Cold Chain Global Forum West Coast

February 25 - 27, 2020 | San Diego, CA

Archived Content [Hidden]

Global Mastery eBook

Global Mastery eBook

Let's be honest--your ultimate objective is to make your cold chain a world-spanning behemoth with tentacles in all nations. We want to help: to this end, we have complete a multi-part eBook to facilitate your conquest. This eBook includes perspectives from six speakers from top industry companies, focusing on regulations, packaging, logistics, and security in the international cold chain.
Temperature Controlled Logistics: Optimizing Strategies and Cost-Balancing

Temperature Controlled Logistics: Optimizing Strategies and Cost-Balancing

In the mission to further refine a pharmaceutical’s path to market: Risk conduct, compliance and cost balancing are three key pillars to be optimised in any temperature controlled logistics strategy.
Decision Making Agility: Temperature Controlled Logistics Reactions

Decision Making Agility: Temperature Controlled Logistics Reactions

Damage from disruptions in the supply chain can’t be completely eradicated, however they can be mitigated. Disruptions could occur in the form of natural disasters, equipment/vehicle failure or unforeseen transport delays. Companies which apply –what if – scenarios are noted to be much better equipped and agile towards facing unforeseen occurrences in the supply chain. A wrong decision made within the temperature controlled transit of a pharmaceutical, may not only be costly in a financial sense but it also in terms of physical harm caused to patients in extreme cases.
Reduce the Complexity & Cost of Your Packaging Solutions

Reduce the Complexity & Cost of Your Packaging Solutions

Jean-Pierre Emond Ph.D., Director of Cold Chain Research at Georgia Tech Research Institute, has over 25 years of experience researching the cold chain and packaging systems. In this exclusive Cold Chain IQ interview he discusses capability gaps in the temperature controlled supply, developments in cold chain ocean freight and understanding the purpose and function of each cold chain packaging component in order to find the right packaging solution.
Guide to Global GDP Guidelines

Guide to Global GDP Guidelines

There is no single global GDP standard, but we hope this infographic will help you to more easily navigate the global regulatory landscape. The guide includes a map that highlights the latest national, regional and organizational guidelines with links to the source documents.
E-Book: Cold Chain Global Forum - Spring

E-Book: Cold Chain Global Forum - Spring

Ahead of our first ever Spring iteration of the world's largest event on cold chain, we sat down with four of the industry's leading experts to get their perspective on topics specific to each of their areas of expertise. Receive insight on topics that include roadblocks and supply chain challenges, clinical and commercial operations, validation protocols and many more. Through this EBook, you'll gather the resources necessary to bring your cold chain to the next level.
Optimizing the Last Mile of the Supply Chain Industry Report

Optimizing the Last Mile of the Supply Chain Industry Report

Although the full supply chain is valued by life sciences companies, it’s the last mile that matters the most to the customer. With this in mind, we surveyed 150+ pharma logistics leaders to learn more about the key challenges, solutions and trends impacting the last mile of the life sciences supply chain.


Highlights include:   

  • Analysis of what causes the most last mile disruptions and how firms are addressing these issues
  • An overview of our respondents top strategic priorities
  • Facts & figures that outline where pharma logistics leaders are looking to invest in 2019
Preparing your Supply Chain for the Regulatory Provisions

Preparing your Supply Chain for the Regulatory Provisions

This presentation explores the Health Canada Guide-00069 regulations and requirements in Canada and provides detailed examples of compliance and non-compliance regarding:

  • Review guidelines for products in transit: stability data requirements and temperature mapping
  • Discus the regulatory scope of temperature monitoring for CRT
  • Risk valuation and mitigation and analyze examples of compliance and non-compliance
  • How to implement locally to distribute to Canadian customers to fulfill authority requirements
  • Discuss the global regulatory landscape for CRT products and where they may get flagged


Presentation by:

Tonino Antonetti, M.Sc., Executive Director, Regulatory Affairs & Quality Management -SHE, Roche Diagnostics

Rafik H. Bishara, Ph.D., Technical Advisor & Former Director QKMTS, Eli Lilly and Company (retired)

Optimizing Lane Qualification with all Supply Chain Stakeholders

Optimizing Lane Qualification with all Supply Chain Stakeholders

With the variety of product lines increasing and the regions, companies are shipping to growing. There are a lot of variables to account for when qualifying your shipments. In particular, USA’s vast geography and temperature gradients pose a big challenge for logistics and supply chain professionals. These challenges show direct parallels with the current environment in Brazil. Shipping from South to North Brazil brings about similar roadblocks as shipments to distant US regions. These issues can be mitigated through smart supply chain management, streamlines logistics, and open communication with supply chain partners. What you will learn:

  • Qualifying solutions that worked for Brazil national operations
  • Establish an evaluation tool characterize your shipping lanes by riskiness and discuss solutions to decrease that risk.
  • Review best practices for managing your partner relationships, both local & internationally through the use of correct relationship models
  • Where does lane qualification fit into your overall supply chain management initiatives? How do you prioritize?

