Oracle Safety Focus Group Meeting

Justin Alexander
Industry Senior Principal
Accenture

Mr. Alexander is an Industry Senior Principal in the Life Sciences team at Accenture. He has over 20 years' experience in digital marketing, information technology, process improvement, and healthcare informatics. Justin has provided strategy and change management consulting within the pharmaceuticals, biotechnology and medical device business sectors for a Accenture’s Accelerated R&D Services, and has managed the strategy and implementation of IT systems across all departments in pharmaceutical R&D for a medium size pharmaceuticals manufacturer. Justin holds a Masters in Technology Management from the University of Pennsylvania (Penn Engineering and Wharton Business School), and is a Moore Fellow in Engineering at University of Pennsylvania.

Tim Billington
Chief Sales Officer
Pharmasol

Tim has been working in the pharmaceutical industry for more than 20 years, in CROs, technology providers and systems integrators. Leading the pharmasol sales activities, he works with customers to detail how the pharmasol technology solutions can meet their specific needs.

Michael Braun-Boghos
Director of Safety Analytics
Oracle Health Sciences

Michael has been working in medicinal product safety for 21 years, the first 13 in the pharmacovigilance departments of life sciences companies and the last 8 in the safety product strategy teams of software development firms. He is currently Director of Safety Analytics at Oracle Health Sciences, driving the strategy of the Oracle Health Sciences Safety Suite and the Oracle IDMP Enterprise Foundation Suite. He came to Oracle with the Relsys acquisition in 2009. Before that, he led the Safety Data and Quality Management group in the European PV headquarters of Fujisawa and Astellas.

William DuMouchel, PhD
Chief Statistical Scientist
Oracle Health Sciences

William DuMouchel is Chief Statistical Scientist at Oracle Health Sciences. His current research focuses on statistical computing and Bayesian hierarchical models, including applications to meta-analysis and data mining. Dr. DuMouchel has developed data mining algorithms for drug adverse event associations in spontaneous reports and in clinical research data that have been used widely within regulatory agencies and industry. Dr. DuMouchel received the Ph.D. in Statistics from Yale University and has been a member of the faculties of the University of California at Berkeley, the University of Michigan, MIT, and Columbia University.

David Judge
Senior Director Alliances
Oracle Health Sciences

David is Director for Alliances in Oracle’s Health Sciences Business and works closely with many partners to develop and execute joint solutions that bring added value to our mutual clients. David has extensive experience of managing and developing Alliances and is passionate about the value that these Alliances can bring to customers.

Una Kessi
Principal Product Strategy Manager
Oracle Health Sciences

Una has been working as a Principal Product Strategy Manager at Oracle Health Sciences for 3 years. Her main focus is on Regulator Strategy, Safety and PV Regulations Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also responsible for products in the Oracle Health Sciences Safety Suite defining product requirements for E2B(R3) ICH and regional, IDMP and medical devices. Una joined Oracle Health Sciences in 2011 as a Safety Manager within the Audit and Compliance team. Prior to that, she worked at Roche with a career spanning 16 years. She held various roles there including Drug Safety Manager (13 years) and Subject Matter Expert for the re-engineering of their Drug Safety Processes and Systems.

Bruce Palsulich
VP Product Strategy
Oracle Health Sciences

Bruce has over 25 years of experience in the healthcare and life sciences industries. He currently oversees safety product strategy at Oracle Health Sciences, including the Argus and Empirica software suites, and 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 Argus before serving as President of Timeln Inc. He later returned to Relsys as the Chief Innovation and Strategy Officer and then joined Oracle through the acquisition of Relsys.

Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.

Philippe Rogiers
Consulting Technical Management Director
Oracle Health Sciences

Philippe Rogiers is Technical Consulting Director with Oracle HSC based in Paris, France.

He has 15 years of experience working in the Pharmacovigilance industry on Global and Japan Safety system implementations.

He worked from 2005 until 2009 for Relsys who developed Argus Safety and has worked for Oracle HSC since in solution architect and project management roles, broadening his experience across the full range of Oracle Safety products and technologies and managing the HSC Safety EU team.

He is an expert on integration of Oracle OBI, ODI and B2B with Argus Safety.

