Samantha Soto

PM team lead of GPRC5D CAR T asset.

Global Project Team PM Lead for Abecma® and Global PM lead for Breyanzi LBCL and special initiatives.

Global lead supporting the Abecma® product lifecycle and submission activities, dedicated to supporting the cell therapy portfolio management. Key Achievements: • Partners with functional leaders to develop strategies, plan and execute BMS’s drug development and in-line portfolio •Work closely with senior leaders and functional leaders to provide program progress, communication, and process management. • Maintain the portfolio view for the breadth of projects within Cell Therapy, including timing and anticipated milestones, in partnership with the Cell Therapy Head, Functional Core Team Leads and other subject matter experts. • Prepare periodic reports that convey portfolio metrics, issues and opportunities for senior management and governance committees. • Develop and lead the Abecma® global submission plans for supplemental submissions and post-marketing commitments. • Define project strategies and proactively identify and escalate risks, gaps and challenges, key dependencies, and decisions points. Works with teams to develop scenarios and solve problems.

• Provide strategic and project management oversight for NIBR components of Health Authority Submissions, via a focus on cross-functional collaboration and delivery of timely, quality content. Ensure the technical and strategic direction of NIBR submission activities is in compliance with internal and external guidelines and business objectives • Collaborate with multiple line functions (Regulatory Affairs, Pharmacokinetics, Pre-Clinical Safety, Pharmacology, Clinical) in the planning, preparation, QC and publishing of regulatory documents required for submissions • Responsible for developing and implementing resource planning across functions, to ensure that adequate resources are tendered, throughout the various stages of the Submission process. • Develop and implement a critical path analyses to identify potential ways to accelerate timelines, reduce costs or mitigate risks. • Partner with NIBR Technical Management and Submissions Standard Forum in the development of standardized Project Management tools, templates, processes, and best practices for the effective and integrated management of Submissions and Documentation projects. • Train global NIBR submission teams and / or line functions on requirements for submission components and submission preparation.

Global Project manager responsible for the operational delivery, quality, and timeliness of all IIS deliverables for NIBR and development projects (70+ trials) through activity planning, operational management and cross-functional leadership support of multi-disciplinary Project Teams. Provides Project Management leadership in areas of planning, tracking, problem solving and plan execution in line with project team goals of speed, value, quality and productivity.

Provided project oversight across multiple investigative and marketed drugs, to ensure that Health Authority submissions (i.e. Annual Reports/DSUR, Amendments, HA Request for information, and labelling submission etc) were accurate and filed in a timely manner. • Maintained IND and NDA submission timeline targets by coordinating document reviews, providing QC of submission deliverables and communicating with various line functions within clinical, DRA, and DRA Operations • Steered cross-functional meetings with key stakeholders to streamline project objectives, communication and mitigate potential obstacles • Tracked and managed monthly Investigational New Drug (IND) reconciliations in partnership with Development QA geared towards fostering and ensuring Regulatory compliance • DRA representative for the AQWA (Trackwise) system implementation for SOP Deviations, CAPAs, and Quality Events • Developed and implement quality and regulatory training, in correlation to Novartis’ compliance with the existing Corporate Integrity Agreement

Training Project Lead and Subject Matter Expert (SME) for developing and deploying document management systems online training modules Developed and implement quality and regulatory training, in correlation to Novartis’ compliance with the existing Corporate Integrity Agreement Managed the system administration of Novartis’ Documentum (xEDI) and eCTDXpress to ensure submission critical and non-critical service level agreements were met at 100% Contributed to strategic planning and technical direction that resulted in creation of new DRA applications, as well as integration of existing ones. Awarded the Pharma Development Business Excellence Award for Deploying Electronic Document Management System (EDMS) Conducted training seminars to improve end users awareness and usage of Novartis validated applications resulting in a 10% reduction in overall tickets submitted by end user Reduced turnaround time from 1-2 weeks to 2-3 days by eliminating time consuming and costly steps for end users to retrieve access to DRA validated applications Analyzed issues and trends and proposed system improvements that resulted in a 45% decrease in system reported issues for 2009 Created and maintained system knowledge base for global support, leading to quicker and more accurate solutions and responses Contributed to the creation of functional specifications, design specifications and consulted on conceptual design reviews based on business requirements for implementation of multi-million dollar applications Created and conducted training to Global Business Administrators in India, Basel, and Hungary, which led to round the clock coverage for submission applications

Significantly improved service by replacing current training and incorporated new multi-media training Conducted road shows to super users to significantly improve quicker response to client requests Sought out new and innovative solutions resulting in two new system upgrades Led negotiation of service contracts (internal/external) for application support with a 3% savings Coordinated system releases with system owners and conducted training for planned shutdown for business continuity Managed system implementation and drive change in an organization that resulted in a smooth transition and increased customer satisfaction