May 2005
Elan and Wyeth: A Case Study on Joint Drug Development
Presented by Julianne Hull, Wyeth
Discussion of the Clinical Data Management considerations for success in joint drug development programmes. The discussions will include considerations of data ownership, data structures, data mapping, data sharing and data exchange. It will also suggest best practices to assure appropriate management of the project understanding that very differnt company cultures and decsions processes are involved.
The basis for the presentation was the work being done by Wyeth and Elan in jointly developing an Alzheimer's vaccine. Julianne presented some of the drivers for such development and the key things to get right 'up front' in such a venture. Key issues were presented and some of the important risks to manage were outlined.
Key drivers for such development include sharing of the financial burden as well as having greater access to a wider group of expertise. Another by-product, is the skills gained by both organisations in learning the 'skills of partnering', which may form the basis of competitive advantage in the future.
A core theme, that underpinned many of the issues, was the importance of thinking the approach through 'upfront' and documenting clearly how various issues from finance, intellectual property, communications and even cultural differences would be handled by both parties.
Risks, including suggestions for mitigation, were identified. Critical to the mitigation approach was the importance of breaking down barriers within each organisation and sensitivity to the different pressures that may exist on either side.
In summary, Julianne presented an informative and challenging insight into this increasingly important approach and the implications for not just Data Managers, but all involved in Joint Drug Development.
Martin Giblin
Quintiles Ireland Ltd.