Umesh Gangishetti

• Design implement and oversee functions of clinical trial data (Phase1 to Phase 3) for companion diagnostics and several biologics for oncology and chronic inflammatory diseases
• Project management right from design to implement and supervise clinical production team and timely transfer of biological deliverables supporting several assays to the decentralized clinical production labs across the globe while simultaneously functioning as an active member on study/project teams
• Coordinate between multiple sponsors on technical inquiries, troubleshooting, and test results to ensure critical deadlines are met
• Apply technical acumen to provide technical resources needed to conduct clinical and/or laboratory studies and have deep knowledge of the multidisciplinary functions involved in drug development process including the clinical operations, data handover to biostatistician
• Strong focused on data analysis using SPSS, R and other Bioconductor tools
• Hands-on experience with translational sciences with extensive knowledge of clinical research and has successfully worked across preclinical drug development to various stages Phases of clinical trial developments.
• Provided oversight during pre-study site visits prior to initiation of a study at a given location.
• Prepared reports summarizing findings from studies which were submitted to governing bodies for approval.
• Provided guidance on regulatory requirements to ensure compliance with applicable laws and regulations.
• Developed strategies for recruitment of participants into studies according to inclusion and exclusion criteria established by protocol guidelines.
• Collaborated with other scientists, clinicians, and regulatory personnel to design research protocols.
• Developed and implemented clinical protocols to evaluate the safety and efficacy of novel therapeutics.
• Maintained records detailing all aspects of a study such as enrollment numbers, adverse events reported.
• Performed statistical analysis of clinical data using specialized software tools.
• Assisted in development of new drug applications by providing detailed documentation of clinical trial results.
• Presented findings at scientific conferences and meetings to promote new treatments or products.
• Monitored operations of clinical trials ensuring that all processes are compliant with Good Clinical Practices.
• Reviewed and evaluated patient data from clinical trials for accuracy and completeness.
• Trained staff on proper procedures for conducting clinical trials including collection of data points, sample handling techniques.
• Ensured that all project timelines were met while adhering to budget constraints.
• Created reports summarizing progress of studies being conducted as well as any changes that may need to be made based on collected information.
• Evaluated current trends in the field through review of published literature and attended relevant conferences.
• Analyzed laboratory results to assess potential drug interactions or adverse reactions in patients.
• Coordinated research activities between multiple departments within the organization.
• Conducted literature reviews to determine appropriate therapeutic approaches for patients.
• Designed methods for collecting, analyzing, interpreting, and reporting medical data related to pharmaceuticals or devices under study.
• Oversaw statistics documentation and archiving, logging entries within dedicated software program.
• Performed and documented preventive maintenance and quality control practices, noting best corrective action to remediate issues.
• Collaborated with laboratory staff to ascertain group needs and improve test accuracy.
• Verified report accuracy by assessing statistics, specimen identification and critical values.
• Monitored proficiency testing within laboratory environment, handling necessary corrective action.

o Patient profiles
o Safety listings
o Other data listings, including Efficacy listings
o Coding for Adverse Events (AEs)
o Concomitant medications o Safety listings review and queries generation, where appropriate
o Protocol Deviations Log review
o Concomitant medications and coding o Participate in the preparation of information and summary slides for client mtg
o Manage and track action items from Medical Delivery Services Kick-off mtg o Investigator meetings o Protocol training
o CRA training
o Program kick-off meetings o Disease area research
o Standard of care o Results from clinical trials in specific indications o protocol concept development by providing input to the Medical Writer o clinical study reports by providing input to the Medical Writer
o clinical sections of Regulatory documents by providing medical team input

• Collaborate with the Medical and Safety Data Review teams to ensure timely progress and consistency with deliverables associated with medical data review (e.g., summary of clinical trial data) and, where appropriate, review of:
• Participate in the preparation of medical monitoring plans in collaboration with Drug Safety and Medical Data Review teams.
• Respond to protocol questions/CRAs/Sites under direction and supervision of the global study TMA.
• Collaborate with Project Leads and Contract Analysts to review and finalize the contract/budget and future COs.
• Prepare for and where required attend Safety review meetings with Sponsors under the supervision of the global Medical Advisor and the Medical Safety physician, covering areas such as:
• Coordinate activities and ‘flow of information’ with Medical Safety Advisor, Medical Data Reviewer and Medical Surveillance Specialist during study start up and throughout the project lifecycle, such as:
  
• Support quality assurance and other audits that involve the review of medical services (e.g., preparation of files, tracking and management of audit follow up actions and preventatives).
  
• Conduct electronic Trial Master File (eTMF) maintenance in relation to Medical and Scientific Services activities.
  
• Prepare and deliver presentation materials under the supervision and review of the global TMA, such as:
• Perform literature searches and summarize data/information including:
• Where appropriate, contributes to:
• Contribute to Medical and Scientific Services and other initiatives that support the advancement of IQVIA therapeutic capabilities

• Recognize the role of cytokines and circulating immune cells in chronically inflamed tissues
• I have years of experience in measuring cytokine levels in several human biofluids (CSF, Synovial fluid and IBD) including plasma in clinically diagnosed patients
• Utilized knowledge amassed as a research fellow to complete two complex projects, which are now published in 4 peer-reviewed publications, one oral presentations, and 5 poster presentations.
• Designed experiments to test hypotheses related to chemical processes and interactions.
• Collaborated with other departments within the organization on cross-functional initiatives related to research projects.
• Participated in weekly team meetings to discuss progress towards project goals and collaborate on solutions.
• Prepared reports summarizing research results for presentation to colleagues and management.
• Monitored laboratory equipment performance, performed repairs, calibrations, and preventative maintenance as necessary.
• Conducted literature reviews to support research projects and identify new areas of exploration.
• Documented all laboratory activities in compliance with established standards and regulations.
• Presented findings at internal meetings as well as externally at industry events or conferences.
• Maintained accurate records of experimental protocols and results in accordance with regulatory requirements.
• Developed and tested prototypes for new scientific instruments.
• Interpreted complex scientific information into understandable language for non-scientific audiences.
• Presented findings at national and international scientific conferences.
• Supervised junior scientists and laboratory technicians, providing mentorship and training.

• Developed an integrated imaging platform for 4D image analysis
• This is now also used a plugin for ImageJ software.
• Assessed current technologies available for scientific investigations and recommended new solutions as needed.
• Facilitated communication between internal departments by providing expert advice on complex issues.
• Conducted research projects and analyzed data to identify trends and develop conclusions.
• Provided technical expertise in areas such as biochemistry, molecular biology, immunology, or cell biology.
• Authored manuscripts for publication in peer-reviewed journals related to research findings.
• Mentored junior scientists on best practices for conducting experiments, interpreting data, and presenting findings.

• Extensively worked on Hedgehog signaling
• Understanding the oncogenic role of Hedgehog signaling during development and in neuroblastoma
• Successfully performed genome-wide RNAi screen for Gli transcription factor proteolysis.