Critical Path is a series of discussions focused on moving emerging biotech companies along the path to commercialization. This issue centers on developing and implementing an effective Program Management Office to bridge the gap between business strategy and project execution while alleviating risk and creating competitive advantages.

Process-based training enables organizations to create training programs that focus on employee and company performance. Getting products to market in today's demand driven market place depends on employees who understand the entire product development lifecycle approval process and how their individual responsibilities contribute to the overall success of the company.

The costs associated with cGMP non-compliance are skyrocketing; many non-compliance issues directly relate to inadequate training. Developing an effective training strategy that encompasses seven key elements will greatly reduce risks and control costs.

Adopting a risk-based approach to compliance enables companies to successfully meet Part 11 challenges while effectively managing costs, mitigating risks, and increasing business value to shareholders.

Clarkston Consulting surveyed leading pharmaceutical companies to understand their plans and actions around the FDA’s focus and draft guidance on Process Analytical Technology (PAT). Is your company moving down the PAT path?

EAI can provide enormous benefits to organizations that run multiple computer-based systems in regulated environments. The seamless flow of information across systems can ensure 21 CFR Part 11 compliance, improve decision-making capabilities, and reduce data maintenance costs.

Implementing an effective contract management strategy can provide the framework needed to not only meet today’s requirements but prepare for the future life sciences global marketplace. Aligning people, process, and technology will directly impact business.

Enterprise Project Management (EPM) blends people with knowledge and experience, formal processes, and the right technological tools to achieve corporate objectives. Seven key considerations can help your organization define and execute the critical elements of establishing a successful EPM landscape.

A pharmaceutical company’s environmental monitoring (EM) program is one of its most critical assets. Whether you have one sterile manufacturing facility or a host of sterile and non-sterile manufacturing facilities, upgrading your EM program will yield tangible business benefits.

Executives of FDA-regulated companies must be acutely aware of where they place their investments—pipeline growth will occur only by focusing on key initiatives and getting more product through the rigors of R&D development.

Regardless of their type, portals share a number of similar characteristics, and can help companies improve customer service and forecasting through increased visibility to mission-critical information enterprise-wide.

The Food and Drug Administration is changing, and the pharmaceutical industry needs to be aware, prepared, and change accordingly. Recent publications indicate a change in strategy for inspections with a risk-based approach, which must be supported and controlled through effective quality systems.

By aligning the entire portfolio with overall business strategy, a PMO improves decision-making capabilities to prioritize and measure value from key initiatives.

Advantage Advocate, a forum of leading life sciences executives, predicts that by 2010, Big Pharma will outsource 50% of its R&D activities—resulting in better pipelines and directly contributing to the bottom line. Are you on the fast-track to growth?

Clarkston Consulting conducted a survey of ten leading companies to determine plans and actions for Sarbanes-Oxley remediation. The survey revealed a high sense of awareness and ownership from CIOs, as well as the belief that the need for timely and more accurate information is more critical than ever before.

When approached strategically, Sarbanes-Oxley compliance can be turned into a real way to increase confidence, impact shareholder value, and get ahead in the new area of SEC compliance.

Many life sciences companies continue to sustain huge economic losses as a result of inefficient scale-up, from R&D to full-scale manufacturing. Learn more about powerful techniques that can eliminate or minimize these unnecessary losses through the ability to scale production to demand.

When approached from a strategic vantage point, scorecards and dashboards can provide focus, measure success, and drive business value. However, executives must define the type of information they want to quantify, as well as who will need access to these metrics.

The investment in variation research can yield long-term dividends through streamlined efficiencies, reduced waste and rework, and faster market delivery.