2006– Present (7 years)Global

My role as Managing Partner for Pharma Logic Solutions, LLC leverages my deep subject matter and extensive management experience to help solve complex business problems for leading life sciences companies.

I am currently focused on pharmaceutical serialization, track and trace and anti-counterfeiting including the US Drug Quality and Security Act of 2013 (DQSA), formerly HR 3204, China, Turkey, India, Brazil, South Korea and EU countries. I have developed serialization, e-Pedigree, EDI and EPCIS strategy, requirements, vendor selection and project planning for multiple companies.

I have also has spoken and published numerous times on issues within the pharmaceutical industry (see below on this page), including recent presentations in Philadelphia (www.exlpharma.com/serialization) and as Chairman for the European Serialization and Traceability Summit (www.exlpharma.com/euserialization).

My recent projects have included solutions involving serialization, track and trace, electronic pedigree (e-Pedigree or epedigree), radio frequency identification (RFID), barcoding and scanning, GS1 electronic product code information services (EPCIS), supply chain, warehousing and EDI.

I have developed strategy, business and user requirements (URS), designs and implementations have included solutions from SAP (ECC, SCM, Aii, OER, PI/XI/iDoc/PML/MI/ITSmobile/Dynpro, Aie), Oracle (OPSM, OPM), Acsis (ProducTrak), Axway, rfXcel, IBM, Systech (Guardian, Advisor, Sentri, OEE), Optel Vision, Cognex, Antares Vision Systems (Xyntek in US), Mettler Toledo, Laetus, RocIT, Seidenader (Körber Medipak), TAKE Solutions, Uhlmann/VisioTec, Nosco, Werum PAS-X, Tracelink and others.

I have designed many packaging lines and hold a Bachelor of Science in Electrical Engineering. I am a long standing member of the Project Management Institute (PMI), GS1 US Healthcare and I have received various industry certifications, including SAP Auto identification infrastructure (Aii) and SAP OER ver 7.1.

2006– 2008 (2 years)

Leveraging past experience to manage multiple simultaneous projects focusing on improving and advancing pharmaceutical drug safety, efficacy, discovery and pharmaceutical research.

Consultant with multiple pharmaceutical companies. Projects included systems used in pharmaceutical Packaging and Anti-counterfeiting, e-Pedigree and serialization, Discovery Research (R&D) and Compound Testing, Biomedical research.

Extensive experience with regulated system, including GLP, GMP, GxP, and US Code of Federal Regulations (CFR), Title 21, Part 11 compliance. In addition, projects have involved compliance with section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS § 351), current good manufacturing practices (cGMP), World Health Organization (WHO) and European Union's GMP (EU-GMP), United Kingdom Rules and Guidance for Pharmaceutical Manufacturers and Distributors or "The Orange Guide," and International Conference on Harmonization (ICH). My projects have also involved Good Distribution Practice (GDP) such as 21 CFR 210/211, USP 1079 and the European Community 92/25/EEC requirements.

I have developed and refined Standard Operating Procedure (SOP), Project Management and Software development and testing practices.

Project to implement serialized product tracking packaging/labeling using radio frequency identification (RFID) and 2D RSS or DataMatrix barcodes and data carriers.

2005– 2006 (1 year)

Reporting to CEO when I resigned to pursue consulting. Company provides pharmaceutical packaging execution solutions (PES), including automated camera inspection, packaging performance management (PPM), overall equipment effectiveness (OEE), anti-Counterfeiting, e-Pedigree, SCADA, bar-coding and radio frequency identification (RFID). Integration with several ERP systems, including SAP Auto ID Infrastructure (AII) and Netweaver.

Managed team of software and hardware development engineers, documentation staff, and consultants. Provided technology strategy for product and lead the development of the Product Roadmap and strategy. Served as a technology liaison to clients. Developed primary architecture for new products.

Company restructured following resignation of key executives. Resigned in the wake of the restructuring to consult.

