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Biopharma Group

phone +44 (0)1962 841092
email bps@biopharma.co.uk
web http://www.biopharma.co.uk
email Head Office, Biopharma House, Winnall Valley Road, Winchester SO23 0LD

Quality By Design

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.
Quality By Design
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News and Press Releases

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

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

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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