PSR joined a total of two FP7 consortia for stage 2 of the 2012 FP7-HEALTH-20120-INNOVATION-1 call: preclinical and/or clinical development of substances with a clear potential as orphan drugs.
Dr Anthony Hall, PSR’s Chief Medical Officer, will be leading an orphan drug Masterclass on 7th December 2011.
The event, organised by SMi will take place in London and will cover the following topics:
• Designing clinical trials for orphan indications
• Rare diseases from the patient’s perspective
• Market access and reimbursement for orphan drugs
• Patient advocacy groups
• Guide to writing an orphan drug application (EU&US)
• Variations in patient access between countries
• Predictors of success or failure
• Roles & achievements of EURORDIS
Both PSR and EGAN acknowledge the importance of involving patient groups at an early stage in the development of Orphan drugs and their clinical study programs. The advantages range from valuable input in the creation of study protocols to having access to patients and overcoming the logistical challenges of sparsely distributed patients.
PRESS RELEASE
Hoofddorp, The Netherlands, July 5, 2010 / – PSR announced today the launch of its new service and dedicated website, OrphanIQ™. OrphanIQ™ is a quick and easy way for companies involved in Orphan Drug development to ask a short question on a variety of topics without the need for setting up time-consuming agreements and contracts. Questions will be handled by the relevant expert, who will first assess whether the question can be answered without obtaining further information, and within a reasonable time-frame, and will subsequently provide a written answer.
“We often come across companies who are thinking of developing their drug according to the Orphan Drug legislation, but are unsure of some of the fundamentals they need to know to get them started,” said Dr Anthony Hall, Chief Medical Officer, PSR. “OrphanIQ™ provides such companies an easy and accessible way of gaining insight into this highly specialised area of Drug Development. Even when the development process is already underway, companies often have short but important questions relating, for example, to their clinical plan or to reimbursement issues.”
“The launch of this service is part of PSR’s continuous strategy to provide expert services for Orphan Drug development in an innovative way,” said Dr Roger Legtenberg, General Manager, PSR. “The need for this service shows that, even in the non-standard environment that is Orphan Drug Development, practical and quick solutions can be provided for pharmaceutical and biotech companies, without having to put in heavy upfront investments.”
About PSR
PSR Group B.V. is a leading expert in Orphan drug development, providing the essential ingredients necessary to help its clients through the logistical and regulatory hurdles which are the hallmark of development programs for rare diseases. Our services span the planning, design and implementation of the program providing a one-stop-shop from start to finish.
OrphanIQ™: http://www.orphan-IQ.com
For more information:
PSR Group B.V.
Planetenweg 5
2132 HN Hoofddorp
The Netherlands
Tel: +31 23 556 3220
Dr Anthony Hall, tony.hall@psr-group.com
Dr Roger Legtenberg, roger.legtenberg@psr-group.com
03-02-2012 - PSR is part of two stage-2 FP7 applicationsPSR joined a total of two FP7 consortia for stage 2 of the 2012 FP7-HEALTH-20120-INNOVATION-1 call: preclinical an ... |
07-12-2011 - PSR to lead orphan drug MasterclassDr Anthony Hall, PSR’s Chief Medical Officer, will be leading an orphan drug Masterclass on 7th December 2011. ... |
01-02-2011 - PSR patients group EGAN sign intent to collaborateBoth PSR and EGAN acknowledge the importance of involving patient groups at an earl ... |
05-06-2010 - PSR launches new service: OrphanIQPRESS RELEASE Hoofddorp, The Netherlands, July 5, 2010 / – PSR announced today ... |
