Live-Licensing and In-life testing RandD Processes and Regulation for New Drugs, 2008-2020

Visiongain predict that the current phase I to IV clinical testing process will eventually be selectively or wholly replaced by a system known as “in-life” testing or “live” licensing. Those proposals involve cumulative testing of the drug throughout its lifecycle. The industry would continually test drugs with smaller, more focused clinical trials. If a trial shows efficacy and safety, a live license would be given, allowing the company to market the drug in a limited manner. Already, the FDA and the EMEA have shown favourable interest in such developments - amongst other amendments to current practice.

In particular, R&D Processes and Regulation for New Drugs, 2008-2020, concentrates on the following essential aspects of the market:

• Forward-looking development of R&D methods and regulatory policies in theory and practice

• Discussion of the relevant technology and methods, including accompanying diagnostic tests (theranostics/companion diagnostics)

• Discussion of un-met/under-met therapeutic needs and relative advantages of emerging developmental methods and regulatory policy

• Discussion of the current global pharmaceutical market and where it is heading

• Drivers and restraints facing new drug development from 2008-2020

• Opportunities and threats facing drug development from 2008-2020, with SWOT analysis

• Detailed interviews with leading experts in regulatory affairs in academia and industry

Why you should buy this report:

• To receive a comprehensive analysis of the prospects for new drug development from 2008-2020

• The views of leading experts in regulatory affairs concerning present and future issues in new drug development and regulatory trends

• To discover the most important existing and potential future regulatory developments

• Predictions for key developmental metrics that can be improved via the new methods and regulatory initiatives

• To determine the forces that influence new drug development:

• Competitive characteristics

• Drivers

• Restraints

• Strengths, weaknesses, opportunities and threats

• To find out where pharmaceutical R&D is heading - both technologically and commercially, with emphasis on all healthcare stakeholders.

Further clinical testing during the marketing of the drug could allow the marketing restrictions to be gradually lifted, providing access to greater numbers of patients, including an expansion of indications. This proposed testing system has the advantage of allowing companies to gain revenues from the drug candidate earlier, while benefiting patients earlier as well. The tests combined with treatment could also cut developmental costs significantly, since large-scale clinical testing is very costly and time consuming. This is a win-win situation for you and your company – you must be fully informed of it now.

Visiongain believes that in life testing/live licensing will be fully operative next decade.

The future of current and potential blockbusters is therefore vitally important to all companies in the pharmaceutical sector, especially in this period of economic pressures and regulatory uncertainty. This report concentrates on arguably the most exciting challenge facing the industry and regulators: how to adapt medicine to patient sub-populations and emerging regulatory demands, improving safety and efficacy markedly. No pharmaceutical company can afford to ignore those issues.

- PRICING -

- Single use licence $2995.00

- Departmental copies (this entitles up to 5 individual users in your department) of this report are available for only USD $5,995.00. This is not suitable for library usage.

- Allow your whole company to have access to this information for only USD $9,995.00. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

- Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only USD $13,995.00

January 2008
Table of Contents

Price
Single Use Licence $2995.00
Department Licence 5 Users $5,995.00
Company-wide Intranet Licence $9,995.00
Company over 2500 employees $13,995.00