Project Managers in the Spotlight - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Project Managers in the Spotlight
Strong demand is straining service providers' project-management capabilities; Patheon receives a much-needed cash infusion.

Pharmaceutical Technology

I received a call the other day from a sourcing professional at a top five pharmaceutical company looking for recommendations for manufacturers of clinical supplies. It seems that his current three suppliers aren't answering his phone calls in a timely manner, and he is getting fed up with the poor service he is receiving. He's also frustrated with the constant turnover in project managers at his suppliers.

The sourcing professional's problems are a common story these days, as demand for development services has never been greater. Major biotechnology and pharmaceutical companies are under enormous pressure to advance their pipeline compounds, while funding for early-stage companies continues to flow. As biotechnology and pharmaceutical companies push to keep studies moving, contractor resources are being stretched as they try to meet client requirements.

Jim Miller
Project managers are the focal point of most customer interactions once a contract has been signed, and their performance affects both the reality and the perception of how well a study and a relationship are going. Clients depend on project managers to be their advocates to ensure that their studies get scheduling priority and the necessary resources. They also expect project managers to keep them informed about progress and problems as they arise. When a project manager has worked a long time with a particular client, he or she can make studies run more smoothly by knowing the way a client expects work to be done or reports to be written. The very personal relationship between a project manager and his or her client counterpart is viewed as critical to study success, and any disruption is seen as putting the project at risk.

Clinical contract research organizations (CROs) have long been aware of the critical role of the project manager in maintaining client confidence, and have occasionally taken advantage of it during the competitive bidding process by promising to assign a trusted project manager to a study. Too often, however, the promised project manager was moved to another study shortly after the contract was signed, creating a sense of distrust and alarm on the part of the client. Many biotechnology and pharmaceutical companies have taken to insisting on contract language that assures the client that this "bait-and-switch" doesn't happen again.

Attributes of the current market environment are particularly tough on project managers. The large number of early-stage companies needing services is especially demanding because managers at those companies often have little hands-on drug development experience and depend on project managers for guidance on what needs to be done and when. As a result, the project management input for these clients is often way out of scale to the size and nature of the work that actually has been done.

As for the major pharmaceutical companies, many are using contractors to an unprecedented degree so their sourcing managers have little direct experience with contractor performance or managing outsourcing relationships. The fact that much of this work was previously done in-house may mean that the client-side managers are unaware of the cost and time implications of changes to the scope of work or project schedules. It may take all of the project manager's diplomatic skills to explain to the client that doubling the order for clinical trial supplies will increase delivery time because suite capacity already has been committed to other projects.

Company Web sites
Clearly, the industry must invest more in its project-management capabilities, but it's not always easy to justify. The benefits of excellent project management are often intangible and difficult to justify on a cost-benefit basis, so it may be easier to spend $40,000 on a new high-performance liquid chromatography system than it is to invest that amount in training project managers (especially given the rate at which project managers seem to be changing companies). Still, companies are getting the message, and companies such as Bilcare (Phoenixville, PA) are going so far as to have their project managers earn professional certification from organizations such as the Project Management Institute (Newtown Square, PA).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here