The Nomoramide the synthetic morphinomimetic drug project - Essay Example

Project Management Ans The 'painfree' i.e. Nomoramide the synthetic morphinomimetic drug project appears to be a very ambitious project for Alpex Pharma AG. The drug was being termed as a breakthrough derivation of a common herb extract with Alpex pinning all hopes on its non-addictive yet high potency effect. To this end Alpex Pharma formed an independent project team in August 1989 and the project went ahead with glitches in between. A project as such can be rated as successful if the project takes off well, it is executed well, and it finishes off successfully. The 'painfree' project appears a rather 'painful' project. Potential of the drug Nomoramide (painfree) appears to be immense, as specialists as well as General Physicians are fully convinced and have echoed their support for the drug, but the major drawback in managing the project has been a lack of sound understanding and respect for the views different departments within the company. Project management as such is a set of principles, practices, and techniques applied to lead project team and control project schedule, cost, and performance risks in order to in delight the customers. But in case of 'painfree' the end result appears to be resulting in a rather painful experience for the company as well as for the customers. The project appears successful to the extent that it succeeded in convincing the General Physicians and specialists about the usefulness of the drug. It generated lot of curiosity about the company and the product, which can go a long way in generating marketing potential for the company in the long run. It appears the company has been able to make good use of its contacts in the regulatory and licensing departments of the governments in different countries, yet it appears at loggerheads with authorities like BGA for continuously ignoring the genuine concerns of the people, which is resulting in restriction of the use of the drug to the post-operational pain, in Europe. In US though the company appears to have convinced in regulatory authorities regarding the drug's unrestricted acceptance with specialists and GPs able to prescribe it for pain relief. The project team chose to launch the drug in Germany in November when accidents cases are at its peak and a large number of migraine cases are linked to the dark season of the year. The launch was a big success with over 700,000 packages being sold from November 1994 to March 1995. The drug even received rave reviews form experts, medical journals and magazines. But in the absence of adequate market communication from the company, about the precautions after the intake of the drug, the cases of orthostatic hypotension soon started reaching alarming levels. The company could have retained the successful beginning, if it had immediately launched an information campaign for consumer and medical fraternity informing them about the precaution like taking rest after the drug intake, no doing physical exercises etc. But the company appeared grossly under-prepared for taking up such an initiative. This resulted in damaging the credibility of the drug and the company. Therefore, despite a promising start and good product the Painfree project appears to have earned limited success. Ans 2: From the available documents it is more than evident that the project was not managed in a very professional and successful manner. It appears unsuccessful on several counts; i. In this market driven economy when we talk about global village concept, any company studies the market with long term perspective, in such a manner that the customer feels being valued. Data and information is gathered from the market regarding the competitor's position, availability of alternatives, outcomes of similar launches etc. In case of a new drug launch additional care is to be taken regarding its side-effects, safety of the consumer etc. To this end extensive researches are carried out for testing the effects of the drug, data is also compiled from existing studies etc. Here it appears the company, despite knowing the side effects, almost kept aside the fatal side-effects while highlighting the sales potential of the drug. The company, in a way, treated the gullible patients/ consumers as guinea pigs. This, in fact, amounts to criminal negligence on the part of the company. ii. The painfree team did not get the requisite support from all concerned department of the company, which is very crucial for a project of such a sensitive nature. So much so that, despite the toxicity of Nomoramide coming to surface during the early clinical developmental process, there was not enough drug supply for large scale clinical trials of the drug. Though there was close coordination amongst the team, yet the support from the management level was limited. The project team should have been made aware about any news/ announcement related to the product, but the communication gap appeared on several occasions, like after the hue and cry over its side-effects, when during marketing in China, Chrysantheme sent out a notification of packaging change to all regulatory agencies, Roland Peterson did not know about it. iii. Project success in general terms means completing all project deliverables on time, within the planned budget, and to a level of quality that is acceptable to all sponsors and stakeholders (like the general public, shareholders etc.). This will happen if the project team/ manager keeps receiving regular updates about the progress of the project, and the general feedback from the stakeholders concerned. The project manager is then required to keep the team's attention focused on achieving the broad goals of the project. But in this case, the 'painfree' team was looked upon with suspicion by the rest of Alpex an Teutonia. The team did not have access to the pharmacovigilance status reports in the monthly worldwide development meetings. The team often felt that it had to make independent decisions in order to get to the market on time. The dual reporting of costs too exacerbated the coordination. iv. Even the crucial regulatory affairs were left for the project team to handle, while it should have been fully take care of by the corporate regulatory affairs department of the company. It resulted in undue pressure and drain on resources for the project team. v. For the market launch of the drug the company chose Germany as the lead country, with Planomed taking the lead. Roland Peterse, the GM of project team, used his earlier links for