Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

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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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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach. How regulators will interpret and enforce its provisions may not become clear for some time.

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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. The global preclinical CRO market was estimated to be valued at US$5.7

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PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.

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Clinical Trials Trials Clinical Research Research 52

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

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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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Drug Target Review

MAY 23, 2025

It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team. I take responsibility for identifying pre-clinical research that can support our clinical programs, as well as designing and overseeing its execution, he explains.

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Conversations in Drug Development Trends

JANUARY 6, 2025

Regulators are especially concerned about potential bias in the acquisition of data and the preservation of statistical validity, as adaptations are based on newly collected data compared to those anticipated in study planning.

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PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

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Crown Bioscience

MAY 4, 2021

In addition, owing to the rarity of these diseases, it can be extremely challenging to gain to patients and perform the clinical research necessary for regulatory approval. In August 2020, new US legislation was passed which promises to have a major influence on the way companies approach pediatric drug development.

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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?

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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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PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

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Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. Reach out to connect with us.

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H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.

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PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

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Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Can you identify a safe AND efficacious clinical dose? Prior to clinical trials, the focus is typically on evaluating safety.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. However, they also bring unique regulatory challenges.

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Perficient: Drug Development

FEBRUARY 27, 2025

The event also featured a presentation from Dr. JP Clancy, CFF VP of Clinical Research, about the latest medical and scientific advancements to treat cystic fibrosis. Understanding Cystic Fibrosis According to the CFF , cystic fibrosis is a progressive, genetic disease that affects the lungs, pancreas, and other organs.

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Perficient: Drug Development

JULY 24, 2023

How are you making a difference for our clients, colleagues, and communities? As a lead business consultant in the computer system validation department, I plan, write, implement, and review the computer systems validation plan and protocols within highly regulated industries. Thanks for joining me today, Kaushal.

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Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Vial

MAY 1, 2024

The company has a history of strongly advocating for clinical trials driven by artificial intelligence (AI) using research data captured in a secure, compliant cloud platform to help expedite the drug development process. Read more here about how Vial’s EDC system compares with that of industry giants.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating This desperation is apparent through the higher suicide rates for individuals suffering from high levels of pain. However,

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Perficient: Drug Development

SEPTEMBER 25, 2024

Collaboration barriers : Disparate teams often struggle to share insights and work cohesively, slowing down the research process. Regulatory compliance : Keeping up with evolving data management regulations adds another layer of complexity to clinical trials.

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