About Us - Profile

We are founded on the belief that modern clinical research requires more than standard data collection - it demands a seamless integration of medical expertise and advanced analytics.

Data, Bioinformatics & Biostatistics Team

Focuses on turning complex, high-dimensional datasets into clean, submission-ready clinical intelligence.

  • Multi-Omic Data Parsing & Integration.
    Advanced processing of genomics, transcriptomics, proteomics, and metabolomics datasets to identify biomarkers and patient stratification sub-populations.
  • Biostatistical Architecture & SAP Development.
    End-to-end design of Statistical Analysis Plans (SAPs) utilizing industry-standard SAS and R environments, fully mapped to CDISC (SDTM/ADaM) standards.
  • Synthetic & External Control Arm Design.
    Leveraging historical clinical trials and real-world data to construct validated synthetic control cohorts, reducing patient recruitment burdens and accelerating timelines.
  • Decentralized Trial (DCT) Data Pipelines
    Seamless integration and cleaning of high-frequency remote data streams, including electronic Clinical Outcome Assessments (eCOA) and electronic Patient-Reported Outcomes (ePRO).

Epidemiology & Pharmacovigilance Team

Focuses on proactive safety science, regulatory compliance, and real-world therapeutic value.

  • MD-Led Medical Review & Signal Detection
    Continuous, physician-directed oversight of aggregate safety data to catch subtle adverse event trends early and protect asset valuation.
  • Full-Lifecycle Case Management
    End-to-end processing of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) from intake through medical narrative generation.
  • Expedited Regulatory Reporting
    Fully compliant, rapid submission workflows to the FDA (FAERS) and EMA (EudraVigilance) using validated, secure safety database infrastructure.
  • Epidemiological Frameworks & RWE Generation
    Design and execution of rigorous observational studies, post-market commitments (Phase IV), and natural history registries to expand product indications.

Meet Our Chief Officers

Our leadership brings together two distinct yet complementary pillars:

Isaac W. Hammond, MD, PhD, MPH

A physician-scientist, epidemiologist, and former FDA Medical Reviewer, my career is dedicated to establishing world-class clinical safety frameworks that protect patients and accelerate drug development and lifecycle strategies. Armed with a rare triple-credential; an MD, a PhD in Epidemiology & Biostatistics, as well as an MPH, I bring over three decades of elite regulatory and corporate leadership to Inshirah Ventures.

Before co-founding Inshirah, I operated at the absolute pinnacle of global drug safety, serving as Vice President and Head of Pharmacovigilance and Medical Surveillance at several multi-billion-dollar organizations including Radius Health, Shire, Otsuka, and GlaxoSmithKline (GSK). Throughout my executive career, I have personally architected global safety and pharmacovigilance departments from the ground up, built cross-functional safety review teams, and successfully directed the medical surveillance and risk management strategies behind major global therapeutics, including Tymlos (abaloparatide), Xiidra (lifitigrast), Samsca (tolvaptan), Tykerb (lapatinib), Promacta (eltrombopag), and Votrient (pazopanib). My foundational expertise in the cardiovascular space was further refined during my tenure at the U.S. Food and Drug Administration (FDA), AstraZeneca as Global Safety Officer for Crestor (rosuvastatin) and at Eli Lilly & Company.

My perspective on regulatory compliance is uniquely informed by my early service within the U.S. Food and Drug Administration (FDA) as a Medical Reviewer in the Cardio-Renal Division, where I served as the primary medical reviewer for critical NDAs, including Integrilin (eptifibatide). This regulatory experience, combined with decades of managing global regulatory audits and inspections, allows me to provide Inshirah’s clients with authoritative, defensive strategies for global health authorities.

At Inshirah Ventures, I drive clinical, medical, and safety oversight of our asset-light CRO model. I translate my deep expertise in signal detection, disproportionality analysis, and aggregate safety reporting (including DSURs, PSURs, and PBRERs) into agile, digital-first clinical workflows. I direct our Phase IV post-market surveillance and automated pharmacovigilance (PV) strategies, ensuring every pipeline strictly adheres to ICH-GCP, FDA 21 CFR Part 11, and global data privacy mandates. Parallel to my industry work, my commitment to data-driven medicine includes holding prior academic appointments as an Associate/Assistant Professor of Epidemiology and Biostatistics at elite institutions, including Weill Cornell Medical college of Cornell University, Tulane University, Indiana University and University of North Texas, Health Sciences Center at Fort Worth.

