NIH Director's Blog: Drug Development

SEPTEMBER 27, 2022

Now a new study published in the journal Science Advances [1] demonstrates the promise of wearables also extends to the laboratory. A team of engineers has developed a flexible, adhesive strip that, at first glance, looks like a Band-Aid.

Drug Development 52

Drug Development Drugs Engineering Therapies 52

Drug Target Review

AUGUST 28, 2024

Most recently Dr Brass was Vice President, Head of Clinical Sciences for Hepatology, Gastroenterology and Transplantation in Global Drug Development at Novartis. He is named on 15 patents relating to drug development in liver disease.

Therapies 116

Therapies Disease Engineering Medical Schools 116

BMG Labtech

MARCH 11, 2024

Enzyme-Linked Immunosorbent Assays (ELISAs) are an essential technique in today’s laboratory with many applications in the life sciences. They are often the method of choice to detect or measure specific biological molecules (analytes) for diagnostics, drug discovery or fundamental research.

Vaccine 98

Vaccine Molecular Biology Laboratories Virus 98

Agency IQ

JULY 22, 2024

BY LAURA DIANGELO, MPH In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

FDA 59

FDA Laboratories Regulations Drug Development 59

PPD

MARCH 13, 2024

Laboratories Clear coordination for timely delivery of collection kits ensures there are no on-site delays once the allocated slot has been assigned and the patient’s journey has begun.

Clinical Development 95

Clinical Development Clinical Trials Therapies Trials 95

PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

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 52

Clinical Research Clinical Trials Research Trials 52

PPD

JULY 20, 2023

For companies that do not have a dedicated, experienced laboratory partner, retesting packaging is a heavy lift with downstream impacts on patient safety. pharmaceutical company enlisted PPD Laboratory services to establish USP-NF <661.2> Recently, a major U.S.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

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.  .” In case you missed it, we’ve highlighted the top four takeaways: 1.

Clinical Trials 87

Clinical Trials Laboratories Trials 87

PPD

DECEMBER 18, 2023

A good central lab will help reduce the costs and accelerate the timeline of a sponsor’s drug development program. A laboratory services partner that provides globally standardized clinical testing, centralized data visibility and a robust drug development database solution will help drive clinical trial success.

Clinical Trials 52

Clinical Trials Laboratories Trials Drug Development 52

Reprocell

NOVEMBER 1, 2022

1 The piece, titled "How science is getting closer to a world without animal testing", explores the complicated relationship between drug development and animal research, and lists some of the alternatives that are being used in laboratories today.

Animal Testing 52

Animal Testing Pharma Companies Laboratories Drug Development 52

Labcorp Drug Development

APRIL 24, 2023

Clinical trial sponsors rely on the data from laboratory tests to bring clear insights that advance studies. Labcorp Central Laboratory Services generates more clinical trial data than … The post What does a central lab do? 4 core services to know appeared first on Insights From Our Labs to Yours.

Clinical Trials 52

Clinical Trials Laboratories Trials Treatment 52

Conversations in Drug Development Trends

JANUARY 24, 2024

Fortunately, today, various genetic testing laboratories have significant amounts of genetic and genomic data that can support life cycle management, clinical development plans, and country/site selection. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Alta Sciences

NOVEMBER 13, 2024

Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Drug Development Pharmaceuticals 40

The Connected Lab

APRIL 8, 2020

How is AI being applied in Drug Discovery efforts? It is reported that every one of the major pharmaceutical companies has announced a partnership with at least one AI-based drug development company, but how is AI being used to facilitate drug development?

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

The Connected Lab

JUNE 2, 2021

The impact of these technologies on drug development, production and logistics is so disruptive that many consider the sector to be entering a fourth industrial revolution, known as Pharma 4.0. Sharing data from process sensors, laboratory instruments, and other relevant monitoring systems sits at the heart of the Pharma 4.0

Pharmaceuticals 52

Pharmaceuticals Laboratories Pharmaceutical Companies Production 52

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

These body-on-a-chip (BOC) devices place each tissue type in its own pea-sized chamber and connect them via fluid-filled microchannels into living, integrated biological systems on a laboratory plate. For those drug candidates that are ultimately doomed, “failing early” is key to reducing drug development costs.

