Vylroh Advisory / Hiroshi Kawamoto MD
From unmet need to clinical evidence, regulatory strategy and approval — with hands-on experience across the full development pathway. That experience is what we bring to your challenge.
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Hiroshi Kawamoto, MD
Clinical Development Strategist · CEO, Vylroh Co., Ltd.
Who We Work With
Pharmaceutical Companies & CROs
Japan development strategy, PMDA consultation planning, clinical trial design review
Biotech Startups
Clinical validity assessment, development strategy, ongoing medical advisory
Digital Health & AI Companies
SaMD development strategy, medical AI evaluation, product medical oversight
Medical Device Companies
Clinical evidence strategy, healthcare system integration feasibility
Venture Capital & Investors
Medical due diligence, clinical feasibility assessment of portfolio companies
Overseas Companies Entering Japan
Japan medical environment, regulatory pathway, development strategy
What Makes This Different
Most advisors offer perspective. Dr. Kawamoto offers something rarer: the experience of having actually done it — from identifying an unmet need and negotiating directly with overseas manufacturers, to securing government grants, finding a Japanese import partner, building the trial organization, managing the data center, and delivering the approval package. Twice.
This capability is therapeutic-area agnostic. Oncology and pediatrics are clinical specialties; fetal medicine, digital health and other areas have also been supported. The foundation is clinical trial methodology, not disease knowledge alone.
Overseas manufacturer negotiation → grant acquisition → import partner → trial organization → data center → IIT execution → approval package. Two treatments approved as a result.
Clinical trial methodology training at JCOG across oncology, gynecology, urology, hematology and more. Methodology expertise that travels across disease areas.
Active clinician, investigator-initiated trial PI, Janssen TA Lead (Director), PMDA consultation experience, SaMD company advisor. No single vantage point dominates.
Core Expertise
Applicable across therapeutic areas. Drawing on experience as both an investigator-initiated trial PI and a pharmaceutical company TA Lead, we bring both sides of the development equation to your strategy.
Direct PMDA consultation experience across multiple indications, combined with hands-on experience bringing unapproved drugs through the Japanese regulatory pathway from overseas negotiation to approval.
Clinical expertise in pediatric oncology and solid tumors at the National Cancer Center and JCOG, combined with portfolio management experience as Janssen Oncology TA Lead. Available as KOL and clinical advisor.
Four years as advisor to a Japanese SaMD-approved digital therapeutics company, combined with active medical AI evaluation work. Grounded perspective on SaMD development, regulatory pathway, and clinical evidence strategy.
Advisory Examples
Unapproved drug introduction for pediatric malignancy
Led full cycle: overseas manufacturer negotiation, government grant acquisition, import partner identification, trial organization, IIT execution, approval package preparation. Approval achieved.
Fetal therapy: from advanced medical treatment to insurance coverage
Built research organization and data center, led advanced medical designation application, through to reimbursement. Two fetal therapies now covered by national insurance.
Oncology portfolio evaluation at Janssen
Evaluated 10+ early-stage global oncology assets for Japan development. Led 10+ indication go/no-go decisions. Structured and led development strategy for multiple approved compounds.
SaMD development advisory (4 years)
Four-year R&D advisor to Japan's first SaMD-approved digital therapeutics company. Direct involvement in regulatory strategy, medical evaluation and development planning.
Pediatric oncology development strategy — Bayer
Contracted consultant representing Japanese pediatric hematology/oncology physicians. Development strategy advisory and domestic KOL coordination.
PMDA consultation preparation
Multiple PMDA consultation preparation engagements across therapeutic areas. Briefing document review, clinical argument structuring, medical evidence framing.
Background
Full oncology portfolio management. Evaluated 10+ early global assets for Japan. Led 10+ indication decisions. BD asset evaluation and TA analyst management.
Clinical practice: pediatric oncology, hematology, soft tissue sarcoma. PI/coordinating investigator for multiple IITs (Phase I/II). 2 treatments approved from IITs conducted from zero.
Clinical trial methodology training. Protocol development and trial management across lung, gynecologic, urologic, hematologic, sarcoma and radiation oncology groups. Chair, Quality Management Subcommittee.
Built research organization and data center for fetal therapy trials (twin-to-twin transfusion syndrome, fetal pleural effusion). Advanced medical designation to insurance reimbursement. Both now covered under national insurance.
Advisor to Japan's first SaMD-approved digital therapeutics company. Active involvement in SaMD development strategy and medical evaluation.and medical evaluation.
Contracted consultant representing Japanese pediatric hematology/oncology physicians for development strategy and domestic KOL coordination.
Credentials
Policy Contributions
Contributed to MHLW guidance on clinical evaluation of anti-cancer agents for pediatric malignancies (2015). Co-author, JSNM guidelines on ¹³¹I-MIBG radiotherapy.
Advisory Process
Tell us your challenge. No cost, no NDA required at this stage. We'll give you an honest view of whether and how we can help.
We execute a mutual NDA before reviewing any confidential materials. Standard process, no friction.
We propose a scope and fee structure matched to your needs — single-session review, project engagement, or ongoing advisory retainer.
Work begins promptly after contract. Available by email, video call or in person in Tokyo.
Get in Touch
Initial consultations are conducted in confidence, at no charge. We will listen to your challenge and give you an honest assessment of whether and how we can help — regardless of therapeutic area.
Send an Inquiry →