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An Expanding Event for an Expanding Industry

Inside: Meet the Speakers ● Exclusive Insight ● Health Canada Update

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WELCOME LETTER > Dear Supply Chain Executive –

A massive influx of life sciences investment in Canada, particularly in Montreal, is just one of the major reasons why the 12th Annual Cold Chain GDP & Temperature Management Logistics Summit – Canada is more relevant than ever.

Another reason is our best ever speaking faculty. This eBook includes introductions to 31 of our speakers, insights with 3 of our international speakers, and an introductory article on the latest Health Canada Guidelines. We hope you will join these speakers and 200+ other attendees at the Summit! Shawn Siegel Digital Content Manager, Cold Chain IQ

TABLE OF CONTENTS > Latest on Health Canada Guidelines……………………….… 3 Speakers: Regulatory & Supporting Agencies………….… 5 Interview > Belén Escribano Romero, AEMPS Speakers: Industry………………………………………………….. 11 Interview > Vikas Chandra, Abbott India Speakers: Sponsors…………………………………………………. 19 Interview > Paddy Hanlon, Marken About the Event……………………………………………………… 23

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LATEST HEALTH CANADA GUIDELINES > By Shawn Siegel, Cold Chain IQ

Canada is playing an increasingly large role in the biopharma industry following a recent surge in investment. This rise in prominence is taking place along with the global growth in the biopharma cold chain. Various reports estimate that the global cold chain market will grow at an annual rate of 10-15% (depending on the report) over the next five years. This rise is in large part due to the rapid growth of emerging markets, but also due to a new focus on biologics and clinical trial materials that rely on temperature controlled transportation.

To match these changes, regulators around the globe are adjusting their GDP guidelines. This year, Health Canada began its 3 year cycle of updating its Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069). These guidelines came

into force on April 28th, 2011, superseding the guidelines originally released in October of 2005. (Download the Guidelines).

The additions introduced in GUI-0069 built on the good practice that has formed around the distribution of temperature controlled pharmaceuticals, in part as a result of the greater emphasis being placed on the growing biopharmaceutical and life sciences industries. According to WT100, the newest proposed guidelines from earlier this year do not add new obligations, but mostly go into greater depth about monitoring and supervising existing practices. Some of the most important revisions include:

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• Shippers and carriers need to have contingency plans in case of delays. These plans must include corrective actions and specific timeframes.

• Logistics providers should sign quality

agreements. This follows a general industry-wide trend in the use of quality agreements, although Sarah Skruce, Compliance Specialist with Health Canada, says that transportation providers are still reluctant to sign quality agreements.

• There are new packaging guidelines including handling requirements being affixed to containers, as well as labels being affixed to individual boxes.

• New guidelines about employee training.

• New recommendations about temperature mapping.

According to Skruce, Health Canada plans a Q&A document for their website and a new guide on written

agreements with transportation providers. There will be separate guidance focused on counterfeit products as well Active Pharmaceutical Ingredients.

Related Sessions at the Summit: Keynote: A Regulator’s Advice: Health Canada’s GUIDE-0069 Compliance 9:00 AM – Wedensday, February 26th Panel: How Do Heatlh Canada Guidelines Truly Impact the Industry Featuring experts from AbbVie, Sunovian and the PDA 11:15 AM – Wedensday, February 26th

Panel: Ensuring Compliance w/ a Pre-Qualified Packout Featuring leaders from Sensitech and the USP 2:00 PM – Thursdayy, February 27th

Download the Brochure to Learn About These Sessions

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REGULATORY & SUPPORTING AGENCIES >

Rafik H. Bishara, PDA Chris Chandler, GS1 US Belen Escribano Romero, AEMPS Mary Foster, USP Ian Holloway, MHRA Jean Landreville, Canadian Blood Services Mark Newburgh, Canadian Blood Services Louis Sanson, Canadian Border Service Agency Sarah Skruce, Health Canada Mark Soloman, Canadian Border Service Agency Darren Uchman, Canadian Border Service Agency David Wilt, TAPA USA

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PDA Technical Advisor & Leader PCCIG

Dr. Bishara is one of the most respected figures in the pharmaceutical cold chain distribution sector, following a distinguished 35 year career with Eli Lilly & Co. as Director, Quality Knowledge Management and Technical Support. He received his Ph.D. from Purdue

University in 1972, adding to his B.S. Pharmacy & Pharmaceutical Chemistry and an M.S. Phytochemistry from Butler University. Dr. Bishara has authored numerous articles, and technically advised several organizations on Good Cold Chain and Temperature –

Controlled Management.

