Andy Chu Email & Phone Number

Boston, Ma, Us

The inaugural Head of IT, brought in to development, and implement the strategic vision for all information systems and technology. The technology thought Leader, collaborating across Sionna leadership, and shepherding Sionna's IT and IT Security in the transition from early stage post-stealth as a pre-clinical biotech, and advancing as a clinical stage biotech, and staging Sionna for the future.

As the overall Head of I&T (Informatics and Technology), reporting into the Deputy President (COO) of H3, bringing together a unified portfolio and capability driven approach to all aspects of information technology solutions: from infrastructure, to scientific systems in a discovery & research centric environment to implementing leading edge platforms to best enable research and clinical development goals.• Recognized by parent company Eisai as top strategic leader, and selected into the Business Transformational Leadership Program (BTLP), which featured SECI/Design Thinking brought to life with real world fast prototyping and supported by faculty from the Stanford Design Institute, London School of Business, Harvard Business School and other distinguished institutions• Unified segmented Informatics & Enterprise IT groups into a cohesive I&T organization responsible for all H3 technology needs• Redesigned and transformed the structure and model of the I&T team, providing a focused support and delivery model against the capabilities model and roadmap• Introduced a new data paradigm and an unified architecture across the enterprise, anchored against a research-centric capabilities model, with a continuously evolving 3-year roadmap.• Influenced and led formally stagnant one-off approaches on bespoke aged applications and infrastructure into an implementation program that is cornerstone to the H3 Lab of the future

Cambridge, Ma, Us

Driving how the Global Safety and Regulatory Sciences engages with industry and agency telematics strategies, and bringing together technology, processes and people.• Engaged, representing Global Safety and Regulatory Sciences in the Business-IT governance across the R&D capabilities roadmap• Evolved Regulatory Systems Strategy into the Regulatory Information Management (RIM) model through development and implementation of RIM Operations, and executing the re-platform of the Regulatory operating model (business, process, and systems), with cornerstone centered on the Regulatory Information Management practice and capabilities to align with industry best practices. • Assemblage of a new RIM Operations team providing the enabling operating framework to exploit the full potential in revamping the RIM ecosystem coupled with a multi-year roadmap and vision to realize and employ AI, data and digital against Regulatory backstop, while advancing data analytics across GSRS and against the enterprise.• Elevated the Biogen profile across industry engagements, from evolving agency telematics related initiative to key partnerships. Member of European Medicines Agency (EMA) IDMP SPOR Task Force; Key Opinion Leader (KOL) RIMNET, PXL Product Advisor Board; eFPIA ERAO, PHRMA-IT, etc.

New York, New York, Us

As part of the Pfizer acquisition of Hospira, aligned to the Worldwide Safety, Regulatory and Medical Business Technology organization as a Client Partner. • Recognized as an industry leader in R&D, Regulatory: keynote address at 1st annual Identification of Medicinal Product (IDMP) cross industry conference (CBI)• Primary legacy Hospira integration lead for R&D technical capabilities and data architect• Harmonization of the to-be 2016 PFE-HSP Regulatory BT application capabilities portfolio

Lake Forest, Il, Us

Engaged to design and build a new R&D IT organization. Based on that success, was then drafted to transform the delivery of Global Enterprise Application Support with a pre-existing failing partnership, and a sub-optimal retained organizational model, while retaining R&D IT Delivery accountability. From selection to go-live in <6 months for a portfolio of ~200 global applications including SAP ERP, Commerical, R&D and all enterprise applications. Redesigned retained organization to optimize alignment with business and partner model• Orchestrated multiple changes with both new and existing strategic partners to provide key improvements to delivery while recognizing cost avoidance and savings - 40% decrease on ~$2 million annual spend in commercial invoice management system - 10% cost saving on $6 million core, with an additional 10% investment from partner • Oversaw ~125 direct-indirect-outsourced global organization with $10-$15 million budget while driving process improvements throughout the operation and improving customer service• Designed R&D IT organization roadmap, recruited and staffed fully (no pre-existing organization or plans), while introducing new partners and delivering against ~$10 million annual delivery portfolio • Influenced CSO decisions to achieve IT roadmap for R&D IT portfolio, including closing out strategic selection of new Pharmacovigillance (PV) capability that had lingered for 2 years prior• Reset two top 10 IT Programs that had been failing through re-invigorating strategic internal and external relationships and developing new partnerships. • Improved delivery across multiple areas: closed out projected that had gestated for multi-years.• Recognized as an industry leader in Regulatory: keynote address at 1st annual Identification of Medicinal Product (IDMP), cross industry conference with panelists including Acting Deputy Director, FDA.

