Q: It has been claimed that many Big Pharma companies are losing interest in nano-enabled drugs. Do you agree with this statement?
Have they ever been very interested?
This statement is not true given my understanding of the term "nanomedicine". It is always dangerous to make generalisations
such as overhyping a field at the outset and then over condemning it later on.
Certainly, parenteral drug-targeting strategies have never been an easy fix and scientific experts in this area have always
known that. There are too many claims of 'platform technologies' that able to deliver any drug candidate, but this is naive
because every system needs to be optimised on a case-by-case basis.
Many basic science publications claim that new technologies—not only nanotechnology—are not practical for translation/industrial
development. This can be because of:
- difficulty in achieving reproducible quality
- safety issues regarding the dose and route of administration
- lack of enhanced efficacy
- issues regarding scale-up potential or cost/practicality for clinical use.
However, if you look at the drug attrition rate for candidates that have entered clinical trials, I don't believe that nano-enabled
systems have fared any worse than traditional low-molecular chemical entities. I think more data in this area would be beneficial.
Q: How are regulators addressing nanotechnology?
The development and routine use of nanomedicines is not new. Regulators review each new technology on its own merit and make
an integrated assessment of quality, safety and efficacy to understand whether the risk–benefit profile is acceptable. This
will continue to happen for all medicines, nano or otherwise.
With the advent of novel nanomaterials and the growing interest in complex, multicomponent nanomedicines, regulatory agencies
continue to review all specific/emerging needs in this field. Both the FDA and the EMA have established specific teams to
address nanomedicines at both national and international levels.