Girish Malhotra sees CDMOs as potentially a source of process innovation but warns both regulator and license holders need to move past regulatory diktats
CPhI Worldwide taking place in Madrid from October 9-11 and organised by UBM (part of Informa plc) – releases the first part of its sixth 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 successful pharma companies (brand and generics) it needs 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.
Analysing 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, commercialisation and/or operation of pharmaceutical plants.
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.
“Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation,” concluded Malhotra.
Tara Dougal, Head of content, Pharma at UBM, added, “This report highlights a number of important long-term issues for the industry and pharma manufacturers, whose efforts to innovate in process development and formulation are often reported to be hampered by long regulatory pathways. It’s also why we have a number of experts presenting at CPhI this year to discuss how the regulators should tackle process timelines, whilst safeguarding patients.”
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.