The Pharma Data

JUNE 24, 2025

The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.

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Conversations in Drug Development Trends

JANUARY 6, 2025

In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for Clinical Trials for Drugs and Biologics Guidance for Industry, published in 2019.

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PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. With FSO, all tasks for a clinical trial are outsourced.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.

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PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Overseen by an insourced project manager. Contracts are milestone- or unit-based.

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The Pharma Data

JUNE 27, 2025

The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. The full dataset is expected to be presented at an upcoming international scientific conference, which will provide greater clarity on the magnitude of fenfluramine’s clinical benefits.

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PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

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Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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The Premier Consulting Blog

JANUARY 14, 2025

Oncology Regulatory Affairs and Policy Program Advancing Oncology Decentralized Trials Multiple trial modernization initiatives Evaluate the benefits and challenges of decentralized trials to prioritize streamlined procedures for future trials. Provides the Oncology Dosing Toolkit.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

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Clinical Development International Drug Development Clinical Research 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery. Cell Stem Cell. 2013;13(6):734-44.

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PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions. EMRs give clinical operations teams direct, remote access to an array of patient health information.

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Clinical Trials Trials Clinical Research Research 52

Conversations in Drug Development Trends

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Are you aware of the challenges you must address for a successful radiopharmaceutical trial? These include ensuring informed consent, particularly around the risks and benefits of participation.

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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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Clinical Trials FDA Drug Development Trials 52

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

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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. Starting with the right internal standard Selecting the appropriate internal standard (IS) is vital in toxicology, as inaccuracies could obscure toxic metabolites and lead to flawed safety evaluations.

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International Laboratories Drugs Pharmacokinetics 52

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Each nation has varying definitions of what qualifies as a pivotal study.

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Alta Sciences

JUNE 6, 2025

For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. This can result in failed runs and wasted reagents.

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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 an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

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Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry.

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Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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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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H1 Blog

JULY 19, 2023

Streamlining recruitment and reporting to support advanced oncology drug development In March of 2023, the U.S. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

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Clinical Trials Trials FDA Treatment 52

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success.

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Clinical Development Clinical Trials Therapies Trials 98

Conversations in Drug Development Trends

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan?

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The Pharma Data

DECEMBER 11, 2020

Among the targets, the majority are vaccine makers that have COVID-19 vaccines in various stages of clinical trials. One is a clinical research organization involved in trials, and one has developed a COVID-19 test,” Microsoft said.

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LifeSciVC

OCTOBER 5, 2023

An oft-cited motive for biotech peers leaving their current roles is the aspiration to re-engage in the genuine work of scientific innovation and drug development, evading the trappings of bureaucracy in larger organizations. Reflecting on my seven-year journey at Synlogic, I’m reminded of our nascent days in drug development.

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NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread. Similarly, COVID-19 patients taking antipsychotic drugs like haloperidol that target SIGMAR1 were half as likely as those taking other types of antipsychotic drugs to require mechanical ventilation.

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Drug Development Drugs Virus Science 52

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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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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LifeSciVC

JANUARY 16, 2024

The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g., Additional trials (e.g.,

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The Pharma Data

OCTOBER 25, 2020

26, 2020 /PRNewswire/ — Gmax Biopharm today announces that the first dose of GMA301 was given to the patient in its phase 1B trial to investigate the drug efficacy to treat pulmonary arterial hypertension (PAH). GMA 301 is the first antibody drug for PAH treatment. Orphan drug designation has been granted by FDA.

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The Pharma Data

JUNE 13, 2025

“Through this collaboration with Astellas, we aim to enable promising Japanese biotechnology companies to accelerate their path toward commercial application by strengthening their international competitiveness.”

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