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08:30-8:45 am Welcome Address: “Life Depends on Us” 

Devendra Mishra, Executive Director, BSMA and Dave Malenfant, EVP, Industry Liaison & Talent Development, BSMA

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8:45-9:25 am  “PANEL: “SCM 360: Pursuit of Transformation in Life Sciences”

Executive leaders of the industry will address how the end-to-end supply chain is being transformed through digitalization, data analytics, networked solutions, globalization and talent development to achieve exponentially greater efficiency, quality and integrity in the delivery of patient care.

Panelists:  Stefano Volonte, Vice President, Supply Chain, North America, Genentech; Kevin Pegels, Vice President, Global Supply Chain, Illumina​; Robert Bottome, Executive Director, Global Supply Chain, BioMarin; Ratna Shekhar, Head, External Site Operations, Small Molecules OpU, Takeda Pharmaceuticals

Moderator: Robert Lamont, Partner, Clarkston Consulting

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9:25-9:40 am  “2019 Digital Health Trends Report”

The Digital Health Research Report based on the participation of 184 companies will demonstrate how Digital Health will transform and improve patient outcomes, revitalize operating profits, generate exceptional revenue growth, and help build a unique blend of talent for the 21st Century healthcare system. The cornerstone of this study is the paradigm shift of placing patients at the center of the healthcare experience, enabled by technology. Enhanced patient engagement will be realized via a connected device world when digital health services match the seamless experiences that patients encounter in their other digital interactions.

Betosini Chakraborty, Research Lead, Senior Manager, Accenture Life Sciences Strategy; Elizabeth Gibson, Vice President, Marketing, Programs & Talent, California Life Sciences Association (CLSA)

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9:40-10:05 am  “New Policies to Advance Development of Safe & Effective Cell and Gene Therapies”

Unique insights will be provided of the current policies to advance development of safe and effective cell and gene therapies where the FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications. It is anticipate that by 2020 more than 200 INDs will be received per year, building upon a total of more than 800 active cell-based or directly administered gene therapy INDs currently on file with the FDA.

Dr. Zehra Tosun, Division of Cellular and Gene Therapies, US Food & Drug Administration/CBER

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10:05-10:30 am  “Our Journey Blending Physical and Digital Supply Chain Worlds”

Thanks to digital capabilities, Supply Chain is becoming a key element of the organization value chain. Our challenge is to define a clear vision and roadmap to accompany the journey to physical and digital convergence. A clear strategy defines how we connect with the external ecosystem, how we inspire our people on their transformational journey and how we succeed on delivery value.

Stefano Volonte, Vice President, Supply Chain, North America, Genentech

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10:30-11:00 am  NETWORK BREAK

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11:00-11:30 am  “A 25-year Journey from Drug Discovery to Four Approved New Cancer Therapies Delivered to Patients: The Exelixis Story!”

The journey of pivotal transformations from an extraordinarily successful discovery organization to an early stage development company to a clinical stage organization and finally becoming a growing biopharmaceutical company with 4 approved products will be revisited. Success factors will be shared about smart clinical trial execution and creation of a strong life cycle management portfolio, building a strong commercial organization, establishing strong partnerships with global organizations, and restarted internal and partnered discovery program initiatives.

Khalid Shah, Head and Vice President, Pharm Operations, Manufacturing and Supply Chain, Exelixis

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11:30 am-12:00 pm  “Using Blockchain for Inventory Transparency at Merck Animal Health” – Case Study

As interest in Blockchain is arising from multiple stakeholders in Merck’s supply/distribution chain, Merck Animal Health conducted a proof-of-concept and a pilot project to explore the impact of tokenizing and tracking its products on a Blockchain. This talk will share Merck’s lessons learned from both the proof-of-concept and the ongoing pilot to provide a practical example of how we see life sciences companies using Blockchain in the future.

James Canterbury, Principal, Risk Advisory Practice, EY

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12:00-12:30 pm  “Operational Efficiencies & Outsourced Procurement Solutions: How a Biotech Giant Turned it Around After a Clinical Trial Setback”

After a mid-stage trial failure put Neurocrine on high alert, the biotech company known for their focus on neurological and endocrine-related diseases made some critical improvements to their supply chain operations through comprehensive, strategic partnerships with Biocom and Thermo Fisher Scientific.  Advancements were made organization-wide to maximize operational productivity through dual world-leading networks. This panel will spotlight specific resolutions to common sourcing pains and operational inefficiencies, as well as highlight the innovative solutions used to support Neurocrine’s laboratory equipment and consumable supply needs.

