Live-Licensing & In-life testing: R&D Processes and Regulation for New Drugs, 2008-2020

March 19, 2009 - PRLog -- Report Details
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.

Companies Listed
Abbott Laboratories
Affymetrix
Amgen
AstraZeneca
Bayer HealthCare
Cambridge Antibody Technologies
Chiron
CyGene
Dako
Digene
Eli Lilly
EXACT Sciences
First Horizon  
Genaissance Pharmaceuticals
Genentech
Genetic Vectors
Gen-Probe
Glaxo Wellcome
GlaxoSmithKline
Hoechst Marion Roussel
Human Genome Sciences
IGEN International
Innogenetics
Millennium Pharmaceuticals
Myriad Genetics
Organon
Pfizer
Roche
Sanofi-Aventis
Schering Plough
Sequenom
Teknika
Tibotec-Virco
Visible Genetics
Vysis
Warner Lambert
Wyeth

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Visiongain is an independent business information provider for the Telecoms, Pharmaceutical and Defence industries. We organise conferences, publish reports and newsletters, and provide consultancy services.