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September 24-27, 2018
Pennsylvania Convention Center

Main Conference Day 1

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

8:05 am - 8:15 am Opening IQPC & Chairman Remarks

8:25 am - 9:10 am Keynote: End-to-End Visibility Keynote: How to Increase Communication/Visibility Across various Functions to Lower Drug Costs for the Ultimate Benefit of the Consumer

David Merritt - Executive Vice President of Public Affairs and Strategy America’s Health Insurance Plans & Adviser to three Presidential Campaigns, Political Policy and Communication Strategist

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David Merritt

Executive Vice President of Public Affairs and Strategy
America’s Health Insurance Plans & Adviser to three Presidential Campaigns, Political Policy and Communication Strategist

9:15 am - 10:00 am Keynote: Blockchain Expert: The Cold Chain in the 2020’s – The Blockchain Enabled Digital Transformation of Life Sciences Supply Chains

Jack Shaw - Executive Director & Technology Futurist American Blockchain Council
·         Discussing Blockchain, IOT, AI, and other technologies will radically transform the Pharmaceutical Cold Chain over the next 5-10 years
·         Developing Blockchain Transformation Strategy
·         Outlining Blockchain Procurement and Supply Chain Management
·         Addressing the Blockchain Transformation of Healthcare 
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Jack Shaw

Executive Director & Technology Futurist
American Blockchain Council

10-11AM Morning Networking Break

10:00 am - 11:00 am Morning Networking Break
*Enjoy morning refreshments whilst you choose to participate and experience one or more of our amazing networking and educational enhancement opportunities:
 
 
-Global Forum Passport:  Grab a passport card and travel the expo hall floor, a great way to visit the many industry exhibitors and earn a chance to win valuable prizes. 
 
                                                                                                                 
 - Speakers Labs: Lets you reserve time to meet individually with the participating speaker of your choice in a quiet setting and talk with them directly — a great opportunity to ask questions, dig deeper into case studies and address concerns. Participants will be senior speaker faculty      
 
                                                                                                                                                                                                                                                                                                                                            - Keynote Book Signings: Featured keynote book signing in the HUB                                                       
 
 
–Morning Keynote Interviews: Meet our keynotes for a chance to ask the right questions that apply to your supply chain.     
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
                                                 
                                                                                                                                                                                                      - GF Chill & Wellness Lounge: Are you running out of air? Take a moment to kick back and breathe in the GF Chill & Wellness Lounge. Charge your devices, relax your mind, nap in a hammock, or order a healthy elixir from our juice bar.        
                                                                                   
 
                                                                                                                                                                                                                                                     - Personal Career Development Zone: Progress your personal career!  Browse our job boards, speak with career development counselors, and learn the best ways to take that next step in your career.                

10-11AM Opening of Expo Hall

10:00 am - 11:00 am Hub Stage Session 1- Start- Up Demo
Sid Chakravarthy - CEO & Founder Statwig
Ravi Kumar - Chief Operating Officer & Co- Founder Statwig
10:15 AM Expo Hall- Hub Stage Session 1
 
Disruption in the Pharma Supply Chain-Demo
* Hear from Statwig, a company that has been in operation 16 months or under focusing on disrupting the Supply Chain industry with various focus areas including:
·         Tracking Counterfeit Drugs
·         Utilizing Blockchain Technology to Track and Source all Pharma Supply Chain Components
·         Digitizing the Supply Chain to Streamline and Simplify
·         Creating Supply Networks of the Future
·         Leveraging new Technologies like IOT, AI, Cloud, and Blockchain across New Products Driving the Digital Reinvention
 
Company 1: Statwig
Sid Chakravarthy, Founder, Statwig
Ravi Kumar, Chief Operating Officer & Co-Founder, Statwig
 
Company 2: Chrissa McFarlane, CEO, Patientory
 
Company 3: + 1 speaker
 
 
Judges:
1. Carolyn Williamson, Principal Packaging Engineer, Bristol-Myers Squibb
2. Geoffrey Glauser, Senior Consultant Supply Chain, HHS/ASPR/BARDA
3. Thomas Scalone, Director, North American Logistics Operations, Celgene 
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Sid Chakravarthy

CEO & Founder
Statwig

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Ravi Kumar

Chief Operating Officer & Co- Founder
Statwig

Interactive Discussion Sessions

IDG 1: How can we Achieve Sustainability & Environmental Packaging Designs in Temperature Controlled Packaging?

