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Rare diseases: Regulatory and reimbursement submissions, the challenges

Companies developing new rare disease treatments face several unique challenges when it comes to their regulatory and reimbursement submissions.

One of the most pressing of these is the paucity of information on patient populations, disease progression and appropriate Clinical Outcome Assessments (COAs), which form an important part of assessing signs and symptoms of rare diseases and treatment response.
Recorded Mar 22 2016 74 mins
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Presented by
Dominic Tyer
Presentation preview: Rare diseases: Regulatory and reimbursement submissions, the challenges

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    There are a number of factors at play within the world of medicines access: from industry who need to navigate requests for their pre-approval and unlicensed medicines, to healthcare professionals who are looking for options for their patients and ultimately to the patients and patient advocacy groups who are more empowered than ever and are driving for more timely access to treatments. Today’s healthcare, political and regulatory environments burden have generated a rapid, increasing and significant expansion in the need for access to these medicines. Mark Corbett, Executive Vice President at Inceptua Medicines Access talks about the company’s transformative approach to medicines access, designed to rise to the evolving challenges of the environment, offering unsurpassed understanding and insight into the needs of biopharmaceutical companies and healthcare organisations.

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    Everyone in pharma is talking about patient centricity, but how is the drive received ‘on the ground’ among patients who are its focus? How is it unfolding and how far is it being implemented? Do patients even notice it is happening?

    On the 24 January, Cello Health Insight in association with PMGroup, will host a free webinar which will look to unravel the multi-faceted issue of patient centricity from the patient perspective.

    What does it really mean for patients and how are they befitting from the initiative? What can market research contribute to our understanding of the current state of play of patient centricity?

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    Involving public affairs early during the development and commercialisation process of a new asset is critical to success when demonstrating value to payers and policy makers.

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    Immuno-oncology therapies that harness the body’s own defences to fight tumours are widely acknowledged as the new frontier in cancer treatment, but until recently only a few products had reached the market for a limited number of indications.

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  • Title: Rare diseases: Regulatory and reimbursement submissions, the challenges
  • Live at: Mar 22 2016 3:00 pm
  • Presented by: Dominic Tyer
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