In a future issue of the print edition of Bio-IT World, the magazine will publish an exclusive interview with Joerg Reinhardt, head of pharma development at Novartis. Two questions seemed especially appropriate for eCliniqua readers, and we saved them exclusively for this newsletter.*
Novartis has an enviable track record of late: 13 new medical entities approved by the FDA from 2000-2005, which (as Novartis calculates such things) is exactly one new drug more than Lilly, Abbott, Schering-Plough, and Merck combined. Yes, combined.
In the interview, Reinhardt covers some ground that will be familiar to eCliniqua readers. That would be the story of how and why Sylva Collins led the Novartis effort to customize an open-source application for electronic data capture (EDC).
It’s no secret that Novartis felt that major EDC vendors were immature at the time it evaluated them several years ago – and that the prices asked were steep. For months, there have been rumors Novartis is reconsidering this approach, but we simply forgot to ask Reinhardt about them.
There is also new ground. Reinhardt notes that it is possible to make very rough calculations of the research dollars needed to bring a blockbuster to market. At Novartis, Reinhardt estimates, his colleagues expend a billion dollars to get a drug approved at the FDA. In the rest of the industry, the typical figure is roughly $3 billion. Please don’t tell the people at Tufts, who have their own estimate of the industry’s costs, or the shareholders of pharmas less productive than Novartis.
Reinhardt won’t itemize the savings, but he believes that the company’s use of EDC is one reason it is bringing drugs to market cheaper and faster. Since the EDC solution at Novartis is unique, it’s impossible to extrapolate whether other sponsors that rely heavily on EDC are likely to realize similar savings.
Here are Reinhardt’s answers to two questions that you will read exclusively here:
Q. Are you optimistic about clinical trial modeling and simulation?
A. From my personal perspective, this is a very important field that does not yet get enough emphasis and investment. We have very recently recruited a new leader for this field who is a very well known player in the industry. We as an industry don’t make, yet, enough use of the opportunity that that technology offers. You can only do that if you have buy-in from the regulatory authorities. We need much more work with the regulators to get us there. We do have discussions with the FDA and others. We want to intensify those dialogues, be it with the FDA or with the European regulators. If we don’t start to talk through options with the authorities – to debate the specifications of development work now – we will not be able to implement anything two to three years from now.
Q. Adaptive clinical trials might use data from EDC to make strategic, statistically valid decisions during a trial, not afterwards. Will Novartis use its own solution for adaptive designs?
A. We have very intense internal discussions on the use of adaptive designs. We have an interim program that we call Delphi, which is a program that looks at new ways of improving drug development. Adaptive designs play a very important part in that.
I agree with you. If you want to do adaptive designs, you need quick feedback from ongoing trials. EDC helps you there. If you have to wait weeks and months [for paper-based data], there is not much to adapt to.
If you talk about the combination of a Phase II and Phase III program, you need quick feedback from regulators in a timely manner in terms of whether your dose selection is right. I believe, again, in order to make adaptive programs a reality, especially at the interface of Phase II and III, it’s not only a technology, it’s also the regulatory buy-in that is needed.
From a technology perspective, I don’t think – given our history – that we would rely too much on commercially available systems. We do have excellent internal specialists on adaptive design principles that do already work on adaptation of our internal systems to apply these principles much more broadly than we have been doing in the past.
*This article was first published in Bio-IT World's eCliniqua newsletter. Sign up for a free subscription.