eli lilly analysis

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What is a "heavyweight project team" and how does it differ from the traditional approach used for organizing development projects at Eli Lilly? This consists of two issues. First, is an evaluation of the changes taking place in the pharmaceutical industry and what it is that caused Lilly to feel compelled to try the heavyweight development approach on two of its drug development projects? Second, is understanding the essence of the heavyweight team approach, particularly as it has been used by Lilly? A Heavyweight team structure is a project management organizational structure that consists of specialized experts led by a project manager that engages members from different functions to relate to each other to improve products and processes that need to undergo major changes. The project manager – usually a higher officer in the company is responsible for the work of all those involved in the project. A functional structure on the other hand, is a traditional approach found in most mature and larger companies where people are grouped in disciplines that work under a sub-function manager. The different sub-functions coordinate ideas through detailed specifications that all parties agree to at the onset and meet occasionally to discuss issues that cut across the various groups. Over time, primary responsibility for the project passes sequentially from one function to the next - a transfer process termed "throwing it over the wall". Five key characteristics defines a heavyweight team at Lilly. First and foremost, the teams were each given a very clear business charter “to focus exclusively on the development of a single compound.” Second, each team was co-located and cross functional. Third, the teams were each led by a “heavyweight” project manager. Fourth, each team took responsibility for the sub-stance of the work, how the work was accomplished, and the ensuing results. Finally, each team had two executive sponsors, one from LRL (Lilly Research Laboratories) and one from the business group, who guided them and worked to resolve conflicts between the team and the rest of the Lilly organization.

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Page 1: ELi Lilly Analysis

What is a "heavyweight project team" and how does it differ from the traditional approach used for organizing development projects at Eli Lilly? This consists of two issues. First, is an evaluation of the changes taking place in the pharmaceutical industry and what it is that caused Lilly to feel compelled to try the heavyweight development approach on two of its drug development projects? Second, is understanding the essence of the heavyweight team approach, particularly as it has been used by Lilly?

A Heavyweight team structure is a project management organizational structure that consists of specialized experts led by a project manager that engages members from different functions to relate to each other to improve products and processes that need to undergo major changes. The project manager – usually a higher officer in the company is responsible for the work of all those involved in the project. A functional structure on the other hand, is a traditional approach found in most mature and larger companies where people are grouped in disciplines that work under a sub-function manager. The different sub-functions coordinate ideas through detailed specifications that all parties agree to at the onset and meet occasionally to discuss issues that cut across the various groups. Over time, primary responsibility for the project passes sequentially from one function to the next - a transfer process termed "throwing it over the wall".

Five key characteristics defines a heavyweight team at Lilly. First and foremost, the teams were each given a very clear business charter “to focus exclusively on the development of a single compound.” Second, each team was co-located and cross functional. Third, the teams were each led by a “heavyweight” project manager. Fourth, each team took responsibility for the sub-stance of the work, how the work was accomplished, and the ensuing results. Finally, each team had two executive sponsors, one from LRL (Lilly Research Laboratories) and one from the business group, who guided them and worked to resolve conflicts between the team and the rest of the Lilly organization.

Regarding the Eli Lilly, what compelled Watanabe – Executive VP of science and technology t implement change – use the heavyweight approach is that, there were significant delays with meeting deadlines. As stated in the article (page-5), “timelines didn’t mean very much” as affirmed by one the companies researchers. In fact, between 1985 and 1995, the company of its size had only launched two major therapeutic products that was of major concern as it had begun impacting revenues causing Lilly to loose $18 billion in market capitalization between 1991 and 1995.

Mr. Watanabe felt that the traditional approach – functional structure needed an overhaul, as there was no accountability and responsibility on “project-by project basis”. Furthermore, no systems to track resources and measure progress was in place except at the macro level.

Page 2: ELi Lilly Analysis

What is your assessment of the performance of the two heavyweight project teams described in the case? What factors contributed most to these performance results? In the pharmaceutical context, how far back in the development process should heavyweight teams be deployed (e.g., just for Phase III, Phase II-B, Phase-in-A, Phase I)? Why? Here you will be examining the impact of this team structure on the Zyprexa and Evista projects (i.e., what the benefits have been of the heavyweight approach) and exploring what is it about this team structure that provided those benefits.

