Main Day Two

7:15 am - 7:20 am Registration and Breakfast

8:35 am - 9:40 am OPENING KEYNOTE: Why You Matter: Saving Lives through Evolving Supply Chain and Patient Centric Delivery Models

This inspiring keynote will focus on the importance of a patient-centric company culture for adding deeper meaning to drug development and building patient advocacy into everyday business practice and strategy. Hear John’s experiences on how he went about setting up Novazyme Pharmaceuticals and overcame challenges in R&D to final drug delivery, saving his childrens’ lives against Pompe disease.

John Crowley is a well-chronicled biotech executive famous for his quest to cure two of his children of Pompe disease, a rare genetic disorder. Crowley’s life in biotech is well documented. Recent books include The Cure by Pulitzer Prize-winning author Geeta Anand and Crowley’s memoir Chasing Miracles. The movie Extraordinary Measures, starring Brendan Fraser, Harrison Ford, and Keri Russell depicted Crowley and his wife Aileen’s path to find a cure for Pompe disease.

9:40 am - 10:10 am POWER PANEL DISCUSSION: Adopting a Patient First Mentality: Create the Culture Vital to Success in Your Temperature Controlled Logistics Supply Chain

Our distinguished panelists are creating a strong culture that puts patients at the front and center of all business decisions. Discover how the culture sets the tone for daily decisions, behaviors and performance in their logistics supply chain.

  • Develop a customer first mentality that drives behavioral standards and maintains accountability
  • Discover new, more personal ways to connect with patients
  • Put the focus on the patient first, offering information, and resources throughout the care journey that helps them better understand their own condition, and more easily find and follow the right treatments
  • Improve communication and collaboration across the organization
  • Delivering a patient-centric delivery model while ensuring long-term sustainability

10:10 am - 11:00 am Speed Networking Session and Morning Refreshment Break

This is the perfect ice breaker for you to get to know your fellow attendees in the shortest possible time. Think of this as speed dating, but without the pressure, and definitely more results!

11:00 am - 11:30 am Using Leading Edge Pharma Technology to Enable Business Transformation in Premium Fruit

This case study will explore how the world’s largest producer of berries found answers to some of its most vexing strategic questions by looking to pharmaceutical cold chain technology.
• Using precise temperature control to significantly reduce temperature variability in the cold chain.
• Test results indicate that precise temperature control can extend shelf life and reduce spoilage
• Using integrated telemetry to provide assurance of an unbroken cold chain / greater understanding of ambient temperature profiles on airfreight lanes / ability to monitor and audit shipment details, from ambient and
payload temp to container movement
• Opportunities exist to make broader use of this technology beyond pharmaceutical transportation/logistics

11:30 am - 12:00 pm Addressing the Complexities of Delivering Cell Therapies

·        The pioneering days of cell therapy
·         Developing the infrastructure for commercial delivery of cell therapies
·         Creating a system with the future in mind 
·         Forming a blueprint for the next generation 

12:00 pm - 1:00 pm Lunch in the Technology Hall and Exclusive Book Signing with John Crowley

Rub shoulders and get a signed Chasing Miracles book and picture opportunity with John Crowley, our inspirational opening keynote speaker! It’s not every day that you get the chance to not only hear from a sitting CEO of a pharma company, but also be inspired by his journey to save his family.

1:00 pm - 5:00 pm One-to-One Business Meetings at Our Brand New Meeting Lounge in the Expo Hall from 1pm-5pm (Reserved for Pharma Company Attendees and Sponsors Only)

We all know time is of the essence, and finding the right person to connect with in a room full of hundred people can be daunting. Come to the Cold Chain Global Forum with a pre-arranged schedule and fully prepared to have benchmarking and business meetings. Whether you’re a pharma company or a sponsor, the One-to-One Business Meetings ensures that you walk away with at least 5-6 solid business meetings onsite over two days.

