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 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
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Risk Assessment
Risk assessment is, at best, an honest attempt to find a rational basis for decisions by analysing the available scientific evidence. In theory it is still an attractive ideal - to make rational decisions based on scientific evidence - because in principle it should allow diverse parties to agree on what needs to be done. However, years of actual practice have badly tarnished the ideal of risk assessment.
In the first place, the necessary data are not always available, even today. In the second place, traditional toxicological assumptions do not always hold up under scrutiny. There is no agreement on which tests to use to determine whether someone's immune system has been damaged. There is no agreement on which tests should be used to assess damage to the nervous system. There is no agreement - and there may never be - on ways to test for genetic damage.
Without agreement on test methods, people cannot agree on which data to include in a risk assessment. Under these circumstances, different risk assessors will select the data that they believe is relevant and they will usually reach different conclusions - often vastly different conclusions. Risk assessment is not a science, it is an art, combining data gathered by scientific methods with a large dose of judgment. Judgment is not reproducible from laboratory to laboratory so different risk assessors reach different conclusions.
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By Sean Flanagan, Commercial Director at Kryotrans Ltd, and Adrian Shaw, Partner at Ikon Associates
Sean Flanagan is the Commercial Director at Kryotrans Ltd. A qualified accountant, Sean has considerable financial and operational experience with a range of large and small organisations, such as United Technologies Corporation and PROTX Ltd, an Internet start-up company. He is one of three directors at Kryotrans Ltd. He is responsible for marketing, finance, sales and administration and has also developed a number of strategic partnering relationships.
Adrian Shaw is a Partner at Ikon Associates, Marketing Consultants. Having trained in accountancy with Coopers and Lybrand, Adrian has spent the last 15 years working in the PR and marketing services world. He has previously worked as a Director for Gavin Anderson & Co, a PR consultancy, before moving on to Burston Marsteller, where he was a Managing Director responsible for financial and corporate communications work across Europe. He now runs his own corporate brand and marketing services consultancy.
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Adrian Shaw |
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Industry Events |
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BioPartnering North America™
26-28 February 2012, Vancouver Convention Centre, Vancouver, BC, Canada
BioPartnering North America 2012 (BPN) in Vancouver, Canada brings together senior executives from venture capital firms, major pharmaceutical companies, academic institutions and biotechnology companies of every size from mature to start-up.
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News and Press Releases |
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AMRI Announces Preferred Provider Agreement with BioPontis Alliance LLC
AMRI, a global contract services organization, announced today that it has entered into a preferred provider agreement with BioPontis Alliance LLC. The agreement is aimed at supporting BioPontis’ mission to bridge the gap between early-stage research and technologies being discovered and developed in academia and other research entities. AMRI will provide its services in small molecule discovery, development, and manufacturing in BioPontis’ drug discovery research programs. The agreement also supports the need for proof-of-concept data that is required in the current pharmaceutical company licensing environment. The goal of BioPontis Alliance is to identify promising early stage product opportunities and utilize a preferred network of CROs and leading research companies to apply appropriate expertise to develop these opportunities enough to attract pharmaceutical company licensing partners.
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