The Cold Chain IQ advisory board consists of key thinkers and thought leaders in the temperature control and logistics industry. These seasoned experts guide the topics on the Cold Chain IQ site in addition to contributing presentations, webinars, and media. These industry leaders were selected due to the calibre of their work within their respective areas of expertise.
About our Advisors
Aidan Sexton has a Bachelor of Science in Industrial Chemistry and a Doctorate in Catalysis/Physical Chemistry, both from the University of Limerick. He has more than 25 years of experience; 10 years in research and development and 15+ years in the pharmaceutical industry.
Aidan has held a number of senior roles in the areas of Validation, Quality Assurance and Engineering. These roles have been in biopharmaceutical, sterile fill finish and API manufacturing organisations, including Pfizer and Janssen Biologics (a Johnson & Johnson company). His current role is Senior Process Validation Engineer in Technical Operations at Janssen Biologics, Cork. His responsibilities include supporting the assessment and use of disposable technologies throughout Janssen. He represents Janssen Biologics in the Extractables and Leachables work stream in the BioPhorum Operations Group (BPOG), an industry collaboration body. Aidan is the Janssen corporate vote holder in the ASTM E55.04 General Biopharmaceutical Standards subcommittee. He also lectures in three modules for an MEngSc program in Pharmaceutical and Biopharmaceutical Engineering, at University College Cork.Back to Top
Arminda Montero has worked in the pharmaceutical industry over 15 years. She is the distribution quality assurance program manager for the global pharmaceutical products division. Her current responsibilities include the development and implementation of strategies and quality systems for distribution, with specialized focus on cold chain management. Arminda holds a Bachelor of Science in Chemical Engineering from the University of Illinois at Urbana-Champaign.Back to Top
Neritan Mustafa is Associate Director at Genzyme A Sanofi Company. He is the leader of the Supply Chain Operations Engineering & Performance for Genzyme Industrial Organization. Neritan's focus for the past 13 years has been understanding the requirements of the Global Cold Chain process, lead, manage and support key activities achieving business excellence aligned to strategy based on robust science, risk management while meeting global regulatory requirement.
Neritan 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 University, Framingham Massachusetts, USA.
Neritan is an active member of ISPE and PDA and contributing member of Industry Working Groups.
Humberto has gained 7 years of experience in quality system, cold chain process and project of continuous improvement, during his previous position as quality assurance inspector at Wyeth Pharmaceutical. His current position is a quality coordinator and Pfizer, based in Peru. He holds extensively knowledge in the different worldwide tendencies in cold chain in USA, Europe and Latin-America and has experience in maintaining the cold chain in places without electricity, available roads and extreme weather. Knowledge about ISO 9000, PMBOK, Six Sigma, 6S, Poka Yoke, Risk Management and all the activities regarding to Good Manufacturing Practices including validations. Red Belt and Trainer Certification.Back to Top
Benjamin Romero is a Senior Engineer in the Pharmaceutical & Packaging Engineering department of Genentech. He has over 12 years of regulated packaging experience, most of which focused in the field of thermal package design, validation and manufacturing for the biopharma industry. He has been deeply involved in most areas of cold chain packaging including insulation, phase change material science, electronic temperature monitors, and predictive simulation. His work in the field of cold chain has yielded a US patent, as well as peer recognition in the form of a 2004 IOPP Ameristar, and WPO Worldstar awards in the pharmaceutical category. He has a BS in mechanical engineering from Stevens Institute of Technology, and is a CPP (IOPP Certified Packaging Professional).Back to Top
