Featured Articles
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Phase 1 Trials: Strategies For Site Selection And Dose-Escalation
11/18/2021
This white paper explores key considerations for site selection and dose-escalation design strategies in early-phase oncology trials.
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Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial
10/28/2021
The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, and the approval pathway depends on product classification. This case study describes how product classification may not always be clear-cut, given the proliferation of novel approaches to ATMP development.
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A Primer On Cancer Immunotherapy Part 2: The Cancer Immune Response & Mechanisms Of Resistance
9/29/2021
This article examines the rationale for combination therapies, mechanisms of resistance, and where to go from here.
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Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study
9/10/2021
Patient recruitment gets all the attention at an oncology study’s inception, but enhancing patient engagement throughout the study bolsters retention, long-term follow-up participation, and the likelihood of patients volunteering in future trials.
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A Primer On Cancer Immunotherapy Part 1: Goals And Major Approaches
8/27/2021
This post provides an introduction to cancer immunotherapy, exploring its immunological basis and the fundamental principles guiding the development of new treatments.
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Gene Therapy For Parkinson's Disease: Strategies And Operational Requirements
7/29/2021
Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. Download the available white paper to find out more.
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Introduction To CAR T-Cell Therapy Part 2: Additional Considerations & Future Opportunities
7/15/2021
Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), read how chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies.
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Can Technology Replace Medical Coders?
6/29/2021
All data generated in a clinical trial must be uniformly interpreted to ensure accurate results. Correct medical coding plays a critical role — and how that coding happens may be shifting. How is technology affecting the process of medical coding in clinical trials? Watch our webinar to find out.
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Dermatology: The Changing Landscape Of Psoriasis Treatment
6/29/2021
Over the past two decades, biologic therapies have revolutionized the treatment of psoriasis, with more than half of treated patients now able to achieve essentially complete clearing of their disease. Learn more about these therapies as well as new topical and oral therapies that are emerging.
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Choose The Right FDA Program To Expedite Your Rare Oncology Trial
6/28/2021
With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. This blog post reviews the regulatory programs available to expedite treatments for rare disorders and serious diseases.