Broad Institute

JUNE 27, 2024

Delivering genes into the human brain is challenging; many clinical trials have used adeno-associated viruses (AAVs) as gene-delivery vehicles, which are small and can only contain a small amount of genetic code.

Disease 142

Disease Therapies Clinical Trials Engineering 142

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 52

Drug Development Clinical Trials Animal Testing Trials 52

Reprocell

MARCH 6, 2023

expands the range of models that can be used to test a compound before clinical trials. 1 Under this new law animal testing can still be used, but alternative testing methods now also represent a legitimate option. With support from over 200 organizations, the "FDA Modernization Act 2.0"

FDA 52

FDA Animal Testing Clinical Trials Trials 52

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 112

Animal Testing Therapies Clinical Trials Research 112

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.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

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. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al.

Drugs 112

Drugs FDA Disease Animal Testing 112

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 40

FDA Animal Testing Clinical Trials Pharmaceuticals 40

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 64

FDA Packaging Animal Testing Production 64

Drug Target Review

OCTOBER 3, 2024

FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al. Antibodies to watch in 2024. 2024 Jan 5;16(1). www.science.org. Available from: [link] ‌Baker M. Reproducibility crisis: Blame it on the antibodies. 2015 May;521(7552):274–6.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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 40

FDA Science Small Molecule Immune Response 40

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 119

Research Engineering Disease Science 119

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 106

Animal Testing Drugs Pharmacokinetics Regulations 106

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. The guidance notes that all approaches should be justified.

Trials 40

Trials Marketing Clinical Trials Disease 40

PLOS: DNA Science

APRIL 4, 2024

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. The chemo trial preceded Lume by more than a decade, so you’d think the product name would have been better researched. Remember the statins?

Disease 89

Disease Production Testimonials FDA 89

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. Each animal had a different microbiome. Free-range mice? .” A third experiment found no effect.

DNA 52

DNA Laboratories Engineering Animal Testing 52

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 123

Laboratories Research Disease Science 123

The Pharma Data

OCTOBER 27, 2020

National Institute of Allergy and Infectious Diseases, which sponsored the Lilly study, pulled the plug on the trial Monday — not because of any safety problem, but because there was only a slight chance that the drug would be effective, the AP said. But the U.S. Food and Drug Administration while late-stage studies continue.

Trials 52

Trials Hospitals Drugs FDA 52

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 40

FDA Packaging Science Drugs 40

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 59

Therapies FDA Production Disease 59

Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA 114

DNA RNA Molecular Biology Laboratories 114

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 98

Animal Testing Research Laboratories Hospitals 98