Sandra B. Ogueta

Lead the advancement of Phase 3 autologous cell therapy program in a rare autoimmune disease (generalized Myasthenia gravis). Enhance operational efficiency, improve reporting by incorporating key performance indicators and facilitate decision-making. Drive the development of strategy and plans for BLA submission.

Focused on helping organizations streamline programs and projects to ensure alignment with strategic goals and deliver tangible results: • Immediate visibility: Gain clear insights for informed decision-making. • Collaborative decisions: Foster teamwork for impactful outcomes. • Robust plans: Create actionable strategies supported by data-driven reporting. • Smart alerts: Utilize systems that flag risks and keep projects on track. • Seamless execution: Achieve efficient implementation with cross-functional synergy.

• Spearheaded the progression of development activities for Inozyme’s asset INZ-701 from Phase 1/2 to Phase 3 (ENPP1-def, ABCC6-def), including BLA planning for the lead indication. Partnered with line function heads to address complex regulatory pathways and enrollment challenges associated with a rare patient population. • Deployed changes in operating model to improve decision-making while maintaining simplicity and flexibility. • Launched a Portfolio Governance forum to drive strategic focus on pipeline projects and boost innovation • Assumed pivotal leadership roles to address urgent organizational needs, including a) driving CDMO collaboration to streamline decision-making and fast-track contract approvals; b) spearheading global compassionate use initiative, ensuring swift and efficient delivery of INZ-701 to critically ill children. Successfully enrolled 7 subjects, with transformative 6-12+ month data from 3 ENPP1-deficiency cases showcased in a high-impact corporate update in January 2024. • Unified organizational focus and inspired alignment across all levels to drive strategic clarity.

• Single point accountability leading Phase 3 program for refractory GERD (IW-3718) and a preclinical program for bladder pain (IW-3300), driving strategy and galvanizing leadership alignment. • Championed game-changing program revisions, including a decisive Go/No-Go call that saved ~$100M in development costs and optimized Phase 3 endpoints. • Built momentum for Linzess® global partnerships with AbbVie, Astellas, and AstraZeneca, streamlining governance and unlocking life-cycle opportunities like new indications, formulations, and pediatric studies. • Sharpened NDA submission strategies and pre-commercial readiness, earning organization-wide recognition for elevating transparency and accelerating submission timelines.

• Directed a cross-functional team (~70% external resources) to advance NDI-034858 from Lead Optimization to Clinical Phase for an autoimmune indication. • Delivered high-impact strategic presentations that unlocked rapid progress in development activities, such as streamlining starting material synthesis pathways, optimizing impurity qualifications, refining SAD/MAD study designs, and crafting cost-effective Phase 1 and Phase 2 scenarios. • Spearheaded joint committees with BMS (formerly Celgene), crafting scenarios for parallel indications, drug combinations pathways and capital projections to secure Alliance and Board approvals. • Achieved an IND submission and clinical study initiation 1-month ahead of schedule.

• Drove global teams to advance 5 biologics projects (gene therapy, antibodies, sustained release) and 3 small molecules from candidate selection to Phase 2 proof-of-concept. Streamlined governance and decision-making to hit critical milestones on time. • Partnered with NIBR strategists to sharpen the Ophthalmology disease area roadmap, aligning experts across indications and delivering robust portfolio analytics, including 10-year plans, financial projections, and competitive intelligence. Fostered alignment with development and commercial teams to integrate market insights, payer strategies, and patient advocacy needs. • Managed $150M global budgets with precision, keeping variances within ±1% while mitigating risks and seizing opportunities. • Mentored early-stage discovery teams introducing tools like scenario mapping, decision trees, SWOT analysis and criteria for Go/No Go. Assisted in the development of early TPPs. • Oversaw academic and business collaborations, terminating misaligned contracts, while ensuring resources were strategically aligned with disease area priorities.

Led development for 3 rare oncology programs, including AZEDRA® (neuroendocrine tumors), ONALTA (carcinoid), and SOLAZED (melanoma). Delivered strategic proposals, integrated plans, risk registers, and budgets, driving key program decisions and resource forecasts. Spearheaded CMC planning for NDA submissions, with focus on Module 3, ensuring efficient execution and continuous improvement.

Oversaw Quality Control lab operations for product release and stability testing, with zero observations from Japanese regulators during an unannounced inspection. Led Cell Bank enhancements and generated dashboards for senior management decision-making.

Pioneered Phase 3 CMC strategies for pancreatic cancer immunotherapy, steering Module 3 BLA submission and authoring key regulatory documents.

35 pdu- Aiming PMP certification by end 2010