| Time is of the essence when developing an efficient, safe, commercially successful drug delivery device, argues Jay Bhogaita at Bespak
The general principles and benefits of accelerated feasibility testing (AFT) are well known to many pharmaceutical companies, those being: an efficient and timely assessment of the appropriate drug delivery method for your formulation; accelerating the device development phase; and ultimately, minimising time-to-market. Perhaps less well recognised, and providing the focus for this article, are the particular benefits that an experienced speciality medical device manufacturer can bring to the development process in terms of timely objective advice, a cost effective methodology and, critically, real world expertise in managing the complex relationship between the formulation and the device – for example, the interactions between a pressurised metered dose inhaler (pMDI) valve, actuator, formulation and container pack.
The successful pairing of a drug and delivery device is critical to the safety and efficacy of the product and usually its commercial success. Harmonising these elements can be complex, requiring several iterations and consuming time and money. In both established and emerging markets, AFT is helping pharmaceutical companies develop alternative methods of delivery using inhalation technologies, and this article will explore the particular benefits that AFT can bring to help speed the progress of such innovation.
WHY OUTSOURCE YOUR AFT PROGRAMME?
Traditionally, the concept of outsourcing any element of the development process has been perceived by pharmaceutical companies as bringing risk and complication. There are naturally concerns around sharing commercially sensitive information; a sense that ownership of the project will be lost; that the company entrusted with that element of development may not meet all the regulatory requirements for launch; or simply that the cultural differences and working practices of the two companies mean that outsourcing is not always a straightforward affair. The reality can be quite different but there are criteria by which potential partners should be measured. Their facilities, experience, technical capability, procedures and track record are all factors which should be considered. There must also be a meeting of minds both culturally and scientifically and a mutual commitment to develop and build a strong relationship. Such a close relationship can deliver many benefits: faster development time; enhancements to formulations; and a more robust product overall. |
