Main Conference Day One: Thursday, October 17, 2019
7:15 am - 7:20 am Registration and Breakfast
7:20 am - 8:35 am By-Invitation Only VIP Breakfast with John Crowley, Chairman & CEO, Amicus Therapeutics
Rub shoulders and network with your peers and John Crowley, Chairman & CEO, Amicus Therapeutics at this exclusive 20-slot, by- invitation only 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.
JOHN CROWLEYChairman & CEO
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
SHITAL PARIKH MARSCEO
DAVID KIMDirector of Global Logistics
Kite Pharma, a Gilead Company
LISA WYMANVP Quality
10:10 am - 11:00 am Morning Refreshment Break, Demo Drive and Book Signing Session with John Crowley, Chairman & CEO, Amicus Therapeutics
Meet with best in class service providers, get a signed copy of John Crowle’s book and earn a chance to win valuable prizes.
11:00 am - 11:30 am Session Reserved for Case Study by Sonoco Thermosafe
11:30 am - 12:00 pm Critical Updates on Brazil’s Transport Qualification Guidance for Biologics
Bernardo was the main author for the 2016 Transport Qualification Guidance for Biologics, which aims to describe the information that ANVISA needs to receive and evaluate operational and performance qualification of cold chain shipments within Brazil. Hear about updates to ANVISA’s guidelines about transportation qualifications of biologics and what it means for cold chain logistics in Brazil.
- Understand the regulatory requirements regarding the transportation qualifications of biologics.
- Clarify the guidance’s updates on: operation qualifications for active solutions. temperature controls, data reporting and lane qualification requirements
- Sourcing effective cold chain solutions in the absence of sufficient regional infrastructure for transportation and warehousing
12:00 pm - 1:00 pm Lunch and Visit to the Technology Hall
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.
Commercial/Strategic1:00 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
TOM SCALONEDirector North American Logistics
Commercial/Strategic1:00 pm - 3:00 pm 4. Setting Strategy for Transportation Qualifications
- Dealing with legacy systems and new products
- Addressing issues arising from a changing portfolio
SHUBHRA KOCHARSenior Engineer- Distribution Technology
Genentech, A Member of the Roche Group
Commercial/Strategic1:00 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
MARK LOVELLAssociate Director Commercial Supply Chain Project Management
Commercial/Strategic1:00 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
Commercial/Strategic1:00 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 Logistics1:00 pm - 3:00 pm 2. Risk Assessments and Simulation Technology
- Are simulations a short cut or a more thorough form of lane qualification?
- Will automation and machines continue to streamline non value added activities?
BENJAMIN ROMERODirector Global Logistics Temperature Control
Technological Innovation in Temperature Controlled Logistics1:00 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
JOHN JANCZY PH.DHead of Research and Development
Technological Innovation in Temperature Controlled Logistics1:00 pm - 3:00 pm 8. Maintaining the Appropriate Temperature throughout the Pharmaceutical Transportation Cycle
- 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,
Technological Innovation in Temperature Controlled Logistics1:00 pm - 2:00 pm 11. IoT; Digitize and Connect Vital Functions
- Track the movement of drug inventory at every point
- Use digital technology including GPS location monitoring for real time visibility and securing drug transport
Technological Innovation in Temperature Controlled Logistics1:00 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
ANTHONY (TJ) RIZZOSenior Vice President
Cold Chain Technologies
Operational1:00 pm - 3:00 pm 3. DSCSA/FMD Traceability Challenges and Opportunities
- Meeting Saleable Returns deadline, handling exceptions
- Deriving business value, e.g., integrating traceability with cold chain management, working with downstream trading partners
NICHOLAS BASTAEditor in Chief, Managing Partner and Founder
Operational1:00 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
TIMOTHY I. MCCULLOCHPractice Department Chair Cannabis
Operational1:00 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
Operational1:00 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
CHUCK H. FORSAITHSenior Director, PCSC (Pharmaceutical Cargo Security Coalition)
HDA (Healthcare Distribution Alliance)
Operational1:00 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
1:00 pm - 1:30 pm Afternoon Coffee Break and Networking
Based on popular demand, our track sessions are based on maturity levels of the audience. You are welcome to move in and out of the different track streams as you see fit.
Early Maturity Track: Cold Chain 101 (0-3 Years)1:30 pm - 2:00 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
BILL MCGILLIANAssociate Director Supply Chain Management, Product Handling and Technology
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
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
WASIF S. AZEEM PHDSenior Director Quality Operations
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!
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
KEVIN HICKMANSenior Manager, Supply Chain and Distribution
Early Maturity Track: Cold Chain 101 (0-3 Years)5:00 pm - 5:30 pm BIOGEN CASE STUDY: Leveraging Process Efficiencies to Reduce Temperature Control Completion Time
Find out how Biogen leverages process efficiencies through automation. This session will walk you through how to shorten your temperature control completion time cycle from one week to days.
- Create an actionable metrics dashboard fed by the temperature database
- Leverage automation to Improve accountability for all stakeholders
Mid-Maturity Track (4-9 Years)1:30 pm - 2:00 pm END USER CLIENT CASE STUDY: Safely Transporting Pharmaceuticals, Clinical Trials, Diagnostics, Tissue, Vaccines and Blood Supplies
In this case study, find out how to leverage cold chain performance solutions that best meet your needs.
