Drug development – Drugo http://drugo.biz/ Tue, 23 Nov 2021 18:54:15 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://drugo.biz/wp-content/uploads/2021/10/icon-24-120x120.png Drug development – Drugo http://drugo.biz/ 32 32 The BBB threat to biosimilar drug development https://drugo.biz/the-bbb-threat-to-biosimilar-drug-development/ Tue, 23 Nov 2021 14:00:00 +0000 https://drugo.biz/the-bbb-threat-to-biosimilar-drug-development/ In 2019, longtime pharmaceutical industry critic Peter Bach spoke the Wall Street newspaper to announce that the United States should throw in the towel at copied versions of the country’s most expensive specialty drugs in favor of government price controls. The recommendation has been rightly decried by those who recognize the undeniable role that drug […]]]>

In 2019, longtime pharmaceutical industry critic Peter Bach spoke the Wall Street newspaper to announce that the United States should throw in the towel at copied versions of the country’s most expensive specialty drugs in favor of government price controls. The recommendation has been rightly decried by those who recognize the undeniable role that drug competition plays in reducing drug costs for patients and taxpayers.

Yet two years later, the Democrats in Congress, perhaps unwittingly, seem poised to embody Bach’s proposal.

Democrats have included a number of provisions designed to cut drug prices in the Build Back Better bill, currently being debated in the U.S. Senate after being passed by the House of Representatives on Friday. But having provisions in the current bill that require Medicare to essentially regulate prices and limit any future price increases would come at a high cost.

For starters, it would completely upset our country’s model which has enjoyed great success for decades, of allowing new drugs to benefit from short periods of exclusivity, followed by a period of strong competition from generics and, for large molecule biological drugs, biosimilars.

The inevitable result of such a price regulation regime would be the likely gutting of the biosimilar drug market, leaving us with less drug development, less competition, and reduced progress in the biologic drug market.

Biologics, complex drugs made using living cells, are the fastest growing class of drugs in the United States. In the last decade, almost all of the successful drugs that have been introduced have been biologics.

Biologics have also proven to be very expensive to develop and manufacture. Unlike conventional small molecule drugs, biologics are created within living systems and are very sensitive, which means manufacturers have to control the nature of raw materials and use hundreds of process controls to ensure quality. The cost of research, development and production of these drugs contributes to their high price.

One way the United States has tried to lower the price of biologic drugs has been to encourage the introduction of biosimilar drugs. Biosimilars are related to generics in that they are near-replicas of the original biologics, but creating the therapeutic equivalent of a biologic is a much more complex task than making a biologic. generic equivalent of a small molecule drug: manufacturers of biosimilars do not have access to the DNA used in reference products, and must invest in research and development to create facsimiles that resemble the originals. Thus, if biosimilars are presented as less expensive versions of their reference products, they nevertheless also require significant investments.

However, the United States was slow to approve biosimilar drugs, which lessened their effect on drug prices. For example, the EU approved its first biosimilar drug in 2006, but the first American drug – Zarxio – only reached the market in 2015. Today the EU approved 69 biosimilar drugs and the United States has only 31, many of which were only recently approved and have yet to hit the market.

No one will argue that the huge difference in approvals between the US and the EU has to do with a lax EU regulatory state, given its famous sclerotic and cautious bureaucracy and unconditional adherence to the precautionary principle: it is clear that something is wrong with the US biosimilar market. This is in part because the current system has allowed drug companies to delay competition for biosimilars through the courts and what some interpret as a form of patent abuse, but the long and complex process for the FDA to approve them. biosimilar drugs is a bigger problem. .

A stronger FDA, combined with legislation removing most of the legal barriers and patent abuses that hinder competition from biosimilars, would make it easier for biosimilars to enter the market. This would go a long way in restraining the prices of new drugs in a way that would not adversely affect development.

Instead, many Democrats view bureaucratic and legalistic barriers as an immutable reality rather than a problem to be solved, and embrace government pricing instead.

As such, the current drug provisions in Build Back Better would end the decades-old model of encouraging competition through generics and move towards a centrally regulated market, more than even Europe.

Orrin Hatch, my former employer in the US Senate, recently came out of retirement to publish a statement denouncing the notion of price controls and the possible demise of the Hatch-Waxman Act, the legislation that created the market for generic drugs and, later, biosimilars.

Current members of Congress should heed Senator Hatch’s caution. Even a sham towards such a market for command-and-control drugs would cause investment in biosimilars to plummet: it might be difficult to fully revive such an investment later if the pharmaceutical companies fear that such a drastic measure remains possible with it. the next administration.

The most practical and least damaging way to help reduce prescription drug pricing pressures would be to fix the biosimilars pipeline and let competition drive prices down, just like generics did.


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Accelerating Drug Development, Health News, ET HealthWorld https://drugo.biz/accelerating-drug-development-health-news-et-healthworld/ Mon, 15 Nov 2021 00:38:00 +0000 https://drugo.biz/accelerating-drug-development-health-news-et-healthworld/ through Sanjay Vyas It is no longer news that the COVID19 pandemic has taken the world by surprise. As deadlocks ensued in different countries, scientists and the healthcare community had to keep up with this sudden change and find effective preventive and curative treatments. Given the rigorous and process-oriented requirements of drug development, immediate efforts […]]]>
through Sanjay Vyas

It is no longer news that the COVID19 pandemic has taken the world by surprise. As deadlocks ensued in different countries, scientists and the healthcare community had to keep up with this sudden change and find effective preventive and curative treatments. Given the rigorous and process-oriented requirements of drug development, immediate efforts were focused on identifying existing drugs that could help control the disease. Drugs like Favipiravir, Remdesivir, Tocilizumab and recently 2-DG have been seen as breakthroughs in reuse for use against COVID19 infection. The pandemic has highlighted the importance and potential of repositioning or reorienting drugs as alternative therapies.

The development of new therapies is a tedious, long and expensive process. Even with the best resources, the risk of failure is high. In comparison, reuse costs 50-60% less than new drug development, and drugs are typically approved earlier due to their existing evidence in multiple geographies. In addition, reused drugs have gone through the process of preclinical and clinical development for the treatment of other diseases and have therefore already been tested for their toxicity. This allows them to move directly to Phase II clinical trials, dramatically reducing the time to deployment compared to the regulatory and approval processes required to launch a new drug.

