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September 30 - October 03, 2019
Seaport Boston, MA

Main Conference Day One: Wednesday, September 26th 2018

7:30 am - 8:15 am REGISTRATION OPENS – COFFEE AND NETWORKING IN FOYER

8:15 am - 8:45 am Verizon Opening Remarks

KEYNOTE ADDRESS

8:30 am - 9:15 am KEYNOTE: Health Reform Expert: 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 & Adviser to three Presidential Campaigns, Political Policy and Communication Strategist, America’s Health Insurance Plans
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David Merritt

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

9:15 am - 9:45 am Case Studies on Bulk Reusable Packaging and Real-Time Asset Tracking Technologies

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


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Chris Day

Director of Business Development, Leasing Services
Sonoco ThermoSafe

9:45 am - 10:30 am KEYNOTE: Blockchain Expert: The Cold Chain in the 2020’s – The Blockchain Enabled Digital Transformation of Life Sciences Supply Chains

  • 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

10:30 am - 10:45 am MORNING NETWORKING BREAK, DEMO DRIVE, AND GRAND OPENING OF HUB STAGE

Enjoy morning refreshments whilst you choose to participate and experience one or more of our amazing networking and educational enhancement opportunities

10:45 am - 11:30 am HUB STAGE SESSION 1: Disruption in the Pharma Supply Chain-Start-Up Demo

Sid Chakravarthy - Founder, Statwig
This session will consist of Statwig company presenting and demo-ing their latest technologies in the following areas:

  • 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
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Sid Chakravarthy

Founder
Statwig

11:30 am - 11:35 am Transition to Interactive Discussion Groups

Interactive Discussion Groups

During this part of the event, practitioner attendees will be sorted into groups of up to 20 people to take part in Interactive Discussions around 2018 hot topics. Each IDG includes both the end user and thought leader perspectives. Attendees will get the opportunity to select and pre-register for two topics and will rotate between each 30 minute IDG. Discussion groups are kept small to ensure all delegates get the opportunity to ask their most pressing questions ensuring a perfectly tailored experience.

Rotation One: 11:35-12:05 | Rotation Two: 12:10-12:40

CHOOSE 2 AVAILABLE IDGS!

Topic 1

11:35 am - 12:45 pm How can we Achieve Sustainability & Environmental Packaging Designs in Temperature Controlled Packaging?
11:35 sold out!

Topic 2

11:35 am - 12:45 pm How can we Successfully Transport Liquid Nitrogen Products Internationally & to Emerging Markets?

Topic 3

11:35 am - 12:45 pm How can we Implement Lean Six Sigma Methods & Strategies to Create an Agile and Flexible Supply Chain?

Topic 4

11:35 am - 12:45 pm Regulatory Audits- How can we Ensure that all Regulatory Requirements are met through Good Manufacturing Practice (GMP) and Clinical Practice (GCP)?

Topic 5

11:35 am - 12:45 pm CRT Product Solutions- How can we use Phase-Change Materials (PCM’s) or Water-based Refrigerants to Successfully Ship Compliance ready Materials?
11:35 sold out!

Topic 6

11:35 am - 12:45 pm 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
12:10 sold out!
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Rod Patch

Senior Director, TCS, Center of Excellence
Johnson & Johnson

Topic 9

11:35 am - 12:45 pm 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?

Topic 10

11:35 am - 12:45 pm End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Valueadded Opportunities?

Topic 11

11:35 am - 12:45 pm 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

Topic 12

11:35 am - 12:45 pm Blockchain Innovation- How can we use Blockchain Technology to Keep Detailed Records or Products & Lock in Data Transactions?
Kevin Otto - Senior Director, Foodservice, GS1
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Kevin Otto

Senior Director, Foodservice
GS1

Topic 13

11:35 am - 12:45 pm 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

Topic 14

11:35 am - 12:45 pm How can we Manage Customer & Clearance Issues to Prevent Long Delivery Delays and Shortages?

Topic 15

11:35 am - 12:45 pm 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

Topic 17

11:35 am - 12:45 pm Transportation Vendor Qualifications: What are the Challenges and Risks with Transportation Vendors and How to Mitigate Risk with Standard Vendor Qualification Practices.
Tom Heavrin - Healthcare Compliance (QA) Manager, UPS Temperature True
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Tom Heavrin

Healthcare Compliance (QA) Manager
UPS Temperature True

NOT AVAILABLE

Topic 7

11:35 am - 12:45 pm Blockchain Innovation- How can we use Blockchain Technology to Keep Detailed Records or Products & Lock in Data Transactions?

Topic 8

11:35 am - 12:45 pm How can we utilize IOT Technology to Maintain Safety and Efficacy of Drug Products while Maintaining Storage Conditions and Extended Visibility?

Topic 16

11:35 am - 12:45 pm End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?

