The Ferryman

Knowledge Management in Pharmaceutical Manufacturing - optimising efficencies in knowledge transfer

The pharmaceutical industry has made impressive strides forward over the past decade in optimising how it manages clinical development. One important result has been a significant decrease in the time required to gain regulatory approval for a new drug. In the past it was common for clinical development to require in excess of ten years whereas today, especially for innovative treatments for unmet needs, this can be as short as 3 to 5 years.

The impact of this time compression on technical development and manufacturing is significant. In the old days, process technologists and chemists had many years during which to develop the manufacturing and analytical processes. A good example is the time to optimize chemical processes for active pharmaceutical ingredient (api). Best practice in drug development today means that the launch formulation of the drug should be the same as that used in the pivotal trials (late phase II and phase III). In order to have the formulation ready for these trials, the process chemists need to have frozen the final synthetic route shortly after the first trials in man have commenced. This means they have months in which to work compared to the years they had in the past.

Transfer of technology between development and manufacturing is now a key success factor to achieve robust processes and minimize cost of goods. This demands standardization of equipment, processes and materials between development and manufacturing, but also much greater interaction and dialogue from the earliest days of new product development. In the past this involved having experts from manufacturing participate in development project teams, often attending meetings during which their input was minimal and for projects for which the success likelihood was low. In manufacturing parlance this process is not fit for purpose and a better way of sharing and managing knowledge is needed.

The Life Sciences industry has recently started implementing concepts such as “Design for Manufacture” (DFM) which have been in use for over thirty years in industries such as automotive and electronics. These concepts recognize that most of the cost of a product is locked in early during the design phase and with ever-decreasing life cycles, the opportunity to optimize production processes post-launch are minimal.

In life sciences we face subtly different challenges. Life cycles are not so short, but the pressures on technical operations to reduce cost of goods sold (CoGS) are immense and this, combined with the new approach by regulators, such as the FDA, to compliance mean that improvements in integration between technical development and manufacturing operations will bring significant benefits. These benefits are to be found not only in costs but also in faster product throughput times, robust processes and greater control over issues affecting regulatory compliance.

Knowledge management is key to making this work. Research and development functions need to have a better understanding of preferred standards in equipment and materials used by technical operations; on the other hand technical operations need adequate warning of new product technologies which might require new investments or the selection of strategic outsourcing partners. In the past the high attrition rates suffered by early phase compounds made it difficult to set priorities and allocate time for technical operations’ involvement in development projects. This cannot be allowed to continue because development times are reducing with the implication that the launch molecule and formulation need to be finalized relatively early.

We will be having two workshop sessions this Autumn to address and discuss the above issues:

InterAction Meeting Session, Philadelphia, USA, 12 October 2005
chaired by Jack Vinson (Knowledge Jolt)

InterAction Meeting Session, Basel, Switzerland, 9 November 2005
Workshop delivered by Jim McKiernan (CEO, McKiernan Associates) and Mike Dey (VP, Pharmaceutical Development, Ipsen)

During these sessions case studies from pharmaceutical companies where knowledge management issues in transfer from R&D to manufacturing have been successfully addressed will be presented. They will then facilitate an interactive workshop with the participants in order to identify key concerns and to identify the steps to be taken to achieve excellent knowledge management in technical development and manufacturing.

You can SignUp for these sessions through the InnovationWell website.

Barry Hardy
InnovationWell Community of Practice Manager

manufacturing pharma knowledge management innovationwell events

Confidence in Safety

For any drug on the market the key question with regards to safe use is: Can we assess how much of the medically relevant safety profile is known? At what point(s) in time? How much remains unknown? The reductive approach to drug development pre-supposes a scope of what needs to be known and proceeds to answer questions within those boundaries. Alternatively, “Confidence in Safety” assumes that all medically relevant information needs to be known, but that we cannot realistically presume to have such complete knowledge until late in a product’s lifecycle, if ever. In order to assess the risk associated with a marketed product we need to be able to assess how much we know about a drug’s safety profile or, more importantly, how much is not known.

Innovation Café on Confidence in Safety
Innovation Café workshops demonstrate a new kind of conversation that quickly leads to documented, useable tactics in authentic language. We are holding an Innovation Café on Confidence in Safety in Basel, Switzerland on 8 November 2005:

Innovation Café
2-6pm, Tuesday, November 8, Basel, Switzerland
moderated by Victor Newman (Knowledgeworks)

This Innovation Café will involve participants in two types of innovation thinking about Confidence in Safety by:
1) Inviting participants (InnovationWell members, Biovalley organisations, pharma orgs, community of practice meeting attendees, etc.) to visualize a scenario where optimum confidence in safety has been realized, and then work backwards to define and prioritize the necessary capabilities that need to be constructed to make it happen;
2) Using reversal-thinking to pose questions about innovation failure to identify what we know intuitively works, now; and turn it into usable knowledge to make the capabilities developed in the success visualization a reality.