a smooth marketing. Pre-marketing started in March 1994, but there were no drug samples available in the market till August 1994. This prevented the all important pre-marketing feedback from market. vi. The promotional campaign by the company had a serious flaw. The promotional material concealed more and revealed less. This showed an immature approach on the part of the company in marketing such a drug having serious implications if taken with wrong prescription. Alpex new it well that after taking the drug the patient should not resort to some heart beat increasing activity, but in their over-enthusiasm to get maximum profit out of the drug sale in the initial years of its launch, the company allowed to slip away a golden opportunity from its hands. vii. The statements like, "We can't make responsible - nobody did anything wrong in the strict sense" coming from the likes of Dr John Hammer smack of less than professional attitude, that too when the failure are there to see for everyone. viii. Even after the reported spurt in orthostatic hypotension cases in US, and the halting of all clinical trials for a week, Roland Petersen did not recognize the relevance of this data for Europe, citing the reason that, 'the US adverse events (AE) were concerned on trauma and treatments, and indications not included in the European indications.' It was also said that the American monitoring of AEs is stricter than in Europe, and the reported cases in US were found in California, a place for more active than typical European patient. This was like turning a blind eye towards the fire signals in a multistory apartment. Can a ground floor resident say that the fire indications appear at the top and I am least bothered! Such an approach not only results in losses for the company but presents a grave danger for the prospective consumers of the product. In this case also, ignoring these early warning signals proved very costly for the company. ix. Alpex Pharma conveniently resorted to concealing the facts in its eagerness to get the go ahead from the German regulatory body BGA. The corporate pharmacovigilance took refuge in the technicalities like the definition of 'serious' side effects being different in US and Germany. At this step as well the company allowed to slip away an opportunity to take corrective steps and come out with a safer drug. x. Downplaying the early warning signals kept reflecting in the approach of the company even after it decided to take note of the orthostatic hypotension cases in US and decided to put a warning on the label. The company placed the label at the second position in the package insert without emphasizing the warning. It took couple of more precious lives for the company to realize the necessity of putting up such a warning with more prominence. xi. The project appears to be in crisis with widespread condemnation from the regulatory bodies and experts about the marketing strategy of Nomoramide as it was commercialized in the general market rather than being left to the exclusive use. Though majority of the analgesic experts present in the meeting on July 26, 1995 appeared in favour of retaining the drug in the market, citing its excellent effectiveness, but the project has taken its toll already earning more of adverse publicity than loyalty. Ans 3: Launching a new 'drug' is somewhat different than launching a new 'product'. While a customer centric approach is a prerequisite in all such new launches, thinking about ensuring the safety and well being of the drug consumer is very crucial for the drug company. Therefore, if Alpex Pharma is to decide for the launch of a new drug, it has to do some homework early on. i. The top management must actively set priorities regarding the project. No doubt profit is a motive for being in the business, but one should realize that profit will accrue only when the company remains in business. And the company cannot remain in business if it continues to ignore the health and safety issue of its consumers. ii. Planning in advance helps in attaining the targets, but taking corrective steps in between to set the course right is equally crucial for the successful implementation of the project. Michael Greer1 points out that, "The single most important activity that project managers engage in is planning - detailed, systematic, team-involved plans are the only foundation for project success. And when real-world events conspire to change the plan, project managers must make a new one to reflect the changes. So planning and replanning must be a way of life for project managers." In case of a new drug launch, we must keep a tab on the test reports with all fairness and sincerity, and try to take corrective measures during the development stage itself, because once the gun is fired it becomes too late. iii. Alpex Pharma AG also needs to sew the loose ends in the organizational structure as well. The project team will have to be in regular touch with all concerned departments like marketing, Corporate R&D etc. to get a feel of the progress of the project and its impacts on the organization. iv. We must not take refuge in the technicalities of the regulatory bodies, instead an effort be made to come out with the best drug, which can pass even the stringent tests. This will go a long way in establishing the credibility of the company and the drug in all types of markets. v. Roping in the experts from medical field will not doubt help in smooth sailing for the product, but the common man for whom the drug is meant should also be informed about the features of the drug, and precaution, if any, to be taken before or after taking the drug. Therefore we'll try to communicate such features to the general public through the media or forums like workshops, seminars etc. vi. At times companies do resort to concealing some facts from the competitors, but concealing facts having an of life of the user definitely needs to be placed in public domain, so that the public in general is aware about this info. vii. Though it will be our endeavor to earn profits, but sustainability in the market comes from a long lasting relationship with the consumer. In case of drug, the consumer will come back to use the drug if he feels fully satisfied that there are no side effect, and of course, the consumer remains live for using the drug the second and subsequent times. The company cannot survive another painfree is known to one and all. Therefore this drug will be launched in market if it is found to be safe for the consumer, after substantial clinical trials. Read More