Senior Consultant Lisa Loram, PhD is a seasoned regulatory strategist with a broad background across multiple modalities including small molecules and biologics, and in depth experience with ex vivo lentiviral cell and gene therapies, adeno-associated viral vector gene therapies, cell therapies, and in vivo lentiviral vectors. Lisa has wide-ranging experience across therapeutic areas including ultra-rare lysosomal storage disorders, immunology rare pediatric disease, neurological disease (rare pediatric neurological disease, Alzheimer’s disease, ALS and Parkinson’s disease), renal disease, autoimmune disorders, oncology, dermatology and rheumatology. She is a critical and analytical thinker with demonstrated ability to develop and implement regulatory strategies, and apply strong influence skills to drive cross-functional teams to meet regulatory milestones.
Lisa has served as Global Regulatory Lead for multiple companies based in the US and UK supporting programs from pre-IND through Phase 3 and commercial stage. She has led the preparation of INDs, briefing packages, and other submissions including pre-IND meetings, has successfully obtained orphan, rare pediatric disease, ILAP, RMAT and other designations, and prepared teams for meetings with regulators. Lisa's background also includes supporting the preparation and defense of an NDA, label development, and advertising and promotion regulatory review.
Lisa has served as interim head of regulatory for early phase companies and is an efficient and organized leader, developing the appropriate regulatory strategy to support the organization’s goals, and establishing systems and processes to support growing regulatory teams.