Drug Target Review

JULY 12, 2023

Many cell lines used in pancreatic cancer research, for example, are generally not genetically aligned with most patients in the clinic. If researchers continue to use an intuitive approach of chronically suppressing the MAPK pathway, we will likely continue to see the same results in patients with little improvement.

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Biochemical Assays Treatment Bioinformatics Disease 98

Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials 52

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Alta Sciences

AUGUST 28, 2023

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study.

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Vial

MARCH 15, 2024

A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

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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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PPD

OCTOBER 12, 2023

Parallels between pharmacokinetic (PK) analyses for CGTs and immunotherapies, conducted through PCR-based assays and plate-bound antibody assays, respectively, can inform a successful approach. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

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. Could you share an example of a specific project or research that you have worked on and the impact it has had in your field?

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Clinical Development Drug Development Therapies Disease 52

PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. Bonus: Can your CRO singlehandedly advance your molecule from research to market?

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Clinical Trials Drug Development Trials Clinical Research 52

The Pharma Data

AUGUST 9, 2021

POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level.

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International Treatment Pharmacokinetics Therapies 52

The Anticancer Fund

APRIL 1, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. All articles need to be critically assessed and viewed in their broader research context. Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ).

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Clinical Trials Drugs Trials Pharmacokinetics 40

The Anticancer Fund

JUNE 7, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. All articles need to be critically assessed and viewed in their broader research context. Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ).

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Clinical Trials Drugs Trials Treatment 40

The Pharma Data

SEPTEMBER 1, 2021

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva*, M.D., DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

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FDA Approval FDA Treatment Clinical Trials 52

Agency IQ

AUGUST 11, 2023

These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

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FDA Compliance Clinical Trials Pharmacokinetics 40

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. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Clinical Trials Trials Treatment Disease 40

The Pharma Data

DECEMBER 23, 2020

Ilya Pharma – Sweden’s Ilya Pharma announced it extended its research collaboration in immunophysiology with Uppsala University. The study’s primary endpoints include safety, tolerability and pharmacokinetics of anle138b in Parkinson’s patients in order to establish the optimal dosing scheme for future long-term efficacy trials.

Licensing 52

Licensing Licensing Vaccine Trials 52

The Pharma Data

OCTOBER 14, 2020

AOP anticipates new opportunities in Austria as a hub for research and business. 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.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

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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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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Trials Disease Treatment Pharmacokinetics 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

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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. Abstracts include company-sponsored and collaborative studies with academic partners such as Brigham and Women’s Hospital and Cleveland Clinic.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.

Clinical Trials 52

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. See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ].

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