Innovation "hindered by regulators"

CPHI Annual Report expert sees CDMOs as potentially a source of process innovation but warns both regulator and license holders need to move past regulatory diktats.

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) 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.

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, 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.

“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. But my fear is that we are still at least three years away from this,” 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, suppliers and CDMOs – 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 and industry should tackle process timelines, whilst safeguarding patients. The agenda will also explore new manufacturing approaches, such as, continuous processing and QbD.”

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.