CPhI Worldwide and CPhI Pharma Evolution have released the first part of its annual report, which examines the global implications of regulatory failure, single-use technologies, and the potential of antibody drug conjugates (ADC).
The report features article submissions from Piramal Enterprises, Fujifilm Diosynth Biotechnologies. and Vision Consulting.
The outlook for the next few years is optimistic for the ADCs market, according to Piramal Enterprises Executive Director and COO Vijay Shah. He predicts increased global investments, the arrival of a new blockbuster drug to treat solid tumors and expects this class of therapeutics to extend to other indications such as inflammation.
Fujifilm Diosynth Biotechnologies Senior Vice President of R&D and Innovation, Mark Carver 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 increasing the costs of development and putting at risk promising targets that are deemed unviable before their true potential has been explored.
Vision Consulting CEO, Dilip Shah, after examining the current regulatory environment, concludes that safety and compliance can be both increased by regulators simplifying and unifying their codes and working closer with industry. However, he anticipates an increased number of deliberate infringements (FDA warning letters), particularly as analytical technologies increase. The implication of these well publicized large pharma infringements is increasingly restrictive regulations will prevent smaller, more innovative players entering the market. The answer, Shah believes, will lie in producing a more transparent process.
CPhI and Pharma Evolution will release its remaining annual report findings (10 additional expert submissions) at CPhI 2013, Frankfurt Messe, October 22-24.
Source: CPhI Worldwide