November 2004– June 2005 (8 months)

Leveraging past experience to manage multiple projects focusing on improving and advancing technology solutions for multiple companies.

Multiple pharmaceutical consulting projects, including for a top 10 global Pharmaceutical Company to manage multiple software development projects in Drug Discovery and Compound Management, Drug Metabolism and Pharmacokinetics and R&D. Projects included leveraging barcoding and auto-identification technology to facilitate the drug discovery and testing processes.

Recruited to join packaging automation company to lead teams of software developers, hardware engineers and documentation professionals to implement RFID, serialization and track and trace technology.

January 2004– October 2004 (10 months)

Reporting to CEO. Data management solutions for healthcare and life sciences companies.

Manage team of software development personnel, IT support staff, and consultants in the US and India. Provided technology strategy for both business infrastructure and product. Served as a technology liaison to clients. Senior manager for all technology infrastructures, application development services and IT budgets.

Venture funded company failed to obtain necessary second round funding.

Privately Held; 51-200 employees; Marketing and Advertising industry

2002– 2004 (2 years)

Reported directly to four owners/partners. Advertising, Multimedia and PR Company focused on Healthcare, Pharmaceutical and eCommerce industries.

Managed staff of development personnel, technology project manager, IT/Network support staff, and several consultants. Provided technology strategy and presentations, including new product concepts for the sales and marketing departments. Served as a technology liaison to clients. Developed the primary architecture for new products. Managed development services and IT budgets.

Recruited to Peminic following their initial round of investment. Resigned from Vox Medical to join Peminic

2000– 2002 (2 years)

Reported directly to CEO. Company provided medical error reporting and Consumer Directed Healthcare (CDH) portals and online tools.

Managed staff of application development and network/computer support. Interfaced with clients on technology issues and provided strategies and guidance to the sales and marketing departments. Developed Internet-based Application Service Provider (ASP) model to offer solutions to organizations without requiring them to manage the solutions. Developed hosting infrastructure and HIPAA compliant security from the ground up. Managed departmental budgets and developed the primary architecture for new products and services.

Recruited to Vox Medica following the resignation of DoctorQuality’s founder and key personnel and the pending sale to a west coast competitor.

Information Technology and Services industry

June 1982– 2000 (18 years)Global, Multiple locations

Prior to this point, for 18 years, I held roles of ever increasing responsibility (and senior management roles) in healthcare technology, global enterprise resource planning (ERP) and supply chain/logistics management, and life sciences.

Defined requirements and process design and led projects relating to supply chain, logistics and ERP projects as a consultant. Clients included Philips, Siemens, NCR, AT&T, General Motors, General Electric, Ford Motor, Hewlett-Packard, Procter & Gamble, Kraft Foods, Intel, Honeywell International, General Dynamics, 3M, Northrop Grumman, Xerox, Medtronic, Pfizer, Johnson & Johnson (J&J), and more.

Multiple global projects and deployments. Multiple technologies and industry verticals. Seasoned project leadership and planning.

Projects in life sciences, pharmaceuticals and biologics in the last 30 years have been with Pfizer (and Wyeth), Johnson & Johnson, Amgen, Astellas Pharma, Biogen Idec, Shire, BioMarin, Celgene, Harvard Drug Group (including Major Pharmaceuticals), Noven, Endo (and Qualitest), Eisai, PAR, Perrigo, Smith Nephew, Jubilant, Aptalis, Santarus,Roche, GlaxoSmithKline (GSK), Shionogi, Sanofi-Aventis, AstraZeneca, Abbott Laboratories (now including AbbVie), Merck & Co., Bristol-Myers Squibb (BMS), Baxter International, Nycomed, Genzyme, Allergan, Cephalon, Carolina Medical, SiO2 Med. Projects have included commercial and clinical supply chain, packaging execution systems (PES) and machine vision inspection and control, serialization, electronic pedigree, warehouse systems, shipping and distribution systems, research and development systems, animal and human clinical testing systems, patient and physician education.

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