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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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

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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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Drug Target Review

JUNE 6, 2023

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Currently he is Alkermes’ Oncology Fellow and Head of a Oncology Preclinical Research at the company.

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Drug Discovery World

APRIL 10, 2024

There is a significant need for clinical research and treatment options for newborns with severe, neonatal onset OTC deficiency,” said Gabriel Cohn, Chief Medical Officer of iECURE. Secondary objectives are to assess the pharmacokinetics and efficacy of ECUR-506.

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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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Drug Discovery World

JULY 11, 2024

Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK. Katharina Klapper, Director of Clinical Research at MJJF, added: “Mission Therapeutics has made great advances in the understanding of how mitochondrial health can play a pivotal role in the development of PD in recent years. million from The Michael J.

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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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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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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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Drug Discovery World

APRIL 11, 2024

The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research. Research highlights Blacksmith Medicines announced preclinical data on its oncology programme targeting flap endonuclease 1 (FEN1). And thanks to the city of San Diego for its hospitality.”

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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

SEPTEMBER 19, 2023

Our early development organization expanded offerings in Phase Ib patient trials to characterize the pharmacokinetics and pharmacodynamics in patients and to assess safety and early efficacy signals. We have three PPD clinical research units, located in Austin, Texas , Orlando, Florida , and Las Vegas, Nevada.

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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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Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. National Institutes of Health researcher Ping Jin, Ph.D.

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Drug Discovery World

AUGUST 8, 2022

SS: Doing clinical research and development in any rare disease including haemophilia is very different from diseases with a larger population, such as diabetes. A Research Study Investigating Mim8 in People With Haemophilia A (FRONTIER1) (NCT04204408). References . 1 ClinicalTrials.gov.

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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.

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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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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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Drug Discovery World

FEBRUARY 20, 2023

An ongoing Phase I clinical trial will assess the safety and pharmacokinetics of AVA6000, which has potential in a range of cancer types. Capivasertib could offer a completely new treatment option for these patients.

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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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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.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

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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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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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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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

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.

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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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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.

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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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