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| Applying Complex Systems and Organisational Development Approaches to Life Science Product Development and Drug Safety Decisions |
chaired by Jim Cook (Volutio) and Barry Hardy (Douglas Connect)
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Presenters and Discussion Leaders
Social Complex Systems Expert, David Snowden, Founder, The Cynefin Centre
Organisational Development Expert, Adam Filler, Managing Director, Denison Europe
Executive Leadership Practice Expert, Thomas Kell, Senior Partner, Heidrick & Struggles
Life Science Product and Drug Development and Safety both involve complex, difficult and important decision-making by an organisation. In a perfect world the best decisions should be prepared for and supported by as thorough an understanding both by individual experts and managers and the organisation as a whole. All available relevant knowledge, both internal and external to the organisation, should be available and actionable at key decision points in the product life cycle. Such a prepared organisation should be able to ask powerful questions, quickly obtain reliable answers, have the ability to react pro-actively and wisely to new and unexpected events, and to integrate risk and uncertainty evaluation in the organisation's preparation for the future using all knowledge flows available to it.
However the world is all too often not perfect and is inherently uncertain. Weak signals go un-noticed and small changes result in producing unexpectedly large consequences. Traditional approaches to decision support have relied on screening or filtering data so that the decision maker only sees what is relevant. Unfortunately such approaches screen out the very data that in retrospect the decision maker will realize they needed. Recent developments, driven in some cases by the information processes of anti-complexity are offering a new approach to decision support in which all data is made available at all times and the principles of serendipity and necessary ambiguity are used to focus the organization on resilience rather than stability and effectiveness rather than a blind focus on efficiency. Such systems aim to a achieve a symbiosis of human and machine intelligence and capabilities.
Although informatics approaches such as data-warehousing in the pharmaceutical industry capture and integrate a vast amount of data, it is questionable that such an approach alone enables the organisation to make the best decisions it could make based on all knowledge it could have. We raise the question: what methods could enable an organisation to maximise its human capital and knowledge potential in its preparation for decisions it makes in the future involving the currently known and the inherently unknowable?
In this session we consider approaches that offer potential contributions to organisational development in the above context:
Sense making and Complex Systems Analysis - Sense making draws on a variety of scientific understanding, principally from the cognitive sciences, narrative theory and the science of complex adaptive systems theory to deal with inherently complex and unknowable realities of the world. The developments in this field have been funded over the last seven years in the complex and uncertain field of anti-terrorism and are now starting to be applied in the agrochemical and pharmaceutical sectors.
Organisational Culture & Assessment - Organisational culture can critically impact business success including how critical decisions are made. Clarity of purpose, speed to market, employee commitment and transparent internal processes are some of the key success factors in the life-science sector which differentiate the winners from losers. Large organisations often suffer from over-reliance on established decision-making processes and procedures. By conducting organisational assessments, one can identify trends by looking for example at:
* How well understood and supported is the organisational strategy and direction?
* How close and responsive is the organisation to its customers and the marketplace?
* How involved and empowered are the employees?
* How do the organisational systems support the achievement of agreement and how coordinated are the various organisational activities?
Executive Leadership & Competency Assessment - We can prepare the organisation for improved decision-making readiness and prowess for the future through:
* Leadership Assessment
* Future Competency Requirements and Gap Analysis
* Human Resources and Capital Management
* Talent and Change Management during Industry Change, Mergers and Acquisitions
We will consider and compare how organisational development and complex systems approaches could benefit a life science organisation in the following decision-making situations:
A. Decision to advance drug candidate in research and early development
B. Decision to advance drug candidate into full development
C. Decision to file
D. Decision for action upon discovery of a safety signal or unexpected adverse event
E. Corporate Risk Management decisions for a portfolio of products
F. Cross Silo collaboration and interaction
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