BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

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.

Kevin Snyder recently served at FDA/CDER as the Associate Director of Nonclinical Informatics, where he managed data science and informatics initiatives to support the pharmacology/toxicology review program. These initiatives included research efforts to develop methods to optimize the regulatory use of standardized electronic CDISC-SEND-formatted toxicology study data as well as internal informatics projects to promote the development of scientifically sound, data-driven regulatory policies. Kevin has joined Certara in a new role as Director of Nonclinical Innovation and Emerging Technologies, guiding pharmaceutical sponsors in their efforts to strategically integrate nonclinical data across all phases of pharmaceutical development and enhance new drug safety. Prior to this transition, Dr. Snyder had served in various roles at the FDA: first in CDRH as a bioinformatician and in vitro diagnostic device reviewer and then as pharmacology/toxicology reviewer in CDER. He has played a leading role in several precompetitive consortia, including the Pistoia Alliance, CDISC, PHUSE, VICT3R, and BioCelerate, supporting efforts to enhance the implementation and utilization of standardized toxicology study data. Kevin is a dedicated advocate for the modernization of regulatory toxicology via strategic adoption of data standards and data science techniques to drive innovation in areas such as predictive modeling, virtual controls, and new approach methodologies (NAMs).

Marc has 25+ years of experience in Safety Pharmacology, Pharmacology, Pulmonary, Cardiovascular (hypertension, thrombosis, heart failure), inflammation, early and late nonclinical program design and execution. He is also a thought leader in cardiovascular risk assessment.

Georgi Kapitanov, PhD is a Senior Director in Certara’s Applied Simulations group, where he leads QSP strategy across multiple programs and therapeutic areas. He joined Certara through the acquisition of Applied BioMath and previously worked in Pfizer’s Translational Modeling and Simulation group within Pharmacometrics, Dynamics, and Metabolism.

Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing.  She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).