Monica E. Luchi, MD, FACR, MBA
Dr. Monica Luchi is a creative, energetic executive and corporate officer with 17+ years of healthcare experience across academia, clinical medicine and pharmaceutical companies. She has played a key role in defining the direction of organizations as well as creating and implementing innovative clinical programs. Additionally, she possesses extensive experience across all phases of development and multiple therapeutic areas, and has worked closely with regulators throughout the development process.
A board-certified physician with an MBA, Monica has a strong business acumen. She is recognized for her leadership, team development and cross-functional collaboration. She also drives risk assessment, alliance creation and business strategy, and has interacted with analysts, investors and shareholders.
During her tenure as President, Chief Medical Officer (two months) and Chief Medical Officer, EVP Global Clinical Development at Immune Pharmaceuticals, Monica made a great impact in preparing the company for future development. She was active in board meetings and financial partnering discussions, and was the primary representative alongside the company’s CEO. She also participated in corporate restructuring efforts during a period of recapitalization.
At Mesoblast Ltd., a growing stem cell company, Monica was Product Head, Immunology/Inflammation. She set the therapeutic strategy across indications and had oversight of projects related to manufacturing, cross-indication regulatory requirements, safety reporting, budgeting and resource allocation. She also provided medical expertise to support Business Development and presented clinical programs at board meetings. Most notably, she negotiated a path to accelerated approval for GVHD.
Prior to Mesoblast, Monica led Inflammatory Diseases Development for Incyte Corporation, and was a senior management team member and a core/voting member of the Joint Development Committee for comanagement of the Lilly Pharmaceuticals alliance. She was previously at Novartis, where she held Global and US Clinical Development roles after coming out of a full-time academic practice. She led phase 3 registration studies, which led to NDA submission and approval for a new intravenous drug for metabolic bone disease. She also served as Chair of the US Protocol Review Committee and Immunology Expert on the visible Global Scientific Review Committee.
In addition to her governance experience on corporate committees, Monica provided board leadership to the Metro Chapter of the Healthcare Businesswomen’s Association (HBA). There, she drove programming to further the chapter’s educational efforts as well as the impact of women in the healthcare industry.
Throughout her pharmaceutical employment, Monica continued clinical patient care at her academic Rheumatology practice, maintaining requirements as a full adjunct faculty member of Rheumatology Associates of the University of Pennsylvania. She holds an MBA from George Washington University, an MD from Northeastern Ohio Universities and a BA from the University of Maryland, Baltimore.