2011 Cold Chain & Temperature Management Global Forum Speakers

Anthony Alleva
Technical Services Manager, Cryopak
a TCP Reliable Company

Anthony Alleva has been a packaging professional for over thirteen years with eleven of those years specializing in thermal packaging design. He has been a consultant to Wyeth Pharmaceuticals helping to set up their qualification program for temperature controlled packaging. The last ten years he has served as Laboratory Manager, Package Engineer and currently Technical Services Manager for Cryopak, a TCP Reliable Company.

Mr. Alleva has managed the creation of hundreds of successful package designs for a variety of clients, among them many major pharmaceutical companies. His designs include new thermal packaging components and the methodologies for their use in the field. He guides new products through specification to implementing manufacturing processes and procedures. He is regularly called upon by clients to evaluate and improve their current practices to better secure the cold chain. He underwent the Certified Packaging Laboratory Technician program at Dimensions in 2002. In 2004 he was a co-recipient of the AmeriStar and WorldStar Packaging Awards for TCP’s “Thermal Control Panel” product. He is a graduate of Stevens Institute of Technology in Hoboken, NJ with a Bachelor of Mechanical Engineering.

Chris Anderson
Director, Quality and Regulatory Affairs
Cardinal Health

Mr. Chris Anderson has been with Cardinal Health since 1987 in Quality and Regulatory Affairs, at both the field and corporate levels, responsible for wholesale drug distribution compliance. Over the past four years he has managed a project to develop a new quality system for Cardinal Health’s Pharmaceutical Distribution operations as well as leading projects to select, standardize and deploy a qualified refrigerated pharmaceutical packaging process. Today, Mr. Anderson manages the Quality System functions for corporate Pharmaceutical Distribution and is responsible for cold chain packaging; the document center; and compliance reporting and tracking websites such as the CAPA system. He holds a Bachelor of Arts degree from Norwich University in Political Science and a Master of Arts degree in Organizational Behavior.

Steven P. Atcheson
Senior Vice President, Strategic Customer Development – Global, Pharma & Healthcare
Kuehne + Nagel Inc.

I hold a Bachelor of Science degree in Business Marketing from Stockton College. Upon graduation was recruited by one of the world’s largest steamship companies United States Lines which was the start of my career in the logistics industry as Account Manager in Far East Inbound trade. I have remained in the logistics industry for the last 26 years. In 1986, I moved to Puerto Rico Marine Management Inc as a Sales Representative. I remained in this position until 1988 when recruited by ABF Freight Systems Inc. as their Director of Caribbean Sales to develop and oversee their sales effort in the Caribbean. I held this position until 1991 and was promoted to Director of National Sales and remained with ABF until 1997.

In 1997, I join the Navieras/NPR organization as their Sales Manager responsible for managing the company’s sales team and activities in the Mid-Atlantic and Canadian regions. I remained with Navieras/NPR until 2000, when I was recruited by Rely Software / Right Freight as their Executive Vice President - Sales to develop and manage a global sales team responsible for marketing Transportation Management Software Solutions.

In 2001, I joined Danzas AEI as Director of Global Business Development – Life Science & Healthcare and shortly after moved into their Multinational Customer organization as Director of MNC within the same vertical. In 2004, I was promoted to Global Customer Manager (GCM) within the newly formed DHL business unit of DHL Global Customer Solutions - Life Sciences & Healthcare. In March 2008, I was promoted to Vice President – Global Customer Development to manage the worldwide wide team and drive the DHL short and long term strategy as it pertains to the Hewlett Packard / DHL partnership.

In 2010, I was recruited by Kuehne + Nagel as Global Senior Vice President – Strategic Customer Development – Pharma & Health responsible for managing the global team, driving the vertical’s strategy and development of new solutions and products. This is the position that I currently hold.

Philippe Boyer
Export Sales Manager
Emballiso

Philippe Boyer: Major accounts manager for Smurfit (former AssiDomän) for the packaging industry, Philippe works for the past ten years as Export Sales Manager for insulated packaging for the transport of temperature sensitive products at Emball'Iso.

As an expert in cold chain he has been involved in drafting the standard AFNOR NF S99-700, on "Packaging thermal cooling and packaging for healthcare products - Method for Thermal Performance Qualification" published in 2007 and the "Practical Guidelines Cold Chain for Medicines "published in 2008.

Speaking on various topics in international conferences related to transportation of temperature sensitive pharmaceuticals, one of his last speech was "The Last Miles" at the 2nd day of "cold chain of health products" in Lyon, France in November 2010. Philippe has obtained a degree in Law and Economics in Paris.

