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Unconventional Partners, Like FDA, Can Drive Adoption of New Tech


Xconomy Boston — 

We’ve heard it time and again. Drug development is too expensive, takes too long, and many drug candidates that show promise in preclinical trials end up failing because testing methods don’t predict how they will work in humans.

Recently, new technologies have emerged that offer disruptive potential for steering the development of drugs in more precise, more predictable ways. These include artificial intelligence, gene editing, and Organs-on-Chips. And yet, this potential will only be realized if stakeholders from the entire drug development ecosystem collectively adopt and apply them to the complex drug development process.

A potentially disruptive technology won’t be disruptive if nobody uses it.

But adoption of a new technology in this field isn’t achieved simply by putting it in the hands of drug developers. Each stage of the development process is guided by intricate standards and established regulatory processes. Because of these conventions, it’s not possible to ‘push’ a new technology onto the industry. Adoption requires a ‘pull’ from stakeholders who see the value of a disruptive technology. And these stakeholders must come from across the continuum of drug development—from academic experts, to pharmaceutical companies, to clinicians, to regulators.

Let me offer some thoughts on how to foster this pull of disruptive technology, along with an insight from the high tech industry.

The Power of Collaboration

In drug development there is precedent for technology companies to establish collaborations with pharmaceutical companies. Indeed, these working relationships are essential to evaluating and advancing new approaches to developing drugs and putting new technologies in the hands of the industry’s power users.

But today tech developers need to look beyond pharma to include regulators like the FDA.

For example, as an industry we are observing how the gene-editing technology CRISPR-Cas9 is going through a series of steps to be approved for adoption by regulators. Last June, a federal biosafety and ethics panel unanimously approved the first study to use the technology in patients. FDA will next determine if an experimental drug using gene-editing can be tested in people.

In my view, FDA can be a key collaborator in the process of adopting a new technology that is creating a disruptive change in drug development. And consulting with the FDA early in the process and giving agency experts an opportunity to have first-hand experience with a technology can improve the approval process.

In the case of Organs-on-Chips—which feature tiny channels lined with human cells that recreate the environment of an organ—FDA and Emulate, the company I run, recently formed a collaborative research agreement through which the agency uses Organs-on-Chips technology in their own labs. The goal of the agreement is to qualify the use of the technology for toxicology testing to meet regulatory evaluation of products that include foods, dietary supplements, and cosmetics. If we meet our collective goals, this collaboration will lead to the development of safer foods, medicines, and consumer products.

Collaborating with FDA is part of working in an ecosystem to pull a new technology as we work to make the drug development process more efficient.

Mixing biotech with high tech

Collaborations are essential for adopting a new technology in the drug industry. But I also believe that as an industry we need to look to the high tech community and change the way we think about, manage, and integrate the data we create.

Waze is an excellent example of a tool that utilizes data created by a community of users for the common good. Waze isn’t simply a technology, but is a platform that has a community of users whose use of the platform instills additional value, and that value feeds back into the platform and increases its utility. Users of Waze provide valuable data about traffic patterns, road construction, and accidents back into the system. As more users provide more data, the system becomes even more accurate.

In considering the ways that large datasets can be used in drug development—with technologies such as AI and Organs-on-Chips—it is valuable to follow in the steps of high tech and take the approach of building a community of users. In this way, a standard baseline of the discoveries and insights from the new technology can be integrated back into the platform to create a foundation that benefits everyone who uses the technology. On top of this foundation, individual companies and organizations can then build their own proprietary discoveries and products.

Working together in a collaborative environment to create a more accurate and validated technology is the way that a disruptive technology can have impact on human health. In order to make a technology truly revolutionary in our field, we must rethink the way technology platforms are designed and share data to help achieve a shared vision. By adopting the concept of a platform that embodies the collective input of many stakeholders—where the users enrich and validate the system—we will learn and achieve much more together than we ever would apart.