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September 24-27, 2018
Pennsylvania Convention Center

Main Conference Day Two: Thursday, September 27th 2018

7:30 am - 8:00 am REGISTRATION OPENS – COFFEE AND NETWORKING IN EXPO HALL

8:00 am - 8:30 am Dokasch Opening Remarks & Day One Recap

KEYNOTE ADDRESS

8:30 am - 9:20 am KEYNOTE: The ELD Transportation Mandate

Bill Mahorney - Chief, Enforcement Division FMCSA, Department of Transportation
As of December 18th, The ELD Mandate was passed in congress - the new rule mandates any driver required to previously keep a paper record of duty status must install an ELD (electronic logging device) in their vehicle which means instant third party verification that Drivers cannot work more than 14 hours a day and not drive more than 11 hours. It’s an open industry secret that truckers lie about how long they spend on the road. In an industry that already has a crippling shortage of drivers and capacity issues, the bandwidth will now shrink as much as 15% more. As of April 1st – the grace period was over. Bill will be addressing how this will affect the supply chain, logging books, hours of service regulations, and shipping/distributors collaboration with truckers. Bill will tie in Compliance with Collaboration as he details the FMCSA’s role within the new regulations.

  • Investing in new tacking systems
  • Creating client animosity and delivery limitation
  • Moderating the new trucking landscape with third part verification
  • Installing Electronic Logging Devices
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Bill Mahorney

Chief, Enforcement Division
FMCSA, Department of Transportation

9:20 am - 9:40 am CCGF EXCELLENCE AWARDS

Join us as we award your peers for their most innovative achievements in the last year.
An independent group of drug manufacturers and suppliers has formed with the goal of developing and publishing technical guidance that addresses the relevant needs of the industry. The first workgroup focused on the reuse of passive thermal packaging systems. This peer developed and reviewed guidance defines a representative standard and hopes to drive standardization for the advancement of the industry. This panel discussion will cover:

  • Details about the formation of the group
  • An overview of the technical paper content including passive thermal packaging system types, reuse qualification, refurbishment service and inspection details
  • Future of the group including new topics and membership
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Rey Chern

Engineering Director, Drug Product Technology
Amgen

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Arminda Montero

Program Manager, Global Supply Chain QA
Abbvie

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Bryan Cardis

Distribution Platform Steward
Eli Lilly & Company

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Bill McGillian

Associate Director, Logistics
Merck

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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Jason Sawicki

Principal, US Commercial Distribution
Genentech

10:30 am - 10:40 am DEMO DRIVE RAFFLE WINNERS ANNOUNCED & MORNING NETWORKING BREAK

Enjoy morning refreshments whilst you choose to participate and experience one or more of our amazing networking and educational enhancement opportunities.
  • What are your current projects in the Supply Chain Space?
  • How are you leading your team to leverage innovation in line with regulations?
  • What are some of the biggest challenges you have faced in your current role within the supply chain?
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Meg Duskin

Product Manager, Advanced Therapeutics,
Thermo Fisher

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Karen Giraudo

Global Product & Cost Account Lead
Pacira Pharmaceuticals

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Angela Fernandez

Vice President, Retail Grocery & Foodservice
GS1

CHANGE MANAGEMENT

11:30 am - 12:15 pm Preparing & Training Staff for Qualification and Validation Inspections from Regulators to Avoid Fines, Penalties, and Damaged Products
Supply chain professionals have pressure to protect the payload, ensure plastic bags don’t shatter and that transition temperature is met and in alignment with regulatory requirements.

  • Implement in house qualification training and validation product training
  • Train new staff to be SME’s on regulatory audits and investigations on packaging qualification.
  • Collaborate with packaging engineers internally and with consultants to qualify all products before shipping
  • Align staff on standards fluctuations and capabilities of all shipments if exposed to potentially damaging temperatures
Transport, handling and storage of temperature sensitive pharma-products throughout the entire supply chain have during the last 5 years reached an un-necessary high level of complexity. Beside the huge amount of regulatory demands, manufacturers of cold chain bio-pharma products struggle themselves to find the best and most efficient solution to meet an ever growing market, volume and new product port-folio. Hence, this presentation will share the specifics of a best practice approach for the industry - on a best-in-class approach to transport qualification and validation. The latter developed by collaboration between biopharma manufactures, freight forwards and shipper vendors.