Interactive Discussion Groups

The Interactive Discussion Groups session provides the perfect opportunity for all delegates to participate in multi-directional, interactive roundtable discussions on up to three topics that are directly relevant to their day-to-day challenges. During this session, delegates will be sorted into groups of 12-15 and allowed to pick from the 15 various topics broken up by commercial/strategic, tech innovation and operational themes. Each roundtable rotation will rotate every 40 minutes. Discussion groups are kept small to ensure all delegates get the opportunity to ask their most pressing questions, ensuring a perfectly tailored experience.


1:00 pm - 3:00 pm 1. Track and Trace: Build Capabilities from 2019 to 2023
  • Translate requirements to build the right capabilities
  • Work with internal and external partners


1:00 pm - 3:00 pm 4. Setting Strategy for Transportation Qualifications
  • Dealing with legacy systems and new products
  • Addressing issues arising from a changing portfolio


1:00 pm - 3:00 pm 7. How to Scale for Growth Within Individualized Medicine
  • Work with existing vendors and ensure appropriate support and growth within your network
  • Ensure you have coverage and support in a global network as you expand


1:00 pm - 3:00 pm 10. Create a Sustainable Supply Chain
  • Create a supply chain that’s easy to navigate
  • Enable your distribution and quality teams to understand it without needing a logistics expert


1:00 pm - 3:00 pm 13. Quality: The Key Ingredient to Patient Safety
  • Pinpoint the quality systems that should be included in pharmaceutical supply chains
  • Assess what should be included in quality agreements

Technological Innovation in Temperature Controlled Logistics

1:00 pm - 3:00 pm 2. Good Distribution Practices (GDP) - Risk Assessment
+ The development of shippers - Qualifications
+  Shipping lane qualification – Hot and cold profiles, carrier, temperature monitoring, etc.

Technological Innovation in Temperature Controlled Logistics

1:00 pm - 3:00 pm 5. Creative Solutions to Cost Effectively Manage the Transportation of Ambient Products
  • Assessing how the changing regulatory environment will impact what’s required for transportation
  • Working with stakeholders and legislators

Technological Innovation in Temperature Controlled Logistics

1:00 pm - 3:00 pm 8. Maintaining the Appropriate Temperature throughout the Pharmaceutical Transportation Cycle
ALLAN KLINGE - President, Klinge Corporation
  • Using pharmaceutical reefer units equipped with sensors to control the temperature and allow the shipper to monitor it throughout the journey.
  • Employ refrigerated containers to lower shipping and handling costs and prevent losses in the form of damaged products,



Klinge Corporation

Technological Innovation in Temperature Controlled Logistics

1:00 pm - 2:00 pm 11. Achieving Digital Supply Chain Transformation

• Reviewing how quality and operational processes are changing
through digital technology including IoT, cloud, real-time visibility
solutions, and machine learning
• Discussing how pharmaceutical enterprises are overcoming the
challenges of adoption

Technological Innovation in Temperature Controlled Logistics

1:00 pm - 3:00 pm 14. Achieving Sustainability and Environment Packaging Designs in Temperature Controlled Packaging
  • New developments in reuse and refurbishment including phase change materials (PCM)
  • Reusing and making a closed loop supply chain that’s economical


1:00 pm - 3:00 pm 3. DSCSA/FMD Traceability Challenges and Opportunities
NICHOLAS BASTA - Editor in Chief, Managing Partner and Founder, Pharmaceutical Commerce
  • Meeting Saleable Returns deadline, handling exceptions
  • Deriving business value, e.g., integrating traceability with cold chain management, working with downstream trading partners


Editor in Chief, Managing Partner and Founder
Pharmaceutical Commerce


1:00 pm - 3:00 pm 6. Cannabis and Industrial Derived CBD: Navigating the Labyrinths of State and Federal Regulations
  • Current state of FDA regulation of cannabis and cannabidiol
  • Highlights of state regulation


1:00 pm - 3:00 pm 9. Determine the Optimal Shipping Mode for your Product Lines
  • Evaluate the size and weight of the goods being shipped along with the costs, urgency of the shipment, and value of the goods
  • Understand the benefits and limitations of ocean freight, air freight, rail, road and multimodal


