Zhen Zhang

Lead operational execution at Fasikl as the company brings NeuroAI technology to market. Work closely with the CEO on company strategy and organizational execution. Oversee clinical, regulatory, quality, compliance, medical affairs, manufacturing, and reimbursement functions to support global market access and scalable commercialization. Direct clinical collaborations with leading key opinion leaders (KOLs), guide global regulatory strategy across multiple jurisdictions, and lead Medicare and commercial payer market access initiatives. Engage with medical societies and patient advocacy organizations to advance the adoption of non-invasive neuromodulation therapies. Focused on translating advances in AI-enabled neuromodulation into accessible therapies for patients with neurological disorders.

Oversaw product development. Developed and implemented clinical and regulatory strategy. Lead the development of Fasikl’s quality management system.

Oversaw all of Abbott Vascular's premarket clinical programs

Oversaw all aspects of the clinical programs for Abbott’s PCI Optimization portfolio (optical coherence tomography (OCT)/PressureWire/percutaneous heart pump (PHP)), which came from Abbott’s acquisition of St Jude Medical in 2017. Collaborated with internal stakeholders including the executive team, R&D, regulatory, marketing, and others on product/program development. Identified business/product clinical needs and created matching clinical programs. Defined and executed on clinical/regulatory strategies. Lead the cross-functional clinical program teams. Oversaw the development of all product/study-related clinical deliverables. Represented clinical in interactions with the executive team, KOLs, and global regulatory agencies.

Oversaw all clinical science and biometrics activities for the first-in-kind fully bioresorbable scaffold, Absorb BVS franchise (a $1bn investment of Abbott). Led the extensive analysis based on pooled ABSORB family of studies and identified the optimal implantation technique that will result in improved clinical outcomes. Acted as the internal clinical subject matter expert (SME) on Absorb BVS. Led the campaign with study PIs and KOLs to drive awareness and adoption of study findings in the clinical community. Represented Clinical and presented study findings in face-to-face meetings with US FDA, UK MHRA, Singapore HSA, China NMPA, and Taiwan FDA. Successfully gained alignment from global regulatory bodies on the safety of Absorb BVS and maintained or gained regulatory approval.

Core team member of the extensive preparations for US FDA advisory panel on Absorb BVS. Statistical SME at the US FDA advisory panel (unanimous vote for approval by the panelists). Core team member that delivered the early Premarket Approval (PMA) of Absorb BVS by US FDA.

Biostatistics program lead for the pivotal ABSORB US IDE program consists of two large RCTs (ABSORB III and ABSORB IV) for Absorb BVS. Led the design, monitoring, analysis, reporting, and publication of the studies. Led the exploratory analysis of the potential benefit of Absorb BVS in reducing post-PCI angina based on pooled ABSORB global data. Presented critical study findings to the executive team and study PIs.

Led all statistical aspects of the trial, including trial design, SAP, DSMB SAP, CRFs, analysis, reports, and publications for multiple IDE studies. Responsible for interactions with the FDA on all statistical issues. Represented Biometrics at study team meetings, management strategic meetings, and meetings with PIs and KOLs. Managed contracting and consultation with external experts. Led statistical research on innovative methods. Identified and adopted new statistical developments in trial design and analysis, which resulted in significant trial budget savings.

Led non-clinical statistics. Provided consultation and created customized statistical solutions for R&D projects. Supported experimental design and analysis, bio-equivalence and In-Vitro In-Vivo Correlation (IVIVC), and shelf-life projection following ICU guidelines