PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.

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Quanticate

SEPTEMBER 13, 2024

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

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Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

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Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. But a new path for bringing treatments to patients is starting to emerge. We all recognize the vast, unmet medical need.

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PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.

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DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.

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Drug Target Review

NOVEMBER 25, 2024

As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.

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Drug Target Review

MARCH 17, 2025

Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “Zelquistinel is a positive modulator of NMDA receptors,” Donello explains.

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Treatment Licensing Licensing Science 52

DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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Drug Target Review

DECEMBER 23, 2024

Antibody-drugconjugates (ADCs) represent a significant advancement in drug discovery, combining the precision of monoclonal antibodies with the cancer-killing power of cytotoxic drugs. Properly managing these toxicities is crucial to enhancing the safety and therapeutic effectiveness of ADC treatments.

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.   What sets RADR ® apart is its robust data-driven approach.

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Conversations in Drug Development Trends

MAY 10, 2024

By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment.

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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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PPD

JUNE 7, 2023

As therapies for the treatment of NASH in adult patients go this year to the U.S. Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Partnership with an experienced CRO is essential to your trial’s success.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. No matter how small, any lack of efficiency can snowball into costly delays in drug approval.

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. million people every year.

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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. A large body of evidence demonstrates that these platforms can accurately predict tumour response to drugs.

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Conversations in Drug Development Trends

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). There have been challenges in gene therapy development.

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Drug Target Review

DECEMBER 13, 2024

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 15 Figure 1: A schematic illustrating a bispecific antibody-drug conjugate (ADC).

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Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Do you have various stakeholders invested in the success of your development programs?

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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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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.

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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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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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Drug Target Review

MARCH 4, 2025

Obesity treatment is undergoing a major shift, much like the advances seen in cancer care. Phenomix Sciences , led by CEO Mark Bagnall, is using precision medicine to make treatments more targeted and effective. Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach.

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PLOS: DNA Science

MARCH 28, 2024

A new drug has entered the arsenal against Duchenne muscular dystrophy (DMD), a genetic disease that affects boys and is challenging to treat. FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. In 2023, two gene-based treatments became available.

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Crown Bioscience

MARCH 14, 2025

The Importance of Biomarkers in Drug Development Biomarkers have become essential tools in modern drug discovery and development, enabling researchers to predict drug efficacy, monitor disease progression, and tailor treatments to specific patient populations.

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Drug Patent Watch

DECEMBER 12, 2024

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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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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PPD

OCTOBER 17, 2024

In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market.

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Conversations in Drug Development Trends

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. There are so many patients suffering from diseases that have no treatments.

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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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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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