POLICY & REGULATION
of a number of biomarkers for kidney disease. So what about the numbers and kinds of antibiotics. This is a worry for everybody, not
Now three new biomarker qualifi cation products that will be submitted to the agency just for us.”
procedures have begun, and are under in future years? He believes the overall number
evaluation by the two agencies, and the of applications will increase, while applications
safety issues
EMEA has been contacted by companies and for new active substances will stabilise, with a
Another major concern, for companies and
consortia on a number of others. higher proportion of biologicals. By 2010-
regulators alike, is ensuring new drugs are as
He also notes that the EMEA has modifi ed 2011, applications for new compounds will be
safe as possible and getting the right balance
its scientifi c advice procedure so that dominated by drugs for cancer, immunologicals
between the benefi ts and the risks. This may
companies can come to the agency for advice (including vaccines), neurology, endocrinology
well become more diffi cult as applications for
and feedback when they are starting their and cardiovascular. Oncology “is the big one,
substances with novel mechanisms of action –
biomarker project, and again later when they and it seems most R&D-based companies are
gene therapy, cell therapy and the like – start
have conducted their studies and want to rushing into this area”, he says.
landing on the EMEA’s doormat.
begin the qualifi cation process.
The agency has begun a project that it says
“The question is, will it help?” Hopefully,
advanced therapies could improve evaluation of the real benefi t-
these initiatives will help to make drug
Advanced therapies will also fi gure in new risk profi le of new medicines. A new kind of
development more predictable from a
applications. These will be dominated by cell- benefi t-risk template is being piloted, with a
regulatory point of view, says Mr Lönngren,
based medicines, while applications for gene more structured list of the criteria used in
but whether this will result in more new
therapy and tissue-engineered products are making benefi t-risk assessments. The hope
substances on the market is another matter.
expected to be fewer in number. A limited is that it will provide a sort of “checklist” for
Companies are now looking to more
number of new applications are expected in assessors and rapporteurs to show that all the
complex targets, right down to the molecular 2009, although on the basis of the increase necessary elements have been addressed.
biology level, and “this is one reason why we in requests for scientifi c advice on advanced One of the problems with the agency’s
see so many failures”, he suggests. “Maybe this therapies, the number of such products should current approach is that there is no proper
is an issue the R&D-based industry needs to increase over the next few years. methodology, and no standardisation of
address. Maybe it should adapt its business But not all therapeutic areas are rich in the parameters used to reach benefi t-risk
model, maybe there is a new drug discovery research, and in some cases Mr Lönngren conclusions. It has no guidance on benefi t-risk
tree related more to disease management.” sees a discrepancy between public health principles, or on how to describe how the
Another possibility, Mr Lönngren says, is needs and what is coming through company evidence is weighed. The agency is not alone
that industry is simply fi nding it increasingly pipelines. He is worried in particular about the in this respect: the US and Japan have no lists
diffi cult to come up with new ideas. “Maybe lack of applications for new antibiotics in view of benefi t and risk criteria either. “Everyone
mother nature is tricky – it is not so easy of concerns among experts about growing realises that there is a need to somehow
anymore. The low-hanging fruits have been microbial resistance to current drugs. “We see standardise how we do it,” says
picked.” anti-infectives for diseases like HIV, but not Mr Lönngren.
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