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October 15 - 18, 2019
Sheraton Boston, MA

Main Conference Day Two: Friday, October 18, 2019

8:00 am - 8:35 am Registration Opens

8:35 am - 8:45 am Opening Address by Forum Chairman

8:45 am - 9:30 am C-Suite Perspective on Top Business Challenges: Seeing Global Supply Chains Through to the Last Mile

Progressive Care provides services to 5,000 patients and 2,600 physicians 4 South Florida Counties and delivered over 90,000 prescriptions in Q3 2018. The estimated worth of cold chain biopharma products in 2018 was $318 billion; Sales of cold chain and biologics will outpace overall industry growth through 2022. In this inspiring CEO session, hear how Progressive Care has successfully ensured global supply chains through to the last mile.

  • Defining last mile objectives and overcoming challenges
  • Ensuring end-to-end supply chain visibility
  • Minimizing the two greatest risks in pharmaceutical and biotechnology supply chains: risks of product becoming adulterated during transport and non-compliance with federal regulations, guidelines and standards
  • Managing both direct and indirect costs which are typically hard to identify and consolidate because they are tracked and accounted for in different silos of the organization
SHITAL PARIKH MARS, CEO at Progressive Care

SHITAL PARIKH MARS

CEO
Progressive Care

9:30 am - 10:15 am Biologics Keynote: Overcoming the Greatest Supply Chain Challenges in the Transit of Cell and Gene Therapy Products

While cell and gene therapy promises massive breakthroughs in medical science, there are massive challenges to ensure quality control of these products in transit. This session will showcase how to overcome these challenges.

  • Understand the environment through which a product must pass including knowledge of fragility limits and visibility into the transportation environment
  • Use new tools that allow for more precise temperature control and far greater visibility of products in the supply chain with real- or near real-time data streaming of location and condition
  • Employ smart shippers to provide documented evidence of lane, mode and time of travel and hazards incurred throughout the shipment
  • Manage international shipments of temperature-sensitive goods often get held-up while transiting airlines, ground services, freight forwarding companies or customs
CHRIS WALLACE, Senior Director, Global Logistics Operations at Celgene International Sàrl

CHRIS WALLACE

Senior Director, Global Logistics Operations
Celgene International Sàrl

10:15 am - 11:00 am Morning Refreshments and Speed Networking

11:00 am - 11:45 am The Temperature Controlled Supply Chains of the Future: Alternative Transportation Energy Sources as Competitive Advantage

Going green is no longer a gimmick, and there is money to be made. However, what are the challenges for the industry moving forward? What will ultimately be a competitive advantage for pharma companies and supply chain stakeholders in the next 10 years?

The majority of the world is realizing that burning fossil fuels is no longer a “free for all” game, and that we need to start moving towards alternative energy sources sooner than later or face disastrous consequences for our environment. More importantly, regulators around the world have started to clamp down on traditional ‘dirty’ sources of energy.

This provocative session will explore how both pharma companies and the their supply chain partners will need to start exploring alternative transportation, and push 3PLs and other shippers to start addressing the fact that moving around trillions of tons of goods without reducing emissions might soon become unsustainable.
EUGENIO FILIPPI, Head of Manufacturing, Vienna, Austria at Takeda Pharmaceuticals

EUGENIO FILIPPI

Head of Manufacturing, Vienna, Austria
Takeda Pharmaceuticals

This session will provide a critical update on how both pharma companies and the packaging industry have collaborated to drive standardization of re-usable packaging solutions, allowing the use of more robust shippers at a reasonable price and reducing waste and negative environmental impact.

  • Update on packaging and standardizing Operational Qualification (OQ)
  • New developments in the re-use of materials
  • Overview of the technical paper’s content soon to be published by USP including: passive thermal packaging system types, reuse qualification, refurbishment service and inspection details
  • Upcoming group projects including new topics and membership
CAROLYN WILLIAMSON, Former Principal Packaging Engineer at Bristol-Myers Squibb

CAROLYN WILLIAMSON

Former Principal Packaging Engineer
Bristol-Myers Squibb

REY CHERN, Engineering Director, Drug Product Technology at Amgen

REY CHERN

Engineering Director, Drug Product Technology
Amgen

BEN VANDERPLAS, Global Product Manager at Sonoco Thermosafe

BEN VANDERPLAS

Global Product Manager
Sonoco Thermosafe

BILL MAYER, Director of Research & Development at Pelican BioThermal

BILL MAYER

Director of Research & Development
Pelican BioThermal

BRYAN CARDIS, Consultant Packaging Engineer at Eli Lilly & Company

BRYAN CARDIS

Consultant Packaging Engineer
Eli Lilly & Company

ARMINDA MONTERO, Program Manager, Global Supply Chain QA at AbbVie

ARMINDA MONTERO

Program Manager, Global Supply Chain QA
AbbVie

ANTHONY (TJ) RIZZO, Senior Vice President at Cold Chain Technologies

ANTHONY (TJ) RIZZO

Senior Vice President
Cold Chain Technologies

12:30 pm - 1:30 pm Lunch and Visit to the Technology Hall

Early Maturity Track: Cold Chain 101 (0-3 Years)

1:30 pm - 2:00 pm Managing the Relationship with Logistics Partners to Optimize Collective Value of your Partnership
In this session discover how to create a stronger collaboration with logistics partners.

