Amsterdam, 23rd August 2018: CPhI Worldwide the world’s largest pharma event – taking place in Madrid October (9-11) and organized by UBM (part of Informa plc) – releases the first part of its 6th Annual Report with a stark warning from Girish Malhotra, President of EPCOT International, that regulators are holding back the industry’s ability to innovate.
The report’s findings foresee regulators inducing ‘innovation inertia’ without a change of philosophy, but encouragingly – for contract service providers at ICSE – predict CDMOs can potentially form a key part of the solution, as they have strong economic incentives to innovate process and manufacturing improvements.
“The problem we have presently is that for manufacturing technology innovations to be successfulpharma companies (brand and generics) need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators – in particular the FDA – are still dictating approaches to industry without asking what the commercial justifications are to support them,” added Malhotra.
Analyzing the negative impact, Malhotra argues that if regulators do not stop dictating approaches, valuable process advances could potentially be lost. In his view, the cGMP practice guidelines essentially force a ‘cultural dogma’ in pharma companies, where their main aim is to meet regulations rather than to encourage to innovate. He also questions whether these recommendations are being introduced by people that have ‘hands on’ experience in process development, design, commercialization and/or operation of pharmaceutical plants.
The report highlights that for pharmaceutical companies with patented products there is little incentive to innovate due to the short patent life after new drug discovery, ability to secure their demanded selling price and long approval times. However, Malhotra has suggested that by shortening approval times, companies will be incentivized to innovate, compete on a cost and quality basis, and allow them to capture a bigger market. Under his guidelines, not only would drug affordability improve, but drug shortages could also decrease, aligning with the manufacturing philosophy of maximizing profits, whilst retaining product quality and safety.
Most promisingly, Malhotra suggests that with contract services increasing globally, and a little adjustment to the approval process, we could potentially create an entire sector innovating for its pharma customers and driving efficient manufacturing process. A new golden era of innovation and drug affordability.
The full findings of the CPhI Annual Report will include more than 10 in-depth expert contributions as well as the CPhI manufacturing and bio leagues tables, which will be released on the first day of the event.
