Conference Partners:

8:45-9:15 am 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

9:15-10:00 am 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 the outlook for SCM 2020.

Panellists: Kevin Pegels, Vice President, Global Supply Chain, Illumina; Prashant Yadav, Strategy Leader-Supply Chain Integrated Delivery, The Gates Foundation; Paul Seaback, Senior Vice President, Manufacturing and Supply Chain, Dermavant Sciences; Jian Irish, Senior Vice President, Global Manufacturing, Kite Pharma

Moderator: Robert Lamont, Partner, Clarkston Consulting

10:00-10:30 am “The Supply Chain eCommerce Flywheel”

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. Many years of experience in leadership roles at Amazon.com will provide context and actions for success. Further discussion will include specific ways for organizations and supply chains to win in the short and long term in eCommerce.

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

10:30-11:15 am NETWORK BREAK

11:15-11:45 am “Blockchain & AI: Building the Networked Supply Chain of Life Sciences”

Presentation will demonstrate that blockchains will do for networks of companies and business ecosystems what ERP did for the single enterprise: enable a new era of collaboration and integration based on common information and process. Combined with decision-making tools based on machine learning and what will emerge is radically more adaptable, responsive and flexible supply chain environment in everything from product development to large scale manufacturing. Light will be shed on digital services, payments and IoT coming together in the new ecosystems and building a strategy and technology roadmap.

Paul Brody, Americas Technology Sector Strategy Leader, EY

11:45 am-12:30 pm 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; Jason Dean, Director, Bracket Global; Dan O’Donnell, Former Associate Director of Cell Therapy Logistics, Fisher BioServices; Jan Pieter Kappelle, VP of Strategy, 4GClinical

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

12:30-1:45 pm NETWORK LUNCHEON

TRACK 1: SUPPLY CHAIN MANAGEMENT

1:45-2:15 pm PANEL: “Handling the Tumultuous Global Economic and Political Uncertainties”

Several real word challenges of Tariffs, Brexit, Product Pricing and Regulatory Requirements of Serialization are impacting the decision making in the supply chain end-to-end. Practices and principles will be shared to address concerns of importation of API, instruments and materials from China which is sending shockwaves into the industry. Insights will be provided as to how to mitigate risks and ensure a reliable supply of drugs to patients. The evolving drug pricing situation in the US appears to have significant impact into pharma with potential for adverse impact on future levels of investment in US pharma.

Panelists: Khalid Shah, Vice President & Head of Pharmaceutical Operations and Supply Chain, Exelixis; Franck Toussaint, Managing Director, Biolog Europe; Paul Anderson, Senior Director, Toll Manufacturing and Supply Chain, Illumina Cambridge, UK; Horacio Enriquez, Senior Manager, Global Supplier Quality Management, Bio-Rad Laboratories; Jason Mieding, Vice President, North America Supply Chain, Pharma Services, Pantheon

Moderator: Ed Arntheiter, Assistant Professor, Operations Management, Eberhardt School of Business, University of the Pacific

2:15-2:45 pm “Semantic Technology-Assisted Data Harmonizing and Joining Optimizes Transportation – A Case Study”

How Amgen uses Semantic Technologies to Unlock logistics digital information. A practical innovative deployment of data analytics to improve Lane Management and Logistics will be presented along with how to overcome challenges in connecting data due to multiple data structures, inconsistent terminology, descriptions and internal systems gaps to facilitate meaningful analytics. An interesting design pattern relating to fact extraction from unstructured content and joining with structured data has enabled re-use of stagnant data locked in documents for meaningful analytics.

Claire Alice Augustine, Information Scientist – Vocabulary Management Lead, Amgen; Bill Fox, Chief Strategist, Global Healthcare, Life Sciences and Insurance, MarkLogic

2:45-3:30 pm “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 the 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 are decentralized and the ability to collaborate are game-changing.

