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Overview of InnovationWell
| The overarching theme of the Community’s program is ‘Integrating Knowledge Across the Life Science Product Life Cycle’ with the goal of achieving improved outcomes in healthcare product development & delivery, reducing costs and improving productivity and quality through cross-disciplinary and cross-organisational use of innovative technologies, knowledge-based strategies and supporting integrated and semantic-based informatics systems.
Our program explores current best knowledge-based strategies, practices and supporting solutions in the life science & healthcare industry that enable innovation, effectiveness and success in the competitive market. We address issues that include: | | • | How can existing knowledge and intellectual property be more effectively deployed into new business situations? | | • | How do we enhance the organizational appreciation and use of drug safety knowledge throughout product development and clinical use? | | • | How do we protect patient safety against the delivery of drugs through illegal distribution channels? | | • | What are the novel and effective approaches that are contributing to progress in drug discovery and development innovation? | | • | What is the current impact of new advances in chemistry and biology (biomarkers, toxicology, proteomics, toxicogenomics, metabolomics, etc.) on drug development? | | • | What practices can enable an organisation to maximise its human capital and knowledge potential in its preparation for decisions it makes in the future? | | • | How do we assess, reduce the risk and increase the confidence associated with a marketed product? | | • | How should we manage our technologies and knowledge around the product life cycle to maximise their value in the market place? | | • | What new knowledge management approaches offer greater productivity for the individual worker? For the team? For collaborators and partners? For communities of interest and practice? | | • | How should we classify our knowledge better semantically so that we may retrieve more of what we know, is known or to determine what is not known? | | • | What new approaches for managing knowledge are being created by the increasingly electronic nature of information capture, management and collaboration? What are the legal and regulatory risks and how do we manage them? | | • | How do the new standards and initiatives allowing the improved exchange and combination of data between different systems and domains create opportunities for improved access to knowledge? | | • | How can improved knowledge management help to reduce the high cost of clinical trials and patient recruitment? | | • | How do we increase the effectiveness of knowledge-supported healthcare delivery? |
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Innovation & Knowledge Management
A tremendous volume and variety of technologies and complex information is created around drug discovery, clinical trials, regulatory review and healthcare delivery. The associated investment in both the private and public sector involves tens of billions of dollars. However, information is often not easy to retrieve and new technologies are challenging to launch and integrate. A significant amount of knowledge and understanding remains inaccessible and it is challenging to share and combine knowledge from different areas of expertise or past experience. Bringing together the right competencies, technologies, knowledge and information is critical to the success of any current new research, market or healthcare delivery situation.
The purpose of our community program is to examine and explore business strategies, new technologies, knowledge management applications, innovation practices, modern information and semantic approaches and integrated product life cycle management in the pharma, life science and healthcare industries with the goal of obtaining
• improved use and deployment of knowledge and information
• reduced costs of research, clinical trials and regulatory compliance
• increased innovation and productivity of individuals, groups and organisations
• improved returns of investment in research and clinical trials
• improved healthcare delivery and safety
Knowledge is created and used at all stages and processes of a product's life cycle to address business strategies, enhance collaborative efforts and make intellectual use of data and information acquired from established databases, the laboratory, clinical trials, regulators and the market place. Knowledge originates from diverse sources at different times in a product life cycle. Knowledge management strives to expose critical knowledge and make it apparent at those times when it is most valuable. | | Top |
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Program Scope & Topics
| Knowledge-based Business Strategies
• Effectively deploying knowledge resources into new business opportunities
• Alternative and novel business models in the life sciences industry
• Applying knowledge resources to third world health challenges
• Pharmacovigilance and risk management
Innovative Life Science Product Development
• Entry and exit strategies in life science product development
• Managing risk and the future in product development
• New advances in drug discovery approaches; beyond massive screening
• Applications of genomics and proteomics: successes so far and what's on the horizon
• Emerging Research Domains: Systems biology, nanotechnology
• Electronic-based systems for clinical trial management
Drug Safety
• Risk Management Planning & Assessment
• Drug Safety Knowledge Management
• Labeling Decision-Making
• Enhancing Confidence in Safety
• Knowledge-based Clinical Decision Support
• Personalised Medicine & Pharmacogenomics
• The Drug Safety Body of Knowledge
Combating Drug Counterfeiting & Trafficking
• Advances in Track-and-Trace technology
• Radiofrequency identification (RFID) tagging
• Integrated federated identity management
• New regulations, laws and international agreements
• Impact on Patient Safety
Drug Discovery Innovation
• In Silico approaches & computational models
• Predictive Toxicology
• New advances in targeted drug discovery approaches
• Cheminformatics & Bioinformatics
• Combinatorial & Medicinal Chemistry
• Biosensors & Nanotechnology
• Molecular Medicine & Biotechnology
• Protein Folding, Misfolding & Aggregation: Applications to Disease
Drug Development Innovation
• FDA Critical Path to new Medical Products
• Managing risk and reducing cost in product development
• New advances in chemistry and biology (biomarkers, toxicology, proteomics, toxicogenomics, metabolomics, etc.)
• Clinical trial design, modelling, evaluation techniques, endpoint selection
• Early development screening models & predictive capability
• Scientific and technical hurdles in the development process
Electronic-based R&D Systems
• Pros and cons of centralisation and localisation
• Creativity and intuition, how do we best support novel ideas and innovating?
• How do we make collaborative virtual work environments for R&D work?