He has a Civil Engineering degree from the University of Leuven, Belgium, a MBA from the University of Chicago and is a certified 6 Sigma Black Belt.

Sameer Thapar, PharmD
Global Pharmacovigilance Director
Oracle Health Sciences

Dr. Sameer Thapar is Oracle Health Science Consulting’s Director of Global Pharmacovigilance and on faculty as Assistant Professor for the Drug Safety and Pharmacovigilance track of the Masters in Clinical Trial Sciences program at Rutgers University (USA). Dr. Thapar holds a doctorate of pharmacy (PharmD) with 18 years of experience in within the pharmaceutical, biotech, and CRO industries, with certification as QPPV/RP-EV. Dr. Thapar is a subject matter expert in pharmacovigilance (PV) operations and audit compliance. He has built global PV departments and defended in successful FDA, MHRA, and EMA health authority inspections. He is well versed in a multitude of therapeutic areas and PV-related databases. Dr. Thapar is an active member and judge of the DIA Americas Poster Committee and continues to participate as an invited speaker and panelist in numerous industry conferences.

Bill Triebel
Senior Solutions Architect
Oracle Health Sciences

Bill Triebel is the Senior Solutions Architect in the Oracle Health Sciences’ product management team, responsible for the Oracle Argus and Oracle Health Sciences Empirica product lines. His current areas of focus are reporting, integration of the Oracle the Safety Suite, risk management, and IDMP.

Bill 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. Outside of the software business software, he has taught t’ai chi for 30 years.

Barbara van de Weerdt
Senior Manager
Accenture

Barbara van de Weerdt is a Senior Manager in Accenture´s Life Sciences Research & Development practice, and is the R&D Technology Consulting and Alliance Partner Lead across Europe. Barbara has over 11 years of project management and business analysis experience working with pharmaceutical and medical product companies as well as regulatory agencies. She holds a Ph.D. in Molecular Biology, obtained from research performed at the Dutch Cancer Institute in Amsterdam, and a M.Sc. in Medical Biology from the University of Utrecht, the Netherlands.

Robbert P. van Manen, M.Sc., B.Sc.
Master Principal Solutions Consultant
Oracle Health Sciences

Rob van Manen is Master Principal Solutions Consultant at the Oracle Health Sciences Global Business Unit; he 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.

Mr. van Manen 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, Mr. van Manen 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, Mr. Van Manen 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.

Mr. van Manen holds B.Sc. and M.Sc. degrees in Biochemistry and Bioinformatics from Leiden University in the Netherlands and has affiliations with several professional organizations including the Drug Information Association (DIA) and the Society for Clinical Data Management (SCDM) as well as current and past memberships of the CDISC XML Tech Committee, the CDISC Industry Advisory Board and the ISPE Industry Council.

Andy Watson
Chief Commercial Officer
MyMeds&Me

Andy is the Chief Commercial Officer at MyMeds&Me. He is responsible for driving business growth and developing and maintaining client relationships. Andy has many years of experience working within the Life Sciences industry, selling and delivering innovative software solutions, including roles at IMS, Phase Forward, Oracle and IntraLinks. He has a strong belief in providing solutions that simplify and improve the user experience, whilst delivering economic benefit and enhanced compliance. This belief underpins his drive to provide SaaS solutions to life sciences.

Robert Weber
Senior Product Strategy Manager
Oracle Health Sciences

Robert Weber is a Senior Product Strategy Manager in the Oracle Heath Sciences Global Business Unit. His responsibilities include the Oracle Health Sciences Empirica Signal, Topics and Inspections products in the Oracle Health Sciences Safety Suite. Robert works with regulatory agencies and key industry clients to provide direction and manage priorities for the Oracle Safety products, define areas for enhancements and identify new solution opportunities.

Robert Weber is a qualified physician with practice background in neurology. He has worked since 1995 in the area of drug development, clinical research and pharmacovigilance. Earlier positions included Senior Manager and Principal Consultant at PAREXEL International, a contract research organisation, in Berlin and London; Senior Project Manager at DocCheck Medical Services in Cologne; and Principle Consultant at Phase Forward’s Lincoln Safety Group.