You may ask yourself, what is Condorcet’s Paradox and how might it apply to pharmaceutical distribution? First, a background on the paradox: Condorcet was an 18th century French mathematician. He looked at the effect that three equal voting blocks had on the outcome of elections. The best way to visualize his paradox is with the following Soviet era joke:
God comes to Moscow in 1930 and says to the people: “I will give each of you a choice of three blessings in life, but you can only have two out of the three. You can be an honest person, you can be a smart person, or you can be a member of the Communist Party. If you are smart and honest, then you cannot be a communist. If you are a smart communist, then you cannot be honest. And if you are an honest communist, then obviously, you must not be very smart.”1
An extensive treatment of this paradox is available on the web. The point of mentioning it here is to highlight the immobilizing effect it can have when it occurs within the context of pharmaceutical commercialization.
The typical “trilemma” follows:
- The product requires strict 2-8°C or 20-25°C storage conditions.
- The cost of the protective packaging cannot exceed $2 per unit dose shipped.
- The logistics cannot deliver the product in less than three days.
In some companies, this trilemma repeats itself with the introduction of every product. It pits the areas of development against those of regulatory, against the operations components of the company. There is no way out of the trilemma unless a tech transfer strategy can be established from late stage development to commercialization. It requires that one of the three positions support one of the other two in order to resolve the trilemma. It does not necessarily mean that the same resolution be applied to all projects.
- Thermally sensitive product may indeed require strict adherence to storage conditions.
- Acceptable product margins may be eroded with high-cost packaging.
- Supply chain logistics may require an extended time to clear import/export.
How these competing requirements can be resolved is something that should be facilitated with early discussions, specifically looking at Phase IIb as the ideal time to identify a scalable commercialization strategy.
Sources
Formed in 2011, Modality Solutions immediately began the design and construction of a Transport Simulation Laboratory. This laboratory employs a custom interface to expose a variety of pharmaceutical products to rigors of the transport environment in a controlled setting. The samples in the lab can literally experience transport around the world without leaving the controlled setting of the facility at BioConvergence. In addition, Modality offers a wide range of consulting capabilities. From leading the RFQ process for clients wanting to implement compliant passive packaging systems, to qualifying critical active and passive systems, Modality provides specific and targeted capabilities to complement their clients’ in-house staff. www.modality-solutions.com.
