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European Biopharmaceutical Review
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| In the last decade, the biopharmaceutical industry has been plagued by inefficiency.
R&D spending has increased while return on investment has decreased (1). The time
it takes for a drug to get to market successfully is reportedly between 10 and 15 years,
at a cost of more than $850 million (2). With those estimates in mind, over 90 per
cent of biopharmaceutical drugs in development do not make it through clinical trials
(3). This inefficiency is a growing problem that can be addressed from different
angles. In a report from the Boston Consulting Group, it is estimated that $100 million
dollars can be saved per drug if a company can decide early on against pursuing an
investigational new drug (IND) (4). But there is another major area of inefficiency in
a drug’s timeline that must be addressed – development and manufacturing.
TRIAL AND ERROR
The core problem that underlies the inefficiency of
biopharmaceutical manufacturing is the unpredictable nature
of a cell. There are still biochemical pathways and mechanisms
in living cells still yet to be discovered. For small molecule
pharmaceuticals, the chemistry is relatively straightforward
– a specific volume of chemicals in a controlled environment
yields a consistent result – but this is not the case with
biopharmaceuticals. The complex biochemical pathways of a
living cell, many of which are not fully understood, necessitates
much trial and error during the research and development stage
in order to produce the desired
product consistently. |
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Andreas Schneider is Director Global Sales, at
Innovatis AG, based in Bielefeld, Germany. After
graduating in Business Administration (BA) in 1990, he
worked in leading positions in IT business, such as data
management, data integration and information management
for various branches of industry. In 2003, he joined Innovatis
where he held various positions, including Head of Sales at
DACH, Head of Business Development at Europa and Director
Operations at US. Since 2007 he has been responsible for
global sales at Innovatis AG. Andreas has a broad range of
global experience in PAT, process automation and data
integration projects, especially the biopharmaceutical industry.
Within the ISPE organisation he is an active member of the
PAT Community of Practice (CoP) and takes the co-chair
of the global PAT Data Management Team. |
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Industry Events |
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3rd African Regulatory Conference (ARC)
3-4 May 2012, Accra, Ghana
The African Regulatory Conference offers the opportunity for key stakeholders active on the continent, including representatives from Ministry of Health, local and multinational pharmaceutical companies, to meet to exchange views, discuss topics of interest and identify focus areas for ongoing efforts to increase patient access to new and improved medicines.
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Increasing employer brand – the key to successful recruitment for engineering SMEs
Cheadle based industrial automation specialist SolutionsPT has appointed Louise Potts as People and Culture Manager. Potts will be focusing on increasing the company’s employer brand and achieving Best Companies and Investors in People accreditation for 2012.
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