EDUCATION/TRAINING

A. Personal Statement

I have over 20 years of experience in business development, managerial and health IT consulting. As an independent business owner, I am very self-motivated and identify new opportunities where I can provide added value for my clients. I manage internal business operations while also providing C-suite executive consultation to businesses. I currently serve as COO of DNA HIVE; a biotechnology firm focused on solving complex healthcare challenges by providing innovative solutions for both public and private sectors. I deeply value and appreciate the relationships I develop with my clients and colleagues and always strive to partner and make their unique mission my own. I have a passion for advancing healthcare in America and globally, seeking to embrace novel innovations by partnering with organizations that have direct impact and access to our patient population. I am currently supporting DNA HIVE, LLC in a variety of roles, spanning from organizational operations to program management, partnering with the executive board to create a roadmap for achieving our fiscal year goals and execute across our pipeline of multi-disciplinary projects and federal grant awards.

B. Contributions to Science

I am currently leading an 8M+ project for the development of a Federated Ecosystem for Analytics and Standardization Technologies (FEAST) for the Advanced Research Projects Agency for Health (ARPA-H) Biomedical Data Fabric (BDF) Toolbox program. This requires managing a large team of staff across globally dispersed institutions, including NIH, Kaiser Permanente, Vanderbilt University Medical Center, Georgetown University, George Washington University, Weill Cornell Medical Center, New York Presbyterian Hospital and the European Bioinformatics Institute. I am responsible for a wide variety of company workstreams, including risk analysis, resource planning, developing vision and concept documents, management plans, schedules, risk mitigation, as well as marketing and communication plans. I have supported data registry and web development in the commercial space as well.

I recently supported the NIH NCI with a landscape analysis of tools and technologies that may be effective strategies for reaching all children and AYA with a cancer diagnosis. In addition, I captured the requirements for future tool selection. I also supported the NCI with enterprise architecture and requirements analysis activities on the PMACC’s MyloMATCH project. Additionally, I led a landscape analysis of consumer and clinician tools available for improving access and enrollment in pediatric cancer clinical trials to reach a more diverse patient population across the US in support of the Childhood Cancer Data Initiative (CCDI).

I have led several EMR related implementations for Novant Health, an integrated network of physician clinics, outpatient centers and hospitals across SC, NC, GA and VA. I led enterprise-wide projects for the Chief Medical Information Officer (CMIO), managing disparate teams and vendors to ensure successful project delivery. I led the project to re-engineer an antiquated paper-based fax transmission process across Novant’s hospitals and clinics, creating a hybrid cloud solution, resulting in time and cost savings. I also helped reach a broader community by expanding Novant’s MyChart web and mobile applications to support Spanish speaking patients.

I served as project manager for the FDA directly reporting to both the Chief Technology Officer and the Chief Health Informatics Officer. In this role, I led a technology evaluation and tools selection for an enterprise data warehouse initiative. I developed a new technology evaluation program to review and adopt new technologies more rapidly and efficiently. I also supported the CIO office with business re-engineering and requirements analysis across their wide portfolio of programs.

Additionally, I led the FY14 acquisition and procurement planning and spend plan development for FDA CIO office, which consisted of over 70 unique contract procurements and coordination across 52 staff members. I was responsible for the acquisition, procurement and spend plans for FDA’s CIO office. I prepared presentations for the CHIO for conferences where he was invited to speak on topics such as Big Data, Moving to the Cloud, and Enabling a Mobile Workforce.

As a senior associate at Book Allen Hamilton for approximately 10+ years in the government healthcare sector. A significant achievement during my career working alongside the FDA, was expanding a custom application from a single Center within FDA where it was initially conceptualized to 6 Centers in a 6-year period. This program included the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH) and Center for Veterinary Medicine (CVM) and grew to $5M in revenue across multiple contract awards. In this role, I was responsible for FDA’s eSubmitter Program, a large-scale electronic submissions program supporting both Industry and FDA-wide stakeholders. This also included the new Center for Tobacco Products (CTP) during its inception upon signing the Tobacco Control Act in 2009. This required strategic planning, legislative analysis, business process definition and development of systems to facilitate data capture, analytics, workflow and content management.

At FDA’s Office of Regulatory Affairs, I managed the development and adoption of FDA’s first ruggedized mobile application for FDA’s disperse district offices to conduct their regulatory inspections of manufacturing sites across the US.

I led the FDA-wide Employee Mobility and Virtualization Workgroup to support the implementation of key mobile applications to perform regulatory compliance activities. I served as the primary business liaison across regulatory entities from the US, Canada, Brazil and Australia as part of a third-party audit platform for medical device manufacturers.

Speaking Engagements

Conducted 25+ live training and educational webinars to FDA and participants in big pharma and the device industry.

Led process modeling and re-engineering for Pre-Market Approval and Investigational New Drug (IND) applications.

Held speaking engagements at the following industry-wide conferences to large audiences on behalf of FDA clients:

• American Association of Blood Banks Annual Meeting & CTTXPO, 2011, San Diego, CA,
• Seventh Annual Medical Device Quality Congress, 2010, Bethesda, MD
• Twelfth Annual FDA and the Changing Paradigm for Blood Regulation, 2009, Las Vegas, NV

C. Positions and Honors

D. CERTIFICATIONS

Publication, 2025

Journal of Informatics in Health and Biomedicine

From use cases to infrastructure: a cross-institutional survey of priorities in data-driven biomedical research - PubMed