Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. All types of activities encouraging women in STEM is important, like this article.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This article provides a comparative overview of Vial and IQVIA. increase on a reported basis and an 4.8%

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. As von Itzstein et al.

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Conversations in Drug Development Trends

FEBRUARY 6, 2023

For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases. Read the full article!

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Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Conversations in Drug Development Trends

OCTOBER 31, 2023

Discover how to strengthen site partnerships, develop a strong sponsor-CRO partnership, earn a patient’s confidence during a study, and more in our article: Trust: The Key to Operational Success in Post-COVID Oncology Trials.

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The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric.

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Alta Sciences

SEPTEMBER 13, 2023

Pain models can be important clinical tools to characterize a novel analgesic, and determine its potential effectiveness in models simulating varying pain stimuli. Here are four main pain models we use to assess treatments in clinical trials: 1. At Altasciences , we have extensive experience testing various pain models.

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Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

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Vial

DECEMBER 11, 2023

According to a study by the Tufts Center for the Study of Drug Development, the average time from site identification to study start-up completion is approximately 31.4 Site selection and assessment Embarking on the journey of clinical research site start-up begins with the process of site selection and assessment.

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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. The drug development industry is undoubtedly in a season of change.

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Vial

DECEMBER 5, 2023

Next-generation sequencing (NGS) has revolutionized scientific research and clinical genomics due to high-throughput multiplexing and shed light on genome structure, function, and dynamics. It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development.

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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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Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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Vial

FEBRUARY 15, 2024

According to the 2022 Polaris Market Research Report , the global clinical trials outsourcing market reached USD 38.11 This article discusses current challenges in managing clinical trials and elucidates the pivotal role that CROs play in overcoming these obstacles. over the forecast period (2022-2030).

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Vial

MAY 1, 2024

Among the leading contract research organizations (CROs) providing these technologies are Castor, with its established reputation for reliable EDC technology, and Vial CRO, a newer player quickly becoming well-known for its digital innovation.

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Vial

MARCH 25, 2024

Lastly, Vial’s experienced CRO executive team works closely with the expert site operations team to continuously review execution strategies, closely monitor patient recruitment efforts, and mitigate key study risks for all its clinical trials. According to Hardman et al.,

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Vial

FEBRUARY 26, 2024

The pharmaceutical and biotechnological landscape is constantly evolving and a key partner within the drug development process is contract research organizations (CROs) , who are at the forefront with sponsors to drive innovation in clinical research.

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Vial

DECEMBER 13, 2023

Strong and meaningful site, sponsor, and contract research organization (CRO) relationships enable efficient and effective clinical trials. This article presents strategies sponsors can develop to build strong site relationships at scale.

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Clinical Trials Trials Clinical Research Research 52

Vial

MAY 13, 2024

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. An estimated 80% of clinical trials do not finish on time. What are CROs doing to deliver for sponsors?

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Vial

MARCH 27, 2024

In this article, we delve into the factors influencing costs of working with a CRO, expenses associated with clinical trials, and whether CROs are more cost-effective than sponsors acquiring support themselves. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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Drug Target Review

DECEMBER 13, 2024

Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Fcgamma Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates. Antibody-drug conjugates: Principles and opportunities. MET alterations in advanced non-small cell lung cancer.

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The Anticancer Fund

OCTOBER 22, 2021

Our intention is to help bring these findings to the attention of the broader cancer research community. Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context.

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The Pharma Data

OCTOBER 22, 2020

Conclusive Evidence from Rigorous Clinical Trials Nine months later, results from the randomized, controlled trials of Veklury involving thousands of patients have been published in peer-reviewed journals, conclusively demonstrating the clinical benefits of treatment with Veklury. Published online on October 8, 2020. Source link.

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Agency IQ

SEPTEMBER 1, 2023

These evaluations will inform the suitability of the data source to the clinical research question and estimate how precise its outcomes may be. In other words, the sponsor needs to be familiar with the data in the chosen RWD source in order to understand what relevant questions it may answer.

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Agency IQ

OCTOBER 27, 2023

Start Date End Date Event Event Type Center 10/30/2023 10/30/2023 Defining ‘Candy-Like’ Nonprescription Drug Products Workshop CDER 10/31/2023 10/31/2023 Cellular, Tissue, and Gene Therapies Advisory Committee Advisory Committee Meeting CBER 10/31/2023 10/31/2023 Webinar – Proposed Rule: Medical Devices; Laboratory Developed Tests (..)

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. has published psychedelic-specific guidance and has several ongoing psychedelic clinical trials.

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Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

MAY 28, 2024

drug supply chain’s heavy reliance on foreign countries, especially those that are considered “adversarial” to the United States, said E&C Committee Chair CATHY MCMORRIS RODGERS (R-Wash.). A number of E&C Committee members remain concerned about the U.S.

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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

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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.]

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