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It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
Given macro healthcare influences (eg, economic uncertainty, environmental changes) and the numerous available treatments for major diseases, drugdevelopers may need to reassess their therapeutic strategies. This has led drugdevelopers to unintentionally limit their potential within chosen therapeutic spaces.
As the pharmaceutical industry continues to evolve, drugdevelopers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinicalresearch business of Thermo Fisher Scientific conducted its third global survey of 150 drugdevelopers to capture a comprehensive view of these evolving trends.
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Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drugdevelopers, driven by a combination of internal and external pressures that have intensified in recent years.
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinicalresearch, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Your DrugsDevelopment Stage The stage of your drugdevelopment is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.
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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. 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.
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A recent white paper from the PPD clinicalresearch 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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In this interview, Bagnall explains how this approach is improving patient outcomes and driving the development of better obesity drugs. Phenomix Sciences, built on over a decade of clinicalresearch at the Mayo Clinic, is disrupting this outdated approach.
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In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
While another pandemic has not reached our doorstep at least not yet our sense of urgency and creativity should be the fuel for reimagining clinicaldevelopment processes. The staggering average cost of bringing a drug to market (more than $1 billion) is accompanied by a dismal success rate of justfive to seven percent.
The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes. Participant fatigue in GLP-1 clinical trials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.
Implications for Future of ClinicalResearch R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.
In a recent webinar, Challenges of DrugDevelopment in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.
Solid tumors present a significant challenge to clinicalresearch due to their complex and heterogeneous nature. Proactively Address Key Recruitment Challenges in Solid Tumor ClinicalResearch Solid tumor clinicalresearch is challenging, especially because of tumor heterogeneity.
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Stephen Apps discusses how technology can help improve the speed and quality of clinicalresearch and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
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Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. 5 Organoids are recognised as New Alternative Methods (NAMs) in drugdevelopment. billion by 2030.
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Introduction Contract Research Organisation (CRO) outsourcing has become a vital strategy for pharmaceutical and biotechnology companies aiming to optimise clinicalresearch and drugdevelopment.
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