Animal Testing, Treatment and Trials

4 Unique Challenges of Oncology Trials

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors.

Trials

Trials Clinical Trials FDA Approval Therapies

Ubiquitous pyrogens and 3D cancer models

Drug Target Review

MARCH 11, 2024

How can this finding potentially reduce the reliance on animal testing in the field of cancer drug testing? 3D printing allows innovators to produce complex structures and intricate organ models, which can be used to study diseases and test new therapies in a more realistic and efficient manner.

Animal Testing

Animal Testing Therapies Clinical Trials Research

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

Vial

MAY 20, 2024

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. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

Clinical Research

Clinical Research Clinical Trials Research Trials

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Appendix A.2

Trials

Trials Marketing Clinical Trials Disease

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. 26 Outside of drug safety, we also plan to adapt our model to anti-epileptic drug discovery.

Drugs

Drugs FDA Disease Animal Testing

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

A therapy candidate for fatal prion diseases turns off disease-causing gene

Broad Institute

JUNE 27, 2024

Neurons were classified by software as either positive for prion protein expression (yellow) before treatment with CHARM (left panel), or negative (purple) after treatment (right panel). Credit: Neumann EN, Bertozzi TM, et al. Vallabh soon found out that she inherited the same disease-causing mutation in the prion protein gene.

Disease

Disease Therapies Engineering Clinical Trials

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

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research

Research Engineering Disease Science

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

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs.

FDA

FDA Packaging Science Drugs

Origins of the Lab Mouse

Codon

JUNE 2, 2024

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. The majority of lab animals (about 95 percent) are mice or rats.

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. Next, sponsors should consider no-treatment control.

Therapies

Therapies FDA Production Disease

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectivenes

The Pharma Data

OCTOBER 27, 2020

27, 2020 — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection. Chris Christie said he had received Lilly’s experimental treatment shortly after he was diagnosed with COVID-19, The New York Times reported.

Trials

Trials Hospitals Drugs FDA

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Human constraints also play a role at a later stage, when clinical trials are involved.”

DNA

DNA RNA Molecular Biology Laboratories

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. The three opinions—the majority opinion and the two dissents—are worth reading.

Animal Testing

Animal Testing Research Laboratories Hospitals

Drug Discovery Digest

4 Unique Challenges of Oncology Trials

Ubiquitous pyrogens and 3D cancer models

Webinars

Trending Sources

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

Webinars

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

Human neuronal cells: possibilities in drug safety testing

Exploring alternatives to animal testing in drug discovery

A therapy candidate for fatal prion diseases turns off disease-causing gene

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

Raising Welfare for Lab Rodents

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

Origins of the Lab Mouse

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

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectivenes

Levers for Biological Progress

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

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