Miles Y. Yeh

Experience

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  National Tsing Hua University

  Sept 2007 - Jul 2013

  Ph.D. student

  Decipher the molecular mechanism and clinical relevance of microRNAs that regulating ovarian cancer metastasis.

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  General Biologicals Corporation

  Aug 2013 - Jul 2017

  Associate Manager, R&D

  Lead the R&D team and bring multiple IVD products and LDT services to Taiwan and European markets.Design and development of in vitro diagnostic (IVD) products/assays for oncology and infectious diseasesCommunicate and establish scientific relationship with KOLs and manage the clinical studies for IVD medical devicesApply the government grants and execute the projectSchedule and monitor the product development timelineCoordinate projects across departmentsSupport regulatory unit for registration of IVD medical devices Show less

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  Mycenax Biotech Inc.

  Aug 2017 - Jun 2022

  Supervisor Of Product Development

  Act as project lead for cross-functional team and achieve notable out-licensing milestones of the biosimilar asset. Independently contribute to the regulatory affair activities for authority submission and consultation. Coordinate the process development, analytical, GMP production, and quality unit team for process improvement of the biological product during the clinical stage. Complete the asset & technology transfer to the asset buyer within the defined timeframe and resource.Manage the multi-national biosimilar PK equivalence trial and achieve the planned endpoints. Be in charge of the global authority consultation and obtain the authority acknowledgement to the trial design and endpoints with much less sample size.Product development: Generate project plan and negotiate for timeline and budget. Monitor the progress/budget and verify the quality of project deliverables. Integrate cross-functional team and breakdown into functional tasks to achieve the corporate goal. Escalate issue or risk identified and coordinate for mitigation. Evaluation of the potential in-licensing assets. Project lead: Coordinate in-house CMC tech transfer activities including process, analytical and quality units. Regulatory affair: Account for the consultation to regulatory authorities, including EMA, PMDA and TFDA, for development strategies of biologics. Identify and integrate the authority's feedback into CMC and clinical programs and generate actionable plans.Clinical development: Perform CRO audit, evaluation, and contract management. Monitor the trial progress & budgeting. Review and approve the study deliverables. Support the business licensing-out activities by hosting the due diligence and audit events and lead the technology transfer program to the buyers. Show less

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  AcadeMab Biomedical Inc

  Feb 2022 - now

  Director Of Product Development

  Lead young R&D team and achieve the US & TW IND clearance milestone of a new therapeutic antibody within the timeframe and resource. In charge of the early stage CMC, Non-clinical, and Clinical development activity of the therapeutic biologics.Pipeline Management: Monitor the progress/budget and verify the quality of deliverables for pipeline development. Review internal and external technical deliverables. CDMO and CRO audit, evaluation, and contract management. Support the fundraising. Project Management: Oversee product development activities and set up essential project master files. Establish SOP and the project management function from scratch. R&D Staff Management: Act as trainer for young staff for essential knowledge for biologics development. Allocate relevant tasks and resources for the organic growth of the staff. Breakdown corporate goals into personal and review the staff performance. Show less