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Biopharm Knowledge Publishing is developing a series
of expert Guides to key outsourcing issues in the pharmaceutical and
biotechnology industries. Cardiac Toxicity Cardiac Toxicity – drugs causing heart muscle, valve damage or potentially fatal arrhythmias in patients - has been implicated in 28% of drug withdrawals in the USA over the last 30 years. The significance for patients, regulators and the pharmaceutical industry is immense. If cardiac toxicity is discovered during a drug’s development the programme will, almost invariably, be terminated. If cardiac toxicity is discovered after launch then the drug may be withdrawn or new labelling will almost certainly be required. The consequences for the global pharmaceutical industry can be huge, with major drugs being withdrawn and companies being sued for negligence. But often cardiac events are so rare that they may only be found many years after launch and after thousands, or even millions, of patients have been treated. And when cardiac events do occur the exact mechanism involved may remain a mystery. This unique report covers all aspects of cardiac toxicity, from physiology and pharmacology to regulation by the FDA and EMEA. It looks at:
It will help you to:
The report is edited by Dr Graham Hughes and includes a chapter on the commercial implications written by Yann Bonduelle and Jo Pisani of PwC. Key industry and academic figures have also contributed significant chapters to the report:
This report, published in association with Oxford Cardiac Pharmacology is essential reading for anyone in biotech, pharmaceuticals or contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an up to date, authoritative, detailed and clear explanation of the issues surrounding cardiac toxicity and its implications for the pharmaceutical market. Download the table of contents Download the introduction £1495 ($2950) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Immunogenicity
to Biologics Understanding immunogenicity, a detrimental and potentially dangerous response to therapeutic proteins, is vitally important for the successful development and marketing of biotech drugs. Failure to predict and minimise levels of immunogenicity may have harmful and sometimes disastrous results for both patients and the industry. This comprehensive new report written by leaders in the field, gives you the information you need to understand immunogenicity and to implement relevant safety strategies. The commercial implications are covered in a section written by experts at PricewaterhouseCoopers (PwC). This unique 170-page report includes chapters by the following industry experts: Dr Stephen Swanson, Director, Clinical Immunology,
Amgen Plus an additional chapter on the commercial implications
by PwC experts Jo Pisani and Yann Bonduelle.
Contents include:
This report is essential reading for anyone in biotech, biosimilars and pharmaceuticals, and for contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an authoritative, detailed and clear explanation of the issues surrounding immunogenicity and its implications for the market and the biotech, biosimilar and pharmaceutical industries. Download the table of contents £1450 ($2900) For further information about this report contact
Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Central
and Core Laboratories Updated, October 2007 The Central and Core Laboratories market is now worth more than $1.5 billion a year and is vital to the successful development of new drugs. It is a truly global business dominated by major players. Choosing the right Central Laboratory and handling the relationship effectively is vital to the successful management of clinical trials, as is the complex business of getting samples from the patient to the laboratory. In a publishing breakthrough this 250 page report – updated October 2007 – gives comprehensive cover the Central Laboratories market, the major companies involved, the processes, including testing and logistics and the future challenges for the market. It is a vital resource for anyone involved in drug development, clinical trials, the central labs market and logistics. Contents include:
The comprehensively-referenced report is published by Biopharm Knowledge Publishing, Part of the Technomark Group and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing and one of the founders of Technomark. Contributors include: Dr Graham Hughes This 250 page report provides a full picture
of a fast-growing industry now worth more than $1 billion and vital
to the success of drug development. It also gives a complete guide
to managing the outsourcing and logistics process. Download the table of contents or moneill@biopharmkp.com Contract Research Annual Review 2006 The Complete Picture of the Contract Research Market The contract Research market is growing rapidly - far faster than the industry it serves. This report analyses the market, looks at trends and developments and explains how they will affect the future of the market. With 35 graphs and tables, this 150-page review includes:
Written by industry experts the Contract Research Annual Review costs just £245 ($475)
or moneill@biopharmkp.com Click here to order Biosimilars - Evolution or Revolution? A detailed guide to the factors that will shape this vital market, including company strategies, comparability, regulation, the implications for clinical trials and legal issues. With a chapter written by PricewaterhouseCoopers looking at the commercial implications for the biotech and pharmaceutical markets The market for biotech drugs grew by 18% last year and now exceeds $50 billion – that’s 10% of the global pharmaceutical market at nearly three times the growth rate. But the first biotech drugs were launched in the mid 1980s and now patents have expired on drugs worth more than $13 billion. Until very recently generic competition was not possible but now in Europe, the EMEA has issued guidelines and the first biosimilar has been approved. In the USA the FDA still has to act, but the direction is becoming clearer. How this market develops will be vital for all the players involved – major pharma, biotechs, generic companies and CROs. This unique, detailed, 200+ page report, includes a chapter on the commercial implications written by Jo Pisani and Yann Bonduelle, Pharmaceutical & Healthcare strategy consultants at PricewaterhouseCoopers. The report will enable you to:
Contents include:
This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.
£1950 ($3600) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632or moneill@biopharmkp.com Click here to order Outsourcing
Chemistry Services Made Easy Pharmaceutical and biotech companies are outsourcing more of their work than ever before – the list includes drug discovery, development, manufacture and marketing. This new report provides a clear, comprehensive guide to the processes involved in outsourcing chemical and biotech development and production. It will help you to: • Understand the rationale for outsourcing As well as the complete guide the report contains in-depth interviews with development service providers and outsourcers to give a real life understanding of the issues from both sides of the fence. And it has a full listing of service providers categorised by services offered and location. Contents include: • Rational for outsourcing This 120 page report is published by Biopharm Knowledge Publishing, part of the Technomark group and costs just £695 ($1290). It is written and edited by Dr Ed Sampler of Charnwood Molecular and Hooshang Zavareh of Chempharmaserve Ltd. DOWNLOAD THE TABLE OF CONTENTS £695 ($1290) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632or moneill@biopharmkp.com Click here to order
Legal aspects of outsourcing contracts in the pharmaceutical industry Price: £495 ($895)
Clinical
Trial Supply
DOWNLOAD THE TABLE OF CONTENTS 
Click
for PDF file.Price: £595 ($1075) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Click here to order |
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