Overseas Think Tank for Indonesia

Image source: healthcareskills.nhs.uk

By Beni Bevly
The Evista Project case provides an opportunity for us to look at a major drug company, Eli Lilly and Company, and their efforts to improve their drug development process through the use of “heavyweight” team. It also provides an opportunity to examine the detailed workings and basics of heavyweight teams, the potential impacts that such teams can have, and some of the challenges of transitioning from a more traditional functional, or lightweight team approach, to heavyweight team approach. Therefore, I brought up this case for us to learn, and if possible, to emulate this project’s method of completing its tasks.

Heavyweight project team, according to Clark and Wheelwright in ”Organizing and Leading ‘Heavyweight’ Development Teams,” California Management Review, Vol. 34. No. 3, Spring 1992, is a development project team consists of specialized experts that led by a project manager who has direct access to and responsibility for the work of all those involved in the project.

There were five keys characteristics defined a heavyweight team at Lilly. First, the teams were each given a very clear business charter “to focus exclusively on the development of a single compound.” Second, each team was collocated 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. Fifth, 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.

Such as leaders are “heavyweight” in two respects. First, they are senior managers within the organization; they may even outrank the functional managers. Hence, in addition to having expertise and experience, they also wield significant organizational clout. Second, heavyweight leaders have primarily influence over the people working on the development effort and supervise their work directly through key functional people on the core teams. Often the core group of people are dedicated and physically collocated with the heavyweight team project leader.

When managed effectively, heavyweight team offers improved communication, strong identification with and commitment to a project, and a focus on cross-functional problem solving. However, this team is not so easily managed and contains unique issues and challenges.

Other than the above characters and assigning heavyweight project leaders to lead these teams, “heavyweight project teams” had two major assignments that were not assigned to the traditional approach that Lilly used before for organizing development project. First, heavyweight project team was getting all necessary components and subsystem to complement one another and win approval from the FDA (the Food and Drug Administration). Second, heavyweight project team also effectively addressing the needs of the prescribing physicians, health care insurers, and patients’ physicians.

There are two major successes that showed in the performance of the two heavyweight project teams described in the case. First, time. the Evista team had saved months in completing their assignment compared to conventional development process. 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.

The cross-functional between IT and other specialized experts in Evista team had 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.

Second, quality. With heavyweight project team, the better quality of work can be achieved compare to conventional 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. A conference room in Indianapolis was linked to a similar room at FDA head quarters in Rockville, Maryland.

Effective product and process development requires the integration of specialized capabilities (Clark and Wheelwright, ”Organizing and Leading ‘Heavyweight’ Development Teams,” California Management Review, Vol. 34. No. 3, Spring 1992). The integration of specialized capabilities realizes in heavyweight project team. Because of this factor, the heavyweight project team contributes its best performance.

The Evista Team went smoothly 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 ensued the esprit de corps and resulted a good teamwork, which was the basic requirement to the high quality development.

In pharmaceutical context, heavyweight team should be developed in development process for Phase III and included FDA Review/Approval (registration) phase because in these phases, the tasks are most complicated, expensive, critical, meticulous, and involved many volunteers and related directly to FDA. In these phases, to get things done faster, accurately, and correctly, the combined specialized capabilities are needed. If there is any mistake, it would take long time to correct it.

To describe how complicated, expensive, critical, meticulous, and involved many volunteers and related directly to FDA, below is the brief discussion in each phase III and FDA Review/Approval (registration) phase (Rhomke and Nimgade, “Note on New Drug Development in the United States,” The President and Fellow of Harvard College, 1998):

Phase III: Long-Term Efficacy Trials (Three Years). Phase II trial is by far the most expensive phase of drug testing, involving thousands of volunteer patients (approximately 1000 to 3000 volunteer patients) at hospital sites scattered around the country and ever overseas. In Phase III, researchers monitor long-term drug use for safety and optimum dosage levels. By studying far more patients over longer period of time than in Phase II studies, they can uncover subtler and more insidious side effects. Over one-fourth of drug candidates pass this hurdle and move on to the FDA review stage.

FDA Review (about two to three years). The NDA (new drug application) represents a tribute to the 20th century pharmaceutical industry’s data-generating capacity, with its contents running into hundreds of thousands of pages. The NDA includes data not only on each patient, but also on the company’s plans for producing and stocking the drug. Not surprisingly, the FDA committee has historically taken two to three rears to review the NDA and make recommendations about marketing the drug. Often, the FDA and sponsoring drug firms work closely to iron out potential problems with the data or other technical problems.

At the end of the project, this heavyweight team successfully produced Evista, which had received the United States FDA approval on December 9, 1997, for the prevention postmenopausal osteoporosis. Evista also generically know as raloxifene hydrochloride.

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*Beni Bevly holds BA in Political Science, MBA in Marketing, and is a DBA (Doctor of Business Administration) candidate. He is the founder of Overseas Think Tank for Indonesia.