Poona University

Massachusetts Institute of Technology

Nortwestern University Medical School

Consultant at Thermo Fisher Scientific

San Ramon, California, United States

Helping with the launch of clinical diagnostics assays including SARS CoV-2 testing efforts

Thermo Fisher Scientific

Consultant

Company enabling high- throughput easy to use automated systems for health & safety setting

LexaGene

Member Board Of Directors

Investor in small biotech and bio pharma start-ups. Investor in InvVax, Seal Rock Therapeutics, Mission Bio, First Light Diagnostics, Combinati etc.

Life Science Angels

Member

Building highly multiplexed target detection and sequencing applications on a  high throughput, single molecule/single fluorophore detection system for understanding cellular processes, changes due to external stimuli, disease prognosis, drug  discovery, treatment selection and patient management by deciphering complex biological processes. Enabling single molecule detection of DNA, RNA and protein with a multi-analyte detection system that will eliminate the need for target amplification.  Enabling low-cost Cluster & Single Molecule Sequencing to enable a $10 genome

Apton Biosystems Inc.

Chief Scientific Officer & Chief Regulatory Officer

Biology for Global Good LLC, was started to serve as a Strategic Consulting service that will work with biotechnology & pharmaceutical companies and non-profit organizations to enable the development, launch and implementation of policies and products that improve diagnostics, public health and public safety. The consulting service will provide expertise for the development & implementation of human & animal diagnostics, genetic testing for crime scene investigations, industrial safety testing, environmental safety testing & food safety testing using cutting edge molecular biology based technologies. -access to a very large base of experienced professionals in the molecular testing space. Projects included:Providing a leading software company with a market intelligence, potential and scope for data interpretation needs in the Personalized/Precision Medicine and CDx. testing.BD Advisor to  Advanced Cell Daignostics to help position their novel in situ hybridization technology for RNA detection (RNAScope) in the translational research and diagnostic arenas -analysis tumor and rare cell detection in cancer and infectious diseases.BD consultant to Bio-Rad laboratories to enable the use of droplet digital PCR as a diagnostic tool by working with key opinion leaders in cancer therapeutics, transplant medicine and infectious diseases. Regulatory affairs consultant for Bio- Rad BCR-ABL assay.BD for Vibrant Health a company with a novel peptide/PNA microarray for Diagnostics- infectious diseases, auto- immune and allergy,  gut microbiome.BD for DxNow a company that has novel Surface Plasma Resonance based methodologies for molecular detection. Developing a portfolio of applications that will be a best fit for this novel technology.BDAdvisor to RxFulcrum for development of novel platform enabling connectivity amomg companies, CROs and consultants. BD& Regulatory strategy advisor to LynnTech. BD consultant to Yield Engineering Systems for Life Sciences Application’s

Biology For Global Good LLC

Founder & President

Work with Regulatory Affairs to ensure that documents provided to the FDA (pre-submissions, IDEs, 510(k) and PMA submissions, CE-IVD submissions etc.) contain Analytical & Clinical Validation studies that are in compliance with test plans & acceptance criteria. Develop guidelines for IVD submissions studies  with clear test plans, well defined acceptance criteria, good designs that are adequately powered to meet expectations. Review IVD study reports prior to submission to ensure technical compliance. Submissions for Infectious Diseases and Oncology related applications. Also responsible for ensuring that Health Care Professional and marketing related documents are in alignment with assay claims and Cepheid's Code of Ethics.

Cepheid

Senior Director, Technical Compliance, Regulatory Affairs

Define areas in human biology and diagnostics that would be most impacted by Apton's highly innovative technology platforms. Build product concept validation, estimate market size and enable collaborative projects by discussions with key opinion leaders in  academia, industry, clinical translational research and molecular diagnostics.  Presented to Venture Capital firms to raise Series A funding. Enabled series seed funding of $10M.

Chief Scientific Officer, Consulting

Positioning droplet digital PCR as a diagnostic tool in molecular diagnostics areas of Oncology, Transplant and Infectious Diseases.

Bio-Rad Laboratories

Consultant for Business Development- CLIA Applications

Positioning RNAScope as a molecular tool for translational research and potentially a  Diagnostics tool.

Advanced Cell Diagnostics

Science Advisor for Business Development- CLIA Applications

Advisory Board on Biodefense to DHHS. The board was created under the Pandemic and All-Hazards Preparedness Act of 2006 and chartered in May 2007. Since then, the board has provided recommendations on a variety of federal disaster preparedness and response issues. The issues include, the effectiveness of the National Disaster Medical System and federal management of the research and development medical countermeasures – the medicines, vaccines and equipment needed to protect health from bioterrorism and pandemic disease. In addition, the board assessed the department’s progress in integrating behavioral health into emergency preparedness and response activities. HHS incorporated the NBSB recommendations in the first federal disaster behavioral health concept of operations which ASPR recently released. The board also has recommended ways to improve the nation’s ability to mobilize scientific resources quickly and comprehensively in support of public health emergency response

