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European Biopharmaceutical Review

Monitoring Malignancies Through Assay Development

Advances in the treatment of haematological malignancies through scientific discovery and innovation in drug development have dramatically improved both progression-free survival (PFS) and overall survival (OS) for blood cancers, including multiple myeloma and acute lymphoblastic leukaemia (ALL). In light of these continued improvements in clinical outcomes and survival rates, evaluating patients and assessing tumour burden at the time of diagnosis and monitoring disease progression throughout treatment and remission is important.

One method to assess tumour burden in lymphoid cancers is to determine minimal residual disease (MRD) or, perhaps, more appropriately referred to as measurable residual disease. MRD refers to the remaining number of cancer cells (ie, malignant B- or T-cells) that are present in a patient’s body during and after treatment and may eventually lead to recurrence of the disease. These residual cells can be present at very low levels, undetectable by traditional morphologic methods, such as microscopic examination of blood or a bone marrow or lymph node biopsy and require highly sensitive tests to be identified.

MRD in Lymphoid Cancers

Studies have shown that the presence of MRD is one of the strongest predictors of a patient’s long-term clinical outcome (1-2).

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Ilan Kirsch received his MD from Harvard University Medical School, US, and, subsequently, completed his residency at Children’s Hospital Medical Center, US, and his fellowship in paediatric haematology/ oncology at the National Cancer Institute. He also completed a three-year postdoctoral fellowship in molecular genetics in the laboratory of Dr Philip Leder at the National Institute of Child Health and Human Development. Ilan currently serves as the Senior Vice President of Translational Medicine at Adaptive Biotechnologies and is an author of more than 160 peer-reviewed manuscripts and over 30 books, chapters, and reviews.
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Ilan Kirsch
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Protagen Protein Services and BioAnalytix Merge to Create Global Analytic Service Partner for Biopharmaceuticals

Protagen Protein Services GmbH (PPS), a full-service contract research organization (CRO) in protein analytics and BioAnalytix Inc., a Cambridge (MA)-based specialized provider of advanced analytics in biopharmaceutical development announced today a merger that will transform the combined company into a leading global analytic services provider for the biopharmaceutical industry. Today’s announcement creates a best-in-class partner for biopharmaceutical companies worldwide to benefit from the most advanced, integrated and complete analytic services capabilities in biopharmaceutical development, from clone selection through drug approval to commercialization.
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The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
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Industry Events

Highly Potent Active Pharmaceutical Ingredients (HPAPI)

13-14 May 2019, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019. The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.
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