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)
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.
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.
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.