OHE Lunchtime Seminar: Health Technology Assessment Scientific and Outcomes Advice on Medicinal Drug Development

On Wednesday 5th October, OHE will host a lunchtime seminar on the topic of: Health Technology Assessment Scientific and Outcomes Advice on Medicinal Drug Development: Current and Future Perspectives and Challenges.

On Wednesday 5th October, OHE will host a lunchtime seminar on the topic of: Health Technology Assessment Scientific and Outcomes Advice on Medicinal Drug Development: Current and Future Perspectives and Challenges.

Health Technology Assessment (HTA) scientific advice (SA) was created by the National Institute for Health and Care Excellence (NICE) in 2009. More recent initiatives have sought to coordinate HTA SA across Europe and promote the integration of HTA SA with the advice provided by regulatory authorities (Medicines and Healthcare products Regulatory Agency, MHRA, and European Medicines Agency, EMA).

Despite these efforts HTA SA is not routinely integrated into the clinical development of new medicines and it faces new challenges with the development of advanced therapy medicinal products, stratified medicines and medicines used in orphan diseases. The role of outcomes advice in HTA is not well understood, yet is equally important.

The seminar will involve three panellists, all of whom are involved in issues directly relevant to HTA SA:

• Dr Leeza Osipenko, Head of Scientific Advice, NICE
• Professor Nancy Devlin, Director of Research, OHE
• Dr François Maignen, Head of Operational Research and Data Analytics, OHE.

The panellists will give their perspectives on the influence of HTA scientific and outcomes advice on both the clinical development of new medicines and evidence generation to support reimbursement.

Their presentations will cover:

• The importance of developing a value proposition early in clinical development;
• The different types of scientific advice procedures;
• The timing of scientific and outcomes advice in the clinical development of medicines;
• The integration of HTA with regulatory scientific advice;
• Issues associated with new approaches to drug development (adaptive licensing, real world evidence and advanced therapies);
• Future developments in HTA scientific advice;
• Issues specific to outcomes advice.

View the full seminar invite here.

The seminar will be held in the Marriott County Hall, King George V Suite, Westminster Bridge Rd, SE1 7PB. A buffet lunch will be available from 12:30 pm. The seminar will start promptly at 1:00 pm and finish promptly at 3:00 pm.

Please contact Kerry Sheppard if you wish to attend. Kerry will provide confirmation once she has received your request.