Rachel Salazar

Ushering in a new era for treating diseases with high unmet needs.

Project Insulin has one clear mission: To ensure that everyone who depends on insulin has access to it. The strategy is simple, create a biosimilar insulin and sell it directly to patients at cost, regardless of insurance status.

• As part of the Executive Leadership Team, played an integral role in shaping and driving company strategy, resulting in an oversubscribed $108M Series B, a $165M Series C, and a successful $362M IPO. • Serve as global program head for ficerafusp alfa, directing development strategy, leading program to a Ph3 in 1L HNSCC through comprehensive integration of translational, regulatory, clinical, CMC, medical affairs and commercial strategies with a potential market opportunity targeting over $1B in peak revenues. • Directed team to pursue bold regulatory strategies leading to leveraging Project FrontRunner, successful negotiations around Project Optimus, CDRH CDx alignment, and achieving breakthrough designation (BTD) in 1L HNSCC. • Brought forward additional indication strategies based on strong scientific rationale and high probability of success (POS), providing additional LCM opportunities for additional revenues. • Management of Research and Translational Medicine leading development of internal research strategies and established external collaborations with academic institutions and key opinion leaders to advance clinical development optionality and expand the intellectual property portfolio. • Led early-stage pipeline activities focused on bifunctional assets and T-cell engagers. • Manage Program Management & IT to establish operational excellence and drive efficiencies. • Partner with Medical Affairs and Commercial for pre-launch planning to ensure critical data and information needed at time of launch to ensure rapid capture of potential market. • Established operational framework for organization including decision-making, budgeting, and reporting. • Regularly interact with board of directors, as well as external investors.

• Develop and manage early phase portfolio for start-up oncology company focusing on modulation of the tumor micro-environment. • Responsible for Program Leadership as well as Operations, Portfolio and Alliance Management. • Work closely with COO and Business Development on strategic partnerships supporting the long-term company strategy.

• Served as global project lead for bintrafusp alfa (M7824), a bifunctional anti-PD-L1/TGF-β trap, guiding the program from pre-IND to Phase 3 and influencing decisions on indications, combinations, and strategic direction. • Led Portfolio Combination Initiative as part of the Global Clinical Oncology Leadership Team to ensure maximization of portfolio opportunities and focus on franchise growth. Shaped indication prioritization, lifecycle management, and competitive positioning for multiple assets, directly influencing revenue potential and market strategy. • Directed a major company initiative aimed at accelerating early-phase clinical development and improving portfolio management, leading to the implementation of a new organizational operational model, a reduction in time to IND from candidate selection by 30%, and reduction in associated operational costs. • Fostered strategic collaborations with key academic centers such as MD Anderson and the National Cancer Institute, enabling opportunities to assess unique combinations and generate critical clinical and translational data. • Received the 2015 Global Clinical Development Award in recognition of developing enterprise-wide solutions that facilitated globally aligned decision-making. • Provided guidance to external innovation / BD team on potential co-development programs.

• Directed global project teams and clinical sub-teams for both early- and late-stage programs, maintaining an operational focus on achieving key objectives and managing multimillion-dollar budgets. • Demonstrated expertise in late-stage program planning and regulatory NDA submission strategies, including the Phase 3 orteronel (TAK-700) program in prostate cancer. • Oversaw late-stage lifecycle management for Velcade®, including shift to subcutaneous delivery, a more patient-centric regimen, while partnering with Commercial and Medical Affairs to ensure rapid uptake. • Helped drive indication expansion efforts for ADCETRIS® in CD30 expressing CTCL, including development of a CDx leading to increased sales revenues for the brand, which exceeded $1.3B in 2024. • Guided pre-IND assets, such as TAK-659, a dual SYK/FLT3 inhibitor through IND submission and Phase 1 execution, and progressed TAK-580, a pan-RAF inhibitor into Phase 1 development. • Lead various workstreams to improve the efficiency and output of the Drug Development Management group

• Led the creation of an improved operational framework for managing projects within the research department. Reduced number of low POS and follow-on programs to unvalidated clinical targets, leading to a 15% reduction of the portfolio and increasing the focus on high-potential opportunities. • Served on both the leadership and biotherapeutics review teams, updating senior leadership about achievements and upcoming major project milestones in areas such as Inflammation and Immunology, Oncology, CVMED, and other therapeutic areas. • Contributed to the development of the business strategy for the global biotherapeutics technologies unit. • Managed research partnerships between Pfizer and outside organizations.

• Managed cross-functional project teams for early-stage pipeline programs. Resulted in productive and efficient teams focused on delivering program goals. • Led EMA approval of Opgenra in and increased potential for $MM in revenue. • Effectively led Phase I safety study in osteoarthritis (OA) program and initiated preparation for Phase II • Program lead for new process development programs to introduce new & improved cell culture and purification processes • Streamlined and focused development programs by contributing to the portfolio strategy and assessing opportunities for new programs with market opportunities ranging from $100M to $1B. • Maintained budgets, developed timelines and led strategic assessments for ongoing programs • Involvement with regulatory submissions for both drug (biologics) & device applications for US, EU and ROW

Managed various development programs in the area of biomaterials for orthopedics. • Worked to develop biologics/cellular based programs to enter new area of biomaterials market • Successfully led the development and submissions of newly launched products: Beta-BSM, Gamma-BSM and EquivaBone • Organization of project timelines, budgets, resources & teams to successfully complete new product development projects in orthopedics market • Managed Regulatory Affairs and contributed to various regulatory filings including 510(k)s & INDs • Improved product development cycle by creating and implementing new Quality Systems procedures such as Design Control, Change Control and Risk Management • Involvement with various FDA & ISO audits

Led development teams. • Acted as project leader on multiple sustaining and development engineering projects • Execution of project objectives by coordination of supporting functional groups such as Regulatory, Quality, Manufacturing & Marketing

Focus on tissue engineering and biotechnology products and processes