FREQUENTLY ASKED QUESTIONS
Exactly how pharmaceutical companies develop new products can be something of a mystery. So we'd like to throw some light on our R&D
AFT has quite a successful track record when it comes to regulatory approval. Why?
The main reason is that we have frank, open conversations with regulators very early on in the development process. As much as possible we optimise our development plan before we start in terms of things like patient sample sizes and end-points that the regulator will require.
We actively identify risks for the regulator and show them our risk mitigation strategies. This can be quite an exhaustive process, but the first customer you have to satisfy is the regulator. Because we’re not a large multi-national pharmaceutical company, and we have to ensure we spend our R&D budget wisely, we absolutely have to get the process right. And we do.
How long does drug development take?
It can depend on a whole lot of variables, such as the complexity of the product, how long it takes to undertake clinical trials, and what view the regulator takes of the safety and efficacy of your product. So it really is a case of ‘how long is a piece of string’.
It’s not unheard of in the industry for a development process to last 10 or more years. Our timelines tend to be much shorter than that. We’ve been doing this for a number of years now and we’ve learnt how to execute ideas as a team, and to be aware of the pitfalls you have to look out for. Our R&D team has grown and we have some extremely high calibre people here.
Where do you undertake your R&D?
Our R&D programmes are coordinated in our Auckland HQ. The actual clinical trials are carried out in a number of places, including New Zealand and Australia. We’re very fortunate to have some exceptionally good clinical trial operators operating in Australasia. We’ve also have had fantastic support from a number of hospitals and surgery centres in term of R&D programmes. We also do a great deal of clinical trial work done in the United States, Europe, and the Middle East.
Where do you get your ideas from for new or improved products?
Largely it’s driven by patient needs. We have our own sales team within the same company, so that is a big advantage. Our sales people connect the R&D team with the coalface. They help us understand how needs are changing and what solutions are needed. And because we’re not a giant multi-national pharmaceutical company, we’re quite nimble and can move quickly. Ideas for orphan drug development basically come from our assessment of where there is an unmet need for treatments.