One of the things I look forward to during a conference are the scientific debates. With so many topics being buzzed about in MS research, and many studies ongoing that often provide different data and views on the topics, there is an opportunity for researchers to provide unique perspectives that often challenge those of other researchers. This year the conference organizers changed things up a little, by including Twitter to allow people – both researchers and the public – to participate and ask questions remotely and in real-time. This is certainly a great move as social media has weaved itself into our everyday lives, and is proving to be an important part of research as well.
So the debate, referred also as a social media session, focused on clinical trials for drugs. The topic up for debate was whether pharmaceutical companies play a larger and more significant role than academic institutions in running clinical trials for MS therapies. The argument was phrased as, The only way is pharma: academic trials go nowhere. Once a researcher myself, I can say that this is not always the case, as I have witnessed successful drug trials led by a number of academic institutions including the one I did my research in. But as a professional who interacts with people affected by MS, I will say that this is a very important and talked about topic that people have conflicting opinions on. Here is what the experts – and Twitter – had to say.
“The only way is pharma: academic trials go nowhere” – FOR THE ARGUMENT
Neurologist and drug development expert Dr. Volker Knappertz from Teva Neuroscience noted that developing a new drug in the U.S. can cost an estimated $1.2 billion, and take upwards of 15 years. Thousands of compounds are identified in labs, but only very few make it past the stages necessary to produce a viable and safe agent. In the case of MS, clinical trials take between 7-10 years, and require significant resources in terms of money, infrastructure, and highly qualified personnel. The scientific and administrative responsibilities that come with planning and implementing a clinical trial can be substantial, which leads Dr. Knappertz to argue that involvement of pharmaceutical companies is not only the best approach, but in most cases the only approach, to delivering a drug for MS. He went on to say that the track record speaks for itself, with the development of current and emerging MS drugs being led by pharmaceutical companies. These companies can meet regulatory and patient timelines, as well as develop training programs that generate and sustain the expertise required to manage clinical trials.
While these points are valid, they do not capture the entire story of what is required to develop a drug. Dr. Bibiana Bielekova from the National Institutes of Health shares her view on why pharma may not be the only important player.
“The only way is pharma: academic trials go nowhere” – AGAINST THE ARGUMENT
According to Dr. Bielekova, there have been a number of successful academic-led clinical trials. This means that the trial is undertaken by one or more researchers working at a university or medical institution, versus a private organization. One recent example of this was a UK-based academic clinical trial in which a cholesterol-lowering drug demonstrated to be beneficial for people with progressive MS. Dr. Bielekova added that knowledge about MS disease, and important discoveries that have led to robust therapies, stem from academic environments. Academic research has improved clinical trial design by developing and optimizing the imaging technology and biological markers used to assess how a person is responding to treatment. It was also emphasized that targets of drugs are often first identified in the lab.
Which is the correct answer?
Following the debate, many people flocked to Twitter to share their views in response to some of points that were made. Many of the Tweets states that collaboration between academic and pharma is necessary and that one cannot achieve the goal of creating a new drug without the other. Both Dr. Knappertz and Dr. Bielekova agreed that academia and pharma contribute different strengths and resources at various stages of drug development, and that working together as well as with organizations like the MS Society is important to foster drug development and identify new therapeutic targets.