Science and TechnologyWritten evidence submitted by Professor Michael Ferguson

RESPONSE TO ITEMS 1 AND 2 RELEVANT TO NATIONAL LIFE SCIENCES (BIOMEDICAL) RESEARCH

1. Fundamental Issue: Why does UK Pre-eminence in Academic Life Sciences Research (Biomedical) Not Translate into New Drugs Discovered and Patented in the UK?

1.1 What is early stage drug discovery?

Early stage drug discovery is the process of translating ideas for new medicines from basic research into “drug leads” or “pre-clinical drug candidates” ready for licensing to industry, partnering with industry or spinning out into new companies.

1.2 Why should we be doing this in UK Universities?

Our universities are a rich source of internationally competitive life sciences discovery and innovation. Independent assessments of Life Sciences research impacts generally rate the UK as second in Europe, just behind Switzerland. Consequently, we sit on a massive bank of potential intellectual property (IP) that has been created from taxpayer and medical charity investment. This IP needs to liberated and accelerated towards commercial and therapeutic benefit. A key engine needed to do this is early stage drug discovery.

1.3 Where are the early stage drug discovery units?

Until recently, almost all aspects of drug discovery and development had been the exclusive domain of the Pharmaceutical Industry. However, wider availability of technologies has allowed smaller biotechnology or “BioPharma” companies to compete in this market. Indeed, many of the new medicines currently in development were discovered in BioPharma and then sold or licensed to larger companies. This is a good paradigm, but it translates only a tiny fraction of translatable academic life sciences research. Thus, the connectivity between novel drug targets discovered in academia and their development into new drugs by industry has been relatively poorly exploited.

1.4 How can we realise innovation in drug discovery and create jobs and wealth for the UK?

Most would accept that here is a National, and moral, imperative to innovate by translating academic IP into the commercial and healthcare sectors. The problem is getting life sciences IP into a state that is an accepted starting point for the commercial sector; ie, ‘drug leads’ or ‘pre-clinical drug candidates’ (see box). This is only done seriously and professionally in a handful of academic centres (notably, by MRC Technology, Cancer Research Technology, Institute of Cancer Research, The University of Dundee) and the capacity and focus of these organisations is woefully insufficient to translate all of the IP opportunities in the UK biomedical arena.

2. The Opportunity

Several major Pharma companies (eg. GSK, Pfizer, Astra-Zeneca, Johnson & Johnson, Merck-Serono, Sonofi-Aventis) as well as BioPharma development or investment companies (eg Union Life Sciences, Debiopharm, Frontier IP and TPP Global Developments) are looking for innovative and validated therapeutic targets and are actively seeking engagement with academia. Indeed, considerable amounts of company R+D budgets are now being directed that way by their senior management.

Recent discussions with all of the above companies have shown that an ideal engagement point is at the stage of targets plus pharmacological lead compound material that provide proof of concept in an animal and/or tissue model of disease. The value of such a package for out-licensing, partnering or the creation of spin-outs can be very considerable.

In brief:

Novel target = no commercial value.

Novel target plus proof-of-concept lead compounds = considerable commercial value.

Therefore, to capture the inherent value of its basic Life Sciences research, which is strong across many Universities and their Medical Schools, the UK needs to increase its capacity for early stage drug discovery.

3. The Proposition

The UK University sector needs to be better served for Early Stage Drug Discovery to de-risk its wide portfolio of potential opportunities into a short-list of validated opportunities of serious interest to industry and/or investors. The expansion of capacity at existing proven centres and the creation of a small number of additional centres (using the skills of those recently lost from major Pharma downsizing in, or withdrawal from, the UK) would achieve this and keep us competitive with the US which is investing massively to solve this “valley of death” between discovery and medical exploitation.

Declaration of Interests

I am passionate about the UK not loosing this opportunity to be the best in the world at translating its basic biomedical research (which itself represents an enormous government and charity investment). To realise this vision locally, my colleagues and I created a Drug Discovery Unit at the University of Dundee in 2006 to do exactly that. It has been a palpable success. The potential conflict of interest is, therefore, around the fact that I am recommending further national investment in an area where my own institution already holds a leading position.

February 2012

Prepared 11th March 2013