- Using passive single-use and reusable temperature controlled patented packaging solutions for the safe distribution of frozen, refrigerated and controlled ambient temperature-sensitive payloads in profiles ranging from -50°C to 25°C and payload capacities ranging from 2 to 96 liters.
- Leverage track-and-trace software to monitor temperature controlled packaging inventories throughout the entire end-to-end distribution cycle
- Meet increasing global regulatory demands, manage challenging shipping lanes and unforeseen delays while reliably and confidently tracking critical, high-value payloads around the world.
JAN GERBERS R.PH.PharmDWholesale Drug Distributor Licensing Consultant
Eli Lilly and Company
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
REGGIE FOSTERSr. Director - Packaging, Labeling, & Logistics
Kite Pharma, a Gilead Company
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
AXEL HARTMANProject Manager, Product Handling – Global Strategy
Mid-Maturity Track (4-9 Years)5:00 pm - 5:30 pm SANOFI CASE STUDY: Shipping Outside Label Claim Versus Shipping per Label Claim
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
LISA MOHERHead of North America Distribution Package Engineering and Graphics
Advanced Maturity Track (10+ Years)1:30 pm - 2:00 pm BD CASE STUDY: Standardizing Processes and Solutions Globally to Ensure Global Supply Chain Delivery
Ilyaas Shaaf is in a global role assessing temperature controlled solutions in all regions around the world. BD is in multiple segments with each business using multiple solutions that need alignment. Discover how the company is working on layering continuous improvement into a standardization model.
- Reducing risk from a cold chain perspective
- Assessing the temperature controlled requirements of new product innovations
- Working with research/development and quality for alignment on stability data, shipping and compliance
ILYAAS SHAAFAssociate Director, Temperature Controlled Solutions Global Logistics
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
K. NICOLE HARTERConsultant Quality Assurance – Global Marketing Affiliates and Global Logistics
Eli Lilly and Company
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.
LISA WYMANVP Quality
Advanced Maturity Track (10+ Years)5:00 pm - 5:30 pm IoT: The New Rx for Pharmaceutical Manufacturing and Supply Chain
Discover how to use IoT platforms and solutions to digitize and connect vital functions, improve efficiency and assure product quality and compliance.
- Leverage IoT to help clear bottlenecks and ensure greater GMP/GDP compliance and reduce operating expenses
- Connect opportunities across the pharma spectrum by equipping every “thing” with a sensor
- Track the movement of drug inventory at every point and monitor cold chain conditions on shipping vehicles.
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.1:30 pm - 2:00 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
BRYAN CARDISConsultant Packaging Engineer
Eli Lilly & Company
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
ARMINDA MONTEROProgram Manager, Global Supply Chain QA
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
REY CHERNEngineering Director, Drug Product Technology
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
CAROLYN WILLIAMSONFormer Principal Packaging Engineer
Supply Chain Leaders RoundTable (By Invitation Only)1:30 pm - 2:00 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
Kannalife Inc., A Phyto-Medical Company
ASHESH C. (ALEX) SHAHFounder and CEO
Supply Chain Leaders RoundTable (By Invitation Only)4:00 pm - 4:30 pm Continued from above
Supply Chain Leaders RoundTable (By Invitation Only)4:30 pm - 5:00 pm Industry Disruption: “The Amazon Movement”
Amazon’s pharmaceutical ventures have faced roadblocks. They had trouble breaking into hospitals based on strong relationships with existing distributors and also can’t provide higher “Class III” medical devices like pacemakers. But, let’s not rest on our laurels as they are hiring experts to help break into this space. They’ve already carved out a “sweet spot” with smaller practices and dental offices. They acquired Pillpak and now many are nervous how they will use Whole Foods as a potential delivery channel. This panel of experts will explore how Amazon may fit into the future of pharmaceuticals.
Supply Chain Leaders RoundTable (By Invitation Only)5:00 pm - 5:30 pm Summary, Key Takeaways and Networking Session
During the final session of the exclusive executive track, we will be summarizing the key lessons learned. We will break into groups and each group will come up with their top 5 takeaways from the track stream and day one’s keynote sessions. Each participant will also fill out a simple form highlighting their current challenges and greatest recent accomplishments. The event’s producer, Lisa Schulman, will gather all the data and will create a post show report summarizing the learnings, challenges and greatest accomplishments. It will be shared via e-mail post event to our exclusive group.
5:30 pm - 6:10 pm Extending the Cold Chain with Automated Drone Delivery: A Real Life Operating Case Study
WILL HETZLER Co-Founder Zipline
WILL HETZLER Co-Founder Zipline
The infrastructure and transportation technologies of the last century failed to enable universal access to healthcare. Automated drone delivery has the potential to affordably provide every human on Earth with instant access to vital medical products. Zipline is an automated logistics company that is working to build this future.
Zipline already operates the largest automated logistics network in the world, providing over 11,000,000 people with instant access to hundreds of medical products by drone. Zipline routinely delivers chilled, frozen, and deep-frozen products, such as antivenom, blood products, insulin, laboratory reagents, and vaccines. Instant delivery by drone enables a new just-in-time supply model that improves supply chain efficiency and reduces medical product waste. Find out how Zipline’s drones fly over 25,000 miles every week through wind and rain to make lifesaving deliveries.
4:10 pm - 4:10 pm Networking Cocktail Reception
Here’s your chance to connect with the speakers, sponsors and your fellow attendees.