Better together: Changing the conversation around digital transformation and regulatory

Q&A with Doug McKinnell, partner, Deloitte AG; and Dan Ressler, principal, Deloitte Consulting LLP

The pace of technological advancement in life sciences, including the emergence of new digital health products, is adding to the complexity and, in some cases, the uncertainty around regulatory expectations and requirements. It is also prompting life sciences companies and regulatory authorities—influenced by growing patient engagement—to identify new pathways to progress the product life cycle in today’s more agile, fast-moving digital health market.  

In episodes 3 and 4 of the Deloitte Tales of Transformation podcast series, excerpted below, Doug McKinnell and Dan Ressler discuss the potential impact of evolving industry regulations on life sciences digital transformation, and whether increasing consumer engagement in life sciences and health care will likely spill over into the regulatory environment.

Q: Doug, life sciences companies already operate in one of the world’s most regulated industries. How do you see the regulatory landscape evolving to keep up with the surge in digital innovation?

A: I spend quite a lot of time thinking about digital innovation as it applies to the traditional pharmaceutical business, and I think that it's poised for incredible disruption. For at least 10 years we have been talking about the paradigm shift from submitting license applications to regulatory [authorities] via huge dossiers to managing [the process] through electronic data submissions. We’ve also talked about controlled launches, where companies will give information very early to the authorities, who reward that with limited marketing for that product. With the introduction of disruptive, cognitive technologies, we're suddenly reaching tipping points where these things become far more tangible and far more real…setting in place all the prerequisites of a real shift to data and a new relationship between pharma and the authorities.

Q: Dan, consumer engagement in life sciences and health care continues to grow; everything from searching for and accessing new channels of care to tracking and sharing health data and using new digital tools and technologies. Could this increasing engagement directly influence the industry’s future regulatory direction?

A: I think patients will absolutely have a role in the regulatory landscape, both directly and indirectly. We've talked a lot about regulation and about the balance: It's about keeping patients safe but, I think, it will be increasingly about making sure that patients have the information to make the best decisions about their health and that we're bringing the best medicines to live long and healthy lives.

You're already seeing patients treating health care more as a benefit and needs-based decision like anything else we shop for. Patients go to multiple sources for information when developing their own perceptions and plan before they speak to a doctor. They're going to want more information, not less, and they'll want it to be right. How we're buying health care and medicine is already beginning to influence our regulations, although we don’t always recognize it.  

Also, consumers don't like to take no for an answer. There's a good amount, I think, of skepticism about whether government is behind the times [from a regulatory perspective]. That in and of itself will begin to have a dramatic impact on the regulatory environment.

Q: Doug, where do you see the influence of regulation as it relates to digital advancements with a patient-centered view?

A: I think patients are having a phenomenally profound impact on regulation in all kinds of ways; not necessarily deliberately, but just through voting with their feet as consumers. Patients do not behave as subjects who say, “Yes, doctor, you know best; I will do exactly as you advise me to do.” They are informed. They are empowered. They are proactive.

Q: Dan digital advancements can offer opportunities, for life sciences companies and regulatory agencies to improve current processes and many of the ways they work together. Are both groups prepared for the opportunity?

A: I think digital brings a huge opportunity for data and information, both rich and very much at scale. You're now looking at genomics, real-world evidence, access to large longitudinal public health databases—these are bringing life sciences companies new opportunities for discovery. Concurrently, digital capabilities that unlock insights should help regulators deliver on their mission of protecting the public health and ensuring that patients have access to the very best medicine.

The question is can digital help life sciences companies and regulators work better together through more transparency and communication? I think both are pretty actively involved in the digital wave. However, right now both sides are focusing very much on their own space to coordinate, communicate, and work better. Can they agree on what’s most important and marshal the right resources to accomplish that? I think that [alignment] is something that we're starting to see.

Continue the conversation with Dan and Doug in episodes 3 and 4 of Deloitte’s Tales of Transformation podcast series. Listen to all four episodes on how life sciences companies can move from doing digital to being digital.  

Any use of pronouns such as “we”, “us”, “our” throughout this podcast refers to the broader Life Sciences industry as whole and does not refer to any one person, project team, or work related specifically to Deloitte.

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