The rapid expansion of regenerative medicine has driven the development of innovative therapies and technology to address the unmet medical needs of patients suffering from serious or life-threatening conditions.
These novel medicines help address gaps in current treatment methods to provide novel treatments to patients with high unmet medical needs to repair and restore tissues and organs, reestablishing their normal function. The Food and Drug Administration (FDA) offers a program called the Regenerative Medicine Advanced Therapy (RMAT) designation to expedite the availability of promising therapies for patients.
In this whitepaper, our experts discuss the growing field of regenerative medicine, the FDA’s expedited review program, how to prepare a successful RMAT designation request, and the role of a regulatory affairs consulting firm.
Written By:
Isaiah Manoogian, PharmD, Senior Regulatory Affairs Scientist
Dr. Isaiah Manoogian graduated from the University of Connecticut School of Pharmacy in May 2021. After earning his doctorate, he moved to DC to begin his career in the pharmaceutical industry as BioPharma Global’s inaugural Post-doctoral Regulatory Affairs Fellow. Following the completion of the 1-year Fellowship, Isaiah is now a Senior Regulatory Affairs Scientist with the company. In his current role, Isaiah has solely authored and supported numerous successful applications to FDA and EMA, including orphan drug designations, rare pediatric disease designations, and fast track designations.
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.