11:20 am - 12:20 pm IDG 1: How can we Achieve Sustainability & Environmental Packaging Designs in Temperature Controlled Packaging?

IDG 2: How can we Successfully Transport Liquid Nitrogen Products Internationally & to Emerging Markets?

12:20 pm - 1:20 pm IDG 2: How can we Successfully Transport Liquid Nitrogen Products Internationally & to Emerging Markets?

IDG 3: How can we Implement Lean Six Sigma Methods & Strategies to Create an Agile and Flexible Supply Chain? How can we deal with Continuous Improvement?

12:20 pm - 1:20 pm IDG 3: How can we Implement Lean Six Sigma Methods & Strategies to Create an Agile and Flexible Supply Chain? How can we deal with Continuous Improvement?
Krista Hamilton - Head Advisor Aralez Pharmaceuticals
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Krista Hamilton

Head Advisor
Aralez Pharmaceuticals

IDG 4: Do we Allow Products to be Grandfathered? Can we fix this through process monitoring? How?

12:20 pm - 1:20 pm IDG 4: Do we Allow Products to be Grandfathered? Can we fix this through process monitoring? How?

IDG 5: CRT Product Solutions- How can we use Phase-Change Materials (PCM’s) or Water-based Refrigerants to Successfully Ship Compliance ready Materials?

12:20 pm - 1:20 pm IDG 5: CRT Product Solutions- How can we use Phase-Change Materials (PCM’s) or Water-based Refrigerants to Successfully Ship Compliance ready Materials?

IDG 6: Packaging Validation- How can we Develop a Packaging Ongoing Process Verification Program to Protect our Products from Environmental Effects, Contamination, and Physical Damage?

12:20 pm - 1:20 pm IDG 6: Packaging Validation- How can we Develop a Packaging Ongoing Process Verification Program to Protect our Products from Environmental Effects, Contamination, and Physical Damage?
Rod Patch - Senior Director, TCS, Center of Excellence Johnson & Johnson
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Rod Patch

Senior Director, TCS, Center of Excellence
Johnson & Johnson

IDG 7: How can we Prepare for the Future of the Automated Supply Chain by Analyzing Technology from other Industries?

12:20 pm - 1:20 pm IDG 7: How can we Prepare for the Future of the Automated Supply Chain by Analyzing Technology from other Industries?

IDG 8: How can we utilize IOT Technology to Maintain Safety and Efficacy of Drug Products while Maintaining Storage Conditions and Extended Visibility?

12:20 pm - 1:20 pm IDG 8: How can we utilize IOT Technology to Maintain Safety and Efficacy of Drug Products while Maintaining Storage Conditions and Extended Visibility?

Interactive Discussion Sessions

IDG 9: Stability Budget- How can we Calculate Total Time Out of Refrigeration (TOR) Across Supply Chain Legs to Save the Life of Our Products and Prevent Dollar Loss to the Company?

12:20 pm - 1:20 pm IDG 9: Stability Budget- How can we Calculate Total Time Out of Refrigeration (TOR) Across Supply Chain Legs to Save the Life of Our Products and Prevent Dollar Loss to the Company?

IDG 10: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?

12:20 pm - 1:20 pm IDG 10: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?

IDG 11: Risk & Third Party Management: How can we Adopt a Standard Process for Supplier Risk Management through Process Standardization & an Advanced Operating Model?

