ISAM-Woolcock Conference 2014
The International Society for Aerosols in Medicine and the Woolcock Institute of Medical Research (WIMR) hosted the 2014 Conference and Workshop at the WIMR Headquarters on 25-26 Sept 2014 in Sydney, Australia. The topics focused on paediatric respiratory medicine and bioequivalence of inhaled formulations. There were two Plenary speakers: Dr. Mark Everard, Professor of Paediatric Respiratory Medicine (Perth, Australia), led-off the conference with a presentation on “Why aerosolized therapy has underachieved and what we can do about it.” From Dr. Everard’s clinical perspective, while inhaled therapy has transformed the lives of many people, there are still too many patients who are misusing or not using their inhaled therapies and this leads to unnecessary deaths or poorer outcomes. Dr. Everard discussed the roles that Industry, Clinicians, and the Regulators play and what can be done to change this paradigm.
Dr. Peter Byron, Professor and Chairman of Pharmaceutics (VCU, USA), spoke on “Inhaler bioequivalence: Evolving theory and practice.” Dr. Byron presented the challenges with demonstrating bioequivalence for inhaled products, and the differing guidance promulgated by the FDA versus the EMA. While the EMA can approve inhaled generic products based strictly on in vitro similarity, the FDA requires comparability from in vitro, BE and PD studies. The difficulty with demonstrating in vivo BE, is that 21CFR 320.1 specifies bioequivalence “at the site of action”, in this case the lung, but there is no feasible way to measure concentrations in the lung and so systemic BE is typically required. Dr. Byron went on to share recent in vitro methods and data which may have the sensitivity to replace the BE requirements.
A hands-on workshop was also conducted by Smita Shah, Sinthia Bosnic-Anticevic and Mark Everard. The workshop focused on the practical aspects of inhaler technique, with a particular focus on paediatric patients. Regardless of the inhaler device, the issue of inhaler technique is problematic. While this is recognized, in practice it is often overlooked and consequently a high proportion of patients do not use their inhalers correct, or if they do master their use, do not necessarily maintain correct technique. The workshop covered the important device, health care provider and patient-related factors that can contribute to poor inhaler technique and discussed strategies to overcome common challenges associated with poor inhaler use. Hands on practice with placebo inhalers completed the workshop and practical tips for delivering inhaler device education to paediatric patients and their parent/caregivers were discussed. Device selection for the paediatric patients was also considered.
There were more than 50 attendees including industry, regulatory and academic scientists, students and clinicians. There were a number of other invited speakers, too numerous to cover in this brief update. If you want to catch up on what you missed you can view the abstracts and powerpoint slides by clicking on the links at the following website: http://woolcock.org.au/isam2014. There is also a photo gallery that shares a sense of the passion and enthusiasm that was expressed at the conference. We look forward to seeing you at one of our future conferences and workshops.
The Woolcock and ISAM Team: Dani Traini (WIMR), Paul Young (WIMR) and David Cipolla (Aradigm)