While reused drugs are one of the positive outcomes of adaptive therapy, adaptive trial designs are another important factor being explored to revolutionize trials. Defined as designs for making changes to tests or procedures once a test is underway, adaptive designs preserve the overall validity and integrity of tests. When carefully designed and executed, these trials can provide multiple results, such as increasing the likelihood of success of a new therapy, shortening development times, and reducing overall development costs and risks associated with volunteers. and the study sponsors.

One of these successful and important adaptations observed in the field of adaptive assay design is the development of core protocols. In 2018, the Food and Drug Administration (FDA) announced draft guidelines for core protocols to accelerate the development of drugs and biologics in oncology. This guide aims to provide sponsors with a manual for conducting clinical trials intended to evaluate multiple drugs (oncology) and / or multiple types of cancer in adult and pediatric populations within the same main protocols.

Core protocols designed using a unique infrastructure, trial design and protocol allow multiple drug and disease populations to be evaluated simultaneously. Compared to a traditional trial where a single infrastructure is used to evaluate a single drug in a single disease population, this can help improve efficacy and speed up drug development. To better understand the main protocols, it is important to know the different methods such as umbrella, cover and platform test designs. A primary protocol designed to examine multiple treatment options or drug combinations for a single disease population is called a general trial design. On the other hand, basket trial designs assess a single drug or combination of drugs at multiple stages of disease from different populations based on the number of prior therapies, genetics, or demographics. The platform’s trial designs assess multiple drugs or drug combinations in multiple disease populations and help add or remove regimens based on decision algorithms.

The industry is witnessing how newer and repurposed test designs are paving the way for building a well-organized testing infrastructure that will continue to help reduce time to market and decrease the cost of time to market. overall drug cost, thereby allowing therapies to reach needy patients more quickly.

Sanjay Vyas, Executive Vice President and General Manager, Parexel India

(DISCLAIMER: Opinions expressed are solely those of the author and ETHealthworld.com does not necessarily endorse them. ETHealthworld.com will not be liable for any damages caused to any person / organization directly or indirectly.)


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Opioids Market – Increasing research into new developments through new drug development is expected to drive market growth https://drugo.biz/opioids-market-increasing-research-into-new-developments-through-new-drug-development-is-expected-to-drive-market-growth/ https://drugo.biz/opioids-market-increasing-research-into-new-developments-through-new-drug-development-is-expected-to-drive-market-growth/#respond Tue, 09 Nov 2021 10:32:46 +0000 https://drugo.biz/opioids-market-increasing-research-into-new-developments-through-new-drug-development-is-expected-to-drive-market-growth/ Opioids are psychoactive substances known to be opiates or have opioid-like effects. Fentanyl, alphamethylfentanyl, alfentanil, and sufentanil are some of the examples of synthetic opioids. Key players in the world opioid market focus on adopting collaboration and partnership strategies to increase their market share. For example, in January 2018, Depomed, Inc. signed an agreement with […]]]>

Opioids are psychoactive substances known to be opiates or have opioid-like effects. Fentanyl, alphamethylfentanyl, alfentanil, and sufentanil are some of the examples of synthetic opioids.

Key players in the world opioid market focus on adopting collaboration and partnership strategies to increase their market share. For example, in January 2018, Depomed, Inc. signed an agreement with Collegium Pharmaceutical Inc. for the commercialization of NUCYNTA Extended Release and NUCYNTA Immediate Release for the management of short-term (acute) pain in adults in the United States. .

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The increasing prevalence of chronic diseases is expected to propel the growth of the global opioids market during the forecast period. For example, according to the American Cancer Society, in 2020, approximately 276,480 new cases of invasive breast cancer will be diagnosed in women, and the disease will result in approximately 42,170 deaths, in the United States.

Moreover, the increasing number of emergency surgeries is also expected to contribute to the growth of the market. For example, according to the 2017-2018 report from the Australian Institute of Health and Welfare’s Hospital, updated in August 2019, emergency surgery admissions increased between 2016-2017 and 2017-2018 by 2.9% in public hospitals and 5.1% in private hospitals. in Australia.

Funding for opioid R&D is expected to provide lucrative growth opportunities for players in the global opioid market. For example, in the United States, the National Institute on Drug Abuse (NIDA) provides funding for R&D on drug use and its consequences.

The global opioid market is estimated to be worth US $ 51,005.8 million in value by the end of 2027. Market growth is driven by the approval and launch of new products. For example, in November 2018, the United States Food and Drug Administration approved DSUVIA from AcelRx Pharmaceuticals, Inc. for use in adults in health facilities certified to be medically supervised for the management of acute pain severe enough. to require an opioid pain reliever.

The North America region held a dominant position in the global opioid market in 2018, with a share of 64.8% by volume, followed by Europe.

The morphine segment in the global opioid market was valued at US $ 13,697.6 million in 2018 and is expected to reach US $ 17,766.2 million by 2027 at a CAGR of 2.9% over the course of the forecast period.

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The use of synthetic opioids can lead to several side effects thus hampering the growth of the global opioid market. For example, remifentanil causes reduced sympathetic nervous system tone, respiratory depression, and analgesia.

Moreover, the increase in drug overdose cases is also expected to hamper the growth of the market. For example, according to the 2018 National Survey on Drug Use and Health, in the United States, approximately 164.8 million people aged 12 or older in the United States were addicted to drugs in the past month, especially tobacco, alcohol or illicit drugs.

The major players operating in the global opioids market are Actavis Plc., Boehringer Ingelheim, Endo Pharmaceuticals Inc., Janssen Pharmaceuticals, Inc., Mallinckrodt Pharmaceuticals, Pfizer, Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd. and Zyla Life Sciences.

The major players operating in the global opioid market are focusing on R&D to expand their product portfolio. For example, in August 2021, Averitas Pharma Inc., the US subsidiary of Grünenthal, enrolled the first patient in AV001, a phase III study that evaluates the efficacy, safety and tolerability of the QUTENZA (capsaicin) topical system. at 8% in post-processing. -surgical neuropathic pain.

Reasons to buy this report

• Current and future outlook of the global opioid market in developed and emerging markets.

• The segment which is expected to dominate the market as well as the segment which holds the highest CAGR during the forecast period.

