These points are gleaned from a talk given by Tony Rollins
at the CIPA Life Sciences Conference on 14 November 2013.
1. Drug discovery
used to be a much simpler process, essentially involving chemistry, biology and
pharmacology components. However today it
is much more complex and multidisciplinary, being carried out in a networked
environment and involving many more types of analysis, such as pharmacogenomics.
2. A new drug needs
to satisfy many criteria, including:
- being able to target the relevant pathway to give an
appropriate efficacy,
- being able to target the right tissue,
- being safe, with the risks versus benefits being clearly
understood,
- targeting the appropriate patient group, and
- having the appropriate value proposition, i.e. being able
to compete in the market with other drugs.
There is a trend towards drugs which are more personalised,
rather than one drug being able to treat all people.
3. The sector very
much relies on patents in its business model, and differs from other sectors in
that a product might be covered by very few patents, and perhaps only a single
patent. This is necessary because chemical
drugs are easy to copy.
4. Development of a single drug costs $1 billion,
requires 7 million hours of work, 6587 experiments done by 423
researchers. Drug development typically
takes 10 to 15 years, starting with 5000 to 10,000 initial candidate compounds
to give a single drug. Research
continues even after registration of a drug in the form of post-marketing
surveillance.
5. At the moment
there are many candidates in the pipelines, in many cases 100 or more different
drugs are being tested across the industry for many diseases. There is increasing research being carried
out into neglected diseases, many of which are vaccines. No other sector spends more on innovative
research.
6. Pharma R&D is being
eroded in Europe, with much of it going to the US in the 90’s and then to the
Far East in recent years. Between 1990
and 2009 pharma R&D investment grew by 5.6 times in the US, and 3.5 times
in Europe.
7. Clinical trials in
particular have shifted to Asia where many new research sites have opened. The UK government is in the process of reconsidering
the Bolar exemption to counter this.
8. Incremental
innovation is becoming increasingly important.
Typically this would be discovering new formulations for existing drugs
to improve their properties, versus radical innovation (e.g. finding new classes
of compounds) and revolutionary innovation
(e.g. finding new pathways). However it is no always easy to get patents for
incremental innovations.
9. Personalised medicine is increasingly important.
Essentially this concerns identification of the optimally responding patient
subgroup. However it means reduced market
size for the drug, whilst R&D costs are often the same. Many drugs are only effective in
subpopulations or exhibit toxicity only in subpopulations, and therefore this
provides the opportunity of revisiting previously rejected drugs. Statins have surprisingly
been found to not work in 40% of patients.
For warfarin it has been found that half the dose used Caucasians is
therapeutic in the Chinese population.
10. However
personalised medicines come with other complexities. The party with the rights to the technology
which identifies the subpopulation may not be the same as the party that has
the rights to the drug. Patent life on
the drug may not be long enough to take full advantage of the personalised use
of it. One may not be able to get a
patent for the personalised use, phrasing of the patent claims may be difficult
and it is unclear whether SPC’s will be available for personalised uses.
You may also wish to see related articles What
Do You Need to Know about Commercial Biotech? and What
is Wrong with Pharma R&D?
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