What Patients Need to Know about Pharmaceutical Supply Chains—Chapter 5

Everything a critcal thinker needs to know about the supply chains for SARS-CoV-2 injections—packed with facts and evidence that can't be refuted.

PRODUCT DEVELOPMENT AND SUPPLY CHAINS

Pharma doesn’t follow other industries.

In most industries, supply chains are created as part of a new product development program. The developers work together, consulting product end-users, producers, and distributors to ensure the physical supply chain they put together can deliver what is required by consumers. For reasons we shall go into later, pharmaceutical new product development does not follow the customary approach of other industries. Rather than beginning with a consumer and working upstream to the beginning, the process begins with a patented compound and moves forwards. This results in supply chains ‘evolving’ with the passage of time, rather being designed and planned with the consumer in mind. This is how it works, taking the most straight forward example of small molecule products. The ‘R’ of R&D (Discovery Research) discovers (or finds) molecules using advanced technologies such as molecular modelling. Once it is confirmed a patent is in place, promising compounds are handed to ‘D’ (Development). Development is a completely new team of specialists responsible for building a supply chain for pre-clinical testing initially. That means proving the test compound that will be produced by the supply chain is safe to study in humans. Supply chain for preclinical testing For small molecule products, around 5 – 10 kilograms of compound will be produced.

Figure 5 shows a typical small molecule supply chain