Meet The Speakers
Chairperson
Rafik H. Bishara
Ph.D, Technical Advisor
PCCIG Chairperson PDA
Rafik H. Bishara, Ph.D., is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA). Dr. Bishara has served as a Temporary Adviser to the World Health Organisation (WHO) since July, 2007.
Dr. Bishara retired from his position as Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company after a 35-year career. During his tenure at Eli Lilly and Company, Dr. Bishara was responsible for the Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration.
Dr. Bishara frequently chairs and presents at industry leading conferences, has authored numerous articles, and technically advised several organisations on Good Cold Chain and Temperature Controlled Management Practices. Dr. Bishara received his Ph.D. from Purdue University, Indiana, USA.
Dr. Peter Kulmburg
Head of Global Quality Assurance TR&D
F. Hoffmann - La Roche AG
Dr. Peter Kulmburg is Head of Global Quality Assurance Technical Research and Development (Global QA TR&D) at Hoffmann La Roche. He holds a Global Quality Management function in Roche TR&D sites, “Responsible Person” named to Swissmedic for release of IMPs manufactured in Basel and/or Kaiseraugst (corresponds to QP in EU, “Fachtechnischer Leiter”).
He is a member of the Pharma Global Technical Development Management Team and Member of the Pharma Quality Steering Committee. Dr Kulmburg has implemented requirements of EU Clinical Trial Directive 2001/20/EC, created a new subgroup responsible for release of packaged IMP and established PTDQ as global function with audit authority over other Roche TR&D sites. His degree from Universität Graz / Austria, is Biotechnology and Molecular Biology and he also holds a Ph.D. in Orsay (Université de Paris-Sud / France) with distinction, in “Mechanism of induction and catabolite repression of the ethanol regulation in Aspergillus nidulans”.
Dave Ulrich
GPO QA Distribution Manager
Abbott
Currently, Dave is the QA mgr for Distribution and Logistics for Abbott’s GPO division. His responsibilities include standardization & optimization of quality systems (cGDPs), cold chain management and import export compliance activities (FDA, USDA and EPA). He has been at Abbott 20 years, with the majority of time spent in bulk (API) manufacturing operations, manufacturing QA and plant maintenance & engineering.
David Walsh
CEO
DGP Group
Founder and CEO of DGP Group Ltd.
Developed DGP from start-up in 1999 and has successfully built DGP to become a Global manufacturer of temperature control packaging systems for finished pharmaceuticals, API’s and clinical trials materials, supplying customers worldwide from 4 locations in North America, Asia and Europe. David has 17 years experience in the Life Science Packaging and Dangerous Goods Packaging.
Gert-Jan van Diest
QA Specialist Cold Chain Management
Abbott
Management project. In this short period he became subject matter expert on temperature controlled supply chain in Pharma.
With a former position within one of the largest food companies in The Netherlands, responsible for planning and transport, Gert-Jan brings a lot of cold chain experience in the project.
In his role Gert-Jan lead the migration project team in Abbott’s brand new warehouse in Breda, The Netherlands, and implemented new solutions for large volume international shipments.
Gert-Jan hold’s a degree in Business Economics and Logistics at the HES Amsterdam.
Henry Ames
Director of Strategic Marketing
Sensitech
Henry Ames joined Sensitech in 2004 as the director of strategic marketing. He focuses on global market analysis and strategic marketing initiatives for the Life Science Vertical.
Prior to Sensitech, he was a principal at Megunticook Management, a venture capital firm in Boston with $150 million under management and investments in promising communications, media and technology companies. While at Megunticook, Ames focused on supply chain-related investments. Before that he was manager of business development for Yantra, a leading provider of distributed order management and supply chain-fulfilment software.
Ames earned an MBA from the F.W. Olin Graduate School of Business at Babson College, and a double major in Business Management and Entrepreneurship from Florida State University. Ames also serves as a member of the Board of Overseers of the Beth Israel Deaconess Medical Centre in Boston, MA.
