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by Ingmar de Gooijer | 15 Jun 2018

Drug development needs to change. The younger generation gets it, how about you?

Imagine a world where physicians and their patients with no treatment options have timely access to promising drugs in development

When discussing the current drug development and market access model with university students we usually get the same surprised reactions: “Is this for real? Why has the model not evolved with the advances in science and technology? Are healthcare insurers really denying care because the prices of some treatments are too high?”

 

But perhaps more striking is their reasoning that when it comes down to their own health they will not accept a system that prevents them accessing the treatment they need. They indicate that they’re willing to support initiatives that improve the current model and view technology as a key enabler.

 

The good news is that we’re seeing various developments and trends coming together that are offering new opportunities to physicians, drug manufacturers, regulators and payers that will greatly benefit patients. Especially those with unmet needs.

 

A flourishing ecosystem of competing organizations developing affordable healthcare innovations

 

Imagine a world where physicians and their patients with no treatment options have timely access to promising drugs in development (those that successfully completed Phase I safety trials and one or more Phase II trials demonstrating continued safety and initial efficacy). Where the treatment results are captured in a public database accessible to researchers, and where manufacturers are paid according to the real-world performance of their drug. Where there is a flourishing ecosystem of competing organizations developing affordable healthcare innovations.

 

It’s possible and students already get it, which could be viewed as a wakeup call for those players sitting reluctantly on the fence. Change seems to be coming sooner rather than later.

 

You don’t need to take my word for it. Just listen to FDA Commissioner Gottlieb explaining that they have already leveraged the use of real-world data to reduce the time and cost of clinical evidence development. Have a read in Forbes magazine about the shortcomings of randomized controlled trials and the potential of real-world evidence. Or the Economist mentioning that the demand for ever-larger clinical trials of new drugs has done little for safety, has raised costs and rewarded chiefly the very largest companies that can afford to run them.

 

Frontrunners within the pharma industry agree that their current business model is broken

 

Frontrunners within the pharma industry agree that their current business model is broken and that they are on the brink of terminal decline if nothing changes. The crystal clear analysis on the return of investment of R&D by industry veteran Kelvin Stott in Endpoints tells it all. Needless to mention is the overwhelming coverage on the (unfair) high prices of drugs, even in the most reputable research journals such as Nature Reviews.

 

Most importantly, patients are taking positions on the topic and demanding change, as covered by the NYT already in 2016. Having been silent on the topic of drug pricing for quite some time there is a growing understanding of the relationship between a drug’s price and access.

 

So where do we go from here and what’s myTomorrows’ role in it all?

 

 

Internet is famous for taking away the asymmetry of information and creating new business models. As in the music, travel or retail industry with Spotify, Booking.com and Amazon, we believe it’s about to happen in drug development sector.

Our contribution to a new drug development model is a straightforward approach, which has been described as innovative because it combines existing technologies (internet, big data and artificial intelligence capabilities) with existing regulations (compassionate use / early access laws).

 

Physicians and patients with unmet needs have access to information and drugs in development

 

What we’ve done is develop a digital healthcare platform that works as a 2-sided marketplace where physicians and patients with unmet needs have access to information (all ongoing clinical trials and early access programs around the globe) and drugs in development. We’re in the process of capturing the effectiveness (real world) data of patients being treated and making it publicly available. With payors (governments and/or healthcare insurers) we will agree on the price setting of the drug before and after approval based on various outcome data. This approach encourages innovation, shortens the drug development timelines and increases competition, which is the only sustainable approach to lowering drug prices.

 

The younger generation supports this approach, how about you?