Wenyan Wang, PhD

Focus: MASH/NASH (pegozafermin) Global Infrastructure & Execution: Architected the operational and clinical infrastructure for the Phase 3 pegozafermin ENLIGHTEN program, orchestrating high-stakes global execution across multi-regional workstreams to ensure clinical rigor and milestone acceleration. External Ecosystem Governance: Established global Steering Committees, National Leaders and regional/subject KOL networks to drive clinical strategy, trial execution, and scientific advocacy. Global Regulatory Strategy & Advocacy: Orchestrated high-stakes Health Authority engagements with the FDA, EMA, and PMDA, securing BTD and PRIME designations. Expert in aligning complex clinical strategies with global regulatory requirements to de-risk portfolios and significantly accelerate development timelines toward commercialization. Data Integrity & Safety: Architected independent DSMB governance and adjudication frameworks, ensuring rigorous scientific oversight and patient safety across the portfolio. Strategic Alliance & Vendor Governance: Orchestrated the design and oversight of Global CRO Partnerships, establishing high-performance infrastructure and governance models to optimize critical-path execution and ensure data integrity across the ENLIGHTEN program.

Focus: Clinical development strategies and projects at startup biotech companies Dedicated to steering CVRM and rare disease programs through the complex transition from early-stage research to clinical execution, especially from Phase 1 to 2. I partner with startup biotech leadership to build robust program frameworks, optimize asset value, and navigate the unique operational hurdles of emerging lean organizations.

Focus: Hemophilia (SerpinPC) Asset Accountability: Single point of accountability for the SerpinPC development roadmap, from strategy through global clinical integration. Matrix Leadership: Architected and led the Global Program Team (GPT), ensuring cross-functional alignment across Clinical, Regulatory, and CMC. Strategic Alliance & Advisory Management: Orchestrated a Strategic CRO Partnership model and led KOL/Scientific Committee governance to optimize critical-path milestones and clinical credibility. Regulatory Excellence: Directed the end-to-end strategy for IND/NDA/MAA filings across small molecule and biologic portfolios. Portfolio Strategy: Driven by value inflection points, including Life Cycle Management (LCM) and commercial readiness.

Focus: Heart Failure (Entresto) & Autoimmue/Nephrology (Fabhalta)/Resistant Hypertension Global Program Governance: From Study Lead to Clinical Science Lead in Global Clinical Teams (GCT), architecting the Clinical Development Plan (CDP) and PIP/PSP strategies to ensure synchronized global regulatory approvals and commercial strategies. Late-Stage Clinical Leadership (PARAGON-HF): Directed the design and execution of the PARAGON-HFpEF outcome trial (800+ sites, ~5,000 patients), securing sNDA approval (Feb 2021) and successfully expanding the CHF label. Submission Strategy (Entresto): Key strategic lead for the global submission of Sacubitril/Valsartan (Paradigm-HFrEF), leading to first-in-class approval in 100+ countries and establishing a new Standard of Care (SOC). Multi-Regional Orchestration: Leveraged deep expertise in the US, EU, India, Japan, and China markets to navigate localized regulatory requirements and clinical strategies Stakeholder & KOL Governance: Cultivated high-level alliances with Global Steering Committees and KOLs to integrate real-world insights into trial design and clinical evidence generation. Executive Mentorship: Established a high-performance culture by mentoring junior clinical staff, accelerating professional development and cross-functional operational excellence.

Focus: ACS (Zonivity, Vytorin) & Dyslipidemia (Zetia) & NASH & Obesity Clinical scientific lead for CVM (and infectious disease studies in adult and pediatric populations. Led study design, supervised trial execution, established and managed KOLs, and authored regulatory submission documents. Key contributor for NDA of Zonivity (Vorapaxar). First global approval in the US in May 2014.