• Semantic Web: next generation web services for the life sciences
• Usability and retrieval of electronic data
Knowledge-based Ontologies, Language and the Semantic Web
• Applying the Semantic Web within the Life Science Industry
• Embedding knowledge into working processes and workflows
• Enabling the understanding of knowledge for groups distributed in space, time and expertise domain
• Developing shared languages and ontologies for life science knowledge domains and communities of practice
Knowledge Transfer
• Strategies for spontaneous knowledge exchange
• Knowledge fairs or cafes
• Partnering, mentoring, coaching and apprenticeships
• Knowledge maps
• Trust and motivation
• Development of common language
• Cultural changes (acceptance that talk is work, incentives and rewards, risk taking and tolerating creative mistakes, etc.)
• Creativity and intuition, how do we best support novel ideas and innovation?
Electronic Lab Notebooks
• Managing the transition to mixed paper-electronic and electronic-only approaches
• Best practice and Standard Operating Procedures for electronic record-keeping
• Challenges, benefits and investment analysis from Case studies
• Integration of laboratory data into the global knowledge environment
• Effective classification and indexing of laboratory data
Data Integration and Standards
• Supporting effective decision-making: interoperability and data standards
• XML-based scientific communication
• Future proofing of software and data storage systems
• Industry and government initiatives
• Deployment, effectiveness and productivity gains from integration initiatives
• Open Standards and Open Sources: initiatives, adoption and effects
• Enterprise Records Management
Autonomous Agents
• Automating data communication between systems
• Embedding intelligence in drug discovery autonomous agents
• How should we personalise agents for R&D investigators?
Grid Computing
• When to deploy? Advantages and disadvantages of grid approaches
• Applications to biological screening and drug discovery
• Business models for distributed computing approaches
• Licensing and intellectual property issues and approaches
Collaborative Knowledge Management
• Embedding JIT Knowledge into health product development
• Effective planning and reaction to adverse clinical and market events
• Data-sharing and analysis between remote team members
• Management of multi-site, multi-organizational collaborative projects including data management in contract and outsourced R&D projects.
• Applications of social software to collaboration
Outsourcing & Partnering
• Intelligent outsourcing of product development and clinical trials
• Managing knowledge in partner situations
• Intangible asset auditing in licensing decisions
• Global outsourcing opportunities: present and near future
• Expertise location inside and outside the organisation
Regulatory Issues in Data Management
• FDA compliance in electronic R&D systems, 21CFR-11
• Planning for future trends in the regulatory environment
• Expanding products into new regulatory markets
• International similarities and differences regarding keeping, managing, and submitting electronic records for IP/patents, drug approvals for FDA and equivalents.
• Legal guidelines, practical experiences, law/legal case studies relating to use/acceptance (or not) of electronic records and submissions
• Reports on rates of adoption of electronic record-keeping and submissions by industry, regulatory body, and country, and other details on accepted practices, and review of audits/validation
Data Mining, Analysis & Visualisation
• Application of integrated decision-making tools into Life Science Data Analysis
• Enabling the asking of powerful questions
• Automation solutions for data mining
Patent & Intellectual Property Issues
• Protecting intellectual property in collaborative knowledge management systems & partnerships
• Security and Risk Management of product data and knowledge
• Knowledge management and International technology transfer: regulations, licensing and strategies
• Analysis of legal case studies involving electronically captured data
• Licensing issues in database mining | | Top |
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Activities & Format
| | Ongoing Seminars & Discussions | InnovationWell holds an ongoing series of online seminars by leading international experts and researchers. Members are also encouraged to submit their own presentation of a topic within the scope of the community.
Web-based Seminars consist of Internet-based Virtual Lectures accompanied by slides and audio. Discussions with the audience can take place on the Web site using both asynchronous and synchronous discussion-based mechanisms, streaming audio and by phone-based teleconference. Archived recordings of presentations and discussions are usually also viewable on the Web site.
Face-to-face InterAction Meetings | InterAction meetings are held periodically to give InnovationWell members and new participants a chance to meet face-to-face for exploration and discussion of specific issues driven by a problem-solving agenda, including case studies, customer-supplied issues, strategies, integrative approaches etc.
Presentation materials are usually also made available on the website, so that the time at the meeting can be used more for in-depth discussions and networking. Presentations at the meetings concentrate on the main points of view, key ideas, proposals or findings.
As the presentation materials are usually available on the website after the event, community members who are unable to attend in person can also review them and post questions, comments etc. | | Top |
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Audience
| | The participants in this community typically work in the biotech, pharmaceutical and healthcare industries and include decision-making executives, strategists, product, marketing, and R&D managers, knowledge management & IT managers, research and product team members, networkers, trainers and mentors, consultants and solution vendors, patent experts, investors and legal and financial analysts. | | Top |
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Advisory Board
| | Community Coordinator: Barry Hardy, Douglas Connect | | • Jeff Spitzner, Rescentris | | • Victor Newman, Knowledgeworks | | • Robert Scoffin, CambridgeSoft | | • Harvey L Wiener, Bristol-Myers Squibb | | • Jon Harman, Syngenta | | • Tonya Hongsermeier , Partners Healthcare | | • G. Scott Lett, Bioanalytics Group | | • Peter Elkin, Mayo Clinic | | • Sidney Kahn, Pharmacovigilance & Risk Management, Inc. | | • Michael Elliott, Atrium Research & Consulting | | | • Eric Neumann, w3c | | • James Averback, Life Science Integration Partners | | • Leander Fontaine, Pharmiceutics | | • Domenico Alexakis, Swiss Biotech Association | | • Ulrich Meier, Sun Microsystems | | • Lorie Karnath, Rescentris | | • Charles Sodano, Berlex Biosciences | | • Douglas Weidner, KM Institute | | • Saad Shakir, Drug Safety Research Unit UK | | • Patrik Frei, Venture Valuation | | | | Top |
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