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News : Healthcare

30 July 2008

208 The use of low dose -cryo-irradiation’ in therapeutic cancer vaccine production

11:30 – 11:50 Tuesday 23 September | Heathcare 2: Process Stephen Ward: Onyvax Limited, London, United Kingdom E-Mail: sward@onyvax.com Abstract Therapeutic vaccine strategies can be used to harness the selective power of the immune system to treat life-threatening cancer. The use of whole tumour cells as a vaccine strategy is advantageous as the resulting formulation […]

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30 July 2008

210 Combination products – What effects might processing conditions and product composition have on microbial radiation response?

11:00 – 11:30 Tuesday 23 September | Heathcare 2: Process Alan Tallentire: Air Dispersions Ltd, Manchester, UK E-Mail: Abstract The sterilization of drug-device combination products can necessitate the use of radiation processing conditions significantly different from those normally employed for the sterilization of medical devices. To minimise the detrimental effect that exposure to radiation can […]

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30 July 2008

222 Regulatory Approaches for Novel Processing and Innovative Products

9:30 – 9:55 Tuesday 23 September | Heathcare 2: Process Anastasia Lolas: Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration E-Mail: Abstract Recent global developments such as the harmonization of regulatory standards and scientific and technological advances have led to the reexamination of traditional terminal sterilization cycles. The dosing […]

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30 July 2008

225 Product and Process Convergence

8:40 – 9:05 Tuesday 23 September | Heathcare 2: Process David Liu: Johnson & Johnson – World Wide Supply Chain/Operations P.O. Box 16594 New Brunswick, NJ 08906-6594 USA E-Mail: Abstract Over the last 25 years, medical science has advanced at an unprecedented rate. During this time, a wide range of radiation-compatible materials was developed. Medical […]

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30 July 2008

Global Healthcare Trends and the Role of Innovation, Plenary: Guy J. Lebeau, MD

13:30 – 14:15 Monday 22 September | Plenary Session 1: Healthcare Guy J. Lebeau, MD: Company Group Chairman, Johnson & Johnson Medical Device Diagnostics Companies, Europe, Middle East & Africa Presentation Abstract The environment in which healthcare is provided is undergoing a fundamental change; the needs of patients are colliding with economic realities and this […]

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23 July 2008

SAL Presentation to AAMI WG 90

24 June 2008 | Approved – The recommendation outlined in the presentation that I made (on behalf of iiA) to the AAMI WG 90 that they undertake:- “a work item to develop an approach to the choice of SAL that will more closely result in the selection of radiation sterilization doses that render products safe […]

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20 July 2008

165 Overcoming Challenges For Irradiation Of Allograft Tissue

9:55 – 10:20 Tuesday 23 September | Heathcare 2: Process Martell Winters: Nelson Laboratories 6280 S. Redwood Road Salt Lake City, UT 84123 E-Mail: mwinters@nelsonlabs.com Abstract Irradiation of human tissue for transplantation (allograft tissue) has been performed by some for over 20 years. Currently, as regulatory bodies pay increasing attention to the tissue industry, sterilization […]

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6 June 2008

San Diego Drug-Device Workshop Presentations

San Diego iiA Workshop on Radiation Sterilization of Advanced Drug-Device Combination Products On December 6, 2006 the iiA sponsored this workshop on radiation sterilization of advanced drug-device combination products. Several presenters have made available copies of their presentations in .pdf format. Just click on the highlighted name of the speaker. Scientific Advances Speaker 8:30 – […]

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6 June 2008

San Diego Drug-Device Workshop Reflections

Reflections on the recent iiA Workshop on Radiation Sterilization of Advanced Drug-Device Combination Products John Masefield and Ruth Brinston, Medical Device Technology, Vol. 18 no. 2 March-April 2007 .pdf copy On December 6, 2006 pharmaceutical, biotech, medical device manufacturers and radiation processing experts came together in La Jolla, San Diego California at a Workshop sponsored […]

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