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He was head of Safety and Efficacy of Medicines at the European Agency of Medicines for almost seven years, and he is an internationally recognized expert in the clinical development of drugs. Now he is back in Barcelona, we have taken the opportunity to speak to him about scientific development and to learn about his projects on the regulation and development of drugs.
You divide your time between London and Barcelona. How would you compare the situation of public research in our country?
Biomedical research is below the minimum level whatever country you compare it with. Management of the current financial situation is far from easy, but statements made by many political leaders and economists have implied that measures will be applied to preserve what is most substantial in this area. Unfortunately, the data show that this is not the case however much the figures are smoothed down. Direct and indirect financial aid to biomedical research has been cut dramatically and this places the future of the country in these areas at risk.
On the other hand, although biomedical research in the UK has also been reduced in the past 10 years, in this case the economic crisis has only contributed marginally. The United Kingdom is still an important part of the global context, even though it is true that a range of competitive elements developed in USA and Asia have negatively affected the country.
With the lack of public aid, philanthropy is becoming increasingly more important for the survival of research projects. This can be seen by the recent meeting with experts, organized by the Esteve Foundation. What should be done to promote sponsorship in science and for society to understand its importance?
Decisive legislation on sponsorship is required. My position is clearly directed at English models where we have seen greater levels of success.
We need simple, transparent regulatory systems, in which those who have some financial resourses -and particularly those with a lot – feel objectively attracted to investing part of their resources in biomedical research projects.
Saying it like this makes it appear simple, but the lack of leadership and competence of some politicians and academic and industrial leaders to launch innovative and creative measures have left us at a standstill.
Next May, we are once again collaborating in the course, Keys for bio ventures in times of crisis, organized by the Fundación Escola Emprenedors and the Asociación de Biotecnólogos de Catalunya. Does this encourage young people to start up ventures in spite of the outlook?
Without a doubt. Current ventures of entrepreneurs are not limited to biomedics, but this is what I know best. Young researchers have the energy, vision and required knowledge; these three attributes are essential, but there is also a fourth one which they are also able to do: attract investors through excellence.
If our country survives the crisis with a certain competitive structure in the area of biomedic research, this will be due mainly to the enormous amount of talent and efforts of everyone involved in the creation of projects and companies.
What is the best recommendation you could give to young people who decide to start out on a business venture related to biomedicine or biotechnology?
1) Not to limit themselves geographically, 2) to seek excellence, and when they have it in sight, to go beyond it, 3) to associate with other people and institutions which can mutually benefit from collaboration, 4) to never stop collaborating- this is one of the magical phases of entrepreneurship-, 5) to recognize the areas they do not know, 6) to surround themselves with good advisers in areas they do not know, and to subject themselves to transparent and flexible “peer reviews”, 7) to carefully follow international success cases, 8) to accept sooner rather than later that a product should be discontinued, 9) that those in a company who have led the pre-clinic development of a product know how to trust experts in clinical development and not to interfere unnecessarily, and 10) to surround themselves with the best and trust in them.
A couple of years ago, you set up a consultancy office in Barcelona on the regulation and development of drugs, and you have recently created the Support Business Center. Who can benefit from your experience and to whom is your new business centre addressed?
The (DDR, Drug Development and Regulation, www.ddrmedic.com) consultancy office was indeed set up in Barcelona and London two years ago. It provides services to governments in the regulation of research and medicines and health products. It also promotes educational activities through courses in various universities and institutions in Europe and the USA, and lastly it advises biopharmaceutical companies on regulatory strategy, along with specific activities in Europe (EMA and member state agencies), USA (FDA) and in Japan (PMDA).
The Support Business Center (www.supportbusinesscenter.com) is a new challenging initiative, which offers an excellent space in the centre of Barcelona, furnished with all technical requirements and administrative, legal, tax and computer back-up, for small biomedical companies and entrepreneurs to have a place and tools to contribute to their success. The centre also provides co-working options, a virtual office and meeting room.
We know that you follow our series Pharmacotherapy revisited. In what branch of pharmacology would you like to see their most outstanding articles printed.
I have been a follower of Pharmacotherapy revisited for a number of years, and I think that the contribution of this series has been magnificent and I only hope it continues in the future. A special area of interest is the search and establishment of suitable doses for new medicines, and in this regard, the progressive development of personalized medicine.