Golden Rules of Drug Development
How to win people to your way of thinking:
The only way to get the best of an argument is to avoid it.
Show respect for the other person’s opinions. Never say, “You’re wrong.”
If you are wrong, admit it quickly and emphatically.
Begin in a friendly way.
Get the other person saying “Yes, yes” immediately.
Let the other person do a great deal of the talking.
Let the other person feel that the idea is his or hers.
Try honestly to see things from the other person’s point of view.
Be sympathetic with the other person’s ideas and desires.
Appeal to the nobler motives.
Dramatize your ideas.
Throw down a challenge.
–Dale Carnegie
PRINCIPLES AND GOLDEN RULES AS STARTING POINTS FOR THINKING ABOUT PROBLEMS
Many presentations at professional meetings as well as articles in the literature describe principles of drug development. Principles are useful places to begin thinking about a problem and perhaps guide one to the best (or at least a reasonable) direction to follow, in order to solve the problems at hand, but principles rarely answer problems. Experienced and intelligent employees who know how to choose the best path for resolving the problem are also needed. They can evaluate whether or not the current situation represents an exception to the principles.
A number of so-called principles of drug development written by management consultants often describe methods to reduce the time of drug development to get products to the market faster. Although some of these principles may appear reasonable at first glance they are often naïve and impossible to fulfill. A few examples are listed:
Write all clinical protocols within a few weeks and do not stretch this out to months. Approval inside a company should be completed within three days.
Develop all drugs using a simultaneous plan and not a sequential plan.
Stick to development plans and target dates. Do not waiver or change dates.
The author has read each of these and others on many occasions, but there are so many exceptions to each of these statements that it would be foolish to call them either principles or “golden rules”; they are simplistic generalizations that are impossible to achieve.
Golden rules of drug discovery are discussed in Chapter 9; this chapter discusses golden rules for drug development. Golden rules may be thought of as the most important principles in a specific area. Most of these are well known but are inconsistently followed for a variety of reasons.
Each of the golden rules described has exceptions, sometimes many, but the rules still provide an important measurement with which to guide behavior. Adherence often saves years of unnecessary or inefficient work and large amounts of resources. Because all of these principles are described in detail elsewhere in this book and in Guide to Clinical Trials (Spilker 1991) crossreferences are not given in this chapter.
The underlying principle of drug development is that activities must be planned, coordinated, and, to some degree, controlled using appropriate systems and methods—after the specific compound to be developed has been identified. The processes of drug discovery, on the other hand, are much less conducive to planning or control. Attempts to control drug discovery often stifle and destroy the creative process.
PLANS, STRATEGIES, AND SYSTEMS
Formulate an overall concept and strategy of how each drug, indication, and formulation will be developed. Seek input from marketing to help formulate various goals and strategies. Establish minimally acceptable criteria that a drug must achieve to continue its development. Detailed strategies must be developed in several functional areas (e.g., marketing or research and development) and at several levels (e.g., individual sections and departments). Ensure that effort is appropriately divided between planning and carrying out of plans. This principle is schematically represented in Fig. 11.1. This figure shows that equal efforts on planning and conducting activities are not desirable.
Create an international development plan that minimizes duplication and stresses efficiency. An unsound development plan may actually hamper development of a drug (Fig. 11.2). Determine the appropriate balance between a “lean” plan that will generate the absolute minimal amount of data required for regulatory approval and a “fat” plan that goes far beyond what is required.
Use a team approach to manage the project through product launch and beyond (e.g., to develop new indications and dosage forms). The ultimate target should be to achieve market launch and not New Drug Application submissions.
Avoid tangents that depart from the chosen path of development, except when (a) the tangent is to become the new path (i.e., a new strategy is adopted) or (b) the tangent is carefully reviewed before it is implemented and is considered worthy of pursuit. The tangent is then incorporated into the existing strategy.
Focus on a parallel and not sequential development plan insofar as possible. This goal has to be modified if compound supplies are limited, or for other agreed-to reasons (e.g., a low priority).
Protect and extend the drug’s indications and formulations after initial marketing. Protection may include conducting additional clinical trials, synthesizing additional compounds, or conducting postmarketing studies. Extension of a product’s available formulations, approved indications, and current packaging usually enhances appropriate medical uses of a drug and improves its commercial returns.
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