Capabilities
Experience across the operating model.
Clinical purpose, product choices, data, delivery, and commercial reality have to work together.
| Capability | Documented experience | Project records |
|---|---|---|
| Clinical technology leadership | Established the Innovation Lab within Global Development Operations, with product, engineering, quality, informatics, and service delivery under one operating model. | |
| Global teams and organizational scale | Built and led a globally distributed organization of up to 54 staff; owned staffing, operating cadence, priorities, performance expectations, and executive reporting. | |
| Budget and resource allocation | Managed a departmental budget recorded at approximately $9 million in the earlier CV and approaching $10 million in later materials; balanced platform development with study and service commitments. | |
| eCOA and ePRO | Led and mentored buy-versus-build evaluation and delivery of electronic clinical outcome assessment and patient-reported data capabilities supporting Phase II–III and Phase IV programs. | |
| Digital endpoints, sensors, and wearables | Led CGM product management, strategy, Dexcom licensing negotiations, IQVIA vendor management, research requirements, and execution oversight. Dexcom-related Rarify mobile and cloud components created a credible vendor replacement threat without entering production. Kevin reports that IQVIA’s separate Dexcom data contributed to evidence supporting Genglycos’s accelerated approval. | |
| Patient-data product strategy | Established clinical informatics and connected patient, site, device, and operational data with reusable structures, metadata, provenance, business rules, and governed use. | |
| Decentralized and hybrid trials | Designed and deployed Rarify and led the supporting organization for patient/site data capture, remote participation, device logistics, and study support. | |
| Rare-disease and longitudinal research | Worked across XLH, LC-FAOD, GSD Ia, and GSD III clinical technology contexts; contributed to disease-monitoring work and an identifiable LC-FAOD conference abstract. | |
| Protocol and operational feasibility | Participated in protocol development with responsibility for technology feasibility, endpoint strategy, patient/site experience, device integration, and operational risk. | |
| GCP, validation, and quality | Built QA/CSV and service responsibilities into the clinical technology organization; career records report a pre-pivotal Phase III audit with zero findings. | |
| Vendor selection and technology diligence | Led regulated vendor selection and governance while developing an internal delivery option. Kevin reports approximately $150,000 in Rarify mobile/cloud development created a credible replacement threat that improved performance from an approximately $2.5 million IQVIA engagement. Those components did not enter production; the engagement value is not savings. | |
| Product strategy and upstream innovation | Owned roadmaps, concept development, business cases, prioritization, gating, resource allocation, and transition from prototype into operational use. | |
| Hardware, software, and cloud integration | Led development across six wireless diabetes devices and the associated hosted data, analytics, remote-management, and caregiver workflows. | |
| Virtual care and disease-management operations | Built programs linking devices, home diagnostics, patient support, clinical review, telehealth coordination, reporting, and payer/provider workflows. | |
| Direct-to-patient access and service delivery | Connected referrals, enrollment, remote diagnostics, device logistics, support, clinician participation, and reimbursement-related processes. | |
| Patient/member activation and retention | Designed low-friction entry points, relevant feedback, family/community participation, and pathways into continuing services. | |
| Behaviorally informed engagement | Collaborated on Kaiser social-support research and translated behavioral principles into digital workflows, with participant-selected supporters and practical relevance. | |
| Omnichannel and physical/digital programs | Used SMS, prepaid surveys, printed materials, home kits, connected devices, web tools, and human support within shared operating models. | |
| AI governance and human review | Exploratory work addresses consent, narrative provenance, user control, human review, AI-assisted prototyping, and the relationship between source material and derived insight. | |
| Operational analytics and decision workflows | Established clinical systems informatics and later authored a framework for governed signals and accountable action across trial operations. | |
| Commercialization and partnerships | Combined enterprise sales, platform partnerships, licensing, payer-connected services, diagnostics, and direct publishing channels. | |
| Enterprise integration and channel strategy | Worked across mobile/network platforms and middleware distribution; career records include the Optus platform deployment and Amdocs strategic partnership. | |
| Research and public evidence | Co-authored a Diabetes Care randomized trial, authored a Diabetes Spectrum article, and contributed to Kaiser and LC-FAOD abstracts; named inventor in the public patent-application record. | |
| Patient advocacy and expert collaboration | Worked with patient advocacy organizations, academic investigators, community consultants, families, and clinical co-authors to shape useful experiences and information products. | |
| Education, content products, and commerce | Co-authored Sugar Surfing and operates MediSelf Press across expert collaboration, product packaging, production, distribution, fulfillment, and customer experience. | |
| International programs and service adaptation | Led globally distributed clinical technology work and participated in U.K. remote-monitoring and population-health programs, with earlier international enterprise-platform responsibilities. | |
| Trial operational readiness and pre-FPI review | Authored Trial Telemetry and a pre-FPI review approach addressing signal definitions, source readiness, ownership, review workflows, and escalation before first patient in. | |
| CGM adoption, usability, and patient/provider education | Co-authored Sugar Surfing with Stephen W. Ponder and sustains its publishing and educational reach, supporting CGM uptake and practical use by people with type 1 diabetes and clinicians. | |
| Consulting and advisory problem framing | Combines prior operating responsibility with vendor evaluation, product and program architecture, and current trial-operations frameworks to inform a focused assessment or advisory mandate. |
Pre-launch signal design
Trial Telemetry extends this operating experience into a framework for defining and governing trial signals before first patient in.
Pre-FPI review: signal feasibility and operational readiness