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September 24-27, 2018
Pennsylvania Convention Center

Main Conference Day 2

7:30 am - 8:00 am Registration Opens – Coffee and Networking in Foyer

8:00 am - 8:30 am Breakfast Briefings

8:30 am - 9:00 am Chair Day 1 Recap & Briefing of Conference Day 2

9:00 am - 9:35 am Keynote: Collaboration & Compliance 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 – this Monday, the grace period is over.
 
•Investing in new tacking systems 
•Creating client animosity and delivery limitation
•Moderating the new trucking landscape with third part verification 
•Installing Electronic Logging Devices

Bill Mahorney

Chief, Enforcement Division
FMCSA, Department of Transportation

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Rey Chern

Director, Thermal Engineering Systems
Amgen

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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Jason Sawicki

Principal, US Commercial Distribution
Genentech

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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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Arminda Montero

Global Supply Chain QA Manager
Abbvie

Networking Break

10:30 am - 11:30 am Networking Break
Hub Stage Session 4
 
Women in Supply Chain Fireside Chats
 
1.       What are your current projects in the Supply Chain Space?
 
2.       How are you leading your team to leverage innovation in line with regulations?
 
3.        What are some of the biggest challenges you have faced in your current role within the supply chain?
 
Speaker 1: Karen, Giraudo, Global Product & Cost Account Lead, Pacira Pharmaceuticals
 
Speaker 2: Roxanne Tata, Vice President and Chief Quality Officer, Institute for Transfusion Medicine
 
Speaker 3: 
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Roxanne Tata

Vice President and Chief Quality Officer
Institute for Transfusion Medicine

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Karen Giraudo

Global Product & Cost Account Lead
Pacira Pharmaceuticals

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Meg Duskin

Product Manager, Advanced Therapeutics,
Thermo Fisher

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Angela Fernandez

Vice President, Food Service
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
Roxanne Tata - Vice President and Chief Quality Officer Institute for Transfusion Medicine
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
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Roxanne Tata

Vice President and Chief Quality Officer
Institute for Transfusion Medicine

Panel: Compliance Towards GDP Transport Qualification- The Case of BPOG
Carolyn at BMS and Cold Chain Technologies have been working on publishing their research on reuse standardization. They will release their published research at the conference.
·         Top results and update on Bristol-Myers Squibb’s new published work on standardization of reuse in the pharma supply chain
·         Discuss themes and implications on improving reuse across the supply chain and within your organization
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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Michael English

Associate Director, Engineering – Packaging Technical Operations
Merck & Co., Inc.

Traceability & Tracking

11:30 am - 12:15 pm Sponsor Session: Berlinger
Maintaining Temperature Control Distribution with New Reduced Delivery Targets
Many pharma companies like Nant Pharma have a goal to get the shipment to the patient within a 5 day period form the request time. With the constant pressure of delivery time deadlines, supply chain professionals also must ensure the temperature is controlled through the entire product shipping lifecycle.
·      Qualify warehouse, cooler, and trailer for testing to see if they are areas prone to temperature exposure
·      Using IT solutions to drive clinical delivery
·      Implement new technologies and temp monitoring for real-time data updates 

12:15 pm - 1:15 pm Networking Lunch, Advisory Board Lunch & Women in Supply Chain Meet & Greet

Panel: Planning and Executing Change Management Practices- Avoiding the “Lost in Translation” Effect
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
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Tonino Antonetti

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

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Thomas Scalone

Associate Director Logistics Supply Chain
Celgene

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Seth Dunn

VP of - Lead Buyer Clinical Investigator Products & Logistics
Sanofi US

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Bruce Guenter

Director Logistics and Distribution
Radius Health

Supply Chain Strategy

1:15 pm - 2:00 pm Sponsor Session: Sendum
The price of failure in the pharma temperature-controlled chain has never been greater. Failure to implement successful risk assessments can lead to increased regulatory scrutiny and steep financial penalties up to 30,000- 90,000 USD per shipment. Should we implement a quantitative risk assessment based on risk index method and a qualitative risk ranking method?
·         Invest in inventing a smarter life sciences supply chain
·         Incorporate expert end to end control to reduce costs, improve compliance, and serve the patient more effectively
Quantify each process in a risk category with determined parameters 

Traceability & Tracking

1:15 pm - 2:00 pm Regulatory Briefing: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?
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

Brian Files

Former Director of Regulatory Compliance& Policy
CVS Health

3:00 pm - 3:40 pm Collaboration Between Supply Chain and Quality Assurance to Ensure Optimal and High Quality Supply Operation to Final Customers : How Q.A and Supply chain in Merck Cooperate in an Effective Manner to Ensure Seamless Integration of Their Efforts in Order to Achieve the Optimal and Robust Quality Supply Chain Solution to the Customers

Ahmed ElSheemy - Head of Quality Assurance Middle East & Turkey Merck Consumer Health UAE
Collaboration Between Supply Chain and Quality Assurance to Ensure Optimal and High Quality Supply Operation to Final Customers : How Q.A and Supply chain in Merck  Cooperate in an Effective Manner to Ensure Seamless Integration of Their Efforts in Order to Achieve the Optimal and Robust Quality Supply Chain Solution to the Customers
·         Ensuring visibility of the incoming shipments and orders to both functions to allow better monitoring and close follow up of critical shipments under specific shipping conditions 
·         Using technology & IoT to achieve the highest degree of visibility on the different quality conditions the shipment could be subjected to 
·         Reviewing and optimizing the existing technical agreements  with all stakeholders involved in the supply process 
·         Field visits and process tracking by qualified personnel to ensure real life follow up when possible 
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Ahmed ElSheemy

Head of Quality Assurance Middle East & Turkey
Merck Consumer Health UAE

2:00 pm - 3:00 pm Closing 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 - 4:10 pm End of Main Conference Day 2