Michael Shanler covers industry technologies used by manufacturers, with a specific focus on scientific R&D, product innovation, collaboration, laboratory operations and informatics. His vertical life science coverage specifically includes drug discovery, clinical development, regulatory submission, document management, compliance and related technologies for pharmaceuticals, biotechnology, contract research organizations (CROs), medical device manufacturers, and contract manufacturing organizations (CMOs).
R&D is a broad category and spans the nonregulated and regulated (e.g., GxP) space. "Research" (e.g., drug discovery) inquiries generally cover molecular modeling, laboratory informatics, laboratory automation, logistics and scientific informatics (bioinformatics, cheminformatics and so forth). "Development" topics (e.g., clinical development) include trends and vendor positioning for e-clinical systems, electronic data capture (EDC), clinical trial management system (CTMS), electronic trial master file (eTMF), regulatory information management systems (RIMS), ECM, electronic core technical document (eCTD), e-submission systems, pharmacovigilance (PV) and safety, and regulatory intelligence.
His coverage for laboratory informatics spans all R&D and manufacturing. This includes electronic laboratory notebook (ELN), laboratory information management system (LIMS), laboratory execution system (LES) and scientific data management systems (SDMS).
CTO, CSO, CIO
VP/Directors - R&D
Directors - Informatics
Project/Program Managers and Directors
Clinical Operations/Clinical Development
Prior to joining Gartner, Mr. Shanler supervised an R&D engineering staff focused on new product development (NPD), technology development and continuous improvement activities. He drove new initiatives and assessed external technologies and acquisition candidates. He also has experience in developing strategic technology and product roadmaps; leading NPD programs and managing project teams (concept-launch) for consumables, reagents and instruments; managing innovation efforts for new product ideas; and driving global collaboration efforts.
R&D Engineering Manager - New Product Innovation
Delivering Winning Products and Portfolios with PLM in Manufacturing (retired)
Life Science Digital R&D and Commercial Strategy and Innovation
B.S., Biomedical Engineering, Boston University
1How to manage laboratory process and information
2How to improve life science innovation processes within R&D in the digital era
3How to leverage complex data in a life science company for accelerating innovation
4How companies can achieve more effective collaboration for new product innovation (drug discovery & clinical development)
5Setting R&D IT strategy and roadmaps