An extensively published author, my research in signal detection, post-market surveillance methodologies, and cardiovascular epidemiology has been featured in prominent peer-reviewed journals such as Expert Opinion on Drug Safety and the Journal of the American College of Cardiology. I remain an active, trusted figure in the global pharmaceutical ecosystem, holding lifelong memberships across the Drug Information Association (DIA), the International Society for Pharmacoepidemiology, American College of Physicians, International Federation of Associations of Pharmaceutical Physicians, American Society of Hypertension, the American Medical Association (AMA) and Society for Epidemiologic Research.

Areas of Strategic Leadership

  1. Global Pharmacovigilance & Safety Systems: Designing, staffing, and scaling multi-million-dollar global drug safety infrastructures from inception through market authorization.
  2. Regulatory Intelligence & FDA Navigation: Deploying insider knowledge of FDA review processes to guide mid-sized biotech firms through complex safety hurdles, IND/NDA filings, and REMS mandates.
  3. Signal Detection & Risk Management Strategy: Pioneering statistical and epidemiological methodologies to isolate true safety signals from spontaneous reporting databases.
  4. Aggregate Medical Surveillance Reporting: Expert authoring and executive review of global safety documentation, including DSURs, PBRERs, and complex Risk Management Plans (RMPs).
  5. Statistics & Data Analysis: data driven leadership is anchored in a suite of advanced analytical, interpretive, and decision shaping capabilities that enable organizations to anticipate trends, optimize performance, and execute with precision.

Dorothy A. Hammond, PhD, MPH

An expert in computational biology, data engineering, and epidemiology, my career is built on a single objective: architecting elite data platforms that transform complex biomedical and Real-World Evidence (RWE) datasets into definitive, decision-ready clinical insights.

Before co-founding Inshirah Ventures, I operated at the intersection of advanced data science and translational medicine. As Senior Research Investigator in Computational Biology at the University of Pennsylvania Perelman School of Medicine and Assistant Director of Computational Biology & Data Science at the Penn Center for Global Genomics & Health Equity, I engineered enterprise-scale data platforms. My work at Penn, alongside breakthroughs driven as a Bioinformatics Research Fellow at the Children’s Hospital of Philadelphia (CHOP), successfully automated deep multi-omics integration (genomics, transcriptomics, and microbiomes) and implemented cloud-native ecosystems that slashed data processing cycles by up to 40%.

At Inshirah Ventures, I drive both corporate strategy and technological execution. I oversee the architecture of our asset-light, fully compliant data management systems, utilizing pre-validated, industry-standard infrastructure to ensure all active workflows strictly meet FDA 21 CFR Part 11, ICH-GCP, and GDPR data privacy standards. My mission is to shift the CRO paradigm away from legacy inefficiencies. To achieve this, I manage our long-term technology roadmap, directing the future development of our proprietary intellectual property—including upcoming AI-driven pharmacovigilance triage tools, predictive epidemiological site selection software, and synthetic control engines.

Rather than managing from a distance, I personally execute Inshirah’s technical workflows to transform high-dimensional data into submission-ready clinical intelligence. My hands-on work bridges multi-omic data integration (genomics, transcriptomics, proteomics, and metabolomics) with robust biostatistical architecture, including end-to-end Statistical Analysis Plan (SAP) design mapped to CDISC standards. Additionally, I engineer decentralized trial infrastructure to clean high-frequency remote data streams like eCOA/ePRO, while developing the mathematical frameworks required to build validated synthetic control arms from real-world data.

An accomplished author and investigator, I hold a Ph.D. in Bioinformatics and a Master of Public Health (MPH) in Epidemiology/Biostatistics. My research, backed by prestigious NIH predoctoral and training fellowships and published in journals like the Annual Review of Biomedical Data Science, directly informs modern industry standards for precision medicine and inclusive clinical R&D.

Areas of Leadership

  1. Technical Leadership: Directing cross-functional teams in biostatistics, bioinformatics, data engineering, and technology strategy
  2. Advanced Analytics & Causal Inference: Deploying machine learning, Bayesian analysis, and causal modeling to isolate biological mechanism from association.
  3. Compliant Data Infrastructure: Designing enterprise-grade, cloud-native pipelines aligned with CDISC standards (SDTM/ADaM), HIPAA, and global privacy mandates.
  4. AI & Technology Roadmap: Integrating NLP and LLMs to automate scientific synthesis today, while scaling Inshirah's shift toward proprietary platform technologies tomorrow.