DHHS National Biodefense Science Board

Managed R & D groups that develop applications and validated solutions to improve the human condition. Developed companion Dx applications for personalized medicine. Worked on developing a gene expression profiling assay that would predict response to an immunotherapeutic (collaboration with GSK). Worked on acquisition of Acrometrix (a company that made controls) and PinPoint Genomics, a company that had a CLIA assay that was an aid to staging of lung cancer. Developed a Sanger sequencing assay for HIV-1 mutation detection for use in South Africa. Developed LDT/RUO assays on the TaqMan Array for infectious disease assay panels fro GI infections and antibiotic drug resistance. Developed proof-of -concept applications on the Personal Genome Machine for study of HIV-1 mutations, cancer mutations,metagenomics and infectious disease panels.  Developed key applications that ensure safe food and water supply, tests for surviellance of biothreat pathogens in the environment, help maintain the quality of pharmaceutical products and improve human & animal diagnostics. Desigbed assays for the H1N1 virus.launched and obtained AOAC and AFNOR validation for major pathogen detection kits.Designed assays for the E.Coli O104 outbreak strain in EU.Developed key nucleic acid extraction formats for forensic applications, food testing etc. Enabled 510 (k) clearance for the influenza detection kit on the ABI 7500 Dx platform (CDCs assay).Developed IP positions in the Y-STR and Body Fluid identification areas and collaborated to develop SNP panels for ancestry and lineage analyis.Served as a Member of the Scientific Advisory Board of the Worldwide Innovative Network (WIN) for Cancer Research (2009-12),

Life Technologies

VP  R & D, Molecular Dx, Public Health, Human ID, Food & Env., Animal Health & Pharma Analytics.

Distinguished Scientific Fellow & Vice President of R & D at Life Technologies/ Applied Biosystems in Applied Markets working to build up their Public Health, Human Identification, Food Safety and Pharma Analytuics applications. Launched products for genetic analysis, sequencing, human diagnostics, companion diagnostics, animal diagnostics, forensic testing/crime scene investigations, food safety testing, environmental safety testing and industrial safety testing. Continued efforts to develop assay formats for HID, Food and environmental testing and Pharma Analytics. Initiated efforts for protein detection by PLA. Initiated collaborations with TGen on MRSA, UNT on SNP panels and source attribution etc. Started defining SNP panels for human ID with collaborators at Yale. Initiated collaborations with Food testing groups at the FDA/CFSAN and the USDA/FSIS.

Vice President and  Distinguished Scientific Fellow, Applied MarketsR & D

Developed Forensic testing applications in quantification and moved STR testing to non-autosomal Y-STRs. Developed all of the Human Identification (HID)'s nucleic acid isolation chemistries and automation on Tecan, KingFisher and iPrep/Automate Express systems.  Pioneered research in SNP selection for Human Identification, Ancestry Inference, lineage determination and novel Y-SYRs with a high mutation rate. Developed detection kits for major Food pathogens and initiated sequencing efforts to generate additional information to enable robust assay designs. Initiated collaborations with Cornell for Salmonella typing, the FDA-CFSAN for Salmonella detection assays, USDA for STEC assays and Penn State for Salmonella Enteriditis,

Senior Director, Applied Markets R & D

Developed kits for STR detection, established cloned allelic ladder formats for human identification kits. Developed body fluid Identification marker panel. Developed tests for anthrax, biothreat pathogens, food pathogens and biopharmaceutical contaminants (Mycoplama, MMV, Residual DNA etc.)

Director R & D , Applied Markets

Developed the Assay by Design pipeline for Gene Expression and SNP detections and the  Assays on Demand pipeline for Gene Expression assays. Introduced assays for the all major transcripts from the humen genome (~20 K assays)  to te market, Initiated work on mouse, rat & other model organism genomes. Developed Slective TaqPipe an automated tool for design of assays that maximizes the effect on mismatches in primer and probe sequences to generate assays with the highest Seelectivity.

Sr.Staff Scientist, Genomic Assays Group

Developed molecular Diagnostics Assays for HIV-1, HLA, Cystic Fibrosis, Fragile -X etc. Set up collabortaions with the ACTG, investigators at Stanford, John's Hopkins, University of Pittsburgh, Northwestern University Medical School. Developed a Personalized Drug Resistance Interpretation Algorithm that enabled physicians to individualize therapy based on the mutations present in the viral population in a patient

Staff Scientist,  Molecular Diagnostics, Head HIV Genotyping R & D

Worked on molecular diagnostics assays for HIV, Cystic Fibrosis, HCV, Fragile -X. R & D Lead for the  510 (k) submission for the HIV-1 Genotyping System. Developed HIV-1 viral genotyping panels for validation studies, developed the drug resistance interpretation report, managed the analytical validation and clinical validation studies. Moved the Cystic Fibrosis kit to the 3100 platform. Developed the HCV genotyping assay on TaqMan.

Celera Corporation

Senior Staff Scientist, Molecular Diagnostics R & D

Directed Protein Sequencing, DNA sequencing, Oligonucleotide synthesis and microarry applications at Northwestern University's Biotechnology Center.

Northwestern University

Director , Biotechnology

PI leading invetigations at the Cancer Centre. Teaching Tumor Cell  Biology to graduate students. Funding from the Amercian Cancer Society, AMFAR and March of Dimes.

Principal Investigator, Robert H. Lurie Comprehensive Cancer Center

Teaching Tumor Cell Biology, Molecular Diagnostics. Research in Virology & Cancer

Assistant Professor

Supervised the Clinical Virology CLIA lab activities, viral diagnosis, HIV western blots, implemented branched DNA and PCR -Based tests at NMH for HIV, HCV,HPV Chlemydia etc. Taught virology applications to MD Pathology Residents. Worked on protocols for cell-based therapy in bone marrow transplants. Worked with the ACTG and MACS HIV clinical trials groups on HIV-1 detection and Viral load studies using  Chiron and Roche assaysExperience working with pathologists, oncologists, infectious disease experts, health administration as well as major diagnostic companies to define clinical utility and test implementation criteria at CLIA labs in major medical centers.

Northwestern Memorial Hospital

Director, Clinical Retrovirology & Virology

Teaching Physical Chemistry, Organic Chemistry, Biochemistry, Molcular Genetics and Molecular Biology

Manohar R. Furtado

Manohar R. Furtado