Carmella Moody, PhD.

Regulatory Advisor

Dr. Moody serves as the Regulatory Program Manager at RTI International and has more than 30 years of experience in developing small molecules, biotechnology, and biological and combination products, with an emphasis in regulatory affairs, project management, and quality assurance. Dr. Moody has also served as the primary contact for regulatory agency interactions and have developed strategies and trained teams for participation in global regulatory agency meetings, including formal meetings with the FDA (pre-Investigational New Drug [IND]), End of Phase 1, End of Phase 2, pre-New Drug Application, Scientific Advice, and pre-Marketing Application Authorization meetings with the EMA. With her team at RTI, Dr. Moody has been working with AnelleO to generate a regulatory pathway document for the development of AnelleO PRO. Dr. Moody will continue to advise AnelleO on the regulatory pathway and preparing for a pre-IND submission.  

Dr. Moody received her Ph.D. and master’s degrees in Microbiology from North Carolina State University (NCSU) and a BS in Biology from the College of Charleston. Dr. Moody has a broad experience in working with scientists and clinicians from pharmaceutical companies and with academic investigators working to advance products through the drug development process. Specifically, in this capacity, she will lead the team through the process of developing the Quality Target Product Profile for the compound and will work with AnelleO to use this profile to develop a final pre-IND and IND strategy.