At the Summit > Panel: How Do Health Canada Guidelines Truly Impact the Industry? 11:15 AM – Wednesday, February 26th

GS1 US Sr. Director, Healthcare

Chris graduated from the University of Illinois College of Pharmacy and began her career at the VA Lakeside Medical Center as a clinical pharmacist practicing within an interdisciplinary medical team. Throughout her VA career Chris

worked in the National Pharmacy Benefits Management Strategic Health Group, as a Quality Assurance Specialist for the Consolidated Mail Outpatient Pharmacy Program and in the Office of Informatics Bar Code Resource Office. In 2013 Chris joined GS1 to support the Healthcare Provider Community in the adoption and implementation of GS1 Standards. At the Summit > The Use of GS1 Standards for Healthcare Product Identification & Traceability 3:45 PM – Thursday, February 27th

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Speaker Interview >

Spanish Agency of Medical & Health Products (AEMPS) Head of Pharmaceutical Dept.

How have the latest GDP Guidelines impacted the efforts to prevent falsified medicines? The new EU GDP guidelines came into force in September 2013, so

the impact is still unknown but they aim to reinforce the supply chain and avoid the entry of falsified medicinal products in the legal supply chain What type of changes were made with respect to “risk assessment”? Risk assessment (ICH Q9) is introduced as a tool to be used in many of the activities to be performed.

What are the biggest challenges that wholesalers will face due to the new GDP? The adequate implementation of risk management, the qualification of suppliers and customers and the transport aspects, specially ‘last mille transportation’ In your opinion, what type of changes are still needed to improve the EU GDP? Training of the wholesalers personnel is a key issue, the adequate evaluation of companies with whom activities are contracted and the qualification of suppliers and customers In general, do you think more effort should be made to unify US, EU and other Internal GDP Guidelines? Absolutely, there is a global supply chain for medicinal products and the GDP requirements should be very similar all over the world.

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United States Pharmacopeia Chair of Expert Committee on Packing, Storing & Distribution of Drug Products

Mary is responsible for revision, creation, and/or rescinding current USP General Chapters. Installed international team including regulators, academia, industry and consultants. Five year committement of volunteerism to create standards

for the pharma/bio industry. At the Summit > USP Update for Transportation & Distribution Practices for Biotech & Clinical Supply Products 9:45 AM – Thursday, February 27th

MHRA Senior GMP Inspector

Ian 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 authorized 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 as a site inspector for Good Manufacturing Practice and Good Distribution Practice at sites in the UK and worldwide. At the Summit > Keynote: EU GDP Updates New guideline on GDP of medicinal products for human use 9:00 AM – Thursday, February 27th

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Health Canada Compliance Specialist

Sarah Skuce is a Compliance Specialist at the Drug GMP Inspection Unit in the Compliance Coordination and Licensing Division at the HPFB 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 and shortages. Sarah has been with the Drug GMP Inspection Unit since November 2005 and has been the lead on the Transportation and Storage of Drug Products file since February 2006.

At the Summit > Keynote: Health Canada’s Perspective on GUIDE- 0069 Compliance 9:00 AM – Wednesday, February 26th

TAPA USA Global Supply Chain Security Manager, Xerox Corporation

David is currently the Chairman for TAPA Americas and is the Global Supply Chain Security Manager for Xerox Corporation. As the Global Supplier Chain Security Manager,

David is responsible for ensuring the appropriate security criteria is in place throughout the Xerox global supply chain. Prior to starting his career at Xerox, David served as an officer in the U.S. Army Military Police Corps with duty at U.S. installations and in Europe. David has also served on two on two sub-committees of the U.S. Department of Security Commercial Operations Advisory Committee (COAC) that made recommendations to the U.S. government regarding Air Cargo Security and Global Supply Chain Security.

At the Summit > Reducing Cargo Crime: An Update on TAPA’s Standards & Facility Certification Process 2:45 PM – Thursday, February 27th

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Jean Landreville Manager of Distribution Mark Newburgh Director of Logistics Planning

Jean is the Manager of Distribution while Mark is the Director of Logistics Planning. At the Summit, they will co-present a session overviewing Canada’s blood management system. At the Summit > Safe Distribution & Storage Practices for Blood Products 3:55 PM – Wednesday, February 26th

Louis Sanson Intelligence Officer, Intelligence Division Mark Solomon Intelligence Officer, Intelligence Division Darren Uchman Program Advisor, Manager for Outreach at eManifest

A look into Canada’s partners in protection and eManifest.

