On Sunday May 30 we host an OpenTox Workshop near Berlin in Potsdam that will bring many leading international research program directors and leaders together to discuss how collaboration and the increased linking of resources over the World Wide Web could progress human safety research and safety assessment. By linking resources and data increasingly powerful computer-based models can be built for predicting and avoiding unwanted adverse toxic side effects of drugs, chemicals, ingredients in soaps and cosmetics, pesticides etc. thus enhancing human safety and protecting the environment better. Such methods should also eventually lead to the replacement of many animal experiments.
During the workshop we will apply a variety of design, informatics and modelling methods to predictive toxicology problems guided by workshop leaders with expertise in the approaches used. A case study approach will additionally be followed so that groups can work together throughout the week on their case study problems. The case studies will also be developed virtually before the workshop week with support extended afterwards for further work including experimental testing of interesting results and hypotheses developed. The virtual aspects of the case study work will additionally be supported by the Synergy and OpenTox infrastructures and related Collaboration Pool and pilot collaboration study.
Case studies will focus on the development of innovative integrated testing strategies applied to the problem of predicting the toxicity of a molecule. Such strategies are becoming an increasingly important part of drug design strategies so as to remove toxic liabilities as early as possible in the design processs. REACH legislation is also requiring organisations in coming years to carry out a more extensive safety testing of all chemical ingredients in a variety of products ranging from consumer products to food to agrochemicals. Related to this activity is the relatively unsatisfactory use of animal experiments to predict human toxicity, which are not only complex and expensive, but also often do not predict human effects well, if at all. Hence new approaches combining computational modelling, in vitro assays, systems biology, stem cell technology etc. are required.
We will apply techniques to the study of existing knowledge (e.g., from adverse events, biological literature, pathway models etc.) to help support mechanism-based hypotheses and strategies. Modelling techniques based on data-mining, database searching, and read-across will be applied to chemical categories. Integrated QSAR-based models supported by the new OpenTox infrastructure will be used to build properly validated models including estimation of applicability domain. We will also research ADME and kinetics properties of structures as relevant to their toxicity profiles. We will attempt to predict primary metabolities based on P450 metabolism simulation and model the potential toxicities of metabolites. Population-varied physiologically-based ADME Simulations will be carried out for in vitro-in vivo extrapolation, exposure estimation and to study the variation across individuals and populations. We will also apply workflow techniques to the combination of methods and Bayesian networks to the evolution of weight of evidence based consensus predictions.
The most promising strategies and predictions developed will be used to design experimental human toxicity-oriented in vitro assays which will be run after the workshop as part of the virtual case study extension work. Both computational and experimental work will be documented according to industry best practices in a collaborative electronic laboratory notebook. We will attempt to develop new combined in silico - in vitro strategies superior to existing approaches which should help advance the field and industry testing and regulatory needs.
Through the time spent working and discussing together combined with the availability of a variety of leading software and expert support from workshop leaders, workshop participants should take home ideas and learning to help accelerate their own projects related to safety design and risk assessment. The location and atmosphere in Oxford is also an ideal background for networking, getting to know your peers and joining the ongoing eCheminfo community of practice activities. As is often common with eCheminfo gatherings the workshop usually attracts a variety of backgrounds including industry, academia and government research instititutes and from many different countries. We also welcome the participation of non-modelling specialists from different areas of chemistry, biology and toxicology to participate and bring an interdisciplinary interaction to the collaborative group work.
The question I am asking here is "How can lessons from Trident Missiles improve future patient healthcare treatment?" or more prosaically "What is the business case for knowledge management in healthcare product and service development and delivery?"
A number of times in recent weeks the topic of the business case for knowledge management (KM) has arisen in my interactions, conversations and activities, and from which some initial reflections are convincing me of the need and importance for new work, approaches and applications in this area. Personally I would like to develop the case approaches in the life science/pharmaceutical/healthcare area but new approaches may apply across sectors and cross-industry comparisons may be insightful.
Before getting into the challenges let me mention one story I came across recently that really brings home the future benefits of KM applied to technology development over the long term. It is the one of how the knowledge required to refurbish Trident missiles has been literally lost: http://kerrieannesfridgemagnets.posterous.com/did-we-throw-out-that-fogbank-stuff-no-probs Ignoring the question of why the missiles are being refurbished and whether that should be done, you can simply focus on the issue of huge cost gain and loss of investment through inadequate KM. This case involves not only inadequate explicit knowledge management of data, procedures and processes, but also the loss of human and social capital knowledge associated with the technology due to worker loss and retirement unaccompanied by tacit knowledge sharing, transfer and alumni retainment measures. So there simply has been an almost complete organizational memory loss of a key competency; lack of KM is now costing tens if not hundreds of millions of dollars of squandered taxpayers’ money to reinvent the wheel.
