What have been the main highlights for Interbiome in 2023?

We are seeing market expansion. The US and other advanced economies have tremendous expertise in developing and producing new drugs, but we do not have fundamental expertise in developing reserve capacity for drug manufacturing and addressing unmet population health needs. Worldwide, we are spending more and more, for less health. These are not predominantly bioscience challenges. Rather, they are primarily unmet industrial engineering and policy challenges where there is a tremendous opportunity for businesspeople to take the lead. We have large and growing volumes of missing diagnostics and therapeutics that never even go through the pharma pipeline, not to mention the growing number of neglected products languishing in the development pipeline. These are products that are needed by populations but are neglected or abandoned by impatient investors because the profit margins are low or prolonged. The delayed, distributed costs to electorates of neglected, missing, and abandoned health products dwarf the entire volume of the pharmaceutical industry private profits. That is now a fundamental issue. It is past time to carve out a small part of the pharmaceutical industry as a virtual “Population Health Utility.” How is the unique Interbiome franchise model being received by the biopharma industry?

Awareness is just beginning. There is growing public as well as private awareness of the need to generate additional surge capacity since we still cannot make adequate volumes of novel drugs on demand when emergencies, disasters, or political squabbles impair existing production streams. Sustainable health resiliency is replacing industrial colonialism at an accelerated pace, domestically as well as internationally. The bigger the blockbuster drug market, the more critical it has become to have reserve production capacity, even in the commercial supply chain. Interbiome has partnered with innovative developers, builders, industrial engineers, and architects to define a novel franchise CMO approach. Domestically, that is extremely important for all aspects of reserve capacity, and it is even more important for emerging economies. This is why Interbiome is continuing to evolve our franchise model, for advanced economies. For developing countries around the world that do not want to suddenly run out of any product - whether aspirin, insulin, or critical drugs - due to the unreliability of international supply chains, we pitch our franchise model for the launch of a Sovereign Pharma industry.

So far, interested groups include governments and large pharma firms that might want a backup facility for their product, but they are mostly interested in building large, dedicated, single-purpose facilities. Other groups that are interested in this model domestically are the patient advocacy groups and institutions that are trying to help rare disease patients, rural communities, displaced populations and ethnic subgroups obtain access to unique, needed health products. What makes Maryland attractive as a life sciences hub?

Maryland is mostly attractive as a less expensive alternative to Boston, California, or the Research Triangle. Maryland has a rich supply of federal agencies with huge stocks of highly specialized research scientists. In addition, Maryland’s greatest asset is the world’s biggest concentration of experienced quality assurance and regulatory staff concentrated near the FDA headquarters. The perennial issue, however, is that the state is still limited by a very parochial political, business, and financial community. How do you assess the current state of the pharmaceutical industry?

There is a growing divide between the mission-oriented uses for inventions and the investment and policy communities. In the bio-pharma world, people are getting lost in molecular mechanisms, biomarkers, and platforms, and oftentimes are disconnected from the actual diseases targeted and the populations the methods are being developed for. There is growing demand for all industries and policy systems to become more mission-driven, and this can only be achieved by continuously rewiring our interaction patterns. For that we need better/faster/cheaper methods for re-mapping, re-modeling, and then re-wiring interaction patterns. Teamwork lags when the definition of team keeps changing at an accelerating pace. What are the key objectives for Interbiome in 2024?

We have settled on a base initial design from which we can scale up or scale-down given biologics-CMO franchises. Next, we will turn our attention to an analogous approach for small-molecule production, especially for the volume of many legacy abandoned drugs.