What makes Interbiome’s CMO model unique?

We started with a systemic point of view, and we entered the CMO business with the thought of utilizing a CMO facility in the best way to best serve the NIH, the FDA, and patients. That led us to several conclusions about the many opportunities to use CMOs in more ways than only a commercial business, by overlapping the nexus of both policy and business. Markets run autonomously when there is stability but are very dependent on policy changes. We are at a time when we see huge changes in the industry. In the past 20 years, the US outsourced much of its pharmaceutical capacity to Asia, and we are now seeing this trend reverse. In the past decades, we also had the reemergence of gene therapy licensing. Now it is increasingly possible to do genetic profiling and provide individualized medicines. These factors are turning the CMO industry upside down.

The bottom line is that despite all the recent pharmaceutical innovations, the health of the median US citizen has declined in the past 30 years. This leads to opportunities to look at neglected niches in drug manufacturing. We see a need to get into the foundational stages of small-scale drug manufacturing of both neglected and abandoned, yet still needed, drugs, which calls for the creation of a new CMO business focused on affordable sustainability. We need to transition a small portion of the industry to the equivalent of a nationwide, commodity utility model. To start, we have plans to create two specialty manufacturing facilities within Maryland. Multiple US agencies are interested in having our utility approach distributed across the country, for resiliency.

Must innovation be managed to improve median health?

We need multidisciplinary feedback to select net innovation from unproductive churn. This is where reviewing a broader range of data has helped. Health = Baseline minus Damage plus Repair. If we do not maintain basic health, repair costs aren’t sustainable, and uncoordinated innovation becomes a threat to human health. A purely market-driven life sciences industry inevitably becomes a health repair industry that eventually forces us to think about what we can do better. Historically, biology involves more than 80% avoidance behavior and prevention, and less than 20% repair.

I expect the industry to move towards prophylactics in the coming years. We have known about Type-1 Diabetes for nearly 100 years, yet today we are approaching 90% Type-2 Diabetics, which is nearly completely preventable. Yet the focus of reimbursement policy is to repair rather than avoiding Type 2 Diabetes. That is an unproductive approach. The increasing incidence of NASH is another example that is almost entirely preventable, yet we are not interacting and coordinating enough to approach that task productively. No matter how many drugs we invent to repair NASH, the impact will be overwhelmed by the food and beverage industry - unless other policies change. I think sweeping changes in the role of the life sciences (and other) industries in population health will gradually occur. Today, too much of pharmaceutical innovation is necessary but not sufficient, and prone to unproductive patterns of investment.

Why will your model be a success in the future?

Beyond the changing role of drug manufacturing on population health, we are seeing continuous changes in the intersection of business and policy. Two topics come up repeatedly: all countries need to sustain both a minimal capacity and a minimal workforce so that the two together can help manage national and regional resilience, not just transient profits. Interbiome has no illusions about solving all the problems we mentioned, yet we see the need for a foundation or reserve level of drug-manufacturing capability that can survive and re-expand faster after a downturn. Every country in the world needs such a model – there is no reason why any country should be without critical pharmaceutical commodities. We want to pioneer a commodity utility approach for needed areas of pharmaceutical manufacturing and make that available as a sustainable platform that any country can start with and innovate from.