Yesterday, an FDA panel started writing the first chapter in the new novel of modern medicine. With a unanimous recommendation for Novartis’ CAR-T gene therapy, this is the clearest indication that the FDA is not only ready for but supportive of the age of personalized medicine.

The personalization of medicine is a concept that goes back to the early 1960s but only in the past decade have we reached a point where we have the understanding, means, and resources to achieve it. Even now, with this monumental breakthrough, we’re only scratching the surface of the potential therapeutic applications. But as anyone familiar with Gartner’s Hype Cycle concept knows, we’re likely approaching the Peak of Inflated Expectations. With any breakthrough innovation, there is a period where the excitement of the potential applications outweighs the realistic possibilities – these treatments will certainly prolong and save lives beyond our current capabilities but they can’t fix everything.

The implications of the FDA’s approval are enormous. It’s nearly impossible to say with certainty how this will impact all aspects of your business but there are absolutely considerations that drug manufacturers can keep in mind as we navigate the new era, chiefly in supply chain and quality.

A Personal Supply Chain for Personal Treatment? 

As with any drug manufacturer’s supply chain, the ability to move product safely and quickly is paramount. With personalized medicine, however, the stakes are a bit higher as the production cycle now starts and ends with the patient.

As manufacturing personalized medicine requires live cells, proximity and travel time will be critical factors in the managing the process effectively. Drug makers need to assess their current manufacturing locations. Are they strategically placed to serve the greatest percentage of the population? Furthermore, given the relatively small and dispersed population of patients in most disease states, how can you make this both cost-effective and feasible for your current operational structure? Carefully analyzing capacity, patient population density, and physician availability will better inform where you position manufacturing operations.

Personalized medicine will also shift the way manufacturers manage demand. To navigate the new dynamics of the supply chain, drug makers will need to start small. Understanding at the micro level how to manage demand for a targeted patient population lays the foundation to apply those principles at the macro level for more common and widespread disease states.

The Quality Implications

From the first mention of personalized medicine, the industry’s well-documented focus to quality controls, metrics, and processes was the first objection, and with good cause. How can we set precise standards and controls around a drug that by definition is variable from patient to patient? In this respect, demonstrating control around the factors that are not variable will be critical to success.

With such a high degree of specificity, processes like adverse event tracking are even more complex. When each treatment is unique to each patient, how do we truly define what is a side effect for one vs. a side effect for many? Pharmacovigilance, an already intricate practice, will require a concentrated focus on the pieces you actually can control, i.e. the processes behind the drug development and production. Root-cause analysis as a part of pharmacovigilance will need to go much deeper to account for the individualized nature of each drug, and partnering with the providers will be critical to understanding root-cause.

In an industry that already manages a tsunami of data, personalized medicine will add more data and more stakeholders to the process. The privacy and safety of protected health information is even more critical as pharma will require information down to the individual genetic code. Establishing a baseline operational structure of managing data effectively will mitigate the risk of potential breaches.

What Now?

In an age where the patient is king, personalized medicine is the ultimate representation of that ideal. It’s not just that the patient receives a drug specifically tailored to their genome, the underlying process behind the treatment requires a collaborative effort. As the process is time-sensitive and incredibly complex, multiple stakeholders in the patient’s sphere of care – geneticists, physicians, pharma – will need to carefully coordinate treatment to drive real outcomes for the patient.

Supply chain and quality are just two small pieces of the puzzle but as we move forward, there will be new challenges and opportunities across your business. Reimbursement policies, intellectual property, and physician education and collaboration are just a few areas that will also require attention in the near future. Regardless of the business challenges – what remains is a new treatment that is likely going to permanently alter the future of the industry.

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