for jobs in Project ManagementDrug development is unpredictable
The course of drug development is unpredictable and therefore it is critical to have realistic expectations for any given project (1). There are inherent difficulties in running a drug development successfully and the larger the project the more numerous potential problems can be. Accounting for the factors that can stand in the way of a project’s success and being able to take an objective view of the strategies required is a demanding, but necessary task (1).
Regardless of the amount that a pharmaceutical company decides to invest in its new drug pipeline, there is no chance of success unless a project is effectively managed. At present the pharmaceutical industry is under pressure to improve its productivity, as the number of new products reaching the market has been on the decline for a number of years. The productivity decline has led to many observers believing that the industry requires a new approach to the way in which it runs its projects.
It is these circumstances that have led to the rise of project managers in the pharmaceutical industry. Project managers are able to apply past experience to ongoing projects in order to solve problems in a practical manner whilst also being able to develop new approaches to resolve project-specific issues. Although it is impossible to predict every factor that will affect a project, by being proactive the major issues can be identified. Furthermore, any preconceptions can be challenged and alternative scenarios can be devised (1). Focus on Pharmaceutical licensing
Alliances and collaborations are playing a greater role in drug development. Companies are finding that by licensing in compounds they are able to supplement their pipelines. In 2004, over a quarter of the sales of the top 15 pharmaceutical companies were derived from in-licensed drugs (2). This approach allows the parties to benefit from the commercial and technical strengths of the other organization and the sharing of risk. Yet once again, careful management of a project is required if it is to have any chance of success. Poor project management could negate all the advantages that have been gained through potential collaboration.
The area of project management in licensing has not been thoroughly explored, but there are efforts underway to change this. The Pharmaceutical Industry Project Management Group (PIPMG), a not for profit group, has been holding industry-wide meetings in the UK to examine relevant issues in licensing (2). Delegates examine real case studies and participate in discussions to see how they can learn from the experience of other companies. PIPMG has over 500 members representing a broad range of companies in the biopharmaceutical sector. PIPMG has examined the role of project management in a number of pharmaceutical R&D areas, but is now particularly keen to emphasize its benefits at the early stage of licensing (2). Outlook
There has never been a tougher time to be involved in drug development. In recent years, the market has become much more competitive and the political, regulatory, social and economic pressures more intense. Merck’s recent problems with Vioxx and Bayer’s withdrawal of Lipobay from the market in 2001 are timely reminders that there are no certainties in the field of drug development. If companies are to maximize their financial investment and allocation of resources then project management will be key to success. New approaches to solving productivity problems, such as collaborations, are a step forward but they will require careful management to ensure that potential benefits are realized. References
- Kermani F. and Narayan C. (2005). Thinking ahead for effective clinical trials. Nature Biotech. Vol 23 (4): 499-501.
- Anon (2005). Licensing: A better way forward? Pharmaceutical Industry Project Management Group (PIPMG).
Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.
You can contact Dr Kermani via firstname.lastname@example.org