 William
(Bill) Fletcher (social@pharma-logic.com)
In
June 2013, I rolled off my 18th 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.
Project
deliverables have included:
(a) global Strategy
for traceability, serialization, barcoding, RFID, EPCIS,
& pedigree (ePedigree),
(b) Roadmaps and Project
Planning,
(c) User Requirement Specifications
(URS),
(d) Functional & Design specification,
(e) Vendor assessment/comparison/RFP
prep/selection,
(f) Pilots,
(g)
regulatory Validations & Risk Evaluation and Mitigation
Strategies (REMS).
(h) Overall Project
Management,
(i) Packaging line risk assessment
and recomendations.
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).
My experience in life
sciences includes supply chain track & trace, Electronic
Data Interchange (EDI), packaging/labeling execution
systems (PES) & machine vision inspection,
serialization, barcoding/DataMatrix, radio frequency
identification (RFID), e-Pedigree/RxASN, Electronic
Product Code Information Services (EPCIS).
Solutions have involved SAP (ECC, SCM, Aii, OER, PI/XI,
Aie), Oracle (OPSM, OPM), Acsis, Axway, rfXcel, Systech
(Guardian, Advisor, Sentri, OEE, SPT), Optel Vision,
Cognex, Antares Vision (Xyntek in US), Mettler Toledo,
Seidenader (Korber Medipak), Uhlmann, Nosco, Werum
PAS-X, Tracelink and others.
Member GS1 (active
in GS1 US Healthcare) and PMI (Project Management
Institute).
More at www.pharma-logic.com,
www.bfletcher.com, social@bfletcher.com.
Specialties
Life Sciences,
pharmaceutical and biologics technology. Serialization,
drug track and trace, anti-counterfeiting, packaging,
logistics and distribution. Background includes
technology roles and experience with SAP
Aii/OER/ECC/SCM, IBM, Axway, and Oracle OPM/OPSM.
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. I have
developed serialization, e-Pedigree, EDI and EPCIS
strategy, requirements, vendor selection and project
planning for multiple companies. By June 2013, I have
completed my 18th serialization and traceability
strategy/requirement/vendor selection project in life
sciences.
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 version 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
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 help company
Privately Held; 11-50 employees; Information
Technology and Services industry
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.
Various roles worldwide, Information Technology &
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,
Perrigo, Roche, GlaxoSmithKline (GSK), Shionogi,
Sanofi-Aventis, AstraZeneca, Abbott Laboratories (now
including AbbVie), Merck & Co., Bristol-Myers Squibb
(BMS), Baxter International, Nycomed, Genzyme, Allergan,
Cephalon. 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.
#
Bill Fletcher's Publications
Editor, Pharmaceutical Serialization Playbook,
2012
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
Drug
tracking left out of PDUFA.
Presenter, ISPE
San Diego, CA
May 17, 2012
Authors: Bill
Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill
Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors: Bill Fletcher
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
Authors:
Bill Fletcher
Speaking on Deploying
Serialization and Track & Trace in the Global Regulatory
Environment.
Bill Fletcher's
Organizations
GS1 US Healthcare
Member, 2006 to Present
GS1 Healthcare
US is an industry group that is driving forward open,
global standards to help healthcare companies improve
the accuracy, speed, and efficiency of the supply chain
and care delivery.
Through the collaboration and
cooperation of companies and organizations throughout
the healthcare supply chain, GS1 Healthcare US is making
it possible for healthcare to move toward adopting GS1
Standards for identifying, capturing, and sharing data
as the foundation for improved business and care
delivery processes.
Bill Fletcher's
full resume is available by
clicking here.
A Printable version is available by
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