Geoffrey Glauser is a K.W. Tunnell Contractor in support of the Manufacturing, Facilities, and Engineering Division of the Biomedical Advancement Research Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPER) within the U.S Department of Health and Human Services (HHS). This division supports the development, contracting and supply of vaccines, antivirals, diagnostics, therapeutics and ancillary products. As a subject matter expert in supply chain functions for biologicals and pharmaceuticals, Geoff works in support of the development, testing, and manufacture of Pandemic Influenza vaccines, antiviral compounds and Radiological, Nuclear and Chemical vaccines and therapeutics. Geoff reviews contract proposals and related documents for product development, manufacturing processes, logistics, storage and distribution issues. He provides assessment and guidance reports on contract issues involving product delivery, quality, regulatory compliance, oversight of facility design, construction, and monitoring contract progress. Geoffrey Glauser has previously worked with Pfizer Pharmaceuticals (formerly Wyeth) in the Global Packaging Technology group supporting biotech, vaccine, consumer and nutritionals with temperature controlled shipping expertise and solutions. In previous industrial positions, he has directed supply chain, biological, sterile and chemical manufacturing activities with Merck & Co. Inc. (25 years) and Fisher Clinical Services for in-line, new product and clinical biological and pharmaceutical entities both domestically and internationally. A former US Navy officer and engineer, Mr. Glauser has a microbiology degree from Indiana University. As an active member of the PDA, ISPE, and APICS, Geoff speaks and writes for industry forums on supply chain issues.Back to Top
Saddam Huq is QA Senior Manager, Global Logistics and Cold Chain at GSK Vaccines in Belgium. Previously Cold Chain Technology lead at Wyeth Biotech/Pfizer in the UK, Saddam is a Subject Matter Expert for Cold Chain Shipment, Road Freight, Air Freight, Controlled Temperature Storage and Temperature Excursion Management. He held previously positions at Fresenius Kabi as a QA Officer and at Tycohealthcare as Process Engineer. Saddam as a BSC in Chemical Engineering.
Richard Ellinger is Principal at Temperature Assurance Group, a Cold Chain Research, Training, Consulting and Packaging Solutions organization. He has been active as a Cold Chain Supplier since 2005 working first with ThermoSafe Brands and now with TAG. His supplier experience includes global management responsibility for lab services, product development, business development, marketing, sales and customer service. His current research study involves discovering the best 'track and trace', 'chain of custody' and full-service logistics services; and his current training program is dedicated to suppliers so they might improve their ability to win business by maintaining a high-quality, regulatory compliant service or product while working within the framework of the ColdChain decision-making process.Back to Top
A veteran journalist with 28 years of trade publication experience, including 23 in packaging, Jim Butschli is responsible for editorial planning, writing, and editing for print, Web, and electronic publications produced by Healthcare Packaging and Packaging World, published by Chicago-based Summit Media Group.
Jim has served as Editor-in-Chief of Healthcare Packaging magazine since its inception as an electronic publication in 2004. He also serves as Features Editor with Packaging World magazine, where he started in 1994.
Jim has attended recent Cold Chain for Pharmaceuticals events in Philadelphia, is an active member of the Institute of Packaging Professionals, is experienced in speaker acquisition, and has served as a moderator and/or speaker at packaging-focused events. Jim has visited numerous plants throughout the U.S., Canada, and Europe to report on packaging machinery and material applications, focusing primarily on pharmaceutical, medical device, and biologics issues and trends, including cold chain distribution issues.
Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management - US an international provider of consulting, research and training services to manufacturers, airlines, forwarders and other stakeholders in the life science logistics sector. With its unique cross-sector knowledge of the industry, Exelsius has been consulted on a diverse range of projects around the world including in-house and public training, logistics product development, Quality Management System introduction and facility design. Mr. O’Donnell’s contributions to industry are widely recognized. He is internationally respected as an advocate, author, blogger, educator, training developer, and champion of good distribution and logistics practices for temperature-sensitive drugs. His involvement with industry spans such organizations as the International Air Transport Association, where he serves at Chair of the Time & Temperature Task Force; the World Health Organization, as a temporary advisor; the United States Pharmacopeia, as a member of the 2010-2015 Expert Committee on Packaging; and the Parenteral Drug Association, as a founding member of the PCCIG, co-author of Technical Report #39, and training co-developer. Prior to joining Exelsius, Mr. ODonnelll was Director and Chief Technical Advisor to Industry at ThermoSafe Brands. He retired in 2005 as a Principle Packaging Engineer after a 26-year career at Abbott Laboratories.Back to Top