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William (Bill) Fletcher (social@pharma-logic.com)

In December 2014, I rolled off my 25th serialization and traceability strategy/requirement/vendor selection project in life sciences. My recent clients have included several of the top 10 largest life sciences and biologics companies in the world.

I have also helped previous clients to rollout production serialization systems around the world, including projects involving the H.R 3204 - US Federal Law Drug Quality and Security Act of 2013 (DQSA) and Title II: Drug Supply Chain Security Act, California ePedigree, China, Turkey, India, European Union countries and others. Updating many strategy and project roadmaps for DQSA now.
_______________________
Seeking a new project now.

Project deliverables have included:

(a) Global Strategy for traceability, serialization, barcoding, RFID, EPCIS, pedigree (ePedigree),
and Electronic Data Interchange (EDI) efficiencies (including serialized ASN for tracking),

(b) Roadmaps and Project Planning, Detailed Project plans, (I am a longstanding member
PMI - Project Management Institute)

(c) User Requirement Specifications (URS),

(d) Functional & Design specification, Technical Design and architectures,

(e) Vendor assessment/comparison/RFP prep/selection,

(f) Pilots, Detailed Test Scenarios,

(g) Regulatory Validations & Risk Evaluation and Mitigation Strategies (REMS).

(h) Overall Project Management,

(i) Packaging line risk assessment and recommendations,

(j) dynamic and advanced covert and overt anti-counterfeiting and consumer/patient authetication.

My background spans over 30 years in pharmaceutical, supply chain/logistics, enterprise software and healthcare systems. I have obtained GS1 US certification (Barcode Professional Certification), PMI certification (PMP) and SAP Aii 7.1 trained/certified (2011). Member GS1 (active in GS1 US Healthcare).

More at www.pharma-logic.com, www.bfletcher.com, social@bfletcher.com.

Bill Fletcher's Experience

Managing Partner

Pharma Logic Solutions, LLC

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.

Project Manager / Subject Matter Expert

Leading Pharmaceutical Company

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.

Director, Product Development

Packaging/Labeling Automation Software Company

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.

Technology Consultant

Technology Consultant

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.

Vice President, Technology and Software Development

Privately Held Company

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.

Chief Technology Officer (CTO)

Vox Medica, Inc

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

Chief Technology Officer (CTO)

Doctor Quality

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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Bill Fletcher's Publications

  • Editor

    • Pharmaceutical Serialization Playbook
    • 2012

    Written for the entire serialization team, from packaging through IT, this Playbook is jam-packed with hands-on, actionable advice from those who’ve been there. This is the only guide that bridges the theoretical to the practical. Designed to bring you up to speed quickly on serialization and avoid the mistakes that the pioneers made. We break down what is an unimaginably complex undertaking into...more

  • Congressional Briefing

    • June 6, 2012

    Congressional staff briefing in US Capital Building, one of four panelists, organized by PEW Trusts to discuss track and trace, serialization and electronic pedigree (e-Pedigree) in life sciences.

  • Presenter - State of California

    • State of California Board of Pharmacy (BoP)
    • September 11, 2012

    Webcast http://youtu.be/uUo2d39TUQM, agenda http://www.pharmacy.ca.gov/meetings/agendas/2012/12_sep_enf.pdf, schedule of meetings http://www.pharmacy.ca.gov/about/meetings.shtml

  • Track and trace left out of recent law

    • www.securingpharma.com/track-and-trace-left-out-of-pdufa/s40/a1264/
    • June 2012

    Drug tracking left out of PDUFA.

  • Presenter, ISPE San Diego, CA

    • May 17, 2012

    Presenter, ISPE, Implementing a serialization and traceability project in life sciences.

  • Serialization and Traceability for Brand Protection in Life Sciences

    • http://www.exlpharma.com/event-agenda/2279
    • May 10, 2012

    Chairman and speaker for the May 10-11, 2012 Traceability Summit in Philadelphia (http://www.exlpharma.com/event-agenda/2279) and a preconference podcast at http://info.exlpharma.com/P744-Podcast-Video.html.

  • PODCAST: Serialization and Traceability for Brand Protection

    • May 2012

    Chairman and speaker for the May 10-11, 2012 Traceability Summit in Philadelphia preconference podcast at http://info.exlpharma.com/P744-Podcast-Video.html.

  • Chairman: European Serialization and Traceability Summit - Berlin Germany

    • August 2011

    Chairman and speaker at the European Serialization and Traceability meeting in Berlin Germany (www.exlpharma.com/euserialization).

  • PODCAST: Track and Trace in Life Sciences

    • August 2011

    Podcast with speakers from Merck, Pfizer, SAP and others (see http://2020pharma.com/podcast/how-counter-counterfeiters-serialization).

  • 20/20 Pharma: How to Counter Counterfeits

    • June 2011

    Recent article in 20/20 Pharma (see info is at the bottom of 31 and my part of the discussion goes from the end of page 29 through 31 - http://www.2020pharma.com/emag/2011Q2/pageflip.html).

  • California Track-and-Trace Law Is Good Model

    • The Pink Sheet: Article # 14120607002
    • June 7, 2012

    California Track-and-Trace Law Is Good Model, by Cathy Dombrowski / Email the Author / “The Pink Sheet” DAILY Jun. 7, 2012 Word Count: 764 / Article # 14120607002. Executive Summary: The company has been tracking shipments of its growth hormone agent Serostim since 2002 to forestall counterfeiting and fraudulent claims and backed a full track-and-trace system during a forum sponsored by PEW Trusts...more

  • The Arguments for Unit-Level Track and Trace

    • The RPM Report: Article # 2012500085
    • June 1, 2012

    The Arguments for Unit-Level Track and Trace By Laura Helbling / Email the Author / The RPM Report June 2012, Vol. 8, No. 7, FDA Beat / Word Count: 1297 / Article # 2012500085 - Executive Summary: The effort to get requirements for real-time track and trace systems to the unit-level into federal legislation through the PDUFA V process highlighted some of the benefits and early experiments with the...more

  • Speaker: Deploying Serialization and Track & Trace in the Global Regulatory Environment

    • June 10, 2012

    Speaking on Deploying Serialization and Track & Trace in the Global Regulatory Environment.



Bill Fletcher's full resume is available by clicking here.  A Printable version is available by clicking here.

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