Research bid writing

Attended a research away afternoon yesterday which was really helpful in clarifying what is required (and how to reduce the waffle I have written in current draft bid) 

There’s the general good writing advice to make it succinct and readable – is a 14 yr old interested based on whatever you’ve written, can a family member understand it etc

Don’t just write for academic, submit articles to professional journals.

Impact – what are the world’s most important questions and can you show how you changed the world. Does your evaluation demonstrate evidence for outcomes / causal inferences.

The gold standard is being referenced by policy makers as well as public – have we changed the way we think about X.

Check funding panels, they may not even read yours if have 80 others, the best bids get funded not necessarily the best research.

We don’t know if we will be successful in our bid which currently includes only one sub project of a possible larger bid, but it’s currently a joint multidisciplinary effort. 

As we expand to others we will learn further whether we can trust them or not (as many others have walked those paths). 

People’s Uni pharna final story and examples

Final draft: https://www.dropbox.com/s/vbumeufw06bdd7h/2017_06_08_final_PharmaStory.doc?dl=0

Reasons for edits – mostly scientific and both reviewers wanted clarity on monitoring of herb whilst at customs I.e. being stored appropriately so it doesn’t change.

Examples / explanations to be added to sections (some minor wording to be finalised)

1. 

Y checks the FDA & MHRA databases and public acccess regjstrations. X should be looking because advancing technologies allow compounds to be created and shared more quickly. It’s possible a similar product already exists in India. He could also check international trials registries.

Patents. In both cases the brothers should find a lawyer. For X, a patent is not marketing approval e.g. it’s about characteristics – is he patenting a molecule, a compound, texture, size, shape, a chemical process or developmental process. He can’t apply for marketing authorisation without verified pre-clinical and clinical studies so perhaps he could apply for patent before trials. However he also needs enough evidence to apply for patent so it’s not easy to decide and lawyers should be able to help.

Whilst X may or may not be stopped using the mice he finds, ethically and practically he can’t progress a marketing application. For example in laboratories, they use specific mice & clones which also make it easier to demonstrate efficacy and scale up trials.

2.

Good laboratory practice includes SOPS, being able to replicate your experiments and results under same conditions. To pass an inspection there must be robust processes in place where you can measure, justify and prove the steps happening in the process.

With lots of chemical reactions you need to know what you are getting and supposed to get. From starting materials, environmental conditions, manipulation, labelling, roles / responsibilities.

Good Manufacturing Practice – they key is scale. For example using a natural source such as plant, you need lot of chemical research to see how you can change it or develop synthetically to reduce environmental damage and loss of species. The development requires good heat, light conditions and for higher volumes. 

You need to prove that product does not degrade during manufacturing. The drug must still have the same characteristics as it did in the lab. You don’t want it to change composition or you have to start again from beginning.

A common supply chain problem is buying intermediates (not the main ingredient but other parts of drug). If one of intermediates is not available your factory production stops. It’s possible another company will have the intermediates but this needs to be planned as part of the risk assessment.

Always have backups, if supplier becomes a problem find a second one. Labelling can also hold up supply due to requirements of different country regulations on size, type, content on them.

3

Active ingredient and stability – this will also have diagram but will include

With some traditional medicines, it is sometimes the combination of active ingredients/herbal form is more effective than a single extracted ingredient – this may be because some extraction processes do not capture some isomeric forms of the active ingredient so they are not as effective in the body or the extraction process only captures the main active ingredient but not a secondary molecule which maybe catalyses a reaction in the body or promotes absorption.

People’s Uni module story 0.2 

Main reasons for edits are whilst it’s good in principle to highlight unethical practices, there is a danger in highlighting specifics; also some practical industry points. Will not be shown in detail in this post but for example – gathering local mice will be used as example to explain lab mice and good practice. 

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 herb in Poland 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 develop 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 other reports 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 composition. (link to api & excipient diagram / explanation)

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). Y gets regulatory approval for his app and pre-orders are 100 times more than expected.

Two, three years pass. 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 produce the pill but then has to stop because he runs out of money to develop 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 creates a poster showing early results. At the conference he meets a Russian company who are successfully selling a Siberian drug to treat indigestion in India. They decide to help him and agree to invest in the development of the pill.
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 the same drug 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 tries a self experiment and adds the herb to some juice. He tries drinking over a month and notices that his eczema cleared up.

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  and health technology assessment 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.

And the world goes on regardless

Someone pointed out that Brexit activity may result in another general election within a year. More media coverage to drive the inane celebrity culture of politicians & generate biofeedback for their egos, more trees destroyed for paper progaganda, more blame heaped on the undeserving, more wasted £millions that could have fed & treated those in need.

Economically impossible for everyone’s voice to be important, economically impossible to pursue austerity on a lie of scarce resources that need to be allocated. 

There isn’t a Great British ship to be steered, a Great British society to socially engineer, a Great British plc to compete globally. 

But we will all carry on in our own weird wonderful ways.

People’s Uni pharma module – new story and edits (long)

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.

Sections:

  1. Is your idea marketable?
  2. How do you choose partners?
  3. How do you get the product fit for marketing?
  4. 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.

 

freelance contracting costs – updated

For paid eLearning contracts in UK at my career level experience, start up from nothing with no guaranteed work is minimum:

£50 – £100 general set up & registration

£100 insurance (various) p/yr

£775.00 elearning software costs  for 1 yr (not including systems e.g. hosted Moodle could be £40 p/yr or hosted WordPress with LMS £160 per year)

£300.00 accountancy fees for 1 yr including tax return submission

£150 business banking for 1 yr

Total approx £1,600

If you factor that into hourly contracting rate that’s over £13 p/hr on top to break even.

Martial Arts summer camping

There’s no official one this year, but some of us may go to Bude and train anyway.

Tbh I prefer it this way, it’s how we started out – informally. There’s no need to have a specific field or marquees, just turn up and go with the flow.

Liberating lavender update

This year has been the worst for weeds, brambles & grasses that the team have ever seen. During two weeks they completely took over the field. The bottom end of field was cleared this week by a rare volunteer day and looks fab.

I’ve been working at top end. For example, this is a very small bush but

Before:

After:

There’s about 6-7 rows left which are currently invisible then each row will need maintenance so that everything ready for the open harvest 29/30 July. I had never heard of it before moving here but people came from all of London and parts of Surrey & Kent last year.

If anyone wants a personal tour,  please get in touch.

In the meantime the lavender grows just as it did 200 years ago in this area. The blue/purple already starting to peep through in the sunshine:

Russia update 

Went with a friend to Yuri Vashenko exhibition at Pushkin House tonight, lovely illustrations, My friend said that the long necks reminded her vaguely of Lowry. she found the exhibition quite charming. Yuri spoke briefly and genuinely humble with his words. The geometry was fascinating e.g.

http://www.pushkinhouse.org/events/2017/6/2/in-conversation-with-artist-yuri-vashenko-conducted-by-liza-dimbleby
In July,  they are showing a film of Lewis Carroll’s brief trip to Russia in 1870.

The president of our taekwondo association recently popped over from Korea, I asked him if he had any Russian connections. He said that when he first came to UK, he taught a Russian student from one of the big Russian ballet companies. He also said there is a Korean Master he knows of who is ‘somewhere’ in Russia. Somewhere is a good place to start looking should I ever be there long enough 😉