Presentation by:

Luiz Barberini, Operations Manager, External Manufacturing Organization Latin America, Bayer Consumer Health

Eli Lilly and Company & Dispensary of Hope’s Partnership for Insulin Access

Eli Lilly and Company & Dispensary of Hope’s Partnership for Insulin Access

  • Highlights an innovative partnership and solution to provide insulin access to patients in need, through free clinics and charitable pharmacies.
  • Objective: Highlight considerations for both Lilly and Dispensary of Hope

Presentation by:

Suzette Figueroa Diaz, Director Access & Affordability, Lilly Diabetes

Steve Stapleton, Director Patient Assistance Programs, Lilly USA & President Lilly Cares Foundation

Scott Cornwell, Chief Supply Chain Officer, Dispensary of Hope Eli Lilly and Company & Dispensary of Hope’s Partnership for Insulin Access

Getting Patients Involved in the Cold Chain

Getting Patients Involved in the Cold Chain

One State now requires that a pharmacy shall ensure the integrity of any drug requiring temperature control that is delivered by mail order by enclosing in each package a measurement device to alert consumers that drugs have been exposed to temperatures that could affect their potency and stability. So how has one of the major pharmacy chains decided to meet that requirement?


Presentation by

Alan Kennedy, Founder and Executive Director, PHARMA TEAM-UP

Ensuring Quality through Supply Chain and QA Collaboration

Ensuring Quality through Supply Chain and QA Collaboration

  • What is the concept of product quality and what is the philosophy surrounding quality management in supply chain environment
  • Correlation between little q and bigger Q in relation to the product quality and supply chain management and how can they impact each other
  • How Q.A and Supply chain can cooperate in an Effective Manner to Ensure Seamless Integration of their efforts in order to achieve the Optimal Quality - Supply Chain Solution to the Customers
  • Real examples of successful collaboration approaches between Quality and supply chain department

Presentation by

Ahmed ElSheemy, Head of Quality Assurance Middle East & Turkey, Merck Serono Middle East (a subsidiary of Merck KGaA Germany)

Bulk Reusable Packaging and Real-Time Asset Tracking Case Study

Bulk Reusable Packaging and Real-Time Asset Tracking Case Study

  1. Innovative Reusable Bulk Container for Shipping Drug Substance <-30°C
  2. Real-Time Supply Chain Visibility to Provide Flawless Performance


Presentation by....

Jennifer Antonetti, Sr. Supervisor Global Distribution Packaging & Shipping Qualification, Biogen

Chris Day, Director of Business Development – Leasing Services, Sonoco ThermoSafe



Defining Strategies on How to Effectively Manage Suppliers

Defining Strategies on How to Effectively Manage Suppliers

Bayer’s Unique Relationship Model that will Help you Improve Data Exchange, Network Platforms, and Integration.

Ensuring that all products are delivered on time and that no back orders occur, is an essential KPI across supply chain professionals. Bayer is taking the necessary steps to improve data exchangeand supplier network platforms to achieve better integration and create a balance between supplier collaboration, customer collaboration and peer collaboration.

  • Invest in correct programs and architecture to allow successful collaboration through joint ventures.
  • Improve relationships with all third party suppliers to increase efficiency of your supply chain
  • Allude to the effects of Supply Chain 4.0 and how this will affect relationship management of the future
  • Formulate strategic models to improve supplier relationships across every point of the supply chain

Presentation by Luiz Barberini, Operations Manager, External Manufacturing Organization, Latin America, Bayer Consumer Health

Guidelines for EUFMD Implementation

Guidelines for EUFMD Implementation

No country is immune to the problems associated with counterfeit medicines. Across the planet, governments are enforcing new regulations and directives to counter the threat of illegal pharmaceuticals to public health and safety.

In this report, ACG examines the EU’s Falsified Medicines Directive – due to be rolled out on February 9 next year.

This paper outlines the insights ACG have gained from their experience in Track & Trace implementation, highlights the challenges faced by pharmaceutical companies across the EU, and posits potential methods of overcoming them. With awareness of counterfeiting increasing, the pharmaceutical industry should be agile in the coming months, and learn to consider regulations as obligations in the years to come.

