Leading the Manufacturing and FDA Regulatory functions for a leading developer of pigs for xenotransplantation.- Producing Clinical Grade pigs in a Designated Pathogen Free facility (DPF)- Meeting Pathogen Screening FDA requirements.

Information Technology for Transplantation

Leads efforts in startup, small and large organizations to implement new business strategies, business development and technologies. Provides technical and management services for - Biotech services including including authoring academic publications, FDA filings, IRB protocols, grant submissions * Specific Expertise in Xenotransplantation, Transplantation, Comparative Genomics, Gene Editing- Cloud computing, systems architecture, development and integration; - Business planning and change management; and proposal, - Funding through private investment, corporate partnerships, grant and program development. Major clients include the Starzl Transplantation Institute, United Therapeutics, Araim Pharmaceuticals, University of Pittsburgh, Indiana University, University of Alabama Birmingham, BNY/Mellon Bank, and other mid, small, and startup organizations

Founded the New Zealand company aimed at xenotransplantation with Professor Bob Elliot, and served as Board Member and Advisor through the first investments.

Led the effort to introduce fresh approaches to the pig to human xenotransplantation research community with new bioinformatics methods to identify genes to change and cutting edge genome engineering capabilities to modify the pig genome.Genome Engineering: Identified, initiated and structured relationships with prospective genome fabrication partners using proof of concept qualifying projects to evaluate technologies and capabilities resulting in:• insertion of top down and bottom up artificial chromosomes into pig cells; and• birth of a 5 gene knockout pig created using multiplexed CRISPR gene editing techniques in 5 monthsBioinformatics: Recruited and established a small team of research scientists working with consultants, academicians, and companies to implement a cloud based bioinformatics cluster computing environment running on Amazon Web Services (AWS) that efficiently performed our computational research.Scientific and administrative leader for the first ever genome‐wide comparative study of pig and human genomes and functional genomics (transcriptomics) of xenograft and allograft models using RNA‐seq technology resulting in short lists of previously unrecognized target genes.Constructed a secure, AWS VPC cloud‐based web environment for data consolidation and visualization in support of the main goal of identifying additional genes to change to make xenotransplantation a clinical reality.Program successfully ended with a $50M equity investment and ongoing program with Synthetic Genomics Inc.

Provided non‐scientific operational leadership during a period of rapid change at a pharmaceutical startup. • Developed the cost, management approach, program management, security sections and supporting information/appendices of grant applications and proposals to broad agency announcement RFPs that resulted in $5M of support from CDMRP and BARDA. • Led the team through a successful key negotiation milestone of a $118M R&D proposal with a successful three day Federal Acquisition Regulation (FAR) mandated Defense Finance and Accounting Service (DFAS) audit with special emphasis on supporting our salary projections and establishing indirect overhead rates. • Obtained a >$1M tax credit in the form of cash grant offered by NY State R&D tax credit laws • Negotiated significant reduction of accumulated IP legal expenses; improved overall IP Legal cost efficiency• Authored various Investigators Brochure sections and Phase I Safety reports submitted to the EMEA and FDA. Active participant in the executive team on all aspects of the effort.

2001 – 2009 Recruited by Dr. Starzl to join his executive team introducing an innovative, research-driven treatment designed to decrease the toxic immunosuppression required for organ transplant recipients.• Served as the overall Program Manager for the Tolerogenic Immunosuppression effort that expanded to over 1000 organ recipients in six transplantation services influencing treatment practices worldwide. • Pioneered a system that produced graphical representations of patient courses that were used to manage the process of clinical change. These graphical charts allowed 100 times more data points per square inch than textual presentation and were used in patient care, clinical research, and teaching situations.• A contributing co-author with Dr. Starzl in peer-reviewed works in prestigious medical journals.1995 – 2001 An increasing level of contribution began with an engagement to lead a group developing a new clinical information system for one of the largest and most well known transplant centers in the world. • Developed and implemented a new transplant clinical information system covering inpatient and outpatient activities.• Led the effort to accumulate, transform and load more than 20 years of historical data into the new system to create the single largest transplant clinical dataset worldwide.• Integrated the system with the hospital’s information infrastructure using industry standard HL7 real time messaging and traditional extract, transform and load (ETL) technologies. • Instituted data management practices to ensure accurate, timely, and complete records that were available to research through a HIPAA-compliant honest broker system.• Formulated, negotiated and structured the spin‐out of the EDIT technology to a systems vendor. ( https://editlife.msa.com/ )

Senior technical executive at the Manufacturing Execution Systems division of this factory automation vendor. Fifth employee hired in the effort that was spawned by a $12M equity investment and $25M program funding from a strategic relationship with Ford Motor Company. Expanded our customer base by planning, recruiting talent, and managing the productization of our software. Delivered complete MES systems (software and services) to electronic manufacturers including AT&T, Digital Equipment Corp, and NEC Electronics/ZDS). My groups successfully billed $45M in software revenue within $125M factory automation contracts.