Michal Chodorek

Practice Areas

Michał Chodorek specializes in Life Sciences law (including pharmaceutical law and the medical device law), intellectual property law and personal data protection law.

Michał provides both regulatory and transactional assistance to Life Science businesses in both the drug and medical device markets.

In his transactional work, Michal led the KRK team that assisted Mabion S.A. in one of the largest transactions of the Polish pharmaceutical industry in recent years (deal value USD 372 million), where Mabion concluded an agreement with Novavax Inc. for the production of the Covid-19 (NVX-CoV2373) Novavax vaccine.

Michal also advises clients in projects concerning drug development and manufacturing, which often require both regulatory and IP law advise. Among many such projects he assist clients in negotiations with CDMOs (contract development and manufacturing organizations) regarding rules for division of IP rights to inventions and discoveries arising in connection with conducting R&D activities by the CDMOs at the client's request. One such recent project is valued at EUR 2.4 million.

In his work combining Life Sciences law and intellectual property law and personal data protection law he advises clients on e-Health and m-Health projects, the use of medical data – including for training neural networks, the re-use of data from subjects of clinical trials and the development and implementation of AI/ML tools supporting diagnostic and therapeutic decisions.

Michał works on cutting-edge projects regarding the use of Artificial Intelligence / Machine Learning in Healthcare and Life Sciences applications – e.g. AI/ML in medical devices. Michał helps clients identify and navigate through the regulatory requirements throughout the lifecycle of AI/ML-driven medical devices, starting from the design & development stage (e.g. requirements regarding quality of training and validation datasets, requirements regarding AI/ML explainability) through clinical investigations / performance evaluations, up to post-marketing obligations specific to AI/ML-driven medical devices.

He has represented associations of pharmaceutical companies in legislative work on amendments to the Pharmaceutical Law and the Reimbursement Act. He is one of the key members of KRK’s Life Sciences practice.

Professional Memberships

Michał is a member of the governmental Artificial Intelligence Working Group (GRAI), which was established to identify activities intended to ensure appropriate conditions for the development of AI applications both in the private and public sectors in Poland, as well as in conducting scientific research.