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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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PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer

Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
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Respiratory Drug Delivery (RDD®) Europe 2019

7-10 May 2019, Estoril Congress Center, Lisbon

Respiratory Drug Delivery (RDD®) Europe 2019 connects emerging and high-level scientists, academics, industrial and regulatory specialists, and clinicians. It is a must-attend conference for companies involved in research, development, testing or marketing of medicines, devices and services associated with pulmonary or nasal pharmaceutical products. This year, RDD Europe 2019 will be held in Estoril (Lisbon), Portugal, May 7-10, 2019, and, as in previous years is jointly organized by RDD Online and Aptar Pharma.
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