At the Summit > Customs & Borders: Reducing Delays Critical to Your Product’s Integrity 12:15 PM – Wednesday, February 26th

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INDUSTRY SPEAKERS >

Jim Bacon, Grifols Lise-Ann Bernier, AbbVie Vincent Bureau, McKesson Vikas Chandra, Abbott India Matthew Cherian, Hospira Richard Ellinger, Temperature Assurance Group Shamilla Gounder, Sunovion Maryann Gribbin, Ridge, Boland & Associates Claude Jolicoeur, McKesson Marie Laird, Luminex Eric Malouin, Abbott Canada Eric Newman, ProTecht Risk Solutions Kevin O’Donnell, Exelsius USA Oumer Salim, o2s Consulting John Targett, uniPharm Wholesale Drugs

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Grifols Senior Director, Global Demand Planning

Jim is Senior Director, Global Demand Planning & Customer Operations at Grifols, Inc. Reporting to the President – Sales & Commercial Operations, Jim has responsibility for Global

S&OP Demand Management, international customer operations and logistics, and is a resident expert on cold chain management. Jim has oversight of 3PL operations in Canada and as Grifols expands its’ business worldwide, continues to provide direction in this area. Jim also participates in an advisory capacity for continuous improvement with our partner providers including Envirotainer, and also for IQPC Cold Chain and is a member of the PDA-PCCIG. Jim has presented on cold chain best practices at IQPC Cold Chain events in the US, Canada, and Europe and has been published in various industry publications featuring Talecris. At the Summit > Case Study: Creating a Shipping Solution That Works For You 4:40 PM – Wednesday, February 25th

McKesson Transportation Manager

Vincent Bureau has been with McKesson Canada for almost three years in the role of National Transportation Manager. He has more than 15 years of experience in the supply chain and transportation

industry. Lately at McKesson, Vincent has been focusing on transportation challenges in compliance with Health Canada regulations. At the Summit > CRT/Ambient Compliance Through the Last Mile Presenting along with Director of Regulatory Affairs 2:00 PM – Wednesday, February 26h

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Speaker Interview >

Abbott India General Manager – Distribution & Logistics

What are the keys to successfully shipping pharmaceuticals to India? Generally, when a company exports Pharmaceutical products to another countries there are some important points which should be focused upon

- The journey of the product in the right temperature zone and preparedness with the regulatory and statutory compliances of the other country.

Same with India. In addition to the maintenance of the requisite cold chain, these regulatory points are important to keep in mind: 1. Registration With DCGI. For any supply of FG or API to India,

supplier needs to obtain Registration Certificate with DCGI and Similarly, importer should also obtain import license from DCGI.

2. Labeling Requirement: As per Standards of Weight and measures act 1976.

3. Shelf life - Minimum 60% remaining shelf life should be there at the time of import.

4. Packaging and Storage condition for transportation as per requirement.

Is there anything particularly different or unique about OPPI standards when it comes to pharmaceuticals? We need to first understand what OPPI is. It is an association of research and innovation driven pharmaceutical companies in India and a scientific and professional body. It is not a government regulatory body. OPPI contributes meaningfully in policy dialogues with Govt. of India. OPPI recommend its member companies to follow GMP and OPPI code of pharmaceutical practices. The mandatory guidelines are provided by Drug & Cosmetics Act 1940 & 1945 law and FDA. The DCGI has the primary responsibility for approving new drugs, molecules and standards, Vaccines & Sera, new usage and claims, new method of administration, clinical research and trials, introductions of a new unique formulation and granting import and export licenses. It oversees the activities of the Central Drugs Standard Control Organization (CDSCO).

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Temperature Assurance Group Principal

Richard has been active as a Cold Chain Supplier since 2005 working first with ThermoSafe Brands and now with TAG. His current research study involves discovering the best monitoring, '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 cold chain decision-making process.