1:00 pm - 3:00 pm 12. Risk and Security for your Supply Chain
  • Take precautions against supply chain disruption including theft and pilferage
  • Understand advancements in shipment monitoring technologies


1:00 pm - 3:00 pm 15. Last Mile Distribution: Lock in the Risky Part of your Supply Chain Journey
  • Leverage big data analytics to reduce risk and improve last mile logistics
  • Explore alternative strategies for validating distributors including prioritizing the most significant risks to product quality and ensuring patient safety

3:00 pm - 3:30 pm Afternoon Coffee Break and Demo Drives Begin

This innovative experience provides you with the perfect opportunity to find and hear elevator pitches from solution providers in a carefully curated and ushered manner. Better still, stand a chance to win some fantastic prizes when you go around the various demo participants and collect stickers for your Demo Drive Bingo competition! The raffle results will be announced on Main Conference Day 2 lunch break in the Exhibition Hall.

Early Maturity Track: Cold Chain 101 (0-3 Years)

3:30 pm - 4:00 pm Improve Lane Performance through the use of Real-Time Temperature and Location Monitoring
In this session, discover how to reduce temperature alarms and discards.
  • Gather real-time data to impact process improvement around quality and reliability
  • Address IOT hot topics including various aspects of GPS tracking and sensors
  • Integrate temperature and position data with your enterprise data system

Early Maturity Track: Cold Chain 101 (0-3 Years)

4:00 pm - 4:30 pm Overcoming Challenges with Managing End to End to Cold Chain Integrity
WASIF S. AZEEM PHD - Senior Director Quality Operations, Jamjoom Pharmaceuticals
Most of the world is challenged with managing end to end cold chain integrity of pharmaceutical products – especially in emerging markets. Chemical and physico-chemical stability of drug product mainly depends on storage temperature, once cold chain breaches it rapidly changes & may lead to ineffective & harmful product. In this session, find out how to:

  • Gain a high level of commitment for compliance throughout the storage, distribution, shipment & transportation of products
  • Balance quality, risk and cost to achieve compliance & maintain end-to-end product integrity Work closely with business partners to prevent inventory breaches and employ innovative end-to-end technology solutions


Senior Director Quality Operations
Jamjoom Pharmaceuticals

Early Maturity Track: Cold Chain 101 (0-3 Years)

4:30 pm - 5:00 pm Ensuring On-Time Delivery and Mitigating Carrier Excursions- Also How to Deal With This!
KEVIN HICKMAN - Senior Manager, Supply Chain and Distribution, Gilead Sciences
Stuff happens and we need to be prepared. In this session, discover how to set an action plan for dealing with the most likely scenarios and avoiding excursions and lost product.

  • Building the relationship with your partners including CMOs and logistic companies
  • Setting clearly defined expectations and managing the accountability of all stakeholders
  • Developing an action plan if something goes wrong including: product gets stuck in customs, flight delays, weather delays or accidents


Senior Manager, Supply Chain and Distribution
Gilead Sciences

Early Maturity Track: Cold Chain 101 (0-3 Years)

5:00 pm - 5:30 pm Transforming Pharmaceutical Clinical Supply Messaging with Blockchain
Imran oversees IRT and other systems within clinical drug supply at Biogen,. This session will focus on the clinical Supply Blockchain Working Group pilot program. Hear about results and a vision for the future.

Mid-Maturity Track (4-9 Years)

3:30 pm - 4:00 pm The Critical Value of a Certified Services Provider for the Maintenance and Management of Multi-use Shipping Solutions
We will share one pharmaceutical company’s assessment of the significance of a structured and quality-driven program to manage the maintenance of multi-use shippers to ensure consistent performance over the life of the components, regardless of the number of uses, to maximize return on investment.  The key learning will be the importance of a quality-based refurbishment program for multi-use shippers and the capabilities and quality metrics implemented by a refurbishment service provider should be included in the due diligence process when selecting multi-use systems. 

