Animal Testing, Drug Development and Trials

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

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

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2).

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

4 ways ex vivo models offer Pharma better alternatives to animal testing

Reprocell

NOVEMBER 1, 2022

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.

Animal Testing

Animal Testing Pharma Companies Laboratories Drug Development

In Silico for Drug Discovery

biobide

JUNE 8, 2023

The in silico method represents an increasing role in drug discovery as technology becomes more sophisticated. It is fast becoming a cost-effective and efficient alternative to animal testing. It can be used in all stages of drug discovery, from screening to pre-clinical trials and greatly reduces drug development time.

Animal Testing

Animal Testing Clinical Trials Drugs Drug Development

Increasing the probability of technical success in drug development using AI and patient heterogeneity

Predictive Oncology

AUGUST 8, 2024

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.

Drug Development

Drug Development Clinical Trials Animal Testing Trials

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

Streamlining the path from lab to market with 3D bioprinting

Drug Target Review

MARCH 18, 2024

How do recent advancements in bioprinting technology promise to revolutionise the traditional drug development process, in terms of cost and timeline? By enabling a more direct assessment of drug interactions with human tissue, bioprinting can streamline the path from lab to market.

Marketing

Marketing Animal Testing Engineering Drug Development

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 Clinical Trials Research Trials

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs

Drugs FDA Disease Animal Testing

The essential role of recombinant phage display antibody libraries

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

Molecular Biology

Molecular Biology Pharmacokinetics Laboratories Animal Testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

Liver toxicity is a major safety concern during drug discovery and development, with the potential to terminate clinical trials and result in expensive program failures. Dr David Hughes, Chief Executive Officer, CN Bio, said : “This publication is invaluable in confirming the utility of our system in the labs of the FDA.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The draft guidance helpfully adds a few examples of appropriate Type D meeting scenarios, and they are: A specific question about an aspect of a complex or innovative trial design (e.g.,

FDA

FDA Packaging Animal Testing Production

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 Science Small Molecule Immune Response

Origins of the Lab Mouse

Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market.

Laboratories

Laboratories Research Disease Science

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

Therapies

Therapies FDA Production Disease

Unhappy Elephant: New York’s Highest Court Holds that Animals Are Not Entitled to Writs of Habeas Corpus

Drug & Device Law

JULY 21, 2022

After recounting the many laws that protect animals generally and animals used in research specifically, NABR warned that extending habeas rights to animals would upset the current balance between animal welfare and critical human interests.

Animal Testing

Animal Testing Research Laboratories Hospitals

Drug Discovery Digest

Exploring alternatives to animal testing in drug discovery

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

Trending Sources

4 ways ex vivo models offer Pharma better alternatives to animal testing

In Silico for Drug Discovery

Increasing the probability of technical success in drug development using AI and patient heterogeneity

Advanced 3D cell-based technologies

Streamlining the path from lab to market with 3D bioprinting

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

Human neuronal cells: possibilities in drug safety testing

The essential role of recombinant phage display antibody libraries

CN Bio’s PhysioMimix Technology Receives FDA Recognition

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

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

Origins of the Lab Mouse

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Unhappy Elephant: New York’s Highest Court Holds that Animals Are Not Entitled to Writs of Habeas Corpus

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