Shailendra Kumar, Ph.D Email & Phone Number

Cambridge, Ma, Us

• Led a pioneering team in the development of a diabetes diagnostic product using a novel biomarker (Glycated CD59), enhancing diabetes, pre-diabetes, and GDM detection capabilities, as evidenced by securing a competitive NIH funded SBIR grant for a urine-based POC device for Gestational Diabetes. • Orchestrated cross-functional collaboration with partners for the development of high-sensitivity GCD59 immunoassays on automated and POC diagnostic platforms, demonstrating adeptness in managing complex stakeholder relationships. • Managed the development of a Mass Spectroscopy (MS) based iMRM assay for the pathologically relevant biomarker GCD59, aligning with stringent global regulatory standards and contributing to the project's strategic direction and compliance. • PI for NIH funded SBIR grant for developing urine based POC device for Gestational Diabetes.

• Led the development of innovative diagnostic and therapeutic devices for Sepsis, leveraging technology licensed from Harvard/Wyss Institute, which enhanced disease detection and treatment options. • Directed cross-functional teams and managed collaborations with CROs and CMOs, ensuring the successful development and manufacturing of diagnostic products, as evidenced by securing external funding from the Department of Defense (DoD). • Coordinated and executed clinical studies to validate diagnostic biomarkers and safety of therapeutic devices, contributing to the strategic direction and compliance with global regulatory standards. • Co-PI for “Transforming Technologies For The Warfighter, TTW4” POC Diagnostics project “COMBAT (Comprehensive Biomarker and Translational) Sepsis Initiative” from DoD.• Co-PI for DTRA MCDC project “Rapid and Universal Sample Preparation of Pathogens using Broad-Spectrum Magnetic Bead Capture and Magnetic Ratchet-based Processing

IVD EXPERTS is a full-service consulting firm that specializes in providing a wide range of IVD Assay and Product Development, Product Validation, Quality Assurance and Regulatory (FDA and CE Mark) services. IVD EXPERTS has over 20 years of experience and has successfully helped many In Vitro Diagnostic (IVD) companies achieve their goals. IVD EXPERTS is committed in improving the early diagnosis and treatment of disease by helping our clients bring novel and innovative In Vitro Diagnostic (IVD) products to market. We do this by utilizing our Product Development, Validation, Regulatory Affairs, Clinical Affairs and Quality Assurance expertise to help our clients succeed in bringing their products to market in the shortest possible time frame. Our services include: * IVD Assay Development- immunoassays, ELISA, biochemical and molecular* IVD Product Development (lateral flow immunoassays, microfluidics, western blots, plate ELISAs, end-point and kinetic biochemical/enzymatic assays and molecular assays)* Product Validation- analytical and clinical* Design Control Process- to comply with FDA and EU requirements* Clinical Study Design- planning and protocols writing * Quality System Development- SOP writing, implementation and compliance* Regulatory- U.S. FDA 510(k), pre-IDE, IDE and PMA submissions Global Product Submissions/Registrations (i.e. Canada, EU)Contact Information: IVD EXPERTS website: http://www.ivdexperts.com Telephone: 617-792-3818 Email: info@ivdexperts.com

Medford, Ny, Us

• Managed the development of IVD assays on Chembio's DPP and LumiraDx microfluidic platforms (high sensitive immunoassay platform), achieving full product production and adherence to the Design Control process. • Led the submission of a BARDA proposal for a POC Anthrax test from blood samples, securing approval and navigating funding delays due to the SARS-CoV-2 pandemic. • Directed a team in the innovation of microfluidic devices for HIV, Dengue, and Covid-19 on LumiraDx microfluidics, culminating in FDA emergency use authorization (EUA) for the Covid-19 antigen test• Directing new immunodiagnostic product development and transfer of technology through the Design Control process, to full production and market release. • Develop a pilot line manufacturing for high-sensitive LumiraDx test platform at Chembio.• Advised team for validation of product, process, regulatory and clinical requirements.• Managing external funding’s and project management from concept to regulatory clearance • Managed development of companion diagnostics products and regulatory and quality systems requirements for biotech/pharmaceuticals partners such as AstraZeneca

Chelmsford, Ma, Us

• Led a team in pioneering automated multipath immunoassays on First Light's MultiPath platform, enhancing early Anthrax diagnosis capabilities from fingerstick blood samples, and securing BARDA support for test development. • Directed the immunoassays program for Clostridium difficile toxins.• Collaborated in a cross-functional team for FDA pre-submission, advising on regulatory requirements and contributing to the strategic direction and compliance of Anthrax Test Development. • Helped in establishing core SOPs and the design control process, which streamlined First Light's quality management system and ensured compliance with global regulatory standards.• Advised team for regulatory requirements and worked in a team for first pre-submission with FDA.