• Regions / countries expected to experience the fastest growth rates during the forecast period

• The latest developments, market shares and strategies used by the main market players

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Contents

  1. Research objectives and hypotheses
    • Research objectives
    • Hypotheses
    • Abbreviations
  2. Market Snapshot
    • Description of the report
      • Definition and scope of the market
    • Abstract
      • Market extract, by product type
      • Market extracts, by application
      • Market extract, by region
      • Coherent Opportunity Map (COM)
  3. Analysis of market dynamics, regulations and trends
    • Market dynamics
      • Conductors
      • Constraints
      • Market opportunities
    • Impact analysis
    • Highlights
    • Product launch
    • PEST analysis
    • Regulatory scenario
    • Mergers and Acquisitions
  4. Global Opioid Market, By Product Type, 2019-2027, (USD Million)
    • introduction
      • Market share analysis, 2019 and 2027 (%)
      • Year-on-year growth analysis, 2017 – 2027
      • Segment trends
    • Morphine
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Codeine
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Fentanyl
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Meperidine
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Methadone
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
  5. Global Opioid Market, By Application, 2019-2027, (USD Million)
    • Analgesia
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Cough suppression
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
    • Suppression of diarrhea
      • introduction
      • Market Size and Forecast, and Year-on-Year Growth, 2016-2027, (USD Million)
  6. Global Opioids Market, By Region, 2019-2027, (Million US $)
    • introduction
      • Market share analysis, by region, 2019 and 2027 (%)
      • Year-on-year growth analysis, for regions, 2017-2026
    • North America
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
    • Latin America
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
        • Germany
        • UK
        • France
        • Italy
        • Spain
        • Russia
        • The rest of europe
    • Asia Pacific
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of the APAC
    • Middle East
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
        • CCG
        • Israel
        • Rest of the Middle East
    • Africa
      • Market Size and Forecast, by Product Type, 2016-2027, (USD Million)
      • Market Size and Forecast, by End User, 2016 – 2027, (USD Million)
      • Market Size and Forecast, by Country, 2016-2027, (USD Million)
        • South Africa
        • central Africa
        • North Africa
  7. Competitive landscape
    • Company Profiles
      • Pfizer Inc.
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Boehringer Ingelheim
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Janssen Pharmaceuticals, Inc.
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Actavis Plc.
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Sanofi SA
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Sun Pharmaceutical Industries Ltd.
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Mallinckrodt Pharmaceuticals
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Endo Pharma inc.
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
      • Zyla Life Sciences
        • Company presentation
        • Product portfolio
        • Financial overview
        • Highlights
        • Market strategies
  8. Section
    • The references
    • Research methodology
    • About us and commercial contact

About Us:

Coherent Market Insights is a global market intelligence and consulting organization focused on helping our plethora of clients achieve transformational growth by helping them make critical business decisions. We have our head office in India, an office at Global Financial Capital in the United States, and business consultants in the United Kingdom and Japan. Our clientele includes players from various industries in more than 150 countries around the world. We pride ourselves on serving clients of all backgrounds, from Fortune 500 companies to nonprofits and startups looking to enter the market. We excel in providing unmatched actionable market insights across various industry verticals including chemicals and materials, healthcare, food and beverage, consumer goods, packaging, semiconductors, software and services, telecommunications and automotive. We offer syndicated market intelligence reports, customized research solutions and advisory services.

Contact:

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Neuro Vigor and University of Western Australia announce collaborative drug development agreement https://drugo.biz/neuro-vigor-and-university-of-western-australia-announce-collaborative-drug-development-agreement/ https://drugo.biz/neuro-vigor-and-university-of-western-australia-announce-collaborative-drug-development-agreement/#respond Tue, 26 Oct 2021 16:06:34 +0000 https://drugo.biz/neuro-vigor-and-university-of-western-australia-announce-collaborative-drug-development-agreement/ The focus will be on new chemical entities to neutralize reactive aldehydes associated with multiple inflammatory and traumatic diseases HAMMOND, Ind. – Neuro Vigor, a Purdue University-affiliated biotechnology company developing drugs that neutralize reactive aldehydes, announced on Tuesday (October 26) a collaboration agreement with the University of Western Australia jointly develop proprietary drugs to initially […]]]>

The focus will be on new chemical entities to neutralize reactive aldehydes associated with multiple inflammatory and traumatic diseases

HAMMOND, Ind. – Neuro Vigor, a Purdue University-affiliated biotechnology company developing drugs that neutralize reactive aldehydes, announced on Tuesday (October 26) a collaboration agreement with the University of Western Australia jointly develop proprietary drugs to initially target neurodegenerative diseases and pain in spinal cord injury, or SCI.

Reactive aldehydes are highly toxic molecules released by cells in response to external or internal stress and trauma. They significantly increase in inflammatory, neurotraumatic and neurodegenerative disease states, damaging tissue at the cellular and molecular levels, perpetuating a destructive cycle of inflammation and oxidative stress.

“This agreement launches the science and technology needed to provide relief to patients with neuropathic pain or neurodegenerative diseases,” said Mark Van Fleet, CEO of Neuro Vigor. “It combines Neuro Vigor’s understanding of preclinical neurobiology and the importance of neutralizing reactive aldehydes with the discovery by the University of Western Australia of new drug compounds that have exciting clinical promise.”

From a group of compounds identified by researchers at the University of Western Australia, the partners will initially assess preclinical reactive aldehyde scavengers, which have the best potential as therapeutic agents to curb pathology in multiple diseases, including SCI neuropathic pain.

The first stage of the two-year joint R&D effort will be funded by grants to Neuro Vigor by the Indiana Spinal Cord and Brain Injury Fund and the University of Western Australia. Under the agreement, the university grants Neuro Vigor an exclusive option to license the resulting intellectual property of chemical entities resulting from the collaboration.

“We are delighted to have partnered with Neuro Vigor and look forward to seeing this collaboration grow,” said Dr Louis Pymar, Senior Marketing Manager at the University of Western Australia.

