Abstract
The European Union's Joint Clinical Assessment (JCA) heralds a dramatic change in the landscape of health technology market access, starting in 2025. While this new framework promises greater EU-wide harmonization, its practical implications are still uncertain. One certainty, however, is that the JCA’s requirement to benchmark every proposed therapy against a large number of PICOs (Population, Intervention, Comparator, Outcome) will lead to a dramatic increase in workload for healthcare developers. Without technology, these deadlines are impossible to meet. It is here where AI will play a pivotal role in bringing new drugs to patients faster.
This talk will shed light on the emerging JCA regime, explain why healthcare innovators must tackle market access early on, and showcase a cutting-edge generative AI application for the automatic interpretation of clinical results.
Speaker bio
Heike Kielhorn-Schönermark
Chief Operating and Transformation Officer
Heike Kielhorn-Schönermark is Chief Operating and Transformation Officer at Kintiga, a pan-European market access and regulatory consulting company. Trained in business administration and economics (Uni Bayreuth, Siemens AG) and with a strong prior track-record in auditing, corporate finance and M&A (KPMG, HypoConsult), Heike then joined BCG working across Hamburg, Amsterdam, Paris and London.
In 2005, Heike co-founded SKC (now Kintiga) advising the top management in healthcare on strategy, business models and digital transformation.
Prof. Matthias P. Schönermark
Chief Strategy Officer
Prof. Matthias P. Schönermark is Chief Strategy Officer at Kintiga, a pan-European market access and regulatory consulting company. Trained as a head & neck surgeon with a Ph.D. in molecular oncology, Matthias has more than three decades experience in strategy consulting (BCG, A.T. Kearney), advising the leadership of health insurance and provider organizations, as well as of medtech and pharma companies on strategic management, innovation and organizational change.
As a co-founder of SKC in 2005 (now Kintiga), Matthias holds an unrivalled track record of solving complex and demanding market access challenges, especially in the orphan drug and oncology sector and is one of the most experienced negotiation leaders in reimbursement and pricing for the German AMNOG procedure.
Space is limited, registration via Luma required.