Mid-Maturity Track (4-9 Years)

4:00 pm - 4:30 pm KITE PHARMA CASE STUDY: Enabling Personalized Medicine through a Flawless Supply Chain
Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. With an unrelenting drive and a singular focus on cell therapy, this session will explore how the team is executing a personalized medicine strategy to bring life-saving therapies to patients through a flawless supply chain. There is no margin for error in the end-to-end supply chain process as the patient is not given a second chance.

  • Understand cryogenic cold chain’s complexity with respect to products, integrity, temperature, label adhesion, and relationships with third party logistics partners
  • Achieve complete end-to-end visibility from shipping to delivery and secure the chain of custody
  • Reduce risk of CAR T-cell therapy to a comfortable level and overcome unique challenges

Mid-Maturity Track (4-9 Years)

4:30 pm - 5:00 pm CLIENT CASE STUDY: How Softbox and Merck Developed a Drone Delivery Enabled System to Support Disaster Relief and Disease Outbreaks
  • Learn about Merck’s project to provide life-saving medicines for humanitarian disasters
  • Get a glimpse into the collaborative partnership to provide medical supplies by drone
  • Discover how a temperature control packaging system was especially designed for the delivery of lifesaving medicines by drone, and how a Smartbox with Internet of Things technology was developed to provide real time data on temperature, location and security

Mid-Maturity Track (4-9 Years)

5:00 pm - 5:30 pm SANOFI CASE STUDY: Shipping Outside Label Claim Versus Shipping per Label Claim
LISA MOHER - Head of North America Distribution Package Engineering and Graphics, Sanofi
This session will explore planned versus unplanned temperature excursions against label claims. We’ll look at shipping with a planned excursion for the duration of the shipment versus shipping at label claim while in transit.

  • Understanding how different regulators have different requirements for label claim shipping
  • Excursion data vs label claim- How do you marry both in a cost-effective manner?
  • Pros and cons of shipping inside and outside label claim
  • Sanofi’s experience and best practice so far


Head of North America Distribution Package Engineering and Graphics

Advanced Maturity Track (10+ Years)

3:30 pm - 4:00 pm Tackling Current and Future Business Disruptors with Agility
  • How relevant and ready is your supply chain strategy and infrastructure today to deal with emerging disruption in the pharma space?
  • Which trends are poised to have the biggest impact on supply chain stability?
  • How do you expand and respond to the globalized supply chain and ensure that it remains optimized and uninterrupted?
  • Moving from 3PL to 4PL- Is this worth it?
  • Designing specialised patientcentric supply chains in a sustainable, cost-effective manner
  • How do you accelerate the digital transformation of your supply chain?
  • Achieving the optimal balance between patient-centricity, innovation, operational excellence and cost control

Advanced Maturity Track (10+ Years)

4:00 pm - 4:30 pm ELI LILLY CASE STUDY: Implementing Technical Data and an Effective Stability Budget to Test Product Capability and Prepare for Unplanned Excursions
Implementing technical data and authenticating the life history of a product can improve supply chain security and streamline processes. Eli Lilly is using an effective stability budget for unplanned excursions and testing the capability of a product that is shipped around the world across a multitude of suppliers, regulations and patients.

  • Model statistics around the analytical methods
  • Piece together the time and temperature allowed outside the label claim
  • Leverage capability to ship products around the world
  • Discovering the limits of time and beating the expectation
  • Discuss the global perspectives on stability budgets and impacts on supply chain products

Advanced Maturity Track (10+ Years)

4:30 pm - 5:00 pm CASE STUDY: Mitigating Supply Chain Disruption While Ensuring Product Quality in Developing Markets
This case study will analyze how to mitigate disruptions in your supply chain while maintaining product quality and regulatory compliance in China- a fast-growing market for clinical trials and drug manufacture. The case study will showcase how small-mid pharma companies can overcome these global supply chain risks through innovative solutions and strategies, while at the same time analyzing the importance of collaborative efforts across departments to ensure smooth end-toend distribution.

