Bindu Bennet

• Lead a team that provides diligent nonclinical safety, DMPK, clinical pharmacology and pharmacometrics strategies and assessments, risk/benefits analyses of molecules across research, development, and post-marketing, ensuring adequate support and conduct of all relevant studies in accordance with regulatory requirements and leveraging innovative tools and technology including AI. • Lead the team by setting technical and organizational vision for the department, providing direction for strategy and implementation, establish competency level, utilize available talent, plan for future growth, recruit, retain and develop high quality staff to ensure the future success. • Served as member of R&D leadership team responsible for scientific and regulatory strategy, and as a member of governance committee that oversees R&D up to proof of concept for BI’s Inflammatory disease portfolio (respiratory, immunology, dermatology, rheumatology, gastrointestinal etc). Strong collaboration with Research, CMC, Clinical Pharmacology, Experimental Medicine, and Clinical Development. Partnered with discovery teams to integrate target biology, safety, and translational strategy early in candidate nomination. Defined preclinical-to-clinical transition strategies bridging target validation and IND readiness. • Ensured compliance with all required training, safety, regulatory, HR, laboratory notebook and intellectual property activities and corporate policies

• Served as member of R&D leadership team responsible for cross-portfolio scientific and regulatory strategy. Developed, led and executed scientific strategy and IND-enabling preclinical and clinical development across multiple therapeutic areas. Partnered with discovery teams to integrate target biology, safety, and translational strategy early in candidate nomination. Defined preclinical-to-clinical transition strategies bridging target validation and IND readiness. • Provided diligent nonclinical safety assessments and risk/benefits analyses of molecules across research, development, and post-marketing, ensuring adequate support and conduct of all relevant studies in accordance with regulatory requirements and leveraging innovative tools and technology including molecular and digital pathology, and AI. Collaborated with computational and modeling teams to assess translational biomarkers, exposure-response models, and predictive safety signals. • Led the team by setting technical and organizational vision for the department, providing direction for strategy and implementation, establish competency level, utilize available talent, plan for future growth, recruit, retain and develop high quality staff to ensure the future success. • Member of internal and external nonclinical safety committees. Strong collaboration with Research, CMC, Clinical Pharmacology, Translational Medicine, and Clinical Development. • Ensured compliance with all required training, safety, regulatory, HR, laboratory notebook and intellectual property activities and corporate policies

• Set the vision for the department and lead a team of over 30 toxicologists, across different functions such as project toxicology, discovery safety, and mechanistic and investigative laboratory that develops innovative tools to advance R&D, located across Sweden, UK, Maryland & Boston. • Provide expert guidance on the interpretation and management of toxicological challenges arising in programs. Represent nonclinical safety and provide expert input into senior-level management, governance body activities and global safety reviews. • Set and execute overall nonclinical safety strategy across a wide-ranging portfolio that covers all modalities including all novel modalities, ensuring the highest quality standards consistent with regulatory guidance and evolving industry standards in the field. • Ensure appropriate resourcing, timely and cost-efficient toxicological support for completion of all toxicology programs, studies and reports, toxicology content for regulatory submissions, and due diligence efforts. • Resource/budget planning and management, performance monitoring, maintaining high standards for novel tools/technologies/resources to maintain a state-of-the-art approach • Build and maintain a robust and sustaining department, mentor the team, develop skills and knowledge that align with portfolio needs. • Monitor external environment, guide strategy and process to stay in the forefront of advances in technology, modalities, tools, regulations, and guidance. • Lead and influence the nonclinical development field, engaging in discussions with industry groups such as BioSafe, Boston Area Pharmaceutical Toxicology Group, ACT, STP, and regulatory authorities to impact the best practices, streamline regulatory expectations, and address opportunities to accelerate the development of novel transformative medicines that may require more creative, less traditional, or guideline-based approach to nonclinical drug development while assuring safety.

o Develop, implement, and manage overall nonclinical development strategy and plans for studies conducted internally or at CROs for discovery, preclinical, and clinical programs o Conduct global vendor assessment to enable timely/successful execution of nonclinical plans o Provide budgets for bioanalytical/PK, pharmacology and toxicology studies o Collaborate closely and align with clinical research, clinical pharmacology, translational research, medical affairs, program management, regulatory, biology, quality, and CMC tech ops o Author, review and approve regulatory submissions and responses to health authority questions o Provide nonclinical expertise for interactions with health authorities, vendors, and partners o Effectively engage key opinion leaders and contractors o Serve as toxicology lead in several discovery and development phase project teams o Successfully lead the group by mentoring/coaching scientists and people leaders

1. Preclinical development project team leader: responsible for overall strategic direction of project, cross functional alignment and decisions; executes IND enabling studies, ensures drug supply and distribution for trials, and executes clinical pharmacology plan; ensures alignment on strategy, goals, decisions, key messages, publications and disclosure plan, across various functions, project team, and organizational leadership including governance committees and executives; works with the project manager to ensure objectives and timelines are met and the team stays on track; keep organizational leadership and governance committees informed of the progress, and any risks, challenges, and issues that may arise; provide perspective and propose risk mitigation and issue resolution strategies as necessary; works with the team on resourcing estimates and timely and successful execution of goals; works with organization’s leadership team to secure the required resources for the program’s success; proactively identifies potential issues and makes appropriate contingency plans to handle these; integrates information across functions to drive efficient decision making.; helps resolve any conflicts especially in areas that are interdependent; solicits input from subject matter experts as and when needed 2. Pharmaceutical development team lead: represents the following functions in the core team: Clinical Supplies, Clinical Pharmacology, Drug Substance, Drug Product, DMPK, Regulatory affairs, Quality & Toxicology. 3. Head of nonclinical safety: build the function by hiring/mentoring/coaching colleagues; develop/implement overall toxicology strategy/plans at CROs for al discovery/preclinical/clinical programs; global vendor assessment to enable timely/successful execution of tox plans; provide budgets for tox studies; collaborate/align with clinical, DMPK, pharmacology & CMC; author regulatory submissions and responses; provide toxicology expertise for HA interactions