Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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Agency IQ

AUGUST 11, 2023

While the notice itself does not spell out “BEST,” AgencyIQ would assume it means the Biologics Effectiveness and Safety (BEST) System , a branch of the FDA’s active surveillance initiative for drug products, Sentinel. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. What programs or products need a DAP? Read AgencyIQ’s extensive analysis of the draft guidance here.]

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. The Phase 2b trial is expected to begin during the second half of 2021.

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Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.

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Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

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PPD

APRIL 14, 2025

Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

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Drug Target Review

OCTOBER 16, 2024

In reality, our deep understanding of disease pathology and patient needs is instrumental in shaping both basic and clinical research into viable treatments. This flexibility fosters creativity and productivity. We’ve seen significant progress in representation, especially in leadership roles.

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The Pharma Data

OCTOBER 14, 2020

The new services have been developed to support pre-clinical research by optimizing hiPSC-derived cell culture, while providing high-quality electrophysiological data acquisition and analysis from physiologically relevant human cell models. Axol Bioscience – Based in the U.K., Growth Programme. Dolmatics – U.K.-based

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The Anticancer Fund

APRIL 1, 2022

This randomised controlled phase I/II trial assessed the safety, pharmacokinetic impact, and efficacy of the GR antagonist mifepristone (Mif) in combination with enzalutamide vs enzalutamide alone for CRPC. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). population demographics.

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PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Does your CRO look after your most valuable resources?

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Clinical Trials Drug Development Trials Clinical Research 52

The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. after ischemic heart disease and stroke. A specific pediatric oncology guidance is also available.

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.] What do DAP submissions entail?

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The Pharma Data

DECEMBER 23, 2020

Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife. The TMVR technology developed by HighLife uses a transeptal approach to treat patients with MR, and is currently evaluated in international clinical studies in more than 20 sites on three continents. .

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

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