Project Managers Wanted

Outsourcing by bio/pharmaceutical companies is increasing in volume and scope, but what are some factors that may constrain growth? Effective communication and effective relationship management, from both a sponsor company and contract manufacturing organization (CMO) perspective, pose a potential bottleneck to realizing the potential of outsourcing.

Even before the current economic downturn, biomanufacturers said that "establishing a good working relationship" was the most difficult and challenging aspect of outsourcing (1). As outsourcing expands, CMOs and client companies will need to improve their respective skill sets to manage these external relationships. The great majority of CMOs surveyed in BioPlan Associates' 7th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production said their customers had unrealistic timeframes (82% said so) and lacked the ability to communicate effectively (80% said so). The survey included 327 individual respondentsat biopharmaceutical manufacturers and CMOs in 35 countries.

Insufficient communication is a well-documented managerial problem. Managers must be able to lead in a highly dynamic environment and create an organization where communication effectively flows at all levels (2), which is sometimes a skill set not adequately developed by biomedical scientists in managerial positions. Academic entrepreneurs account for 43.1% of founders of biotechnology companies, a level that is far greater than any other industry (3). There may be some correlation between this predominance of scientists in managerial roles and the relative success of biopharmaceutical organizations as businesses.

CMOs' perspectives

Perhaps as a result of the growth in outsourcing, problems in the client–contractor relationship continue to expand. The 2010 BioPlan study identified 11 crucial issues that CMOs cited as the most common mistakes made by their clients (i.e., biomanufacturers). CMOs cited two main points: "clients don't plan their technology-transfer process" and "clients don't communicate with us effectively."

Eric Langer

Operational issues are also crucial. Seventy-eight percent of the CMOs surveyed said that "clients wanting to contain cost by doing limited development runs but still expecting successful full-scale manufacturing" was either a "very important" or "important" problem. This issue involves cost containment and time-to-project completion. It also suggests that the majority of biomanufacturers, who are under increasing cost and time pressures, are pushing that stress onto their suppliers. The second relationship problem involves unrealistic expectations: Forty-six percent of CMOs cited as a "very important" concern that "clients don't build in sufficient time for the project" (i.e., unrealistic timeframes).

Sponsor companies' perspectives

Among the 25 factors evaluated in the BioPlan survey, relationship issues are near the top of the list of problems cited by sponsor companies (see Figure 1). Although the relationship trend improved slightly this year compared with the previous years, relationships between sponsor companies and CMOs are far from optimal Only 58% of CMOs said that "establishing a good working relationship" was "very important" in the 2010 BioPlan survey compared with 63% in the 2009 survey (see Figure 1).

Figure 1: Crucial issues in biopharmaceutical outsourcing (1).

One industry expert sums up the problem. "The recent increase in pharmaceutical outsourcing activities is creating headaches at pharma companies," said Mark Mazzie, managing director at the Center for Professional Innovation and Education (Malvern, PA), a pharmaceutical training company, in a recent interview with BioPlan Associates. "This is especially true for companies that haven't trained their managers to manage these new relationships or to understand how time-consuming and difficult offsite managing can be. With the current economic crunch, everyone is being asked to do more with less, so these problems are likely to increase unless personnel are given the requisite skills to manage these tasks."

Operational concerns are also an issue. The 2010 survey showed that 64% of respondents said that compliance with quality standards was "very important" compared with 59% in the 2009 survey. These quality issues may be the result of worries about possible cost-cutting and service reductions on the part of vendors. Biologics manufacturers may not yet be sufficiently confident that their outsourcing partners can guarantee quality standards.

Sixty percent of respondents said that "protecting intellectual property (IP)" was critical. These IP concerns may be surfacing because of increased interest in offshore (i.e., international) outsourcing. Also, sponsor companies' worries about handling cross-contamination issues increased again in 2010. Only 20% said that it was important in 2007, but 52% of client companies identified it as important in 2009, and 58% did so in 2010.

CMO industry shifts

This year, nearly half (48.2%) of biopharmaceutical manufacturers surveyed said they expect to increase their budgets for biopharmaceutical CMO outsourcing. As more companies outsource, the need for effective project management will grow. In times when there was less available capacity, CMOs with better technologies, expertise, and facilities, would have simply been too busy and prebooked to handle new clients. Many of these shifts are the result of financial pressures, which are creating real concerns over hiring and staff allocation. Not only do outsourcing service providers need to justify the cost benefits, they now need to evaluate the effect of outsourcing on fill-time equivalents, staff allocations, and speed to project completion.

Looking ahead

Until effective project-management processes are in place, and the skills to manage external relationships are established by both CMOs and client companies, the limiting factor in outsourcing may be relationship management. Human factors such as relationship building, effective communication, and risk sharing are difficult to quantify but are crucial for long-term success.

Eric Langer is president of BioPlan Associates, tel. 301.921.5979, elanger@bioplanassociates.com ,and a periodic contributor to Outsourcing Outlook.

References

1. BioPlan Associates, 7th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (Rockville, MD, Apr. 2010).

2. E. Langer, "How Scientist/Founders Lead Successful Biopharmaceutical Organizations: A Study of Three Companies," Antioch University, Yellow Springs, OH, 2008.

3. J. Zhang and N. Patel, The Dynamics of California's Biotechnology industry (Public Policy Institute of California, San Francisco, 2005).