Patrick J. Bell is the Associate Director, QA for the Quality Operations at Wyeth at Richmond, Virginia. He holds a B.A. in Chemistry with a minor in Math from the University of Northern Iowa. Mr. Bell is responsible for overseeing the site's Stability, Annual Product Reviews, Change Control, Record Review, Specification, Document Repository & Management, and Technical Specification Programs. He served as a project leader for the Lab's Y2K implementation SQL*LIMS project and was an active member of the planning and designing a new QA and Stability Laboratory building. Mr. Bell has 26 years of pharmaceutical laboratory experience working for Whitehall Laboratories, Whitehall-Robins Laboratories, and Wyeth Pharmaceuticals.

Sean is an analytical chemist now working as the Validation Specialist for the Canadian affiliate of Abbott Labs. He has been with Abbott for 5 years innovating quality solutions in diverse areas like manufacturing, importation, distribution and customer support. Sean has more than 10 years experience in the pharmaceutical industry with previous experience developing new analytical test methods, qualifying analytical instruments and as an international consultant.

Thomas Berger is a Senior Manager for WEi Engineers and Integrators Inc., a global integrator of supply chain and demand driven supply network solutions headquartered in Chicago, IL. Mr. Berger’s three decades in the industry has given him a unique perspective on the material handling industries support of the dynamics of the supply chain.

Mr. Berger has an undergraduate degree from The University of Oklahoma and is an industry certified professional by Material Handling Management Society with the credentials of Professional Certified Material Handling (P.C.M.H.). He has taught for several years at The World Food Logistics Institute on the subject of automation and the food industry. Mr. Berger just recently joined WEi after a 5 year tenure with DAIFUKU as a senior manager for applications. He also heads WEi’s seminar and speaker bureau, speaking to end users groups on the evolution of material handling and its impact on delivering the “Perfect Order”.

Founder and CEO, Michel Comtois formed Micom Laboratories Inc. after having spent 14 years at research and contract laboratories managing various types of departments all related to physical chemistry, physics, mechanical and material testing. Michel’s role gave him firsthand experience and in-depth understanding of the development and testing process.

Taking this valuable insight and his vision to provide high quality, cost-effective product testing for other technology companies, Micom Laboratories began providing specialized testing services.

Using proven processes and quality procedures in its specialized lab, Micom Laboratories staff delivers the end result companies need - products that meet all necessary requirements to ship their products around the globe. This frees firms from costly and time-consuming testing and allows them to focus on their essential engineering and business issues.

Michel Comtois holds an M.Sc. from the University of Sherbrooke.

Over the past 18 years Mr. Comtois has been extensively involved with various standard writing committees.

• The American National Standards Institute (ANSI)
• The Business Institutional Furniture Manufacturer’s Association (BIFMA)
• The Canadian General Standards Board (CGSB)
• The International Standards Organization (ISO) / head of the Canadian Delegation.

Today Micom Laboratories has a 11 000 square feet facility in Montreal, Quebec, offering a wide range of test services all related to material and product testings,

Micom laboratories has invested in technically strong people oriented toward high quality standards and also capable of great creativity which allows its team to fulfill mandates undertaken by the company.

Mr. Eric D. Isom

Mr. Eric Isom is recognized by his colleagues as a leader in the field of pharmaceutical cold storage, logistics and inventory management. He brings years of experience to his role as Sentry’s manager of warehouse operations where he is responsible for maintaining the security and stability of client products throughout all phases of shipping and storage. Mr. Isom develops solutions for domestic and international packaging, logistics and transportation; supervises day-to-day warehouse and storage facility operations; develops, implements and manages cold chain shipping and tracking processes and procedures; and ensures that all warehouse operations adhere to FDA requirements, Good Laboratory Practice (GLP) and other applicable regulations. Mr. Isom also oversees package configuration and distribution channel management.

Prior to Sentry, Mr. Isom served as manager of distribution for Baxter Pharmaceutical Solutions. In this role, he directed the global distribution of pharmaceutical and biotechnology products and designed cold chain shipping solutions for clients. Mr. Isom was responsible for supply chain logistics and security, hazardous shipping regulations and exporting. He was integral in facilitating Baxter’s growth by directing the relocation of the company’s cold storage warehouse, which nearly doubled the size of Baxter’s operations. Additionally, Mr. Isom identified new distribution strategies and third party vendors, which produced an annualized savings of more than $100,000.