Cambridge, Ma, Us

• Led the strategic development of point-of-care liver function tests and pathogen detection assays, pioneering the use of DFA’s patterned paper microfluidics platform• Established and maintained DFA’s quality system in compliance with ISO 13485 and QSR requirements, serving as the primary liaison with regulatory agencies such as the FDA• Primary contact between the organization and regulatory agencies e.g. FDA and notified bodies. • Oversees quality Control, document control, design control and compliance functions.• Leading product development, validation, manufacturing, and clinical teams at DFA and CROs.• Organized human factor and clinical studies at multiple sites for FDA’s 510K and CE mark submission.• Collaborated with multiple pharmaceutical and diagnostics partners for developing liver function test and low-cost pathogen detection (immunological) and confirmation tests (biochemical) for food pathogens (Salmonella and Listeria).• Successfully completed first phase of Bill and Melinda Gates foundation funded program as a principal investigator for developing micronutrients assays on patterned paper technology integrated with flexible electronic (microLEDs and photo detectors) for on device quantification. Also awarded $2M Grand Challenges Exploration Phase II grant from the Bill & Melinda Gates Foundation to continue development of the point-of-care micronutrient diagnostic in collaboration with MC10.

Medford, Ny, Us

• Directed an R&D team in pioneering lateral flow tests for infectious diseases, culminating in the development of a groundbreaking point-of-care Syphilis Screen and Confirm Test, leveraging Chembio's patented DPP lateral flow platform for enhanced detection accuracy. • Managed the seamless transfer of Syphilis, Leishmania, and HIV immunoassay tests to both internal and external manufacturing partners, ensuring continuity and scalability of production processes. • Helped in development of rigorous protocols and studies, achieving CLIA waived certification for the Syphilis test, thereby significantly broadening market access and compliance with regulatory standards. • Successfully transferred Syphilis, Leishmania and HIV products/reagents processes to internal manufacturing facility and external (Brazilian) manufacturing partner. • Oversees program for producing recombinant antigens, antibodies and their conjugates (Gold and latex). • Lead a team of scientists to drive the development, optimization, scale-up of reagents and device manufacturing, conducting validation and verification studies under the design control process. • Worked with Quality and Regulatory groups, prepared technical files for 510K, PMA and CE mark submission.• Established protocols and studies for CLIA waived certification of Syphilis test.

• Lead a small team of R&D and product support scientists.• Managed an in-house lateral flow immunoassay development program for bladder cancer diagnostic marker.• Initiated new programs to develop specific reagents (ELISA) for serum based breast cancer biomarker detection. • Developed a bladder cancer test (NMP22 BladderCheck) which Alere (now Abbott) market in USA• Developed and validated ELISA’s for breast cancer marker from serum sample.• Oversees the development of methods for producing antigens and antibodies of interest• Established and maintained collaborations with other groups on interdisciplinary projects for the identification of tumor markers as well as the development and characterization of marker-specific monoclonal and polyclonal antibodies.• Worked for designing oligonucleotide primers and developing real-time PCR methods, cloning and purification of nucleic acids.• Developed and implemented murine models of breast cancer, and conducted studies to better characterize the disease progression and for serum biomarker identification.• Worked on Mass spectroscopy (MALDI-TOF and LC-MS-MS) for the serum cancer biomarkers identification.• Used immuno-staining and immunohistochemistry approach to identify the cancer biomakers.• Followed company’s design control process, worked with quality/regulatory group and helped in preparation and submission of 510k application of Bladder Cancer test.

Boston, Ma, Us

Chicago, Il, Us

Post Doctoral, Oncology And Cancer Biology

Ph.D., Biochemistry

M.Phil, Ph.D., Biochemistry