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Virtual Workshop

Patient focused research to inform Regulatory and HTA assessment

Half day - 9.00-1.00pm - via Zoom
Thursday 10 June 2021, 9:00 AM - 1:00 PM

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Overview

HTAs are increasingly considering the views of the patients, family and carers, and patient advocacy groups in their decision making regarding the reimbursement and access to therapies. 

With this in mind there has been an increasing acceptance of patient preference studies with the likes of the FDA, EMA, CADTH, NICE and GBA showing an interest in the outcome of these studies. This course will discuss the methodological considerations and requirements along with the practical steps to ensure acceptance of the final outputs by key stakeholders.

Learning objectives / Key topics:

This course will touch on the methodological considerations and requirements as well the latest guidance from groups working in this area along with the practical steps to ensure acceptance of the final outputs by key stakeholders.

 - How to incorporate relevant endpoints in clinical studies (both RCT and RWE)

 - How to provide evidence, acceptable to regulatory and HTA bodies, that unique patient relevant product features really can / will make a difference for patients:

  • in benefit-risk assessments
  • in clinical pathway and treatment guideline development
  • in technology assessments

 - How to build the patient perspective into reimbursement and market access decision support

 - How to address Publication and Patient education

The workshop is suitable for pharma insight managers and agency researchers involved in providing patient preference style research.

Speakers

The session will be run for us by Ipsos Healthcare. We are very grateful to the team for sharing their time and expertise for the benefit of BHBIA members.

Ipsos has expertise in market access combined with physicians and patient expert researchers to give the complete picture with respect to the landscape of healthcare stakeholders. As patients gain a greater stake both in terms of knowledge and financing they have a key role and payers are more concerned about meeting their needs outside simple efficacy. 

Chris Teale brings extensive practical and academic experience, across both Marketing and R&D, from a 30-year career within the pharmaceutical industry, having held a number of leadership positions at both Global and European level, at AstraZeneca, Allergan, Novartis and Fisons.

Within Ipsos, Chris leads the Market Access European Oncology and Personalised Healthcare Practices and is also Lead on Global Biosimilar Strategy and War Gaming / Competitive Simulation as well as Payer Insights Tracking.

Chris gained a BSc degree in Mathematics from Newcastle University, and also studied at Loughborough University and INSEAD Business School. He is an occasional lecturer on health economics and pricing and reimbursement at Kings College London and the University of California (San Diego).

Samantha has been in Market Access consulting for 15 years and previous working in medical publishing, training and PR.

She has supported pharmaceutical and medical device products from early development to launch and throughout the life cycle, across a wide range of therapeutic areas. Country expertise extends across Europe and the USA, as well as other major markets including Japan and the MENA region.

Samantha focuses on access strategy specifically pricing research, access and contracting strategy, and supporting training and preparation via workshops and mock negotiations. In the last year this has also focused on preparing teams for virtual negotiations. 

Samantha graduated with a BSc (Hons) in Biochemistry with Biological and Medicinal Chemistry from Keele University. 

With 30 years of experience in global market research and observational studies, both in pharmaceutical (Rx) and consumer markets, Jörn has worked with Ipsos Healthcare (and previously GfK Health) for 20 years, and has managed studies throughout the entire product life cycle.

Jörn’s methodological expertise encompasses qualitative, using in-depth, enabling/projective and ethnographic techniques, as well as digital approaches, and quantitative research projects, incl. observational studies. He also successfully led large-scale patient studies focusing on topics in the area of health economics, real world evidence and  epidemiology, like burden of disease, unmet needs, patient journey and preference studies, with both medical professionals as well as patients and caregivers. His renowned reputation has led to invitations by various client companies to present papers on marketing research at internal marketing meetings and at training/information sessions.

Delegate Fees

'Early bird' delegate fees for bookings made on or before 15th April 2021:

  • Members: £189 + VAT
  • Non-Members: £234 + VAT

(These prices include a 10% early booking discount).

Cancellation Policy for early bird bookings: full fee payable / no refunds given; however a substitute delegate can be accepted. (Our standard cancellation policy does not apply).

Delegate Fees for bookings made after 15th April 2021:

  • Members: £210 + VAT
  • Non-Members: £260 + VAT

Cancellation Policy: standard cancellation policy applies, as stated on booking form

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