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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?
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.
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.
Its ability to maneuver persistent drugdevelopment challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. Alternatively, rapid growth may have stretched personnel and resources thin, necessitating a quick ramp-up as the asset develops.
Meeting the never-ending challenges of drugdevelopment in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinicaldevelopment functions.
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster.
Biopharmaceutical and biotech drugdevelopers 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
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. These delays financially disrupt the potential of both current and future clinicalresearch. With a median delay of 12.2
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. Bagyinszky E, et al. 21(10):3517.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.
It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinicalresearch.
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).
The PPD clinicalresearch business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.
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.
Food and Drug Administration (FDA) for approval , much work remains for drugdevelopers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinicalresearch into treatment for pediatric populations.
Among the targets, the majority are vaccine makers that have COVID-19 vaccines in various stages of clinical trials. One is a clinicalresearch organization involved in trials, and one has developed a COVID-19 test,” Microsoft said.
However, clinicalresearch around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.
The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams. As a conduit, their role is to assess the timelines together, being the liaison with the manufacturing organization and implementing risk management and mitigation.
QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drugdevelopment.
If recruitment moves slowly or individuals with the wrong skills are selected, the clinicalresearch process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinicalresearch outsourcing models have changed over time to accommodate the industry’s evolving needs.
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.
Clinicalresearch 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 clinicaldevelopment.
Global Collaboration and Data Sharing International collaboration and data sharing are crucial for advancing adaptive trial designs. By pooling data from multiple trials across various regions, researchers can increase the power and relevance of their findings.
Nearly two-thirds of drugdevelopers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinicalresearch business of Thermo Fisher Scientific. Ready to work with a transformative FSP partner?
Non-footprint countries are regions where drugdevelopers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drugdevelopers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.
Pain models can be important clinical tools to characterize a novel analgesic, and determine its potential effectiveness in models simulating varying pain stimuli. Here are four main pain models we use to assess treatments in clinical trials: 1. WHY IS PAIN RESEARCH SO IMPORTANT?
However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.
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. According to Hardman et al.,
Breaking the Barriers: How Inaccurate Trial Records Are Delaying DrugDevelopment 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.
Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinicalresearch and development at companies across Europe and the US. Prior to VHsquared, Suhail was Senior Vice President and Head of Development and Medical Affairs for Shionogi in Europe.
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.
CNS-related issues account for nearly a quarter of failures during clinicaldevelopment, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinicaldevelopment, a phase where consequences are high in terms of resources and patient impact.
Drugdevelopers 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. Clinicalresearch and post-marketing surveillance involves ongoing data analysis and interpretation.
Which high throughput screening (HTS) approach is the most productive in finding hits for drugdevelopment: target-based or phenotypic? These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Outsourcing is filling internal gaps when it comes to screening.
According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internalresearch shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Ready to fuel more efficient drugdevelopment?
The type of sponsorship must also be accounted for because academic institutions sponsoring clinical trials often have access to fewer financial resources compared with commercial sponsors, which typically have larger budgets for their drugdevelopment programs.
BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinicalresearch. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. enrollment by diversifying U.S. altogether.”.
When outsourcing some or all key functions to an FSP provider, a drugdeveloper gains access to a wider pool of talent, including specialized functional, scientific and technical experts. This approach enables unbroken continuity of support and resources across clinical trial operations.
Our experience also shows that providing adequate continuing education materials to internal site-level committees is particularly important; doing so ensures that each site is always in compliance and provides a smoother study process.
At present, the company has developed a number of original new drug product lines for oncology, metabolic diseases, autoimmune diseases, central nervous diseases, and antiviral diseases. View original content: [link].
The Role of Biomarkers in Alzheimer’s Disease DrugDevelopment. Alzheimer’s Association International Conference; 2024 July 28 – August 1; Philadelphia, PA. A how-to guide for a precision medicine approach to the diagnosis and treatment of alzheimer’s disease. link] Cummings J. Adv Exp Med Biol. 2019;1118:29-61.
The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He currently serves as chair of the medical and scientific advisory group and as a member of the Board of Directors of the Alzheimer’s Association.
Biopharma R&D is gravitating toward increased decentralization, outsourcing much high-risk work to specialist contract organizations while keeping IP and data storage centralized internally. BioDAOs, however, offer an alternative by federating IP and data on Ethereum instead of keeping them siloed.
FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinicalresearch, agency and industry representatives gave a status update on implementation. she explained, including Central and South America and Africa.
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