Katherine Novak provides experience as a strategic consultant across the full drug product lifecycle, including Clinical Operations, Regulatory Operations, Regulatory Informatics, Pharmacovigilance, and large-scale Manufacturing. Katherine supports clients in global Regulatory strategy, digitalization, system implementation, process development, and data quality. Her passion is in data standard harmonization and collaboration, specifically submission data and optimization for Regulatory decision-making.

Nicholas Rattenni is currently a Senior Advisory Consultant at NNIT within the US Life Sciences Advisory and Consulting team. Nick has worked in life sciences, focusing primarily on global regulatory initiatives and labeling including data standards and business development

Sarah Powell is the President of Powell regulatory Services. Sarah has over 35 years of experience in pharmaceutical and related regulated industries. Sarah has worked as an independent consultant assisting clients with projects related to process improvements, standards development, and implementation of new technology. While in industry, Sarah performed roles within the Clinical, Quality, Regulatory Affairs and Regulatory Operations groups. Sarah has extensive experience with preparing regulatory submissions for biologic products for submission in the US and EU. She also has detailed knowledge on the requirements for the regulatory information systems.

Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse to leverage time. quality and efficiency for content within documents . Over the last fifteen years, she has led improvements in electronic documents, structured content management reuse implementations. Mitzi participates in the TransCelerate Clinical Content & Reuse workstream and ICH M11 Working group. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.

Twenty-five years of drug development experience focused on medical writing. Highlights include developing content reuse and generative AI strategies for Lilly, retooling Lilly's medical writing staff to structure its content, leading a medical writing start-up in India, designing a Question Based Review (QBR) document development strategy, expanding medical writing's influence in clinical pharmacology, and playing key roles in developing integrated outsourcing strategies.

Todd has been working in Drug Development for more than 30 years. He has extensive experience in clinical operations and also participated in and led many large-scale change and process improvement initiatives. Todd is currently Product Owner for implementation of a new Protocol authoring. Prior to his current role, he was Roche’s Program Lead for TransCelerate.