The Centre for Human Drug Research provides a full range of early stage clinical pharmacology services. The CEO discusses the vision behind the creation of the foundation as well as some of its most recent educational and funding initiatives destined to help biotech companies develop new drugs.
You founded the Centre for Human Drug Research in 1987. What was the vision behind its creation?
Back then the pharmaceutical industry was at a turning point: large drug manufacturers were starting to outsource drug development, while previously they had done everything in-house. We had the clear vision that this practice was going to increase and decided to help companies in this process. However, our premises were different from other contract research organizations (CROs). First, we were funded by the Dutch Ministry of Health and established as a foundation, which we still are today. Second, whereas other large CROs conduct all phases of clinical trial, we decided to focus on early stage (phases I and II): CHDR concentrates on early proof of pharmacology and methods aimed at demonstrating it By conducting highly informative early-phase clinical studies, we help companies minimize development risks and costs.
In 2014, the revenue growth of CHDR increased by an impressive 46 percent. What was the key to this success?
The growth is the result of moving to a new building with state of the art, fit for purpose facilities. Most of the growth came from CHDR’s long-term clients, while we decided to continue investing in new research methods for improving the outcome of clinical trials for our sponsors. We do not see drug development as a linear process, but rather as a journey influenced by chemical and physiological mechanisms that help patients feel better. We think it’s a step-wise cyclical process, which requires methods.
In the CHDR blog you state that “we have a duty to keep new medicines affordable to the whole world. The cost of current drug development is without a doubt unsustainable and the efficiency of the process must be increased.” What is CHDR doing to achieve this?
At the beginning, groups of researchers in the CRO industry ran trials at different sites and collaboration was strong. However, over time the logistics became complicated, people started losing commitment as they felt they were not doing it for the sake of science but only executing a ready-made protocol provided by the sponsor. Also, over the past 30 years healthcare has changed dramatically: doctors are busy between patient care and medical school, and little space is left to research, especially if there is no scientific incentive. Hence, companies started shifting towards multicenter trials in more affordable countries such as India and China, which results in quality problems, as you have to guarantee the protocol is followed thoroughly everywhere.
We decided we had to change this model. Today we work with healthy volunteers and patients at a single site, our monocenter. We have recently done a study on psoriasis for a company that had done a trial with a predecessor of the drug in 25 centers across the US, each with three-to-four patients. Thanks to the large network of dermatologists we work with, we were able to do the same trial on nearly 50 patients with therapy-resistant psoriasis in one center. The trial was much more efficient and cost effective and allowed us to apply innovative methods. We think we have to disrupt the old system, as it is not working anymore.
What types of clients seek your services?
50 percent of our client base are large pharmaceutical companies, while the rest are mid-sized, mainly biotech companies. We are also increasingly working with universities, which was not the case in the past.
The CHDR has developed the NeuroCart, a proprietary central nervous system (CNS) test battery, which allows researchers to measure the effect of a drug on the brain. What is the impact of this technology on the research carried out here?
The computerized system rapidly and unequivocally quantifies a wide range of neurophysiological and neuropsychological effects of CNS-active compounds and provides data-intensive quantitative information on mechanisms of action. This is a pretty unique system, which can easily predict the effects of CNS drugs that otherwise would rather be tracked through qualitative methods such as surveys and questionnaires.
The CHDR collaborated in the foundation of the Trio Innovation Initiative, a funding program for start-ups. How is this benefiting companies?
Financing is always a key topic in the industry, particularly for biotech companies, which can struggle to find the necessary funding to carry out their research. Our experience has shown us that often biotech entrepreneurs lack compelling business plans to present to potential investors, hence do not get funds for early stage development. We decided to create this funding program to provide non-dilutive financing for early-stage clinical trials of drug development, as thanks to our technology we can identify the efficacy of a drug at an early stage. Venture lending offers the great advantage that you keep all the equity, as you borrow the money only for a short period of time. So far we have had only one company benefitting from the initiative, but more are currently under scrutiny.
Education is an important element of the work of the CHDR. Could you please elaborate on the various educational programs you are running?
The undergraduate program we have is very important to us, and the center includes some of the best people in the world mostly because we train them. Our 20 interns per year do a huge amount of useful and innovative work. Our educational efforts also keep our expertise up-to-date and our staff at the level we want to maintain. We also run undergraduate drug development programs at the Leiden Academic Center for Drug Research.
Overall, I think we need to provide more education to help scientists to establish their start-ups. If you are a biomedical scientist, wanting to start a biotech company and have to ‘fly for the first time’, it can be a frightening experience. This has led the Dutch Ministry of Health to fund a new academic program for scientific bio-entrepreneurs – the Leiden Future Lab- where people learn on a case-by-case basis. It’s a superb learning opportunity and I think it’s going to be a good program.
What is the achievement you are most proud of and what keeps you motivated after so many years?
My most important achievement is the CHDR per se. We managed to get a EUR 1.5 million fund and turn it into the CHDR, a profit-making and independent institution — that’s definitely something! I am a doctor, and it’s motivating to make healthcare better, especially if people are learning in an environment where if you have a good idea, you can execute it.
Where would you like to have taken the center by 2020?
I think by 2020 our monocenter and drug development approach will have taken off. I also hope we’ll have more satellite sites across Europe —probably in the Netherlands, in Germany and Belgium — where we’ll be able to teach more people what we do here.