In this time of cost-cutting responses to the finance industry triggered economic recession and mass follow-me psychological depression, it would be pertinent for long-term investment stakeholders to consider the above lesson in lack of KM. As executives are cutting costs and jobs to survive and human and social capital in the organization is being lost or destroyed, one should ask what is the impact of knowledge loss on the long term value and growth of the organization. What KM measures are being taken so that the organization is simply not forgetting what it can do?
Let’s return to focus on the challenges with formulating the business case for KM in the life science/pharmaceutical industry case. If the case is for a small tactical project and we concentrate on short term benefits and localised returns, then one can probably do a reasonable job with existing best practices. However this is of very limited value in assessing the impact on factors that are really strategically important – e.g., longer term overall financial performance, sustainable development, stakeholder value, innovation success etc.
If we accept the statement that no major organisation in the life science/pharmaceutical industry has yet implemented a successful quantified global organisation-wide KM strategy, then we are immediately and obviously in the situation of having no previous data or case study as reference. (I welcome exceptions even if partial cases added as comments and links to this initial post.)
Moreover the situation is even worse in terms of complexity. The current industry business models are in their old age years; the current approaches of pharma mergers and biotech acquisitions are intermediate strategies, and the models of the future e.g., service oriented approaches combining knowledge, diagnostics and interventions for population segmented personalised medicine are currently plans and pilots. Such factors will certainly distort many of our calculations for mid and long term returns.
According to the Economist’s 2020 study Pharma industry executives considered KM as the greatest potential source of productivity gains between 2005 and 2020. (Reference: “Foresight 2020: Economic, Industry and Corporate Trends”, The Economist, (2005). http://www.eiu.com/site_info.asp?info_name=eiu_Cisco_Foresight_2020&rf=0) Although looking promising at first sight, my concern is what definition of KM was understood by respondents to this survey. If the understanding was similar to what I have often encountered, there will be a great spectrum of definitions included in the survey sample and unseparated in the results analysis. So we need to consider the question (and our business case ones) in the light of considering all KM impacts on value including structural, human and social capital values, and hence needing consideration of intellectual capital approaches. Of course the current impact of mergers and acquisitions and associated job cutting complicates significantly an intellectual capital analysis applied over time.
A further significant complication in pharma is the long development cycle and time gap between initial R&D and market returns. There will in general be a lag between gains in an intellectual capital index and a stock market financial metric, but the long lag time in drug development with complexities such as mentioned above make a clear return analysis very difficult. We know at least anecdotally that many pharmaceutical companies often face knowledge loss issues similar to that depicted above for the Trident with their drug products. The loss of personnel associated with mergers, acquisitions or recessions exasperates the already challenging issue of knowledge integration, sharing and translation across the life cycle.
The Dow Jones Sustainability Index has now been applied to pharmaceutical, biotech and healthcare companies for a few years and provides some initial insight on the KM business case problem for this sector as it includes some KM-oriented components such as human capital and talent management valuations. However it appears that several extensions and elaborations to such indexes are necessary. The ideal would be a KM index component that predicted future stock market index gains for organization or sector which could guide both current strategy and investment decisions.
However as KM increasingly becomes integrated with operations and work processes, it will become more challenging to separate out components as suggested above and inter-dependency may favor smartly aggregated multidimensional metrics.
Finally, there is the issue of the prospect of the increasingly collaborative approach to work in life science R&D, translational medicine and healthcare service provision. If infrastructures increasingly involve virtual organization approaches sharing risk, practices and value creation across organizations, the KM evaluation and measurement situation has a further series of differences in these contexts. At this stage one might just think one should give up on a detailed approach to intangibles and a quantitative KM business case for the industry.
However, let’s finish on an optimistic note. What we may be happy to settle for here are metrics which can successfully guide decision making rather than scientifically rigorous ones. We should therefore remind ourselves of the bounded rationality theory of Herbert Simon, which would point to our only needing to guide the non-optimal decision making of managers, based on metrics which are good or useful enough. There should only be so many pairs of shoes for me to choose from in the shop before I decide; for me 2 or 3 good pairs are enough! We can also remind ourselves that although Herbert Simon was awarded his Nobel in economics, he spent much of his life working in AI. (If you are an economist expert reading this post and encountering imponderable conjunctures, please reach out to correct, extend, enlighten and collaborate…!)
