GLOBAL, 360 CONSULTING EXPERTISE

A global 360 consulting service providing versatile and comprehensive consulting based on more than 20 years of technical, operational, and regulatory experience in Oncology with focus on CLIAA, diagnostic, & prognostic assay development/validation/automation, biomarker target identification and assay development, regulatory affairs, medical affairs, and implementation of companion diagnostics and device studies globally including China and Australia.

VERSATILE

For over 15 years, I have not only provided technical expertise in genomics, in situ hybridization, IHC, anatomic pathology, microscopy, image capture and analysis but also have conducted competitive intelligence, comparative assessment of platforms and assays, diagnostic market trend, biomarker trending, assessment of new technologies, and have provide subject matter expertise for acquisitions of new technologies .

EXTENDED PORTFOLIO

My clients have spanned from venture capitalists, investment firms, leading consulting companies, entrepreneurs, government agencies, hospitals, reference laboratories, biotech, pharma, accelerator programs, incubators, KOLs, and CROs.

Vash ImmOnc Consulting Services

*Provide technical expertise in:

FISH, Genomics/molecular, liquid biopsy, NGS, RNAScope, various sequencing platforms, single-cell assays, IHC (including Multiplex IHC), CISH, ISH, anatomic pathology: including digital pathology & microscopy, set up and automation of: assays, platforms, image analysis.
Technical, operational, and regulatory expertise for setting up CLIAA labs, conducting CLIAA validations, composition and implementation of technical SOPs, development, implementation & execution of global technical competency & training programs, global implementation of assays and platforms.
Technical, operational, and regulatory expertise for validation and launch of global, multi-site, companion diagnostic, Device, & reproducibility studies for pharma and Device companies, preparation for SIV, SQV, OQ/PQ of the instrumentation, implementing training and competency assessment of the staff (including pathologists), and qualification of instrumentations, effective implementation of Design Control.
Regulatory expertise in the diagnostic, hospital, reference lab, clinical trials, CLIAA labs, & CRO setting in preparation for regulatory audits, conducting regulatory audits, & preparation of regulatory submissions (Pre-IND, IND, IDE, PMA).

*Conduct:

Competitive intelligence, comparative assessment of platforms and assays, assessment of market trend, biomarker analysis and trending, assessment of new technologies, and provide subject matter expertise for acquisitions of new technologies.

GLOBAL, 360 CONSULTING EXPERTISE

VERSATILE

EXTENDED PORTFOLIO

Vash ImmOnc Consulting Services

*Provide technical expertise in:

FISH, Genomics/molecular, liquid biopsy, NGS, RNAScope, various sequencing platforms, single-cell assays, IHC (including Multiplex IHC), CISH, ISH, anatomic pathology: including digital pathology & microscopy, set up and automation of: assays, platforms, image analysis.

Technical, operational, and regulatory expertise for setting up CLIAA labs, conducting CLIAA validations, composition and implementation of technical SOPs, development, implementation & execution of global technical competency & training programs, global implementation of assays and platforms.

Regulatory expertise in the diagnostic, hospital, reference lab, clinical trials, CLIAA labs, & CRO setting in preparation for regulatory audits, conducting regulatory audits, & preparation of regulatory submissions (Pre-IND, IND, IDE, PMA).

*Conduct:

Competitive intelligence, comparative assessment of platforms and assays, assessment of market trend, biomarker analysis and trending, assessment of new technologies, and provide subject matter expertise for acquisitions of new technologies.