Disruptive Innovation and the Future of the Drug Lifecycle

Paul Howard, Senior Fellow and Director of the Manhattan Institute’s Center for Medical Progress, offers his perspective on disruptive innovation as its being discussed in San Diego for #PhRMA13. To learn more, tune in to the live stream now.

I’m at the PhRMA 2013 Annual Meeting in San Diego, where a panel is discussing disruptive innovation and the new challenges and opportunities it opens for the biopharmaceutical industry. It’s a great topic.

Medicines have always been disruptive innovations. Take the polio vaccine, which helped eradicate polio in the U.S., and also made polio wards and iron lungs obsolete virtually overnight. Or look at how anti-retroviral drugs have transformed AIDS from a deadly illness into a manageable chronic disease. Ideally, new drugs displace other less effective or more expensive technologies by allowing physicians to manage, treat, and even prevent illnesses before they become debilitating or deadly.

Still, we’re just scratching the surface of how new technologies – like genomics, proteomics, gene therapy, nanotechnology, and “Big Data”-driven predictive analytics – will revolutionize health care in the coming years. As Eric Topol noted in his recent book, emerging medical technologies will be very disruptive to old ways of practicing medicine, and unleash a (much needed) wave of “creative destruction” across the U.S. health care system.

That’s about to be just as true for the biopharmaceutical industry.

When we think about the lifecycle for biopharmaceutical medicines, we think of research and development, FDA approval and manufacturing medicines as a “one way” pipeline that makes new products available to patients. Industry tests and develops the medicines under FDA regulations, and then the FDA is responsible for the review and approval of new medicines, assessing their safety and efficacy.

But, thanks to some of those emerging “disruptive” new technologies I mentioned earlier, we have an opportunity to look at the drug lifecycle as more than just a linear process culminating with FDA approval.

New technologies should allow us to start the lifecycle for a new medicine by pinpointing specific patient needs, beginning with how a patient’s own molecular profile can determine the best treatment for them (and for other patients who share a similar molecular profile). Molecular medicine will break down the invisible walls between clinical trials and real world outcomes, accelerating innovation cycles.

Researchers have always tried to keep the patient in mind when developing new treatments, but new social media tools also allow patients to enter into a more collaborative dialogue with regulators and industry.

What is it about a potential new treatment that patients would value most? Is it increased productivity and the ability to enjoy everyday activities? What side effects are they willing to tolerate for a given sent of benefits? How do patient’’s treatment preferences and tolerance for risk change with disease progression – say late stage versus early stage cancers? How can we get more patients involved in clinical trials?

These are questions patients, regulators, and industry should join together to discuss as early as possible in the R&D process. Asking them at the beginning of the process may change the way a treatment is developed and valued as the drug moves toward regulatory review.

Disruptive innovation for the industry is not only going to mean operating more collaboratively with other stakeholders and regulators in pre-competitive forums. It’s also going to mean thinking creatively about how new therapies can help to “bend the curve” of health care costs, empower patients and physicians to make smarter treatment decisions, and reduce the burden of disease on patients and caregivers.

The biopharmaceutical industry has always been in the better health business. But the unique position of the industry – at the cutting edge of molecular medicine and new digital tools – has the potential to advance medical breakthroughs that “disrupt” the entire sector, benefitting patients, payers and physicians.
If this sounds interesting and you would like to learn about disruptive innovations in the industry, tune in now to PhRMA.org to watch the annual meeting now.

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