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.

FDA Approval 264

FDA Approval Laboratories FDA Research 264

Broad Institute

APRIL 5, 2025

The organization has honored Liu for the development of the gene editing platforms base editing and prime editing, which can correct the vast majority of known disease-causing genetic variations and have already been used in at least 15 clinical trials, with life-saving results.

Science 144

Science Clinical Trials DNA Disease 144

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.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

Drug Target Review

APRIL 30, 2025

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?

Drugs 90

Drugs Therapies Clinical Trials Trials 90

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.

Therapies 72

Therapies Clinical Supply Clinical Trials Trials 72

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.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

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.

Clinical Trials 59

Clinical Trials Animal Testing Drugs Pharmacokinetics 59

Fierce BioTech

JUNE 17, 2025

Whether you're navigating your first trial or scaling a growing pipeline, see how a purpose-built lab model can help you move smarter and faster. Whether you're navigating your first trial or scaling a growing pipeline, see how a purpose-built lab model can help you move smarter and faster.

Laboratories 52

Laboratories Trials 52

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.

Laboratories 113

Laboratories Drugs Disease Trials 113

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.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Reprocell

NOVEMBER 14, 2024

To address the issues of time and cost, pharmaceutical companies rely on central laboratories (CLs) for consistency, organization, and efficiency during the clinical trial phase, which is essential for drug approval.

Marketing 52

Marketing Pharmaceutical Companies Clinical Trials Laboratories 52

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.,

Laboratories 45

Laboratories Clinical Trials Clinical Research Compliance 45

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.

Clinical Research 131

Clinical Research Clinical Trials Laboratories Trials 131

Advarra

JULY 3, 2025

Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness.

Compliance 52

Compliance Trials Clinical Trials Laboratories 52

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?

Clinical Trials 52

Clinical Trials Trials Laboratories Research Laboratories 52

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).

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials. National Research Council.

Drug Research 52

Drug Research Research Animal Testing Drugs 52

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.

Clinical Trials 59

Clinical Trials Trials FDA Production 59

Drug Target Review

JUNE 19, 2025

SRP-001 has already moved beyond the laboratory. South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. The next milestone is a Phase II trial, aiming to begin in 3Q2025, evaluating SRP-001 in acute pain following third molar extraction (wisdom tooth removal).

Clinical Trials 52

Clinical Trials Molecular Biology Treatment Trials 52

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.

Clinical Trials 52

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.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

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.

Clinical Trials 87

Clinical Trials Laboratories Trials 87

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

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.

Clinical Trials 52

Clinical Trials Regulations Drugs Trials 52

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.

Clinical Trials 52

Clinical Trials Trials Laboratories Research 52

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.

Clinical Trials 69

Clinical Trials Laboratories Trials Treatment 69

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.

Clinical Trials 52

Clinical Trials Laboratories Trials Treatment 52

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.

Clinical Trials 134

Clinical Trials Trials Small Molecule Disease 134

The Pharma Data

SEPTEMBER 22, 2020

Clinical trials testing Russia’s Sputnik-V coronavirus vaccine in India could begin in the next few weeks, according to Indian pharma firm Dr Reddy’s Laboratories Ltd. . The trials are part of a deal by Dr Reddy’s and the Russian Direct Investment Fund (RDIF). Photo by NIAID. Dr Reddy’s signed a deal with the RDIF last week.

Clinical Trials 52

Clinical Trials Vaccine Trials Laboratories 52

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?

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

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.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

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.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

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.

International 52

International Laboratories Drugs Pharmacokinetics 52

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

None of these approval trials was conducted among opioid overdose patients at risk for naloxone-precipitated withdrawal. The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4

FDA Approval 52

FDA Approval Pharmacokinetics Packaging FDA 52

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.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

FDA Approval 52

FDA Approval Therapies FDA Trials 52

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.

Therapies 118

Therapies Clinical Trials Cell Biology Trials 118