“Neurodegenerative diseases and spinal cord injuries present significant unmet medical needs, and we hope this discovery may lead to new, differentiated treatment options. “

About Neuro Vigor

Neuro Vigor, a company affiliated with Purdue University, is pioneering the development of drugs to scavenge reactive aldehydes at a dosage and formulation targeted to the conditions in which the aldehydes play a central role. The company’s first clinical priority is the treatment of neuropathic pain in spinal cord patients for whom current care is inadequate. Neuro Vigor’s search for more effective pain treatments with fewer side effects is also supported by the National Institute of Health’s Helping to End Addiction Long-term initiative (Helping to End Addiction Long-term), which supports research aimed at improving management. pain and treatment for opioid abuse and dependence.

About the University of Western Australia

The University of Western Australia (UWA) is one of Australia’s leading research-intensive universities in the top 1% of world universities on the Shanghai Jiao-Tong Academic Ranking of World Universities (ARWU). This collaboration with Neuro Vigor is led by Associate Professor Phil Burcham of the UWA School of Allied Health and School of Biomedical Sciences, as well as Associate Professor Matt Piggott of the School of Molecular Sciences.

Contacts:

Neuro Vigor: Mark Van Fleet, mvanfleet@convergeventures.net

University of Western Australia: Dr Louis Pymar, louis.pymar@uwa.edu.au

Purdue Research Foundation: Steve Martin, sgmartin@prf.org


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How artificial intelligence can accelerate drug development https://drugo.biz/how-artificial-intelligence-can-accelerate-drug-development/ https://drugo.biz/how-artificial-intelligence-can-accelerate-drug-development/#respond Wed, 20 Oct 2021 07:00:00 +0000 https://drugo.biz/how-artificial-intelligence-can-accelerate-drug-development/ Artificial intelligence – the ultimate optimization engine – takes on one of its biggest challenges: unraveling the complicated, slow, and expensive work of drug development. Why is this important: Even though computing power has become faster and cheaper, drugs remain slow and expensive to develop, in part because of the work that goes into selecting […]]]>

Artificial intelligence – the ultimate optimization engine – takes on one of its biggest challenges: unraveling the complicated, slow, and expensive work of drug development.

Why is this important: Even though computing power has become faster and cheaper, drugs remain slow and expensive to develop, in part because of the work that goes into selecting a candidate and getting them to cross the finish line.

  • AI – with its ability to quickly identify data patterns in galaxies – can provide a vital shortcut.

What they say : “What you see [with AI] is a platform for a new generation of drugs, biologics, life extension, all of which are building at a rate impossible to describe, “says Eric Schmidt, former CEO of Google and co-author of the new book”Age of AI. “

The big picture: Drug development is great business, if you don’t mind repeated and costly failures.

  • The process of finding and developing a new drug can take more than a decade and costs an average of $ 2.8 billion – and even so, 9 out of 10 drug molecules fail Phase II clinical trials and regulatory approval.
  • There are many possible points of failure – identifying a drug candidate from the more than 10⁶⁰ atomic configurations that exist in chemical space, optimizing it for delivery and testing it on animals and humans to see if it is both safe and effective – and they all add to the total cost drugs and health care.
  • “Imagine you build 10 skyscrapers and you can guarantee nine will collapse,” says Isaac Bentwich, CEO of new AI drug discovery startup Quris. “But you have no idea which ones will fall, so all you can do is build them and charge higher rent on the one that’s left standing.”
  • “This is the problem that we are trying to solve.”

How it works: AI can provide a boost at almost any stage of a drug’s development cycle, evangelists say.

  • Exscientia “Centaur Chemist” AI Platform sort by calculation through and compare millions of potential small molecules, looking for a handful to synthesize, test and optimize in the lab before selecting a candidate for clinical trials, which has enabled the company to help bring a drug against cancer in trials in just eight months, compared to a more standard period of four to five years.
  • Quris is working to speed up the testing process by testing drugs on miniaturized organs and tissues on a chip that “represent the full genomic diversity of the potential patient population,” notes Bentwich, which in turn generates data that can help train your AI platform to predict the clinical safety and efficacy of new drugs.
  • Lantern Pharma is partnering with digital healthcare company Deep Lens to use AI to match the right type of new molecule with the right patient profile for clinical trials for accelerated clinical trials.
  • This AI-based approach “can save hundreds of millions of dollars in past drug development costs by ensuring that it is tested on a very specific patient platform,” said Panna Sharma, CEO of Lantern Pharma .

In numbers : The AI ​​market for pharmaceuticals has grown from $ 200 million in 2015 to $ 700 million in 2018, and is expected to reach $ 5 billion by 2024, while job postings related to the AI in the pharmaceutical industry have tripled over the past two years.

The trap : Even as AI becomes more powerful, data sets for drug development can involve millions of compounds, which may exceed the capabilities of current machine learning tools.

  • The ultimate ability of AI to change the fundamentals of such a huge, expensive and regulated industry as drug development is “yet to be proven,” Paul Nioi, senior director of research at Alnylam Pharmaceuticals, told Genetic Engineering and Biotechnology News.

The bottom line: Sharma argues that will change – over the past 20 years, technology has “shattered the costs of product development in everything except drug development,” he says.

  • “And over the next 20 years, it’s going to totally change this industry.”

Go further: how AI could revolutionize biology – and vice versa


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Raman Spectroscopy Market, 2026 – Increased Focus on Drug Development in Healthcare to Fuel Market Growth https://drugo.biz/raman-spectroscopy-market-2026-increased-focus-on-drug-development-in-healthcare-to-fuel-market-growth/ Tue, 12 Oct 2021 07:00:00 +0000 https://drugo.biz/raman-spectroscopy-market-2026-increased-focus-on-drug-development-in-healthcare-to-fuel-market-growth/ DUBLIN, 12 October 2021 / PRNewswire / – The “Raman spectroscopy market with COVID-19 impact analysis by instrument (Raman microscopy, portable and portable Raman), sampling technique (improved surface Raman scattering), application (pharmaceutical, life sciences) and region – Global forecasts until 2026 “ the report was added to ResearchAndMarkets.com offer. Global Raman Spectroscopy Market Expected To […]]]>

DUBLIN, 12 October 2021 / PRNewswire / – The “Raman spectroscopy market with COVID-19 impact analysis by instrument (Raman microscopy, portable and portable Raman), sampling technique (improved surface Raman scattering), application (pharmaceutical, life sciences) and region – Global forecasts until 2026 “ the report was added to ResearchAndMarkets.com offer.

