Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. What Was your dream job as a child?

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PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

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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. We have you covered in our comprehensive overview of outsourced clinical trial models.

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Clinical Trials Drug Development Trials Clinical Research 52

The Pharma Data

AUGUST 9, 2021

Safety outcomes were consistent with those seen in previous trials. The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level. Roche’s Chief Medical Officer and Head of Global Product Development.

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International Treatment Pharmacokinetics Therapies 52

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

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Biochemical Assays Treatment Bioinformatics Disease 98

The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. This pharmacokinetic study (n=9) compared half-dose erlotinib (75 mg/day) with the HIV drug ritonavir (200 mg/day) with full-dose erlotinib (150 mg/day).

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Clinical Trials Drugs Trials Treatment 40

The Anticancer Fund

APRIL 1, 2022

A small phase I clinical trial (NCT04942626) is testing this hypothesis in rectal cancer patients. In this small (n=25) Phase I clinical trial imiquimod was compared to topical ascorbic acid (30% solution) for 8 weeks. These results are supportive of further clinical trial investigation in this very common cancer.

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Clinical Trials Drugs Trials Pharmacokinetics 40

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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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. This enables patient selection, stratification and other adjustment in clinical trial design planning.

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Clinical Trials Trials Treatment Disease 40

Agency IQ

AUGUST 11, 2023

In AgencyIQ’s thinking, the contract notice could also indicate that the FDA is working to build out its capabilities related to its new authority to conduct RRAs of facilities involved in clinical trials. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

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The Pharma Data

SEPTEMBER 1, 2021

The safety profile observed in the trial was consistent with previous studies of INVEGA SUSTENNA ® and INVEGA TRINZA ® with no new safety signals emerging. 5%) in the INVEGA HAFYERA™ clinical trial were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

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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. Global trials, enrollment targets, and how to account for a DAP population Quick definition: What are the enrollment goals?

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Science FDA Production Trials 40

The Pharma Data

OCTOBER 14, 2020

The designation of lanifibranor as a Breakthrough Therapy for the treatment of NASH follows the publication in June 2020 of positive topline results from Inventiva’s NATIVE Phase IIb clinical trial with lanifibranor in NASH patients. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.

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Clinical Trials Trials Pharmaceuticals Therapies 52

The Pharma Data

DECEMBER 23, 2020

Additionally, Avacta announced it submitted a Clinical Trial Application in the UK for a Phase 1, first-in-human, open label, dose-escalation and expansion study of its lead pre|CISION prodrug, AVA6000, in patients with locally advanced or metastatic selected solid tumors.

Licensing 52

Licensing Licensing Vaccine Trials 52

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. As AgencyIQ discussed in-depth at the time , the committee grappled with data flaws and gaps within the context of positive trials and high unmet need.

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The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM. and in Europe.

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Trials Disease Treatment Pharmacokinetics 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. DAPs for clinical trials are not new inventions, as previously mentioned; however, the new mandates under FDORA are designed to shift these plans from “should” to “must.”

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The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). of participants in the trial, respectively.

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Clinical Trials Treatment Trials Disease 52

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs.

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