12:45 pm - 12:50 pm SENDUM LUNCH WELCOME



12:50 pm - 1:00 pm NETWORKING LUNCHEON

A perfect time to create onsite contacts while enjoying a delicious meal as we move into department specific tasks.
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Suzette Diaz

Director, Insulin Access & Affordability
Lilly Diabetes

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Steve Stapleton

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

1:40 pm - 1:50 pm Transition to Track Sessions

LOGISTICS

1:50 pm - 2:30 pm 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
Tony and Rafik will discuss the Health Canada Guide-00069 regulations and requirements in Canada and provide detailed examples 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 more often
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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Tonino Antonetti

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

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Rafik Bishara , Ph.D.

Technical Advisor & Former Director QKMTS
Eli Lilly & Company

PACKAGING/SHIPPING

1:50 pm - 2:30 pm 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

2:30 pm - 2:35 pm Track Session Transition

LOGISTICS

2:35 pm - 3:15 pm Tissue Engineering, Banking and Transport
Risako Yamada - PCM Business Promotion Team, Kaneka Corporation


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Risako Yamada

PCM Business Promotion Team
Kaneka Corporation

QA/QC & REGULATORY COMPLIANCE

2:35 pm - 3:15 pm Application of Life-Cycle Concepts from the ICH and FDA to Supply Cold Chain with a Focus on Continued Verification
Carolyn Williamson - Principal Packaging Engineer Bristol-Myers Squibb
Ajay Pazhayattil - Former Associate Director, TOPV, Apotex Inc.
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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Carolyn Williamson

Principal Packaging Engineer
Bristol-Myers Squibb

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Ajay Pazhayattil

Former Associate Director, TOPV
Apotex Inc.

PACKAGING/SHIPPING

2:35 pm - 3:15 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
There are many different shipping solutions for active and passive shipping methods; the 1st priority of most pharmaceutical companies is to design effective packaging at a low cost, ensuring compliance with internal quality systems and external regulatory requirements

  • Share an overview of the options and factors in the cold chain selection.
  • Discuss regulatory considerations for both active and passive sipping methods
  • Promote product protection while upholding safe and effective shipping methods
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Sameer Upadhyaya

Head of Technology, Global Packaging Development,
Genentech

3:15 pm - 3:20 pm Track Session Transition

COLLABORATION

3:20 pm - 4:00 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
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

DATA MANAGEMENT & MONITORING

3:20 pm - 4:00 pm PANEL: 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
2018 innovation trends are focusing on blockchain technology, new GPS tracking and traceability devices, realtime 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
  • 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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Meg Duskin

Product Manager, Advanced Therapeutics,
Thermo Fisher

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Dan Mirica

Former Head of Logistics
Lonza Biologics

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Geoffrey Glauser

Senior Consultant Supply Chain
HHS/ASPR/BARDA

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James Lucie

Associate Director Supply Chain
AMAG Pharmaceuticals

4:00 pm - 4:05 pm Track Session Transition

COLLABORATION

4:05 pm - 4:45 pm The Case for Fully Standardized Packaging Vendor Qualification Requirements
Craig Vermeyen - Senior Manager, Packaging Engineer, Kite Pharma
Vendor qualification claims are becoming increasingly difficult to accept at face value, and an industry-wide standard Baseline Insulated Shipper Test (BIST) used by all vendors would allow for easier comparison by consumers.

  • 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

4:05 pm - 4:45 pm Eli Lilly’s Journey with Implementing Technical Data and an Effective Stability Budget to Test Product Capability and Prepare for Unplanned Excursions
Aimee Buesgen - Research Scientist, TS/MS Statistics, Eli Lilly & Company
Implementing technical data and authenticating the life history of a product can improve supply chain security and streamline processes. Lily is using an effective stability budget for unplanned excursions and testing the capability of a product that is shipped around the world across a multitude of suppliers, regulations and patients.

  • Model statics around the analytical methods
  • Piece together the time and temperature allowed outside the label claim
  • Leverage capability to ship products around the world
  • Discovering the limits of time and beating the expectation
  • Discuss the global perspectives on stability budgets and impacts on supply chain products
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Aimee Buesgen

Research Scientist, TS/MS Statistics
Eli Lilly & Company




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Meg Duskin

Product Manager, Advanced Therapeutics,
Thermo Fisher

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Christopher Oles

Canadian Pharma Sales Director
Cryopak

4:45 pm - 5:15 pm AFTERNOON NETWORKING BREAK

Enjoy afternoon refreshments whilst you choose to participate and experience one or more of our amazing networking and educational enhancement opportunities.

5:15 pm - 5:30 pm HUB STAGE SESSION 3: Speaker Spotlight: Past 2017 Award Winner Presentation

Stephen Kolb - Business Development Manager, Cold Chain Technologies
Stefan Braun - Managing Director, SmartCAE
  • 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:




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Stephen Kolb

Business Development Manager
Cold Chain Technologies

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Stefan Braun

Managing Director
SmartCAE

5:30 pm - 6:30 pm KEYNOTE: Healthcare Reform with Billy Tauzin

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 lifesaving medications. In his presentations, he weaves his experiences as a patient and a policy maker together to address one of the most pressing issues today.

6:30 pm - 6:30 pm END OF MAIN CONFERENCE DAY ONE

6:30 pm - 6:30 pm Expo Hall Welcome Reception & Billy Tauzin Meet & Greet!