Mr. Isom is recognized as a thought leader in the global cold chain industry. He is a frequent speaker at cold chain distribution conferences and a contributor to influential warehouse and logistics trade publications. He is also a member of the PDA’s Pharmaceutical Cold Chain Discussion Group. He received a B.A. degree in business management from Indiana State University and a degree in law enforcement from Vincennes University.

Claude Jolicoeur is Director, Quality and Corporate GMP officer for McKesson Canada. Claude started with McKesson Canada in October 2004 and his primary responsibility was as Director of Specialized Distribution. In that function he was given the mandate to develop a qualified packaging for McKesson Canada. With the introduction in 2005 of Health Canada’s Guide 0069 and considering he was given the responsibility the additional responsibilities of Quality and regulatory affaires for McKesson Canada.

He is responsible for ensuring compliance with all regulatory body and more particularly with Heath Canada. He has developed specialized distribution services for cold chain and customized distribution solutions for manufacturers.

Claude has 24 years of experience in distribution and has a degree in Business Administration. Prior to joining McKesson Canada, Claude spent a number of years managing warehousing and distribution for Bayer in Montréal and Johnson and Johnson in Markham.

Mitchell Kennedy is currently a Senior Quality Consultant with DSA Consultants. He specializes in validation, mapping, auditing and GMP compliance. Mitchell has many years of experience in cold chain matters including packing and shipping lane qualification. Also, he has been involved in various HACCP and Six Sigma projects. In addition, Mitchell has taught classes and workshops in several areas of the pharmaceutical, medical device and biotechnology industries.

As the Senior Project Manager of the Cold Chain Visibility Advisors, Mark is responsible for managing a cross functional team of Project and Assistant Project Managers with backgrounds in Industrial Engineering, Food Science, and Technical Writing. The team focuses on defining and executing projects such as facility, trailer, and container thermal mappings, shipping studies and site audits. These cold chain visibility solutions enable Sensitech customers to make decisions that impact product quality and improve profitability. Mark has been with Sensitech for over three years.

Mark worked previously at United Parcel Service for sixteen years as an Industrial Engineering and Operations Manager. While at UPS, Mark completed numerous projects as a Project Manager focused on supply chain and warehousing improvements.

Mark earned his Masters in Industrial Engineering and Bachelors in Architecture from the University at Buffalo.

Mr. Neritan Mustafa

Neritan Mustafa’s background is in Cold Chain Management more specifically in Validation, Supply Chain Audit, Thermal Package System Design and Testing, Project Management, start-up and New Product Development. Innovative professional with nine years of solid and invaluable experience in Management, Project Management, Engineering, R&D, NPD, Validation and Total Quality Management. Solid experience working in the pharmaceutical industry and strong knowledge of Good Cold Chain Management Practices (GCCMP), USP 1079 and FDA regulations related to temperature management.

Neritan is a current member of the International Society for Pharmaceutical Engineers (ISPE), the American Society for Quality (ASQ) and the Parenteral Drug Association (PDA).

Neritan received training and certification from the Pharmaceutical Training Institute (PTI) in “Mastering your Performance as a Quality Assurance Professional” the International Safe Transit Association (ISTA) in “Certified Packaging Laboratory Technician” (CPLT) and the Institute of Validation Technology (IVT) in “Validation”.

Neritan Mustafa received his Bachelors of Science in Chemical Engineering with a Minor in Chemistry from the University of Massachusetts Lowell, USA, and his Masters of Arts in Business Administration from Framingham State College, Massachusetts, USA.

Kevin is Technical Director at SCA Americas, ThermoSafe Brands. He retired in 2005 from Abbott Laboratories, as Principle Packaging Engineer, responsible for the design, development, qualification and implementation of all temperature controlled distribution packaging for the Abbott Global Pharmaceutical Division. His 26 year career at Abbott included more than 20 years of cold-chain experience in the Diagnostics Division and in the International Division Global Logistics and Supply Chain. Kevin is well known throughout the Pharmaceutical industry in the US and in Europe as a leading advocate for implementing good distribution practices. He is active in providing his knowledge and expertise to industry and is heavily involved helping draft guidance.

Kevin authors and maintains the first-ever blog site dedicated to pharmaceutical cold-chain distribution. “Where Cooler Heads Prevail” http://www.coolerheadsblog.com/ is an open
discussion forum on all matters related to cold-chain.

