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| Drug Development Innovation |
Session to be held at InnovationWell InterAction Meeting, Philadelphia, USA, 16-19 October 2006
chaired by Barry Hardy (Douglas Connect) | |
This executive InnovationWell forum on Drug Development Innovation discusses the latest key advances in management practices, technology and informatics enabling the integrated advancement of the success, productivity, efficacy and safety of products moving through the drug development pipeline.
As pointed out by the FDA’s report “Challenge & Opportunity on the Critical Path to new Medical Products” (2004), drug development and evaluation has not kept pace with advances in R&D technologies (e.g., genomics, microarrays, in silico) so as to enable better and earlier identification of safety risks, benefits or target sub-populations. Available knowledge is not being applied well enough in clinical trial situations. Only 8% of products going through safety testing in phase 1 trials are reaching the market today cf. a 14% success rate of 10 years ago. We need to better use animal models, in silico modelling, biomarkers, predictive toxicology approaches, etc. in pre-clinical situations to reduce subsequent clinical failure rates.
It appears that new technology generating significant new knowledge has been put into place in the R&D part of the drug pipeline without the ability to interpret and understand it in later decision-making. The InnovationWell theme developed by Dr. Barry Hardy for its 2004 virtual conference “Integrating Knowledge across the Product Life Cycle” has subsequently been adapted as a key vision guiding the community of practice and its development of knowledge management enriched practices for drug development and safety. This thinking envisions key business process change and improvement requiring the introduction of innovative knowledge process management across the product life cycle which enhances multidirectional knowledge flows between research, development, clinical, and marketing functions internally and externally between pharma, healthcare and research organisations, physicians and patients. This framework should be flexible and adaptable so as to quickly incoporate new technology advances or changes in the environment and should include embedded knowledge-based auditing practices aimed towards continued evaluation and performance improvement.
Questions addressed in this forum include:
What are the key new technology advances having measurable impact on drug development productivity?
What are the current best business practices having measurable impact on drug development productivity?
How do we best gather together disparate sources of data so as to provide a framework of relationships for expert questions, assertions, inferences and decision-making in development?
How do we more effectively access and integrate resources and discoveries arising in the academic world into industry-based R&D and product development?
How do we detect earlier compounds that cause idiosyncratic drug-induced injury in certain sub-populations?
How do we make life science product development more predictable and less costly?
How do we better assess the safety of new medical products?
What are the solutions to the most pressing scientific and technical hurdles in the development process?
How do we best proactively collect, combine, analyse and report data from suspected adverse drug reactions?
How do we promptly and effectively respond to new issues and questions raised by regulators?
How do we better communicate and utilise knowledge and understanding between R&D, medical affairs, clinical, regulatory affairs, manufacturing, and marketing?
How do we better communicate and manage knowledge and understanding between multiple organisations and systems?
What is the current impact of new advances in chemistry and biology (biomarkers, toxicology, proteomics, toxicogenomics, metabolomics, etc.) on drug development?
What are the latest advances in computational modeling (disease processes, toxicology, physiology, neurology, etc.) providing predictive capability for safer efficaceous product candidate selection including early development screening models?
What are latest advances in clinical trial design, modelling, evaluation techniques, endpoint selection and support systems improving the productivity, effectiveness and investment return of clinical trials?
What are the latest developments in systems biology and pharmacology providing correlation of early markers of safety and benefit with clinical success in patients?
What are impact of new regulatory guidelines, regulations, standards, initiatives and legislation on drug development processes and practices (e.g., FDA Risk Minimization Guidance, HL7/SPL, Drug Safety Oversight Board, Drug Watch, Grassley Dodd bill, MHRA and EU guidelines and regulations, ICH harmonisation, etc.)?
How do we reduce cost and increase the efficiency of medical product development?
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