Director of Safety Analytics
Oracle Health Sciences
Michael is Director of Safety Analytics at Oracle Health Sciences, responsible especially for the business intelligence, case intake, and behavior analytics strategy of the Oracle Health Sciences Safety Suite. He came to Oracle with the Relsys acquisition in 2009. Before that, he worked for 13 years in the European pharmacovigilance headquarters of Astellas (previously called Fujisawa), ultimately as manager of the Safety Data and Quality Management group.
Consulting Technical Manager
Oracle Health Sciences
Anil has over thirty years experience in drug development and project delivery. He is well-versed in drug development processes from pre-clinical through post-marketing, and currently focuses on Drug Safety offerings. During his career he has managed a number of large implementation programmes involving: Argus SaaS, EDC-Argus Interface, Pre-Clinical Safety Data Warehouse, SOP Management System, Clinical Trial Shipment, Drug Safety Database, eCTD and eDMS solutions. Anil is a Rapid Economic Justification (REJ) practitioner, with focus to forge alliances between Business and IT. He has managed virtual and physical teams in multi-site projects in the UK, USA and Europe. He regularly presents on Global Project Management in the Pharmaceutical Industry at professional forums.
Director
WCI Consulting
Chris has been with WCI for over 15 years and leads the European Practice. He is an experienced business consultant in the European pharmaceutical and Biotechnology industry, and brings leadership, sales, and delivery expertise to global product safety, compliance, and performance programmes. Chris established WCI's two industry forums, pvnet® and pvconnect® which comprise of over 50 leading life science organisations. The forums monitor performance and compliance, establish best practices, and develop the future of drug safety in response to changing regulatory requirements. Prior to working in the Life Sciences practice, Chris managed consulting engagements in UK Healthcare, including advising on improvements to patient care and waiting times for a number of NHS Trusts. Chris has a BA (Hons) degree in Business.
IT Business Partner Global Pharmacovigilance
Bayer HealthCare
Marian has over 20 years of experience in IT as Business Partner, Project Manager, Business Analyst and Developer. He has been working in the pharmaceutical industry for 18 years starting as an external consultant at Hoechst/Aventis. In 2006, he joined Bayer. Throughout the years he worked on implementation projects for pharmacovigilance systems (e.g. Argus, Clintrace), integration of pharmacovigilance systems with up- and downstream systems (e.g. clinical data management, EDC, electronic reporting [E2B]), and various system upgrades and data migrations. In his current role he manages the IT Demand and Project Portfolio of Bayer’s Global Pharmacovigilance function.
Project Manager and IT Implementation Lead
Bayer
Stefanie neumann is the project manager and IT implementation lead for the Oracle Argus upgrade projects within Bayer, which she joined in 2003.
She has over ten years of experience in information technologies for various R&D areas. She’s been the Oracle Argus Application Manager and the Technical Implementation Lead in the different Argus implementation and upgrade projects for Bayer, focusing on a consistent approach for Argus upgrades, enhancements, and support.
Vice President of Product Strategy
Oracle Health Sciences
Bruce has over 25 years of experience in the Healthcare and Life Science industry. Bruce currently oversees Safety product strategy for Oracle Health Sciences with a specific emphasis on leveraging observational and other big data sources for product and patient safety. Prior to joining Oracle, Bruce was one of the founders and served as Vice President of Relsys International, leading the development of the Argus Safety suite of products before serving as President of Timeln Inc. He later returned to Relsys as the Chief Innovation and Strategy Officer. Bruce joined Oracle through the acquisition of Relsys. Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.
Chief Executive Officer and Founder
MyMeds&Me
Oracle Health Sciences
Andrew is the Chief Executive Officer and founder of MyMeds&Me. He is responsible for the delivery of product and company direction, ensuring strong customer experience for all MyMeds&Me clients and building a strong team of enthusiastic, industry specialists who are able to deliver high quality, SaaS products and services to life science customers. Andrew has held senior positions at GSK in the UK, USA and Asia Pacific and has extensive experience in driving significant change and innovation within global drug safety operations.
