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KEYNOTE: “On Demand Supply Chain for Personalized Medicine”

Innovations are required to develop from a nascent stage of the immunotherapy drug industry where the challenges of building raw material supplier base, developing packaging and logistics solutions, instituting data analytics for monitoring operations, assuring product quality end-to-end, and training 3rd party service providers present new dimensions in the cell therapy space. Insights will be provided on the scaling operations to bring cell therapy to more patients and deliver elevated customer experience.

Jian Irish, Senior Vice President, Global Manufacturing, Kite Pharma

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PANEL: “SCM 360: Pursuit of Transformation in Life Sciences”

The evolution of the supply chain of Life Sciences will be discussed in terms of what it will take to make SCM a strategic matter for an enterprise in the C-Suite, adoption of technology for transformation, opportunities in the global marketplace for growth and profitability, learning best practices from other industries, and development of the extended enterprise with seamless relationships. In sights will be shared about current governmental tariffs and outlook for SCM 2020.

Panelists:  Kevin Pegels, Vice President, Global Supply Chain, Illumina;  Paul Seaback, Senior Vice President, Manufacturing and Supply Chain, Dermavant Sciences;

Moderator: Devendra Mishra, Executive Director, BSMA

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“Johnson & Johnson Implements Best Practices of Amazon.com for Demand Planning”

The ongoing transformation of global supply chain, enabled by disruptive technologies, is occurring at an unprecedented speed. The evolution from a clunky, reactive, operational process into a strategic profit driver, woven deep within the fabric of Life Sciences, is imminent for the brave. The driving supply chain digitization focuses on the end-customer in order to win especially in eCommerce where supply chain is recognized as the revenue generator that it always wanted to be and not merely a cost center. Our seat at the “table” has never been more influential for we are all in the supply chain business now. Insights will be shared in the context of Amazon and their various activities that are end-to-end in the health care and life sciences space. Further discussion will include specific ways for your organization and supply chains to win in the short and long term.

Neil Ackerman, Senior Director, Enterprise Supply Chain Global Planning and Innovation, Johnson and Johnson

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PANEL: “Optimizing the Clinical to Commercialization Supply Chain of a Drug”

The traditional autonomy of Clinical Trials, Manufacturing and Commercialization of drugs in an enterprise has game-changing opportunities for optimization in terms of cost, time, quality and success in the supply chain from drug development to patient care. Experts will present best processes, systems, organization structures and technologies which better align the ends of the value chain and create a connected, collaborative workflow. Insights from key stakeholders will be shared about innovations in the lifeline of drug development and delivery to patients.

Panelists:  Bill Coakley, Sr. Director, Global Supply Chain Planning, BioMarin Pharmaceuticals; Khalid Shah, Vice President & Head of Pharmaceutical Operations and Supply Chain, Exelixis; Kristopher Sarajian, VP, Global Marketing Operations,Bracket Global; Ravi Kiron, Head, BioPharma External Innovation, EMD Serono; Steven Yoder, Director, Global Clinical Optimization Services, Fisher Clinical Services

Moderator: Kevin Webb, Former Sr. Director, Supply Chain Business Operations, BioMarin

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PANEL: “Strategic Sourcing Transformation: Recognized Competitive Edge in the C-Suite”

The evolution of Strategic Sourcing has incorporated spend analysis as an enterprise-wide initiative to transform the business, supplier development with QA and risk mitigation as critical

Moderator: Horacio Enriquez, Manager, Global Supplier Quality Program, Bio-Rad

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“Operational Data Hub Road Map for Advanced Data Analytics”

Data analytics is transforming the enterprise with new discoveries, better customer experiences, and improved products and services where time to market is reduced and integrity of the supply chain is enhanced. A major impediment to achieving the goals of an intelligent enterprise is the fragmentation of systems and data within an enterprise as well as external to it with trading partners. A road map is presented for building an Operational Data Hub (ODH) as a layer to sit on legacy systems to serve as a foundation for integrating semantics and document-oriented data. In fact, enterprise data integration eats up 60 percent of a typical IT department’s budget — and it still leaves a gap between the operational and analytical needs of your business.

