Bill Fletcher Email & Phone Number

Pharma Logic Solutions, LLC provides highly trained and experienced resources to the life sciences industry. The principal focus is on serialization, encoding (barcodes, RFID, etc), packaging excellence, warehouse automation, best practices for life sciences (i.e., FDA investigations, VAWD certification, etc.) and supply chain security and collaboration. My role as Managing Partner leverages my deep subject matter and extensive management experience to help solve complex business problems for leading life sciences companies. In December 2020 I completed my 55th serialization implementation for global life sciences, including vendor selection, defining user requirements, implementation, SOP/Procedures, validation and more.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, and more specifically Title II the Drug Supply Chain Security Act (DSCSA), China, Turkey, Russia, India, Brazil, South Korea and EU countries EMVO and unique device identifier (UDI) for medical devices,. Projects have involved solutions from Axway, rfXcel, Tracelink, Optel Vision, Systech (now part of Markem-Imaje), Antares Vision, SAP (Aii/OER/ATTP/WM/eWM), Arvato, Frequentz (previously IBM Traceability Server and now part of rfXcel), Manhattan Associates, Oracle (SCM), Datex, Manugistics, QSSi, JD Edwards, Acsis, Bosch, Cognex, ACG, Jekson, Uhlmann, Körber Medipak/Seidenader, ROC-IT (now part of Tracelink), TAKE Solutions, TraceKey, Navitas, Laetus, Xyntek, Mettler Toledo/PCE, Verify Brands (now part of Optel Vision), Werum PAS-X, and others.

My background spans over 39 years in pharmaceutical, enterprise software and healthcare systems. As an consultant (expert and fiduciary), I have focused on helping life sciences organizations to enhance their warehouse, packaging and supply chain efficiency, reduce risk and comply with global regulations and laws, including traceability and serialization. I leverage my deep subject matter and project management experience to help solve complex business problems. My references here include the US Secretary of Veterans Affairs and several past clients. I have spoken in the US Capital Building to congressional staff and published numerous times on issues within the pharmaceutical industry.In December 2020, I completed my 55th commercial serialization and traceability project for global life sciences companies.I have helped multiple companies obtain NAPB Verified-Accredited Wholesale Distributors (VAWD) and improve their GxP/GMP SOP/procedures to reduce risk and costs and facilitate FDA and other regulatory investigations.Projects have also included strategy, project roadmaps, user and functional requirements, vendor selection and price comparison, SOP/procedures, pilot planning and tests, validation, risk or REMS assessment and project planning for multiple companies. My undergraduate degree is in electrical engineering. I am a long standing member of the Project Management Institute (PMI), GS1 (traceability, RFID/NFC and barcoding standards), ASCM (Association for Supply Chain Management) Member, and experienced with the Supply Chain Operations Reference (SCOR) model with other life sciences companies, member of PMI (Project Management Institute for over 20-years, training for configuring and maintaining SAP Auto identification infrastructure (Aii), SAP Advanced Track & Trace for Pharmaceuticals (ATTP) serialization and the GS1 Certified Professional (demonstrating a detailed understanding of barcoding and serialization standards).

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 on pharmaceutical/biologic serialization, tracking, packaging and unique device identifier (UDI) for medical devices.

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.

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.

New York, Ny, Us

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

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.

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. Example of one of my new Medical Device Submission 510(k) in FDA registry at http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K904088 (note Original Contact name). #