Ian Holloway
Manager, Defective Medicines Reporting Centre
MHRA
Mr Ian Holloway is manager of the UK Defective Medicines Report Centre for the MHRA (UK Regulatory Agency) located in London. The centre liaises with manufacturers, distributors, hospitals and pharmacies to direct recalls, issue timely notifications and oversee corrective actions for confirmed and suspected medicine defects.
He is a registered Pharmacist and has post-graduate qualifications in Pharmacology and Business Studies. He previously worked for the MHRA for over ten years as a site inspector for Good Manufacturing Practice and Good Distribution Practice at sites in the UK and worldwide. Prior to joining the Defect Centre he worked for the Agency as a Pharmacovigilance inspector and helped establish a new system of site Pharmacovigilance inspection systems.
Ingo Ocklenburg
Global Sourcing Manager, Distribution Logistics
Bayer Healthcare
He joined Bayer in 1997 for the function of Logistic Procurement Airfreight and Express Services. Ingo is a logistic expert and has a broad experience within the Aircargo Industry for more than 25 years. In his previous functions he worked for Airfreight Forwarding Agents, for a Canadian Airline and for an Aircargo Broker Company in various management positions for marketing and sales.
In his function as a Global Sourcing Manager Distribution & Logistics, he is responsible for all global logistics spends of Bayer HealthCare for Airfreight and Express Services. In addition, he is also Lead Buyer for the Procurement Synergy Areas Airfreight and Express Services for the Bayer Group globally.
Jeff Sitzlar
Business Development Manager
FedEx Custom Critical
Jeff Sitzlar is a Business Development Manager for FedEx Custom Critical. He has over 15 years of logistic industry experience and knowledge in expedited and sensitive freight. His expertise is at the forefront of air container compressor technology and air shipment protocols for the transfer of temperature-sensitive pharmaceutical and biotech materials.
Jim Bacon
Director, Global Demand Planning & Customer Operations
Talecris Biotherapeutics Inc.
Jim Bacon is Director, Global Demand Planning & Customer Operations at Talecris Biotherapeutics, Inc., at their head office in Research Triangle Park, North Carolina. In his role, Jim has responsibility for global Sales & Operations Demand Management, international customer service and logistics, and is a subject matter expert on cold chain logistics.
In 2006, Jim was responsible for establishing logistics services for Talecris with 3PL’s in Canada and Germany, as Talecris expanded its business worldwide.
Jim has led the cold chain team effort at Talecris/Bayer, since 2002, implementing solutions to improve safety and integrity of product from domestic small package to multi pallet international shipping. Jim has been published in various industry publications featuring Talecris’ advances in cold chain management and describing the process and relationships required to develop sound solutions.
Joachim Kuhn
Physicist CEO and Co-Founder
va-Q-tec AG
Dr. Joachim Kuhn: born May 02, 1964 in Miltenberg / Germany, Physicist, is the co-founder and now CEO of va-Q-tec AG. He has been working since 1989 in thermal physics, graduating in 1990 in “physics of conventional insulation material”, with a PHD on “thermal radiative transport in heat insulation”.
He is a material scientist initiating several innovations for conventional insulation materials which have now become common practise in industry and working on temperature controlled packaging since 2001. His hobbies include sports, in particular table tennis with some responsibilities in German and International Table Tennis Federation.
Michael Schmitz
Compliance and Facilitation Policy
World Customs Organisation
Michael T. Schmitz took up his post as Director of Compliance and Facilitation at the World Customs Organization (WCO) in January 2006 after being elected to this position by the Council of the WCO during their June 2005 sessions in Brussels.
Prior to his appointment at the WCO, Mike held a number of senior positions at the US Customs Service, the US Treasury Department, and the US Department of Homeland Security respectively, including having spent a period at the WCO previously as Chef du Cabinet to the Secretary General. Prior to joining the WCO for a second term, he was Assistant Commissioner in the Office of Regulations and Rulings at US Customs and Border Protection and has extensive experience in legal matters. Mike holds a Bachelor of Science in Economics degree from Marquette University and a Juris Doctor from Georgetown University Law Center
Nicki Jackson
Operations Manager
SCA Cool Logistics
Nicki has been involved in the operations and supply side of temperature controlled solutions for four years. Qualified in business management, Nicki has spent the last four years working closely with developing the operations and customer support aspects of SCA Cool Logistics business. Nicki has been instrumental in the implementation and roll out of solutions for many of the major global pharmaceutical, biotech and clinical trials organisations.