Global Raman Spectroscopy Market Expected To Reach $ 861 million by 2026 based on an estimate $ 602 million in 2021, at a CAGR of 7.4% from 2021 to 2026.

Increasing adoption of Raman spectroscopy in clinical applications and advancing use of Raman spectroscopy techniques for catalysts and catalytic reactions are among the factors driving the growth of Raman spectroscopy market.

The portable and portable Raman segment market is expected to grow at the highest CAGR during the forecast period.

The portable and portable Raman segment market is expected to grow at the highest CAGR during the forecast period. The growth is attributed to the growing adoption of portable and handheld Raman spectroscopy due to their ability to offer a simple point-and-shoot format and fully portable testing with an ergonomic design.

Thus, it enables rapid responses for unknown characterization compared to built-in digital libraries and pre-existing method data. In addition, these spectroscopies can be easily performed and operated by unskilled personnel to acquire the molecular fingerprint of raw materials for pharmaceutical, life science and material science applications.

The Surface Enhanced Raman Scattering (SERS) segment held the bulk of the Raman spectroscopy market in 2020, and this trend is expected to continue during the forecast period.

In 2020, Surface Enhanced Raman Scattering (SERS) held the largest market size for Raman spectroscopy, and a similar trend is expected to be seen during the forecast period. The growth can be attributed to the continued technological development of nanotechnology and extensive theoretical and experimental research, which has significantly broadened the scope of SERS and resulted in an increase in its demand for pharmaceutical, life science and science research. materials.

In addition, the SERS sampling technique can be used to amplify weak Raman signals, especially when the signals use visible light excitation and a low number of scattered photons are available for detection. Therefore, SERS finds application in drug delivery, trace detection of chemical and biological threat agents, point-of-service medical diagnostic (POC) devices, and forensic field testing.

Pharmaceutical application held the largest share of the Raman spectroscopy market in 2020, and this trend is expected to continue during the forecast period.

Pharmaceutical application held the largest size of Raman spectroscopy market in 2020 and a similar trend is expected to be seen during the forecast period. The growth of the segment is attributed to the increase in the use of solid state pharmaceuticals in industries and universities.

Current pharmaceutical applications span a wide spectrum from drug discovery to manufacturing in the pharmaceutical industry, such as polymorphic identification, real-time process monitoring, counterfeit and falsified pharmaceutical detection, and imaging. solid dosage formulations. Due to its ability to visualize the distribution of drugs and excipients in pharmaceutical formulations such as tablets, creams and ointments, Raman spectroscopy is in great demand in the pharmaceutical industry.

On the basis of region, APAC is expected to represent the highest CAGR in Raman spectroscopy market by 2026

In 2026, Raman spectroscopy market in APAC region is expected to register the highest CAGR during the forecast period. This growth is attributed to the growing demand for pharmaceutical, life science and materials science applications in countries such as China, Japan, South Korea, and India.

Moreover, the presence of a large number of pharmaceutical and life science companies and contract manufacturing organizations (CMOs) is also driving the growth of Raman spectroscopy market in the APAC region.

In addition, the increase in healthcare expenditure of government agencies and their initiatives on advanced healthcare technologies in their respective countries is also a major factor in the growth of Raman spectroscopy market in the region.

Thermo Fisher Scientific, Inc. (United States); Agilent Technologies, Inc. (United States); Bruker Corporation (United States); Mettler-Toledo International, Inc. (Switzerland); Renishaw PLC (United Kingdom); Horiba, Ltd. (Japan); Metrohm SA (Switzerland); Kaiser Optical Systems, Inc. (United States); Rigaku Company (Japan); and PerkinElmer, Inc. (United States); are among the key players in the Raman spectroscopy market.

Premium previews

  • Increased focus on drug development in healthcare to fuel Raman spectroscopy market growth during the forecast period
  • Wearable and Handheld Raman Segment to Capture Largest Raman Spectroscopy Market Share from 2021-2026
  • Surface Enhancement Raman Scattering to Capture Largest Raman Spectroscopy Market Share from 2021-2026
  • Pharmaceuticals will be the largest size of Raman spectroscopy market in 2026
  • APAC to Capture Largest Raman Spectroscopy Market Share in 2026
  • China will register the highest CAGR in the Raman spectroscopy market during the forecast period

Market dynamics

Conductors

  • Increased focus on drug development in healthcare
  • Increased adoption of Raman spectroscopy in clinical applications
  • Advancement in the use of Raman spectroscopic techniques for catalysts and catalytic reactions

Constraints

  • High cost of ownership
  • Need a highly skilled workforce to keep pace with advancements in Raman spectroscopy

Opportunities

  • Growing demand for cloud-based spectroscopy
  • Increasing demand for process analysis (Pat) technology in pharmaceuticals

Challenges

  • Lack of improvements in spectrometer design

Trends / disruptions affecting the activities of market players and raw material suppliers

Case study

  • Development of a new technique of Raman micro-spectroscopy that could image the phase distributions of polymers
  • Research and development of a revolutionary biosensor platform for the early diagnosis of cancer
  • Implementation of transmission Raman spectroscopy for rapid content uniformity testing

Technological analysis

  • Complementary technology
  • Inelastic neutron scattering (Ins)
  • Adjacent technologies
  • Fluorescence spectroscopy
  • Infrared spectroscopy

Companies mentioned

  • Agilent Technologies, Inc.
  • Anton Paar GmbH
  • B&W Tek, Inc.
  • Bruker Company
  • Improved Spectrometry, Inc.
  • Hamamatsu Photonics KK
  • Horiba, Ltd.
  • Kaiser Optical Systems, Inc.
  • Laser detection systems
  • Metrohm Ag
  • Mettler-Toledo International, Inc.
  • Overview of the ocean
  • Ostec
  • Perkinelmer, Inc.
  • Photon systems
  • Renishaw plc
  • Rigaku Company
  • Thermo Fisher Scientific Inc.
  • Tornado Spectral Systems, Inc.
  • Witec GmbH

For more information on this report, visit https://www.researchandmarkets.com/r/2c607s

Media contact:
Research and markets
Laura Wood, senior
[email protected]

For EST office hours, call + 1-917-300-0470
For USA / CAN call toll free + 1-800-526-8630
For GMT office hours, call + 353-1-416-8900

