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1: Business Opportunities, Challenges & Strategies
| | » | How do we reduce the risks of unanticipated medically important adverse effects for new products?
InterAction Topics:
| • | Develop “safety first” commercialization strategies | | • | Implement a “prospect and explore” safety management strategy | | • | Conduct safety studies and meta-analyses throughout the product lifecycle, especially in the peri-launch period | | • | Modify current candidate selection decision making processes, e.g., promote objective decision criteria – ensure safety objectives are appropriate for the indication | | | » | How do we make better use of available drug safety knowledge and expertise when selecting new drug candidates? How do we bring greater transparency to these decision making processes?
InterAction Topics:
| • | Enhance dissemination of drug safety knowledge | | • | Align drug safety expertise and knowledge aggregation to a single safety function | | • | Implement internal processes to ensure all potential safety concerns are identified, recognized, and evaluated | | | » | How do we react more effectively to potential safety signals available from clinical trial and healthcare delivery information?
InterAction Topics:
| • | Can a legal/regulatory “Safe Harbor” be constructed to promote objective evaluation of potential safety signals? | | • | Establish “peer reviewed” safety signal triage processes | | • | Establish corporate policies and procedures supporting identification, evaluation and management of safety signals | | | » | How do we partner more effectively with physicians and patients to reduce the potential for serious adverse drug reactions?
InterAction Topics:
| • | Establish direct drug safety communication channels with physicians and formularies, provide real time information to assist physicians in detecting and managing adverse effects | | • | Compensate physicians for real time adverse event reports to the manufacturer to improve timeliness and quality of information (strategy: What we don’t know, WILL hurt us, eventually!) | | | » | How to better manage benefit-risk expectation(s) for new product introductions?
InterAction Topics: | • | Pursue a clinical “Disease Management” marketing strategy, i.e. how the drug enhances management of the disease | | • | Compare alternative therapeutics openly and with “patient-oriented safety criteria” | | | Top |
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2: Knowledge Integrative Strategies & Approaches
| | » | How do we better integrate drug safety knowledge throughout the product lifecycle to minimize the risk to patients, providers, and the business from medically significant adverse effects?
InterAction Topics:
| • | Mandate “interoperability” for product safety information, i.e., across data systems, documentation and business processes | | • | Build integrative knowledge-based systems for aggregation and analysis of product safety information | | • | Mandate records management capabilities to ensure availability and awareness of product safety information throughout the lifecycle | | | » | How can electronic systems be employed to better store, share and integrate drug safety knowledge relevant to marketed products?
InterAction Topics:
| • | Accumulate an actionable knowledge-base of drug safety information, provide tools to enhance the value of existing drug safety knowledge e.g., develop drug safety ontologies to support inference | | • | Represent information in “interoperable” forms to enable aggregation across systems | | • | Establish systems with “transparent” user interactions and highly effective data visualization to maximize “internalization” of drug safety knowledge | | | » | What knowledge management approaches can be used successfully to enhance sharing of drug safety knowledge among domains of expertise?
InterAction Topics:
| • | Implement internal/external expertise location capability for drug safety information | | • | Establish competency enrichment practices for drug safety, e.g., Lessons Learned, Communities of Practice | | • | Establish a practice enrichment intervention to enhance decision making skills under typical conditions of uncertainty | | | » | What is the definition of an adequate Drug Safety Body of Knowledge? What techniques are needed to build and maintain it?
InterAction Topics:
| • | Identify key information forming the market’s current “Drug Safety Body of Knowledge”
ie. what are health authorities, payors, and providers looking at to support their perception of safety? | | • | Determine which adverse effects should be prospectively tested for and when; identify those for which additional trials are required | | • | Determine product exposure needed to evaluate long term adverse effects | | • | What issues would trigger additional evaluation or studies to prospectively enhance drug safety knowledge for a product | | | Top |
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3: Support Systems for Drug Safety Knowledge Management
| | » | How can we categorize drug safety knowledge to improve ”interoperability” in multiple contexts and systems?
InterAction Topics:
| • | Identify key current and needed diagnostic/bioinformatics information sources to predict high impact adverse effects | | • | Identify key drug safety data and supporting systems | | • | Identify drug safety metadata and/or ontologies required to expand the Drug Safety Body of Knowledge | | | » | What should electronic tools, databases and systems do to better capture and re-use drug safety knowledge?
InterAction Topics:
| • | Map high impact adverse effects to key drug development predictors, where known and possible | | • | Implement drug safety decision support systems with simple user interfaces and highly integrated drug safety data | | • | Correlate performance of predictive drug safety approaches with categories of investment in IT systems | | | » | How do we obtain faster and more reliable safety signal information in data from clinical trials and/or clinical practice?
InterAction Topics:
| • | Aggregation and correlation of data from clinical trials and post-market sources | | • | Enhance collection and analysis of Phase IV study information | | • | Identify high impact opportunities for Industry/Payor/Health Authority data set aggregation | | | » | What modeling techniques can we deploy to better include safety knowledge in drug candidate selection decisions?
InterAction Topics:
| • | Identify superior methods & tools for semantic classification and retrieval of knowledge | | • | Identify approaches for the improved transfer of knowledge between enterprise systems, user applications and work processes | | • | Demonstrate productivity gains and value from advanced search technologies | | | Top |
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4: Knowledge Transfer and Product Life Cycle Management
| | » | How to improve the knowledge and learning support of patient populations?
InterAction Topics:
| • | Identify strategies and methods to improve knowledge flow to patients | | • | Identify restrictions & opportunities arising from regulatory issues | | • | Review support systems for patient knowledge transfer and learning | | | » | How to publish and manage delivery of new drug safety knowledge to partners, payors, providers and patients?
InterAction Topics:
| • | Identify specific requirements of recipients of safety knowledge | | • | Review classification and distribution methods of safety knowledge | | • | Identify opportunities in Safety Knowledge-based Services | | • | Review potential impact of current regulatory initiatives, e.g. FDA SPL and e-labeling | | | » | How to increase innovation and returns from product life cycle and intellectual property management of drug-related knowledge?
InterAction Topics:
| • | Enhancing innovation and value with product life cycle management | | • | Intellectual property management of drug safety knowledge | | | Top |
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