Drug Target Review

MARCH 24, 2025

Sujeegar Jeevanandam, an expert with 13 years of experience in life sciences R&D, offers valuable insights into the current state and future trajectory of artificial intelligence in drug discovery. To understand the significance of this goal, it is important to recognise the current drug development process.

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FDA Law Blog: Drug Discovery

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

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Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

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Conversations in Drug Development Trends

OCTOBER 31, 2023

However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. 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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Alta Sciences

MARCH 4, 2025

Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. I have spent the better part of my career working to make drugs safer. Tags Clinical Trials Weight 16

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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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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

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Quanticate

SEPTEMBER 13, 2023

In this article, we delve into six key clinical data management practices for the complex terrain of biotechnology trials. These practices are driven but evolving technologies that are helping to shape the clinical data management stage of drug development.

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Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. In addition to this, I also chaired national trials evaluating an anti-GD2 antibody in pediatric osteosarcoma.

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Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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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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KIF1A

SEPTEMBER 30, 2023

Read the Article Both of these studies reflect a global effort to understand the genetic underpinnings of disorders so people can find the right treatments sooner. In addition to benefiting awarded sponsors, this pilot program will help create best practices of communication with the FDA during rare disease therapeutic development.

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Drug Target Review

AUGUST 28, 2024

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. In this article, we share our hard-earned insights into overcoming these critical challenges.

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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

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. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 An estimated 80% of clinical trials do not finish on time.

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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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Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With more than 30 years of experience in cardiovascular research, Worldwide has global trial experience in all phases.

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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.

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KIF1A

JUNE 3, 2023

In this week’s article, researchers in Japan investigated the genetics of hereditary spastic paraplegia in a retrospective study : this means they went back and analyzed existing data, in this case the genetics and clinical profiles of 37 children diagnosed with HSP. In many cases, drug approval relies on a clinical trial’s primary endpoint.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Drug Target Review

DECEMBER 23, 2024

Furthermore, data from Phase I trials can serve as benchmarks for comparing exposure-AE relationships in new ADCs using the same linker-payload combinations. This type of analysis is crucial for drug developers, providing a framework to identify and mitigate toxicity risks early in the design process.

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The Pharma Data

JANUARY 27, 2021

COVID-19 Antibody Treatments Exceed Expectations in Early Trials. There were roughly half as many infections among those given the antibody treatment versus a placebo, and none on the drug developed any symptoms, the AP reported. Associated Press Article. Professional. WEDNESDAY, Jan. © 2021 HealthDay.

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Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Vial

DECEMBER 5, 2023

It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development. Sponsors have used NGS to screen patients for clinical trial eligibility and patient stratification , expanded CDx development, and comprehensive genomic profiling (CGP).

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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Cytel

MARCH 13, 2023

And despite initial hesitancy in the clinical trials space, simulation-guided design has revolutionized, and will continue to transform, the landscape of clinical trial development. Many industries have long since adopted the practice of modeling and simulating experimental scenarios.

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New Drug Approvals

APRIL 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. ESI-MS m/z calc.475.0922,

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data. Obesity is rising worldwide, driven by lifestyle, diet, and genetics.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

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Reprocell

NOVEMBER 1, 2022

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. An article published in the Financial Times described how scientists are moving away from animal experimentation toward alternatives that more closely resemble human physiology.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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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. Vial stands out from IQVIA in several key aspects.

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