President and founder of Boston Biodevelopment LLC is industry veteran Helena Correia, a leading regulatory affairs consultant in the Boston-Cambridge biopharma community. Helena has more than 25 years of regulatory strategy experience, spanning small molecules and biologics, including cell and gene therapies and gene editing products, across diverse therapeutic areas such as rare diseases, oncology/hematology, immunology/immune tolerance, diabetes, respiratory, vaccines, renal, gastrointestinal, and psychiatry and neurology. She has led the preparation of dozens of INDs and multiple NDAs/BLAs/MAAs, successfully conducted labeling negotiations and defended marketing applications.
Helena has served as Vice President or Acting Head of Regulatory Affairs for more than a dozen companies across the US from start-ups to commercial organizations, including Intellia Therapeutics, Avrobio, Lexeo Therapeutics, Corbus Pharma, Liquidia Technologies, Orchard Therapeutics (US), and Editas Medicine.
Helena has directly led multiple cross-functional teams charged with preparing and defending marketing applications, including the BLA and MAA for the blockbuster Entyvio®. She brings the in-depth understanding of regulatory strategy, influence skills, and leadership ability necessary for successfully initiating and driving to completion the formidable effort of preparing a marketing application.
Helena is a confident and articulate leader, and brings a rare combination of regulatory strategy expertise, influence and team management skill, and wisdom to her clients. She has led regulatory groups and served as head of regulatory affairs, in interim and permanent roles, for more than a dozen companies in various phases of clinical development ranging from pre-IND through Phase 3, and from start-up to commercial stage: Helena is adept at seamlessly assuming the helm of regulatory functions and ensuring that the company’s health authority relationships are maintained, regulatory obligations and development plans stay on track, and the regulatory group remains an engaged and valued development partner.