James Brehm
Senior Strategist
Compass Intelligence

James Brehm is Senior Strategist at Compass Intelligence, where he will contribute to the company’s growing Connected Device practice, as well as lead numerous M2M-related initiatives. Mr. Brehm brings nearly 20 years of industry experience to Compass Intelligence, including positions with Rackspace, Gateway, MCI and most recently, Frost & Sullivan’s Information & Communication Technology practice. Mr. Brehm is a regular contributor to CNBC and is frequently quoted by media outlets such as Business Week, the San Jose Mercury News, and Wireless Week. Of Mr. Brehm’s skills, he brings valuable expertise in several areas including competitive intelligence, merger and acquisition analysis, developing new product offerings and assessing emerging markets.

Robert Bronstein
Clinical Supply Project Manager
MacroGenics, Inc.

After a successful IT career, including serving as Chief Information Officer, at ALMEDICA International, NDC Health, Base 10 Systems, ALMEDICA Technology Group, Warner Lambert and Revlon Health Care Group, Robert Bronstein founded TINAMOU Consulting LLC in 1994 Mr. Bronstein’s consulting focus is clinical supply chain and IT strategy.

Mr. Bronstein has performed numerous projects for a diversity of major life science companies. Most recently Mr. Bronstein’s assignments included directing all activities related to the clinical supply chain for a large global clinical program (31 countries, 30,000 subjects) in cardiology, and acting as an advisor on a clinical supply chain project evaluating offerings from SAP, Rockwell Automation, Aptuit (Clinicopia), Honeywell, and Werum.

Mr. Bronstein has a Master’s of Science degree in Computer and Decision Science, a Bachelor of Science degree in Medical Computer Science. Throughout the course of his career, Mr. Bronstein has published fourteen papers on clinical data management and software validation and has been an invited speaker at numerous professional meetings in the United States and Europe. Robert can be contacted at robertbronstein@aol.com

Alan J. Davis
Supply Chain Temperature Control Leader
Johnson & Johnson

Al Davis began his Johnson & Johnson career at Ortho Pharmaceutical in 1968 in Distribution Services. During the next 15 years his responsibilities increased in several assignments, and Al became Team Leader of second shift operations in the Ortho-McNeil Pharmaceutical National Distribution Center. Al joined the Ortho-McNeil Transportation Team in 1984 and established transportation networks supporting new product launches of numerous temperature controlled products. During the formation of Johnson & Johnson Global Transportation Organization (GTO) in 2000, Al lead inbound transportation programs supporting Johnson & Johnson Strategic Sourcing, Johnson & Johnson Relocation Services, Johnson & Johnson Pharmaceutical Research and Development, Noramco, and Vistakon. In 2003 Al began leading Cordis global inbound transportation and implemented improvements resulting in several million dollars annual savings while continuing to support Johnson & Johnson Strategic Sourcing, and Johnson & Johnson Relocation Services.

In March 2008, Al was appointed to a new position created in GTO. In his new role of Supply Chain Temperature Control Leader, Al is responsible for development of temperature control strategy throughout the global supply chain. Al will leverage his expertise to identify and implement cost and service improvements across sectors. He will drive compliance and reliability for the cold chain and temperature controlled product supply routes from plant to customer destinations. Al has leadership roles in industry groups as well as the lead for Johnson & Johnson Cold Chain Global Meetings.

Randy Desir
Manager, International Sourcing and Supplier Performance
Johnson & Johnson

Randy Desir is currently the Manager of International Sourcing & Supplier Performance for the Johnson & Johnson (J&J) Global Transportation Organization where he leads a team that is responsible for sourcing over $120MM in transportation services across the Air, Ocean, and Cold Chain modes of Transportation in and out of the US and Canada.

Randy began his career with J&J in 2002 and has held leadership roles within various parts of the Supply Chain, including manufacturing, planning, distribution, and transportation. Randy is Six Sigma Green belt certified and holds a Bachelor of Science in Business Administration from Drexel University, an MBA from New York University, and is certified in Production Inventory Management (CPIM) through APICS, the association for Operations Management.

Richard C. Ellinger
Principal
Temperature Assurance Group

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 T.A.G. His supplier experience includes global management responsibility for lab services, product development, business development, marketing, sales and customer service. His current research study involves determining the best scenarios for re-usable packaging systems; 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.

