Drug Target Review

MARCH 24, 2025

Promising areas for AI implementation When discussing the most transformative AI applications in drug discovery, Sujeegar identifies a particularly ambitious goal: developing AI models that can simulate human pharmacokinetics and pharmacodynamics (PK/PD) using only preliminary laboratory data.

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Codon

NOVEMBER 3, 2024

Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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Collaborative Drug

OCTOBER 7, 2024

CDD Vault is affordable to academic laboratories, research foundations, and small companies. Learn more about the benefits of CDD Vault and get your free trial: It has never been easier to collect all your screening data, calculate dose-response, and build SAR tables.

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PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

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Drug Discovery Today

DECEMBER 3, 2021

Alderley Park, Cheshire – One of the UK’s leading infectious disease biotech companies has announced a breakthrough in laboratory trials of a new drug to treat COVID-19 and new variants of the disease, such as the Omicron variant.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Precision for Medicine

APRIL 7, 2023

The custom-designed laboratory accommodates the growth in demand for advanced digital pathology and imaging capabilities, expertise in molecular sciences and a wide array of sequencing technologies. The expansion significantly increases the sample processing capacity of the laboratory. Canada, Europe, and Australia.

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Laboratories Clinical Research Clinical Trials Cell Biology 52

Broad Institute

OCTOBER 3, 2023

Broad Clinical Labs established to expand clinical services By Leah Eisenstadt October 3, 2023 Breadcrumb Home Broad Clinical Labs established to expand clinical services Formerly the Clinical Research Sequencing Platform, the cutting-edge laboratory at the Broad Institute is poised to further accelerate clinical genomics.

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Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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ProRelix Research

MAY 22, 2024

The transition of a drug, medical device, or biopharmaceutical from the laboratory bench to bedside involves a long series of steps starting from drug discovery, computational chemistry, in vitro and […] The post Requirements to Conduct First-in-Human (FIH) Clinical Trials for Biopharmaceuticals appeared first on ProRelix Research.

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Clinical Trials Computational Chemistry Trials Laboratories 52

Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Conversations in Drug Development Trends

SEPTEMBER 20, 2023

Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand binding assays.  The post Bioanalysis through automation: Our top four takeaways appeared first on Worldwide Clinical Trials. Download our poster today.

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The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

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Conversations in Drug Development Trends

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

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The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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Advarra

JUNE 30, 2023

The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible for Medicaid in April 2022. However, a year has passed with no further updates on this letter or Medicaid beneficiaries enrolling in clinical trials. outlining routine costs in clinical trials.

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SCIENMAG: Medicine & Health

JUNE 26, 2023

Copenhagen, Denmark: Women are just as likely to give birth to live babies after fertility treatment if embryos are transferred to their wombs three days after fertilisation in the laboratory rather than five.

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Labcorp Drug Development

APRIL 24, 2023

Every clinical trial relies on data from its study participants to inform decisions regarding the safety and efficacy of a potential new treatment. Clinical trial sponsors rely on the data from laboratory tests to bring clear insights that advance studies.

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Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinical trials  (DCTs) continue to expand and have become a standard solution for drug developers.

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PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Drug Target Review

DECEMBER 11, 2024

Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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International Laboratories Drugs Pharmacokinetics 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Molnupiravir.

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Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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Clinical Trials Laboratories Regulations Clinical Research 59

Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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Broad Institute

JULY 8, 2024

This could lead to more accurate preclinical trials and better predictions of clinical outcomes. Success in this area would mean that organoids could become pre-clinical trial 'avatars' informing on the differential responses of the cells of the brain of each individual to begin to predict clinical outcomes," Arlotta said.

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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Karl Landsteiner in his New York laboratory. In each case, megakaryocyte cells in the laboratory only produced on the order of tens of platelets, far short of the 1,000 platelets generated per megakaryocyte in the human body.

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The Pharma Data

AUGUST 30, 2021

A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “ In 2016, the U.S.

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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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.

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