Attendance at this half day workshop on November 8 in Basel can be booked as an individual item though the InnovationWell website; it preceeds the InnovationWell Community of Practice meeting running 9-10 November 2005 in Basel.

Single Organisation Innovation Café
On-site or single organisation innovation cafes at your own organisation can also be arranged through enquiry.  Contact:
Barry Hardy, InnovationWell Community of Practice Manager (+41 61 851 0170, barry.hardy at douglasconnect.com).

About Victor Newmann
Victor Newman was Pfizer's Chief Learning Officer (2000-2004). His leadership of innovation in the form of pragmatic solutions that connect knowledge in new ways, transformed global best-practice. His leadership of skunkworks projects doubled Pfizer's R&D productivity. Victor has a prevailing interest in the psychology of implementation, derived from diverse and intense consulting experience with all industrial sectors.

His recent application of his influential "BoxLogic" KM technique designed to develop a portfolio of innovative strategies, by exploring the limitations of the existing business paradigm within Pfizer, identified key strategic opportunities to transform business strategy and change the basis of measuring and creating new market value.

As Visiting Professor in KM and Innovation, he leads the Lifesciences MBA Consortium in partnership with the Open University Business School in Europe. Victor has contributed to HBR, is author of "Made to Measure Problem Solving" and his "Knowledge Activist's Handbook" from Capstone/ Wiley & Sons was recently cited as the "best management book within the last ten years".

The Innovation Dilemma
You are aware that innovation is essential to business success, but what can you actually do about it?

You know that bringing in a team of consultants to audit your business around its ability and potential to innovate will lead to some important home truths being embalmed within a report that moulders in the organisational file 13. You probably know the answer to their questions already: that middle and functional management groups kill most of your innovation and that the present political stability of the organisation is based on continuing to allocate resources to leaders of declining products and services. You also know that introducing an external consultant’s language and model of innovation is the fastest way to build up internal resistance and sabotage by leaders, partners and employees. Your leaders’ attitude to innovation is close to St. Augustine of Hippo’s on chastity when he prayed: Oh Lord make me chaste, but not yet.

But you know that you must innovate or die, but how do you give people credible permission to talk intelligently and honestly about innovation without having to excise them from the body of the business as political saboteurs?

Everyone knows that innovation is key, but it remains easier to squeeze the margins and go for minor differentiation around existing products than to do something new. You want a conversation around innovation without the risk of upsetting your people or triggering defensive behaviours. You want to innovate and yet you know that whilst there are pressures to do something, there are even stronger, immediate pressures to maintain the status quo. One of the key tactics for overcoming NIH (not-invented-here) is to begin to shift your culture by introducing opportunities to build an authentic language that describes the problems as well as creating a climate of possibility for new alternatives. If a culture is the by-product of stabilising a successful technology based upon new knowledge that confers advantage, then that culture cannot shift without developing its own language of innovation.

You are probably sick of Staff Attitude Surveys and the resulting communication exercises where leaders talk at their audiences in the name of engagement. You’ve tried Values, Leader Behaviours, Seven Habits, or "death by powerpoint". You’ve chanted the slogan, you’ve got the T-shirt, the sticker, and the banner and the posters are up in the reception area. But even though you tick the box on your personal goals, you know that the real problem around innovation hasn't been solved.

The problem is that at the moment, the innovation opportunity hasn't been defined by your people, the language of the problem and the language of the solution hasn't been articulated. And everyone is so busy running trying to stand still, that they haven't got the time to think about the alternatives, discuss or even give them a name. So now's the time to consider licensing a kind of conversation that builds knowledge-pull instead of knowledge-push through asking open questions that don't initiate defensive behaviours around the status-quo.

What is an Innovation Cafe?
Victor Newman and David Gurteen decided to design Innovation Cafes (iCafes) building on the power of the knowledge café approach by designing rapid, documentable and dynamic conversations that encourage new practitioner behaviours to drive innovation within individuals and organizations. There are 2 types of Innovation Café: open and focused. Open iCafes are designed for mixed audiences; whilst focused iCafes are delivered to dedicated work groups, teams or specific organizations.

The Life Science Innovation Cafe running 8 November in Basel will be a half-day afternoon session addressing innovation issues directed towards building improved confidence in safety in life science, pharmaceutical and healthcare solutions. Followup focused iCafes for single organisations can additionally be reserved for work groups and teams.