US Fax: 646-607-1904
Fax (outside the United States): + 353-1-481-1716

SOURCE Research and Markets

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NanoViricides Provides Update on COVID-19 Coronavirus Drug Development Program at Benzinga Healthcare Small Cap Conference https://drugo.biz/nanoviricides-provides-update-on-covid-19-coronavirus-drug-development-program-at-benzinga-healthcare-small-cap-conference/ https://drugo.biz/nanoviricides-provides-update-on-covid-19-coronavirus-drug-development-program-at-benzinga-healthcare-small-cap-conference/#respond Tue, 05 Oct 2021 07:00:00 +0000 https://drugo.biz/nanoviricides-provides-update-on-covid-19-coronavirus-drug-development-program-at-benzinga-healthcare-small-cap-conference/ “The only dual-mode drug in development against COVID-19 to block the full lifecycle of the virus for potential treatment” Tweet this An updated company presentation that encompasses Dr. Diwan’s presentation at the Benzinga conference will be available shortly on the company’s website on its home page (www.nanoviricides.com). Highlights of the presentation: TWO drug candidates, NV-CoV-2 […]]]>

An updated company presentation that encompasses Dr. Diwan’s presentation at the Benzinga conference will be available shortly on the company’s website on its home page (www.nanoviricides.com).

Highlights of the presentation:

  • TWO drug candidates, NV-CoV-2 and NV-CoV-2-R in development for entry into clinical trials
  • Both have broad-spectrum activities against many coronaviruses
    • Both should therefore continue to work against variants
    • Although SARS-CoV-2 continues to evolve with increasing resistance to existing drugs and antibodies
    • The variants could not therefore escape our drugs, in particular NV-CoV-2-R
  • New mechanism of action, unlike existing drugs
  • NV-CoV-2-R is the only drug in development with a dual mode of action
    • Prevent the virus from attacking cells in the first place, and
    • Inhibit virus replication inside cells, simultaneously
  • NV-CoV-2-R is the only drug in development that blocks the entire life cycle of the virus
    • The NV-CoV-2 component neutralizes the virus outside the cells blocking the cycle of reinfection
    • The Remdesivir component blocks the replication cycle inside cells
    • It is very difficult for the virus to escape from the medicine
  • Animal model studies have indicated that NV-CoV-2 and NV-CoV-2-R are significantly superior to Remdesivir in controlling fatal pulmonary coronavirus infection.
    • Lifespan extension on infected untreated animals:
      • Remdesivir: 2.5 days (only 50% increase)
      • NV-CoV-2: 14 days (180% increase)
      • NV-CoV-2-R: 16 days (220% increase).
  • NV-CoV-2 and NV-CoV-2-R are both extremely safe
    • NV-CoV-2 well tolerated at> 3.3 g / kg body weight in rats by IV infusion
    • NV-CoV-2-R well tolerated at> 1.8 g / kg body weight in rats by IV infusion
    • Anticipate a substantial therapeutic margin of safety in clinical studies
  • Required GLP safety / toxicology studies of NV-CoV-2 completed
    • No Adverse Effects on Respiratory or Neurological Function in a BPL Neuro-Pulmonary Study Model in Rats
    • No adverse effects on cardiovascular function in a BPL study in the cynomolgus monkey model (non-human primate)

“It is important to note that NV-CoV-2 can be administered orally and has been shown to be effective when administered orally in an animal model,” added Dr. Diwan. medical need which remains unmet, even with the current developments of the most discussed drugs “.

About the Benzinga Healthcare Small Cap conference

Benzinga Healthcare Small Cap Conference bridges the gap between small cap companies, investors and traders. Learn about small cap investing with clearly defined educational modules, take a look at an organized group of small cap investing opportunities, and connect with the small cap healthcare audience in an intimate virtual setting. We invite investors and all interested parties to explore investment opportunities in the small-cap healthcare sector through two days of networking, trading and discovery. For more information and / or to register for the conference, please visit: https://www.benzinga.com/events/small-cap/healthcare/.

About nanoviricides

NanoViricides, Inc. (the “Company”) (http://www.nanoviricides.com) is a developmental company that creates special-purpose nanomaterials for antiviral therapy. The Company’s new class of nanoviricide® drug candidates are designed to specifically attack and dismantle enveloped viral particles. We are developing clinical candidates for the treatment of COVID-19 disease caused by the SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as a topical skin cream for the treatment of shingles rash. In addition, the Company has several antiviral programs at various preclinical stages.

The Company is currently working on tasks to complete an IND application for its COVID-19 drug candidates. The Company cannot predict an exact date for the filing of an IND for this drug due to its dependence on several collaborators and external consultants. The Company is currently seeking two distinct drug candidates for the treatment of patients with COVID-19. NV-CoV-2 is our nanoviricidal drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate consisting of NV-CoV-2 in which remdesivir is encapsulated. The Company believes that since remdesivir is already approved by the US FDA, our encapsulating drug candidate remdesivir is likely to be an approved drug, if the safety is comparable. Remdesivir is developed by Gilead. The Company has independently developed its own NV-CoV-2 and NV-CoV-2-R drug candidates.

The Company intends to re-engage in an IND application with the US FDA for the drug candidate NV-HHV-101 for the treatment of shingles once its COVID-19 project goes into clinical trials, according to availability of resources. The NV-HHV-101 program has been slowed down due to the effects of recent COVID-19 restrictions and the re-prioritization of COVID-19 drug development work.

The Company is also developing drugs against a number of viral diseases, including oral and genital herpes, viral diseases of the eye, including EKC and herpetic keratitis, H1N1 swine flu, H5N1 avian flu, seasonal flu, HIV, hepatitis C, rabies, dengue, and Ebola, among others. The NanoViricides platform technology and programs are based on TheraCour’s TheraCour® nanomedicine technology, which TheraCour licenses to AllExcel. NanoViricides holds an exclusive worldwide perpetual license on this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: human coronavirus infections, human immunodeficiency virus (HIV / AIDS), virus of the hepatitis B (HBV), hepatitis C virus (HCV), rabies, herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), influenza virus and Asian avian influenza , dengue virus, Japanese encephalitis virus, West Nile virus and Ebola / Marburg virus. The Company’s technology is based on extensive, exclusive and sublicensable field licenses for drugs developed in these areas by TheraCour Pharma, Inc. The Company’s business model is based on the licensing technology of TheraCour Pharma Inc. for specific vertical applications of specific viruses, as established when it was founded in 2005.

