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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Conversations in Drug Development Trends

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Cytel

DECEMBER 19, 2022

Adaptive clinical trial topics are frequently explored in Perspectives on Enquiry and Evidence. Here are some of our most-read articles on adaptive clinical trials of 2022.

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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.

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Drug Target Review

MARCH 17, 2025

This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK. With over 25 years of experience in the pharmaceutical industry, Donello has been instrumental in drug discovery and development.

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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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Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking.

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Agency IQ

FEBRUARY 12, 2024

Far from just an outline of the work completed by Consortium members to date, the Playbook is a thoughtfully organized “how-to-guide” which walks readers through some of the major milestones of early clinical development in just over one hundred pages.

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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. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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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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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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Cytel

NOVEMBER 6, 2023

The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any drug development project.

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Cytel

FEBRUARY 14, 2024

During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common mistakes drug developers make that can be avoided if they consider their regulatory strategy and adapt it over time.

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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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Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Antibody-drug conjugates: Principles and opportunities. Phuna ZX, Kumar PA, Haroun E, Dutta D, Lim SH. 2024;347:122676. BMC Cancer. 2024;24(1):898.

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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.

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Vial

MARCH 25, 2024

In the past three years, Worldwide has collaborated on 105 oncology studies supported by a global team of oncology clinical development experts. Sponsors increasingly depend on CROs for specialized expertise, global reach, and data capabilities and to navigate the evolving landscape of clinical research and drug development.

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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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Labcorp Drug Development

APRIL 17, 2023

In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an … The post Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct appeared first on Insights From Our Labs to Yours.

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The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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Cytel

JUNE 5, 2023

Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative, computational, regulatory, and strategic drug development capabilities.

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Cytel

JUNE 5, 2023

Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative, computational, regulatory, and strategic drug development capabilities.

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Cytel

MARCH 13, 2023

For this edition of the Industry Voices series, Cytel’s Chief Scientific Officer Yannis Jemiai discusses the current landscape of simulation-guided design, the enhanced role of biostatisticians in drug development, applications of SGD, and a vision of the future in which SGD enables new statistical methodologies.

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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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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.

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Agency IQ

JULY 21, 2023

An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development. EMA notes in the paper that many learnings and best practices from areas such as model informed drug development and biostatistics also can be applied to AI. image refinement).

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Agency IQ

DECEMBER 11, 2023

Progression-free survival (PFS) has been used for accelerated approval, traditional approval, and for measuring direct clinical benefits in certain circumstances. [ For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article.

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Agency IQ

SEPTEMBER 22, 2023

The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process. When should this occur? at the end-of-phase 2 meeting).

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The Pharma Data

NOVEMBER 24, 2020

The safety and efficacy of Oxlumo are also being evaluated in the ongoing ILLUMINATE-C Phase 3 clinical trial in patients of all ages with advanced PH1, including patients on dialysis. Related Articles: Oxlumo (lumasiran) FDA Approval History. Visit OXLUMO.com for more information, including full Prescribing Information.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development.

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Agency IQ

JUNE 26, 2023

Per the 2014 guidance, “Ideally, a therapeutic product and its corresponding IVD companion diagnostic device should be developed contemporaneously, with the clinical performance and clinical significance of the IVD companion diagnostic device established using data from the clinical development program of the corresponding therapeutic product.”

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Agency IQ

AUGUST 16, 2024

Just a few months after the draft guidance on dose optimization was published, a handful of OCE staff, including its leaders, published a landmark article in March 2023. [Read the analysis of the comments submitted here] Since then, this topic has continued to be a priority for the FDA. To be [administered with] food or not to be?

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Agency IQ

AUGUST 2, 2024

On the medicines side, the EMA’s Methodology Working Party is slated to take on guidelines on the use of AI in clinical development. Analysis and what’s next Even with HHS re-organizing to take a more concerted lead on AI policy, the FDA is continuing ahead with its own projects.

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Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The financial burden of drug development is substantial, often exceeding $2 billion per drug.

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Drug Target Review

APRIL 1, 2025

Founded in 2021, SynaptixBio is working to develop therapies for TUBB4A leukodystrophies – a group of rare and severe neurological disorders. Co-founder and CEO Dr Dan Williams brings over 20 years of experience in biochemistry and drug development, with a strong background in research and clinical trials.

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Drug Target Review

MARCH 20, 2025

This potential breakthrough could transform both drug discovery and clinical treatment strategies, with the possibility of enhancing patient safety and improving outcomes in thrombotic conditions like atrial fibrillation. NYSE: MRK), which included leadership roles in early and late clinical development and cardiovascular discovery.

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Drug Target Review

FEBRUARY 25, 2025

As we look to the future, therapies like NKTR-255 could serve as vital components in a new generation of oncology treatments, transforming not only how we address complex cancers but also how we design drug development strategies in immuno-oncology, says Zalevsky.

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