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Drug Commercialization and the Case For and Against Silos

Silos of Drug CommercializationThe FDA is challenging the structure of academia and corporate entities that date back over one thousand years. They are tearing at the foundations of these organizational entities devoted to drug commercialization in order to promote better, safer treatments for acute and chronic disease. The shorthand reference we recognize with respect to organizations within organizations is the term “silos”.

Growing up in Indiana, silos were part of the landscape, noticed as soon as you left any city. Indeed, the grain elevator (a collection of silos) was, and still is, the centerpiece of many small Indiana towns. Silos preserved the integrity of the corn and beans stored inside as they awaited shipment to market. Maintaining the separation is a good thing for agricultural products. Each product has an ideal storage condition and the separation is valued when customers order and expect uniform products.

The concept of silos has been adapted and applied to a number of human endeavors throughout history. The purpose was to maintain purity and integrity. Convents and monasteries served the purpose of isolating and at the same time nurturing the advancement of knowledge since the third century. Later, colleges and universities evolved from the same model. At the time, this concentration of talent and single purpose was seen as the only way to advance the stated goal of the organization. As industry evolved, a separation of labor (into silos) was found to foster efficiencies that previous organizational models could not attain.

The organizational silos that exist in pharmaceutical development at one time helped focus and speed drug development. With the advent of large molecular structures that can cure or control disease states that were previously untreatable, the silo organization is clearly at a disadvantage in commercial drug development. As more companies embrace an outsource model, the existence of silos have slowed the pace of tech transfer.

Don’t get me wrong; the silos will continue to serve the original purpose when applied to fields of basic research. It is at the development/commercialization interface where broken silos will benefit the entire organization. Most large organizations bring individuals together to write the BLA/NDA filing. It is not enough to form a team of silo representatives after the work is all but completed, but it is a start.

The drug commercialization team of the future may consist of a critical mass of individuals with mastery not only of their core function, but who also have a working understanding of at least two other functions within the team. Data sought by the FDA is gently forcing the innovator companies to break the silos. There is more of a patient-centric focus that will compel the companies to apply an “end in mind” strategy during earlier stages of drug development.

Re-thinking the silo structure will accelerate the commercialization of therapies and allow leverage of resources that may be outside of the formal organization to embrace academics, specialized consultants and contract service providers.

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Paul Harber
After a 30-year career with Eli Lilly and Company, Paul became a founding member of Modality Solutions LLC and is now engaged in assisting companies that seek to establish and improve internal methods, practices to meet regulatory requirements related to distribution of high risk-high value drug substance, drug product and devices. Modality Solutions LLC is an alliance partner with BioConvergence and operates a transport simulation laboratory located on site.