Nariaki Uemura
Mountain View,United States
Summary
Results-driven R&D program manager and leader with extensive experience in clinical development, development program management, research program management, portfolio management, and alliance management. Specializing in oncology and immunology, successfully managed projects across various modalities including small molecule, monoclonal antibody, antibody drug conjugates, and cell and gene therapies. Proven track record in drug discovery and development includes IND and NDA submissions. Global perspective with experience in the US, Japan, and China, overseeing clinical programs in the US, Japan, and Asia.
Overview
9
9
years of professional experience
Work History
Lead/ Alliance and Program Management
Xyphos Biosciences, Inc.
South San Francisco, United States
09.2023 - Current
- Company Overview: an Astellas cancer cell therapy company
- Co-leading multiple Cancer Cell Therapy research programs at Astellas with Innovation Leads targeting both hematological malignancies (in vivo convertibleCAR-T in collaboration with Kelonia Therapeutics) and solid tumors (Allogeneic convertibleCAR-T in collaboration with Poseida Therapeutics)
- Co-leading 2nd target selection for in vivo convertibleCAR-T in collaboration with Kelonia Therapeutics and allogeneic convertibleCAR-T in collaboration with Poseida Therapeutics and co-led two targets selection for allogeneic convertibleCAR-T in collaboration with Poseida Therapeutics together with biologists
- Co-leading and advancing the collaborative research programs with Kelonia Therapeutics and Poseida Therapeutics together with biologists and alliance managers in Business Development
- Managing and prioritizing Portfolio in Xyphos and Cancer Cell Therapy at Astellas
- Involved in licensing-in of specific clones from collaboration partner closely working with Business Development
- Co-led Universal Donor Cell (UDC)-NK cell team with biology lead that finally led to quick No-Go decision making for convertibleCAR-UDC-NK cells and contributed to switch Xyphos strategy from NK cells to T cells
- An Astellas cancer cell therapy company
Senior Manager/ Xyphos Biosciences, Research
Astellas Pharma Inc.
Tokyo, Japan
07.2023 - 08.2023
- Co-led multiple Cancer Cell Therapy research programs at Astellas
Associate Manager/ Development, Development Project Management
Astellas Pharma Inc.
Tokyo, Japan
04.2020 - 06.2023
- Global Project Management Lead and Japan-Asia Project Leader/Manager
- Led the Global Project Team through creating the overall plan from pre-clinical to early clinical development plan of an immunology program (ASP5502 [STING inhibitor]) that is currently in Phase 1 in the US as Global Project Management Lead together with Global Project Development Lead
- Led tacrolimus (calcineurin inhibitor) label update during Phase 3 and sNDA and obtained sNDA approval in Japan as Local Project Lead
- Supported Iveric Bio due diligence and acquisition from Development Program Management perspective
- Led out-licensing of peficitinib in specific Asian countries to a collaboration partner (Menarini) as a development lead closely working with Business Development
- Supported peficitinib (JAK Inhibitor) NDA in China for Rheumatology Arthritis that led to NDA approval as Local Project Lead for Japan-Asia (Phase 3, NDA, and Post-launch)
- Created Japan clinical development plan for two gene therapy programs in neuromuscular diseases (Phase 2 and Phase 1 respectively) as Local Project Manager together with Japan-Asia Project Lead
- Development Portfolio Management (Real-time Portfolio Management): Created and implemented the practice of Real-time Portfolio Management in Development to ensure, manage, and report budget, timeline, and risk closely working with project managers, Development Leadership Team, Corporate Strategy, and R&D Finance
- Collaborate with Portfolio Strategy/Corporate Strategy to calculate the pipeline and each product value
- Global Leadership Accelerator Program and Astellas Leadership Accelerate Program: Participated in corporate level new business idea creation program chaired by Chief Strategy Officer and Rx+ Head
- Astellas Leadership Accelerate Program (ALAP): Participated in Astellas leadership training program
- Research-Development Collaboration Initiative: Initiated collaborative scheme between Research Program Management, Translational Science, and Development Project Management
Research, Research Program Management (Dual job)
Astellas Pharma Inc.
Tsukuba, Japan
04.2021 - 08.2022
- Research Lead to lead and manage discovery-phase projects
- Co-led the discovery phase and final compound selection of a new type of antibody drug conjugate for solid tumors as Research Lead with pharmacologist and achieved the stage-up to pre-clinical phase for IND
- Supported a Venture Unit as Contact Research Lead support
Manager/ Development, Development Strategy and Management
Astellas Pharma China, Inc.
Beijing, China
05.2018 - 03.2020
- Local Project Manager/Lead in Mainland China, Korea, Taiwan
- Created the clinical development plan for China for a small molecular compound for solid tumors, and led China IND for early cell therapy programs for both hematological malignancy and solid tumor and a gene therapy program for solid tumors
- Led peficitinib (JAK inhibitor for Rheumatoid Arthritis) development in Rheumatology/Immunology in Mainland China, Korea, and Taiwan during Phase 3 and for China NDA
- Created the clinical development plan for China and led IND for fezolinetant in Gynecology
Associate/ Development, Japan Asia Clinical Development
Astellas Pharma Inc.
Tokyo, Japan
04.2016 - 04.2018
- Clinical Research Associate and Study Management support
- Managed Japan IND and Phase 1 study as Clinical Research Associate and Study Manager support for A7465/Enfortumab vedotin (Nectin-4 targeting Antibody Drug Conjugate) for urothelial cancer
- Supported Japan Phase 3 and NDA for fidaxomicin for Clostridioides difficile in clinical development
- Organized the collaboration team among Research, Medical and Development
- Organized the Development learning team
Education
Ph.D. - Pharmaceutical Sciences
The University of Tokyo
Tokyo, Japan09-2025
Master of Science - Pharmaceutical Sciences
The University of Tokyo
Tokyo, Japan03.2016
Bachelor of Science - Pharmaceutical Sciences
Osaka University
Osaka, Japan03.2014
Skills
- Program management and portfolio management
- Pre-clinical and clinical development
- Alliance management
Industryadvisor
Stanford SPARK (Translational research program at Stanford University)
Leadershipprogram
McKinsey Academy Asian Leadership Essentials (06/24 - 09/24)
Publications
Associations between prognosis and primary endpoint selection in phase III oncology trials in the United States, Nariaki Uemura, Shunshuke Ono, American Society of Clinical Oncology, 2024
Languages
Japanese
Native or Bilingual
Timeline
Lead/ Alliance and Program Management
Xyphos Biosciences, Inc.
09.2023 - Current
Senior Manager/ Xyphos Biosciences, Research
Astellas Pharma Inc.
07.2023 - 08.2023
Research, Research Program Management (Dual job)
Astellas Pharma Inc.
04.2021 - 08.2022
Associate Manager/ Development, Development Project Management
Astellas Pharma Inc.
04.2020 - 06.2023
Manager/ Development, Development Strategy and Management
Astellas Pharma China, Inc.
05.2018 - 03.2020
Associate/ Development, Japan Asia Clinical Development
Astellas Pharma Inc.
04.2016 - 04.2018
Ph.D. - Pharmaceutical Sciences
The University of Tokyo
Master of Science - Pharmaceutical Sciences
The University of Tokyo
Bachelor of Science - Pharmaceutical Sciences
Osaka University