At the Summit > Qualified Packouts A packaing roundtable led by RIchard 12:10 PM – Thursday, February 27th

Sunovion Manager, Quality & Compliance

Shamilla graduated from the University of Durban Westville in South Africa with a BS, majoring in both Biochemistry and Chemistry. She has worked in the pharmaceutical industry for over 12 years in a variety of roles in Quality Assurance and Compliance at Pharmacia/ Pfizer, Taro Pharmaceuticals and Hoffman-La Roche. In her current

role she is responsible for managing all importation and distribution activities at Sunovion Pharmaceuticals Canada Inc. She works closely with global partners and Canadian distribution sites to ensure operational excellence and seamless transition of products into the Canadian marketplace. At the Summit > Temperature Analysis for Ambient Products An ambient roundtable led by Shamilla 11:15 PM – Thursday, February 27th

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Ridge, Boland & Associates Chief Compliance Officer

Maryann is a former FDA Investigator with over 20 years of industry experience in Quality Assurance and Regulatory Compliance. She has worked for several major branded and

generic manufacturers, and has served as an Adjunct Professor teaching graduate level courses in Quality Assurance/ Regulatory Affairs for the Temple University School of Pharmacy. She is also the coauthor of several industry guidance reports/publications. At the Summit > Workshop D: Interactive Audit Training & Fundamentals of Quality Systems 2:30 PM – Tuesday, February 25th

McKesson Director of Regulatory Affairs GMP, Officer

Claude is Director, Regulatory Affairs, situated in the Montréal office. In this role Claude develops Regulatory Strategic Plan for compliance to all applicable regulations for the distribution of products, including but not limited to drugs, medical devices, narcotics

and precursors. In his role he also coordinate actions as primary contact between McKesson Canada’s and Health Canada, helps in the interpretation of the numerous regulations, responds to proposed amendments to GMPs or other regulations and is involved in a number of committees pertaining to regulatory affairs.

At the Summit > CRT/Ambient Compliance Through the Last Mile Including a pharmacy’s perspective on non-controlled drugs 2:00 PM – Wednesday, February 26th

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Luminex Logistics Manager

Marie Laird is a Supply Chain Management Professional working in the biotechnology sector at Luminex Corporation in Toronto, Ontario. As Logistics Manager, she is responsible for Luminex Toronto’s cold chain

distribution as well as procurement, production planning and inventory management. Previously Marie worked for Coca-Cola Ltd. as a Logistics Specialist. At the Summit > Compliant Cold Chains in Biotech & Small Pharma A unique 3-part session about doing it all with less 2:00 PM – Thursday, February 27th

Abbott Canada Manager, International Customs & Traffic

Eric Malouin is the Manager of International Customs and Traffic at Abbott Laboratories Ltd. He has spent the last 9 years in the Pharmaceutical industry with Abbott Laboratories Limited. His expertise expands globally to Customs, Cold Chain Management,

Supply Chain, Logistics and distribution. Eric graduated in Engineering from École Polytechnique de Montréal in 2002, holds a bachelor’s degree in Science from McGill University and is a Customs Certified Specialist. At the Summit > Ensuring Compliance With Imports Into Canada A roundtable led by Eric on pharmaceutical importing 11:15 AM – Thursday, February 27th

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ProTecht Risk Solutions VP for Loss Prevention

Eric is a VP of ProTecht Risk Solutions, a division of Falvey Cargo Underwriting. As practice leader for life science and cold chain supply management, Eric provides

consultative services in risk mitigation programs and practices. Eric consults directly with life science clients as a loss prevention resource in all facets of supply chain management, including development and implementation of packing, shipping and storage procedures that are aligned with industry best practices and best-in-class cold chain distribution processes. Eric is a member of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), Transport Packaging Committee of the Institute of Packaging Professionals (IoPP), Transported Asset Protection Association (TAPA) and the Pharmaceutical Cargo Security Coalition (PCSC). At the Summit > Strategies for Effective Logistical Risk Assessment Eric leads Workshop A on Risk Management 8:00 AM – Tuesday, February 25th

Exelsius US Senior Partner

As an engineer, author and educator, Kevin’s 32 years of experience has centered on continuously improving transport packaging, logistics and distribution within the pharmaceutical industry. As a Principle Packaging Engineer at Abbott Laboratories Global Pharmaceutical Division, his 26-year

career there included more than 20 years of temperature assurance packaging experience. Kevin is recognized internationally as a key opinion leader and devotes much of his time promoting and implementing good cold-chain distribution practices. At the Summit > Training: Global GDP Practices & Quality Agreements A full-day pre-conference training session 9:00-5:00 – Monday, February 24th

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O2S Consulting Principal Consulting

