In the biopharmaceutical industry, outsourcing many facets of development, approval, and manufacture is as commonplace as it is practical. In this young industry, few companies possess all the internal capabilities or experience in every specialty required to discover, create, and commercialize a new product. The use of contract services is often driven by the desire to manage costs and enhance or maintain productivity. Project management is less commonly outsourced because the potential application and impact of doing so is misunderstood. However, firms that have retained professional project managers realize significant value, such as reduced time to market, less costly manufacturing processes, and better information flow among worldwide R&D teams.
C. Richard Panico
TOO MANY STAKEHOLDERS
Start-ups and big pharmaceutical companies alike recognize the potential to generate beneficial new drugs. However, like the large molecules with which biotech firms work, biotech ventures and partnerships are complex — and their complexity increases exponentially with the number of players. The addition of third-party manufacturers, CROs, contract analytical labs, co-development partners, and other parties makes it much more difficult to control budgets, maintain timelines, facilitate decision making, and ensure effective communications.
While technically proficient in their respective areas of expertise, biotech firms often lack an ingredient necessary for success — strong project management experiences and leadership skills. Biotech projects require leaders who can bring together both internal and external stakeholders to reach a common objective. This is why the project management function is absolutely critical: Someone needs to keep an eye on the big picture while tracking the details. It takes experience and discipline to create and manage the project plan, track follow-up, communicate status and issues, resolve conflicts, mitigate risks, verify compliance to requirements, and coordinate different experts with potentially conflicting priorities and agendas.
Coordination between senior management, contract manufacturers, external consultants, bench-level scientists, and other stakeholders increases productivity, job satisfaction, and ultimately the probability of project success. This role cannot be the part-time job of a technical team lead (or even the full-time job, depending on the person's qualifications). Project management is a specific set of skills and processes administered to meet the specific complexities of a project. In today's increasingly competitive environment, excellence in execution becomes even more critical.
GIVE PROJECT MANAGEMENT ITS DUE
The first step is evaluating your company's current ability to accomplish its priorities. Is your staff already over-committed? How often are strategic initiatives or tactical projects behind schedule or over budget?
It is no surprise that for many companies the answers are "yes" and "too often." These stumbling blocks can be at least partially overcome through sophisticated project management practices. Some further questions that can help you assess the project management expertise within your organization include:
- Does your organization have a clearly defined process for managing tasks?
- Do you recruit and dedicate staff specifically to manage projects?
- Are your project managers formally trained and involved in continuing skill improvement?
- Have you collected and analyzed empirical data that categorize and describe projects and identify project management costs?
It is unlikely that your company has taken its internal project management to this level. Your focus is on your core competency, biotechnology, which is no guarantee of excellence in managing teams or coordinating and executing strategies — the forte of a trained, professional project manager.