Christopher Treleaven, LATg, GLP, GDP

Key Responsibilities CRO Management and Oversight • Serve as the primary operational point of contact for CROs conducting toxicology, safety pharmacology, and other nonclinical safety studies • Monitor study conduct from protocol development through reporting and archiving • Coordinate technical reviews, site visits, and follow-up documentation with internal scientific leads and QA. • Travel to CRO sites to perform technical assessments, monitor key study phases, and prepare site visit reports documenting observations and follow-up actions. Internal Study Support • Coordinate and monitor the conduct of internal and exploratory nonclinical safety studies • Facilitate communication between internal scientists, project managers, regulatory leads, and leadership to ensure alignment on study objectives, timelines, and deliverables. • Manage logistics for test article and sample handling, data collection, and document archiving. Study Tracking & Logistics • Manage operational activities including study contracting, reviewing and executing SOWs, generating study and PO numbers, and coordinating with Finance and Legal as needed. • Coordinate test article and sample shipments to and from CROs, ensuring proper storage before, during, and after delivery. • Oversee financial tracking by monitoring installment-based study invoices, ensuring accuracy, timely approvals, and alignment with approved budgets. • Track study progress and maintain oversight of contract deliverables and milestone-based payments to support accurate forecasting and project planning. Documentation & Compliance • Coordinate and manage QC review of study protocols, reports, and regulatory documents • Maintain study documentation in compliance with internal SOPs, GLP standards, and international regulatory guidelines (FDA, EMA, ICH). • Maintain regulatory documentation in electronic systems (e.g., Veeva Vault, SharePoint), ensuring version control, traceability, and audit readiness.

Evaluating business operations within contracting and services procurement to identify opportunities for greater efficiency. Assessing both existing workflows and potential system integrations aimed to streamline processes Optimizing what’s in place and implementing new tools. Reducing friction, saving time, and ensuring contracting and procurement operations run as smoothly and cost-effectively as possible. Continuing to evaluate additional business processes as needed for optimization.

• • Assisted nonclinical toxicology strategy for cross-functional gene therapy development teams. • Executed GLP-compliant toxicology studies with global contract research organizations (CROs). • Ensured scientific integrity and regulatory compliance in all toxicology deliverables. • Managed nonclinical data analysis, regulatory documentation, and SEND submission preparation. • Supported IND and CTA regulatory filings with timely toxicology packages. • Negotiated vendor contracts, agreements, and statements of work (SOW) in collaboration with Finance. • Directed sub-vendor selection, oversight, and specialized assay implementation. • Maintained up-to-date expertise in biologics, gene therapies, and neuroscience drug development. • Developed, monitored, and optimized toxicology budgets for operational efficiency. • Delivered study outcomes within set timelines and resource constraints. • Addressed and resolved compliance issues identified in internal and external audits. • Supported inspection readiness for GLP regulatory audits and submissions. • Led cross-functional scientific training to align teams on program objectives. • Collaborated with project teams to align toxicology strategy with clinical goals. • Fostered knowledge sharing and team growth across nonclinical functions.

• Directed preclinical safety activities for ex vivo gene therapy programs advancing to clinical trials. • Developed and implemented IND/CTA regulatory strategies supporting early clinical development. • Managed budgets, contracts, and preclinical in-life studies for gene therapy candidates. • Oversaw CRO selection, contract negotiation, and ensured timely, compliant deliverables. • Established in vivo infrastructure, protocols, and SOPs aligned with quality standards. • Led initial internally conducted GLP-like IND-enabling study for Pompe gene therapy program. • Unified Preclinical, Legal, and Finance processes into an integrated study management framework. • Delivered study outcomes supporting IND and CTA submissions to regulatory agencies. • Championed development and maintenance of best practices for operational efficiency. • Promoted cross-functional alignment between research, legal, and finance stakeholders. • Enhanced data integrity through robust review and streamlined decision-making processes. • Ensured regulatory compliance throughout nonclinical study planning and execution. • Trained junior staff on protocol development, data analysis, and compliance. • Implemented quality management systems for continuous operational improvement. • Facilitated internal and external audits, proactively addressing process gaps.

