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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.
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!
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.
For pharmaceutical innovators and drugdevelopers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy.
For a more in-depth look at biomarkers, check out our whitepaper. Most IO Biomarkers Require Composite Use IO biomarkers can provide valuable data on a patient’s immune response to treatment and specification of which subpopulations would best benefit from immuno-oncology therapy.
Historically, these indications have challenged the one-size-fits-all treatment approach due to patient variability, such as genetic differences in drug metabolism and underlying health conditions. Hematological cancer cells can also develop resistance to therapies over time, reducing treatment effectiveness.
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
You can learn more about biomarkers and how to use them in oncology studies in this whitepaper. Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.
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.
However, the complex nature of T2D requires a multidimensional treatment approach that extends beyond drugtherapy. Gene therapy, immunology, and CGM innovations provide new treatment possibilities. Research suggests that a combination of drugs and devices is most effective for managing T2D.
Paula Brown Stafford, chairman and CEO of Novan, said: “Covid-19 continues to have a major ongoing impact on global health and there remains a direct need for a safe and effective antiviral therapy. 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.
Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Dr. Russell has managed all aspects of the drugdevelopment and regulatory approval processes for oncology and non-oncology drug candidates.
David Weild IV.
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.
This approach improves treatment outcomes over traditional broad-spectrum therapies, which are prone to more side effects and adverse events. Carefully crafted enrichment strategies optimize recruitment and enrollment, ensuring that the included participants will likely respond to the therapy.
This circumventing the wheel requires navigating around the roadblocks that hampered earlier drugdevelopment efforts to bring new treatment options forward for patients. ADCs are treatments comprised of three components: a drug payload joined by a linker to an antibody. ADCs are here to stay.
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