FEATURED ARTICLES

ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care
ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care

While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.

  • Bringing A Billion-Dollar Drug To Market

    A report by Deloitte on the world’s 12 largest drugmakers shows that the average cost of bringing a product to market rose by more than 25% to greater than $1B in 2011, from $830M in 2010. By Cindy Dubin

  • Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
    Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

    Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

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WHITE PAPERS & CASE STUDIES

  • Considerations When Selecting A CRO For Phase I Clinical Studies

    Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

  • Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway

    An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.

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