A research and development (R and D) management review committee is discussing an investigational drug that has been evaluated in Phase 2 trials in four quite different diseases. It is still uncertain whether the drug has sufficient efficacy in any of these diseases to justify full-scale development. The project leader excitedly tells the group that there is a new physiological (i.e., preclinical) paper published by an independent outsider that suggests with a reasonable extrapolation that the drug may have activity in a new disease area. He proposes a pilot trial to test this hypothesis. Is this a good idea, and how will you question the project leader to decide whether this is a positive or negative tangent?

A medical department head of a major subsidiary expects to be able to increase his headcount, but no firm commitments from the headquarters have been made. Based on these expectations, plans are assembled to have certain clinical trials conducted that he was told are needed (but not yet fully approved) by the parent company in another country and could involve clinical trial sites in the Medical Director’s country. The Medical Director then instructs a clinical monitor to initiate contact with outside investigators for one of the clinical trials.

The investigators who are contacted become highly excited and start planning various details of the trial so that they can be accepted as participating investigators. At this stage, the request for an increased head count is turned down. The monitor then tells the Medical Director that the amount of work necessary to have the trial conducted is far too great for her to do, even if she stops or greatly slows her other work that has previously been given a higher priority.

There is now a crisis brewing, and several intense meetings and discussions are held within the subsidiary. If the trial is canceled, the lead investigator, who is a valuable asset to the company and highly valued by the country’s regulatory authorities, is expected to become very upset. He may say things publicly or to the regulatory authorities that could hurt the company. The trial cannot be delayed by several months because it involves studying the cold sores of skiers, and the season will be over if any delays occur.

Assume that priorities cannot be changed. What is the problem, and what should be done now?

You are head of R and D in the major subsidiary of a large foreign company. Your counterpart at the headquarters calls and says that he and his senior staff are anxious to have your site begin clinical development of a new drug that the headquarters has worked on for five years. The senior staff at headquarters see your role as working under their leadership and guidance and not as taking over total control of the clinical development.

You ask your staff via an e-mail how they feel, and they reply that they are strongly opposed to developing this drug for a variety of logical scientific reasons as well as because of other projects that they believe have a higher priority. Disagreement also exists about the manner in which the drug has been developed thus far.

You know that your company expects you to follow headquarters, and you also owe your counterpart a favor. You were hoping that your staff would have been more favorable toward the new project.

How will you handle this issue?

Your company’s policy on preparing final medical reports is one that you instituted as head of the medical division of a midsized company. The policy has been to process and analyze all data
from clinical trials and prepare a final medical report only after the drug has passed the go-no-go decision point at the end of Phase 2. As a result, you seldom have the full data thoroughly processed immediately after the clinical trial is completed. Of course, you have the essential parameters evaluated in detail to understand the overall and some specific results, and an overview and evaluation of data of all parameters are made.

You have told the statistics and other relevant departments that it is better to wait until each drug passes the go-no-go decision point in late Phase 2 before they start to prepare the final medical report. You understand that this is not how most companies operate, but you feel that it conserves resources for the highest priority projects.

The new head of R and D, who is your boss and has held this position for the past two months, has told you that, starting next month, he would like the data from all clinical trials that are completed to be analyzed within a few months of trial completion. What are you going to say to him about his proposal?

You are in charge of clinical development for cardiovascular drugs and have asked the marketing group for an evaluation of a new product considered for development. Although the marketing view is extremely important, the report you get back is rather vague and noncommittal. In the past, the R and D group has always gone forward with projects under these circumstances, but the company’s resources are becoming scarcer; you do not want to proceed unless there is a true marketing commitment and a worthwhile market to pursue. You approach marketing again and ask for additional information and clarification but are told by senior marketing management that you will not get any more information in the foreseeable future. What should you do?

Your company has two compounds that are somewhat, but not closely, related chemically and have the same biological target. The disease they are focused on is highly valuable commercially. Their chemical properties and biological properties differ to a small degree, and although they are much better candidates for development than other members of their series, it is impossible to state which will be preferable in human studies. Two-week toxicology studies and basic animal pharmacokinetic studies have not helped to differentiate sufficiently between them.

You are the Chief Executive Officer (CEO) of a moderately large pharmaceutical company. Your company has just had a disastrous financial year, and the marketing group does not believe it will really turn things around for three or four years. Your R and D budget is very large as a percentage of sales (i.e., a bit more than the industry average). You have three promising drugs in Phase 2 and one in Phase 3.

Do you respond to requests from the board to cut the R and D budget for a period of time in order to “weather the storm,” or do you fight to keep the budget constant, or even to increase it, to try and move your Phase 2 and 3 products to the market as rapidly as possible? If you decide to try to keep the R and D budget constant, what can you do to expedite the development of your Phase 2 and 3 products?

You are on a management committee for the R and D group in a large company. Each investigational drug that is tested has a draft package label prepared by the marketing, medical, legal, statistical, and technical groups. They hold numerous meetings to prepare a document that describes the profile they realistically expect to achieve. After one of the two scheduled well-designed and well-controlled Phase 2 trials is completed, the efficacy observed is much less than what was anticipated, and yet everything about the trial suggests that it was well conducted. A smaller trial conducted at the same time confirms this failure to show the effect desired, but there are few patients in that trial. At an R and D management meeting, the project leader states, “We do see some degree of efficacy, and I am sure that if we do another trial, the drug will probably demonstrate adequate efficacy.” What should the company do, and what is the real problem here? How can this problem be avoided?

You are requested as head of the medical department to conduct a number of pharmacoeconomic trials for the marketing group, but you are told by the head of R and D that no new resources are available for these trials, and thus, you inform the marketing group about this. Comment on this scenario.

Your boss shows you an advertisement stating that a competitor’s drug is the most cost-effective intravenous treatment for disease X because it costs less for pharmacists to make up the infusion system. Your drug for the same disease requires less physician time for monitoring, and the patients can leave the hospital a day sooner than with the other drug. What is the problem here, and what actions are you going to suggest to your boss?

Your position is the vice president of corporate affairs. Your responsibilities are to deal with the outside world, including the public relations function. The head of R and D just called to say that two people died today from one of your drugs in a city a thousand miles away, and it appears that product tampering was responsible. The CEO has asked you to come to his office immediately to discuss how to deal with this emergency. Reporters are already on the telephone, and your secretary just came in with the news that the TV Action News Team is on their way over. What are your thoughts, and what will you tell the CEO?

The vice president of marketing calls you as head of the medical department. He tells you that some groups in the company are having problems with the licensing agreement signed with Company Q. The people in marketing and medical who deal with their colleagues in Company Q are all enthusiastic about their working relationships and progress, but the production group in your company is not providing agreed information to Company Q to help them begin to manufacture the drug as rapidly and completely as called for in the contract. The marketing vice president suggests that the two of you meet with the production head (whom you both know well) to discuss this situation. He also suggests inviting the licensing manager in your company to this meeting, along with the corporate attorney and the head of another technical group. What is your reaction, and what should be done?