• Managed large, multi-species vivarium operations, overseeing staffing, training, and in vivo research studies. • Directed laboratory expansions, collaborating with preclinical teams on gene editing and immuno-oncology initiatives. • Led companywide training programs to ensure compliance with federal, state, and local regulations. • Chaired Institutional Animal Care and Use Committee (IACUC), enforcing and refining regulatory compliance policies. • Built and coached high-performing teams to support robust study execution and operational excellence. • Provided cross-functional support for gene therapy and immuno-oncology preclinical development. • Developed and updated SOPs to enhance quality and animal welfare compliance standards. • Partnered with study directors to optimize in vivo protocols and experimental design. • Ensured timely completion of in vivo studies within budget and resource constraints. • Drove continuous improvement initiatives for vivarium processes and animal care practices. • Oversaw sourcing and onboarding of laboratory equipment and animal models. • Maintained vivarium accreditation and prepared for regulatory inspections and audits. • Resolved audit findings, implementing corrective and preventive measures for compliance. • Fostered a culture of safety and scientific rigor among in vivo research staff. • Supported onboarding and mentorship for new scientific and technical team members.

o • Managed daily vivarium operations in strict adherence to all regulatory and study requirements. • Partnered with scientific teams to design and execute PK and transporter in vivo studies. • Supported nonclinical operations contributing to accelerated FDA approval of Exondys51. • Developed and implemented comprehensive training programs for technical staff and scientists. • Authored and updated IACUC policies to enhance regulatory compliance and program oversight. • Oversaw animal care, facility safety, and study protocol compliance. • Monitored study progress, ensuring milestones and deliverables were met on schedule. • Collaborated with cross-functional teams for seamless nonclinical program execution. • Supervised maintenance of detailed study records and regulatory documentation. • Facilitated inspections and audits, proactively addressing compliance gaps. • Optimized resource allocation to support multiple simultaneous in vivo projects. • Drove continuous improvement initiatives in operational workflows and compliance. • Provided mentorship and onboarding for new vivarium and research staff. • Ensured adherence to institutional, federal, and state animal welfare guidelines. • Implemented corrective actions based on internal audit observations and external regulatory feedback.

o Collaborated with a team in the development and validation of therapeutic strategies to target Amyotrophic Lateral Sclerosis, Angelman Syndrome, and Alzheimer’s Disease using discovery gene therapy. o • Led research and validation of gene therapy approaches for neurodegenerative disease indications. • Designed, supervised, and expanded complex in vivo study protocols and surgical methodologies. • Directed multi-species preclinical studies to support translational neurobiology research. • Developed and validated novel preclinical models for neurodegenerative disorders. • Authored and presented peer-reviewed research at prominent national and international scientific conferences. • Mentored and trained scientific staff on in vivo techniques and neurobiology methods. • Collaborated cross-functionally to integrate neurobiology data into pipeline development strategy. • Published research findings in top-tier neuroscience and gene therapy journals. • Advanced molecular, behavioral, and imaging endpoints for CNS disease models. • Applied cutting-edge techniques to optimize gene delivery and target engagement. • Ensured compliance with regulatory and ethical standards in animal research operations. • Managed laboratory operations and enhanced technical capabilities for preclinical testing. • Secured competitive research funding through successful grant proposals and collaborations. • Supported IND-enabling studies for gene therapy candidates targeting CNS disorders. • Promoted continuous learning to integrate new scientific and technological advances in neurobiology.

o • Provided technical support for preclinical in vivo studies and facility operations. • Assisted with daily care, handling, and dosing of multiple laboratory animal species. • Ensured adherence to all IACUC and animal welfare protocols. • Maintained accurate study records, logs, and regulatory documentation. • Supported setup, execution, and sample collection for pharmacology and toxicology studies. • Monitored animal health, welfare, and facility sanitation procedures. • Calibrated and maintained lab equipment for consistent study quality. • Coordinated supplies, reagents, and sample inventory for ongoing projects. • Participated in internal audits to support regulatory and quality compliance. • Trained on SOPs, safety guidelines, and facility best practices. • Supported necropsy and routine tissue sample processing. • Assisted in preparing reports for senior scientists and regulatory submissions. • Followed GLP standards and contributed to facility inspection readiness. • Collaborated with research staff to optimize animal study protocols. • Contributed to process improvements in lab and vivarium operations.