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Nirosha Sithirapathy

Counsel
Counsel
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Areas of Focus

Overview

As a seasoned in-house lawyer, Nirosha Sithirapathy’s background has provided her with the business oriented skillset to provide pragmatic commercial legal advice on a wide range of clinical trial procedures and matters. Before joining Crowell, Nirosha had several in-house roles at life sciences companies, including serving as Legal Counsel at PSI CRO UK Ltd., Global Contract Lead at INC Research LLC (now Syneos Health LLC), and ‍Contracts Associate at PRA Health Sciences.

She has assisted numerous clients and stakeholders in the creation of policies and procedures that address various compliance challenges, including contract management flows, anti-bribery, global spend transparency initiatives (such as EFPIA), and data protection requirements.

Nirosha has focused much of her practice in support of global clinical contracting. Her experience managing biopharmaceutical contracting activities includes creating specialized templates and negotiating bespoke clinical trial agreements spanning more than 50 countries.

Nirosha has experience working with clients in the drug and device spaces in a range of therapeutic areas including neurology, oncology, cardiovascular, urology, dermatology, immunotherapy, autoimmune diseases, gene therapy, women's health and neuroendocrine disorders, age related disorders, hemoglobinopathies, rare diseases, metabolic, neurodegenerative and musculoskeletal diseases, antiviral, blood-related disorders, diabetic, and other peripheral neuropathies.

Nirosha supports a range of children’s services in the UK, acting as an independent volunteer, return interviewer, and children’s advocate for the National Youth Advocacy Service (NYAS) and Reconstruct. She also supports the England Korfball Association as the child protection officer for Oxfordshire Korfball Association.

Career & Education

    • Legal Counsel, PSI CRO UK Ltd.
        • Worked on clinical trial related agreements spanning over 50 countries
        • Advised on the legal implications of day to day business operations
        • Supported creation of policies, procedures and processes
        • Lead Attorney resolving various issues arising during the conduct of global clinical studies
        • Experience across various therapeutic and phase areas, including oncology, medical devices, gene therapy, novel antibiotics. hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions
    • Global Contract Lead, INC Research LLC (now Syneos Health LLC)
        • Worked on site and vendor related clinical trial agreements across an international geographical mix, with specialization in Belgium, Germany, and the UK
        • Contract Lead providing support for the resolution of issues arising during the conduct of global clinical studies
        • Experience across various therapeutic and phase areas, including oncology, neurology, hemophilia, kidney disease, immune disorders, and other chronic and acute medical conditions, as well as the design and development of novel antibiotics
    • ‍Contracts Associate, PRA Health Sciences
        • Worked on site level clinical trial agreements across a European and Middle Eastern geomix
        • Assisted with the resolution of issues arising during the conduct of clinical studies
        • Experience across various therapeutic and phase areas, including acting as a dedicated resource for neurology and antiviral focused biotechnology companies
    • Legal Counsel, PSI CRO UK Ltd.
        • Worked on clinical trial related agreements spanning over 50 countries
        • Advised on the legal implications of day to day business operations
        • Supported creation of policies, procedures and processes
        • Lead Attorney resolving various issues arising during the conduct of global clinical studies
        • Experience across various therapeutic and phase areas, including oncology, medical devices, gene therapy, novel antibiotics. hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions
    • Global Contract Lead, INC Research LLC (now Syneos Health LLC)
        • Worked on site and vendor related clinical trial agreements across an international geographical mix, with specialization in Belgium, Germany, and the UK
        • Contract Lead providing support for the resolution of issues arising during the conduct of global clinical studies
        • Experience across various therapeutic and phase areas, including oncology, neurology, hemophilia, kidney disease, immune disorders, and other chronic and acute medical conditions, as well as the design and development of novel antibiotics
    • ‍Contracts Associate, PRA Health Sciences
        • Worked on site level clinical trial agreements across a European and Middle Eastern geomix
        • Assisted with the resolution of issues arising during the conduct of clinical studies
        • Experience across various therapeutic and phase areas, including acting as a dedicated resource for neurology and antiviral focused biotechnology companies

    • School of Oriental and African Studies, University of London, LLB, with Honors
    • London School of Economics, University of London, LLB
    • School of Oriental and African Studies, University of London, LLB, with Honors
    • London School of Economics, University of London, LLB

    • New York
    • New York

Representative Matters

Supported several clients with bespoke template development in global Phase I-IV drug and device trials and studies, including:

  • Pre-screening observational study and Phase 2 study work for studies sponsored by an immunotherapy company;
  • Multiple Phase 1, 2 and 3 global clinical trials across several compounds sponsored by a China based biopharmaceutical company and affiliates;
  • Phase 2 and 3 clinical trials sponsored by an oncology focused biotechnology company across Europe, Asia and the Americas, including observational study work;
  • Several Phase 1 clinical trials and studies sponsored by various clients;
  • Several Phase 2 clinical trials sponsored by various clients
  • Several Phase 3 trials sponsored by an oncology focused biopharmaceutical company in collaboration with European Network of Gynecological Oncological Trial Groups;
  • Phase 4 global clinical trial sponsored by an American clinical stage biotechnology company;
  • Multiple global clinical trials across various phases sponsored by an oncology focused biopharmaceutical company, including multinational Phase 3 trial involving 100 sites in Americas, Europe, and Asia Pacific regions; and
  • Medical device study work for a Swedish based life sciences company.