12:20 pm - 1:20 pm IDG 11: Risk & Third Party Management: How can we Adopt a Standard Process for Supplier Risk Management through Process Standardization & an Advanced Operating Model?
Geoffrey Glauser - Senior Consultant Supply Chain HHS/ASPR/BARDA
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Geoffrey Glauser

Senior Consultant Supply Chain
HHS/ASPR/BARDA

IDG 12: Blockchain Innovation- How can we use Blockchain Technology to Keep Detailed Records or Products & Lock in Data Transactions?

12:20 pm - 1:20 pm IDG 12: Blockchain Innovation- How can we use Blockchain Technology to Keep Detailed Records or Products & Lock in Data Transactions?
Kevin Otto - Senior Director, Food Service GS1
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Kevin Otto

Senior Director, Food Service
GS1

IDG 13: Ocean vs. Air Freight- How can we Lower Costs & Improve Security with Ocean Freight?

12:20 pm - 1:20 pm IDG 13: Ocean vs. Air Freight- How can we Lower Costs & Improve Security with Ocean Freight?
James Lucie - Associate Director, Supply Chain AMAG Pharmaceuticals
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James Lucie

Associate Director, Supply Chain
AMAG Pharmaceuticals

IDG 14: How can we Manage Customer & Clearance Issues to Prevent Long Delivery Delays and Shortages?

12:20 pm - 1:20 pm IDG 14: How can we Manage Customer & Clearance Issues to Prevent Long Delivery Delays and Shortages?
Dana L. Dallas - Cold Chain Program Manager Defense Logistics Agency Troop Support Medical
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Dana L. Dallas

Cold Chain Program Manager
Defense Logistics Agency Troop Support Medical

IDG 15: How can we Successfully Transition from Clinical to Commercial Operations while Remaining Compliant of GMP’s and Regulatory Agencies?

12:20 pm - 1:20 pm IDG 15: How can we Successfully Transition from Clinical to Commercial Operations while Remaining Compliant of GMP’s and Regulatory Agencies?
Tonino Antonetti - Executive Director, Regulatory Affairs, Quality Management, Safety & Health Roche Diagnostics
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Tonino Antonetti

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

IDG 16: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?

12:20 pm - 1:20 pm IDG 16: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?
Thomas Scalone - Associate Director Logistics Supply Chain Celgene
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Thomas Scalone

Associate Director Logistics Supply Chain
Celgene

12:20 pm - 1:00 pm Lunch

Department Networking Luncheon
*Luncheon tables will be assigned to specific functions. Each table will be equipped with department specific industry questions in addition to “ice breaker” questions to help foster more connections onsite. A perfect time to create onsite contacts as we move into department specific tasks. 

1:10 pm - 1:20 pm Transition to Track Session

Dispensary of Hope Special Session- Insulin 
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Scott Cornwell

Chief Supply Chain Officer
Dispensary of Hope

Suzette Diaz

Director, Insulin Access & Affordability
Lilly Diabetes

Steve Stapleton

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

Logistics

1:20 pm - 2:00 pm Optimizing and Mapping the Correct Transportation Routes to Create Optimal Distribution Opportunities
Talitha Hampton - Lead, Supply Chain Packaging and Product Security AstraZeneca
Optimizing and Mapping the Correct Transportation Routes to Create Optimal Distribution Opportunities
Qualifying on an operational and performance level that all equipment and installations perform under the desired operating conditions is a key objective of Shire Pharma for 2018. How can we optimize routes while understating fluctuations in standards across multiple suppliers?
·         Managing & preparing for fluctuations in standards (2C-8C)
·         Ensure USR (User Specification Requirements) performs in accordance and that all design qualifications are in compliance
·         Map routes in alignment with regulations and internal deadlines
·         Manage cross over routes from merges and acquisitions
Strategies for carrying out route profiling before the products are distributed 
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Talitha Hampton

