DIA18: CRISPR, AI, blockchain and the future of drug development
BOSTON — The Drug Information Association's annual conference wraps up Thursday, capping off a five-day whirlwind of demonstrations, panels and roundtables focused on drug development.
Around 7,000 attendees of the membership group of pharmas, CROs and other life sciences types hit the halls of Boston Convention and Exhibition Center. It's an uptick of around 1,000 from last year's headcount, reflective of just how much is going on, and changing, in the world of pharma, according to Sudip Parikh, senior vice president and managing director of DIA's Americas division.
This interview has been condensed and edited for clarity.
BIOPHARMA DIVE: What topics seemed to get a lot of attention at this year's conference?
Sudip Parikh: Right to Try certainly did, and part of that is just the timeliness of it. When we scheduled the conference, we actually didn't think it was going to be that big a deal because we didn't think there'd be any legislation. But when the president put in the State of the Union and it became law, suddenly a whole bunch of people in the industry thought "I guess I should go find out what this means for us." And so there's a lot of work for people who attend this meeting — medical affairs, the regulatory folks — so that was definitely oversubscribed.
Three years ago, if you had come to this meeting you would have seen maybe one session on real-world evidence, you'd have seen nothing on CRISPR, very little on regenerative medicine. There's much more of that in the content of this meeting.
You wouldn't have seen artificial intelligence anywhere across the content, this year it's everywhere.
One of things that we didn't even drive, it just happened, is patient centricity. That's just baked in now. We've got patients all over the place, and part of them came up through our fellowship program. We brought them in as collaborators and they've gotten much more sophisticated. And now they're full partners, they sit on panels, they help create the meeting.
If there are things that I thought would be important [but weren't], I think there are things that people have just sort of taken in and they're now part of what we do in this field. So, for example, some of the basics on project management. We don't need to teach that anymore. Some of the clinical data management like paperless trials; well yeah, that's where we want to go, we want to do that.
And I think that kind of thing really shows the progress that's been made over the past few years.
What's DIA NOW? How did that initiative come about?
Parikh: Novartis came to us and they said: Look, we want to scale the number of people that have access to [DIA's global platform] because we have global systems, global regulatory folks, global quality folks. They're in countries all around the world. We can't afford for everybody go to the meetings on these things, but we need them to have timely information. And we need them to follow a thread, like we don't need it to be a library of all the video from a meeting. What we need is: Can I get all the biosimilars stuff that you have from every meeting?
DIA has 60 meetings a year going on around the world, so every week there's more content being created, some in Japanese and some in Chinese. So how do you get that in a timely way into the hands of the right people at the right time?
We created a data platform that allows us to curate the content for Novartis or for whoever the client is, such that if you want to create a curated content path on biosimilars, you can do that from our publications, from our podcasts, from our conferences.
Our vision is that we're supposed to have impact on this field in terms of learning. Right now we do it for like 15,000 people a year. But this way we can scale that to 100,000 people a year.
There's been a lot of talk here about finding and creating solutions, but what are some questions we still don't have answers to as the conference comes to a close?
I would start with the whole patient centricity question. Are we actually doing anything that's patient-centric? Are we actually doing anything different than we used to?
A second question is have we actually created the regulatory pathways for these new technologies, these new products. And when I say new technologies here, I'm talking to the life science technologies for CRISPR, for regenerative medicine. Do we have an answer for that yet? I don't think we do.
I think it's gonna take the trailblazers to sort of try and go through the process, and the only thing I worry about is when the first trailblazer fails, I hope it doesn't taint entire technologies because the hype gets so high.
What topics or issues do you think the pharmas, payers and regulators who came to DIA are now heading home to tackle?
Parikh: There's a few they actually all share, or they should share.
Getting back to ... regenerative medicine, there's some groundwork that has to be done. When the first CAR-T was approved, one of the things that really troubled me was that people were surprised by the price. People in that patient community were surprised by the price when there, in theory, had been patient-centric work going on. I don't have the answers for drug pricing, but there at least needs to be some storytelling going on here that says, because of the way we do this, the way we administer it, the technology that has to go into it, it's going to be expensive.
Or we have to figure out a new model so that people can start ... working to talk the patients, to talk to the insurers ahead of time from the pharmaceutical side. You're going to see this with them, with CRISPR Therapeutics or Editas or whoever makes it to the finish line first.
It's going to cost a lot of money to take cells out of a person, do gene editing and put them back. We need to have that conversation today so that when it actually happens, we're not spending the first year of the technology being available haggling about the price or trying to figure out what the HTAs are going to say in Europe. We need to do that in parallel.
The other piece is on these technologies, these blockchains and AIs. I think there's three things that have to happen.
The technology has to continue to advance, but then the regulators have to be ready for not where it is today, but where it's going to be — and then the market has to be ready to scale it. My worry is that if all three don't advance at the same time, the technology can be ready but the regulators aren't ready to figure out how to validate it, to figure out how to improve it.
I feel really good because I think this FDA is as proactive as any FDA I've ever seen. I keep saying this is not your father's FDA. Right now you can't throw a rock without hitting a regulator at a meeting, and I think that's really good.
Then the third piece is the providers, our CROs and our IT vendors, they've got to be looking at how they can pair up early with the academics and the regulators so that as soon as there's an opportunity to incorporate one of these things into a regulated industry, they're ready to scale.
We've talked about the stakeholders, but what work does DIA have ahead?
Parikh: We constantly are taking the input from these meetings and saying, "What has to come next?"
For example, some of the input we got is master protocols need to move out of the oncology world and move into pediatrics, move into rare diseases and other spaces where it's gonna be hard to recruit. Master protocols may be a solution. So we're going to put together the small conversations that sort of catalyze the bigger meetings that we do and drive that conversation forward.
A second piece is we're going to continue to work on DIA NOW. When you democratize information it creates a lot of power, because it makes it where more people are able to make a decision in an organization — and when you do that, decision-making goes faster.
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