Senior Product Strategy Manager
Oracle Health Sciences
Marianne has over ten years experience in software used in pharmacovigilance. She came to Oracle via the Phase Forward acquisition. Her primary responsibilities include the strategy of products within the Oracle Health Sciences Safety Suite. She works with customers as well as various external and internal Oracle HSGBU Groups including sales, services, and development in defining and implementing the product strategy and roadmap for Argus and Empirica products. She is currently heavily involved with customers and development in handling the roadmap of Argus mobility strategy. She has over twenty years of experience with delivering on premise, cloud enterprise and mobile solutions into regulated markets.
VP Life Sciences Product Strategy
Oracle Health Sciences
James Streeter is VP Life Sciences Product Strategy at Oracle Health Sciences. James previously held leadership roles at PPD in both operations, as the Global Head of Global Clinical Technical Operations and EDC and recently in IT, as Global Head of Systems Development, Business Operations Teams, and eClinical Strategy and Innovation. James has 25 years of data acquisition and analysis experience utilizing computerized systems and has focused on eClinical systems and processes for trials for the last 15 years. James’ experience includes implementing end to end eClinical Solutions and processes across all therapeutic areas and all phases of studies.
James’ early experience in eClinical was gained at Pfizer Inc., where he was Senior Director of Global Clinical Data Services, heading the global data acquisition department for the company’s global research and development organization. Prior to joining Pfizer, he was a Senior Hardware, Software and Systems Engineer for the U.S. Navy Underwater Sound Laboratory with a focus in data acquisition and analysis.
Senior Applications Architect
Oracle Health Sciences
Bill Triebel is the architect responsible for Oracle Health Sciences' Argus and Empirica product lines. His current area of focus is integration and interoperability across the Oracle Health Sciences Safety Suite. He began his career in drug safety in 1997 as the architect of EventNet which was renamed Oracle AERS in 2002. Before EventNet, he was a programmer, consultant, and software architect in the finance, telecommunications and healthcare industries. His main interest outside of software is t'ai chi, which he has taught for 25 years.
Master Principal Sales Consultant
Oracle Health Sciences
Rob has considerable professional experience not only in the pharmaceutical industry, but also in the application of information technology in industrial scientific research and development in general and is currently responsible for quantitative safety signal detection and pharmacovigilance. He originally joined Oracle through the acquisition of Phase Forward, which he joined through the merger with Clinsoft Corporation in 2001. After the acquisition of Lincoln Technologies by Phase Forward in 2005, he focused primarily on quantitative safety signal detection and data mining as well as general pharmacovigilance. At Clinsoft and its earlier incarnations as Domain Pharma and BBN Software Products, he was initially employed as Senior Technical Consultant in the UK in 1993. He later rejoined the company as Worldwide Technical Director after having held the position of Director of European Operations at NetForce, Inc. Before joining BBN, Rob was Head of the Clinical Data Systems department at Organon International. He also has nine years experience as consultant for Computer Assisted Organic Synthesis and Computer Assisted Molecular Modeling (CAOS/CAMM) at Shell Netherlands in The Hague and the Royal Dutch Shell Research Laboratory in Amsterdam. Rob holds B.Sc. and M.Sc. degrees in Biochemistry and Bioinformatics from Leiden University in the Netherlands.
Senior Product Strategy Manager
Oracle Health Sciences
Robert is a qualified physician with a background in neurology and a Senior Product Strategy Manager in the Oracle Heath Sciences Global Business Unit. His responsibilities include the Empirica Signal, Topics and Inspections products in the Oracle Health Sciences Safety Suite. Robert works with regulatory agencies and key industry clients to provide strategic direction for the Oracle Safety products, define areas for enhancements and identify new solution opportunities. He has worked since 1995 in the area of drug development, clinical research and pharmacovigilance. Earlier positions included Principal Consultant at Phase Forward's Lincoln Safety Group, Senior Project Manager at DocCheck Medical Services in Cologne, and Senior Manager and Principal Consultant at PAREXEL in Berlin and London.