L. Carsten Nielsen

-Global CMC team leader for newly acquired small molecule assets. Led cross functional teams including QA, Regulatory, MSAT, and external manufacturing for the development of PH2 assets. Accountable for successful development, timelines, and budget for all CMC related activities. -Cross functional CMC core team leadership of 10+ indirect reports supported by subteams -Lead supply task force team to ensure clinical supply continuity -Selected for week long Leadership development off-site in Langeland, Denmark

Lead the clinical supply chain activities including label/pack/distribution for the Forma acquired asset, Etavopivat

-Lead supply chain team of 5 direct reports and two contractors to support PH2 and PH3 trials for sickle cell -Joined organization to prepare for commercial supply chain launch activities

-Built a supply chain team of 9, responsible for clinical and commercial planning, sourcing, logistics, commercial packaging and serialization, and clinical supply -Managed inventory from proprietary starting materials through finished product -responsible for implementation of supply chain module for SAP/S4 Hana -Supply chain member for the commercialization team activities of Dicerna's first siRNA -Together with Market Access, established S&OP for commercial supply -Established a Clinical Demand Process for siRNA therapies to determine demand for long lead time starting materials and DS/DP planning -Managed relationships with starting material CDMOs, DS CDMO, and Finished Product CMO -Routinely attended TIDES conference for meetings with suppliers

Commercial Supply Chain Operations: Relationship Management of Strategic Supplier o Oversight/Accountability for business relationship, operations, and performance metrics of device supplier (budget >$20MM) o Formalized business and operations relationship using supplier relationship model to align internal and external goals and joint initiatives o Lead cross functional business review meetings o Lead multiple cross functional initiatives that impact commercial operations/supply o Primary point of contact for supplier's monthly S&OP process Head of Finished Good Production Team o Lead team of specialists to manage all North American commercial production and inventory at external sites North American Operational Excellence E2E Supply Chain Initiatives o Lead cross functional team for investigation of NA Commercial External Supply Network metrics to improve reliability of commercial supply o Represented NA External Manufacturing for fundamental changes to external deviation processing in collaboration with QA o Represented NA External Manufacturing input on Logistics and PO process initiatives

Clinical Supply Chain Operations: Relationship Management of Clinical Suppliers (US/UK/CH) o Oversight/Accountability for business relationship, operations, and performance metrics of clinical suppliers (budget >$8MM) manufacturing materials for over 100 clinical studies o Accountable for all deviations, CAPAs, and change control activities associated with production of finished goods o Lead tech transfer activities o Procured and managed co-therapy materials and components used for clinical studies o Provided monthly dashboards to management on production activities, risks, spend, and issues o Accountable for all activities related to production spend (PO creation, invoice payment and tracking, change orders) o Actively managed activities to meet clinical timeline and study requirements together with clinical drug supply group (achieve FPI, on site delivery of drug, etc. testing requirements and production for clinical studies) o Together with Sourcing/Procurement, lead RFPs (multiple suppliers) and changes to MSAs o Member of audit team and/or consultant for quality audit teams o Lead internal cross-functional teams (regulatory, planning, quality, technical) for operational activities o Expanded vendor utilization to improve cost and supply efficiencies o Evaluated and changed vendors to avoid yearly cost burdens of over $1MM o Implemented mitigation strategies to ensure project successes with minimal financial/scope variance o Lead Collaborations with internal stakeholders including Sourcing/Procurement, Finance, Quality, Planning, Logistics, Legal, and technical functions for activities such as vendor qualification/evaluations

Clinical Supply Chain Operations: Relationship Management of Clinical Suppliers (US/UK/CH) o Oversight/Accountability for business relationship, operations, and performance metrics of clinical suppliers (budget >$8MM) manufacturing materials for over 100 clinical studies o Accountable for all deviations, CAPAs, and change control activities associated with production of finished goods o Procured and managed co-therapy materials and components used for clinical studies o Provided monthly dashboards to management on production activities, risks, spend, and issues o Accountable for all activities related to production spend (PO creation, invoice payment and tracking, change orders) o Actively managed activities to meet clinical timeline and study requirements together with clinical drug supply group (achieve FPI, on site delivery of drug, etc. testing requirements and production for clinical studies) o Together with Sourcing/Procurement, lead RFPs (multiple suppliers) and changes to MSAs o Member of audit team and/or consultant for quality audit teams o Lead internal cross-functional teams (regulatory, planning, quality, technical) for operational activities o Expanded vendor utilization to improve cost and supply efficiencies o Evaluated and changed vendors to avoid yearly cost burdens of over $1MM o Implemented mitigation strategies to ensure project successes with minimal financial/scope variance o Lead Collaborations with internal stakeholders including Sourcing/Procurement, Finance, Quality, Planning, Logistics, Legal, and technical functions for activities such as vendor qualification/evaluations

