Shiva K.

Therapeutic Areas: Rare diseases focused primarily on Oncology, autoimmune diseases Modalities: circular RNA LNP delivery Reporting to Chief Strategy Officer, was responsible for establishing and developing the program management and program leadership team, program strategy, and portfolio governance. • Served as program lead for the Orna’s In vivo CD19 panCAR program, successfully completed a pre- IND submission, and developed and executed IND-enabling study plans. • Developed first-in-human clinical strategy and site engagement. • Built program management principles at Orna, including team model for effective program teams. • Established and led the portfolio and technology review sessions to help streamline the pipeline and platform initiatives with periodic reviews and input from governance committees.

Therapeutic Areas: Rare diseases focused primarily on CV, CNS, NMD Modalities: Gene Therapy • Reporting to Chief Strategy Officer, with dotted line reporting to the president, was responsible for portfolio governance, program strategies, resource planning, and program management team development. • Collaborated with Bayer and AskBio leadership team and developed the pipeline strategy for AskBio. • Established and led the early portfolio strategy and the development strategy committees to ensure alignment of the portfolio programs with the pipeline strategy and organizational objectives. • Built and led a team of seven global program managers and ensured integration into the right programs and projects to support the pipeline strategy. • Established PM best practices to standardize and streamline operations across the various programs. • Led the LGMD2I/R9 team through IND submission and clearance and trial initiation. • Developed and managed the annual and long-range planning for budget and hiring strategy for the therapeutics organization to ensure effective resourcing of programs.

Therapeutic Areas: Rare diseases focused primarily on CNS, Liver, Ophthalmology and Blood Disorders Modalities: Gene Therapy and Gene Editing Reporting to Head of Program Management, was responsible for CNS portfolio programs and program lead for the metachromatic leukodystrophy (MLD)-HMI-202; led the R&D strategy workstream and was the only alliance manager overseeing all external partnerships. • Established and led the R&D strategy team and developed a three-year R&D outlook aligned with finance and resource planning, which was endorsed by the board. • Led HMI-202 through successful pre-IND meeting and IND-enabling studies. • Created and led portfolio governance forums to ensure pipeline and platform activities were aligned with the three-year strategy. • Managed key strategic partnerships and ensured alignment of internal resources with collaboration deliverables and timelines.

Reporting to the Head of Procurement, acted as head of R&D sourcing, a new role created in the organization. As part of this role developed R&D sourcing strategy that was fully aligned with the overall R&D strategy of Biogen. • Established sourcing council with representation from R&D leadership to ensure alignment of sourcing strategy to R&D goals. • Developed and optimized policy compliant human biological sample procurement. • Developed a track record in delivering projects that address demand management, process improvements, vendor consolidation, and cross-category optimization. • Established key performance indicator and service level agreements and chaired strategic vendor management meetings for business-critical vendors.

Undergraduate Student at Nizam College.