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September 24-27, 2018
Pennsylvania Convention Center

Pre-Conference Workshop Day: Tuesday, September 25th 2018

8:00 am - 8:15 am REGISTRATION WORKSHOP A & B

LOGISTICS

8:15 am - 10:45 am WORKSHOP A: Optimizing Lane Qualification with all Supply Chain Stakeholders in Challenging Shipping Environments
Luiz Barberini - Operations Manager, External Manufacturing Organization Latin America Bayer Consumer Health
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 road blocks 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?
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Luiz Barberini

Operations Manager, External Manufacturing Organization Latin America
Bayer Consumer Health

PACKAGING

8:15 am - 10:45 am WORKSHOP B: Choosing the Best Mode of Transport for CRT Products- Your Roadmap to Ensuring Product Integrity while Keeping Control of Transport Costs
The variety of drugs that require temperature control while in transit is driving the change in the pharma supply chain. This costly and complex process requires attention at every level from packaging to logistics and monitoring to data. This storage and distribution of CRT products can prove costly and complex across multiple suppliers and distribution companies. How can we ensure that our CRT specifications are being met and maintained across varying transport routes?

Discussing the Theory:
  • Investment levels for transporting CRT medicines
  • Examining product stability budgets
  • Discussing risks with CRT products
  • Assessing data availability and transport modes most suitable for evolving CRT products of the supply chain

Discussing the Practice:
  • Discussing thermal blanketing vs. refrigeration equipment

10:45 am - 11:00 am REGISTRATION WORKSHOPS C & D

TECHNOLOGY TOOL KIT

11:00 am - 1:15 pm WORKSHOP C: Achieving Cold Chain Cost-Reduction While Ensuring Product Quality and Safety and Gaining End-to-End Visibility Through a Single Real-Time Monitoring Solution
Cold chain management doesn’t have to mean wading through historical data after to determine whether products can be safely consumed by patients, or spending many business hours reviewing shipment data to solve the mystery of what went wrong, and why, each time a temperature deviation occurs, in order to develop a corrective and preventive action (CAPA).
Setting up your temperature data tracking and cold chain management system the right way can in fact enable your business to proactively save product and operational waste and automate processes by letting the system communicate with supply chain stakeholders, and providing greater opportunities for supply chain optimization and quality control.
This workshop will look at how to facilitate digital transformation across your cold chain, using real-time temperature and product movement data to make the most out of your cost-saving improvements while meeting GDP Quality requirements.

  • How to facilitate real-time visibility using analytics,
  • How to enable automatic deviation processing and reduce timely investigations
  • Examples of logistics improvements by trending data of multiple shipments
  • How to track and release shipments, not just individual data loggers
  • How to leverage analytics to forecast and expedite shipment delivery
  • Case Study: Customer implementation of a temperature and product movement monitoring database, including examples of proactive waste prevention
  • Group Exercise: Small-group discussions on overcoming case scenarios of global cold chain challenges in collecting and using temperature data, and exploring solutions for these challenges


DIGITIZATION

11:00 am - 1:15 pm WORKSHOP D: Digital Solutions for Upstream Supply Chain Integration
Dave Malenfant - Director, Center for Supply Chain Innovation Texas Christian University
The notion of the “Supply Chain 4.0” proposes a plethora of new digital solutions for the pharma market to adopt including EWM, Cost Design, Integrated Business Planning, Web Barcodes, IOT, Blockchain, AI, and Cloud-based Solutions to optimize the supply chain. With all of the new technology for integration, what are the best methods for assessing carrier ETA performance, implementing agility with digitization, increasing container utilization improvement, and removing non-value added tasks from our system?

What will be discussed:
  • What is the Industry 4.0 and will it remain a game changer for the entire supply chain?
  • How close are we to the Digital Supply Chain?
  • Discussing processes for digitalization transformation
  • Integration of the upstream supply chain

Practical Module:
  • How can we implement a large-scale supplier management program and KPI based supplier anagement?
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Dave Malenfant

Director, Center for Supply Chain Innovation
Texas Christian University

1:15 pm - 1:30 pm LUNCH

1:30 pm - 1:45 pm REGISTRATION WORKSHOPS E & F

RISK MANAGEMENT

1:45 pm - 4:00 pm WORKSHOP E: Controlling Operating Risks and Potential Supply Chain Disruptions
Jennifer Antonetti - Sr. Supervisor Global Distribution Packaging & Shipping Qualification Biogen
Adhering to the Falsified Medicines Derivative coming into play in 2019 and applying the new ICH Q12 measures across supply chain distribution can prove difficult enough for pharma manufacturers. Throw in spurious drugs, falsely labelled drugs, and counterfeit drugs into the mix, and quality risk management is suddenly becoming daunting and difficult to manage. How can we prepare for disruptions in the supply chain while currently mitigating the normal risks that our products are exposed to across various suppliers, countries, and regulations?