  • Develop a statement of work, set expectations, manage to metrics and conduct business reviews
  • Create a partnership that includes tactical and strategic discussions
  • Build and review business continuity plans
  • Work together on your journey to the future through process excellence and technology integration
BRUCE GUENTER, Director Warehouse and Trade Distribution at Radius Health, Inc.

BRUCE GUENTER

Director Warehouse and Trade Distribution
Radius Health, Inc.

Early Maturity Track: Cold Chain 101 (0-3 Years)

2:00 pm - 2:30 pm Real Life Stories: Discover the Unknown Challenges of Temperature Controlled Products
This session will cover what you need to know from manufacturing to final delivery in temperature control.

  • Overview of cold chain applications in other industries and what we can learn
  • Assess where you are buying your Active Pharmaceutical Ingredients (APIs) and non-actives
  • Understand general requirements around the globe
  • Best strategies for adapting old chain to the pharmaceutical industry
TONINO ANTONETTI, Executive Director, Regulatory Affairs and Quality at Roche Diagnostics

TONINO ANTONETTI

Executive Director, Regulatory Affairs and Quality
Roche Diagnostics

Early Maturity Track: Cold Chain 101 (0-3 Years)

2:30 pm - 3:00 pm Meeting Global Regulatory Requirements For Your New Products
When you have a company that sells globally, it is challenging to make sure products meet regulatory requirements in different countries. In this session, discover how to:

  • Look at products already in the market and come up with a strategy to determine if the products are being properly delivered
  • Develop a strategy for distributing new products globally
RICK CALABRESE, Head of Corporate Quality Systems and Regulatory Affairs at Sartorius Stedim North America Inc

RICK CALABRESE

Head of Corporate Quality Systems and Regulatory Affairs
Sartorius Stedim North America Inc

Mid-Maturity Track (4-9 Years)

1:30 pm - 2:00 pm Leveraging Data Analytics to Mitigate Risks and Improve Last Mile Logistics
We now are receiving a lot of data from temperature readings. What do you do with big data? How do you make sense out of it? Learn how to analyze data, look at what’s trending and mitigate risk. Boriana works at the biggest pharmacy network within the U.S., and is on the consumer side serving a large population of veterans as well as hospitals. Walk away with new insight for leveraging data analytics to reduce risk and improve last mile logistics.

  • Laying out the risk management approach
  • Developing a strategy for digging into the sources of data
  • Merging the risk management and data analysis tools
BORIANA CAVICCHIA, Program Analyst, Office of Research and Development at Veterans Health Administration, VA

BORIANA CAVICCHIA

Program Analyst, Office of Research and Development
Veterans Health Administration, VA

Mid-Maturity Track (4-9 Years)

2:00 pm - 2:30 pm ASTRAZENECA CASE STUDY: Establishing a Centre of Excellence to Streamline Global Logistics and Processes
AstraZeneca recently set up a global logistics function including process control and a Center of Excellence. Hear about the company’s journey and their future plans for 2025.

  • Merging two types of businesses into one global function
  • Establishing future direction for all of the global logistics functions
  • Addressing issues arising with a changing portfolio
  • Shifting from high volume, low value to high value, low volume products.
MARK EVERITT, CSCP, Qualification Engineer at AstraZeneca Pharmaceuticals

MARK EVERITT

CSCP, Qualification Engineer
AstraZeneca Pharmaceuticals

Mid-Maturity Track (4-9 Years)

2:30 pm - 3:00 pm Moving toward 2023: Regulatory Perspective for Compliance toward Serialization Requirements
In this session discover how to move beyond ‘compliance now” in your serialization strategy and plan for the next stages of regulation. Develop a supply chain implementation strategy to make sure you’re compliant.

  • Understand how the last piece at the packaging level requires planning, applications and resources
  • Detect at the user level if a product is counterfeit or diluted
  • Hear an overview of the regulatory background and highlights of the law
DR. AYSE BAKER, Head of Regulatory Affairs at Chugai Pharmaceutical

DR. AYSE BAKER

Head of Regulatory Affairs
Chugai Pharmaceutical

Advanced Maturity Track (10+ Years)

1:30 pm - 2:00 pm Third-Party Logistics: Debate and Panel Session
Taking more ownership of the product- Moving beyond a transactional, volume-based approach to understanding your customers’ needs

  • Dealing with increased pressure to be far more productive and cost-efficient
  • Moving from a 3PL to 4PL model- Can we really harmonize a fragmented system?
  • Customizing bespoke solutions for specialty logistics and distribution opportunities including: newer types of biologics, oncology products and lucrative drugs approved for rare diseases
  • Dealing with the elephant in the room: Is Amazon going to complement or compete with the current supply chain framework?