Advanced Maturity Track (10+ Years)

5:00 pm - 5:30 pm Temperature-Controlled Blockchain as a Key Component of the Extended Patient Centric Supply Chain and Overall Enterprise Operations
The end-to-end chain of custody for targeted therapies, biologics, and personalized medicines, that demand better temperature control in the supply chain, requires the optimization and coordination of people, finances, supplies and processes across the healthcare value chain to effectively enable the “patient-centric supply chain.” This calls for a solution that is tightly integrated with enterprise resource planning, supply chain, people and performance management solutions.  In this session we’ll discuss how the use of a modern and transformative platform can leverage blockchain, IoT, AI/ML with performance management to enable the agility and visibility required in today’s Life Science’s supply chain to help ensure that these temperature-controlled supplies reach the patient safely and cost-effectively.

NEW! Packaging Track This track stream will focus on innovative ways to re-process and re-engineer existing solutions to ensure sustainability and cost savings.

3:30 pm - 4:00 pm Reusable and Recyclable Packaging
New developments in reuse and refurbishment including phase change materials (PCM)

Reusing and making a closed loop supply chain that’s economical

Eco-friendly solutions (parcel( that are budget friendly

NEW! Packaging Track This track stream will focus on innovative ways to re-process and re-engineer existing solutions to ensure sustainability and cost savings.

4:00 pm - 4:30 pm Increasing Speed and Accuracy in Packaging: Rise in Use of Contract Packaging Companies
It’s costly to replace legacy equipment in the face of stricter regulations. That’s why more pharmaceutical manufacturers are turning to specialized contract packagers to ensure a higher level of speed and accuracy in their packaging operations. Focus on your core competency – drug development and leave packaging to the experts.

Rely on specialized packaging companies for full service solutions (i.e. blister packs, RFID tags, tamperevident solutions, etc.)

Reduce total supply chain costs by 25 to 50 percent

NEW! Packaging Track This track stream will focus on innovative ways to re-process and re-engineer existing solutions to ensure sustainability and cost savings.

4:30 pm - 5:00 pm Packaging Implications of the Increased Focus on Personalized Care
There is a greater focus on personalized medicine — one-sizefits- all no longer cuts it. This means smaller batches and shorter lead times for manufacturers up and down the supply chain. This will result in more continuous, localized production in the coming year.

Handling smaller batches with shorter lead times

Shifting toward packaging goods much closer to the point of sale for more efficient distribution

NEW! Packaging Track This track stream will focus on innovative ways to re-process and re-engineer existing solutions to ensure sustainability and cost savings.

5:00 pm - 5:30 pm Track and Trace & Anti- Counterfeiting Measures
Track and trace capabilities make it easier for authorities to identify counterfeit medicine at any stage in the supply chain. They also give police officers new tools if controlled medicines end up on the black market.

Moving away from serial numbers towards smart barcodes or random serialization

Using trackable features on labels to streamline shipping an distribution and safeguard the supply chain

Including verification strategies and tamper-free labels to prevent counterfeiters from distribution medications

5:30 pm - 6:10 pm The Temperature Controlled Supply Chains of the Future: Alternative Transportation Energy Sources as Competitive Advantage

Going green is no longer a gimmick, and there is money to be made. However, what are the challenges for the industry moving forward? What will ultimately be a competitive advantage for pharma companies and supply chain stakeholders in the next 10 years?

The majority of the world is realizing that burning fossil fuels is no longer a “free for all” game, and that we need to start moving towards alternative energy sources sooner than later or face disastrous consequences for our environment. More importantly, regulators around the world have started to clamp down on traditional ‘dirty’ sources of energy.

This provocative session will explore how both pharma companies and the their supply chain partners will need to start exploring alternative transportation, and push 3PLs and other shippers to start addressing the fact that moving around trillions of tons of goods without reducing emissions might soon become unsustainable.

6:10 pm - 6:10 pm Networking Cocktail Reception

Innovation and disruption are the themes for this year’s cocktail reception at the end of Main Conference Day One. What better way to relax after a day of learning, networking and business meetings then with a good drink and beverage of your choice as you unwind!