Helen-Marie has 20+ years Regulatory nonclinical experience (IB/IND/CTA/MAA documentation and FDA/EMA/NCA meetings), Early and late-stage nonclinical program design and execution, carcinogenicity, impurity/excipient qualification, 3Rs, thought leader in advanced therapy modalities.

Here is how Helen-Marie can help you:

• Extensive expertise in managing complex non-clinical R&D projects across diverse therapeutic areas, including oncology, gene therapy, and rare diseases, leading to successful marketing authorization applications.
• Strong leadership in providing strategic non-clinical advice for first-in-human clinical trials and regulatory submissions, including guidance for FDA and EMA processes.
• Proven experience at MHRA in reviewing clinical trial applications and optimizing study designs, ensuring effective transition of therapies from research to clinical development.