Advanced Maturity Track (10+ Years)

2:00 pm - 2:30 pm Blockchain: The Next Frontier in the Fight against Counterfeits?
The 21st-century global pharmaceutical supply chain is complex, fragmented, and involves multiple parties from countries all over the world. This complexity introduces vulnerabilities that allow the infiltration of substandard/spurious/falsified/falsely-labelled/ counterfeit medicines, now an urgent public health and patient safety problem valued in the billions of dollars. Counterfeit medicines have penetrated all aspects of the drug supply chain including: hospitals, distribution networks, global health programs and unregulated settings like night markets and bodegas.

Discover how to use the shared distributed ledger to make drug supply chains more transparent, accountable and trustworthy.

  • Understand why the pharmaceutical supply chain is vulnerable
  • Assess what a pharmaceutical block chain could look like
  • Evaluate policy and future direction
COMBIZ R. ABDOLRAHIMI, ESQ., Emerging Technologies & Innovation Leader, Government & Public Services at Deloitte

COMBIZ R. ABDOLRAHIMI, ESQ.

Emerging Technologies & Innovation Leader, Government & Public Services
Deloitte

Advanced Maturity Track (10+ Years)

2:30 pm - 3:00 pm Bust the Myths on Sea Freight: Fiction and Reality in Sea Freight Temperature Controlled Logistics
This session will explode the myths and share the truth about pharma ocean-freight risks. Hear about some eye-opening facts have emerged from the large-scale Poseidon proof-of-concept field validation exercises.
ALAN KENNEDY, Director, Team Poseidon at Poseidon

ALAN KENNEDY

Director, Team Poseidon
Poseidon

3:00 pm - 3:30 pm Networking Break

This is our final networking break. Here’s your chance to win valuable prizes

Early Maturity Track: Cold Chain 101 (0-3 Years)

3:30 pm - 4:00 pm BAYER CASE STUDY: A Comprehensive Guide to Ensuring Physical and Cyber Security for Your Supply Chain
Find out how to leverage analytics to fight cybercrime and ensure physical security in pharmaceutical supply chains.

  • Investing in solutions with a knowledge of cybersecurity and physical security
  • Combatting the digital challenge posed by 3PLs and the digitization of sales
  • Working with law enforcement and industry leaders
PAUL MAHON, Associate Director, U.S. Corporate Security at Bayer

PAUL MAHON

Associate Director, U.S. Corporate Security
Bayer

Mid-Maturity Track (4-9 Years)

3:30 pm - 4:00 pm Ensuring that Your Supply Chain is Secure from Cyber Threats
We hear about cybersecurity attacks on the news all the time. The FBI sees the impact first hand. Find out what’s happening and reported on a daily basis. These vulnerabilities are being exploited from a cyber perspective and could impact your supply chain operations. When ransomware hits any part of the supply chain, it will encrypt all computers and disrupt the supply flow.

  • Understand key vulnerabilities that are prevalent and exploited heavily
  • Prevent hackers from gathering trade secrets and proprietary information
  • Launch an internal strategy of attack including: employee education, system quarantines, password safety and remote access guidelines
TIMOTHY RUSSELL, Special Agent, Criminal Cyber Squad at FBI Boston

TIMOTHY RUSSELL

Special Agent, Criminal Cyber Squad
FBI Boston

Advanced Maturity Track (10+ Years)

3:30 pm - 4:00 pm Blockchain: How can it Positively Impact the Temperature Controlled Supply Chain and Increase Transparency
Blockchain will provide an excellent framework and foundation to give the end to end visibility with the highest level of trust. Within a closed blockchain, everyone that is part of the blockchain will have total visibility throughout the blocks. If any data happens to change, immediate visibility will be available in the distributed ledger.

  • Improve the visibility and “trust” of all partners within the closed blockchain
  • Enhance safety because of the ability of the blockchain (through cryptology) to maintain total integrity and accuracy of data
  • Address the growing concern on the electrical grid being able to manage all the blockchains that will evolve
DEAN CROKE, Community Ambassador at Blockchain in Transportation Alliance (BiTA)

DEAN CROKE

Community Ambassador
Blockchain in Transportation Alliance (BiTA)

  • Understand the transition of AI (Artificial Intelligence) and IoT (Internet of Things) to make systems more flexible, nimble and robust
  • Advance telemedicine capabilities
  • Case study of the HiRo (Health Integrated Rescue Operations) project
  • Assess the intersection of big data, telemedicine, AI and autonomous capabilities
DR. ITALO SUBBARAO, “Ambulance drone” Creator and Dean, College of Osteopathic Medicine and Professor of Clinical Sciences at William Carey University College Osteopathic Medicine

DR. ITALO SUBBARAO

“Ambulance drone” Creator and Dean, College of Osteopathic Medicine and Professor of Clinical Sciences
William Carey University College Osteopathic Medicine

4:30 pm - 4:30 pm Conclusion of Event