Chris Fore
Compliance Manager
Envirotainer

Chris Fore is the Manager of Industry Compliance and Regulatory Affairs at Envirotainer and a senior member of their Cold Chain Management team. In this capacity, he is responsible for assisting pharmaceutical shippers and logistic providers with operational and performance qualifications, training and the development of standard operating procedures. Chris is also responsible for the Envirotainer QEP/CEP Training and Quality Program which was awarded the ‘Most Influential Project’ at Cold Chain Europe 2009. The QEP/CEP Program was developed to recognize those transport service providers who manage temperature-sensitive shipments in accordance with IATA Perishable Cargo Regulations Chapter 17.

Chris was a principle author of Chapter 17 and served as the Team Leader for developing the quality management system guidance. He also actively participates in the Parental Drug Association Pharmaceutical Cold Chain Interest Group, writes for industry publications and conducts workshops at industry conferences.

Chuck Forsaith
Corporate Director, Supply Chain Security
Purdue

Chuck Forsaith joined Purdue Pharma LP in 2001, after 21 years of service as both a New Hampshire municipal and State Police officer - and also having formally directed security operations for a United States military installation. With the New Hampshire State Police he served in supervisory capacities in both the uniform and detective divisions. He also acted as the Director of the New Hampshire Attorney General's Drug Enforcement Task Force. For the government, Chuck managed a physical security program which protected one of the military’s world-wide satellite tracking installations.

His responsibilities with Purdue Pharma include managing all domestic and international supply chain security efforts, as well as regulatory compliance with all Federal supply chain security programs. He also acts as the Chairman of the Pharmaceutical Cargo Security Coalition (PCSC), a group of over 600 individuals, from a variety of disciplines, who monitor the security of pharmaceutical goods in transit all over the world.

He has lectured both domestically and internationally in the disciplines of Pharmaceutical Supply Chain and Site Security for such organizations as the Federal Bureau of Investigation, the US Food & Drug Administration, United States Customs, the Department of Homeland Security, the United States Merchant Marine Academy, ASIS, TAPA, the HDMA, NADDI, NACDS, Notre Dame College, the World Trade Group and the International Association of Biometrics. He is an active member of the American Society of Industrial Security, the Transported Asset Protection Association, the Overseas Security Advisory Council, the National Association of Drug Diversion Investigators and the International Association of Chiefs of Police.

He currently sits on the advisory council for the United States Merchant Marine Academy's "Global Maritime Transportation School" (GMATS) and is a former member of the Board of Director's for TAPA of the Americas.

Andrea Graf-Gruber
Manager, Cargo Business Process and Standards
International Air Transport Association (IATA)

Mrs. Andrea Graf-Gruber joined the International Air Transport Association (IATA) in 2008 as Manager Business Process & Standards in the Cargo Division and is responsible for delivering the electronic document standards for the air cargo supply chain, including the development, maintenance and promotion of the standards to additionally support the IATA e-freight project. Mrs. Graf-Gruber has as well taken over the responsibility of managing the IATA regulations related to the transport of Live Animals and Perishables Cargo. Mrs. Graf-Gruber is secretary to the IATA Live Animals and Perishables Board and the Time and Temperature Task Force and is in that respect, cooperating with international organizations, such as CITES and the OIE. Prior to working with IATA Mrs. Graf-Gruber joined in 1997 the International Road Transport Union (IRU), where she began her professional career in the transport industry. As head of a division she implemented, at the Customs and business level, tools to assist the application of risk management, allowing Customs' electronic data exchange in real time and ensuring the sustainability of the TIR Customs Transit system. Mrs. Graf-Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.

Paul Harber
Principal
Modality Solutions LLC
former Engineering Consultant, Eli Lilly and Company

Paul Harber is a Principal with Modality Solutions LLC and has than 30 years of packaging and engineering experience with Eli Lilly and Company. Specifically areas of experience include pharmaceutical distribution, clinical trials, and formulation optimization for distribution. Corporate and consulting experiences range from biotechnology start-up to major pharmaceutical firms. Paul has specific expertise in the area of Cold Chain. He has authored numerous technical articles on the subjects of distribution and the associated. Paul was one of the founding members of the PDA Cold Chain Interest Group. He is a one of the authors of the PDA TR-39 Guidance Document on Cold Chain Management. He has been active on the program committee, and as a moderator and speaker at the past three annual meetings at the PDA/PCCIG Bethesda, MD meetings. Paul is a contributor to the ISTA Standard 20 and ISTA 7E profiles. He developed and worked with QA and Product Development to implement the first Shipping and Control Strategy Documents for all Lilly refrigerated finished items. This same document is cited in the TR-39 guidance. Mr. Harber held an academic staff position in the Department of Agricultural Engineering at the Purdue University. He received his Bachelors and Masters Degree in Engineering from Purdue University.

