In early October, CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, released the first section of its annual report, with forward looking article submissions from Piramal Enterprises, Fujifilm Diosynth Biotechnologies and Vision Consulting, examining the global implications of regulatory failure, single use technologies and the potential of antibody drug conjugates (ADC).
The outlook for the next few years is particularly optimistic for the ADCs market where Vijay Shah, Executive Director and Chief Operating Officer, Piramal Enterprises envisages increased global investments and even the arrival of a new blockbuster drug to treat solid tumours. However, beyond the traditional cancer uses of ADCs he also forecasts this class of therapeutics will provide indications such as inflammation, demonstrating that ADCs are on the cusp of being the great break-through that many analysts have predicted.
Unsurprisingly, in the short term the majority of ADCs will be for lymphoma treatment, but Investigational New Drug (IND) submissions for this class of drug will rise over 50 per cent in the next five years and ultimately the market will grow to $10 billion during the next 10 years. With such an increase in the prevalence of new targets, the report predicts that it’s really only a matter of time before we see ADCs providing therapeutic solutions to a range of conditions and this market is likely grow enormously over the next five, 10 and even 20 years.
“In the past a major failing with ADCs has been that cytotoxic agents were simply not active enough to kill the target cell with such a small amount of payload, o.o1 per cent, however, new technologies that improve antibody and antigen conjugation could hold the key to really unlocking their potential. Over the next 10 years we will see ADCs with much higher penetration rates,” said Shah.
Mark Carver, Senior Vice President of R&D and Innovation, Fujifilm Diosynth Biotechnologies warned however that unless we move towards a ‘health-based risk assessment’ approach to single use technologies innovation could be compromised- particularly for promising targets like ADCs that are often required to be manufactured in such facilities. The problem for biologics is that single use facilities are hugely increasing the costs of development and putting at risk promising targets that are deemed unviable before their true potential has been explored. With EMA guidelines likely to exacerbate this trend, many innovative targets are likely to struggle to make it into clinical trials.
The solution to this problem is health-based approaches, such that even when there is only partial data on early phase development work and the likely doses they will be used at to support full PDE and MACO (Maximum Allowable Carryover Calculation) values there is still sufficient information to produce appropriate banding to evaluate risk. The cost reductions and increase in innovation will help accelerate the development of new biologics product classes and its now up to the regulators to implement these changes into the way assessment are conducted that maintain safety without compromising innovation.
Similarly, Dilip Shah, Chief Executive Officer, Vision Consulting, has collectively examined the current regulatory environment and concludes that safety and compliance can be both increased by regulators simplifying and unifying their codes and working closer with industry. The problem, however, is that over the last few years and into the foreseeable future we are likely to see an increased number of deliberate infringements (FDA warning letters), particularly as analytical technologies increase. The resultant implication of these well publicised large pharma infringements is that there is a now a very real threat that increasingly restrictive regulations will prevent smaller more innovative players entering the market.
The answer Dilip Shah believes will ultimately lie in producing a more transparent process – and crucially one that is unified across the globe – whereby regulators take a more active role in working industry to evaluate procedures in a transparent and consultative manner.
However, for this new outcomes based approach to be successfully implemented, it would require global collaboration amongst regulators, which is still something Dilip Shah does not believe will happen for at least another 5-years.
EP News Bureau – Mumbai
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