Drug Discovery World

JULY 11, 2023

Given the state of the field, much of the FDA guidance to date has been around the regulation of AI in medical devices. In 2021, the FDA published an action plan regarding the use of AI and ML as software for medical devices 4 , and this year they published the long-awaited guidance on Clinical Decision Support Software 5.

Big Data 40

Big Data Development Life Science Drugs 40

pharmaphorum

APRIL 15, 2021

Collaboration when innovating in areas of high unmet medical need is critical and at Astellas, it means experts with highly specialised knowledge of these new discoveries often work in close partnership with regulators. “We We connect these subject matter experts with the regulatory authorities to facilitate information exchange.

Development 66

Development Manufacturing Production Bioinformatics 66

STAT News

MARCH 6, 2023

“There isn’t a member of the board of JLF who wouldn’t rather be able to do this without charging people,” said Andrew Jacobs, who sits on the boards of the foundation and NorRD Bio, a small Cambridge bioinformatics firm that helps make the vaccines. “It really was a choice of this or nothing.”

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Vaccination Vaccine Drugs Clinical Trials 98

Drug Discovery World

APRIL 14, 2023

He is being recognised for illuminating research contributions to defining the links between chromosomal abnormalities and cancer, including his discovery of TMPRSS2-ETS gene fusions in prostate cancer, and for pioneering the use of pathological and bioinformatic methodologies to diagnose and track prostate cancer onset and progression.

Genetics 52

Genetics Research Medicine Clinical Research 52

XTalks

NOVEMBER 7, 2022

Optimal methods for bioinformatic analysis are still needed. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study. There is a high risk of false positives and false negatives (variant allele frequencies [VAFs] at frequencies <0.5 percent show less reliability).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

JULY 27, 2021

Teneobio’s discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat® and OmniFlic®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. About Teneobio Teneobio, Inc. Our business may be impacted by government investigations, litigation and product liability claims.

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Production Antibody Sales Manufacturing 52

Drug Discovery World

JULY 29, 2022

Scientists from seven research institutions including the University of Oxford and the University of Edinburgh have used pioneering bioinformatic modelling to investigate the molecular interactions of the p53 protein known to give protection against cancers.

Gene 52

Gene DNA Protein Genetics 52

XTalks

SEPTEMBER 5, 2023

The EMA and other agencies have stringent regulations and guidelines that cover the design of clinical development programs for new vaccines intended to provide pre- and post-exposure prophylaxis against infectious diseases.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

The Pharma Data

JANUARY 10, 2021

I actually think neuroscience is going to heat up in 2021,” said Ben Zeskind , co-founder and CEO of Immuneering , which is using bioinformatics and computational biology to develop new drugs in this space, along with oncology and immuno-oncology. 2020 Was Educational for Industry & Regulators.

Vaccination 52

Vaccination Vaccine Regulation Drugs 52

pharmaphorum

SEPTEMBER 14, 2020

While there may be just under 20,000 confirmed protein coding genes, it turns out that much of the genome outside of these genes is also important in regulating how the genome is controlled. Bioinformatic techniques are then used to piece together the reads into a continuous genomic sequence by aligning them to the reference human genome.

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Genome Genomics Medicine Gene 119

Drug Discovery World

NOVEMBER 13, 2023

Novel/alternative ML-enabled screening technologies for higher POS Following chairperson’s remarks from M Frank Erasmus, PhD, Head, Bioinformatics, Specifica, there will be four presentations and a panel discussion.

Protein 59

Protein Antibody Engineer Scientist 59