Staci Hargraves
Senior Director, Global Clinical Supplies
PPD

Staci Hargraves serves as PPD’s senior director of global clinical supplies. In this role, she directs all aspects of supply sourcing and coordination groups as well as operational warehouses and supports hundreds of Phase I – IV clinical trials via company owned, third-party and independent distribution networks. Hargraves joined PPD in 2007 as global director of clinical supply services. Since that time, she has created operational efficiency under one global reporting structure and has been instrumental in establishing the global clinical supplies network that includes both PPD distribution depots and supplies management services in North America; Europe, Middle East and Africa; Asia; and Latin America. Prior to joining PPD, Hargraves was the head of U.S. clinical drug supply for UCB Pharma, Inc., in Smyrna, Ga., and served as a manager of investigational materials for Otsuka America Pharmaceutical, Inc., in Rockville, Md. Hargraves began her career at the National Cancer Institute, a division of the National Institutes of Health, where she served as a protocol specialist. Hargraves received her bachelor of science degree in biology from George Mason University in Fairfax, Va. She is an active leader in the clinical supplies industry and maintains professional memberships in ISPE, APICS, DIA, EPIC, and MSG.

Ian Holloway
Manager, Defective Medicines Report Centre
The Medicines and Healthcare products Regulatory Agency (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. Scope of the work includes authorised medicines, unlicensed medicines and IMPs. He is a registered Pharmacist and has postgraduate qualifications in Pharmacology and Business Studies. He first 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. During that time he had responsibilities for the GMP of Investigational Medicinal Products Prior to joining the Defect Centre he also worked for the Agency as a Pharmacovigilance inspector and helped establish a new system of site Pharmacovigilance inspection systems.

John Howe
CEO
Active CC Boxes

From 1978 to 1997, John managed Criterion Plastics, Inc., which he founded as a contract plastics molding company, producing components for corporations such as TRW, General Motors, Fisher-Price, Zenith, Trico Products, Bausch & Lomb and Johnson Controls. He sold Criterion in 1990 and remained as its General Manager until it merged with an affiliate in 1997. John achieved ISO 9002 registration for Criterion in 1992, making it among the first 100 companies to attain such status in the U.S., repeating the accomplishment for Kodiak in May, 2000. He directs manufacturing operations for Kodiak in Kingsville, Texas. John holds a Bachelor of Science degree in Physics and Mathematics from Texas A&M University – Kingsville.

Martha Kliss
Manager, US Distribution and Import/Export
UCB Inc.

Martha Kliss has held multiple roles through various company mergers and acquisitions during her 19-year Pharmaceutical experience. Her diverse core responsibilities include: International Relations, Import & Export Compliance, International Policy, Financial Reporting and most recently under her current role with UCB, Inc., as the Distribution and Import/Export Manager; she is accountable for the Transport and Distribution of temperature controlled bio-technology products, and traditional Rx pharmaceutical portfolio. She has been an active member of the US Chamber of Commerce and through its International Business Council (Rochester NY-Chapter) has held various positions including President of the Advisory Board during the 2005 term. Martha is also a member for the Upstate NY District Export Council where she has remained an active member through two consecutive terms. During her professional journey she has presented International Trade Business and Compliance topics to local NY Colleges such as ‘How to Evaluate & Promote your Portfolio in Latin America”, ‘Doing Business in Foreign Cultures’, ‘Export Compliance 101’, etc. Martha has a bachelor degree in International Commerce from the Instituto Politecnico Nacional in Mexico City.

Peter Lockett
Global Thermal Product Manager
AmSafe

Peter Lockett has worked within the cold chain industry for many years, most specifically with thermal blanket products. He is responsible at AmSafe for the thermal blanket product design, development and strategy, working closely with global pharmaceutical and logistics clients. Peter is also a member of the PDA and involved in its PCCIG Thermal Blanket Task Force which is looking to provide guidelines for qualification and instructions on use of thermal blanket systems.

