Perhaps the only thing worse than not having a plan is expecting things to go according to one.

Embarking on something as complex as drug product development invites a host of unknowns that cannot be captured by the best of planners, and the law of Murphy is almost always proven. Even if every contingency could be incorporated into a plan, the cost of mitigating all risks would overwhelm even the most generous budget. Whether you’re building out a plan for a simple toxicology study or for a full blown NDA and commercialization program, here are some planning strategies that can help you prepare for those unexpected bumps and potholes.

Take the time to plan well.

Even though you will likely deviate from your plan, a plan still needs to be generated. While the optimal level of detail is always debatable, I recommend starting the exercise by listing as many tasks as possible. This may require input from experts, vendors, or at least a second pair of eyes. As this is done, capture all the assumptions that feed into your cost and timing estimates. Once complete, you can consider whether it makes sense to apply the timing and costing parameters to individual tasks or to larger buckets.

Understand your plan inside and out.

Understanding your plan means understanding the assumptions that underlie it. This is the basis for a risk analysis. Spend some time and walk through the assumptions and what would happen if they don’t hold up. Jot down the timing and cost differential; this will result in your worst case scenario. If we all had the budget and time frame to plan according to the worst case scenario, our job would be easy. The real challenge lies in working toward the best case scenario, but being prepared to handle the unexpected issues without impacting the final goal.

Plan to deviate from your plan.

Based on your best and worst case scenarios, determine a method to rank your assumptions and build out a budget and timing cushion into your different programs. As a very analytical person, I typically conduct this exercise in a quantitative manner. First, I organize all my assumptions and risks into 3 levels: crisis (worst), predicament (medium), and issue (minor). I then assign a probability to each based on the potential impact of the assumptions and risks to come up with a normalized cushion that I apply to each task. For those of you not as geeky as I, you can apply a sweeping 20% cushion or whatever percentage applies based on the level of assumptions and risks made. By including this approach in your plan, you will have the flexibility to deviate and absorb the shock of the unexpected without requesting new funds or time extensions from your stakeholders, all the while still maintaining a very lean budget and aggressive timeline.

Plan how you will handle those deviations.

Although you can never know or even imagine what problems you might face, you can still establish general outlines for a response. You cannot plan for a toxicology lab burning down on the eve of a critical study, but you can plan for a delay in the toxicology program and, based on typical scheduling times, you can guess at how long that delay might be. Think about how tasks might be reshuffled or if they can be reshuffled. Estimate impacts on time lines and probabilities of occurrence. Think through who will need to be notified and what delays might be incurred in obtaining authorization to go forward with contingency plans.

Maintain the trust of your stakeholders.

Stakeholders always want to hear that clinical trials will begin within a few months of project launch with minimal capital outlay, but they don\’t necessarily expect that. Many projects have faltered because of promises attainable only in the most ideal of worlds, and managers are tested not by their promises of success but by their response to failure. By successfully managing the unplanned activities in your program, you will ultimately gain the stakeholders\’ confidence in your teams’ ability to operate effectively and efficiently, and the benefits of that trust are obvious.

Michelle Higgin, Ph.D., Principal, Program Management at PharmaDirections, a pharmaceutical consulting and project management company specializing in preclinical development, CMC and regulatory affairs. We design and direct preclinical programs for biotech firms.

Michelle Higgin, Ph.D., Principal, Program Management at http://www.PharmaDirections.com, a pharmaceutical consulting and project management company specializing in preclinical development, formulation development and regulatory affairs. We design and direct preclinical programs for biotech firms.

Author Bio: Michelle Higgin, Ph.D., Principal, Program Management at PharmaDirections, a pharmaceutical consulting and project management company specializing in preclinical development, CMC and regulatory affairs. We design and direct preclinical programs for biotech firms.

Category: Medical Business
Keywords: Pharmaceutical Consulting, Project Management, Formulation Development, Preclinical, CMC