Panelists: David Blewitt, Vice President, Cloud Compliance Services and Solutions, USDM Life Sciences; Arun Cavale, Managing Principal & CEO, NexInfo; Phillip Gesualdo, Specialist Leader LifeSciences Industry, Deloitte Advisory; Sudy Bharadwaj, Leader Supply Chain Solutions, SAP Ariba; Todd Hein, Executive Director – Oracle Life Sciences Practice, Oracle

Moderator: Devendra Mishra, Executive Director, BSMA

3:30-4:00 pm NETWORK BREAK

4:00-4:30 pm “Innovative Solutions for Optimizing Your Clinical and Commercial Supply Chains”

Clinical trials require complex logistics orchestration, while commercialized products need solutions to ensure product stability and efficient distribution. The presentation will address the innovations to meet the challenges of the two segments from the integrated experience of the speaker at Marken and UPS Healthcare. Insights will be provided on how to combat trials costs driven by patient recruitment and retention. The set-up process for a successful trial, avoidance of risk, critical touchpoints in the supply chain, and solutions for the last mile will be discussed. Answers will be provided to how DTP/DFP and home health care options are changing the industry and how trial patients experience treatment. For the commercial supply chain, leveraging 3PL and integrator expertise will be highlighted in entering new markets with asset-light outsourced global distribution models, end-to-end cold chain and specimen logistics capabilities, temperature-sensitive packaging solutions, and critical freight capabilities to get products to market quickly, efficiently and in a compliant manner.

John Menna, Vice President of Strategy and Corporate Development, Marken

4:30-5:00 pm “Understanding the Dynamics Associated with TMS System in Life Sciences: A Tale of Two Cities”

In this “Point-Counterpoint” approach to vested partnerships in either in house or outsourced functions requiring an effective Transportation Management System (TMS) software, the presenters will explore best practices, lessons learned and some really challenging dynamics in this ever widening and demanding part of supply chain management. The business requirements of small, medium and large-sized companies with cost-benefit in mind will be addressed. Instead of the necessity to make fixed capital investments in systems, Software as a Services (Saas) solutions will also be discussed.

Jim Peyton, Director, Global Supply Chain, Gilead Sciences; Joel Glende, CEO & Founder, Paladin Logistics Consulting; Dana Regan, VP, Business Development, TranzAct

5:00-5:30 pm “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.

Panelists: Bobbie McClain, Strategic Account Manager, Envirotainer; Rich Kilmer, CEO, CargoSense; Robin Hooker, Director, Global Healthcare Market Strategy, UPS; Dan Walles, Vice President, Solution Marketing, TraceLink; Larry Tillman, Business Development Director, Skycell North America

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

TRACK 2: CAR-T THERAPY SUPPLY CHAIN

1:45-2:45 pm 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: Carlo Guy, Global Head, Supply Chain-Cell & Gene Therapies, Novartis; Kenneth Locke, Global Head Strategic Sourcing-Cell Therapies, Celgene; Jayant Aphale, Executive Vice President of Technical Operations, Gritstone Oncology; Laura Alquist, Vice President, Global Supply Chain, Kite Pharma; Reggie Foster, Director Logistics and Packaging Engineering, Kite Pharma

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

2:45-3:30 pm “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, Former Associate Director of Cell Therapy Logistics, Fisher BioServices

3:30-4:00 pm NETWORK BREAK

4:00-4:30 pm “Global Sourcing of Materials and Technologies for CAR-T Therapy Commercialization”

A robust and resilient supply chain requires manufacturers to identify backup suppliers where possible, and where backup options do not exist, and work with suppliers to de-risk their supply chain. Manufacturers are also working with CMOs for certain critical raw materials and processes that are capacity constrained which impacts both pricing and availability to service market demand. The task of establishing purchasing contracts and ensuring sustainability of supply to meet stringent specifications is formidable.

Kenneth Locke, Global Head Strategic Sourcing – Cell Therapies, Celgene

4:30-5:00 pm “Sourcing, Vetting, Contracting and Developing Reliable Supply: Meeting the Challenge for the Industry”

Identifying and developing suppliers is critica for the success of CAR-T Cell Therapy. Challenges faced by the nascent industry to qualify suppliers who understand the stringent requirements and forge a business relationship will be addressed. The just in time nature of the therapy imposes an unprecedented demand on suppliers.

Howard Bland, Sr. Director of Sourcing and Procurement, Kite Pharma

5:00-5:30 pm “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

5:30-5:45 pm EXCELLENCE AWARDS

“SCM Innovation Awards” have been given since 2014 to the stakeholders of the Biotech industry – Manufacturers, Service and Material Providers, Technology Enablers, Academia, Management Consultants, Trade Associations and Governmental Regulators, in order to recognize exemplary contribution towards advancing the Global Supply Chain.

5:45-7:00 pm NETWORK COCKTAIL RECEPTION