Adnexus Case, Case Study Example

Executive Summary

Adnexus had continued to prosper beyond a successful acquisition program. It faced additional challenges in improving the stage gate review process over its clinical trials procedures, a process that could not be rushed owing to regulatory requirements that prohibited short-cuts. It was important that they developed a structured procedure that would manage the clinical process and ensure that key milestones were successfully achieved in a timely manner. There was little room for compromise and the success of the firm would be measured in this area. The management had in addition identified three main components to ensure a successful drug pipeline in the future:
? They would need to improve the overall ongoing development process, with particular emphasis on the stage gate review process;
? They need to add more structure and process to the research, indicating that the $30 million allocated needed to be optimized for efficient use;
? They need to advocate for new therapies during the regulatory review process, such that the pipeline follows through to full commercialization of the products.
INTRODUCTION
Adnexus had been acquired by Bristol-Myers Squibb (BMS) for $430 million. This had provided the firm with an increased financial base for the clinical development of its products. It was vital, however, that the firm continued to maintain clinical results over the mainstream C-322 program. In order to accomplish this it required a critical stage gate review process that illustrated the progression between the varying phases of the clinical trials development. This demonstrating that key target milestones were being achieved.

Stage Gate Development Model

Fig 1 illustrates the standard Stage Gate development model. Developed by Dr. Robert G. Cooper it was designed to help in providing a conceptual roadmap for taking a new product development from initial scoping through to a successful launch. The Stage Gates provided critical review points to ensure that the specifications were correctly achieved and to meet quality review expectations, thereby allowing the management to sign off the completion of that stage with a high degree of confidence of completion. Equally, should any shortcomings be detected it provided an opportunity for early remedial action and corrections before continuing to the next stage of development. (Stage Gate, 2012).
The Adnexus approach was loosely based upon the standard approach designed by Ulrich and Eppinger (Ulrich, K.T. 2004) but differed in that it was customized in order to meet certain specific needs. The clinical trials on human patients essentially followed three stages and could extend over a 6 or more year period. This was highly regulated by the FDA with an extensive approval process before any new drug could enter the market place. The typical phase development as illustrated in the table in Fig 2
Figure 2

Angiocept

Angiocept was the first major drug concept and was specific to that of Oncology CT-322 for inhibiting tumour growth in cancer patients. Essentially a biological approach in inhibiting angiogenesis by halting the flow of oxygen to the tumours blood supply, thereby inhibiting growth. In 2005 the clinical trials had been delayed owing to the FDA requiring additional information on the manufacturing process. Early results of the clinical trials had illustrated extremely positive results but the Phase 2 trials remained ongoing

Creating a Successful Drug Pipeline

In order to develop a successful new drug pipeline Adnexus identified the following three main process improvements that would be required:-
? They would need to improve the overall ongoing development process, with particular emphasis on the stage gate review process;
? They need to add more structure and process to the research, indicating that the $30 million allocated needed to be optimized for efficient use;
? They need to advocate for new therapies during the regulatory review process, such that the pipeline follows through to full commercialization of the products.

Conclusions

Overall the evolution of Adnexus demonstrated considerable progress and this continued beyond the acquisition process. They now had more money, resources and experience in order to leverage upon their existing achievements. In that sense they have demonstrated a proactive response to turning things around.

References
Stage Gate. (2012, 2 10). Stage Gate Review. Retrieved from Stage Gate: http://www.stage-gate.com/knowledge_pipwhat.php
Ulrich, K. a. (2004). Product Design and Development 3rd Ed. New York: McGraw Hill.