About USDM
25 years at the intersection of technology and regulated life sciences.
USDM is a life sciences technology and compliance consultancy. We help pharmaceutical, biotech, medical device, and CRO organizations govern AI, modernize systems, and maintain inspection-ready operations — inside GxP guardrails.
Regulated expertise, not generic IT
USDM consultants operate inside GxP environments every day. They speak FDA language — CSA, Part 11, GAMP 5, ICH — and understand what defensible compliance actually requires.
Build and govern AI together
Most firms can do one or the other. USDM governs AI and builds it: validated PoCs, GxP-compliant LLM pipelines, production AI systems, and the frameworks that make them defensible.
Follow-the-sun delivery
US and EU delivery PODs provide real regulatory insight and execution across jurisdictions where AI scrutiny is rising fastest.
Life sciences specialists
Our consultants have deep domain experience across pharma, biotech, CRO, and medical device — not generalist IT backgrounds.
US and EU presence
Delivery teams in both US and EU markets provide regulatory depth and follow-the-sun execution where AI scrutiny is rising.
TRUST-AI Framework
Purpose-built AI practice with a proprietary framework spanning governance, validation, implementation, and managed services.
Our people
Subject matter experts and leaders who know regulated work.
Meet the people behind USDM's regulated technology, compliance, AI, cloud, quality, medical device, clinical, Veeva, delivery, and customer programs. Profiles are listed alphabetically by last name.
David Blewitt
VP of AI Governance and Digital Trust
David is a regulatory and IS compliance leader focused on cloud systems, validation, and regulated technology assurance.
Jennell Botero
Principal Consultant
Jennell helps regulated teams modernize regulatory, document, and submission workflows with process discipline and practical change control.
Kevin Brown
CEO and Co-Founder
Kevin leads USDM strategy across regulated technology, continuous compliance, AI, partnerships, and customer outcomes.
Joseph Cassella
Senior Director, Compliance and Data Privacy Officer
Joseph helps life sciences teams address compliance, privacy, quality systems, and regulated technology risk.
Jay Crowley
VP of Medical Device Solutions and Services
Jay helps medical device manufacturers turn UDI, EUDAMED, EU MDR, IVDR, QMSR, and device data obligations into executable compliance programs.
Vega Finucan
Vice President and ProcessX Evangelist
Vega co-founded USDM and leads ProcessX evangelism, business growth, innovation, talent development, and culture.
Kim Guihen
Head of Alliances and Digital Transformation
Kim leads alliances and digital transformation programs that connect technology partners to regulated life sciences customers.
Hovsep Kirikian
VP of Strategy & Operations
Hovsep leads AI-ready operations, Veeva services, and regulated transformation programs that turn executive strategy into governed execution.
Bob Lucchesi
VP of Global Regulatory Compliance, QA & Audits
Bob brings more than 30 years of quality assurance and regulatory compliance experience across pharma, biotech, medical device, engineering, and nuclear industries.
Joe Morgan
Head of People Operations
Joe leads people operations, engagement, culture, recruiting, onboarding, and workforce programs at USDM.
Jim Murray
Chief Technology Officer
Jim leads USDM technology strategy across AI, data engineering, compliant platforms, and regulated system architecture.
Mark Ohrvall
EVP of Strategic Customer Engagement
Mark leads strategic customer engagement, enterprise IT strategy, and complex transformation programs for life sciences organizations.
Lisa Om
VP of Marketing & Communications
Lisa leads USDM marketing and communications across brand, demand generation, content, events, digital growth, and customer-facing campaigns.
John Petrakis
Chief AI Officer
John leads AI strategy and brings 30 years of global experience in business transformation, AI, cloud compliance, cybersecurity, and digital trust.
Brian Rankin
Head of Cybersecurity Services
Brian leads cybersecurity services for life sciences teams strengthening vendor risk, vCISO, FDA cyber readiness, and regulated digital trust programs.
Nithya Sittaramane
Product Portfolio Manager
Nithya leads eSignature product portfolio strategy, roadmaps, implementation oversight, and ongoing validation for regulated DocuSign and Adobe Sign programs.
Brittany Walker
Principal Consultant
Brittany supports clinical operations and Veeva Vault programs with TMF oversight, platform administration, and inspection-ready execution.
Start here
Put AI to work in life sciences — with the right guardrails underneath.
Start with a structured AI Readiness Assessment: fixed-fee, executive-ready, and built to surface the highest-value workflows first.