Jim Lucie
Senior Manager, Material Control
AMAG Pharmaceuticals

James Lucie received a Bachelor of Science in Chemical Engineering from the University of Massachusetts-Lowell and a MBA from Bryant University. Since graduating he has gained experience as a Project Engineer and Manager working for Ingersoll-Rand in the pulp and paper industry; as a Plant Manager for Cold Chain Technologies; as a Facility and Engineering Manager for Celldex (formally AVANT) and Senior Facility Engineer for Alkermes. Currently he is working for AMAG Pharmaceuticals, Inc. as a Sr. Material Control Manager.

Since joining AMAG in August 2005 he has been responsible for the procurement of raw materials, inventory management of production material, drug substance and drug product. He is also responsible for the labeling, packaging and distribution of both commercial and clinical products. Currently AMAG has US approval for Feraheme™ and is conducting several phase 3 global clinical trials to expand the label and sales territories.

Prakash Mahesh
VP Marketing & Business Development
ThermoSafe Brands

Prakash Mahesh is ThermoSafe Brands’ Vice President of Business Development and Marketing. In his new role, Prakash is leading the strategic and tactical business development programs in support of the ThermoSafe Brands’ continued focus on domestic and international growth. Prakash is also leading the marketing initiatives to support the ThermoSafe® brand name. Prakash joined ThermoSafe Brands with many years of experience in the pharmaceutical and health care industries. He was most recently the Senior Director of Marketing and Business Development for Hospira. In this role, Prakash was able to successfully identify and define new markets, opening new sales channels and creating and executing long range strategic plans. In addition, Prakash also led the acquisition and integration process of a company in Salt Lake City and managed the business post-acquisition. Prior to his time at Hospira, Prakash held the position of Global Senior Manager, Imaging Systems for GE Healthcare and Director of Product Marketing and Development for VitalWorks, Inc. Prakash holds a Bachelors Degree in Electronics and Electrical Engineering and a Master Degree in Computer Science and completing his PhD in Strategic Management.

Sai Mann
Manager, Package Engineering
Allergan

Sai is currently the Manager of Package Engineering at Allergan based in California. Prior to his current position he served as a Senior Project Engineer at Allergan for almost three years. And, prior to Allergan Sai spent almost six years as a Senior Project Engineer at Sanofi Aventis. Sai received a Masters in Packaging Science from Michigan State University.

Arminda Montero
Global Distribution QA Program Manager, Global Pharmaceutical Operations
Abbott

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.

Kevin O'Donnell
Senior Partner
Exelsius Cold Chain Management

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. O'Donnell 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.

Aruna Palnitkar
Manager, QA, External Manufacturing
sanofi-aventis, Mumbai, India

Aruna Palnitkar, has attained a degree in Pharmacy from Mumbai University , India , and thereafter she did M.S . from Pilani University , two of most renowned universities in India. She is Manager QA in sanofi-aventis and has been working for past 18 years in the field of Quality Assurance of pharmaceutical products with a particular focus on cGMP audits of external manufacturing sites within India. She is a certified cGMP auditor by international audit committee of sanofi-avenits. She also looks after validations , qualifications , inter-site technology transfers , quality risk management & good storage practices in warehouses for various pharmaceutical dosage forms such as liquid injectibles , lyophilized products which require storage conditions below 25deg C or 30degC .

She is also responsible for 1)Transport validation/qualification study of products manufactured in sanofi plants of Europe and transported to India strictly under cold chain conditions and its distribution within india 2) Audit of any new -third party cold storage ( 2 to 8) facilities on cGDP & GSP aspects and compliance to cold chain conditions as per Indian regulatory and sanofi norms. 3) periodic visits/audits of our own warehouses for cold chain compliance 4) any incidental quality investigations / complaints related to cold chain products

Radharamanan Panicker
Director and CEO
Delhi Cargo Service Center Pvt Ltd

Radharamanan Panicker is the Chief Executive officer of Cargo Service Center India Pvt Ltd and Managing Director of its Subsidiary Delhi Cargo Service Center. CSC India is a cargo ground handling and logistic service provider providing cargo handing services to airline at Mumbai, Delhi and Chennai. The company has recently established a Perishable cargo terminal at Mumbai and is currently building a huge 70000 sq.met integrated air cargo terminal at Delhi airport. He has more than 20 years experience in the field of express logistics, distribution, cargo handling and warehouse management. A highly trained executive, he is qualified Dangerous goods Instructor from IATA and a specialist in the management of dangerous goods and perishable cargo. He has led Cargo Service Center (CSC) since inception in 1995 and made it a strong player in the air cargo handling industry. Besides CSC, he also is Promoter- Director of Dangerous goods Management India Pvt Ltd (DGM India) a company involved in processing and handling of dangerous goods both air and sea, proving technical training to meet the training requirement of international and national law with regards to transportation of dangerous goods. He has done his MBA from XLRI and B.Sc (Physics- Special) from St.Xaviers Ahmedabad. He also holds Diploma in Business Finance from ICFAI, Hyderabad as well as Diploma in Air cargo, ground handling, Perishable handling and Aircargo security all from IATA.