Bill Fox, Chief Strategist, Global Healthcare, Life Sciences and Insurance, MarkLogic(Tentative)

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“Pivoting Data – Product, Manufacturing and Quality – to the Cloud”

Companies employ different research and operations models to succeed in this demanding new healthcare environment. One common challenge across these models – discovery, development and launch of new products – is management of product and process data and be able to interface with regulatory demands of the government.  Furthermore, the necessary business transactions between a drug discoverer, clinical trials support services, CROs, governmental regulatory agencies, CMOs, internal manufacturing, distribution and patient care are of gigantic proportions, fraught with disconnects, errors, delays and lack of 100% integrity. Solutions will be presented for Pivoting data (Product, Manufacturing and Quality) to the Cloud. Access to an integrated data platform in the Cloud where validation and maintenance of data is decentralized and the ability to collaborate are game changing.

Moderator: Todd Hein, Director, Medical Devices, Oracle

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“Disruptive Technologies in Life Sciences: Welcome the Brave New World!”

The science-driven Life Sciences industry is adopting disruptive technologies incrementally and opportunistically from drug discovery to delivery to patient. Executives will identify deployment of Digitalization, Data Analytics, IoT, Blockchain, Artificial Intelligence (AI) and Machine Learning which are making links of the supply chain more intelligent, efficient, secure and transformed. The solutions of technology enablers will be highlighted.

Moderator: Joel Glende, CEO and Founder, Palladin Logistics Consulting

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WORKSHOP: CAR-T THERAPY SUPPLY CHAIN

PANEL: “Commercialization of the CAR-T Cell Therapy Supply Chain”

The Pioneers of the industry will address the supply chain of CAR-T Cell Therapy, from therapy discovery to patient care which faces the formidable challenge of management of cell product, process, packaging, logistics, systems, quality assurance, chains of custody and identity, scheduling of patients, field administration, and governmental compliance. There is an extraordinary need to develop materials and supplies, process engineering, equipment, packaging, cold chain logistics, systems, end-to-end monitoring, customer service and training.

Panelists:   Jian Irish, Global Head, Manufacturing, Kite Pharma; Kimberly Lounds Foster, Corporate Vice President and Head of Global Commercial Supply, Celgene; Jayant Aphale, Executive Vice President of Technical Operations, Gritstone Oncology;

Moderator: Shankar Suryanarayanan, Global Operations Leader, Pharmaceuticals and Medical Devices, Baxter International

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“Global Sourcing of Materials and Technologies for CAR-T Therapy Commercialization”

A robust and low-risk supply chain requires developers to identify backup suppliers where possible, and where backup options do not exist, work with suppliers to de-risk their supply chain. Manufacturers are using CMOs for certain critical raw materials that are capacity constrained which impacts both pricing and availability to service market demands.

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“Empowering Chain of Custody and Identification: Processes and Systems”

The ecosystem of companies developing CAR-T Cell therapies, hospitals with doctors who perform apheresis, re-engineering of cells in the manufacturing laboratory, subsequent infusion into the blood of the patient, product packaging and logistics, and finally patient care is an onerous flow of information and product where time stamp, metadata, accountability and privacy are paramount. The information management system must consistently ensure that the correct dose is given to the correct patient and how the patient’s chain of identity (COI) is defined and controlled through the vein-to-vein supply chain. In the absence of globally harmonized privacy regulations, manufacturers must ensure their COI systems includes unique patient identifiers which protects patient confidential information throughout the cell journey.

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“End-to-End Logistics Considerations for Autologous Immunotherapies”

The Logistics challenges from Vein-to-Vein supply chain of cell-based commercial products are unprecedented. Operational requirements will be comprehensively addressed for standardization of processes, packaging and shipping qualification, shipping configuration, appropriate data logger selection, documentation of chain of custody, transit carrier evaluation, and anticipation of potential problems inherent in shipping at cryogenic temperatures.

Dan O’Donnell, Associate Director of Cell Therapy Logistics, Fisher BioServices

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“Proactive Establishment of Compliance Measures Ahead of FDA Regulations”

The implications of risk in a supply chain of personalized medicine are widespread when you consider the causal factors of an individual’s health, process variables, environmental conditions, machine operations, storage and logistics, post infusion side effects, administration network, privacy, etc.  This session will explore the complex quality and compliance challenges posed under CAR-T and other advanced cell therapy treatment models. The unique characteristics of CAR-T treatments will impact quality management, validation, laboratory operations, regulatory compliance, data management, and other core quality functions.  A comprehensive and holistic approach will be discussed which includes all the parties involved in developing and delivering the treatment.

Janel Firestein, Partner, Life Sciences Industry Leader, Clarkston Consulting

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EXCELLENCE AWARDS

COCKTAIL RECEPTION