The investigational new drug (IND) application is an important milestone in drug development. The aim of an IND is to demonstrate every aspect of the drug is safe for human exposure. It is important for sponsors to evaluate IND readiness to ensure they have enough data to support initiation of clinical trials. Submission of an incomplete IND lacking important studies or data can lead to a clinical hold, thus delaying clinical trials and increasing costs for the sponsor. This presentation will explore the drug development process with specific insights on FDA’s regulations, including an overview of the required content for a successful IND application and recommended interactions with the Agency to ensure success.
Key Learning Objectives:
Who Should Attend:
Paula Garcia Calavia, PhD, Director, Regulatory Affairs
Dr. Paula Garcia Calavia currently functions as Director of Regulatory Affairs at BioPharma Global, a division of Pace® Life Sciences. Paula has experience in drug development, particularly in medical therapeutics and diagnostics. Her regulatory education includes the completion of a drug discovery, development, and regulation course at UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). Paula has broad regulatory experience in feasibility and strategy consulting, novel data analysis, authoring regulatory documents for FDA and EMA, preparing clients for FDA meetings, interacting with regulatory agencies, and leading a team of professionals focused on regulatory affairs. She has worked in diverse projects covering all stages of drug development, from early first-in-human trials to Phase 3 trials, and a variety of indications including oncology, hematology, gastroenterology, immunology, and COVID-19. She is particularly interested in drug development and regulations for rare diseases with unmet medical needs.
Prior to joining Pace®, Paula worked as a research scientist in R&D towards the development of rapid diagnostic tests for infectious diseases, such as influenza virus and norovirus. Her academic background includes a Master of Chemistry (MChem) in Forensic and Investigative Chemistry, with a focus on drug detection and quantification from fingerprint samples, and a PhD in Cancer Bio-nanotechnology, where she worked in the development of nanoparticles for targeted photodynamic therapy using cancer in vitro models and various nanomaterials, both from the University of East Anglia in the United Kingdom.