Lead, Supply Chain Packaging and Product Security
AstraZeneca

QA/QC & Regulatory Compliance

1:20 pm - 2:00 pm Panel: Understanding Global Inspection & Audit Observations for the Implementation of GDP in order to fix Vulnerabilities
Rafik Bishara , Ph.D. - Technical Advisor & Former Director QKMTS Eli Lilly & Company
Panel: Understanding Global Inspection & Audit Observations for the Implementation of GDP in order to fix Vulnerabilities
Supply chain professionals may struggle to prepare for regulatory inspections and audits. Ensuring that all products are qualified and validated can be time consuming and a logistical nightmare.
·         How can we prepare for quality assurance?
·         What do we need to pay attention to with inspection and audits?
·         What have we learned?
How can we fix vulnerabilities before audits and avoid repeat inspections due to citations?
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Rafik Bishara , Ph.D.

Technical Advisor & Former Director QKMTS
Eli Lilly & Company

Packaging/ Shipping

1:20 pm - 2:00 pm Improving Sustainability & Environmental Packaging to Reduce Waste and Ensure Temperature Compliant Packaging Designs
Karen Giraudo - Global Product & Cost Account Lead Pacira Pharmaceuticals
Improving Sustainability & Environmental Packaging to Reduce Waste and Ensure Temperature Compliant Packaging Designs
Creating sustainable products across the supply chain within standards proves extremely challenging. With Thermo Fisher sending out over 100,000 foam coolers every year, they have set a goal to reduce waste by 20% by 2020. How can we improve our sustainability and environmental initiatives while remaining cost competitive and ensuring temperature compliant packaging designs?
·         Reduce waste from packaging and insulation materials
·         Create sustainable packaging designs while ensuring cost savings
·         Sustain delivery time and temperature controlled requirements with environmentally friendly shipping
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Karen Giraudo

Global Product & Cost Account Lead
Pacira Pharmaceuticals

2:00 pm - 2:05 pm Track Session Transition

Monitoring Supplier Performance & Negotiating Price Terms to Prevent Reputation Damage, Cross Contamination of Products, and Product Exposure to Toxic Temperatures
With some of the biggest issues of 2018 logistics being cross contamination of shared dewers, collaboration between suppliers and manufacturers, and cost control between 3PL’s, monitoring supplier performance is crucial to distribution reputation. Educating your third party suppliers on the goals, data, and requirements that need to be met is essential.
·         Identify GPO’s and leverage combined buying power
·         Negotiate purchasing agreements in line with regulatory compliance and user requirements
Align products with ever changing requirements for liquid nitrogen and cryogenic shipments 

Professor Vilana

Researcher, LABiomedical
UCLA Medical Center

Joan Oliva

Manager of Pre-Clinical Research
Emmaus Medical

QA/QC & Regulatory Compliance

2:05 pm - 2:45 pm Application of Life-Cycle Concepts from the ICH and FDA to Supply Cold Chain with a Focus on Continued Verification
Ajay Pazhayattil - Former Associate Director, TOPV Apotex Inc.
Application of Life-Cycle Concepts from the ICH and FDA to Supply Cold Chain with a Focus on Continued Verification
With the FDA’s adoption of policies favoring continuous improvement and use of new technologies, biopharma cold chain sector will also experience fast paces changes for the better. Ajay is working on implementing new innovations within validation requirements and their 45 Million USD budget to improve profitability.
·         Discuss ICHQ12 guidance in order to utilize flexibility across the supply chain
·         Improve the quality of design method by adding trials and studies
Assess distribution, R&D investments, and various studies on distribution and temperature
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Ajay Pazhayattil

Former Associate Director, TOPV
Apotex Inc.

