Shivom Whitepaper

Saturday, June 23, 2018
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o  Support feasibility studies by affording analysis of patient populations, study sites and clinical trial design. Using this information, clinical trial study parameters can be adjusted to maximize the trial’s speed and cost effectiveness.  Help establish patient cohorts and inclusion/exclusion criteria to further support clinical trial optimization. For drugs that are designed to target a specific molecular pathway or gene variant, omics data can provide valuable information to guide the selection of patients for all study cohorts.  Provide insight to further classify the clinical trial population based on molecular signatures to ensure more targeted inclusion/exclusion criteria,

which will lead to smaller study populations, thereby reducing costs dramatically.  Enable adaptive clinical trials by characterizing study cohorts, providing insights on drug safety and efficacy. This information will determine pharmacogenomic effects to support modifications to the drug dosage, patient inclusion criteria or clinical trial sample size. o Patient Recruitment: By some estimates, patient enrollment for clinical trials is responsible for 30% of the time it takes to conduct clinical trials; some sites never enroll enough patients. Shivom’s databases will have the potential to dramatically improve the recruitment process by connecting patients with trials in an anonymous fashion. Pharmaceutical or CRO organizations would have access to a treasure trove of information about potential participants and the users of associated investigative sites who are likely to be motivated to join a study. o Data Quality & Reproducibility: Multiple reports and studies are fueling discussions about reproducibility of results especially in the biomedical sciences. These discussions raise concerns about the level of trust in results in the scientific literature, in public databases, within organizations, and from clinical studies. The Shivom genomics ecosystem will be updated with new data, curated for the quality of records and made compliant with local regulations for genomic data handling. It is essential to maintain integrity, provenance, security and privacy of all sensitive information along the processes of data uploading, processing, analysis, and sharing. Systematizing this process will be essential for Shivom to dynamically accommodate and manage changes to the workflow.

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Global Alliance for Genomics & Health Pistoia Alliance CDISC EBI Ontology service

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Axel Schumacher, PhD Co-Founder & CEO Gourish Singla Co-Founder & COO Sally Eaves, PhD Co-founder & CMO

Akash Gaurav Co-Founder & CTO Henry L. Ines Chief Innovation Officer Natalie Pankova, PhD Chief Scientific Officer Agam Kansal Marketing Lead

Dr. Rashad Ibrahim Middle East Head Stephane Laurent Chinese Subcontinent Head Pierre Maarek Investment Lead Charles Leslie Investment Lead Kayleen Schreiber, PhD Design Lead

Ting Peng PR Manager Azam Shaghaghi Head of Public Relations Ajit Singh Kular Head of Digital Marketing

Dr. Jay Sanders Antanas Guoga David Orban Geoff Hancock

Dr. William Yasnoff Dr. Irshaad Ebrahim Dr. Kamala K Maddali