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A recent whitepaper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.
The year 2022 reflected a transformative path for the drugdevelopment industry. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drugdevelopers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.
In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.
An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing In this whitepaper, Lonza experts delve into the common challenges encountered by ADC developers. Read this whitepaper to learn more. Read this whitepaper to learn more.
Whitepaper validates highly reproducible drug response data. The ability to introduce patient heterogeneity in the discovery and development stages increases the Probability of Technical Success (PTS) and reduces the risk inherent in all aspects of the drugdevelopment pipeline.
Whitepaper validates highly reproducible drug response data. The ability to introduce patient heterogeneity in the discovery and development stages increases the Probability of Technical Success (PTS) and reduces the risk inherent in all aspects of the drugdevelopment pipeline.
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 clinical development functions.
To help determine if a master protocol could be a good fit for your study, check out this whitepaper for a more comprehensive overview of the appropriateness of master protocols in different contexts. Here are some relevant factors below: What Are the Advantages of a Master Protocol? Contact us.
Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drugdevelopment and facilitating faster access to new therapies.
jsabatino Fri, 07/28/2023 - 11:29 In this whitepaper, we look at the past, present and future of antibodies as therapies, explaining how the modality became a key pillar of the biopharma industry—and looking forward to the methods and technologies that could unleash its full potential in the years to come. Download here!
Karen examines trends in drugdevelopment, pricing, and healthcare. To learn more, download Six trends and tactics to thrive in the new healthcare economy , a free whitepaper from Wolters Kluwer. She also serves as co-chair of Maintenance and Control at the NCPDP. Read on for Karen’s insights.
For a more in-depth look at biomarkers, check out our whitepaper. The IO biomarker field is rapidly evolving—check out this whitepaper for the latest details regarding IO biomarkers. Below, we discuss some validated circulating oncology biomarkers, their implementation, and key operational considerations.
We recently published a whitepaper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.
New Findings on the Sinclair Nanopig™ in Safety Studies blussier Thu, 09/05/2024 - 18:00 HTML Recent Scientific Data Challenges the Status Quo Our most recent whitepaper presents detailed genomic, proteomic, and functional data on the Sinclair Nanopig™’s metabolism and immune systems. Read it now! WHITEPAPER Questions?
There is no way to eliminate the risk of failure. However, there are ways to reduce these risks. Learn more in this whitepaper from Recipharm. Source link.
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In contrast, as a nonprofit organization, Every Cure can prioritize assets with the greatest opportunity for impact, filling the treatment gap that many traditional drugdevelopers are not positioned to fill. To learn more about the Every Cure and Worldwide partnership, listen to a recent podcast episode between Dr.
A recent whitepaper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.
Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer WhitePaper offers a detailed look at the findings. It is an ongoing debate.
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However, at Worldwide, we have a proven track record of successfully utilizing biomarkers in oncology development. Check out our whitepaper to learn more about our services, or contact our team to find out how we can help support your oncology drugdevelopment program.
When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drugdevelopment pathway. For additional insights, download our full whitepaper, “ First-in-Human Studies: IND or CTA? ”.
AI content generator: Generative AI is seamlessly integrated into existing content creation workflows to assist marketers in creating various types of content, from text like headlines and whitepapers to images. Customers also have the flexibility to use their preferred AI models or providers.
To learn more about how Medical Affairs teams can leverage AI for smarter drugdevelopment, download our Custom WhitePaper with First Word Pharma: How AI Can Save Medical Affairs from Drowning in Data. Look for more content in our upcoming AI Content Hub.
When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drugdevelopers. A number of strategies can be adopted to put the needs of the child at the center of the study.
We are in the process of finalizing arrangements with a global leader in drugdevelopment to assist in our development activities as we work toward a potential IND filing targeted in 2021.”. Download Medidata’s whitepaper to learn how to virtualize clinical trials and bring new therapies closer to patients.
Often, however, a hybrid use case will fit into one of these general categories: 1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services.
See how to unlock the full power of your CRO partner in our whitepaper, Optimal Outcomes in Clinical Research and Product Development. The post Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program appeared first on Worldwide Clinical Trials.
Ready to fuel more efficient drugdevelopment? Read our whitepaper to learn the keys to successfully implementing functional service partnerships. LEARN MORE The post Dedicated Roles Keep FSP Projects on Schedule appeared first on PPD Inc.
A patient-centric approach that emphasizes empathy, precision, and innovation is essential to advance the standard of care and encourage patients to follow intervention treatments more successfully.
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drugdevelopment. The workshop is also discussed in Cell & Gene here and here.
Dr. Russell has managed all aspects of the drugdevelopment and regulatory approval processes for oncology and non-oncology drug candidates. Mr. Weild authored and co-authored a number of definitive whitepapers that were key catalysts for new legislation and regulatory reforms, including the JOBS Act.
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Receive expert-led insight from Dr. Heiner Oberkampf, Head of Data Governance at OSTHUS and learn how to:
Digitally transform a drugdevelopment strategy.
Develop a fully automated environment to significantly boost research efforts.
However, a significant challenge drugdevelopers face is that of non-enrolling sites. As the clinical trials landscape continues to evolve toward increased complexity, greater efficiency and accelerated development timelines, the ability to manage and optimize site performance has become even more critical.
WhitePaper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the whitepaper. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. Watch it now.
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