This is the view of Biotech PharmaFlow’s Hedley Rees who told in-Pharmatechnologist.com the pharmaceutical industry's separation of research and development functions is part of the problem.
“We have a group of people who find, discover and patent candidate molecules who hand it over to another group of scientists responsible for developing it, who have a need to prove safety and efficacy as quickly as they possible can.
This need means the drug industry often takes less time at the development-stage than other sectors, the result of which, Rees said, can be seen in recent US GAO data which show that only one in 250 preclinical candidates reach the market.
Design and manufacturing
Instead Rees proposes a broad two-stage model where research and development are combined into a single unit that properly tests drug prototypes and a manufacturing-step which tests these prototypes.
“There is a huge reversal of powerbase there that would be difficult for the [drug] industry to understand and take up, but there is no other sector in the world that actually puts commercial manufacturing so low on their priority agenda.”
He also believes that the two-stage approach would encourage the use of QbD and PAT at a much earlier stage because both would be needed to fully characterise the drug prototypes during the design phase.
“We could remove many of the issues of poor solubility, stability limitation, inappropriate material specifications and weak analytical methods before they are locked into the filing.
This would allow the manufacture unit to focus on fewer, more viable molecules, and the implementation of modern production methods to raise quality levels from the 2.5 sigma that is generally accepted to the 6 sigma levels seen in other industries.
Rees admitted that such a change in mindset may be difficult for a drug industry sceptical about spending money on early-stage drug candidates that may fail, but cautioned that not changing will mean the “painful hit and miss” pattern of late-stage disappointments will continue.
Share your thoughts
Rees and colleagues discuss this and other issues impacting the pharmaceutical manufacturing sector in two groups on LinkedIn: Friends of Improvement in Pharma Supply-chains (FIPS) andFriends OF Modernization in the Drug Industry