WIN 2011, 6-8 July, 2011, Paris
Changing drug discovery: share data
Dr Stephen Friend – Sage Bionetworks, Seattle, USA
I spent three portions of my life, eight years in academia thinking that was a realistic way to make an impact, then eight years running a biotech and then eight years running oncology at Merck, a large pharmaceutical company. So I’ve gotten to see a lot of groups that feel as if they have the answer and that they are in a good position to change how drug discovery is done. But the remarkable thing, and this comes from looking a little more broadly and looking from the vantage point of a patient, is that almost every group that’s trying to work in drug discovery is doing it in a siloed way, a way where they’re either headed towards first/last authorship or could then turn this into a company, or companies trying to help investors or large companies trying to compete with each other. So the remarkable problem is that each of these groups thinks that they are solving the issues that need to be there, making an impact, but in fact it’s the fact that they’re doing each in isolation. If there’s one way that we could change how drug discovery is done it would be to say, why don’t we share data at the speed that goes on within groups between groups? What is it that makes it such that the same experiment has to be done by two, three, four academic investigators simultaneously? So I think it’s time to step back and look at our reward structures, our values and ask whether there are more logical ways to bring groups together, still getting the rewards to them but, more importantly, I wanted to put the patient back in the centre.
AstraZeneca and Merck are collaborating on a combo of BRAK and MEK kinase inhibitors. Is this type of collaboration the future?
I think so. I actually set that up and I did two type of projects while I was in pharma of that nature. One of them was getting two companies that each had a compound not yet approved and recognising that they could pool their efforts and have a joint programme, even though they each internally had their own compounds that were the pair. The lessons learned there were that it took a year and a half for legal teams to allow that to happen; when you got to the scientists, they were ready and actually were very efficient. So that’s a great example but never forget there was a year and a half of wrangling to get people to do the logical. The second was an example where Pfizer and Lilly and Merck said, we all want the same data, why don’t we pool our resources, have a third of the cost and all go after and develop a set of data that we each needed individually? So those are beginnings of examples of people realising that they can be competitors but actually build common sets of data. Where that’s migrating is to a place where the question of what’s pre-competitive, what’s competitive, is beginning to shift. We’re working on a project now called ARCH 2 POCM which says why not share efforts, all the knowledge, put it out in the public domain for trying to de-risk high risk, high opportunity targets and move those compounds all the way through to proof of concept sharing that data and then let companies go back, file their IP, bring those forward.
What is the ‘That’s My Data’ campaign?
95% of all data that is generated comes from trials, it comes from a situation where an investigator, either academic or in industry, says, I’m wanting to study a new drug, would you participate in that study? And unknown to the public, or at least unrecognised by most, is the fact that when you enrol in such a trial you give of yourself, you give a sample of yourself to a trial. You sign away any right to have any of that data back. So, across the world, when you sign up for a trial there’s usually a clause in there that says I’m giving up not only my sample but all rights that I’d ever want to see that later. This is strange but what makes it worse is that that data, when it comes to being of value to others at a later time, we can’t get to it because the companies say, we can’t do anything because we can’t go back to the patient and ask them whether they might give permission to look at something in a new way. So it’s doubly bad – the patient doesn’t get it back but it doesn’t allow that patient’s sample to be used for new ideas, for new research. So there’s a campaign we’re working on called That’s My Data and the purpose of that campaign is to give visibility to patients, have them recognise that when they give a sample and they enter a trial that that data should be theirs to be given back to them. So the idea is if I give you my sample, then you should be willing to give the data that you’ve generated back. So to do that there’s the campaign, That’s My Data, that’s getting launched. If you can picture how that would work, you realise that there also has to be a legal document, there has to be actually a legal agreement, a grant-back that gives a legal mechanism by which to get that data back. And that would do a lot to make the type of data that is generated usable and obviously has an impact on other patients.
We’re living in a legacy system, we’re living in a paternalistic world where people think that if there’s data, that someone must interpret it to give it back to that unknowing patient, naïve patient and the patient couldn’t deal with the data. So we’re going to have to exit a world where people feel as if they had to take care of the patients who gave their data and acknowledge the fact that actually patients would love to see that data themselves, no need for a knowledge filter to sit in there.
You were also talking about driving drugs through clinical trials without intellectual property?
Today, as I hope everyone knows, nine out of ten drugs that enter phase I trials don’t become drugs; the compounds that enter phase I trials don’t become drugs. And some strange number, I think it’s two-thirds of oncology drugs that get all the way up to phase III, last before getting approved, end up failing there. If you look at what’s going on you realise that’s a lot of failure, there should be a way that could be a little better. You recognise that actually the same thing is going on in multiple companies so that failure rate is actually even worse because three, four, five companies are all doing that same strange, or at least good idea, in isolation. You begin to realise that there is a de-risking that needs to go on and that concept of de-risking can come about if you actually could share the data that was coming out of any one clinical trial. So if you have IP attached to a molecule, you get very possessive of it, you want to protect that. You begin to think that the compound is the final treatment, whereas usually that compound is a way to have an insight into the biology. So if you were to separate the way to understand biology, if you were to start doing trials where the purpose of the molecule was to have it as a way of recognising what the disease, or the components of the disease, and you did that without any IP on it, it speeds up the ability to share that information, it speeds up the ability of people to work on it, not having to sign MTAs and all these transfer agreements. Once that knowledge is there, then there’s a great opportunity to compete. So this concept of having no IP, which sounds pretty strange, is literally just to help flesh out the biology and then let IP be generated, be placed on molecules that actually are going to be the therapies that people take and are potentially needed to get those through development.