24/7 BIOPHARMA - issue 1 / October 2024

CPHI REPORT

In this special CPHI Milan issue distributed at the event – where the industry is expected to turn out in record numbers with a staggering 62,000 pharma executives expected from more than 100 countries and 2,400 exhibitors – we grabbed a preview of the eagerly-anticipated CPHI Annual Report. In this exclusive article, Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates, a USP company, explores how data harmonisation is set to transform industry. The pharmaceutical industry has yet to fully realise the transformative potential of its most innovative tools despite unprecedented advances in science and technology. Artificial intelligence, organ on-a-chip technologies and advanced predictive modelling promise accelerated development of pharmaceuticals by simply performing key steps in the development process better. What motivates us is the cost of drug development that continues to rise. A recent study concluded that the average cost of developing a new therapeutic agent has nearly tripled in the 21st century, from $1.3 billion in 2003 to $3.4 billion in 2013 (adjusted to 2023 US dollars) 1 . Firstly, the

fact is that 90% of all drugs in development never make it to market 2 and secondly, the industry has been pursuing a fast-to-fail strategy for decades with meagre success. The potential for innovations lies in identifying safe and effective compounds, but regulatory, compliance and organisational barriers exist and full deployment may be years away. In the interim, an enhanced ability to understand a drug’s viability has value in combination with conventional tools and approaches in today’s drug development. Structured portfolio management for early development programs has often drifted toward art over science; however, applying innovation tools that bring insight into higher probability compounds could divert capital to lower risk programs that reduce the high costs that dog drug development. Ours is the only industry where the consumer assumes the product is both safe and effective. The pharmaceutical industry considers itself innovative, but much of the innovation is in discovery with drug development remaining risk averse as programs move to later clinical phases. This is a unique paradox, in part driven by the conservative The innovation paradox

77 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024