Martin Peter
Director
ELPRO

Martin Peter, Director, ELPRO, holds a Master of Business Economics from the University of St. Gallen (lic. oec. HSG), Switzerland. In his previous work assignments he has collected experience in Sales, Marketing, Product Management, Key Account Management and Business Consulting.

As a Senior Consultant and later as Engagement Manager, Martin Peter has worked for a Business Consultancy having a focus on the travel and transport industry. He has worked on various projects for a number of different clients in Europe, Japan and the USA. The main focus areas of the projects where: Strategy, Process Consulting/IT, M&A and Cost Cutting. 2003 - 2008 Martin Peter has been working for Envirotainer. He joined the company in 2003 in the role as Commercial Manager and had roles in product development, business development, marketing and sales. 2005 until he left the company, he was member of the Executive Management Team of Envirotainer in the role as Vice President Sales - being one of the key drivers behind Envirotainer's transition to become a partner to the pharmaceutical clients and the logistics industry focusing on "Cold Chain Management". In this role he founded Envirotainer's "Cold Chain Advisory Board" and represented the company at cold chain conferences and was contributing to regulatory boards in the cold chain and logistics industry. In October 2003, Martin Peter has joined Elpro in the role of a Director responsible for Elpro's Cold Chain activities and continues to be active in various industry associations and boards.

Joe Reedy
Vice President Sales & Marketing
American Airlines Cargo

Joe Reedy leads American's Cargo Sales and Marketing organization where he is responsible for a staff of global sales and marketing professionals and General Sales Agents worldwide. Joe is credited with transforming American’s cargo sales and marketing department into a strategic and forward-looking entity with a focus on improving services for the customer. Reedy was named to this position in late 2006 after serving as Vice President of Cargo Finance and E-commerce. Reedy has a broad background, including top leadership positions in sales and operations at other AMR-affiliated companies prior to joining the Cargo Division. A native of Texas, Reedy graduated from The University of Texas in 1985 with a Bachelor of Business Administration. In 1989, he received an MBA from the University of Texas.

Tom Reese
Senior Director, Business Development
Intelleflex

Tom Reese , Senior Director, Business Development, is responsible for the evaluation and management of new strategic business opportunities, partnerships and alliances; and guiding Intelleflex’s strategy in several markets, with a primary focus on the development of Intelleflex’s Cold Chain Solution. Prior to joining Intelleflex, Tom led Motorola’s Cold Chain Market Development while also supporting other industry solutions including: pharmaceuticals, healthcare, retail and transportation and logistics. He has an MBA from Loyola College in Maryland and a Bachelor of Science in Electrical Engineering from Villanova University.

Anthony “TJ” Rizzo
Director of Sales
Cold Chain Technologies

TJ is responsible for Cold Chain’s sales and customer service departments and continued growth initiatives. Previously he managed key accounts as a Strategic Account Engineer for Cold Chain. TJ has direct contact with clients, as well as corporate responsibilities. TJ is also extensively involved in industry groups including the PCCIG “Last Mile” task force and “Risk Management for Temperature Controlled Distribution” task forces. TJ has a strong understanding of industry requirements including USP 1079, PDA Technical Report 39, and FDA regulations as well as logistics as they pertain to the pharmaceutical and biotech sectors. TJ graduated from Pennsylvania State University with a bachelor’s degree in Mechanical Engineering and is pursuing his M.B.A. from the University of Massachusetts.

D’Arcy Ryan
Director of US Marketing and Business Development
ThermoSafe

Ms. D'Arcy Ryan joined ThermoSafe Brands in January 2011 as the Director of US Marketing and Business Development. In this role, she directs the company’s efforts to develop, expand, and promote sustainable, reusable packaging solutions. Prior to that, she worked in Brand Management in the pharmaceutical industry. She holds a Bachelor of Business Administration in Marketing from the University of Wisconsin – Madison, and a Master of Business Administration degree in Marketing and Organizational Behavior from Northwestern University’s Kellogg Graduate School of Management.

