneficiaries. Product novelty, “value” and potential clinical utility (and others) have been proposed as criteria for making this decision. But clear definitions for these criteria are either lacking, vague or conflicting among various authors, organizations and proposals. One example of ..read more
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Empiric broad spectrum antimicrobial therapy is here to stay.
Antibiotics | The Perfect Storm
by David Shlaes
3y ago
 Recent discussions on the economics of innovation in rapid diagnostic testing for bacterial infections in the hospital setting have inspired me to once again take pen (keyboard) in hand. In most of these discussions, the key variable in the utility of any diagnostic test has been ignored. I’m talking about basic aspects of physician thinking and behavior,    The basic premise is that if accurate, bedside tests were available either in the hospital or in the physician’s office, we could avoid broad spectrum empiric antibacterial therapy and focus on the specific pathog ..read more
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