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Biopharma Group
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Quality By Design
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Quality by Design (QbD) is a systematic approach to development that begins with the defined objectives and emphasizes science and quality risk management in order to achieve those goals. QbD ensures that the quality of the product is built into production processes from the outset, rather than being tested after development has already commenced.
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News and Press Releases |
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Arcis Biotechnology appointments Professor Steve Howell as Non-Executive Chairman
Daresbury, UK, 24 July 2019: Arcis Biotechnology (“Arcis”), the nucleic acid sample preparation solution provider, today announced it has appointed Professor Steve Howell as Non-Executive Chairman of its Board of Directors. Steve takes over the position from Paul Foulger, who was serving as Chairman on an interim basis on behalf of the Board.
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White Papers |
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Case Study: Cmed’s Mobile Data Management Solution
Cmed Clinical Services
The trial presented to Cmed was a randomized, double blinded, placebo
and active controlled study to evaluate the cardiac safety of multiple
doses of [study drug] in health volunteers.
The pharmaceutical
company, who were into the second year of development of a potential
blockbuster compound for the treatment of chronic myelogenous leukaemia
(CML), were requested by the FDA to design a trial to provide
information on the cardiac safety of different dose levels of the study
drug in healthy adult volunteers. The primary objective of the study was
specifically to find the maximum tolerated dose before QTc levels
became unsafe. All development of the compound was put on hold until the
results of this study were submitted to the FDA and approval granted
for the compound to progress into full development.
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Industry Events |
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ESMO Targeted Anticancer Therapies Congress 2020
2-4 March 2020, Paris, France
A unique and international mix of experts, researchers and decision
makers both from academia and industry across the globe, will convene
in Paris for a three-day Congress aiming at exchanging knowledge,
experience and research innovations in cancer.
TAT
2020 will focus, among others, on novel strategies in immuno-oncology,
personalised medicine and molecular tumour boards, preclinical studies
to identify effective combination therapies, use of microbiome, tumour
agnostic trials, ADC technology, oncolytics, multispecific biological
constructs and targeting cytokines.
Participating in TAT 2020 will offer you the possibility to take part in
interdisciplinary discussions inspiring new ideas and new
collaborations.
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