Kevin is a Certified Packaging Professional, (CPP), a member of the Institute of Packaging Professionals and a founding member of the Parenteral Drug Association Pharmaceutical Cold Chain Discussion Group (PDA-PCCDG), and co-author of the Cold Chain Guidance Document for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment, PDA Technical Report #39.

Dr. Claudia C. Okeke has conducted a number of studies relating to the development and establishment of public standards for appropriate packaging and shipping conditions for pharmaceutical dosage forms moving in the interstate and international commerce. She is a member of ASTM packaging Committee, and PQRI Packaging work group. She has authored and co-authored over 40 publications covering different packaging related issues, modern analytical techniques, stability studies, compounding issues, expiration dating, storage conditions requirements, temperature-humidity fluctuations during shipping of pharmaceutical dosage forms, and process for development and establishment of pharmacopoeia standards for pharmaceutical substances and dosage forms.

Mr. Salomon is an Environmental lawyer with advanced degrees from the Paris La Sorbonne and University of Louisville Schools of Law. The eventual link between environmental studies, cold chain management and RFID technologies came from six years of international sales management at Inland Packaging, then joining and eventually directing Evidencia LLP.
Through Mr. Salomon’s leadership, Evidencia has developed a sales network for environmental monitoring solutions supporting major agricultural companies in every major export market and country, among which Chile and Brazil and South Africa to the United States and throughout Europe.

Mr. Salomon’s vision to graft Evidencia’s knowledge of cold chain management for perishables to life sciences and pharmaceutical applications was pursued through relentless development of best of class and leading edge RFID temperature recorders, now positioning Evidencia as one of the world’s leading companies for RFID cold chain management and temperature solutions.

Ms. Skuce is a compliance officer at the Drug GMP Inspection Unit in Compliance and Enforcement Coordination Division, Health Products and Food Branch Inspectorate, Health Canada. Sarah holds Bachelor of Science (B.Sc.) Honors degree in Biopharmaceutical Sciences with an emphasis on Genomics from the University of Ottawa. Her duties include evaluating GMP compliance of foreign drug establishments and contributing to the development of regulations, policies and guidelines. Ms. Skuce has been with the GMP Inspection Unit since November 2005.

Tony Wright is Managing Director of Exelsius, a Cold Chain Management Consultancy. He is a former Executive of British Airways World Cargo & past Senior Vice President at Envirotainer. With over 35 years experience in the distribution and air cargo logistics sector, Tony Wright has become a prominent figure in the increasingly important global cool chain management of temperature-sensitive products.

His initiative in developing the London Heathrow cool chain distribution centre in 1996 for British Airways started a global revolution in air cargo temperature controlled logistics. In his role as Global Sales & Development Manager, he created an integrated approach towards value added distribution giving users extended product life and significantly increased sales. At the heart of this was the ability to profitably coordinate all the principle activities of retail distribution inside one facility, saving both time and cost whilst maintaining product quality.

In 2001, he joined Envirotainer initially as divisional Managing Director and then as Senior Vice President and continued to develop ways of improving the cool chain for many global companies in both the pharmaceutical and high-quality food sectors. Creating industry awareness of the logistical needs of temperature sensitive commodities and the solutions available, led to a significant increase in the company’s business around the globe. Tony went on to establish Exelsius - an independent cool chain management consultancy supporting the development of logistics for the international distribution of pharmaceutical & other temperature sensitive products. Exelsius has helped many companies understand and implement the requirements of Good Distribution Practice (GDP) and through business analysis & workshops, enabled them to introduce differentiated & branded cool chain ‘products’ that meet the distribution needs of pharmaceutical manufacturers, whilst adding value to their own business.

Tony is a member of the Parenteral Drug Association (PDA) and an elected member of the International Air Transport Association (IATA) Time & Temperature Task Force. He is on the editorial advisory board of publications including Pharmaceutical Technology Europe and has recently published a joint study for the Cool Chain Association into CO 2 emissions and their effect upon the use of air cargo. His independence, experience and knowledge of both the pharmaceutical and logistics sectors have provided the opportunity for him to address many industry events & seminars. Tony is also an experienced conference chairman and has recently hosted events in Amsterdam and Rome, with forthcoming events planned in London and Philadelphia.