Smithers : You are on the advisory board again for the conference this year, thanks for your help – what are some key themes the conference is focusing on this year?
Carsten Worsøe: No problem, it is always an interesting task trying to build a scientific program containing the “hot spots” of current E&L areas. Within the advisory board for this year’s E&L USA we have focused on putting some the E&L areas that are current being developed into the agenda such a device chemical characterisation, rest of world health authority E&L expectations, production system E&L qualification and analytical challenges for other drug product types compared to the highly discussed OINDP and PODP’s.
Smithers: You’ve been in the E&L sector for some time – what progress have you seen and what are the key challenges ahead
Carsten Worsøe: The last decade or more it is my experience that the major focus on E&L within drug products have been on OINDP, PODP and SOD’s. At this year’s event we have aimed to dig into the more challenging E&L presentations such as topical drug products being an area where simulation studies potentially can bridge the gap between E&L documentation. Personally I look forward to include discussions on such challenges and good science into the “bridging the gap and levelling the playing field” panel discussion.
Within health authority perspectives at E&L events those have been limited to the FDA, Health Canada and MRHA. In my everyday work I see more and more interest from the “rest of world” health authorities within E&L and I therefore look forward to the presentations from health authorities from both South America and Asia at this event.
Another area where I foresee that more resources will be spend on E&L activities in the future is the chemical characterisation within device testing. In the new ISO10993 part 1 biocompability guideline focus has been shifted from biological qualification towards more chemical characterisation. Part 18 of the guideline dealing with extractions, that are currently being drafted, contains thoughts on extractions solvents and conditions, the use of orthogonal analytical methods and the use of acceptance criteria’s based on the well-established AET principle known from OINDP’s and PODP’s drug product packaging. There are several device related presentations on the agenda that deals with this area, including the presentations from Med Institute, AMRI, ORISE, Interacia Therapeutics and more that I look forward to hear and discuss.
Smithers: Why should you attend and who should you expect to meet?
Carsten Worsøe: As a person being involved with E&L in the pharmaceutical industry and being a frequent presenter and chairman at many E&L events for the last two decades I would say that the E&L USA in my opinion is the leading E&L event in the US with respect to discussions on recommendations, test strategies, health authority interactions, new case studies, material suppliers perspectives and more related to E&L.
Because of the breadth of topics covered at E&L USA, those attending are usually from the full spectrum of the pharmaceutical industry, health authorities, material suppliers from packaging single use equipment, contract laboratories and more covering roles as material experts, pharmaceutical engineers, analytical scientists, toxicologists, regulatory and quality experts, all will find something of interest. If you are new to the E&L field and want to maximise you gain from the conference I can recommend the “E&L workshop” held the day before the conference.
Whilst social media keeps everyone connected these days, there is no substitute for the face to face meeting and one of the major benefits of attending E&L USA is the opportunity to strengthen existing relationships and forge new ones. Not only that, it’ll get you out of the office for a few days and hopefully away from the stresses and strains of your normal day job!