“Driving Innovation and Technology
in the Bio-pharma Supply Chain”
PLENARY SESSIONS (08:30am-03:05pm)
08:30 am-08:40am Welcome Address: Devendra Mishra, Executive Director & Co-Founder, BSMA
08:40am-09:10am KEYNOTE ADDRESS: “Pioneering the Development of the Supply Chain for Immuno-therapy Drugs: The Brave New World” The challenges of developing innovative products that harness a patient’s own immune system to target and kill cancer cells is a paradigm of cancer treatment for the 21st century. The supply chain for such products is personalized, rendering its design, development and execution to be unprecedented. The establishment of processes for manufacturing and logistics, with real time controls, is a pioneering endeavor. Insights will also be provided of early clinical studies in patients who were treated with engineered T cells have produced dramatic results thus far, up to and including complete remission of cancer in some patients who have aggressive disease and have not responded to other therapies.
KEYNOTE SPEAKER: Tim Moore, Executive Vice President, Technical Operations, Kite Pharma
09:10am-09:40am KEYNOTE ADDRESS: “Building a Real-Time Visibility Platform for Supply Chains: Innovation in Progress.” Real time visibility in the supply chain is a strategic area of innovation at Genentech. The presentation will address the challenges and triumphs involved in assessing, selecting, and installing an “extreme visibility” platform over the last year. Our goal is to use this platform to “know what we don’t know,” understanding the real-time movements of our goods, have up-to-the-minute information of global events that could impact our supply chain, and provide this information to groups across the corporation. Insights will be provided in terms of problem articulation, requirements analysis, system solution selection, change management and cultural evolution.
KEYNOTE SPEAKER: Kaoru Nishino, Head of Strategy and Innovation, North America Supply Chain, Roche
09:40am-10:10am KEYNOTE ADDRESS:“Supply Chain Transformation: Improving the Customer Experience for Competitiveness”: Illumina is known for advancing health-care breakthroughs with the world’s leading genomic analysis products. Over the past two years, illumina has increased its focus on improving the customer experience through a customer-centric supply chain vision and strategy. This presentation will share some of Illumina’s segmentation and customer partnership strategies and results in the areas of service, launches, and cost savings.
KEYNOTE SPEAKER: Kevin Pegels, Vice President, Global Supply Chain, Illumina
10:45am-11:15am “President Trump’s Tax and Trade Policies: Impact on Supply Chain and Business Strategy”: Presentation will address how pharmaceutical and life sciences companies should waste no time in evaluating how different tax provisions would affect their business operations. The Trump administration also has begun proposing changes to trade policy. Pharma and life sciences companies should model how these proposed changes could affect manufacturing and supply chains, locations of intellectual property (IP) holdings, unremitted earnings held overseas and planned capital expenditures.
SPEAKERS: Jennifer Parkhurst, Principal, Pharmaceutical & Life Sciences Advisory, PwC; Ben Proce, Vice Partner, Pharma and Life Sciences Tax Practice, PwC
11:15am-12:00pm PANEL: “Industry 360° – Taking a Quantum Leap in Rewiring the Biotech Supply Chain”: Senior SCM executives of the bio-pharma industry will address the challenges of exponentially enhancing the delivery of patient care in the global market place with formidable governmental regulations through processes, systems and technology. What game changing initiatives can the industry engage in the areas of supplier relationships, contract manufacturing and clinical trials management, commercialization, manufacturing QA, temperature-controlled distribution and human resource development. The deployment of disruptive technologies will also be discussed to achieve growth and profitability.
PANELISTS: Sophia Sharp-Donaldson, CEO, SophWiz Consulting; Jim Benkendorf, General Manager, Fisher Clinical Services; Prashant Yadav, Strategy Leader-Supply Chain, Bill & Melinda Gates Foundation; Khalid Shah, Vice President and Head, Pharmaceutical Operations and Supply Chain, Exelixis; Laurent Foetisch, Managing Director, Supply Chain Operations, SA; MODERATOR: Devendra Mishra, Executive Director, BSMA
12:00pm-12:45pm PANEL: “The Resurgence of Manufacturing in Biomedical and Bio-pharma Manufacturing: Overcoming Trials and Tribulations”: Manufacturing has proved to be a strategic asset in the biopharma and biomedical industries where product development, product design iterations after R&D, pilot and small to large scale manufacturing, and customer-driven product innovations, are extremely intertwined in a continuous improvement environment. Achieving responsiveness to product and process changes, agility in delivering innovations, protection of intellectual property, and reduction in time to market, will be addressed by an esteemed panel of stakeholders. The SMEs will also assess the management issues of how to establish manufacturing after the product has been designed and is likely to evolve to a steady-demand, mass-produced product where achieving economy becomes a competitive imperative. In the context of the product life cycle, from conception to becoming a mature product, the decisions to offshore or inshore will be analyzed. Lessons learned from successes and failures will also be examined.