Dublin 2, Ie

Accenture was chosen as the single source IT provider at a top 10 Pharmaceutical client for ongoing operations, application maintenance/development and project delivery. Responsible for the initial implementation, go-live and ongoing delivery for one of the 3 primary business-aligned towers, with an onshore/offshore application delivery team. Responsible for fiscal, budgetary, and other contractual obligations for R&D Tower, which covered both ongoing operations and incremental contracted projects. The R&D applications constituted a portfolio of applications ranging from clinical trial management, critical FDA submission applications, to pharmacovigilance systems, which included capabilities and technologies from:: Documentum , Java, Oracle, SharePoint, supporting both industry standard COTS (FirstDocs, eCTDXPress, ARISg, ARGUS, Trackwise, etc.) and custom applications.Developed the team structure and roadmap for the service, including the growth of service incorporating additional requirements from client merger/acquisitions leading to a twofold increase in the R&D space.

Lawrence Township, Nj, Us

Brought in as a recognized Oracle Life Sciences, R&D thought leader, progressed through multiple roles to deliver, architect and transform organizations, processes, operations, and new capabilities • Led cross-industry collaboration (“Gang of Four”: BMS, Pfizer, PPD, BI), establishing the Oracle RDC Advisory Council - Influenced Oracle Executive levels to accelerate delivery by several years of a complete architectural and UI redesign of the Oracle RDC industry product - Precursor to the Global Business Unit engagement model with Oracle Corporation. - Recognized by Oracle as a Product Champion – a rarity outside of their organization• Industry thought leader - Panel member for Oracle Clinical User Group (OCUG) Technical/Architecture Panel - Forester Group: Vendor and Service Management• Pioneered outsourced engagements. Sourcing locations spanning South America, India, Asia-Pac, and Eastern Europe and services from help desk, to full application maintenance & development and Managed Testing Services. - Initial 30% cost savings model - Scaled across multiple divisions against $7 million annual portfolio with 100+ applications - Early industry adopter: 1st major pharma partner with Accenture 1st pharma partner with C3i leveraging Bulgaria prior to EU inclusion• Rescued failing provider partnership, impacting 15,000+ external clients at 5,000+ globally located clinical investigator sites. - Restored operations to measurable and effective levels, while increasing span of services - Revised commercial model resulting in ~$3 million cost saving/avoidance (75% reduction) • Implemented services governance model yielding improved operational delivery with key strategic partner - 50+% improvement in service governance effectiveness - 10% effective annual cost savings across a $13+million annual engagement

Thousand Oaks, Ca, Us

Architect and technical development lead for all clinical data management systems. Included both new development and ongoing support and operationsHighlights include:- Led clinical development systems integration in the acquisition of Immunex- Consolidation from an international, multi-database/replication environment to a centralized database model for the Industry standard OC/TMS product suite; simplified overall support and maintenance structure with an ongoing overhead savings of 40% and no performance degradation- Led technical evaluation and strategy for new strategic technologies; included establishing Amgen’s initial Remote Data Capture strategy and subsequent key partnership selections; recommendations and pilots for newer technologies (e.g. patient diaries, etc.)- Evaluated and reviewed all technical projects across all divisions as a member of the DEV-IS Architecture Committee, who were responsible for setting overall architecture roadmap and monitoring adherence.- Led support and maintenance operations for all clinical data management systems- Led technical integration with Japan division on OC 4.1 Kanji (Industry product)

Boston, Massachusetts, Us

Moved from business roles within Clinical Data Management to full technical development role for Clinical Applications. Highlight includes leading an International team that developed SeroClin, an in-house developed (Oracle RDBMS, Forms and Reports), full clinical trials data management system, including one of the first full medical auto-encoder modules

Bachelor'S Degree, G.S., Business Information Systems

Education record