The need for a common approach to Transport Qualification and Validation will be discussed through the following discussion points:
  • Fix multiple approaches on how to perform transport qualification and validation to one minimum required approach across manufacturers
  • Align inconsistent industry interpretations of the regulatory requirements to ‘one voice and one approach’ to understand, implement and meet future requirements
  • Meet pharma requirements to aligning specific comprehensive OQ chamber studies, ambient temperature simulation, specific industry demands such as payload, durations, #runs, seasons, materials to test, probe mapping and locations, etc.
  • Increase amount of various shipping solutions to secure ONE standard
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Jennifer Antonetti

Sr. Supervisor Global Distribution Packaging & Shipping Qualification
Biogen

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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Michael English

Associate Director
Merck & Co., Inc.

TRACEABILITY & TRACKING

11:30 am - 12:15 pm Getting Patients involved in the Cold Chain
Scott Cornwell - Chief Supply Chain Officer Dispensary of Hope
Alan Kennedy - Founder & Executive Director PHARMA TEAM-UP
One State now requires that a pharmacy shall insure 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?


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Scott Cornwell

Chief Supply Chain Officer
Dispensary of Hope

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Alan Kennedy

Founder & Executive Director
PHARMA TEAM-UP

12:15 pm - 12:20 pm Track Session Transition

Many companies like AbbVie depend on their supply chain managers to qualify the lane and mange internal collaboration between IT, Finance, Logistics, Quality and Packaging to ensure synergy and overall goals are clear. What are the best ways to manager internal collaboration and align staff to change their mentalities and align them to the companies overall strategy.

  • Launch life science product enhancements and adapting to engineering changes
  • Provide engineering change management for improving handoff from new product development to commercial product support in order to develop change management functions
  • Engage in enterprise-wide response to change through effective management of product, responses to changing market conditions and increased rates of product innovation

Panelists:
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Tonino Antonetti

Executive Director, Regulatory Affairs, Quality Management, Safety & Health
Roche Diagnostics

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Thomas Scalone

Director, North American Logistics Operations
Celgene

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Bruce Guenter

Director Logistics and Distribution
Radius Health


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Jennifer Antonetti

Sr. Supervisor Global Distribution Packaging & Shipping Qualification
Biogen

TRACEABILITY & TRACKING

12:20 pm - 1:05 pm Regulatory Briefing: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?
Scott Cornwell - Chief Supply Chain Officer Dispensary of Hope
Brian Files - Former Director of Regulatory Compliance & Policy CVS Health
Now that we are up to speed on the “why”, it is time to focus on the “what & when” surrounding serialization. Regulations & guidelines are in practice across the globe, all with different requirements and deadlines, some without much guidance at all. The regulatory landscape is constantly evolving with new regions deciding to jump on the bandwagon and others reworking their current plans. With the US & EU leading the way, it is important to fully grasp the international scope of serialization requirements & reporting to ensure that you are fully compliant in all markets that you conduct business.

What you will learn:
  • Overview of the DSCSA & EU FMD deadlines and expectations
  • Review the regulatory changes coming out of Brazil, Russia & India
  • How will emerging markets in the Middle East & Africa decide to map out their guidance’s on tracking and traceability
  • Streamline your reporting to the various regions by understanding what is required
  • How to ensure data integrity & security when operating in multiple regions
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Scott Cornwell

Chief Supply Chain Officer
Dispensary of Hope

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Brian Files

Former Director of Regulatory Compliance & Policy
CVS Health

1:05 pm - 2:00 pm Networking Lunch

1:05 pm - 2:00 pm Women in Supply Chain Meet & Greet Lunch

Taking place at the HUB Stage in the Expo Hall

2:00 pm - 2:40 pm Collaboration Between Supply Chain and Quality Assurance to Ensure Optimal and High Quality Supply Operation to Final Customers

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

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

2:40 pm - 3:40 pm INSPIRATIONAL KEYNOTE: The Future of Robotics & How it Will Affect the Supply Chain: Are we Ready for the Autonomous Supply Chain?

Tom Bonkenburg - Director, European Operations St. Onge Company
Will robotics be the next disruptive technology in the area of supply chain and distribution? Mr. Bonkenburg will discuss the latest available robotic technology, talk about the companies that are using this technology, and what the supply chain professional needs to know now about the possible future impact of this rapidly developing industry. This dynamic presentation will use videos to highlight new technology from startup companies as well as traditional material handling vendors from around the world. Are these technologies able to help your company and will you be ready for them when they arrive?

  • What to expect in Manufacturing, Transportation, Warehousing
  • How Supply Chain Leaders need to Prepare for this Technology
  • Discussing the Autonomous Supply Chain and Models Necessary for 2030
  • Assessing the Improvement of Agility and Enabling New Capabilities of the Supply Chain
  • Future Trends and Speculations of the Role of Robotics on the Supply Chain now and in 2030
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Tom Bonkenburg

Director, European Operations
St. Onge Company

3:40 pm - 3:40 pm Refreshments & End of Main Conference Day Two