Expert Insights: Supply Chain Efficiency and New Technologies

Expert Insights: Supply Chain Efficiency and New Technologies

This whitepaper covers:

  • IoT and blockchain will enable proactive shipment management. No longer will practitioners be restricted to post-shipment for analysis and excursion management, increasing the sector's ability to mitigate risk to the product and the patient.
  • The future of the sector will be characterised by solutions that are software driven rather than hardware driven. The benefit of this is that logistics services and shippers will no longer be tied down to a single device, or group of devices that have restricted connectivity.
  • A device-agnostic software system that can switch to the latest technology, which will put the shipper in a much more flexible position in terms of their purchasing ability. It will also ensure that the sector can maintain fluidity and adapt to newer technologies far easier than ever before.
INFOGRAPHIC: The Logistical Challenges of Global Clinical Trial Supply

INFOGRAPHIC: The Logistical Challenges of Global Clinical Trial Supply

With 253,834 studies located in 200 countries, ensuring smooth and cost-effective global clinical trial supply has become a standard for the pharmaceutical industry. Experts from all regions have answered our survey on the main pain points they face, how they can improve their supply chain and what drives its success. Anat Batsri, Global Clinical Supply Chain Study Lead at OPKO Biologics, had a look at the results and gave us her feedback on what the results showed.

Standardization & Risk Management In Cold Chain

Standardization & Risk Management In Cold Chain

A look into the concept of global standardization with risk management in the cold chain.

This whitepaper explores supply chain security and validation as they pertain to lane qualification, data monitoring, shipping lanes and stability budgets.

PHARMA LOGISTICS COMPLIANCE REPORT

PHARMA LOGISTICS COMPLIANCE REPORT

This whitepapers covers the latest pharmaceutical logistics regulatory developments around the globe related to FMD, MHRA, ICH Q12, PACMP, GMP, DSCSA and more! Designed specifically to keep you up to date with key developments that we believe with shape the compliance agenda over the next year, key developments that you will need to tune in for! Highlights include:

  • GMP inspections international collaboration efforts
  • Supply Chain Security and Traceability – GPS
  • EMA regulations
  • Points to remember for your next GDP inspection
  • The latest on Human Drug Compounding Outsourcing Facilities regulations
  • An analysis of ICH Q12 concepts
  • The cost of Brexit and the road forward
  • An overview of EU's recently published report detailing the implementation of the Falsified Medicines Directive (FMD)


Plus! Commentary by 2018 Cold Chain Global Forum speakers:

  • Rafik Bishara, Ph.D, former Director QKMTS, Eli Lilly and Company
  • Ajay Pazhayattil, Former Associate Director, TOPV Apotex Inc.
Transporting CRT Medicines in 2019

Transporting CRT Medicines in 2019

Top Challenges & Solutions for Protecting Ambient and Room Temperature Products

Not too long ago, “ambient,” “room temperature” and even “controlled room temperature” (CRT)  were considered synonymous and, as they were considered more or less resilient again temperature excursions, were provided little to no thermal protection across the supply chain. However, this is beginning to change. Increased regulatory focus, an improved understanding of how inappropriate storage conditions impact product integrity and the increased volume of temperature sensitive CRT biosimilars/biologics have pushed manufacturers to pay just as much attention to room temperature products as they do traditional cold chain drugs.

This being said, transporting room temperature drugs is not without its challenges. Though it may sound counterintuitive, safeguarding room products from temperature excursions can actually be more expensive and difficult than protecting their cooler counterparts. From reasons raging from costs to simple effectiveness, one simply just can’t apply the same solutions and methodologies to ambient products as they do those that require refrigeration. 

With this in mind, below we’ve outlined the key challenges and solutions associated with protecting CRT and ambient drugs across the supply chain.


Cold Chain 2030 Part II: The Future of Cold Chain Technology

Cold Chain 2030 Part II: The Future of Cold Chain Technology

Industry Brief

3 Emerging Technologies Poised to Transform the Temperature Controlled Life Sciences Supply Chain 


The temperature controlled life sciences supply chain landscape has never been riper for disruption. Though the pharmaceutical industry has changed dramatically over the past 30 years, the pharmaceutical supply chain has remained largely unchained. However, with the influx of biologics and personalized medicine, the growing costs of R&D, increased global regulatory pressure and numerous other emerging trends, the pharmaceutical supply chain is only expected to grow in complexity and expense for the foreseeable future. Given all of the challenges ahead, we asked our Cold Chain Spring 2019 speaker faculty what new, innovations and solutions are on the horizon that could help the reinvent the pharmaceutical cold chain industry as we know it. The following is an overview of the top 3 technologies poised to usher in the next era of temperature-controlled life sciences logistics: Artificial Intelligence, Blockchain and Advanced Analytics.








Current Attendee Snapshot

Current Attendee Snapshot

Get a sneak peek of who you can expect to meet and learn from at Cold Chain Spring!

Serialization Demands Smarter Inventory Tracking

Serialization Demands Smarter Inventory Tracking

Warehouse management systems (WMS) are all too often unable to comply with serialization requirements or deliver mandated reports due to their complexity and high degree of customization.  In order to ensure compliance to DSCSA and FMD standards as well as more effectively control costs, companies need to invest in smarter inventory tracking and more efficient warehousing operations.

In this article, Larry Hall of Tracelink discusses how pharmaceutical serialization requirements are driving demand for smarter inventory tracking and warehouse management. In addition, Hall also provides use cases to highlight key considerations for ensuring life sciences warehousing operations are compliant.