Roger Samways
Director, Global Accounts and Strategy
American Airlines Cargo

Samways brings a wealth of international expertise, including Europe, Latin America and Asia. He has a strong track record in building solid customer relationships through a collaborative approach to meeting customer needs. In this role, Samways also oversees the airline’s Cargo Interline partnerships and network of General Sales Agents worldwide. A native of London, Samways holds a Masters degree in Business, and understands the importance of teamwork—having received honors for his contribution to the Oxfordshire Cricket team.

Bruce C. Simpson
Director, Commercial Operations
Fisher BioServices

Bruce C. Simpson is the Director, Commercial Operations of Fisher BioServices headquartered in Rockville, Maryland. In this role, Bruce has oversight responsibility for six commercial biorepositories located in California, Massachusetts, and Maryland, as well as a direct to patient pharmacy, and specialty Frozen Specimen Transportation operations. Prior to his work within the biosciences industry sector, Bruce had over 20+ years of experience in the pharmaceutical manufacturing industry, where he held increasingly key positions in materials, quality assurance, and manufacturing management. Bruce graduated cum laude with Bachelor of Science degree in biology from Bethany College, Bethany, West Virginia and has a Masters of Business Administration degree with an emphasis in law from Canisius College, Buffalo, New York.

Sarah Skuce
Compliance Specialist
Health Canada

Sarah Skuce is a Compliance Specialist at the Drug GMP Inspection Unit in the Compliance Coordination and Licensing Division at the Health Products and Food Branch Inspectorate in Health Canada. Sarah holds an Honours Bachelor of Science (B.Sc.) in Biopharmaceutical Sciences with an emphasis on Genomics from the University of Ottawa. Her duties at the Inspectorate include evaluating GMP compliance of foreign drug establishments, contributing to the development of regulations, policies and guidelines as well as participating in the management of emergency or crisis situations involving drug products. Sarah has been with the Drug GMP Inspection Unit since November 2005 and has been the lead at the Inspectorate on the temperature control file since 2007.

Rebecca Steffen
Senior Operations Specialist
Takeda Global Research & Development

Rebecca Steffen, Senior Operations Specialist, Takeda Global Research & Development has worked in several clinical supplies roles, most recently for the past four years at Takeda and previously ten years at TAP Pharmaceutical Products Inc. She's taken on responsibilities to execute label text, batch records, release of clinical supplies, clinical supply planning and execution, documentation coordination and verification of scientific datat for pharmaceutical development. She also worked previously at Abbott as an Accounting Technician responsible for monitoring and audit inventory reconciliation’s for raw materials.

Larry Sweeney
Chief Operating Officer
DDN

Larry Sweeney is Chief Operating Officer of DDN, the largest privately-held provider of outsourced channel management and business services to the life science industry. Before joining the Milwaukee-based firm, Sweeney was Senior Director, Distribution and Logistics for Genzyme Corporation in Framingham, Mass., where he oversaw the strategic planning and management of all distribution, transportation, import/export, customs compliance and third-party logistics partner activities worldwide for the past 10 years. Sweeney has a BS in biology from Fairfield University and an MA in organizational design from Pepperdine University. He spent 26 years in active and reserve service with the United States Marine Corps, from which he retired in 2001 as a Lieutenant Colonel. He has 25 years experience in pharmaceutical distribution and logistics, and also has worked for Johnson & Johnson and AstraZeneca.

Sven Verstrepen
Business Development Director & Founding Partner
TRI-VIZOR

Sven Verstrepen holds MSc degrees in Applied Economics (University of Antwerp, 1996), Marketing (Vlerick Leuven Gent Management School, SLM 1997) and Logistics Management (Flemish Chamber of Engineers, 2004). Sven started his career in 1997 as a research assistant at the faculty of Management Information Systems of the Vlerick Business School, where his main research areas included Business Process Reengineering (BPR), Marketing Information Systems, ICT/business alignment and ERP systems.

In 1999, Sven started working as a business analyst and logistics project manager at the Agfa-Gevaert Group, where he was responsible for the implementation of SAP SD/MM and for the design of a new European supply chain organization. This international position offered him the opportunity to gain hands-on experience in process management, inventory reduction, demand forecasting and reverse logistics. In June 2004, Sven took up the position of Senior Expert at the Flanders Institute for Logistics, where he was responsible for an extensive number of research projects in collaborative logistics, closed loop supply chains and sustainable (“green”) logistics. Sven Verstrepen has written several books and academic articles on collaborative supply chains and reverse logistics. He is also a frequent “green logistics” speaker at international conferences and guest lecturer at several Belgian universities. In November 2008, he co-founded TRI-VIZOR, the world’s first cross supply chain orchestrator, where he now holds the position of Business Development Manager.

