Download Podcast (click on link to download)

Length: 8 min, 08 sec

Life Science Leader (LSL): Hello, this is Rob Wright, chief editor of Life Science Magazine, and I want to welcome you to our podcast today with Martin Harvey, head of communications at the European Medicines Agency, and EU advisor to the DIA 2012 annual meeting program committee. Welcome Martin, and thanks for being with us today.

Harvey-Allchurch: It’s a pleasure.

LSL: Now Martin, DIA has evolved from a founding group of thirty professionals to a global association with nearly 18,000 members. The 48^th annual DIA meeting is to be held at the Pennsylvania Convention Center in Philadelphia, June 24^th through the 28^th, and is themed this year as, “Collaborate to Innovate.” So Martin, in the past twelve months, what have been the changes which have most influenced the development of this year’s annual meeting program?

Harvey-Allchurch: The annual meeting this year is increasingly inclusive. You’re going to find regulators from all around the world, from the U.S., obviously, Canada, Latin South America, Europe and Asia. There’s also, I think what you’ll see, much more involvement of other players, such as patients, academics, and healthcare providers, the payers, the people who provide health care to patients.

Obviously another big change is the economic climate. The program this year is tighter and more focused, and it’s not necessarily a bad thing. People who attend the conference, they’ll benefit from a tighter program. It’s a better return on their investment of time and money.

LSL: Now Martin, what are some of the challenges that the health care industry will face over the next eighteen months?

Harvey-Allchurch: The question was about the health care industry. I’d actually like to broaden that a little bit, just to the health care sector in general. One of the big things, I think, has to be the recent development model.

People are talking increasingly about it being broken, and there’s some work going on it, but I think much more is needed, some concrete proposals from industry. The industry’s come up with this, not regulators.

I think another change is the better integration of the health care chain. Everybody has been working very much in isolation. I think there’s been much better integration, more talking together, right from development of drugs all the way through to how it actually gets to patients. People need to be involved, and perhaps more involved outside parties in the process, particularly patients and the payers.

I think another big change is going to be transparency, access to data, access to information about what’s going on. It’s inevitable. Industry sometimes doesn’t like this, but I just think they have to accept it and get with the program, as you say. Two other things I want to talk about is demographics. There’s a big, big change in the patient population, particularly the older population.

That brings issues of disease burden, costs, and these are things that all regulators, industry payers, politicians, all need to address and very quickly. Just to close up on that one is access to medicines. It’s no good if you have the perfect R&D model, a perfect regulatory process, but if the patients don’t get the treatment they need, then it’s all for nothing.

LSL: Okay. Time is one of the most valuable things that we all have, and I know I get to go to a lot of meetings. From your perspective, what role do annual meetings play in helping to bridge the gap between the speed of innovation, the R&D process, and the other challenges that are currently facing the health care sector?

Harvey-Allchurch: The annual meeting, for me, is a great place where you can offer your thoughts and listen to new approaches. Every year I go to the DIA annual meeting, I learn something new. That’s basically it, for me. The DIA annual meeting, it’s quite a rare animal.

It’s a place where you can have a genuine exchange of views between industry and thought leaders, regulators from around the world, academics and patients and other people involved. In fact, in the 2012 annual meeting in Philadelphia, we’ll see the heads of both the FDA and the EMA, appearing together side by side on a public platform. I think that about says it all, about what is the sort of thing DIA represents.

LSL: Here’s a good question, since you mentioned the FDA and the EMA. What do you see as the biggest regulatory challenge, which will need to be overcome to expedite the discovery, development and lifecycle management of safe and effective medical products?

Harvey-Allchurch: The issue around drug discovery is one the industry needs to address, and different companies are taking different approaches. That being said, regulators do have a role to make sure that our own processes are fit for the purpose.

One of the things that the EMA’s working on with other regulators around the world is the idea of adaptive licensing or staggered approval, I think they call it in some parts of the world. So, that’s about challenging the approval paradigms that we have today.

Up until now, it’s been very much based on a single magic moment, where a drug suddenly becomes approvable for everybody. One of the things we are looking at is adaptive licensing - whether there can be more than one magic moment the sort of process that takes into account the body of evidence for drug develops over time as you get more experience with patients.

The idea here is that as more and more patients are exposed to a drug, we take that data and we use it to move forward the drug to the licensing process, all the way through to full licensing.

Harvey-Allchurch: Some people have said that perhaps this is represents a lowering of standards, making it somehow easier for industry to get drugs to market. I don’t think that is the case. I think it is in the interest of patients to potentially allow earlier access to medicines under controlled conditions.

It’s about how we identify a small group of patients who might benefit, and there’s a lot of work going around and biomarkers, and get these patients into randomized, controlled trials.

I think this is also part of the debate about repositioning regulators, not so much as gatekeepers under the old paradigm, but more as regulators as enablers in the health care chain. I think we also have to accept that regulators must evolve, that we have to work with the industry and payers. We’re not the only show in town anymore.

You asked about some of the other regulatory challenges. Well, I one challenge we have to accept is that there’s increasing pressure from politicians and patients. Margaret Hamburg famously said, when she was appointed FDA commissioner, that, “Regulators only have two speeds: too fast and too slow.”

I think sometimes we have to think how can we resist that sort of pressure, and how we can work better? Those are some of the challenges I think we have to look at.

LSL: So Martin, how does an annual meeting, such as DIA, help in overcoming these regulatory challenges that you’ve describing?

Harvey-Allchurch: The annual meeting, I think, is one of those privileged places where you can get industry, regulators and all the key players in the process to come together and talk about these issues. It is unique in that respect.

You get people not just from the U.S., not just from Canada, Latin South America, but from Asia, from Europe, from Africa, from around the world. We’re all facing the same problems, and the annual meeting is one of those places where we can all get together.

LSL: At this year’s annual meeting, what do you hope to learn that you think is going to help you in your day to day functions at the EMA?

Harvey-Allchurch: Where to start? A good place to start, actually, the DIA has a great app available, and you can use it to go through and identify the sessions you want. I’ve looked through and the things that I’m going to be visiting are sessions about ethics in clinical trials. I want to hear about the new FDA syncing of bio-similars.

There are some interesting sessions about biomarketers, personalized medicines and clinical trial disclosure, and one of the things I’m particularly interested in is drug development for special populations, such as pediatric medicines, orphan drugs and, interestingly for the first time this year, geriatric medicines.

Some would say that’s not a special population, but just the population. Of course, there are town halls from the FDA, the EMA, Japan, China, and other regulators. One of the things where I always learn the most, though, is just standing at the EMA booth. We have about 900 people come and talk to us there, and also, I like talking to people in the exhibition hall, going around to some of the other booths and listening to some of the vendors. There’s always a lot to learn, you just need to keep your eyes and your ears open.

LSL: That’s about all the time we have for today. I’m looking forward to attending DIA myself and meeting you in person, Martin. So, I’m just going to wrap this up. If you’d like to learn more about this year’s planned program, check out www.DIAhome.org, and I’d like to thank Martin for being with us today.

Harvey-Allchurch: It was a pleasure. I’ll see you in Philadelphia.

LSL: Thanks to everyone for listening to this Life Science Leader podcast. I’m Rob Wright, and we’ll see you next time on Life Science Leader, the industry’s essential business source.