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Tuesday, June 26 • 8:00am - 9:15am
#216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-569-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Neil McAuslane

Speaker

Early Scientific Advice from HTA Agencies: How Does the Effective Use of the Various Kinds of Advice Support a Positive HTA Recommendation?
Neil McAuslane

Early HTA Scientific Advice: What’s in it For the Agency?
Amy Sood, PharmD

How Can This Aid Companies in Their Development of New Medicines and How Would a Successful Scientific Meeting be Defined?
Matthew Lamb


Speakers
avatar for Matthew Lamb

Matthew Lamb

Vice President, Regulatory Affairs, Inflammation and Immunology, Celgene Corporation
Matthew is Vice President, Regulatory Affairs, at Celgene. He has 20 years of experience in the pharmaceutical industry working within Regulatory Affairs, Clinical Pharmacology and Project Leadership. Matthew previously was Vice President, Regulatory Affairs and Project Leadership... Read More →
avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →
avatar for Amy Sood

Amy Sood

Manager, Scientific Advice Program, Canadian Agency For Drugs & Technologies In Health (CADTH)
Amy Sood is the Manager for the Scientific Advice Program at the Canadian Agency for Drugs and Health Technologies in Health (CADTH). She has been an integral part of early scientific advice since the launch of the program at CADTH. Amy received her Bachelor of Science in Pharmacy... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session