Satya Sisto

• Devised and currently leading Innovation Award Program [Diagnostic Challenge] to fund and accelerate development of new diagnostic solutions for patients • Lead and manage multiple award programs to drive discovery and development of biomarkers and biomarker-based therapies • Oversee alliance portfolio of preclin-PhIII treatment evaluations and initiate commercial collaborations • Created strategy for and implemented new CRO function and revenue model within FARE, from business case to execution of several sponsored research contracts, leveraging build of world’s 1st food allergy R&D network and providing industry clients with specialized food allergy research services • Developed trackers and dashboards via SmartSheet to improve clinical operations recruitment and reporting, increasing efficiency and mitigating delivery risks; trained and guided research staff in successful pharma/biotech collabs • Led FARE’s Industry Advisory Council of major pharma and CPG, including Novartis and Genentech • Led business development of new research industry partnerships

• Supported Chief of Research Strategy & Innovation to build 50+ member R&D network, including academic institutions, research pioneers, and clinical care sites • Developed and led CRO requirements and evaluations to create FARE’s Data Coordinating Center and Biobank • Collected site feasibility and annual reviews across clinical network sites to accelerate onboarding, contracting, and IRB for sponsors • Created and led two biomarker award programs, one solely for food allergy diagnostics • Evaluated and implemented an online grants management system

• Led coordination and alignment of alliance partners and cross-functional global project teams for 2 drug indications in development and commercialization stages • Organized key strategic meetings with NIDA/NIH to advise MedAffairs team on new treatment development, removing barriers to launch Ph 2 • Managed complex timelines, scope, and budget internally and with alliance partners, tracking from task-level to governance review • Improved standard processes to drive efficiency, increase visibility, and improve cross-team communication • Presented timely and comprehensive project/program updates to senior management

• Created and managed successful IND application for Phase I first-in-man oncology clinical trial for orphan drug designation; planned project and led overall clinical operations for trial-startup and execution. FPFV achieved. • Project-managed and led development of 2 drug products across functions including medical director, CTM/CTAs, CMC, CRO staff, preclinical laboratories, veterinary tox, and manufacturers • Guided pre-clinical project development and managed non-clinical to clinical transition of product development • Led regular CMC and cross-functional team operations to modify project plans, study protocols, synchronize timelines, and define requirements • Developed and approved operational plans, including study monitoring, medical monitoring, communication, statistical analysis and data management plans

- Project management of device and drug clinical trials, Phase I-IV - Managed, mentored and trained clinical research staff of 12 nurses, coordinators and assistants - Liaised between FDA, industry, research compliance, hospitals, and patients for simultaneous device and drug trials - Monitored US academic centers for documentation, protocol adherence and regulatory compliance - Increased efficiency in project management strategies with standard operating procedures

- Submitted protocols to IRB, wrote consent forms and developed CRFs for multi-center use, data coordination and supply accountability - Educated patients and families in artificial pancreas device trials - Mitigated study risks with resourceful and creative problem-solving - Presented written and oral study results at academic conferences - Created research budgets for grants and industry trials

Wrote and edited scientific articles for publication for Stanford University researchers and industry startups

Translated complex genetic research findings into user and website content on personalized medicine, ancestry and epidemiology

Disruption has arrived in the pharmaceutical and biotech industry. Driven by artificial intelligence (AI) and machine learning (ML) technologies, new possibilities include everything from molecular design to predictive patient reaction models. However, despite a clear connection between the science of drug discovery, ML, and business decision making, there is a disconnect between the tools that exist and the specialists utilizing them. It’s only by bridging this gap that the full potential of this technology will be realized.