As usual, the Company must point out the risk factor that the path to the development of a drug typical of any pharmaceutical product is extremely long and requires substantial capital. As with any company drug development effort, there can be no assurance at this time that any of the Company’s drug candidates will demonstrate sufficient efficacy and safety for human clinical development. In addition, there is no guarantee at this time that positive results against the coronavirus in our laboratory will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectations regarding future events. Actual events could differ materially and substantially from those anticipated herein and depend on a number of factors. Certain statements contained in this press release and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements, as they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the control of the Company and which could, and probably will, a material impact on actual results, activity levels, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons why actual results could differ materially from those anticipated in such forward-looking statements, even if new information becomes available in the future. Significant factors that could cause actual results to differ materially from the Company’s expectations include, without limitation, factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the Company. from time to time with the United States. Securities and Exchange Commission and other regulatory authorities. While it is not possible to predict or identify all of these factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; the successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we seek; the successful commercialization of our product candidates; and market acceptance of our products.

The FDA refers to the United States Food and Drug Administration. IND’s request refers to the “new investigative drug” request. cGMP refers to current good manufacturing practices. CMC refers to “Chemistry, Manufacturing and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency (EMA) committee responsible for medicines for human use.

SOURCE NanoViricides, Inc.

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Molnupiravir and Drug Development at Emory | Emory University https://drugo.biz/molnupiravir-and-drug-development-at-emory-emory-university/ https://drugo.biz/molnupiravir-and-drug-development-at-emory-emory-university/#respond Fri, 01 Oct 2021 11:13:30 +0000 https://drugo.biz/molnupiravir-and-drug-development-at-emory-emory-university/ Emory University has discovered and advanced the development of some of the world’s most important and valuable antiviral drugs, successfully moving treatments from the lab to the bedside. As one of the nation’s leading research universities, a key mission for Emory is to improve the lives and give hope to all those we serve in […]]]>

Emory University has discovered and advanced the development of some of the world’s most important and valuable antiviral drugs, successfully moving treatments from the lab to the bedside.

As one of the nation’s leading research universities, a key mission for Emory is to improve the lives and give hope to all those we serve in all facets of our work. The criteria by which we measure our success include, but are not limited to, lives saved, partnerships forged, solutions to real-world problems, as well as scientific discoveries and foundations developed that will improve health, well-being. being and the safety of individuals around the world. for generations to come.

About molnupiravir

Drug Innovation Ventures in Emory (DRIVE), LLC, a nonprofit biotech company 100% owned by Emory University, invented EIDD-2801, which is now Molnupiravir. Drugs targets viral polymerase, an enzyme needed by the virus to reproduce. The oral antiviral is designed to work by introducing errors into the genetic code of the virus.

Molnupiravir is currently being developed by Merck & Co. Inc. in collaboration with Ridgeback Biotherapeutics, which licensed the drug to DRIVE in 2020.. This could be the first oral antiviral drug to treat COVID-19.

October 11, Merck and Ridgeback announcement Submission of an EUA application to the FDA for Molnupiravir.

Media contact

Gana Ahn
404-727-0343
gana.ahn@emory.edu


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Experimental approach to drug development indicates better-targeted therapies for treatment-resistant leukemia – ScienceDaily https://drugo.biz/experimental-approach-to-drug-development-indicates-better-targeted-therapies-for-treatment-resistant-leukemia-sciencedaily/ https://drugo.biz/experimental-approach-to-drug-development-indicates-better-targeted-therapies-for-treatment-resistant-leukemia-sciencedaily/#respond Mon, 27 Sep 2021 07:00:00 +0000 https://drugo.biz/experimental-approach-to-drug-development-indicates-better-targeted-therapies-for-treatment-resistant-leukemia-sciencedaily/ New research from researchers at the Johns Hopkins Kimmel Cancer Center shows why some drugs in clinical trials to treat a form of acute myeloid leukemia (AML) often fail and demonstrate a way to restore their effectiveness. The preclinical study, published in September in Discovery of blood cancer, potentially eliminates a pharmacological barrier in the […]]]>

New research from researchers at the Johns Hopkins Kimmel Cancer Center shows why some drugs in clinical trials to treat a form of acute myeloid leukemia (AML) often fail and demonstrate a way to restore their effectiveness.

The preclinical study, published in September in Discovery of blood cancer, potentially eliminates a pharmacological barrier in the development of molecularly targeted therapies for AML.

About a third of patients with AML have a mutation in the FLT3 gene. Normal FLT3 genes produce an enzyme that signals stem cells in the bone marrow to grow and rebuild. Once mutated, FLT3 causes rapid growth of leukemia cells, leading to higher relapse rates after treatment and lower overall survival.

FLT3-mutated AML is particularly sensitive to a class of drugs called electronic family tyrosine kinase (TKI) inhibitors, making them prime candidates for drug development, says lead author David Young, MD, Ph.D., who conducted the study while at the Johns Hopkins Kimmel Cancer Center. Dr Young is now at the National Heart, Lung and Blood Institute of the National Institutes of Health.

However, these and other TKIs often fail and patients relapse. In a series of experiments with human leukemia cell lines and mice, the Kimmel Cancer Center team demonstrated that human alpha (1) -acid glycoprotein (AGP) binds to the drug, effectively preventing it from being released. ‘hit its FLT3 mutation target and kill cancer. cells.

Donald Small, MD, Ph.D., director of the division of pediatric oncology and Kyle Haydock professor of oncology at the Johns Hopkins Kimmel Cancer Center, and colleagues processed FLT3 mutant cell lines grown in human plasma from donors or under standard laboratory conditions with lestaurtinib, TTT-3002 or midostaurin, a drug approved by the Food and Drug Administration (FDA) that targets FLT3 – at various concentrations. Plasma is the clear part of the blood that contains proteins and other non-cellular factors. They found that adding human plasma reduced the ability of TKI to inhibit FLT3, unlike blood components from other sources. Further tests identified human AGP as binding the three drugs and inhibiting their ability to kill leukemia cells.

