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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.
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.
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drugdevelopment has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drugdevelopment.
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Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.
However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
Our annual look at the state of the drugdevelopment 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.
As the clinical trial landscape evolves, drugdevelopers 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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This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
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PPD, Thermo Fisher Scientific ’s clinical research business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drugdevelopment industry. The opportunity to leverage new technologies in drugdevelopment (e.g.,
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Why is detecting cancers via liquid biopsy before they become visible on imaging important for drugdevelopment, not just diagnostics? We believe liquid biopsy is very helpful for oncology drugdevelopment because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.
The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 3D rendering of Antibody Drug Conjugate Molecules.
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The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drugdevelopment process, particularly as the field is highly regulated by health authorities around the world.
Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drugdevelopers. I have spent the better part of my career working to make drugs safer. Tags Clinical Trials Weight 16
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drugdevelopment. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.
Despite their exciting potential, the smooth operation of cell therapy developmenttrials 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.
As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Are you aware of the challenges you must address for a successful radiopharmaceutical trial? These include ensuring informed consent, particularly around the risks and benefits of participation.
Sponsors find that an FSP solution is often the best choice to help advance their drugdevelopment projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions. EMRs give clinical operations teams direct, remote access to an array of patient health information.
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. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.
The PPD clinical research business of Thermo Fisher Scientific has surveyed more than 150 drugdevelopers around the globe to gather annual data on trends in pharmaceutical research and development. Directors, compared to vice president or C-suite respondents, were more likely to report trial complexity as the top challenge.
Developing a new therapeutic is a complex and high-stakes process, often spanning over a decade and requiring investments that exceed billions of dollars. Despite this significant commitment of time and resources, many drug candidates fail in clinical trials, with safety and toxicity concerns being one of the leading causes.
4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drugdevelopment journey. Let the CRO know any key outcomes from each.
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Embarking on a Career in DrugDevelopment nbartlett Tue, 08/29/2023 - 14:38 Getting to the Heart of Science with Amber malloy Amber Malloy, Altasciences At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. They remind us of the immense benefits of drugdevelopment.
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With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drugdevelopment program is a commercial success.
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