Nigel Bleakley
Validation Engineer
UCB Celltech
Nigel Bleakley is currently working for UCB Celltech as a Validation Engineer, and is supporting the global cool chain solutions for UCB Celltech products. He has had 15 years experience in pharmaceutical, biotech and blood products, supporting global drug approvals for all of the major international biotech and pharmaceuticals companies.
His specialist topics are validation compliance for thermal process and products that include both static and mobile solutions. Ideally suited for cool chain at UCB-Celltech that covers warehousing, cell bank (liquid nitrogen), drug substance (solid carbon dioxide), drug product (frozen or refrigeration) and temperate solutions. He is affiliated and is a member of various industrial discussion and task force groups’ world wide.
Phil Skelton
Senior Transportation Risk Manager
ACE European Group
Phil Skelton is a Master Mariner with 14 years experience in tankers, cargo and bulk carriers. After a period in Ship Management and Operations, he joined a predecessor of ACE European Group in 1988 as a Marine Claims Surveyor.
The Transportation Risk Management Department was formed to support the companies own Underwriters, Claims Adjusters, plus their Brokers and Clients in Loss Prevention and assessment of risks.
Phil Skelton has worked closely with Risk Management and Logistics departments within industries as diverse as Gold Mining, Power Generation, Pharmaceutical and Fashion goods and Freight Forwarding on a worldwide basis. His main approach is one of understanding the risk, then educating on prevention from a companies management downwards. This has taken the forms of online training programmes, client seminars and courses plus visits to operations.
He regularly speaks upon Supply Chain issues including Cold Chain, Security and Business Continuity and has been published in both Insurance and Logistic Industry journals.
ACE European Group is a member of the ACE group of companies who are one of the worlds leaders in provision of innovative Insurance and re-insurance solutions operating in 140 countries and jurisdictions.
Pier Pollini
Director of Supply Chain Execution
Baxter Healthcare
Pier has over 25 years experience in Supply Chain Operations, (the last 6 with Baxter) in the computer, book, and now healthcare distribution fields. Currently European SC Execution Director, responsible for 19 DCs, Transportation and Distribution Services, Systems Application Development and Support, Project Development, and (some) Customer Services.
Pier is focusing on delivering Baxter’s end-to-end Pan-European Cold Chain strategy, implementing a Global WMS, and on developing innovative and sustainable warehousing and transportation solutions. He is an Italian National, educated in the USA, obtaining a Bachelor Degrees in Biology and Political Science.
Richard Peck
Cold Chain Technology Lead
Wyeth
Richard Peck is responsible for cold chain strategy for Wyeth's Havant site in the UK, including cold storage, working with hauliers and freight forwarders for cold chain shipping and the testing and implementation of innovative technologies. He also heads up a team of specialists supporting the Wyeth Affiliate Network globally.
Richard Senior
CEO
DGP America
July 1995 - Sept 2001: Sales Manager at Smurfit UK Ltd
Within the Smurfitt team Richard developed a sales approach, which focused upon adding value to client’s business. This was achieved through an increased focus upon the efficiency of the existing supply chain coupled with a commitment to taking cost out of the process in an innovative way. Projects spanned both the UK and mainland European.
Sept 2001 - Present: Global Business Director at DGP Group Ltd / CEO at DGP Americas LLC
Developed a comprehensive range of Specimen Transport Systems and subsequently increased DGPs’ client base. Richard is now leading a programme that focuses upon supporting clients and enabling them to meet their objectives as their business evolves. This programme resulted in the diversification of the DGP product base in response to a growing pharmaceutical demand for finished goods and validated temperature control systems of exceptional quality. In addition, Richard values diversity in his time out of the office and has a number of sporting and design interests.
