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It would seem senseless to start the construction of a house without a blueprint, prepare an unfamiliar dinner without using
a recipe or start a season aiming for a championship without a play book. Unfortunately in the biopharm industry, far too
often such conventional wisdom is lost in the haste to deliver now, and the consequences can be disastrous.
Product development challenges have never been more formidable. Recent economic downturns, along with increasing concerns
regarding the safety of marketed drugs,1,2 have captured a lot of attention. With decreasing investment resources,3,4 mounting regulatory requirements,5 and stiffening competition for subject and site recruitment,6,7 today's market will not tolerate missteps.
Gone are the days of seeding trials, exploratory fishing expeditions, do-over trials, and the like. Today, success is predicated
on implementing an efficient and effective program, while calling for optimally designed trials that are conducted correctly
the first time. Strategic development planning is the means to this end.
Serving a purposeIdeally, strategic development planning should begin with early discussions prior to the start of any activity. The "guidebook"
for planning is the integrated development plan. And this plan incorporates all activities related to the entire development
program.
As the goal for development is to obtain marketing authorization with a desired indication statement and label claim(s), it
is critical that all activities be aligned and integrated to serve that purpose. In this regard, the development plan is an
excellent tool to maximize efficiency and pull together supportive information, while also serving to coordinate efforts.
It ensures and reminds stakeholders that all activities funnel to a common purpose.
Despite the fact that early strategic planning requires an up-front investment of both time and money, the benefits reaped
during the development program far outweigh the initial investments.
An elegant development plan demonstrates a level of thoroughness that is appreciated by regulators and investors alike. Much
like an insurance policy, a development plan offers reassurance to stakeholders, providing a level of security that may be
fostered over time.
The plan
The utility of a development plan lies in its ability to organize and integrate a multitude of information in one place. More
than simply a list of tasks to be completed, it provides a temporal link of activities occurring across disciplines. This
is of value not only with regard to streamlining activities, but also in terms of contingency planning.
The integrated development plan is essentially composed of several sub-plans, among these are:
- Clinical development plan (CDP)
- Preclinical development plan
- Chemistry manufacturing and controls (CMC) development plan
- Regulatory strategy/target product profile (TPP)
- Risk management plan (RMP)
- Commercialization plan
The preclinical, CMC, and regulatory plans are designed to support a clinical program through each study. Therefore, considerable
attention must be given to their timing. For example, it is important for the preclinical and CMC plans to precede sufficiently
the clinical plan to ensure there are adequate toxicology data, as well as sufficient investigational product, to support
planned preclinical and clinical studies. The integration of all these activities can only be accomplished with careful risk
management planning.