What will be discussed:
  • Identify, mitigate, and measure the impact of disruptors in the supply chain
  • Understand the difference between crisis management and supply chain risk management

Practical strategies in action:
  • Take proactive and actionable steps to add resiliency to supply chain operation without large levels of investment
  • Communicate the realities of risks with stakeholders and implement an effective Supply chain risk mitigation program
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Jennifer Antonetti

Sr. Supervisor Global Distribution Packaging & Shipping Qualification
Biogen

INNOVATION

1:45 pm - 4:00 pm WORKSHOP F: Integrating Blockchain and IOT Enabled Supply Chain Visibility
Robert Celeste - Founder Center for Supply Chain Studies
With Shire and Takeda Pharma both taking initiatives to adopting cloud-based solutions and automation processes for their evolving supply chain distribution, how will the regulations of the GTSH and FDA come into play with emerging technology? The WHO estimates that 10% of medicines in emerging markets are counterfeit, proving a need for better traceability, tracking, and locked transactions. How can the Blockchain and better visibility of products save lives and create a more secure global supply chain?

Theory Discussed:
  • Assess the design of the blockchain- explore its five pillars, layered architecture, and its application for the supply chain
  • Connect people, processes, and data through devices and sensors

On the job strategies discussed:
  • Enhance a network that continuously measures, collects, and exchanges “live” data
  • Gain visibility into transportation of goods and enable logistics to optimize shipping routes
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Robert Celeste

Founder
Center for Supply Chain Studies

4:00 pm - 4:15 pm REGISTRATION WORKSHOPS G & H

DATA MANAGEMENT

4:15 pm - 4:15 pm WORKSHOP G: Stability Monitoring & Technology Innovation in the Temperature Controlled Life Science Supply Chain
Jeroen Van Loo - Key Account Manager- West ELPRO
Colleen C. Sheldon - Key Account Manager- East ELPRO
This workshop will walk through the supply chain, complex as it is, to identify areas to reduce and simplify; while considering new technology to automate. In small breakout discussion stations, you will learn how to manage valuable temperature, shipment and stability data to improve your quality distribution operations; and ultimately provide higher patient safety assurance.

Take a Walk on the Wild Side of Cold Chain. From Origin:
  • Global in-transit points and partner sites create disparate sets of data. How can you create a complete picture of product quality in a chaotic global supply chain?
  • Working in a cloud-based data management environment across global sites
  • *In-practice, in-process breakout discussion:* Collecting, storing, and archiving valuable temperature data in a central database to meet data integrity regulatory requirements
  • In-Transit: Managing stability data throughout the supply chain to verify fit for use using a stability budget or establishing an allowable excursion model
  • Have you considered all chaotic points? Warehouses and pharmacy refrigerators? What are the possibilities for batch traceability from manufacturer, through the last mile?
  • Real-time monitoring vs. using milestones to identity weak points in a lane
  • To Destination: USP <1079> and <659> updates and impact to day to day operations including temperature excursion management
  • *In-practice, in-process breakout discussion:* In-transit technology and automated processes
  • Moving from outdated excursion processing to more automated deviation handling and product release.
  • Automation at destination sites: Realistic operational advantages using wireless technology
  • *In-practice, in-process breakout discussion: KPIs* Turning data into business intelligence


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Jeroen Van Loo

Key Account Manager- West
ELPRO

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Colleen C. Sheldon

Key Account Manager- East
ELPRO

PERFORMANCE & COLLABORATION

4:15 pm - 4:15 pm WORKSHOP H: Improving Global Supply Chain Performance through Collaboration and Partnerships
Brian Files - Former Director of Regulatory Compliance & Policy CVS Health
Pharma is anxiously waiting for full scale customer collaboration programs to take off. With pressures from regulatory compliance agencies, labeling and packaging commissions, and user requirements, manufacturers and suppliers must communicate effectively in order to streamline the distribution process of their products. How can we use joint ventures, 3PL management consultants, and data sharing to improve our supplier relationships and promote collaboration across the supply chain?

What will you learn?
  • Assess multiple distribution channels
  • Increase urbanization, rising distribution costs, and growing demands for a sustainable supply chain

What strategies will be discussed?
  • What are the best innovative solutions to enhance partnerships and collaboration?
  • Harness agility and flexibility to deliver optimal performance
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Brian Files

Former Director of Regulatory Compliance & Policy
CVS Health