2023, Animal Testing and Research - Drug Discovery Digest

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

Animal Testing

Animal Testing Regulations Production Research

Scottish drug discovery: advancing new research models

Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. Introduction to the CRUK Beatson Institute The first speaker was Professor Owen Sansom, Director of the Cancer Research UK Beatson Institute, who gave two presentations.

Research

Research Virus Drugs Disease

New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

SEPTEMBER 29, 2023

Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

Animal Testing

Animal Testing Drugs Pharmacokinetics Regulations

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Agency IQ

NOVEMBER 27, 2023

ECHA issues research wish list to aid in its regulatory endeavors The European Chemicals Agency is attempting to guide scientific research toward topics with regulatory relevance. Second , ECHA is requesting further research addressing chemical pollution in the natural environment.

Animal Testing

Animal Testing Research Regulations Compliance

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research

Clinical Research Research Clinical Trials Laboratories

Why have medicines progressed so little in the last decades?

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. After all, these failures come on top of decades and decades of research into these diseases.

Animal Testing

Animal Testing Disease Trials Research

Join DDW for the SLAS2024 Ignite Theater ‘Innovation from lab to patient’

Drug Discovery World

JANUARY 21, 2024

Inspired by the overall event theme of ‘Innovation at Every Turn’, the DDW track will present leading research and case studies from experts in academia, government agencies and the industry on how technology is innovating from bench to bedside, lab to patient. It is sponsored by Integra Biosciences and Hamamatsu Corporation.

Vaccine

Vaccine Computational Chemistry Animal Testing Engineering

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023. She urged that new methodologies are needed to reduce human and animal testing to establish safety and efficacy.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Trials

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

Animal Testing

Animal Testing Regulations Production Marketing

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

AUGUST 18, 2023

BY RAYAN BHARGAVA, MSCAUG 16, 2023 10:33 AM CDT International: World Health Organization The International Agency for Research on Cancer (IARC) classification framework is particularly well-known , consisting of four levels of increasing certainty regarding human cancer risk. please read AgencyIQ’s August 8, 2023 article here.]

International

International Regulations Packaging Animal Testing

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

JUNE 28, 2024

A question-and-answer document answers common questions on clinical investigation ( read AgencyIQ’s analysis of MDCG 2021-6 here ), and a Commission guidance ( 2023/C 163/06 ) outlines the content and structure of the clinical investigation report summary. Read AgencyIQ’s analysis of those exemptions here.

Trials

Trials Marketing Clinical Trials Regulations

CN Bio named winner with most impactful industry collaboration

Drug Discovery World

NOVEMBER 23, 2023

He added: “The data so far further asserts the utility of our OOC technology to provide accurate and reproducible data, encouraging MPS adoption into drug discovery and development workflows, positioning the technology as a viable alternative to animal models, where suited.

Animal Testing

Animal Testing FDA Clinical Trials Government

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 27,28 Since the advent of hiPSC technology almost two decades ago enormous progress has been made in many areas of research. Cell Stem Cell. 2017 Jul 6;21(1):14–7.

Drugs

Drugs FDA Disease Animal Testing

Experimental vaccine protects against deadly Sudan virus

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease. Next, the researchers tested the safety and efficacy of VSV-SUDV in macaques.

Virus

Virus Vaccine Immune Response Licensing

Highlights from SLAS2023: Day One

Drug Discovery World

FEBRUARY 27, 2023

The system features high-throughput fast dual detectors, enabling researchers to screen millions of samples with the increased accuracy, speed and sensitivity. This enables researchers to perform a wide range of assays for different applications within one instrument. The launch follows the FDA Modernisation Act 2.0

Laboratories

Laboratories Animal Testing Production Compliance

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [ For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ]

Packaging

Packaging Regulations Laboratories Animal Testing

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Small Molecule Science Immune Response

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising. ” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”

Disease

Disease Testimonials Production FDA

Drug discovery hotspots: What is the secret to Switzerland’s success? (part 2)

Drug Discovery World

JULY 3, 2024

DDW’s Diana Spencer takes a closer look into why Switzerland is such a life sciences powerhouse and how Swiss researchers are advancing new technology and tackling modern health challenges. Such investments contribute to the emergence of numerous health technologies being developed into innovative products.”

Drugs

Drugs Clinical Trials Science Therapies

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models.

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. DDW Volume 24 – Issue 2, Spring 2023 References Testing for Carcinogenicity of Pharmaceuticals.

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

The agency received $3,530,150,000 in direct appropriations for salaries and expenses in FY 2023, and requested $3,896,028,000 billion for FY 2024 – but is receiving $3,522,150,000 from Congress for this year (note: again, this does not include user fee program funding). One issue here: FDA staff salaries.

FDA

FDA Packaging Science Government

Drug Discovery Digest

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Trending Sources

Scottish drug discovery: advancing new research models

New Alternative Methodologies and Their Applications in Drug Discovery and Development

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Why have medicines progressed so little in the last decades?

Join DDW for the SLAS2024 Ignite Theater ‘Innovation from lab to patient’

Drug repurposing: The benefits, risks and what we learned from Covid-19

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

CN Bio named winner with most impactful industry collaboration

Human neuronal cells: possibilities in drug safety testing

Experimental vaccine protects against deadly Sudan virus

Highlights from SLAS2023: Day One

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

Drug discovery hotspots: What is the secret to Switzerland’s success? (part 2)

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

Accelerating NDA filing through faster carcinogenicity assessment

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

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