The Breakthrough Therapy Designation (BTD) is a unique expedited drug development program created by the US Food and Drug Administration (FDA) in 2012 through the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 902. The BTD program provides developers of drugs and biologics an opportunity to accelerate the development and review of investigational products intended to treat “a serious condition” for which preliminary clinical evidence indicates the drug demonstrates a substantial improvement over available therapies.
In this whitepaper, our experts discuss crafting a successful Breakthrough Therapy Designation, reviewing your application, maintaining designation, and leveraging the benefits of BTD.
Written By:
Darious Devlin, PhD, Senior Regulatory Affairs Consultant
Dr. Darius Devlin is an interdisciplinary molecular biologist and regulatory professional passionate about novel treatments and therapies for diseases/conditions with limited options. He was previously a laboratory scientist with expertise in reproductive biology/infertility, molecular cloning, recombinant protein expression/purification, mouse model generation, and preclinical testing of therapeutic agents. Now Dr. Darius’ regulatory experience includes successful track record with orphan drug designation (ODD) application, investigational new drug (IND), development safety update report (DSUR), and ODD annual report submissions.
Edited By:
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.
