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He Will Deliver

What are your current business goals?

To bring Lucentis to its full potential by fully evaluating all possible indications and technologies. I think Lucentis is a great example of how to manage the life-cycle of a drug. We now have essentially five indications, approved in over 60 countries, and a pre-filled syringe, unique to Lucentis, which represents a great technical advance. But there are still things to do. Lucentis needs to be administered quite frequently, so it would be great to have a sustained delivery system or a formulation that would last longer than the version that we inject into the eye currently.

What else remains to be done?

There are still a number of relatively rare diseases where Lucentis will most likely work but where it is difficult to conduct clinical studies because of the low patient numbers. These are diseases where choroidal neovascularization (CNV) or macular edema (ME) are the cause of vision loss but are not the primary disease. We are performing clinical trials of Lucentis for the treatment CNV and ME of different etiologies, with the aim of gaining regulatory approval for the treatment of these diseases.

Going into ophthalmology was one of my best decisions.

We are also planning to start a study in retinopathy of prematurity (ROP). Anti-VEGF agents are used off-label in this condition, with the most common being Avastin. I find it questionable in premature babies, if you consider systemic anti-VEGF exposure. The question of ‘what is the value of anti-VEGF therapy in ROP?’ has not really been answered fully by the one study on this topic, BEAT ROP, which used Avastin. I believe that a product like Lucentis really should be studied as well. We have been discussing this with the European Health Authority and the pediatric committee of the European Medicines Agency, and we are currently in the process of agreeing a protocol to start our study with Lucentis in ROP next year.

What does your future hold?

I recently became responsible for Novartis’ retina portfolio, with respect to clinical drug development. Some projects will soon enter full, Phase III clinical development. It is now my task to develop these new products – which address different medical needs to Lucentis – as efficiently and as speedily as possible. Basically, my aim is to bring new therapies to the patients within the retina space where there are still unmet medical needs.

What do you think of the field of ophthalmology right now? Is it a good place to be?

It is a great place to be. There is a great deal going on, with lots of energy and technical development. For example, when we did the Phase III studies of Lucentis in 2005–2006, very few patients had OCT measurements, and when they did it was time-domain OCT. Since then, third and fourth generation OCT machines have become available, and the difference is remarkable.

The opportunities in ophthalmology continue to amaze me. We’re starting to better understand the mechanisms of disease, what the treatments are doing, and to understand which patients we should treat with what drugs. This is really great. There is a lot of excellent research and development activity, it is an extremely dynamic field. I think that going into ophthalmology was one of my best decisions.

What’s the secret to a successful career within the pharmaceutical industry?

Acquire as much knowledge and as many skills as you can, and continue to learn all the time. I am a pharmacist who has spent 25 years within Novartis, first in pre-clinical research, then in clinical drug development and project management. I consider myself a drug development expert, as I’ve acquired a lot of knowledge about clinical research, clinical development, and the regulatory aspects too. But I continue to look for opportunities to learn.

You need some luck too; to be on the right clinical development programs at the right time, and have the opportunity to show that you are capable, that you can make things happen… and that you can develop. Essentially, you want to be someone that people want to give responsibility to, the person they will trust to deliver.

What you most enjoy about your work?

That there is something new every day.

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