Archives: Speakers

An experienced digital strategist in clinical R&D space with end-to-end knowledge on dataflow, business processes, systems and technologies. He currently plays a role of IT Business Partner in Otsuka for multiple business functions: Clinical Data Management, Pharmacovigilance, Statistical Programming, Biostatistics and Clinical Operations. He speaks the language of both business and IT and is responsible for large platform transformations, ideations, digital vision and roadmap. He manages strategic R&D partnerships with product vendors in the areas of clinical data review, SCE, clinical analytics and submission platforms. He also works with the leadership of Otsuka affiliate pharma companies: Taiho Oncology, Otsuka Japan etc. Previous to Otsuka, he has provided his consulting services as clinical R&D solution architect to big pharma companies: GSK Consumer Health, BMS, Amgen and Novartis.

How to simplify the data management process and activities. Highly motivated, astute, and results-driven self-starter with exceptional organizational, analytical, and clinical data management skills. B.S. and 15 + years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, Oncology expertise, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. Diligent, detail-centric, and trustworthy. A strategic and critical-thinking collaborator and avid problem solver. Known for taking on the most challenging tasks and the ability to fast break into uncharted areas.
Currently leading data management Inspirna(formerly known as Rgenix) and supporting CMO and the rest of the team.

Dedicated security professional with a diverse history of working in healthcare, education, nonprofit and SaaS environments. Skilled in Microsoft 365 architecture, IAM/IGA and business process automation. Current MSc candidate in Computing Security at Rochester Institute of Technology.

Experienced Clinical Trial Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Strategic Planning, Customer Relationship Management (CRM), Pharmaceutical Industry, Team Building, Change Management and Data Management processes. Strong operations professional with a Master’s focused in Experimental Methodology/ Psychology from Towson University.

Accomplished formulating product strategy and roadmap, leading and delivering complex cross-functional projects driving operational excellence and organizational change focusing on business growth and improving efficiency with specialization in Pharmaceuticals, Retail, Sales and Clinical initiatives

Solution Oriented Business Analyst/Project Manager – Certified by NYU-SCPS, with extensive experience as an IT Business Analyst/IT Lead /Service Delivery and Business Partner

Managed and mentored global teams to drive multiple complex IT digital projects.

Lead project management, monitoring and data management initiatives for 500 projects, using expertise in leadership, analysis, evaluation, resource requirements, and technical tools to increase productivity, and to proactively create contingency plans that resolve significant issues. Extensive global leadership for 80 Biometric professions in the processing of large multi-central trials that achieved NDA/MAA submissions/approvals and post approval requirements, while managing Biometrics department P&L.

• Strategic and analytical senior IS executive and trusted advisor qualified by 20+ years of accomplishments in Insurance, Manufacturing, life sciences and healthcare industries with an expertise in clinical research, data warehousing, business intelligence, and big data applications.
• Offer a rich career encompassing senior IS/IT project/program management, IS/IT leadership, management consulting, IS strategies and roadmaps, business process optimization, vendor negotiations and management, business analytics, enterprise information architecture, and systems architecture, development, and integration.
• Successful in solving challenging business problems with innovative information systems to improve and revitalize business operations.
• Applications focused on data warehousing, Master Data Management, Business Intelligence, clinical data management, clinical operations, manufacturing, clinical safety data management, document management, QA/QC and more, used by 2,000+ global users.
• Led implementation of 10+ major enterprise data warehouse, enterprise architecture, solution architecture, and systems projects, including offshore models used to develop and introduce new pharmaceutical products. Managed $3M+ project and departmental budgets.
• Consistently improved business value by leveraging data as an asset, implementing cutting-edge systems needed for life sciences and healthcare, creating complex software products, and persuading business leaders, scientists, and physicians on the value of new software systems.
• Combine success in IS leadership, IS project/program management, and IS compliance with deep knowledge of healthcare data, drug safety, clinical, regulatory, quality, and new drug development processes.
• Constantly deliver systems 30-40% below the average industry cost. Motivate and empower staff who give much more than 100% of efforts to all projects.

Data Delivery Head, for the Outsourced Projects in Early Development Clinical Operations at Sanofi. Strategic partnerships for the fully outsourced projects, functional services, and resourcing. Partnership management with engagement and collaborations across different functions to align data management deliverables. Define and set deliverables based on Key Performance and Quality Performance Indicators across multiple therapeutic areas.

Betty van Esch is Senior Scientist with a broad background on immunology and allergy. She has received her PhD degree on her research on “Cow’s milk Allergy; Avoidance versus tolerance: new concepts for allergy management” at the department Pharmacology, UIPS, Faculty of Science at Utrecht University.

Her main interest field is immune modulation and immune imprinting by dietary interventions, environmental factors and experimental agents and she published >75 papers related to this topic. She has conducted a project on the immune-modulatory capacities of specific probiotics in allergic disease within BIOASTER, a Foundation for Scientific Cooperation sponsored project (under the laws of France).

She supervised projects on the anti-inflammatory role of short-chain fatty acids in cardiovascular disease (China Scholarship Council) and Nutrition-based approaches to support oral immunotherapy in Food allergy. Current programs include research on the health benefits of raw milk, the immune modulation by fermented raw milk Kefir (SAGST, Germany subsidized project), the immune profiling of eosinophilic esophagitis (NWO, the Netherlands subsidized project followed by a Sanofi subsidized grant) and the effect of nutritional concepts on the microbial composition of gut, lungs and esophagus in relation to disease.

Next to her research, she teaches in the Bachelor and Master program of Pharmacy and she is an elected member of the EAACI Immuno-pharmacology taskforce and the Ethical Committee for Animal Experiments.