David G. Lonza is Head of EU at Lachman Consultants. Mr. Lonza is a leader with significant regional and global management experience who understands the complexities involved in the international pharma industry. He has a successful track record building and directing organizations and is recognized as an exceptional leader with strong commitment to consensus management, team building, and people development. He is adept at developing long-term strategic plans, executing strategies, and handling crises.
David Lonza’s expertise includes servicing pharmaceutical/biopharmaceutical/biotech clients to meet international Regulatory challenges and Operational Readiness.
Fellow, Regulatory Science
Boston Scientific Group
Mac McKeen has over 25 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize.
He also serves as an Adjunct Professor at the University of Minnesota instructing a 4000 level course on medical device development and is also a Faculty Director within the College of Continuing and Applied Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC and Medical Alley. He holds a B.S. in industrial technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC-certified.
Head of Enterprise Analytics
Walt is the driving force for Data Analytics at Shire. His vision for an Enterprise Analytics Marketplace is unique to the industry and has positioned Shire to be a leader in Digital Health for rare diseases. The Analytics Marketplace allows all Shire employees that ability to analyze data to make data-driven decisions and integrate data into a model for connected care. Prior to joining Shire, Walt was a Senior Partner with CSC Consulting where is was known as a leader in Data. In 2010, Walt conducted a special research project for CSC’s Leading Edge forum to look at the future of data. His 2011 report, “Data rEvolution,” foreshadows the explosion in Data Analytics that we all see today. Walt received his Ph.D. in neuroscience from the University of Pennsylvania where he conducted Vision Research and studied brain physiology and microcircuitry.
Bakul Patel (invited)
Associate Center Director for Digital Health
Bakul Patel is a digital-health visionary and entrepreneurial leader focused on creating, shaping, and implementing national and international public health strategies. He has over 28 years of experience in leadership business development, marketing, product management, assessing long and short term needs, establishing objectives, improving organizational performance, and resource management.
Patel is an excellent collaborator, experienced in building effective cross functional teams by establishing and maintaining working relationships with diverse set of internal and external stakeholders. He has strong management, technical and regulatory skills in identifying, analyzing, managing, and solving highly complex issues, policies, procedures, federal regulations, and legislative matters in relation to Food Drug and Cosmetic Act. Patel has a detailed understanding of the regulatory infrastructure needed to balance regulatory requirements with national needs while developing policies and regulations.
He has expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Patel holds a master's degree in electronics engineering, M.B.A. in international business, Six Sigma, and Black-belt certified.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.