A New Pharma–Device Meeting of Minds Began Here

The dramatic convergence that is creating new drug–device combination products needs to be matched by a similar convergence of the pharmaceutical and medical device industries if this area is to make swift progress, said John Masefield, STERIS Isomedix, at yesterday’s radiation industry workshop.

The market for combination products that contain a drug or another active component is forecast to grow to $11.5 billion by 2010. The regulators prefer terminal sterilisation of these products, but large drug molecules are sensitive to the radiation sterility assurance levels (SAL) currently used in the medical device industry. Therefore, there is a need to establish new dose levels, that is, to determine the lowest possible dose that will render the device safe for its intended use, yet not degrade the drug. Work has begun on this and some of the latest developments and thinking were reported during a one-day workshop on Radiation Sterilisation of Advanced Health Care Products, which formed part of the 15^th International Meeting on Radiation Processing (IMRP2008), held this week in London, UK.

The pharmaceutical (pharma) industry has its own concerns about terminal sterilisation. During a lively panel session this question was posed: What is the biggest obstacle to terminal sterilisation from the pharma companies’ perspective? Answers included, pharma companies’ lack of knowledge of irradiation sterilisation, including dose setting and compatibility; and lack of clear information on what the US Food and Drug Administration’s requirements are in this area.

Workshop speaker, Byron Lambert, Abbott Vascular, said that it cannot be underestimated the different worlds that medical device and pharma companies operate in. They may do similar things and use similar terms, but they are not using the same guidance and standards. He cited one project as an example in which the pharma colleagues he was working with had never heard of ISO 11607, Packaging for Terminally Sterilised Medical Devices, which is so fundamental to the medical device industry.

A representative from a pharma company said that radiation is not discussed in the pharma industry, in literature or in the field, and the process is geared to medical device facilities and Good Manufacturing Practices; for pharma companies it represents another unit process and another cost.

Another speaker suggested that pharma companies should be proactive in gaining the knowledge they lack and support the need for data on irradiation of drug–device combination products. The problem here will be that pharma companies do not publish their research. Some would say that the pharma industry is obsessive about confidentiality and it is impossible to get past that “proprietary window.” The pharma industry is opaque to many; it is difficult to find out who to speak to and who is working in the formulation area and the contact details of the formulation manager.

The convergence of the pharma and medical device industries for this product area is a new paradigm that is gaining momentum. The lively exchange of perspectives at the workshop ended on an upbeat note. More meeting grounds for these industries are required so that they can share information and the IMRP programme committee will build on the success of this week’s event to make that happen. There are certainly likely to be many more attendees from pharma companies at the next IRMP meeting, and that will be in Canada in 2011.

The SAL issue

In view of the dramatic increase in the number of complex medical devices and those employing convergence technology, the issue now is how to get them to the market/the patient. Workshop speaker Bob Morrissey, The Wiscasset Group, announced that he and six other experts are to study the issue of SAL with the aim of developing practical guidance that has international agreement. This task force group is made up of Asian, US and European experts, including Professor Alan Tallentire of Air Dispersions and Eamonn Hoxey of Johnson & Johnson UK. The aim is to reduce the SAL and lower the dose, but manufacturers were warned by Morrissey that this would entail additional testing and validation.

Other highlights

The Workshop was part of the successful 15^th International Meeting on Radiation Processing (IMRP2008) that took place on 21–25 September 2008. IMRP2008 attracted an international audience of more than 440 delegates, the largest contingents coming from the UK, the US, China, Japan and Korea. The event is held every three years. This year, the programme committee, chaired by John Woolston, believed it was important to focus on the science and business of the radiation industry and the opening keynote addresses reflected the major elements of the industry. Highlights included the need to be faster and slicker in bringing products to market by employing automated research; for example, instead of making one compound, make 100 compounds and test them at the same time using automated technologies. In addition, governments are getting serious about how exports and inward investment should be managed. For the first time the UK Government has a business and technology representative in every embassy throughout the world. They are charged with feeding back information to a technology strategy board at the newly created Department For Business Enterprise and Regulatory Reform.

The IRMP organiser is the International Irradiation Association (iiA), and REVISS Services (UK) Ltd and Isotron plc co-hosted this year’s event.