Briefly returning to edit the module and whilst creating highly visual scenarios is not an option, I am pitching the below story to a couple of pharma colleagues this week so that the four sections will each have an underlying story and the existing content is referenced with further study. So section begins with another story short episode with explanation and side box with links & existing content where relevant. It will continue to be an un-taught module as an open educational resource with potential interaction via discussion forums. It will remain text only as per original brief from People’s Uni but can add in pictures / video / animation if requested by enough of audience later.
- Is your idea marketable?
- How do you choose partners?
- How do you get the product fit for marketing?
- What happens after marketing approval?
The story begins with two Indian brothers, one married to a Polish lady and he is interested in developing a drug, the other brother wants to develop an app. Neither of them have pharma or health tech experience but the second brother is very experienced at coding applications.
… Following a visit from his Polish in-laws X hears about a Polish herb which is apparently good for treating stomach ulcers. They live in a village / town which has quite poor water sanitation and stomach ulcers are very common. X decides to create a pill using the herb and tells Y brother who decides to develop a skin temperature monitoring app at the same time.
Unfortunately X doesn’t do any online research but Y checks to see if anyone else doing skin monitoring apps. (links to is the idea mine?)
They find an old office and workshop. X persuades the bank to give him a loan to convert the workshop into a laboratory and Y uses the office when needed. It is on the edge of town / village so there are a lot of mice that X can use for his pre-clinical trials. X goes to Poland and tries to bring back 500kg of the herb but gets stopped at customs back in India. He forgot to check the import regulations before he left and he is missing a certificate that he now needs to import the herb. He is stuck in his van for a week whilst his brother manages to arrange the certificate from Poland. (link to conditions and also reference to clinical trial phase with underlying issue of not planning business properly so incurring additional costs and time)
Y is doing well – he has created and tested the first version of his app on neighbours, friends and family and he shows the results to a doctor friend who compares with a pill and finds they are very similar. He applies for a patent in India. He asks his brother to do the same but his brother is reluctant because he is busy with his pre-clinical trials and working out how to combine the substances into the correct pill shape. Y gets patent and with further good results, he researches next steps and goes to Delhi to have a meeting with the regulatory advisers. (link to patent etc)
Six months have now passed. X starts a clinical trial application after a local hospital has a large outbreak of stomach ulcers following the collapse of part of the local sewage system and the repairs being delayed. He has to increase his loan to cover the manufacture of the pill but then has to stop because he runs out of money to create the pill. (link to clinical trials phases and business planning)
Y’s doctor’s friend is going to an international pharma conference in Mumbai and offers him a lift. He packs up the last remaining manufactured pills. At the conference he meets a Russian company who are successfully selling a Siberian herb to treat indigestion in India. They decide to help him and agree to invest in the development of the pill.
It’s a good week as Y got regulatory approval for his app and pre-orders are 100 times more than expected.
X continues to work with the Russian company to continue clinical trials back at the local hospital. However the Russian company realise that there is a very similar pill already with marketing approval in Russia and EMA to treat the stomach ulcers so it is too late for a patent.
Totally fed up, X goes home and realises that he cannot afford his mortgage repayments so they move in with Y. Fortunately Y’s sales are massive and he can afford to buy X and family an apartment. Whilst unable to continue the drug development X spends more time with his daughter and notices that her eczema has completely cleared up. He asks his wife and she says that she has been putting some of the herb in…juice with her breakfast every morning.
He calls the Russian company and they check – there is no patent or similar health drink currently applying for regulatory approval. He sells his car, van and begins pre-clinical trials again. The results are excellent so the Russian company help find a partner to finance the clinical trials. Y also finds him a pharma partner in India who is familiar with the documentation and pays for the service to get it through regulatory approval. (links to clinical trials and obtaining approval)
Several years later, he gets marketing approval and begins selling in India. Meanwhile, the Russian company open up an opportunity to market the pill in Poland after a recent expansion of their own operations there.(links to after marketing approval)
And everyone lives happily without stomach ulcers, ever after.
Will see how colleagues react and take forward. All comments welcome as ever.