Tuesday, 13 March 2012

What about some "Regulatory affairs in the US and EU" - Part VII of X

Preface: It has been a while since I last posted a review on the PTI's regulatory Affairs course. Health issues (fortunately totally resolved now - bloody Winter) and loads of work in one of the most hectic phases in my first PhD semester took my attention from the blog for a while... only to discover that The Toxicologist Today had around 800 page views last Saturday  and that the article "The light of Mr. Solar Demi" hit all the records possible in the history of this blog. Great! I hope you guys are really happy with this blog as I am writing it. So, here we go for another review session when we are almost reaching the tenth and last module of this very good course.

What is reviewed in the seventh module?
Over this seventh module we can find a good discussion on the most rapidly changing areas of the pharmaceutical industry (biologicals, cloning and gene therapy, as well as nutrapharmaceuticals). The way to register these products and which are available in the market these days. There is a special insight on a specific branche of the biologicals (blood and blood products) with good insight on the legislation. Stem cell research and special pharmaceutical products are also put under analysis. Overall, a very interesting and promising module.

What about funny and curious facts revealed in this module?
The history of biotechnology, from cheese to penicillin (that caused me to lie in bed for three days due to its "strong" immunogenecity) is nicely summarised. You even learn about Maurice Wilkins and Rosalind Franklin estranged relationship!!!

Biosimilar products as generics to the biological products - I didn't see that coming, but thanks!

The shameful (in my opinion) market of the nutraceuticals is briefly exposed. I call it shameful because there are a bunch of lies being told to people and because of their lack of knowledge they just accept it in an unquestioned manner. A good example? The gut-friendly yoghurts and especially the so called SUPER-FOODS. I will save some time one of these days just to expose a sham, and if you don't accept this is a sham I call it playing with people's ignorance or lack of insight. Anyway, let's move on.

What about some awesome quality information?
The simplistic definition for biologicals is straight forward. The list of types of biological products is very good, from cytokines to monoclonal antibodies, what is essential to know is definitely there. The UK act as the rapporteur for the biologicals assessment due to expertise gained.

The market in the future will be thriving with recombinant DNA products and monoclonal antibodies. However, releasing a biosimilar can be far more complicated in terms of trials and investment than the biological products. Nevertheless, the growth of biological products in the European Union is expected to rise, as sustained by the author, but a lack of regulatory guide lines in the United States have restrained the evolution of this niche in Uncle Sam's country.

The chapter on radiopharmaceuticals is of great quality and I came across them when I was working as a Portuguese/Spanish/English interpreter for NHS.

Is there anything missing?
OK, we get the whole thing investigated through the module, the topic itself is quite interesting but I'd love to have a few market examples of these biological products, the blood products and its derivatives. I mean names, a few things on composition, not only this is a monoclonal antibody and that is not, this is the directive for X Y Z. Examples, real ones, help the reader to materialise the idea.

There's a lot of common sense, especially when it comes to haemovigilance, but it would be better to make things a little deeper by showing us a troubleshooting position when it comes to marketing these products and the general difficulties one faces. It must be said that when it comes to gene therapy the scenario changes for the better. From different techniques used in gene therapy to a case-study unravelling the case of Ashanti de Silva, you finally get a good structured image of the topic.

A good example of moments where the author could give us a better idea of what he's talking about is, for example, when discussing the licensing of gene therapy products where it is mentioned the only product currently approved worldwide - in China (since 2004) -, to fight cancerous cells; and then nothing else is said about the nature of the product, how it works, why was it regulated in China and not seen anywhere else. I know this is a regulatory affairs course, but sometimes too straight to the point is a lack of dimension whilst gaining focus.

The paragraph in the cloning section where the author gives the example of Dolly the Sheep and explains that due to mitochondria the clones aren't exactly the same, is not clear at all. For those in this scientific area it can be inferred, for those who're not proficient in these it;s just confusing.

No comments:

Post a Comment