Michelle Hylan

Principal Consultant, Halloran Consulting Group, Inc.

Michelle joined Halloran Consulting Group in 2007 as a Director, and assumed the role of Principal Consultant in 2009. She focuses on preparing domestic and international clinical programs for acquisition or alliance and facilitates the integration by effective negotiation, risk mitigation and alignment of operating procedures. In addition, she applies her 14 years in the industry, with 10 years of management, to determine gaps in a company's clinical operations resources and develops and implements plans for program, team or individual development and mentoring. Prior to joining Halloran, Michelle was Associate Director of Clinical Research at Genzyme, acting as the principal clinical and medical liaison between the US headquarters and Genzyme Japan offices, and worked within the changing regulatory environment of Japan on clinical trial design, eCTD regulatory submissions and strategic planning. She was instrumental in the approval of two products for diseases with ultra orphan designation and the team leader for a partner company product for which the IND and NDA were submitted and approved in Japan in unprecedented timelines. Prior to working at Genzyme, Michelle was Project Director at Impact DC, a grant funded Emergency department research project of the Children’s National Medical Center, and co-author of a manuscript published in Journal of Pediatrics, 2006. She recently published a peer reviewed article in the September 2009 issue of the ACRP Monitor entitled, “How Mentoring Benefits Mentees, Mentors and Businesses” Michelle earned a B.A. from Connecticut College and completed the post baccalaureate premedical program at Wellesley College.


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