So for now I will conclude it looks like an interesting problem to work on. Please a) add relevant comments and links to this post and/or b) contact me at Barry.Hardy -(at)- douglasconnect.com if interested in joining a (probably initially small) practice group interested in discussing and developing approaches in this area.
new 3 year European-funded Seventh Framework Research Project which commenced on the
1 February 2008, will research the knowledge sharing and collaboration support needs
of stakeholders working collaboratively both internally within organisations,
and within partnerships and new virtual network and business models. The project offers end user organisations an
opportunity to participate in this leading edge research to address their
unique requirements, to undergo a knowledge assessment of their collaboration
needs, and the potential to pilot and test utility-based services developed
during the project.
Douglas Connect will lead the SYNERGY workpackage on knowledge assessment,
piloting and testing activities of application cases within industry and
business contexts. To provide an opportunity for organisations to learn more
about the initiative and the potential benefits of participation to them, Douglas
Connect will hold a launch and networking event and Knowledge Café at the
Radisson SAS Hotel in Basel, March 6 starting at 15.00. If interested
in attending please contact Nicki Douglas of Douglas Connect, (Email:
Nicki.Douglas –(at)- douglasconnect.com; Tel: +41 61 851 0461) to request a
Following short presentations to inform, the event will feature peer-to-peer
based Knowledge Café discussions on SYNERGY which will be facilitated by:
Prof. Keith Popplewell, Jaguar
Cars Professor of Engineering Manufacture and Management, Coventry University,
Dr. Barry Hardy, Founder, InnovationWell & Knowledge Assessment Leader,
Dr. Nenad Stojanovic, FZI Competence Center for Business
Software, Forschungszentrum Informatik an der Universität Karlsruhe, Germany
Nagesser, Managing Director, INSIDEAN GmbH
Zbinden, CEO, Software for Corporate Leaders LLC
detailed agenda and project overview is provided in the continuation below.
SYNERGY, a new 3 year European-funded Seventh Framework Research Project commencing on the 1 February 2008, will research the knowledge sharing and collaboration support needs of stakeholders working collaboratively both internally within organisations, and within partnerships and new virtual network and business models. The project offers end user organisations an opportunity to participate in this leading edge research to address their unique requirements, to undergo a knowledge assessment of their collaboration needs, and the potential to pilot and test utility-based services developed during the project. A summary of the project extracted from the formal technical proposal is provided below. (in continuation text)
InnovationWell has created a new forum sponsored by Sun Microsystems which is dedicated to discussing approaches for combating drug counterfeiting & trafficking.
We are having a first conference call discussion Thursday 30 March, 11:00am - noon EST (i.e., 08.00 California, 11am New York, 5pm London, 6pm Zurich since daylight-saving-time this week is in effect in the European time zones but not yet in the US time zones.)
To request a place in the conference call simply email me at barry.hardy [at] douglasconnect.com and I will send you dial-in instructions by return via email.
The initial program will address current issues and challenges in the introduction of new technologies and processes for ensuring the legality and safety of drugs obtained by patients, including RFID-tagging, automatic product checking to track product throughout the supply chain and new IT-based approaches to security and privacy protection such as federated identity management.
Conference Call Discussion Agenda: 1. Introduction & Welcome, Ulrich Meier, Sun Microsystems Inc. [5 minutes] 2. Overview of RFID in the Pharma Industry, Jim McKiernan, McKiernan Associates [10 minutes] 3. Sun RFID Solution for Drug Authentication, Liz From and Vivek Khandelwal, Sun Microsystems Inc. [10 minutes] 4. ProIdent Open System for combating counterfeit drugs, Dietrich Heinicke, CADAC GmbH [10 minutes] 5. Identity Management in the Life Sciences: Compliance, Privacy, Information Life Cycle Management, Dr. Hellmuth Broda, Sun Microsystems Inc. [10 minutes] 6. Open Discussion [20 minutes]
Presentations may be viewed prior to the conference call by logging into the InnovationWell website at http://innovationwell.net/. Subsequent to the call I will prepare and post a short summary article.
(Continued with discussion of the background and some the issues raised)