IBCD 2016 - Innovation and biomarkers in cancer drug development
IBCD 2016: Patient access and regulatory challenges
Dr Denis Lacombe - EORTC Director General
We really wanted to initiate this conference because we think it meets a need at a time where cancer clinical research is changing. We are faced with many, many challenges in drug development, in patient access, due to the heterogeneity of the disease so how drug development is going to evolve, how can we best bring therapeutic solutions to patients while integrating novel science that develops extremely fast? So this multi-stakeholder meeting was really meant to bring all the stakeholders together and discuss these challenges in a new form, I believe, of regulatory science meeting.
Could you tell us about the session you chaired?
Yes, the session that I was just chairing actually was dedicated to regulatory science. We were lucky to have the representation of the three major regulators, being the European Medicines Agency, the Food and Drug Administration but also the PMDA from Japan. So it was a unique chance to actually see the three perspectives in terms of drug development, biomarker development and how the field is moving. It was particularly, of course, of interest to confront the regulators, if I can say so, to the other stakeholders being the patients, being the industry, being academia and actually assess how other stakeholders evolve alongside the regulatory agencies.
Do you think that communication between these parties has been an issue?
Yes, there has been communication between these different parties but I think things are changing so fast that actually we need to find new types of platforms to discuss new challenges. It’s true that with the drug development being global, having different sets of regulations, having different, sometimes competing, interests between stakeholders, these types of platform are very much needed to actually identify what are the bottlenecks and how actually together we can solve them. Because there is always more in several brains than in a single one.
Were there any interesting points raised in the discussion that followed the session?
Yes, for me the major point of interest was actually the level of uncertainty. There was a question from Richard Schilsky which was really stimulating because he really put forward the true question: in this changing environment what are the levels of uncertainty? What are the levels of risk you are willing to accept in your business? So being an industry, being a lab, being an academic but indeed, at the end of the day, it was very well said by Kathy Oliver, the patient representative, it’s also, of course, how far the patients are ready to take risks. I think that’s the central question. Our risks that we take as professionals are really negligible, if I can say so, as compared to those that the patients take and I think that we are there to help them and to serve them.
Is there anything from the conference that stands out to you as something that should be taken forward?
It’s a regulatory science meeting so we don’t expect data and changes to come directly from this conference. But what I think, what I hope, is going to happen beyond this conference is certainly how we are going to discuss from there new business models, how we are going to join forces, maybe in a different type of cooperation. Personally I believe a lot in partnerships, in new models of partnerships which are critically needed because things are too expensive, too complex to be done by a single stakeholder. I think that’s what we expect from this type of meeting is a better integration of the various competencies, various knowledge, of all the players in the field.
What should we look forward to at this conference?
We expect a major debate tomorrow which is about healthcare systems and how they are going to evolve in the field, taking into account personalised medicine. That is going to be really the conclusion of this meeting because at the end of the day these drugs have to be made available to patients.
Do you have any closing thoughts on the IBCD 2016 conference?
I’m very pleased to have been able to make this meeting possible. I’m extremely grateful, of course, to our partners because EORTC could not have been put together alone without the support of the EMA, the support of the US NCI and the support of AACR. So I think again it’s an example that partnership and cooperation make this type of happening possible otherwise it’s really a challenge.