Panelists:  Robert Reyes, Senior Director, Strategic Sourcing, Neurocrine Biosciences; John Wieland, Industry Director, Biotechnology, Thermo Fisher Scientific; Rick Fultz, Chief Business Officer, Biocom

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 12:30-1:30 pm  LUNCHEON NETWORK

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1:30-5:30 pm TRACK 1:  SCM INNOVATIONS FROM ClLINICAL TO DRUG DELIVERY

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1:30-2:15 pm  “Technology Enablers for Product Development Through Commercialization: Proven Solutions”

The Holy Grail of life Sciences consists of the links between R&D, Clinical, INB and Commercialization. Clinical trials require complex operational and logistics orchestration between the drug company, CRO and Service Providers. The technology enablers for improving the efficacy of drug development, reduction of cost and time to achieve it, and significantly improving the odds for success and profitability, will be presented by innovative companies with real solutions. Case studies of applications of Operations Planning, Process Control, Data Analytics, Digital Collaboration, Inventory Management, Packaging and Labeling, and Logistics, will be presented.

Panelists:  Jan Pieter Kappelle, Vice President, Strategy, 4G Clinical; Laurent Foetisch, Managing Director, Supply Chain Operations, Switzerland; Ferdi Steinmann, Global Industry Strategist, Life Sciences , OpenText

Moderator: Khalid Shah, Head and Vice President, Pharm Operations, Manufacturing and Supply Chain, Exelixis

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2:15-2:45 pm  “Demand-driven Clinical Supply Chain: A Paradigm Shift for System-wide Benefits”

Fulfilling demand in a dynamic clinical trial environment requires supplying depots and sites ahead of time through a Make to Stock process, which leads to considerable scrapping of excess inventory and associated costs in the supply chain. Presentation will be made of a unique industry-sponsored project, where students of the Keck Graduate Institute (KGI) explored the effects of partially transitioning to a Make to Order clinical supply chain, where products are labeled and packaged after patient demand was realized. Benefits were achieved of agile supply management while reducing clinical finished goods inventory, scrap, storage and handling costs, and extensive labeling. Potential was demonstrated for a 65% reduction in the use of booklet labels and up to a 14% reduction in finished product scrap, along with additional operational savings.

Madhumita Suresh, Senior Associate, ATO Site Supply Chain, Amgen; Leslie Maurer, Senior Associate, ATO Site Supply Chain, Amgen; Pratik Ahuja, Director, Supply Chain, Amgen

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2:45-3:15 pm “Council of Suppliers, Service Providers and Technology Enablers – Unleashing the Intrinsic Energy” and “Continuing Executive Education in Supply Chain Management for Life Sciences”

Horacio Enriquez, Chairman, Council of Suppliers, Service Providers and Technology Enablers, BSMA; Dave Malenfant, Executive Vice President, Industry Liaison & Talent Development, BSMA

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3:15-4:00 pm  NETWORK BREAK

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4:00-5:00 pm  PANEL:  “Disruptive Technologies in Transportation Network: Technology Showcase!”

The science-driven Life Sciences industry is adopting disruptive technologies incrementally and opportunistically from drug discovery to delivery to patient. Presentations will be made of solutions for Digitalization, Data Analytics, IoT, Blockchain, Artificial Intelligence (AI) and Machine Learning which make links of the supply chain more intelligent, efficient and secure.

Panelists:  David Bang, Board Member, MaxQ Research/Hellmann Worldwide Logistics; Rich Kilmer, CEO, CargoSense; Radek Samsonowicz , Business Development Director, Skycell; Sumit Vakil, Chief Product Officer & Co-founder, Resilinc

Moderator: Joel Glende, CEO, Paladin Logistics Consulting

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5:00-5:30 pm  “The Journey Away from Transportation Outsourcing to Strategic Partnership”

The traditional outsourcing of transportation and logistics services is giving way to the establishment of a strategic alliance to achieve exponential value in terms of flexibility, agility and strong relationships with partners. The resultant networked alliance is built on an integrated technology platform. The benefits realized are greater speed and flexibility, reduced infrastructure asset costs, gaining leading-edge IT, and expanding capabilities by leveraging partners’ process expertise. Insights will be provided on how to achieve such a strategic relationship.

