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Orphan Drugs And Rare Diseases: Interview With Shire’s Dr. Gunter Harms

September 2, 2014

SMi is proud to have Dr. Günter Harms, Market Access & Public Affairs Director at Shire, giving the opening address at this year’s Orphan Drugs and Rare Diseases conference taking place, October 20 – 21, London. Dr. Harms’ knowledge and expertise will provide key insight into market access and the challenges faced in the field.

SMi recently caught up with Dr. Günter Harms and here is what he had to say:

Q: What do you believe are the biggest challenges for the pharmaceutical industry regarding Orphan Drugs and Rare Diseases?  

A: With the unique complexities of rare diseases and national differences in patient access it really requires a lot of dialogue between stakeholders. General trends such as the evolving HTA processes also impact orphan drugs and require new approaches and also increased involvement of the patient and patient representatives.

Q: What is the future for Orphan Drugs?

A: R&D of orphan drugs is a long term commitment, with an increasing availability of treatments over the last decade – for numerous serious, life-threatening rare diseases were previously no therapy existed. This is a very successful development since implementation of the EU regulation for Orphan Medicinal Products. With up to 8,000 rare diseases, and for many with still no treatments, there is still a long way to go.

Please visit the conference website for additional information and for more of this interview.


•   Insights from Ian Hudson, CEO, MHRA on the Early Access to Medicines Initiative and adaptive licensing

•    Focus on enhancing development pathways, with the growth of the commercial pipeline for orphan drugs and rare diseases

•   Assess tools for consideration to gain early market access and enhance patient recruitment

•   Interactive round table discussion led by Dominic Nutt, Director of Communications, The Saatchi Cancer Initiative, M&C Saatchi on creating a culture of innovation in the field of orphan drugs and rare diseases.


•   Bertram Haussle, Chairman of the Board of Management, IGES Institut

•   Josie Godfrey, Associate Director-Highly Specialized Technologies, NICE

•   Chris Hart, Information Practice Leader, AstraZeneca

•   Anthony Hall, Co-Founder, Findacure Foundation.

If you would like to attend this conference please contact Alex McCann on +44 (0) 207 827 6128 or email

Meeting Logo courtesy of SMi. The Orphan Druganaut Blog is a Media Partner.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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