My India Visit and why it's good to talk about E&L

Recently I had a opportunity to speak in Hyderabad at the E&L conference organised by CPhI conferences

I presented on two topics. The first one was entitled an overview of extractables and leachables overview and covered my brief review of on guidance available plus how E&L studies contribute to a successful product launch.

The second presentation was more forward looking and gave a personal view on the future of E&L.

I certainly enjoyed the conference as I think I have mentioned before, E&L is a topic I am passionate about and rarely pass up an opportunity to spend hours talking about it.

As with every conference the organisers asked for feedback and I reflected on what to say. What I said was, my favourite part of the conference was the roundtable discussion which we had.

It was actually) the last session. The whole conference contributed to a conversation on three subtopics around E&L; something on validation of E&L methods, a discussion on design of studies and looking at secondary packaging.

So for me, it's not the formal presentations but these conversations which really add value as people share their experiences, their opinions and add to the collective knowledge base.

What I also saw was rather than the mass exits to the airport towards the end of a conference, people chose to stay and engage in this conversation. So I can only conclude people saw the value in the discussion.

So, the point I am making (and it was a point featured in my future of E&L presentation) is that I hope that sharing information regarding extractables is where we should be heading.

In my view this is enlightened self interest and not altruism.

Just look at the benefits:

1. Patients safety is not risked - the extractable information can be risk assessed and if necessary large scale cost effective further testing can be planned

2. Quality of the drug product is maintained - this will build a virtuous circle, high quality materials will be used more, low quality materials will be less likely to be used

3. Cost of medicine development is reduced since extractable studies are conducted, shared and available for all. Patients are waiting right now for all kinds of medicine which are travelling down the development pipelines. Nobody wants to delay these medicines.

4. New Materials can be introduced to meet unmet needs for specialise areas - Currently there are limited benefits for innovation as risks are higher

Without the data, information and knowledge that extractable studies bring; time is taken to do the studies, plan the leachable studies, ask and answer the questions that arise from them.

And what are the risks?

• If you are a supplier, you might have to disclose information - Why is that a problem? I assume the aim of the supplier is to supply what the customer needs. So how can this be a problem? Actually it allows you to ensure the information about your product is accurate and and a fair reflection of your company and its product

• It might cost money to perform the comprehensive studies which are needed - Right now it is costing many groups lots of money as we constantly redo testing on the same or very similar materials or make tests which are incorrect or of limited value.

• Analytical testings CROs would currently test for extractables would lose business because the retesting of materials would happen - I believe this risk is in fact an opportunity. It's an opportunity for CROs to in the short term do the comprehensive tests to fill this database with information on the materials, its a medium term opportunity to then progress to more meaningful testing related to E&L. The leachable testing would still happen - that is product specific but now with the assurance that the extractable data is high quality and useful for the creation of the targeted methods which are easier and more suited to leachable measurements in complex matrices. There is also the opportunity to build more supplementary knowledge around the materials in the database such as variation over the longer term and monitoring change.

Therefore, I want to make a suggestion and it links back to my blog entry I wrote at the start of January. When the ICH expert group is discussed ICH Q3E, make sure it includes and suggest that extractable data is shared and maintained. That all for this blog, as they say in India Namaste.

Next time....Perhaps I will write about, "Why aren’t leachables treated the same as other pharmaceutical impurities?"