Drugs 72

Drugs Science Treatment Clinical Trials 72

Drug Target Review

NOVEMBER 15, 2023

Each team supplies valuable insights throughout the design-make-test-analyse (DMTA) cycle to enable the effective design and optimisation of high-calibre drug candidates. Providing specialist and unique insight, CROs can propel a drug discovery process forward.

Pharmacokinetics 105

Pharmacokinetics International Laboratories Drugs 105

Alta Sciences

FEBRUARY 7, 2024

Strategic Biomarker Integration blussier Wed, 02/07/2024 - 19:27 HTML Optimizing Drug Development With Biomarkers The strategic integration of biomarkers into the drug development process empowers sponsors with critical information at every stage. VIEW FACT SHEET Is the assay you are looking for missing?

Laboratories 40

Laboratories Drug Development Science Drugs 40

Broad Institute

JULY 17, 2024

Srijit Seal, a visiting scholar at the Carpenter-Singh Lab in the Broad's Imaging Platform , trained multiple predictive machine learning models to identify chemical and structural drug features likely to cause toxic effects in humans. A fourth is in the works.

Pharmacokinetics 84

Pharmacokinetics Molecular Biology Drugs FDA 84

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. 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.

International 52

International Laboratories Drugs Pharmacokinetics 52

The Connected Lab

MAY 31, 2022

Poor interoperability between traditional software applications has meant laboratories must typically use separate, vendor-specific systems to store, manage and analyze data generated by different instrument fleets. The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors.

Laboratory Informatics 52

Laboratory Informatics Laboratories Compliance Pharmaceuticals 52

The Pharma Data

SEPTEMBER 9, 2020

. In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. Develop a fully automated environment to significantly boost research efforts.

Production 52

Production Laboratories Compliance Government 52

Drug Target Review

FEBRUARY 19, 2024

Together with many fellow researchers globally, in academic and industry laboratories, we demonstrated that, and more importantly, how p53 worked as a tumour suppressor molecule. I am proud to have contributed to the advancements in monoclonal antibody discovery and development. BECOME A ROLE MODEL!

Molecular Biology 110

Molecular Biology Science Protein Expression Production 110

Drug Target Review

SEPTEMBER 19, 2023

Some of the complex 3D models such as organoids and organ-on-chips have brought in realistic make-over to the drug screening and paved way into implementing high content screening, laboratory automation and miniaturisation in primary drug screening process. Microengineered physiological biomimicry: Organs-on-Chips.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Conversations in Drug Development Trends

DECEMBER 12, 2022

What is the difference between a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory vs a research laboratory? The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on human samples in the US through CLIA.

Clinical Trials 52

Clinical Trials Trials Laboratories Research Laboratories 52

The Pharma Data

NOVEMBER 26, 2020

Study will expand access to antibody testing outside of laboratory settings. “ DNA Link’s AccuFind performs very well in laboratory settings. is a leading genomic service corporation based in Korea with a focus on personalized medicine and new drug development. CHICAGO , Nov. About DNA Link, Inc.

DNA 52

DNA Nurses Research Laboratories 52

The Pharma Data

DECEMBER 16, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

The Pharma Data

JANUARY 19, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

The Pharma Data

NOVEMBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

The Pharma Data

OCTOBER 27, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

As an important step in this direction, NIH-funded researchers at the Morgridge Institute for Research and University of Wisconsin-Madison have produced neural tissue chips with many features of a developing human brain.

RNA 52

RNA Laboratories Science Clinical Trials 52

Drug Target Review

NOVEMBER 6, 2023

Before joining AstraZeneca, he served as the Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center (MSKCC) and led a laboratory focused on drug development for patients with lymphoid malignancies.

Small Molecule 111

Small Molecule Therapies Treatment Disease 111

Conversations in Drug Development Trends

AUGUST 14, 2024

While biomarkers must undergo rigorous validation and regulatory processes, it’s important to ensure the methods for biomarker testing are consistent and accurate across different laboratories and clinical settings. However, at Worldwide, we have a proven track record of successfully utilizing biomarkers in oncology development.

Treatment 78

Treatment Therapies Disease Protein Expression 78

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52