Choose the disease to cure: Diabetes Lung cancer Arthritis Alzheimer’s disease Coronary artery disease (heart disease) Obesity Asthma

Drug Development Summary Sheet Drug name:________________________ Target condition:__________________ (Diabetes, Lung Cancer, Arthritis, Alzheimer's, Obesity, Coronary artery disease, etc) Company name :________________________ Number of Investment Tokens Development Cost (Tokens X £10 Million) Development Time Tokens 4 Years £ _____ ___ yrs

1.At the start of each turn, move forward one space. Put one Investment Token in your beaker (each token is worth 3 months work and £5 million!) 2.If you land on a Results Box, do what it says in the box. If you lose a turn, add 1 Token to your beaker. Then go to step 4. 3.If you don’t land on a Results Box, or when you have finished your Results Box, roll the dice. 4.If you roll a 6, take a Wildcard. If you roll 1-5, don’t take a Wildcard. Your turn is over. 5.Record everything on your Drug Development Tracking Sheet. 6.Move to the next square and start again. Keep going until you will have developed a successful drug.

Working things out 1.Each token is worth £10 million. How much did you spend on your drug? 2.Each token is 3 months work. Divide by 4 to see how many years you took. 3.Use the summary sheet to report on your drug development. Say what it is for, how much it cost and how long it has taken to develop. Talk about any problems you have overcome. Do you expect to make millions?

CTA – Clinical Trial Application: This has to be filed and approved before clinical trials start. EMEA – European Medicines Evaluation Agency: Decides about the testing and licensing of new medicines. MAA – Marketing Authorisation Application Has to be obtained before a new drug is put on the market. MHRA - The Medicines and Healthcare products Regulatory Agency The UK agency that makes sure medicines work, and are safe. NICE – National Institute of Health and Clinical Excellence promotes good health, advises on the use of new medicines. R&D - Research and Development: Comes up with ideas for new medicines.

Examples of successes and problems with the development of real drugs Your clinical trial in patients works so well that the MHRA asks you to stop the trial and submit the drug for approval earlier than expected. Go straight to filing the drug with the MHRA and Phase III trials. This happened during the development of one of Pfizer’s cancer drugs. New evidence shows that your molecule is effective in fighting another disease in addition to your original target. Sometimes this isn’t apparent until a drug has been on the market for a time. A good example is a Pfizer medicine that was marketed for epilepsy. It was later found to work in pain relief. More Phase III studies had to be done and a supplemental MAA filed to get this added to the label. A marketed drug in the same class as the one you are developing has been shown to cause serious adverse side effects. One of Pfizer’s competitors had to withdraw a pain-killer that was found to have serious side effects. All other drugs that worked in the same way – including two of Pfizer’s, had to be reinvestigated.

Counterfeit drug rings are uncovered in Eastern Europe selling fake Pfizer medicines that contain no active ingredient. The internet is awash with people offering counterfeit best-selling drugs. Pfizer and other companies are looking into things like radio frequency tags embedded into pills to prevent counterfeiting. The MHRA decides to hold an Advisory Committee Meeting to discuss your new drug application. When a drug is of a new type or uses a new mechanism, often the MHRA will call this meeting, made up of medical experts. This happened with a new form of insulin that is inhaled, developed by Pfizer. Unexpected side effects cause a drug to be abandoned during Phase III Trials. This happened to a treatment for heart disease that Pfizer had spent £400,000,000 on developing.

If you can’t manage to develop a drug that is safe enough or effective enough to start clinical trials, why not buy in a drug which has already reached that stage? ‘In-licensing’ means buying a drug someone else has developed so far - but can’t afford or doesn’t want to take any further. Choose from: