Bio: Dr. Marlies De Boeck is currently EU head of Submissions within Preclinical Sciences & Translational Safety at Johnson & Johnson Innovative Medicine (J&JIM), in Beerse, Belgium. She is leading a team of nonclinical scientific writers coordinating global regulatory submissions across the different regions in the context of clinical trial and marketing applications throughout the pharmaceutical development phases and covering different therapeutic indications and modalities. She combines drug development, regulatory strategy and framework expertise to drive worldwide submissions.

During 20+ years at J&JIM, Marlies has filled several roles in the Preclinical Safety Department, including positions within genetic toxicology, discovery safety screening, project management, nonclinical writing and as study director, nonclinical safety project leader and people manager. She started her career at J&JIM as a postdoctoral researcher. Marlies holds an MS in Biology and a PhD in Sciences from the Free University of Brussels (VUB).

Marlies has been active in scientific societies including the European and Belgian Environmental Mutagen Society (EEMS, BEMS) and has been involved in collaborative scientific initiatives including those led by the European Federation of Pharmaceutical Industries and Associations (EFPIA), International Workshop on Genotoxicity Testing (IWGT) and Organization for Economic Cooperation and Development (OECD).

Abstract:  In the pharmaceutical industry, nonclinical submissions are essential for demonstrating the safety and efficacy of new drugs and other therapies, supporting the transition from preclinical to clinical development phases, and ultimately securing market authorization. They involve providing nonclinical pharmacology, pharmacokinetics and toxicology study data summaries, their integration and interpretation to global regulatory agencies.

The regulatory requirements are primarily driven by the International Council for Harmonisation (ICH) guidelines, yet regional differences sometimes exist in the interpretation of these guidelines. In addition, for the emerging novel modality therapies, existing guidelines may not fully inform the nonclinical testing approach. This may lead to specific nonclinical packages being prepared to adhere to country specific requirements and may require prior discussion and agreement with health authorities. An example of such specific standards is the Standard for Exchange of Nonclinical Data (SEND) needed for USA FDA submissions which are recently also being requested by some other countries.

To increase operational efficiency, consistency and robustness of these submissions, Johson & Johnson Innovative Medicine is exploring innovative solutions by integrating advanced AI/ML technologies.  These tools aim to streamline the generation of nonclinical summary documents and enhance their quality control, ensuring faster, more compliant, and globally harmonized submissions. This approach represents a significant leap forward—taking nonclinical submission processes to the next level and paving the way for more agile and intelligent regulatory pathways worldwide.