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?