Tech transfer as usual. Is this sustainable in an environment where “usual” can mean a billion dollars in development costs, a 12-to-15 year development cycle, five to eight years of patent protection, and perhaps survival of one candidate product in 10,000?
Given the decline in blockbuster products, and the fact that R&D pipelines are drying up and patents are expiring, there is an urgent need to increase the speed and effectiveness of pharmaceutical tech transfer. In order to do that, a life science company must answer three critical questions:
- What is causing the industry to require more and faster tech transfers?
- What is needed to make tech transfer competitive?
- What does the future hold?
Only then can they create solutions that best fit their organization’s strategy.
Business Models are Merging
There are many factors shortening the duration of tech transfer. One lies in the differences between blockbuster and generic business models, each of which emphasizes a different core competency. With the blockbuster model, discovery is key, and the extra costs of a longer transfer are offset by higher revenue after commercialization. In sharp contrast, discovery is not important in a generic business model. Tech transfer itself is the core competency, with a focus on reengineering and creating a process for an existing product.
The decline in blockbuster products is causing both blockbuster and generic types of business models to merge, with each adopting core competencies of the other—generics companies, for instance, now need to develop the skills of discovery.
As both types of companies shift to niche disease markets, by definition there will be more technology transfers and they will need to be conducted more quickly and easily. More niche discoveries will be needed, and the timeframe before products go generic will shrink. Over time, the blockbuster and generic models will become more alike.
Global Competition is Increasing
Also driving tech transfer is an increase in global competition. Advancements in information and communications technologies, changes in protectionism with the adoption of the Agreement on Trade Related Intellectual Property Rights (TRIPs), and the globalization of research and development activities by multinational enterprises are driving the need to better understand the proper role of intellectual property in a knowledge-based economy.
Between 1976 and 2006 we’ve seen a significant increase in the number of scientists and scientific industries in countries such as Brazil, China, and India . As the growth of these scientific-based industries increase, so will the need to do things differently. Business as usual and tech transfer as usual will no longer suffice.
Knowledge Transfer and Eliminating Rework
Knowledge transfer is a critical part of tech transfer. In fact, it is the thread that ties the stages of development together. A four-stage process includes four to 10 years of discovery, three years of exploratory development, and three years of regulatory development just to launch a three year commercialization . The duration contributes to the potential loss of knowledge at each step of transfer. The net effect of knowledge loss over time is the need to recreate or rework to correct or capture that loss. Recreation and rework contribute significantly to the length of time required from discovery to commercialization.
One useful tool for minimizing rework is ISPE’s Good Practice Guide for Technology Transfer, which outlines standardized processes, defines minimum documentation requirements, establishes key terms, and outlines the time and cost for tech transfer. Although this guide emphasizes active ingredient pharmaceuticals, it outlines principles that can be applied throughout life sciences.
Making Tech Transfer Competitive
The effectiveness of tech transfer is difficult to define . The first challenge is setting a boundary on the technology. This is difficult today, because technology development and transfer processes practices are laden with rework loops. A critical requirement, then, is a methodology that can capture both knowledge and technology, eliminating the need for redevelopment and rework, provide a robust method for handing off knowledge and technology step by step.
The second difficulty is outlining a tech transfer process where concurrent processes are not integral to a single defined system. The next significant requirement is a clear understanding of ownership and the critical interactions between the concurrent processes. A common approach includes basic project management items such as timing, cost, and expected results. An integrated system, however, must be much more and include such factors as adding value by eliminating non-value added activities, using cross-functional teams, and utilizing crisis avoidance, conflict resolution and escalation techniques. Simplifying documentation and records is also important.
The third difficulty is measuring the impact of tech transfer. This requires that the process be structured in such a way to drive consistency and discipline into the organization, yet encourage calculated risk taking to solve problems in new and different ways. Consistency in transfer provides flexibility within structure, eliminates unexpected variables, and shortens the overall transfer time.
The goal for tech transfer is to develop a common system that effectively captures knowledge and technology for handoff, synergistically integrates multiple concurrent activities, and creates the level of consistency and discipline. Certain steps must be taken to move toward that goal.
First, define a structured tech transfer process flow to capture the knowledge and technology:
- Map the preferred process flow, eliminating unnecessary actions and steps that create rework loops.
- Predefine incremental stage gates that separate current processes into defined and integrated work breakdown structures to minimize process independence and maximize interaction
- Define Stage gate approval-to-proceed by specific measurable criteria that must be complete before moving into the next phase of development.
Establish an organizational infrastructure consisting of a single team of management and cross-functional members that govern the structured process: