Drug development is evolving quicker than some might expect from a historically slow-to-change industry.
Big pharmas, many of which built their business on small molecules and then biologics, are now pouring billions of dollars into fields like gene therapy. Contract service providers, while still running clinical trials, are expanding their business both in size and scope. And regulators, traditionally shut off from industry, are now opening up to collaboration.
The new model comes with growing pains, however. Barbara Kunz, global chief executive of the Drug Information Association, noted there are still strides that need to be made in clinical trials — especially with regard to making them more reflective of and helpful to patient needs.
BioPharma Dive spoke with Kunz near the end of DIA’s annual meeting to recap the biggest takeaways, successes and areas for improvement from this year’s conference.
This interview has been lightly edited and condensed for clarity.
BIOPHARMA DIVE: As DIA winds down, what themes are you taking away from the conference?
Kunz: Oh my gosh, so many. How much time do you have?
We are in the era of dramatic transformational change in health, both in product development but also at the system level with the way those products are regulated, the way those products are being discovered and developed, the integration of patients into their healthcare, and the value frameworks on the market access side of healthcare.
That’s the big, world-is-changing view. When you double click to see what’s going on in there, people are really jazzed about the whole evolution of data — that digitization of healthcare and the ability to use data all the way from early discovery to in-use, including EHR [electronic health record] data. This is just an enormous theme, and really fertile because everyone’s imagining now what could be done with it.
Another big theme is around the patient engagement in their healthcare. Where providers used to think of patient centricity as, “This feels like the right thing to do,” it is now very much on the radar screen and in active integration into everything health. But it’s still complicated.
BIOPHARMA DIVE: If you could think of one word that’s on everyone’s lips at DIA this year, what would it be?
KUNZ: Digital and patient. Those are the two words I’m hearing most.
They’re kind of the same, because people know that to get patients involved, you need to figure out how to give them information and get their information in a way that they don’t have to get in the car and sit in somebody’s office for hours.
We also kicked off the conference with a really interesting discussion around data privacy. Who owns the data? Who can profit from patients’ data? Do people really not understand the value of patient’s data?
And the answer to that is probably not. They probably do have some level of understanding … but all of that is really on the precipice. I feel like it’s a bolus of things that are coming in.
BIOPHARMA DIVE: We heard a lot throughout the conference about artificial intelligence, big data, blockchain, machine learning. Are we past the point where these are just buzzwords and to where they’re actually being integrated?
KUNZ: I think we’re at the starting point of that.
What you’re finding is that people are now experimenting with various opportunities and we have some early results where AI is being used for, say, label expansions. You’re finding these technologies are no longer this big scary thing people can’t think about conceptually. People now are getting it and are starting to work collaboratively with some of the new or big technology companies.
I do think if there’s a curve, there’s a pretty big mountain that we’ll be climbing. Some of the early successes will seem trivial a year from now.
BIOPHARMA DIVE: Something we noticed on the exhibition floor were a bunch of niche contract research organizations offering specific clinical trial services. From your perspective, where do clinical trials need to go in order to be more efficient?
KUNZ: You look at the economics of drug development and you look at how much is spent in every phase. It’s all expensive. The price tags are astronomical.
Anything you can do to make all the processes inherent or more efficient — and to use data to get the outcomes more quickly — that’s going to totally disrupt the system. You’ll see the end-to-end players really experimenting across the system.
BIOPHARMA DIVE: And do you think an end-to-end approach will make clinical trials more equitable and representative?
KUNZ: I absolutely do. Most of the time you’re a victim of your circumstance. If you’re sitting in a part of the world where you have access to some level of health care, good or bad or none, you take what’s available to you.
But when everything’s digitized … you can at least go into a portal, perhaps in an ideal state, and say, “Well, I just found out I have this illness, let me go on there and read a little bit about how I might deal with it.”
[You could find out] if the preventative measures are things you can do that are simple. Or, if it’s this very significant health challenge, where are the best places to get involved in a therapeutic regimen or a clinical trial?
BIOPHARMA DIVE: Speaking of therapeutics, what part of drug development do you see as the most in need of change right now and why?
KUNZ: I think really the clinical trial part. It’s not only the one that is most expensive, it’s the one patients find most confounding.
If you look at how some of them are being delivered today, you have a patient community that has to kind of morph themselves to accommodate a system that’s relatively unsympathetic and inefficient. I would say that would probably be the place for the most significant impact quickest. But I also think a lot of progress is being made in this front.
BIOPHARMA DIVE: Some would argue pharma is an industry slow to change. How much pressure is the industry under to adopt new technologies? If drugmakers aren’t adapting fast enough, how can they?
KUNZ: I don’t know that I would say pharma is the only industry that’s slow to adapt. I think we are rightly a relatively conservative, risk-averse ecosystem in health. There are a lot of consequences to decisions people are making today.
For some of the new technologies that are coming out of pharma, you’re seeing incredible ability to adapt to new ways of thinking. To new therapeutic models, to the integration of diagnostic and device technology, to the development of chief data officers that are really looking at data integration of EHRs into their data systems.
Other highly regulated systems in the world have adapted. People aren’t necessarily moving slow intentionally, but there’s a risk-benefit aspect to every part of the healthcare system that we have to take into account.
Date: July 02, 2019
Source: Biopharma Dive