Packaging/ Shipping

2:05 pm - 2:45 pm Exploring Active vs Passive Shipping Methods to Gain Competitive Advantage while Maintaining Shipping and Design Distribution Budget
Sameer Upadhyaya - Head of Technology, Global Packaging Development, Genentech
Shubhra Kochar - Engineer II, Global Packaging Genentech
Exploring Active vs Passive Shipping Methods to Gain Competitive Advantage while Maintaining Shipping and Design Distribution Budget
There are many different shipping solutions for active and passive shipping methods; the 1st priority of most supply chain companies is to design effective packaging at a low cost, within temperature requirements from the user and regulatory agencies. With each shipment at Genetech having an estimated worth of 50 million USD, it is essential for them to choose the correct shipping method in order to deliver the product safely.
·      Apply patient-centric approaches where the patient remains part of the supply chain at multiple pints
·      Discuss regulatory restrictions for both active and passive sipping methods
Promote product protection while upholding safe and effective shipped products 
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Sameer Upadhyaya

Head of Technology, Global Packaging Development,
Genentech

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Shubhra Kochar

Engineer II, Global Packaging
Genentech

Afternoon Networking Break

2:45 pm - 3:30 pm Afternoon Networking Session

Hub Stage

2:50 pm - 3:25 pm Hub Stage Session 3: Speaker Spotlight: Past 2017 Award Winner Presentation
Ben VanderPlas - Global Product Manager Sonoco ThermoSafe
Stephen Kolb - Business Development Manager Cold Chain Technologies
*Each 2017 winner will give a 10 minute ted talk style presentation about their team’s achievements, challenges, and strategies that got them to win a 2017 GF Award.
 
·         How did you achieve this level of success across your organization?
·         Have you continued to build upon your project over the last 8 months?
·         What were notable results from your winning initiative?
·         What are you focusing your team on currently?
·         How are you leveraging collaboration and technical innovation across your organization?
 
Award Winners:

Collaboration Award: Sonoco ThermoSafe
Ben VanderPlas, Global Product Manager, Sonoco Thermosafe
 
Customization Award: ColdChain Technologies Inc.
Stephen Kolb, Business Development Manager, Cold Chain Technologies

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Ben VanderPlas

Global Product Manager
Sonoco ThermoSafe

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Stephen Kolb

Business Development Manager
Cold Chain Technologies

Collaboration

3:30 pm - 4:10 pm Defining Strategies on How to Effectively Manage Suppliers- Bayer’s Unique Relationship Model that will Help you Improve Data Exchange, Network Platforms, and Integration
Luiz Barberini - Head of External Manufacturing Operations - Latin America Bayer
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 exchange and 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 
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Luiz Barberini

Head of External Manufacturing Operations - Latin America
Bayer

Data Management & Monitoring

3:30 pm - 4:10 pm What are the New Methods and Strategies for Better Collecting, Monitoring, and Assessment of Data to Create a Customer Centric Supply Chain?
Victor Lobo - Diretor Técnico BRL Vacinas
What are the New Methods and Strategies for Better Collecting, Monitoring, and Assessment of Data to Create a Customer Centric Supply Chain?
It is the age of the customer centric supply chain and putting the patient first. Collecting and analyzing data on the customer has never been more essential to better understand the needs of the patient. AbbVie has 5-10 government agencies monitoring and evaluating their products on each shipment. How can we create improved visibility and competitive advantage with new products while remaining compliant?
·         Reduce drug development costs with big data
·         Benchmark data standards and data exchange across suppliers and manufacturers
·         Reimagine logistics capabilities to improve visibility and competitive advantage
·         Predict the industries ripe for disruption, and identify potential new products 
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Victor Lobo

Diretor Técnico
BRL Vacinas

Panel: The Brave New Supply Chain World: Looking at 3D Printing, Drones, Autonomous Trucks and Emerging Technologies
2018 innovation trends are focusing on blockchain technology, new GPS tracking and traceability devices, real-time data collection, and thermal battery storage, but what do we need to be prepared for in 2019 and beyond? Let’s take a look at some of the biggest innovators contributing to the evolution of the supply chain.
·         Examine the autonomous truck and how its technology can be directly applied to the pharma supply chain  
·         Focus your innovation on the evolution of the customer centric supply chain
·         Examining cyber risks in global supply chains
·         How are Drones, 3D printing and other emerging technologies going to directly impact the supply chain processes we currently use
·         What regulations do we need to be aware of with these new innovations?
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Geoffrey Glauser

