Michael Janes Email & Phone Number

California, United States

San Francisco Bay Area

Directed the development and execution of analytical, pre-clinical, and clinical validation strategies for in-vitro diagnostic (IVD) products focused on minimal residual disease (MRD) for Breast Cancer and COVID-19.Led successful efforts for the CE-IVD clearance of four critical COVID-19 devices in multiple ex-US markets.

San Francisco Bay Area

Oversaw company-wide compliance with regulatory guidelines, industry standards, and internal policies. Implemented SOPs for process streamlining, generated manufacturing SOPs, and actively participated in QA/QC activities. Successfully led the conceptualization and execution of clinical projects, overseeing ongoing and planned pre-clinical and clinical studies. Conducted site visits, analyzed data, and presented actionable findings to internal teams.

San Francisco Bay Area

Led the design, development, optimization and validation of a molecular diagnostic assay for minimal residual disease (MRD) for breast cancer. Performed analytical development. Designed and performed clinical study analysis and reporting.Developed and optimized sample collection protocols, including isolation of nucleic acids from tissues, in concert with the development and optimization of molecular assays for nucleic acid detection.

San Francisco Bay Area

Genotype bacterial isolates for molecular epidemiology studies aimed at identifying risk factors and impact of bacterial characteristics on the transmission and pathogenesis of Mycobacterium tuberculosis (MTB). Protocol development and implementation towards the development of diagnostic assays for drug resistance in MTB, including cell phone-based nucleic acid amplification, nucleic acid isolation, biomarker selection, sample preparation for whole genome sequencing and fluorescent slide-based assays. Conduct performance analysis, optimize assay conditions, troubleshoot technical issues.Oversee laboratory activities for multi-institutional clinical study investigating transcription regulation in MTB. Develop protocol for RNA isolation, conduct in-country training for laboratory personnel. Monitor progress, coordinate communication between collaborators. Maintain MTB frozen specimen collection, coordinate specimen transfer between collaborators and oversee regulatory compliance for Risk Group 3 pathogens. Supervise and train students and postdoctoral fellows. Synthesize and communicate findings to multidisciplinary collaborators across institutions.

New Haven, Ct

Investigated translation and expression of novel transcripts in Trypanosoma brucei, previously excluded from genome studies due to small open reading frame size (<100 aa). Performed RNAi screen on 42 transcripts with proteomic (mass spec) data, including validation of RNAi knockdown and phenotypic observation, leading to the identification of 7 novel transcripts essential to T. brucei. Performed initial characterization experiments on essential small proteins, including localization studies using cell fractionation, GFP-tagging, immunofluorescent labelling and fluorescent microscopy. As part of a separate study, used transcriptome data from insect and bloodstream forms of parasite to identify regulatory proteins relevant to Trypanosome differentiation in vivo. Experimentally validated RNA-seq expression data via Northern blot analysis. Cloned constructs for inducible overexpression of transcripts of interest, performed expression studies and observed phenotypic variability in culture.

Developed report describing biomedical research incentives and their utility in driving innovation in biotechnology and pharmaceuticals for Neglected Tropical Disease. Evaluated relative advantages of several incentives and appropriateness of use. Synthesized research into 10-chapter guide for product developers, including academia, government agencies, biotechnology companies and non-profit product development partnerships (PDPs).

Portland, Oregon Area

Cultured mammalian bone marrow-derived stem cells for epithelial, neuronal, skeletal and cardiac muscle cell differentiation in vitro. Implemented automated system for the isolation of progenitor cells from whole bone marrow. Characterized differentiated cells for investigational and therapeutic transplantation in vivo. Developed and implemented molecular-based assays for detection of biomarkers and phenotypic characteristics using immunohistochemistry, flow cytometry and confocal microscopy. Performed administrative duties in the start up of core histology facility, including the recruitment and hiring of personnel. Prepared samples for histological analysis, analyzed slides. Procured new equipment for tissue processing, embedding and staining.Assisted with manuscript preparation for publication and drafting grant applications and contract reports for the U.S. Army and Defense Advanced Research Projects Agency (DARPA).

Mph, Epidemiology Of Microbial Disease

Activities and Societies: Yale Health Community Outreach & Education: President 2010-2011, Fundraising Chair 2009-2010. Foundation.

Bachelor Of Arts, Biology