Driving Technology & Innovation
in Life Sciences Supply Chain
October 15, 2019, SF Airport Marriott Waterfront, Burlingame, CA
7:30 – Ongoing: REGISTRATION
7:30 – 8:30 am: MEET & GREET BREAKFAST
8:30 – 7:00 pm: CONFERENCE
“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
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 and talent development to achieve exponentially greater efficiency, quality and integrity in the delivery of patient care.
- Kevin Pegels, Vice president, Supply Chain, Illumina
- Paul Seaback, SVP, Technical Operations, Dermavant Sciences
- Stefano Volonte, Vice President, Supply Chain North America, Genentech
- Moderator: Devendra Mishra, Executive Director, BSMA
“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, Vice President and Head of Pharmaceutical Operations, Manufacturing and Supply Chain, Exelixis
TRACK 1: Commercialization of Cell & Gene Therapy
PANEL: “Commercialization of Cell & Gene Therapy – Meeting Unprecedented Challenges!”
Pioneers of the industry will share the challenges faced and best practices being implemented in the value chain of Cell & Gene Therapy from therapy development to patient care. The interactive session will provide insights in the areas of planning, process development, packaging, logistics, systems, quality assurance, field administration, and governmental compliance. Insightful comparison with bio-pharma will be shared in addition to aspects of centralized vs. decentralized manufacturing and talent development.
- Moderator: Shankar Suryanarayanan, Executive Vice President, Emerging Therapies & Technology, BSMA
“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, 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?
Andy Ramelmeier, Vice President, Technical Operations, Sangamo Therapeutics
“How to Industrialize Strategic Sourcing of Raw Materials and Supplies Globally?”
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. A robust and resilient supply chain requires manufacturers to strategically source raw materials and identify backup suppliers where possible, and where backup options do not exist, 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 impact both pricing and availability to service market demands.
David Karakas, Director, Sourcing and Procurement, Bluebird Bio
“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.
Peter Holman, Global Apheresis Integration Lead and Head of Apheresis Operations, Novartis
“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.
TRACK 2: SCM Innovations From Clinical to Challenges & Technology Innovations
Technology Showcase: “Innovative Solutions for Optimizing Clinical Supply Chains: Technology Showcase”
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
- Jan Pieter Kappelle, Vice President, Strategy, 4G Clinical
- Others TBA
“Temperature Management Trends and Solutions”
Moving temperature-sensitive products within the US and globally demands the custody of a capable and qualified process and established quality system to ensure compliance with temperature ranges often called “cold chain” and sensitive product needs. This has propelled the logistics into a regulated Temperature Management Supply Chain, resulting in higher costs for the manufacturers and distributors. Since there is currently no single standard, guidance, regulator, document or arbiter with the final say on a compliant cold chain for a given region, manufacturers oftentimes struggle to find a solution. This presentation will address the myriad issues manufacturers and distributors face and innovative ways solution.
“The Journey Away from Logistics Outsourcing to Functional Strategic Partnerships”
The traditional outsourcing of 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.
“Protecting Value of Goods and Security in Multi-modal Transportation”
High Value goods in Life Sciences are seeing increased risks in our industry causing many companies to rethink solutions and utilize latest cutting-edge technology and also many practical methods to secure their supply chains. This panel will examine ways to properly assess the risks and deployment options to protect highly valuable and sometimes priceless shipments critical in a company’s logistics execution.
Technology Showcase: .“Disruptive Technologies in Transportation Network
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.
- Moderator: Joel Glende, CEO, Paladin Logistics Consulting
5:30 – 5:45 pm: EXCELLENCE AWARDS
5:45 – 7:00 pm: COCKTAIL RECEPTION