Bill Wyrovsky
Associate Director, Regional Logistics Clinical Supply Operations
Bristol Myers Squibb

Bill Wyrovsky is currently the Associate Director of Regional Logistics for Bristol-Myers Squibb Clinical Supply Operations in New Brunswick, NJ. He is responsible for warehousing and distribution in the “Americas,” and manages a network of depots in the U.S., Canada, Mexico, Colombia, Peru, Chile, Brazil, and Argentina in order to support BMS clinical trials. Some of his other responsibilities include management of Cold-Chain processes and management of third party logistics providers.

Prior to joining BMS in 2007, Bill worked in the Medical Products and Pharmaceutical Distribution business of Cardinal Health. He held positions in manufacturing operations and inventory management, and finally served as a Lean-Six-Sigma Black Belt in Cardinal Health’s Operational Excellence program.

Before entering the pharmaceutical industry, Bill served on active duty in the U.S. Army from 1996-2003 as an Aviation Maintenance Officer and “Blackhawk” helicopter pilot.

He holds a B.S. in Engineering Management from the U.S. Military Academy.

Viq Pervaaz
Senior Vice President, Corporate Transactions and Transformation; Pharma Industry Initiative Leader
Aon Hewitt

Viq came to Aon Hewitt after a strong tenure in the pharmaceutical/clinical industry. He has led operations, project management, business development, marketing and regulatory affairs on an international level. Most recently, Viq leveraged his lean six sigma and alliance management expertise to restructure a global project management solution provider to eight of the top ten global pharmaceutical companies with a focus on timely delivery of quality product. In addition, Viq has served in various capacities in the C-suite with key responsibility for 150+ million USD as well as corporate strategy and development. He has presented at numerous conferences in the healthcare arena and also served as Assistant Professor at Temple University.

Jamie Chasteen
Strategic Account Engineer
Cold Chain Technologies

Jamie earned a B.S. in Materials Science and Engineering from Michigan State University. He has extensive experience in technical sales, account management, and market segment management. In support of his clients on the west coast, he has lived in this region for over three years. Jamie provides account management, product development, industry expertise, cold chain best practices as well as shipping system and logistical consultation for pharmaceutical, biotechnology, and medical device clients.

Jim Nilsen
Strategic Account Manager
Cold Chain Technologies

Jim has over 10 years experience working in cold chain within the pharmaceutical, biotech, and life science industries. Jim has extensive knowledge in cold chain as it relates to handling, distribution and logistics; thermal package design, qualification and implementation; as well as regulatory requirements, guidelines and best practices.

His primary responsibilities are as a cold chain consultant to the industry, offering engineering support through Cold Chain Laboratories and supplying Cold Chain Technologies thermal packaging products. Jim earned a B.S. in Business Administration at Temple University.

David Magargee
Project Manager
Sensitech

David Magargee is currently a Lead Project Manager in Sensitech’s Professional Services Life Science team. He has over four years of experience performing Shipping Studies, Facility Thermal Mappings, Container Thermal Mappings, and Validation work. David has managed domestic and global projects focused on applying Continuous Process Improvement (CPI) and Quality by Design (QbD) methodologies to temperature-sensitive supply chains for many of the world’s largest life science companies.

David has been closely involved in the development of Sensitech’s Standard Operating Procedures (SOPs) for conducting projects and analyzing temperature and humidity data. Additionally, he is co-author of a patent for creating risk-controlled ambient thermal profiles.

David’s background is in Industrial Engineering. His past experience includes work at GE Aircraft Engines, where he conducted process mappings and optimized order fulfillment scheduling. He also spent time at Alstom Power Service, completing on-site inspections of coal and natural gas power plants.

David Magargee received his Bachelors of Science in Industrial Engineering at Northeastern University, Boston, Massachusetts, USA.

Sherri Blanchard
PMP, Director, Operations
CSM®

Sherri Blanchard, PMP, serves as Director of Operations at Clinical Supplies Management, a clinical supplies packaging and labeling company providing cutting edge solutions. As an Executive Staff member, Sherri helps define operational strategies and oversees the project management teams, IT, and facility departments. With 17+ years of experience in project management, facilities management, and information technology, she can assure her teams meet federal regulations, and provide the best clinical trial packaging solutions, and customer service in the industry. Sherri is a Project Management Professional with a Bachelor of Science degree from North Dakota State University.