Top Tips for Utilising Imaging Techniques in Early Phase Clinical Trials
Jan Passchier, Director PET and Radiochemistry, GlaxoSmithKline, talks to Pharma IQ, about the latest developments in imaging techniques and uses, ahead of Pharma IQ's 2nd Annual Innovation in Phase Clinical Development conference.
Pharma IQ: Jan, firstly could you just tell us a bit about your current role?
J Passchier: Sure. I’m the head of chemistry at the GSK Clinical Imaging Centre, and that means that I’m responsible for everything from the radio chemistry side of things to quality control down to establishing the radioactive concentration and parent fraction of the tracer in blood and plasma after it’s been injected into a volunteer or a patient.
Pharma IQ: Jan what would you say are the key challenges for early drug development?
J Passchier: From a drug development point of view the challenges are primarily related to the fact that the way drug development has been conducted has simply been too expensive with too little return on investment. Money was readily available in the past and I think we’ve all seen that is no longer the case. There are a lot of drugs that are coming off patent and the new drugs that are coming through the pipelines of the various companies have proven not to be as successful as everyone had hoped. So that means that doing R&D and trying to bring new drugs through the early stage development process is becoming a lot harder, because there needs to be increased confidence for return on investment. So the biggest challenge is to really optimise the drug development process to make sure that there’s much less risk of attrition during the final stages of trying to bring a new drug to market.
Pharma IQ: And how would you say pharmaceutical companies are using imaging techniques to optimise clinical development.
J Passchier: This is an area that’s still growing. The first good examples are probably from just over ten years ago, and the use of imaging in drug development will continue to expand because companies are looking at ways in which they can improve confidence in moving a drug candidate forward through the development process.
Pharma IQ: What would be your top tips for utilising imaging techniques in early phase clinical trials for development?
J Passchier: The first tip is to make sure that you understand the technique that you want to utilise. Know the can dos from the can’t dos in what you’re trying to do and what you’re trying to demonstrate. The second is to make sure that you’re trying to engage imaging early enough in the development process. For example it’s no good asking for a PET ligand for a completely new target three months before you’re due to start your first time into human. The ligand development process typically takes anywhere between 18 months to two years, so you want to be involved in the development process early enough so that you can actually feed into clinical studies, but also that you can help with the actual candidate selection and generate that confidence at an early enough stage.
Pharma IQ: And Jan how do you anticipate the development of imaging techniques over the remainder of this decade?
J Passchier: There will be a continued increase in using molecular imaging in support of drug development, and that’s not just limited to my area of expertise which is PET, but across the board, simply because of the reasons I mentioned before. The largest need that the field has, particularly in my field, is improving the method development process to support drug development. For example, it’s still very difficult to predict upfront whether a ligand is going to be good or not. And too much time is spent reviewing the wrong compounds. So a lot of effort is being invested currently in trying to identify better ways of predicting whether a particular compound will work well as a ligand or tracer. And, from a PET point of view, I think that’s really where the biggest improvements can be made in the field.
Pharma IQ: And finally to round off I understand that you’re going to be speaking at Pharma IQ's 2nd Annual Innovation in Phase Clinical Development conference, taking place 13th -14th September 2011 in Munich, Germany. For anyone interested in attending what would be your key take home message?
J Passchier: It comes down to the two tips that I gave. It’s trying to explain what you can and what you cannot do with the technology. And trying to explain what the various timelines are, where you need to be in order to make optimal use of this technology in support of any drug development plans that your company is pursuing.
Interview conducted by Andrea Charles.