Albert Cooksey, Senior Vice President, Client Relations, ICS

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1:30 – 05:30 pm  TRACK 2: CELL AND GENE THERAPY

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1:30-2:15 pm  PANEL: “Lessons Learned in the Evolution of Cell & Gene Therapy in the Past Year”

With four drugs approved for Cell and Gene Therapy, unprecedented challenges are being met to advance its supply chain from end to end. From Apheresis to Patient Care, innovations are being made in administration of patients, sourcing of materials, automation of manufacturing, effective logistics and systems for visibility and accountability, to enumerate the major ones. Through sharing of learning, the panelists will engage in accelerating the trajectory of progress.

Panelists:  Heather Erickson, Vice President, Supply Chain, Sangamo; Laura Alquist, Vice President, Global Supply Chain, Kite Pharma; Carlo Guy, Head, Global Head Supply Chain, Novartis; Franck Toussaint, Managing Director, BioLog, Belgium

Moderator: Devendra Mishra, Executive Director, BSMA

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2:15-2:45 pm  “Navigating the Unique Manufacturing and Supply Chain Challenges of Cell and Gene Therapy – Building on Our Past Experiences at Sangamo”

Confronting the unique challenges to the gene and cell therapy manufacturing processes is akin to exploring the Wild West. Experience will be shard in answering questions encountered on the journey. Why supply chain needs a lot of attention, from starting materials, vector banking, and frozen vial to chain of custody? How does cell and gene therapy capacity planning compare to products in the past? How do you re-think the capacity dilemma: CDMO, build our own facilities or partnership strategies for facility build, space sharing, and co-control?

Heather Erickson, Vice President, Supply Chain Management and Business Operations Sangamo

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2:45-3:15 pm  “Commercial Considerations for Planning a Successful Cell and Gene Therapy Product Launch”

A Road Map will be presented to establish a system and a service to integrate the physical custody of the CGT product and patient care with the order-to-cash delivery requirements of the business trading partners in the demand-driven supply chain. The current 3PL and Logistic Services landscape is underdeveloped for the complexities required by CGT therapies. Payment of these high-priced products and Patient Support and Control Tower/White Glove services have to be systematized and integrated. The traditional 3PL model (physical and financial distribution services) has evolved into a Flash Title Model for CGT products. In addition, the emerging role of Specialty Pharmacies vs Specialty Distributors will be presented for its relevance.

Paul Furgal, Vice President, Archbow Consulting

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3:15-4:00 pm  NETWORK BREAK

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4:00-4:25 pm  “Leveraging the Digital Supply Chain to Deliver Personalized Patient Solutions”

Digital supply chain is strategic to transforming the CAR-T business in the Life Sciences industry. In this session, SAP and SAP Ariba join forces to present a comprehensive digital solution to address the requirements for an efficient Targeted Therapy Treatment Management (TTTM) process, including scheduling, management of batch-size-of-1 manufacturing, logistics, global planning and manufacturing processes, data integration, and payment. Learn how intelligence throughout the process can deliver personalized patient solutions at scale.

Mandar Paralkar, Senior Director, SAP

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4:25-4:50 pm  “Understanding and Overcoming the Complexities of the Autologous Therapy Supply Chain”

Operational solutions will be provided for Time and Temperature Sensitivity-Ensuring on time transport of patient specimens to the manufacturing facility and return to patient infusion site within temperature specifications; Chain of Custody-Confirming that each therapy is collected and delivered to the correct patient, pre-and post-manufacturing; Scalability-Ensuring that personnel and systems are robust for commercial growth; Connectivity-Leveraging a robust IT infrastructure capable of integration across multiple platforms; and, ensuring Regulatory Compliance.

Kent Thorup, Regional Vice President, Business Development, Quick Group, Quick, a Kuehne + Nagel Company

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4:50-5:30 pm “Establishing Best Practices for Apheresis Centers: An Industry Initiative”

The status report of an interim industry initiative will be presented by Standards Bodies and BSMA Member for the establishment of best practices for Apheresis Centers with the objective of simplifying and improving qualification, processes and systems. Issues of Apheresis/cell processing credentials, site qualifications, data capture, interfacing systems, cryopreservation, and compliance with regulatory standards, packaging and logistics will be highlighted.

Panelists: Heather Steinmetz, QA Manager for Bone Marrow Transplant, UCLA Health; Gregg Bodnar, Senior Client Engagement Manager, Be The Match BioTherapies; Grace Randhawa, Tissue Operations Expert, Apheresis Operations, Novartis

Moderator: Carla Reed, President & CEO, New Creed

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5:30-5:45 pm  EXCELLENCE AWARDS

5:45-7:00 pm  NETWORK COCKTAIL RECEPTION