Precision Medicine Advisor

Dr. Nathalie Clément, an esteemed gene therapist, boasts a remarkable career spanning over two decades, specializing in the utilization, design, and production of adeno-associated virus (AAV) vectors for gene therapy applications. Throughout her career, Dr. Clément has successfully brought seven AAV vectors into clinical trials and has overseen IND-enabling stability studies for more than eight AAV drug products.

With a publication record of over 30 articles in peer-reviewed journals, alongside contributions to multiple reviews and book chapters, Dr. Clément has established herself as a respected voice in the field. Her work has not only advanced the understanding of gene therapy but also led to five patents directly related to AAV.

Dr. Clément's long-term vision and goals are centered on expanding the reach of gene therapy to a broader population. She is deeply committed to developing highly efficient processes for large-scale AAV production, rooted in a strong belief that success in this field is intricately tied to the interaction between viruses and host biology. Her research has predominantly focused on the large-scale manufacturing of recombinant AAV (rAAV) for both pre-clinical and clinical settings, as well as the development of quality control assays for clinical IND release testing.

As the Head of the Process & Development Laboratory at the Powell Gene Therapy Center, Dr. Clément has pioneered novel methods supporting AAV large-scale production, purification, and analytical techniques. During her tenure at Resilience, she supervised process development for a range of projects, including viral vaccines (Vaccinia virus, Adenovirus, Myxoma virus, Arenavirus, etc.) and gene therapy (AAV, Lentivirus). Her role involved significant client interaction as a Principal Investigator and subject matter expert, coordinating closely with Operations, QC, and MSAT groups. This experience has provided Dr. Clément with a comprehensive understanding of industry-scale manufacturing and purification platforms.

Currently, at Siren Biotechnology, Dr. Clément is responsible for transitioning rAAV candidates into clinical trials safely and efficiently. Her role encompasses overseeing CMC preparation, developing future vector development platforms, establishing manufacturing and testing capabilities on-site, and managing AAV manufacturing for toxicology studies and Phase I/II research.