Oumer has worked in the pharmaceutical industry since 1998. In his capacity as a pharmaceutical packaging engineer at Wyeth / Pfizer, he worked directly with multiple third party suppliers and manufacturing sites on component qualification, packaging validation and

supplier services. He has been directly involved in pharmaceutical cold-chain management and the implementation of GDPs since 2000. Initially at Pfizer and at o2s Consulting since 2011 he identified, initiated and managed projects in the United States and international markets to harmonize the supply chain for temperature sensitive products while ensuring compliance. At the Summit > Qualification of Cold Chain Shipping Systems Workshop C 11:00 AM – Tuesday, February 25th

uniPharm Wholsesale Drugs Director, Purchasing & Distribution

John is a skilled senior manager with expertise in inventory management, logistics, distribution systems and business intelligence. As a key member of the executive team with uniPHARM Wholesale Drugs Ltd., John oversees all areas of purchasing and distribution and is

responsible for the operation of a distribution center based in Richmond, BC that is 58,000 sq. ft. and ships over $500,000 of product each day to independent pharmacies throughout BC, AB and YT. John is an active member of the board of CAPDM (Canadian Association for Pharmacy Distribution Management) and also serves on several committees & workgroups. At the Summit > Cost Effective Solutions for LTL Room Temperature Systems 12:10 PM – Thursday, February 27th

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SPONSOR SPEAKERS

SPONSOR SPEAKERS >

Anthony Alleva, Cryopak Henry Ames, Sensitech Paddy Hanlon, Marken Melissa Iddison, World Courier

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Cryopak Associate Technical Director

Anthony 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. He is a graduate of Stevens Institute of Technology with a Bachelor of Mechanical Engineering. At the Summit > Workshop: The Implications of Non-Temperature Hazards 11:00 AM – Tuesday, February 25th

Sensitech VP of Strategy & Business Development

Henry joined Sensitech in 2004 as the Director of Strategic Marketing where he focused on global market analysis 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. Additionally, Ames serves as a member of the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) and is a member of the Parenteral Drug Association (PDA). At the Summit > Panel: Ensuring Compliance w/ a Pre-Qualified Packout Featuring leaders from Sensitech and the USP 2:00 PM – Thursday, February 27th

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Speaker Interview >

Marken Sr. Director, Business Development

What type of benefits can Direct-to-Patient (DTP) delivery have on Multi-Country Trials? DTP delivery of clinical trial materials can facilitate access to a larger patient population and reduce the burden of long distance travel for those with late

stage cancer or other debilitating conditions. The expanding global market for orphan drugs is particularly suited for DTP solutions, because of the greater geographical distribution of a smaller number of patients and the prevalence of biotechnology derived treatment options that may require more sophisticated handling during transit. In all areas of the world, Marken’s DTP delivery services make participation in clinical trials easier for the patient, which can improve enrollment, compliance and patient retention. Are there regulatory challenges specific to using DTP for clinical trials?

There are regulatory challenges, but DTP delivery of IMP is now being performed by Marken in many countries worldwide, and the regulatory climate is changing as more protocols are being reviewed by local authorities. Having established relationships in over 40 countries for our DTP network, Marken has found that most countries allow for the concept of DTP delivery of clinical trial materials, but each project is subject to individual review and protocol approval in each country. In general, should we expect to see DTP being used more and more for clinical trials? Biotechnology derived therapeutics are continuing to expand in the global market, especially in area of treatments for Orphan diseases. Given that biologically active drugs tend to be more easily affected by environmental conditions, and considering that the geographical distribution of patient populations with a rare diseases is so great, Marken’s direct to patient delivery strategies meet the needs of our evolving industry. Expect to see DTP home delivery become much more mainstream.

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World Courier National Quality Manager

Melissa has over 10 years of experience in the logistics industry and has a strong operational background in domestic and international shipping of temperature-controlled products.

Melissa is currently the National Quality Coordinator at World Courier of Canada. In her role, she oversees the company’s quality management systems, including GxP, ISO 9001, ISO 14001 and related compliance programs. Melissa’s role also encompasses the development and application of company-related metrics and control programs in accordance with corporate operational standards and relevant quality programs. At the Summit > GxP Compliance: Securing Transportation & Storage Challenges faced with complex supplychains 2:45 PM – Wednesday, February 26th

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JOIN US IN MONTREAL!

February 24-27, Hyatt Regency Montreal

Download the Brochure

What’s New for 2014?

● Global GDP Compliance: Regulator, Industry

and Supporting Agencies Perspectives

● Domestic & Global Logistics Case Studies

● Re-Usable, “Green”, Eco-Friendly & Cost Effective

Packaging

● Supply Chain Integrity

● CRT & Ambient Products

● Quality Distribution & Risk Management

● Last Mile Strategies to Maintain Temperature

– Including Perspective from the Pharmacy Groups