Intense interest in risk-based decision-making has been building in the life-sciences industry for the past decade. Encouraged
by investors and regulators, life-sciences companies have recognized that risk-based decision-making should be an enterprise-wide
concern. Although some of this interest has been cGMP-driven, many other areas of the business—including legal, financial,
safety, and others—have also driven it. Most organizations take an enterprise-wide approach, but tend to address only the
broadest risks and isolate efforts into a few areas:
Greg T. Plante
- Product life-cycle risks—a focus on patient safety across the product lifecycle and cost controls during early stages of development
- Compliance—risk viewed through a regulatory lens
- Corporate functions—a focus on legal, financial, and intellectual property risks
- Manufacturing operations and quality—a focus on risk-based approaches to cGMP reviews and processes
- Health, safety and environment—a focus on the occupational and social consequences of operations.
Each area drives independent value at the enterprise level. However, much of the value of risk-based decision-making resides
at the tactical level, that is, in the activity planning, change programs, management of project portfolios, and other investments
that take place below the corporate level. These activities constitute the majority of actions in a company and cumulatively
make an enormous difference in overall value creation.
Organizations can capture that value by integrating risk-based decision-making into all of their activities. Instead of relying
on enterprise-level programs, organizations can work to:
- Recognize the misconceptions that impede integrated risk management
- Integrate risk assessment and mitigation planning into all decision processes and activities
- Identify risks and communicate the value of mitigation projects in a way that enables their comparison with other investments
and expenditures intended to protect or enhance shareholder value.