It’s a truism, that we probably know more than we can say, and that we don’t know what we know until someone asks us a good question. It is also a problem that the literature of management can seem to encourage a myth of competence that ignores failure instead of learning from it. Innovation Cafes begin by asking questions to identify what doesn’t work now and turning it into usable knowledge for an immediate future.

The entry innovation café workshop is designed to demonstrate how a new kind of conversation can quickly lead to documented, useable tactics in authentic language based both on candour as well as can-do. This is done initially by focusing discussion upon failure and encouraging participants to design an innovation process with every imaginable flaw within it. Participants identify the top 3 most powerful elements guaranteeing failure within their collection and are invited to reverse these through constructing antidote tactics expressed in some detail (based on Montgomery’s rule of three: that if you deal with the top 3 issues, everything else will sort itself out). iCafes explore tacit knowledge about failure and turn it into new, authentic rules about innovation, to explore and learn from NIH (not-invented-here), visualizing an "Innovation Machine", building innovating behaviours and constructing new freedoms to think and operate outside the present limited strategic box.

Barry Hardy
InnovationWell Community of Practice

Knowledge-based Intellectual Property Management, Auditing and Investment in the Life Sciences

Value is constantly being created in a life science or healthcare company through intellectual property creation, but additionally through tacit knowledge growth and intellectual capital utilisation, and through innovation-generating knowledge networks leading to action and outcomes. Additionally, technology licensing, out-sourcing and in-sourcing of strategic partners, and acquisitions bring new knowledge and intellectual property opportunities to the organisation.

Techniques such as knowledge audits, inventories and maps can be used to capture the current state of knowledge in an organisation and to identify strengths, weaknesses and gaps. Such analysis accompanied by the selection of appropriate metrics can be used to guide knowledge management strategies and planning. Finally, any proposed knowledge-based initiative needs to be supported by a sound financial analysis, clearly demonstrate investment returns and measurable tangible benefits, clarify intangible benefits that can be understood and tracked, and include a weighting of risks and most probable outcomes in the marketplace.

The goal of this program is to enhance the appreciation, understanding and best practice in life science and healthcare knowledge management so as to maximise the effectiveness, protection and value of organisational intellectual property assets. Questions addressed by this program include:

How do we increase innovation, value and returns from product life cycle and intellectual property management of life science product related knowledge?

How do we manage and value drug-related knowledge that is captured in ontologies?

What are the best practices in knowledge audits, inventories and maps applied to life science product development? What are the challenges requiring methodology development?

What are the appropriate financial analysis tools for evaluating an investment decision in a knowledge management initiative in a life science or pharmaceutical company?

How should drug safety, uncertainty and risk management issues be included in the financial analysis?

What steps should an organisation take to improve its performance in corporate sustainability as measured by knowledge management, organisational learning and human capital assessment metrics?

What is the impact of these metrics and the improvement by an organisation in areas of weakness on sustainability indices and the valuation of a company?

How do we value tacit knowledge and intellectual capital in a pharmaceutical company?

What are the current legal guidelines, practical experiences, law/legal case studies relating to use/acceptance (or not) of electronic records and submissions?

What are the best practices for legal and intellectual property protection in collaborative knowledge management systems and electronic notebook systems?

How do we better manage intellectual property of healthcare product and associated safety knowledge?

How should we publish and manage delivery of new drug knowledge to partners, payors, providers and patients?

What is the potential impact of new regulatory initiatives, e.g. FDA SPL and e-labeling? What are the impacts of new European regulations?

What new approaches for managing knowledge are being created by the increasingly electronic and semantic nature of information capture, management and collaboration? What are the legal and regulatory risks and how do we manage them?

How can existing knowledge and intellectual property be more effectively deployed into new business situations?

We will be exploring some of these questions with a leading panel of financial, investment and regulatory experts at our European InnovationWell meeting in Switzerland in November:

InterAction Meeting Session, Basel, Switzerland, 10 November 2005
chaired by Ronald Layden (Venture Valuation AG)

Presenters & Discussion Leaders:
Dr. Ronald Layden, Senior VP Technology, Venture Valuation
Dr. Rudolf Gygax, Managing Director, Novartis Venture Fund
Dr. Gerard Farmer, Partner and Regulatory Expert, Alfomec International Regulatory Consultants
VP Business Development, Pharma
Dr. Antonino Cattaneo, CEO, Lay Line Genomics
Dr. Stefan Odenthal, Partner, Arthur D. Little

Further information can be found at InnovationWell

Barry Hardy
InnovationWell Community of Practice Manager
Douglas Connect, Switzerland