Introduction. The Human Capital Lens

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1 Open Pharmaceutical Development: Applying the Triple Knowledge Lens By Dr. Minna Damani, Director, CanBiotech Innovations Published in: iknow, Vol 3(2) October Open pharmaceutical development is a term with varied meanings across stakeholders and the drug discovery and development value-chain. With employment of an open source model to open innovation, the need exists for collaborative drug discovery and development. This era is marked with uncertainty in R&D value-creation, looming patent expirations, empty pipelines, global competition, and questions about the role of and value from convergence based innovation. Introduction A Triple Knowledge Lens 1 with its tripartite consideration of intellectual capital drivers namely human capital, relationship capital and structural capital provides a nuanced perspective on open pharmaceutical development. Human capital drivers suggest a role for the creative development and deployment of human capital within and outside organizational boundaries. Relationship capital drivers consider then the impact of network capital, cultural capital, and community capital on collaborative engagements between health innovation stakeholders. At a broader level, structural capital drivers provide a view to the requisite organizational and knowledge based capital as driving investments in intellectual capital development, open knowledge development and subsequently technology development to address disease burden. The Human Capital Lens Any purposeful stakeholder identification exercise will reveal skill sets available within the organization s innovation ecosystem. Internally, employees may be creatively engaged through ideation competitions, intrapreneurship, think tank sessions, shared staffing arrangements with 1 Amidon, D.M., Davis, Bryan Elliott. The Triple Knowledge Lens: Intangible Performance, IC Magazine (2006). 1

2 partners. Externally, new stakeholders patients, physicians, patient advocacy, and even can enhance the diversity of the human capital available to the organization and can serve multiple roles in the knowledge innovation process. These stakeholders can participate in dialogue on new technological opportunities, new knowledge innovation including the generation and/or sharing of knowledge based assets, and the validation of such knowledgebased assets. Knowledge and technological complexities associated with new health technology development affords a convergence paradigm bridging together biotechnology, pharmaceuticals, nanotechnology, and information technology. This creates a new commercialization space where few if any firms have the full scope to embrace the promise of product development. These factors have led many stakeholders public or private, small or large to explore open collaboration, merging together their knowledge and capital (Figure 1). The Relational Lens The need to link stakeholders through virtual and physical programs underlies open biopharmaceutical knowledge innovation from ideation to idea conversion and product development. Of consequence is the management of these resources. Disembodied pure knowledge can be managed through sophisticated and interconnected databases; while embodied knowledge may be physically housed in material and model repositories. In the case of disembodied knowledge assets, the supporting information and communications (ICT) infrastructure should not only facilitate knowledge management (including linkages between the requisite databases), but facilitate participant and user interactions. 2 With respect to embodied knowledge, material and model repositories will be required to organize collections, conserve, curate, and permit the broad exchange of biological/chemical materials, models, and any related data. The relational lens provides an effective perspective, suggesting that organizations may leverage their social capital, brand capital and even cultural capital to establish such networks whereby stakeholders can link to and share with others working in similar biological and disease arenas. More precisely, open knowledge platforms, the focus of value-chain activities (joint R&D, disease focus), and reputation of anchor organization are tangible mechanisms used to take advantage of social capital, brand capital and cultural capital. 2 Reichman, J.H., Uhlir, P.F A Contractually Reconstructed Research Commons for Scientific Data: International Considerations. In Open Access and the Public Domain in Digital Data and Information for Science: Proceedings of an International Symposium, Eds J.M. Essanu and P.F. Uhlir. Washington: National Academics Press,

3 Figure 1: Assessing Opportunities to Engage Traditional and Emerging Stakeholders in Open Knowledge Bio-Innovation 3

4 The Structural Lens Sponsor organizations that champion open knowledge platforms/programs have an opportunity to influence knowledge innovation and knowledge governance. The objective is not to replicate, but to create an open knowledge platform with integrated knowledge sets, query and collaboration tools. Under an open source and open access model, software and data may be available for download and local installation. Depending on access parameters, tools and services can enable query and visualization of data. In addition to data integration for internal usage, sponsors may provide access to increasingly valuable databases and a competence network that allows collective learning as well as high profile research. Requisite technological and legal policy frameworks in turn support these open knowledge platforms/programs. Technology related policies must ensure the efficient sourcing and sharing of knowledge, the standardized representation of data for downstream value-creation, and the creation of appropriate levels of access to drive knowledge innovation. In parallel, a legal framework will comprise material transfer agreements (MTAs) to govern reagent, model, sample deposit and access, intellectual property and licensing governance strategies, the specification of patient rights to privacy, ownership as well as usage rights to patient samples. Application of the Triple Knowledge Lens model to open biopharmaceutical innovation reveals the impact on: (a) human capital development of traditional and emerging stakeholders; (b) the global linkages across stakeholder communities enabled through virtual and tangible collaboration platforms; (c) the crafting of technological and legal frameworks to ensure transparency during knowledge submission, knowledge access, and (d) knowledge appropriation leveraging the organizational and innovation capital whilst preserving the rights of participants (Table 1). Conclusion After an exhaustive analysis of knowledge-driven investment and a plethora of Intellectual Capital (IC) indicators under development from various companies, academic research centers, societal organizations, Amidon and Davis (2006) research findings indicate the evolution of the Triple Knowledge Lens (TKL). Beyond Triple Bottom Line reporting, the TKL offers a balanced triangulation of successful and sustainable results across the knowledge-based community (people), knowledge-based ecosystem (networks), and the supporting knowledge-based infrastructure (organizational, technological and legal). This application to pharmaceutical development confirms the conclusions of Amidon and Davis i.e., collaboration for mutual leverage provides optimal utilization of tangible and intangible resources be it organizational, innovation or intellectual capital; that knowledge multiplies when shared increasingly across the appropriate global communities and stakeholders; and innovation value is created when knowledge moves from origin to the point of highest need. These nuanced models of knowledge innovation suggest the possibility that open biopharmaceutical innovation 4

5 can better meet the needs of global patients and healthcare providers at the top, middle and bottom of the pyramid. Triple Lens Knowledge Innovation Implications Stakeholder Engagement Open Innovation Opportunity Human Relational Structural New stakeholder engagement Lead user opportunities R&D value chain re-design Healthcare service innovation Global knowledge access Cooperative knowledge validation R&D value chain re-design Technology access partnerships Market access partnerships Human capital development opportunities Multi-Partner organizational capital access Multi-Partner Innovation capital access Cooperative and global oversight Global funding opportunities Efficient intervention assessment Healthcare access oversight Universities Research Institutes Service Providers Universities Research Institutes Service Providers Governments Regulators Symbiotic R&D Stakeholder Engagement Cooperative Learning Global R&D Open Value Chains Targeted Development Knowledge Transparency Sustainable Innovation Table 1: Knowledge Innovation Implications, Stakeholder Engagement and Open Innovation Opportunities Arising from the Triple Knowledge Lens 5