PPD

JANUARY 15, 2025

As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.

Clinical Trials

Drug Target Review

JULY 30, 2025

The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment. These digital platforms are designed to manage and automate critical trial processes, especially related to drug management.

Clinical Development

Drug Target Review

DECEMBER 23, 2024

To explore these challenges further, we spoke with Cheng Wang, a postdoctoral researcher at the University at Buffalo. Wangs research focuses on developing mechanistic mathematical models to quantitatively characterise ADC-induced toxicities.

Research

The Pharma Data

JUNE 23, 2025

Primary Endpoint and Clinical Results The HYPERION trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of time to clinical worsening (TTCW). The STELLAR trial, presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23),

Trials

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

Clinical Development

H1 Blog

JULY 28, 2025

More Information, Same Enrollment Challenges In clinical trial feasibility, we face a counterintuitive reality: despite unprecedented access to healthcare professional data, identifying the right investigators and predicting enrollment success has become increasingly challenging. ” Let’s examine these factors in detail.

Clinical Trials

PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

Drug Development

The Pharma Data

JUNE 25, 2025

Biogen Reports Promising Interim Phase 1 Results for Salanersen in Spinal Muscular Atrophy, Prepares for Registrational Trials Biogen has announced encouraging topline results from its Phase 1 clinical trial evaluating salanersen (BIIB115/ION306) , an investigational antisense oligonucleotide (ASO) therapy for spinal muscular atrophy (SMA).

Therapies

The Pharma Data

JUNE 18, 2025

The IDeate-Prostate01 trial marks a significant advancement in the B7-H3 ADC development program and underscores the shared commitment of both companies to addressing difficult-to-treat cancers. Study Design and Objectives The Phase 3 IDeate-Prostate01 study is a randomized, multicenter, open-label clinical trial.

Trials

Drug Target Review

MARCH 24, 2025

Today, researchers must progress through multiple stages of testing: starting with in vitro studies (experiments in test tubes or petri dishes), they then move to animal studies (preclinical testing) before finally advancing to human clinical trials. Nevertheless, developing such complex models presents enormous technical challenges.

Clinical Trials

Covalent Modifiers

JULY 25, 2025

Research Square Preprint, 23 July 2025, [link] Orelabrutinib is a highly selective, irreversible inhibitor of Bruton’s tyrosine kinase (BTK). A multicentre, double-blind, randomised, placebo-controlled, phase Ib/IIa trial (NCT04305197) was conducted. A total of 55 patients completed the trial. Xue Li, Ru Li, Xiaoxia Zhu et al.

Treatment

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

Clinical Development

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. Animal rights groups, policymakers and the public are increasingly vocal in opposing their use in research, with litigation and regulatory interventions intensifying in recent years.

Drug Research

PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

Clinical Research

Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research

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.

Trials

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. Creating replicas of organs in vitro has been a goal of researchers for over a century.

Treatment

DrugBank

OCTOBER 30, 2024

At DrugBank, we’re dedicated to empowering pharmaceutical researchers with data that drives impactful results. Now, through our partnership with Snowflake, we’re making it even easier than ever for you to access high-quality, actionable data in a secure, and scalable environment designed to keep pace with your research needs.

Production

The Pharma Data

JULY 2, 2025

Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan.

Trials

Quanticate

JUNE 13, 2025

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.

Clinical Trials

Crown Bioscience

AUGUST 5, 2025

Organoids are cultured cell structures that mimic the complexities of human organs, allowing researchers to study them under conditions that closely replicate real biological environments. The Promise of Organoids in Modern Medicine The conversation with Dr. Price underscores organoids' potential as accurate models of human tissue.

Drug Development

Crown Bioscience

AUGUST 5, 2025

Organoids are cultured cell structures that mimic the complexities of human organs, allowing researchers to study them under conditions that closely replicate real biological environments. The Promise of Organoids in Modern Medicine The conversation with Dr. Price underscores organoids' potential as accurate models of human tissue.

Drug Development

The Pharma Data

JUNE 23, 2025

Phase 2 Study: Transformative Weight Loss and Glycemic Control The Phase 2 trial focused on evaluating the efficacy and safety of MariTide in individuals with obesity, both with and without Type 2 diabetes (T2D). Executive Vice President of Research and Development at Amgen, emphasized the broader implications of these findings.

Trials

Broad Institute

JULY 29, 2025

Related groups OASIS Consortium Carpenter-Singh Lab Health and Environment Sciences Institute (HESI) Related news A marriage of microscopy and machine learning Roughly a third of drug candidates fail in the first phase of clinical trials, often due to unanticipated toxic effects that weren’t apparent in animal tests.

Animal Testing

Drug Target Review

APRIL 30, 2025

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?

Drugs

Drug Target Review

JUNE 9, 2025

Accelerating drug development with basket trials One of the strategies that Alltrna is employing to accelerate the development of its tRNA therapeutics is the use of basket trials. While commonly used in oncology, the basket trial approach is novel for rare genetic diseases.

Disease

PPD

NOVEMBER 11, 2024

Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise. Partner with us The post Redefining Acceleration of the Drug Development Journey appeared first on PPD.

Drug Development

Drug Target Review

JULY 21, 2025

Current challenges in CNS drug development Drug development for the CNS is particularly challenging and researchers face several hurdles to producing effective and safe treatments, many of which are unique to the CNS. These gaps in knowledge can lead to a trial-and-error approach to clinical trials, which can result in high failure rates.

Drug Development

Drug Target Review

JULY 3, 2025

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Because LLMs are trained on extensive, internet-scale datasets, they can learn to identify contexts linking words and language.

Drug Development

Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. His approach focused on integrating key components of the process: research, clinical, regulatory, and manufacturing into a cohesive, unified system.

Therapies

Drug Target Review

JUNE 6, 2025

This dual role enables him to bridge research and clinical practice, ensuring scientific innovation is directly informed by patient care. “As Delpassand’s clinical experience plays a key role in shaping the research pipeline. This is where the SPICA Center comes in. “The The SPICA Center was built to address this gap.”

Therapies

Broad Institute

AUGUST 1, 2025

The work opens the door to potential targeted therapy for these tumors, particularly for pediatric low-grade gliomas (pLGG), though more research is needed to improve the efficacy of these treatments and to test them in pediatric clinical trials. The research was published today in Nature Communications.

Treatment

Chemical Biology and Drug Design

MARCH 18, 2025

Fosmidomycin, a potent IspC inhibitor with hydroxamate metal-binding pharmacophores (MBPs), has entered clinical trials for malaria but is hampered by pharmacokinetic and toxicity issues of the hydroxamate fragment. Future research could draw from other metalloenzyme studies to develop novel and efficient non-hydroxamate IspC inhibitors.

Drug Development

The Pharma Data

JUNE 13, 2025

Mitsubishi Research Institute and Astellas Forge Collaborative Initiative to Support Japanese Drug Discovery Startups and Boost Global Innovation Mitsubishi Research Institute, Inc. MRI) and Astellas Pharma Inc.

Research

The Pharma Data

JUNE 6, 2025

has announced encouraging interim findings from the pivotal Phase 3 VISIONARY trial evaluating sibeprenlimab in adults with Immunoglobulin A nephropathy (IgAN), a rare and progressive autoimmune kidney disorder. We are grateful to the patients who have contributed to advancing the science through their participation in this landmark trial.”

Trials

The Pharma Data

AUGUST 1, 2025

This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.

Drug Development