Officionardos of Quality by Design (QbD) in Pharma should be moving their line of sight, at least initially, away from the compounds they are studying, on to those using the medicines they help develop and produce – healthcare professionals (HCPs).
Note, patients aren’t mentioned. When you are a passenger in an aircraft, you don’t feel you want to have helped with the development of it, you trust the manufacturer has consulted enough pilots. It could be the same in Pharma, with HCPs co-developing the medicines destined for market. Here is a simple diagram that explains the principle:
Disease treated holistically; prevention/diagnosis/therapy are inextricably linked.
If medicine is required, we need early engagement of a representative number of HCPs with deep knowledge of the indication (disease state)
Involve more stakeholders at concept stage.
Include payers, commercial manufacturing, suppliers, patient groups and charities (if relevant to VOC.)
Integrate the ‘discovery research’ and ‘development’ functions into a single design function, working closely with final product manufacture and supply.
Make prototyping an essential responsibility of design, to cut attrition rates, reduce time to market and significantly reduce testing in animals.
Plan supply chain architecture strategically, optimising quality, cost and speed to market, by striking alliances with key suppliers and other supply chain partners.
So, if you work in the field of QbD, try shaking hands with the HCP fraternity!
If you wish to learn more, you will find it in TAMING THE BIG PHARMA MONSTER
Published by Hedley Rees
Managing Director PharmaFlow Ltd, UK