Rognvald Lamb
EMEA Logistics Manager
Fisher Clinical Logistics
Fisher Clinical Logistics is the Logistics specialist arm of Fisher Clinical Services. Rognvald has been involved in Cold Chain shipping and supply chain roles in Marken, the specialist freight forwarder and Quintiles Clinical supplies, developing and delivering cold chain solutions for global distribution of Clinical Trials Supplies globally. Prior to working in the Clinical Trials arena, Rognvald worked in high service, fast moving electronics logistics, and has extensive Customs experience, having been a UK Customs and Excise Officer.
Steve Moss
Quality Manager, Strategy and Global Logistics
GlaxoSmithKline, Barnard Castle
My role involves ensuring quality and compliance considerations are addressed for GSK Global Logistics projects. This includes developing global processes and standards across the company and a particular focus has been on temperature compliance in distribution.
Previously carried out GMP assessments of contractors and potential business partners for new pharmaceutical and consumer healthcare products for GSK. He is also responsible for preparing for, and managing regulatory inspections for new GSK products at the contractors.
With many years experience of auditing pharmaceutical suppliers and contractors and managing audit teams, and eight years experience in chemical manufacturing, including roles in development, production, project management and engineering.
Tom Bolger
Logistics Coordinator
Genzyme
Tom is married to Linda and had two kids, Caragh & Odhran, and lives on the coast in Co. Waterford. Tom joined Genzyme 5 years ago as Warehouse Leader, and currently works as Logistics coordinator for the Waterford site, planning, routing and developing Cool-Chain solutions for Genzyme’s product portfolio. Coming from a warehousing and distribution background, he is looking forward to the opportunities that lie ahead in this area.
Wilhelm Loskot
Head of Department, “Shipping and Logistics”
Germanischer Lloyd Certification GmbH
Wilhelm Loskot has sailed on Containerships as Nautical Officer for several years. He additionally worked as Nautical Superintendent and Safety, Security and Quality Manager for a Container Shipping Company. Further he was considerable involved in development and introduction of ISPS Certification for ships and ports with Germanischer Lloyd and is involved in the Cool Chain Certification and Logistics Certification with Germanischer Lloyd.
Germanischer Lloyd Certification (GLC) is an integral part of Germanischer Lloyd Industrial Services, the group of companies in which Germanischer Lloyd bundles its expertise in the fields of oil and gas, wind energy, system certification and materials and failure analysis. As a subsidiary of one of the oldest and most renowned classification societies, we have a family affinity with technical monitoring, and the definition and maintenance of standards.
GLC is responsible for the certification of management systems in the fields of quality management, environmental management and security/ risk assessment. Thanks to our extensive global network of highly qualified and customer-oriented auditors and experts, we can offer customer tailor-made, practically focused solutions based on a mutually cooperative approach.
Due to its specific experience and knowledge in maritime and logistics sectors, GLC is able to offer high quality certification services to the logistics industry.
Dr. Michel Zaffran
Senior Advisor, World Health Organisation & Director of
Project Optimize
Michel Zaffran is a French National born in Algeria in 1956. He is an engineer with subsequent training in Tropical Epidemiology. He has worked in Morocco for the French Government, and then in Burkina Faso, Zaire and Ethiopia for GRET, a French NGO where his work focused on the energy needs of the rural health sector of developing countries.
Michel Zaffran has spent the past 20 years working on Immunization. He has held various positions in WHO. In 1998 he became the Programme Manager of the department of Vaccines and Biologicals where he was responsible for strategic planning and was the WHO representative on the original multi-partner Working Group that conceived, designed and launched the Global Alliance for Vaccines and Immunization (GAVI). In 2004, he became the Coordinator of the WHO team in charge of vaccine quality, vaccine management and logistics, vaccine procurement and supply and immunization financing. In 2006 he joined the GAVI Alliance Secretariat as Deputy Executive Secretary, in charge of the Technical and Policy areas.
Since 2008 Michel Zaffran is back at WHO where he is the Director of project Optimize- "Immunization Systems and Technologies for Tomorrow", a collaboration between WHO and PATH aimed at catalysing a shared vision of the future logistics of health programmes. He also serves as a Senior Adviser to the Director of the Department of Immunization Vaccines and Biologicals.