To demonstrate the clinical relevance of the results, the researchers collected blood samples from adults newly diagnosed with AML and examined the effect of their plasma on midostaurin. In the presence of high inflammation, such as in newly diagnosed patients with leukemia, AGP levels are high. As expected, the drug lost its effectiveness in measuring human plasma in these cases.

“Midostaurin is very specific and potent, and we’ve seen about a 10% improvement in patient outcomes since the FDA approved its use in adults with AML in 2017,” Young explains, “but we don’t ‘ve never had the’ home run ‘that we were looking for because it is bound by AGP. “

In another set of experiments, the team showed that this inhibition of plasma proteins could be reversed by adding an agent that also binds to AGP. Mifepristone is known to bind AGP with comparable or greater affinity than the three drugs in the study. The researchers performed the FLT3 test with plasma of human proteins, midostaurin, and mifepristone. They found that mifepristone displaced AGP-bound midostaurin, restoring its anti-FLT3 activity. By testing the concept on mice, they obtained similar results.

“We wanted to release enough midostaurin to allow the drug to do its job,” Young explains. “If we give human AGP and midostaurin plus mifepristone, it kills leukemia cells. Mifepristone acts as a decoy that prevents midostaurin from binding to glycoprotein.”

While more testing and validation is needed, researchers say mifepristone or other agents with similar AGP-binding properties could be tested in future clinical trials of TKI combination therapy, or developed as a Plasma protein “decoys” to increase the effectiveness of molecularly targeted therapies. Johns Hopkins Drug Library Screening – a collection of nearly 3,000 FDA-approved drugs and compounds, curated by study co-author Jun Liu, Ph.D., co-director of the chemical biology program and structural cancer at the Johns Hopkins Kimmel Cancer Center – has offered tantalizing promises of more drugs that might work like mifepristone to restore anti-FLT3 activity and might synergize with TKI therapies in other ways.

“There may be ways to affect the pharmacology of the human body to breathe new life into these old drugs,” Young said.

Bao Nguyen, Li Li, Tomayasu Higashimoto, Mark Levis and Jun Liu also participated in the research.

Work was supported by National Institutes of Health grants R01CA090668 and P30CA006973, Alex’s Lemonade Stand Foundation for Childhood Cancer, Giant Food Pediatric Cancer Fund, National Institutes of Health Fellowship for Pediatric Oncology grant (T32CA060441), Optimist Foundation Fellowship and the Kyle Haydock Chair in Oncology.


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Biotech CEO Launches Paradigm-Shifting Drug Development Model https://drugo.biz/biotech-ceo-launches-paradigm-shifting-drug-development-model/ https://drugo.biz/biotech-ceo-launches-paradigm-shifting-drug-development-model/#respond Tue, 21 Sep 2021 07:00:00 +0000 https://drugo.biz/biotech-ceo-launches-paradigm-shifting-drug-development-model/ Dr. Charles Theuer’s “Unnecessary Expense” is published with ForbesBooks This press release is issued on behalf of ForbesBooks (operated by Advantage Media Group under license). NEW YORK (September 21, 2021) – Wasteful spending: an antidote to the billion dollar drug problem by the President and CEO of TRACON Pharmaceuticals, Dr. Charles Theuer, is now available. […]]]>

Dr. Charles Theuer’s “Unnecessary Expense” is published with ForbesBooks

This press release is issued on behalf of ForbesBooks (operated by Advantage Media Group under license).

NEW YORK (September 21, 2021) – Wasteful spending: an antidote to the billion dollar drug problem by the President and CEO of TRACON Pharmaceuticals, Dr. Charles Theuer, is now available. The book is published with ForbesBooks, the exclusive publisher of business books of Forbes, and is available on Amazon today.

The problem of skyrocketing drug prices in America is well documented. Driven by unchecked drug development spending, the average cost of $ 2 billion is being offloaded to patients and third-party payers at premium rates, perpetuating the accessibility challenges many healthcare consumers face today. hui.

With Unnecessary expenseDr. Theuer exposes the error at the heart of the billion dollar drug problem – that drug development costs cannot be controlled, arguing that the costs of clinical trials are not the price to be paid. pay to do business and instead can be limited by implementing an efficient and cost-effective approach to developing life-saving treatments. Theuer’s alternative approach to the outsourcing behaviors of large pharmaceutical companies is TRACON’s streamlined, aligned drug development model, which harnesses global innovation to benefit patients and enables drug innovators to stay motivated and engaged while ‘They navigate clinical trials and FDA approvals.

“A more streamlined approach to drug development will not only allow new therapies to reach the underserved populations who need them most in less time, but it will also create greater value for stakeholders,” Theuer explained. . “Patients will benefit, drug developers will receive fair profits to reward their continued commitment to innovation, and insurance companies will avoid paying higher prices for drugs approved for rare disease patients.” . “

Dr. Theuer’s work shows that there is a better way. With this new model, it becomes possible for a conscientious and equitably managed biotech company to be both economically and ethically successful in the drug development process, transform an industry, and ultimately save money. lives that would otherwise have been left on the margins of an inefficient system.

About Dr Charles Theuer

Since 2006, Dr Charles Theuer has been CEO, President and Director of TRACON Pharmaceuticals. Prior to assuming the leadership of TRACON, Dr Theuer was instrumental in bringing successful new oncology drugs to market, including Sutent® to treat advanced kidney cancer, while working as director of the clinical oncology at Pfizer. Dr Theuer previously held senior positions at renowned biotechnology companies including TargeGen, Inc. and IDEC Pharmaceutical Corp. Earlier in his career, Dr Theuer also worked at the National Cancer Institute and held academic positions at the University of California, Irvine. He completed a general surgery residency program at Harbor-UCLA Medical Center and was certified in general surgery in 1997. Dr. Theuer’s previous research focused on the development of immunotoxins and cancer vaccines, translational work in cancer patients and the epidemiology of gastrointestinal cancer. He is married with two grown children and enjoys hiking, basketball training and sculling.

About ForbesBooks

Launched in 2016 in partnership with Advantage Media Group, ForbesBooks is Forbes’ exclusive publisher of business books. ForbesBooks offers businesses and thought leaders an innovative, fast, and premium publishing model, along with a suite of services designed to strategically and tactically support authors and promote their expertise. For more information, visit forbesbooks.com.

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Courtney Morrill, ForbesBooks, cmorrill@advantageww.com


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