Scientific Governance
Scientific expertise, distinct roles
External advice on scientific direction and clinical translation, together with internal scientific and technical review, informs HUAHE’s project assessments, management decisions and delivery at each project stage.
Complementary perspectives
Three mandates, One connected review framework.
SAB
Scientific Advisory Board
External scientific adviceRecommendations inform the Board of Directors, internal scientific reviewers and management.
The SAB is a board-level expert advisory body providing non-binding advice on HUAHE’s long-term scientific direction. It examines priority molecular targets and radiopharmaceutical technology pathways, identifies critical evidence gaps and highlights major scientific risks.
Areas of responsibility
- Scientific direction
- Advise on long-term research priorities and the scientific rationale for potential development opportunities.
- Targets and technology pathways
- Review priority molecular targets and radiopharmaceutical approaches, including their supporting evidence and key scientific uncertainties.
- Evidence gaps and risks
- Identify the additional evidence needed to assess an opportunity and the major scientific risks that warrant further investigation.
Committee contributions
- Scientific direction recommendations
- Technology pathway reviews
- Evidence-gap and scientific-risk summaries
- Meeting minutes or written recommendations
Responsibility boundary
The SAB does not assume company management, quality-approval or project-decision responsibilities. Its advice is non-binding and does not constitute project endorsement.
CTAB
Clinical Translation Advisory Board
Clinical translation adviceAdvice informs project screening, clinical validation planning and collaboration with relevant institutions.
The CTAB is a board-level advisory body connecting clinical needs with radiopharmaceutical development. It assesses indications, potential patient benefit, evidence requirements and clinical validation pathways in the context of real-world care settings.
Areas of responsibility
- Clinical needs and translational value
- Consider unmet needs, potential indications, patient benefit and clinical priorities when assessing research opportunities.
- Evidence and clinical validation
- Advise on evidence requirements, investigator-initiated trial (IIT) design, endpoints and clinical validation pathways.
- Development and implementation
- Bring clinical perspectives to target and radiopharmaceutical discovery, radionuclides, chemistry, manufacturing and controls (CMC), translational research, and industrialization.
Committee contributions
- Clinical input to project screening
- Indication priorities and evidence requirements
- IIT and clinical validation design recommendations
- Clinical implementation and industry collaboration recommendations
Responsibility boundary
Clinical research and medical care remain with the responsible institutions; business decisions remain with management. The CTAB does not replace sponsors, investigators, ethics committees or regulatory authorities.
SC
Scientific Committee
Internal scientific & technical reviewDocumented recommendations support stage review and decisions by the General Manager’s Office.
Reporting to the General Manager’s Office, the SC conducts internal scientific and technical reviews using external advice, project records and execution evidence. Reviews are organized by topic, with evidence documented and reviewers recusing themselves where conflicts of interest arise.
Areas of responsibility
- Study design and technical feasibility
- Review scientific questions, study plans and evaluation criteria, together with technical risks and alternative approaches.
- Critical data and stage review
- Assess the sufficiency, consistency and suitability of critical data to support a documented stage recommendation.
- Project-specific scientific support
- Provide technical input across innovative radiopharmaceuticals and IITs, molecular imaging, radiochemistry and automated synthesis, and radionuclide separation.
Committee contributions
- Written recommendations to proceed
- Written recommendations for further work
- Written recommendations to pause
- Project-specific technical input, as requested
Responsibility boundary
Management retains business and project decisions. Independent QA retains its quality responsibilities, and licensed entities retain their statutory responsibilities.
From professional advice to project delivery
Advice informs review. Decisions guide execution.
External advice
The board-level SAB and CTAB provide scientific direction and clinical translation perspectives.
Internal review
The SC conducts scientific and technical review and documents traceable stage recommendations.
Management decisions
The General Manager’s Office makes project decisions and allocates resources under delegated authority.
Project execution
Cross-functional teams execute under the Project Master Plan and produce deliverables against agreed acceptance criteria.
SAB and CTAB members contribute in their individual professional capacities; their affiliations do not imply institutional endorsement. Their advice is non-binding. Authorized management retains business and project decision rights. Independent QA, compliance and radiation-safety duties, and licensed entities’ statutory responsibilities remain unchanged. This framework does not alter the responsibilities of sponsors, investigators, healthcare professionals, ethics committees or regulatory authorities.
Connect with HUAHE
Bring your scientific question to HUAHE
Start with a non-confidential discussion of your project, the evidence available and the next decision you need to make.