WHAT/QUESTION: Would you recommend that Thompson & Co. introduce DIASTOP
WHY IS THIS BEING ASKED/objective: The drug has non-negligible side effects
DECISION OBJECTIVES: To help Thompson & Co. decide on whether or not to release DIASTOP with the patient in mind with very few side effects
ALTERNATIVES
| CRITERIA | RELEASE: WAITZ & HAND | NOT RELEASE: THOMPSON |
| TRIALS’ RESULTS AND SIDE EFFECTS | -FDA approved DIASTOP after the extra trial requested showed no material relationship between daily drug use and the incidence of side effects. -Pharmaceuticals are not an exact science and side effects are acceptable | Non-negligible side effects: -4.5% of test patients suffered heart related complications -0.3% hospitalized |
| COST OF RESEARCH | $12m per year in R&D; $48m in the 4 years it is determined to take for further trials and development | Further development is affordable with $50m in profit as at 2011 and an estimated 10% increase yearly |
| TIME OF RESEARCH AND TECHNOLOGY AVAILABILITY | The 5 years invested to create DIASTOP and another 4 years of major investments in the required technology improvements which has a 50% chance of unavailability till late 2015 leading to an abandonment of project DIASTOP | To be released early 2015 with a projection of $70m per year in profits with 50% chance of not running into technological unavailability. However, patent expires in 2019 giving the company time for improvements if technological unavailability occurs |
| OPERATIONAL COSTS | $5m in operational costs to GFT with a $10m guarantee with production already underway | Profits can cover this cost to GFT with the DIASTOP already produced utilized in further trials |
| MORAL ISSUE AND EXPECTATION | FDA stated that side effects are no worse than the competition. | Patients could suffer long term negative consequences even though DIASTOP was created with the patient in mind to have negligible side effects. |
| PROFIT | Patent expires 2019, if released now, DIASTOP is estimated to make a profit of $70m yearly ($560m by 2019) | If released in 2015, $70m in profits is estimated ($280m by 2019) and a chance to keep their reputation. |
| RECALL | FDA is a reputable institution known for its rigor and fairness and it has given its approval for DIASTOP | Possibility of FDA recall if reported that DIASTOP caused even a few severe episodes of heart problem episodes. Even as little as 1%. This would affect LOBLOPRIN’s sales and company’s reputation |
In a controlled environment, micro-organisms could be grown 200 times faster and for less money thanks to a new technology developed by Arnold Hand and Jeff Thompson. In 2002, BioPasteur was created by the aforementioned and leading MIT chemistry professor, Amy Waitz, to use this technology to develop new drugs. Their first drug was a blood pressure medication; LOBLOPRIN which penetrated the market based on Waitz reputation and the negligible side effects it had compared to the competition.
DIASTOP, the second drug, was developed on the same premise of putting users first and having negligible side effects. The relays that the company is more concerned with the effects on patients’ usage.
The options available to the company are to release the drug in 2011 and make $560m in profit with a chance of ruining its reputation due to a recall and thus affecting the already successful drug on the market and seeing the end of the company
Or
Releasing the drug in 2015 with negligible side effects and making a $260m profit with a chance of delayed technological unavailability with the reputation intake allowing for the further development of other drugs.
DIASTOP was created with the patient in mind and to achieve the same reputable level LOBLOPRIN has, negligible side effects compared to its competition. Although the FDA stated it is no worse than the other drugs on the market, it allows an inference that DIASTOP is not better than but on par with other drugs on the market. The objective of being better and having negligible side effects has not been achieved.
Thus, we at PSL & Co. recommend that DIASTOP not be released now but rather taken back to the labs for further development and trials. This is based, after weighing the criteria, the main objective of the drug: To create a drug with negligible side effects. Furthermore, the company can afford further development. And end to the company would also be avoided on the chance that the drug is recalled if released.
Resource optimisation and decision making