Relationship Management of Clinical Suppliers (US/UK/CH) o Oversight/Accountability for business relationship, operations, and performance metrics of clinical suppliers (budget >$5MM) manufacturing materials for over 80 clinical studies o Accountable for all deviations, CAPAs, and change control activities associated with production of finished goods o Procured and managed co-therapy materials and components used for clinical studies o Provided monthly dashboards to management on production activities, risks, spend, and issues o Accountable for all activities related to production spend (PO creation, invoice payment and tracking, change orders) o Actively managed activities to meet clinical timeline and study requirements together with clinical drug supply group (achieve FPI, on site delivery of drug, etc. testing requirements and production for clinical studies) o Lead internal cross-functional teams (regulatory, planning, quality, technical) for operational activities o Implemented mitigation strategies to ensure project successes with minimal financial/scope variance

Commerical Supply Chain External Manufacturing Production o Led and managed weekly cross functional tactical commercial production meeting to gain alignment on monthly operations at contract manufacturing organizations. o Communicated/Tracked inventory targets for launch projects and management/monitoring/ordering for established projects o Managed production (scheduling/monitoring/initiation) for high throughput US/CAN label/packaging/assembly operations for two US based CMOs o Support of launch activities for multiple products o Team representative for IT initiatives for ERP upgrade activities as they applied to external manufacturing and quality.

o Initiated and reviewed Master Service Agreements, Requests for Proposal, Confidentiality Agreements for new production and new project scope for small molecule API/DP clinical projects o Coordinated with CMOs and point of contact for scheduling, shipping, and manufacturing issues o Cross functional team membership: coordinated with technical teams and business divisions, quality, planning, and logistics to resolve supply chain issues for small molecule clinical and commercial material o Evaluated/Updated contracts, confidentiality agreements, budgets, process flows, meeting minutes, and updated analytical methods o Tracked and ensured alignment between internal processes and technical requirements with CMO processes and development

Investigative research in the areas of experimental physical chemistry and atmospheric chemistry. Head teaching assistant for physical chemistry laboratory. Research included discharge flow mass spectrometry and proton transfer reaction mass spectrometry.

Research on drug toxicity and apoptosis on human prostate carcinoma cell lines and human cervical carcinoma cell lines. Maintenance of a variety of carcinoma cell lines.

Senior thesis (senior individualized project) work in chemistry investigating/improving the solubility of low solubility therapeutic agents.

Laboratory studies of antidepressant therapies on hypothalamus temperature.

Research training in the area of cholesterol research and purification, and served as normal volunteer for cholesterol studies.

Projects (individual or group (#)): -Financial and inventory management using Palisade Decision Tools in application to Pharmaceutical Supply Chain Operations (group (2)) -Corporate financial analysis (group (4)) -Marketing and economic principles analysis for a large supermarket chain (group (5)) -Investigation of an innovation at a large pharmaceutical company (individual) -Marketing analytics of a large convenience store chain (group (4)) -Marketing and analysis (Marketing Engineering) and recommendations for a mid sized fuel company in Massachusetts (group (5)) -technical and strategic business proposal for development of a diagnostic tool in the health industry (group 5)) -Pricing analysis of an internet retail company (individual) -Analysis and trade negotiation exercise (group (3)) -Analysis and in-depth writeups of case studies using Palisade Decision tools (including @Risk, Decision Tree, Stat tools) (group (4))

Foreign Study during junior year.

Thesis/Research: Research/coursework in the area of chemical physics/physical chemistry for investigation of gas phase chemical kinetics of volatile organic compounds with halogens using discharge flow mass spectrometry. Further research in the area of atmospheric chemistry which included experimental work using proton transfer reaction mass spectrometry and kinetic modeling of first and second order reactions of halogens with volatile organic compounds from chamber data.