Senior Consultant Supply Chain
HHS/ASPR/BARDA

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Dan Mirica

Former Head of Logistics
Lonza Biologics

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James Lucie

Associate Director, Supply Chain
AMAG Pharmaceuticals

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Ayman Omar

Associate Professor, International Business & Research Fellow, Kogod Cybersecurity Governance Center
Kogod School of Business, American University

4:10 pm - 4:15 pm Track Session Transition

Collaboration

4:15 pm - 5:00 pm The Case for Fully Standardized Packaging Vendor Qualification Requirements to Enhance the Supplier Qualification Process
Craig Vermeyen - Senior Manager, Packaging Engineer Kite Pharma
The Case for Fully Standardized Packaging Vendor Qualification Requirements to Enhance the Supplier Qualification Process
Kite Pharma is working on enhancing the supplier qualification process by using risk-based tools for monitoring. Through audits of CMO sites, specialty couriers, and 3PL’s, they are developing QTA’s with legal advisers to establish a process to assure quality expectations are met.
·         Utilize Oracle Agile and EBS to testing material specifications
·         Explore the difficulties of selecting cold chain packaging using current methods
·         Explain the benefits of fully standardized test methods and parameters using tangible examples
·         Make the case for packaging vendors to fully align on testing to facilitate the packaging selection process
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Craig Vermeyen

Senior Manager, Packaging Engineer
Kite Pharma

Data Management & Monitoring

4:15 pm - 5:00 pm Eli Lilly’s Journey to Implement a Next Generation Stability Budget
Aimee Buesgen - Research Scientist, TS/MS Statistics Eli Lilly & Company
Mike Broughton - Director, Global Logistics Eli Lilly & Company
Eli Lilly’s Journey to Implement a Next Generation Stability Budget 
A next generation stability budget can be developed using standard allocations based on performance analytics from manufacturing and distribution operations. Lilly is implementing a stability budget allocation process to make risk-based decisions about various allocation scenarios using modeling, simulation, and visualization methods. This innovative, next generation stability budget provides operational flexibility and cost savings throughout the supply chain. Considerations are given within the budget to differing global regulatory expectations to ensure compliance. 
·      Develop a stability budget using standard allocations based on performance data
·      Implement a stability budget allocation process with governance
·       Evaluate stability budget allocation scenarios using modeling and simulation techniques
·       Provide procedural flexibility and cost savings throughout the supply chain
·       Ensure compliance with differing global regulatory expectations
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Aimee Buesgen

Research Scientist, TS/MS Statistics
Eli Lilly & Company

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Mike Broughton

Director, Global Logistics
Eli Lilly & Company

Innovative & Disruptive Supply Chain

4:15 pm - 5:00 pm Sponsor Session Cryopak

5:00 pm - 5:50 pm Healthcare Reform with Billy Tauzin

The Honorable Billy Tauzin - Former CEO PhRMA, Former Louisiana Congressman
A leading voice on healthcare as a member of Congress and a key player in the 2009 healthcare reform negotiations, Tauzin addresses the current state of healthcare reform and its implications for business. His perspective from both the legislative side and the special interest side (as the former president and CEO of PhRMA), provides unique insights into one of today’s most debated issues. As he recently battled cancer, Tauzin also has a personal connection to the issue and developed a program within the pharmaceutical industry to give low income people access to life-saving medications. In his presentations, he weaves his experiences as a patient and a policymaker together to address one of the most pressing issues today.
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The Honorable Billy Tauzin

Former CEO PhRMA,
Former Louisiana Congressman

6:00 pm - 8:00 pm End of Conference Day 1- Networking Cocktails & Award Ceremony