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Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?
Session Chair(s)
Neil McAuslane, PHD, MSC
Scientific Director
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Health technology assessment (HTA) scientific advice is now more critical for companies to take to help them develop the right evidence package. This session will look to bring findings from current studies which have been undertaken to identify the type of advice taken and how this affects the development program as well as case study perspective from a company and an agency on what they believe are the potential issues but also how to define a successful scientific advice meeting.
Learning Objective : Identify different strategic approaches for obtaining relevant HTA advice on evidence development and reimbursement; Recognize the problems of initiating and seeking HTA advice by companies and how effective use can support a positive HTA recommendation; Define measures of success of a scientific advice meeting from the different stakeholders perspectives.
Speaker(s)
Early Scientific Advice from HTA Agencies: How Does the Effective Use of the Various Kinds of Advice Support a Positive HTA Recommendation?
Neil McAuslane, PHD, MSC
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Scientific Director
Early HTA Scientific Advice: What’s in it For the Agency?
Amy Sood, PHARMD
Canadian Agency For Drugs & Technologies In Health (CADTH), Canada
Manager, Scientific Advice Program
How Can This Aid Companies in Their Development of New Medicines and How Would a Successful Scientific Meeting be Defined?
Matthew Lamb
Celgene Corporation, United States
Vice President, Regulatory Affairs, Inflammation and Immunology