• Sign in
  • Communities
  • BillCam
  • About Us
  • Shop
0
DailyClout

Help fund independent journalism.

Donate
  • Sign In
  • Home
  • Opinion
    • Outspoken
    • The Drew Allen Show on DailyClout
    • Heart & Mind
    • Investigate Everything
    • Emerald & Naomi
    • Generation Rogue
    • The Liberty Lobbyist
    • The Shannon Joy Show on DailyClout
    • Man in America on DailyClout
    • The Sarah Westall Show on DailyClout
  • Submissions
  • Events
  • Our Story
  • Shop
  • Become a Member!
  • Donate

DailyClout Opinion
Opinion

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development

December 30, 2022 • by DailyClout
By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies.

By ROBERT ASPBURY

Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal testing in drug development. This will allow drug companies the option to use alternative safety-testing models when making new drug submissions.

This is important because the Federal Food, Drug and Cosmetics Act of 1938, which is still in force, mandates animal testing for every new drug development protocol. Advocates of non-animal experimentation have argued that the cost of animal research is high—in dollars, in time, and in delays in approvals of beneficial drugs for human use. They also maintain that some drugs that were deemed safe by animal studies went on to cause harm in human subjects in clinical testing, although this last position is poorly quantified.

Once the FDA Modernization Act 2.0 is enacted, a transitional moment will follow. The section of the House bill that allows for alternatives to animal use to be incorporated into pre-clinical testing outlines approaches most likely to predict human response based on scientific evidence. These include cell-based assays; organ chips and microphysiological systems; and sophisticated computer modeling. Several of these approaches allow drug developers to incorporate safety assessment alternatives that are robust enough to convince regulators that a program has been adequately de-risked.

The bill comes at a pivotal time; modern toxicity testing has been moving away from a reliance on animal studies. One substitute has been mechanism-based testing strategies, such as cell-based assays. These are already being used as research tools to support the interpretation of in vitro toxicity data, as well as the design of in vitro experiments, and considerable progress has been achieved in making assays available and deployable in a user-friendly form.

So-called organ chips and microphysiological systems began to be used more frequently during Covid-19 drug and vaccine testing, which reportedly helped researchers to better understand how Covid-19 interacted with human organs and elicited an immune response. Using human cells and engineered structures, these approaches create an environment that mimics or models the function of organs, and they may have application in testing drug efficacy in genetically diverse human populations using human genetic material.

The average cost of bringing a drug to market is about $2 billion, of which more than half is spent on clinical trials. But before trials are conducted, researchers are increasingly employing computer modeling, a technology that has been expanding for several decades and which provides several benefits.

Sophisticated modeling that uses in-silico, computer-based testing with virtual patients, biosimulation is fast and relatively inexpensive and reveals rich information about how a drug would perform and how to best design a trial before the drug is ever tested in patients. Biosimulation also offers the flexibility of computer-based testing, allowing developers to optimize trial design and dosing for different patient populations.

By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies.  These alternatives are not yet the complete answer, but by increasingly taking a “totality of evidence” approach where the combination of multiple data points can be used to assess whether a confidence threshold is reached in relation to the safety of a drug at a particular dose, regulators are allowing developers to accelerate the process.

Now that Congress has passed the FDA Modernization Act, drug companies should consider how to take advantage of the translational tools outlined above, which can be an important part of the drug developer’s arsenal. Depending on how they are used, they can result in researchers more cost-effectively developing the lifesaving drugs and vaccines that patients need, faster.

Photo: Rawf8, Getty Images

Author, Robert Aspbury

Robert Aspbury, PhD, is the President of Certara’s Simcyp division, which provides population-based pharmacokinetic modeling used during the drug development process. Dr. Aspbury earned a doctorate in biochemistry from the University of Liverpool in 1995. He is also a chartered accountant.

Originally published on medcitynews.com

Spread the Word

Subscribe to DailyClout so you never miss an update!

DailyClout
This DailyClout article is the writer’s opinion.
One of our country’s most important freedoms is that of free speech.
Agree with this essay? Disagree? Join the debate by writing to DailyClout HERE.
Spread the Word

  • Please support DailyClout.io. Our research, our uncompromising, fact-based journalism, our compelling opinion pieces and videos, our BillCam platform that lets you pass good bills and stop bad bills, and our lawsuits to preserve medical freedom and secure accountability for wrongdoers, have all helped to keep America and countries around the world safer and freer. We need your donations to keep fighting for you and your loved ones. We cannot do any of it without you and your generous support. Please give what you can as a one-time donation, or please, if you can, send us a monthly recurring donation. Please put resources behind the values you support, and that we do so much to help you defend.

    Thank you.

  • $0.00

#FDA #Pfizer #War Room amy kelly brian o'shea claire dooley covid19 dailyclout Etana Hect kate melgoza naomi wolf Robert Aspbury vaccine VigilantFox volunteers
Previous StoryArizona Recount Reveals Democrat Kris Mayes Beat Republican Abe Hamadeh
Next StoryInfant Mortality Spiked in Israel Following mRNA Rollout

Leave your comment Cancel Reply

You must be logged in to post a comment.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Recent Posts

  • USAID Bribery Scheme Exposed: $550M in Fraudulent Contracts Uncovered
    USAID Bribery Scheme Exposed Saturday, 14, Jun
  • US Government Website Could Be Shut Down After Mass Layoffs
    “US Government Website Could be Shut Down After Mass Layoffs” Friday, 13, Jun
  • Copy of Copy of strategy (1)
    “Dr. Hadar Elbaz of TWC: Heavy Metal Detox” (Sponsored) Friday, 13, Jun
  • Rent-a-Riots & Food Sabotage
    In the Lair: “Rent-a-Riots & Food Sabotage” Friday, 13, Jun
  • Failure to Warn
    On Failure to Warn, reasonable suspicion to investigate for the state-level crime of reckless endangerment, and exclusion of federal employees and officials from PREP Act immunity Friday, 13, Jun

Blog Archive

Subscribe to Our Free Newsletter

  • About Us
  • Get Involved
  • Become a Member
  • BillCam
  • Communities
  • Contact Us
  • Donate
  • Submissions
  • Substack
  • Privacy Policy
View Cart Checkout Continue Shopping
Do you really want to logout of DailyClout?
Yes

You are now leaving DailyClout...