"Over recent weeks I have been intrigued to hear some highly negative comments from people outside of the biopharm community on the industries economic value and also concerns regarding the public perception of the potential use of live recombinant products being a reason not to progress along this track. Over the last 30 years, the industry has grown from what was in many cases nothing more than a scientific novelty, into multi-billion dollar products. This has been achieved in the face of considerable levels of scepticism from those outside the industry about the ability to deliver, whether from a technical level, regulatory or economic perspective.
I think it is useful to look back and see what life was like before recombinant therapeutics, with regards to product safety and in some cases the availability of these products. When you look at the monoclonal market for example, this was an idea that was “deemed to be scientifically interesting but of no commercial value” by the UK Medical Research Council. History has shown this not to be the wisest of judgements.
So, I question why are there still concerns about product safety, economic and social benefits the industry has brought to society. I raise these concerns as I think it is important to address them as the industry moves forward. From a public safety perspective it is clear that an increased number of products under development will not only be derived from recombinant sources but will themselves be live recombinant products, such as viral vaccines, gene therapies and phage. Historically the industry has been able to address the concerns that have been continually raised around the use of recombinant technologies and has delivered products significantly safer than could be achieved from natural sources. Consequently, it is essential the industry recognises and seeks to address such concerns reflecting on how we have been able to design in and demonstrate product safety in processes and products before they impact investment decisions and deprive patients of access to potentially life saving medicines.
From an economic perspective it is clear that innovative start-up companies are still struggling to secure investment funds from both private and public funds especially within the EU. It is also clear that whilst there is significant interest in the bio-economy as a whole, much of this is focused on bio-fuels, industrial and synthetic biotechnology, and I think there is real risk that the biopharm industry could miss out.
I would therefore suggest that this industry needs to be less defensive about its achievements at times if we are to address firstly public perceptions around the types of products we are producing in the cell and gene therapy areas as well as more novel technologies such as phage therapies and the track record and benefits of recombinant technologies. Secondly, we need to restate the social and economic benefits of the bioprocessing industry to ensure firstly that we maintain the flow of people and funding into bioprocess research in the industrial setting and also funding of biopharm companies to drive innovation and growth."
Pharma IQ: Making Tomorrow's Medicines