Bringing Your Innovations to European Patients

Expert discussion with IGES: Focus on transatlantic cooperation in the biotech sector

The world's largest biotech congress of its kind, the BIO International Convention, has a strong European focus this year. With the participation of the IGES Group, it brings together major European pharmaceutical and biotech stakeholders to discuss the latest changes in EU legislation and their consequences for the transatlantic pharmaceutical market. The congress will be held in San Diego, California, from 3 to 6 June. More than 20,000 visitors are expected to attend.

The convention will include a panel discussion with high-ranking experts who will analyse the current health technology assessment (HTA) harmonisation process in the EU and the so-called “Reform of the EU pharmaceutical legislation”, which sets out the new legal framework for the pharmaceutical industry. These legislative proposals are intended to improve the supply of medicinal products and location conditions for the pharmaceutical industry in the EU. At the same time, this should promote transatlantic cooperation in the pharmaceutical and biotechnology sector.

One of the panel members is Santoke Naal, Managing Director of IGES UK Pharma Consulting. He will be joined in the discussions by Thomas Bols, Vice President, Governmental Affairs & Public Policy Matias Olsen, Public Affairs & Policy Manager of the European pharmaceutical association EUCOPE, Claire Skentelbery, Director General of the European Association for Bioindustries EuropaBio and Steffen Thirstrup, Chief Medical Officer of the European marketing authorisation body – the European Medicines Agency (EMA) – under the moderation of Justin Pine, Senior Director of the US biotechnology association Biotechnology Innovation Organisation (BIO).

From 2025, the clinical assessment of new medicinal products in the EU will no longer be carried out nationally by individual EU Member States but will be gradually transferred to a centralised, EU-wide process. This new, centralised HTA process poses major challenges for innovative pharmaceutical companies, especially if they are based outside Europe.

“The US biotech industry is well positioned globally. Europe continues to be one of the most important entry markets for it, although China is increasingly coming into play. At IGES, it is our experience that innovative biotech companies from the USA often have little understanding of the multitude of country-specific reimbursement procedures in Europe. The harmonisation of the EU HTA processes will provide clarity. However, it also places high demands on the planning of clinical trials and product launch strategies,” said Naal in the run-up to the event.

IGES has been involved in the congress for many years with lectures and panel discussions. At the present time, the EU HTA and joint clinical assessments are important topics. Companies from the IGES Group participate as EU HTA stakeholders in the public consultations. The IGES Group supports all those involved in the healthcare sector in the transition to the new process.

The IGES Group will also present itself as part of the exhibition programme of the German capital region of Berlin-Brandenburg. It is located in the German Pavilion.
IGES experts will be available for technical talks at the German Pavilion stand no. 4217.