Abstract
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.
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