Two major successes resulted in the performance of the two heavyweight project teams described in the case. First, the Evista team saved months in completing their assignment compared to conventional development process for the first time. For example, in mid-July, only two month before the NDA (New Drug Application) planned submission, a system analyst discovered a data error by Zypreza team that would cause at least a four week delay, because of the heavyweight team, only one week the new database was back on course.

Cross-function between IT and other specialized experts in Evista team provided worldwide remote patient data entry, and affected significantly increasing the speed and accuracy of data acquisition. This new system had helped the team to shave at least 15 months from the development process of Evista.

Additionally, quality improvement was palpable with the heavyweight project team, the better quality of work can be achieved compare to the traditional (functional) development process. Evista team had constructed a worldwide database so the regulatory experts around the world could access information and access regulatory question quickly and easily. Even the FDA review of the package insert was done electronically and in real time by linking conference rooms in Indianapolis and FDA headquarters in Rockville, Maryland for review of the package insert. Because of such integration of specialized capabilities realized in heavyweight project teams, the heavyweight project team contributes its best performance.

The Evista team project also went smoothly largely because it comprised of operations, projects management, manufacturing, medical, clinical research, information technology, biostatistics, medical writings, and clinical operations. The function members of this team integrated less than a month. The above integration of specialized capabilities ensured the spirit of comrade and resulted a good team effort and high quality development.

In the context of pharmaceutical development, a heavyweight team approach should be developed and implemented earlier on in the development process for Phases III, II-B, Phase-in-A, and Phase-I because in these phases, the tasks are most complicated, expensive, and critical. Early development and implementation of Heavyweight team approach will save time, cut cost, and ensure effective management of getting things done faster, accurately, and correctly to meet “deadlines and milestones on-time”. Thus, the combined specialized capabilities and effective management are much needed in “these phases”.

Page 3: ELi Lilly Analysis

Is the "heavyweight" project team an approach that you would recommend to Lilly for purposes of commercializing the Evista product? What additional recommendations would you make to Lilly management concerning the use of heavyweight teams going forward? This consists of two issues. First, is making recommendations with respect to the use of heavyweight development teams at Lilly in the future. Second, is making recommendations regarding the commercialization team for Evista.

In my opinion, the heavyweight team approach is highly recommended and a must for highly specialized capability functions such as drug development as with Lilly. The collective efforts of a heavyweight team is what ultimately led to successful development and launching of Evista upon approval on December 1997 by the FDA. Prior to utilization of a heavyweight team, integration of specialized capabilities was especially difficult in most circumstances at Lilly owing to the culture of “not adhering to deadlines”.

Watanabe’s then creation of the heavyweight team was to reduce time to market for major new compound, and maximize effectiveness of global commercializing process and to revitalize Lilly’s drug development process.

With practical and well-defined goals, effective integration, and management. Each of the two teams (Zyprexa and Evista) became committed and focused to accomplish explicit timelines and deliverables. Not only did each team became dramatically streamlined with efforts to accelerate timelines and efficiency, staffing resource allocation needs that was a unique situation with commercialization with Evista unlike the Zyprexa team was successfully coordinated with strategic integration.

Ultimately, implementation of a heavyweight team approach with Evista proved to be a wise choice as with Zyprexa. Simply because, Lilly’s integration and use of a heavyweight team allowed the company to quickly review a previous 24-month Phase-III data used to secure approval of Evista originally as a “preventative drug for osteoporosis” and not for treatment, which was Lilly’s goal. The strategy worked, and further studies in addition to the previous 24-month Phase-III data helped Lilly secure approval of Evista not only for osteoporosis prevention, but also indicated for treatment of osteoporosis.

In hindsight, I believe Watanabe and Lilly as an organization superbly and strategically implemented a project management approach that resulted in a positive outcome for Lilly’s bottom-line revenue. And position as an industry giant with its competitors.

Therefore, I will recommend to Lilly’s management team to utilize a heavyweight team approach with other project management initiatives as with Zyprexa and Evista. Especially, for the fact that such project needs have critical deadlines, require effective allocation of specialized staffing resources, and enormous capital investment that cumulatively can negatively impact any organizations bottom-line revenue and competitive advantage if such critical project management approach is not utilized.