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.