PANELISTS: Mike Prindiville, Director of Production, Intuitive Surgical; Mike Zuerlein, Director of Production, Illumina; Gregory Theyel, Program Director, Biomedical Manufacturing Network; MODERATOR: Kelly Kline, Economic Development Director & Chief Innovation Officer, City of Fremont
01:45pm-02:25pm “Enabling Technologies for Supply Chain Innovations” Information and Technology are revitalizing the supply chain of bio-pharma in terms of efficiency, agility, visibility and integrity while better sensing of demand. From clinical supply to drug delivery to patients, the emerging technologies of data analytics, artificial intelligence (AI), machine learning, PLM and Blockchain have game changing implications. Further, the Cloud in the digital supply chain is enabling realization of quantum leaps in maximizing drug development and delivery of patient care. SMEs will address the major problems faced by the industry and how solutions are being implemented to solve them.
PANELISTS: Pramod Jain, CEO, Vivio Health; John Danese, Sr. Director, Life Sciences Solutions, KPIT; James Riddle, Vice President of Client Services, Kinetiq; MODERATOR: Todd Hein, Sr. Director – Medical Devices – IBU, Oracle
02:25pm-03:05pm Leveraging Technology-driven Services in Logistics for Quantum Improvement in Cost, Quality and Service” Collaboration, driven by information and technology, is delivering unprecedented services to bio-pharma manufacturers in the form of actionable intelligence for real time decision making; increased agility and improved asset management; and, even customized and personalized service. Solutions to be discussed will include serialization, track and trace, deployment of IoT in transportation networks, new collaborative service models, and leveraging artificial intelligence (AI) and machine learning.
PANELISTS: Rich Kilmer, CEO, CargoSense; Tim Bishop, Senior Manager, Healthcare Compliance and Quality Assurance, UPS; Wahiba Hall, Head Global Transportation and Warehousing, Pharma Division, Bayer; Richard Ettl, CEO, Skycell; MODERATOR: Joel R. Glende, CEO, Paladin Logistics Consulting LLC
TECHNOLOGY SHOWCASE: TWO TRACKS (03:30pm-05:30pm)
TRACK 1: “ADVANCING THE BIO-PHARMA BUSINESS FOR GROWTH AND TRANSFORMATION”
03:30pm-04:00pm “Outsourcing the Clinical Supply Chain: Is a Single Provider Strategy the Solution?”: Under pressure to jumpstart productivity and reduce the time and cost of shepherding new drugs from laboratory through licensure, the biopharmaceutical industry began globalizing clinical trials about 15 years ago. This continued globalization has precipitated a spike in the operational and strategic obstacles faced by clinical trial professionals. Outsourcing models are discussed – multiple vendors versus single provider, with case study examples and guidance on top tips for success. The critical challenges faced by startup, small and mid-sized companies will also be addressed.
SPEAKER: Jim Benkendorf, General Manager, Fisher Clinical Services
04:00pm-04:25pm “Navigating the ASIA-PACIFIC Clinical Supply Chain for Accelerated & Efficient Drug Development”: Representing 60% of the world’s population, Asia continues to rise to the forefront of the clinical trial arena with an estimated 25% of global clinical trials including Asian countries. The presentation will highlight unique clinical supply chain challenges and strategies required to achieve success for the conduct of trials in this varied and nuanced regulatory landscape.
SPEAKER: Luke Moyer, Supply Chain Solutions Manager, Almac
04:25pm-04:50pm “New Generation Supplier Management Platform: Empowering the Enterprise for Competitive Edge” The presentation is the journey of the Global Strategic Sourcing (GSS) team to install a new generation supplier knowledge management platform to increase efficiency and collaboration between procurement and the rest of the business of the $900M biotech company BioMarin. The innovative solution increases access to knowledge and optimizes supplier data while also leveraging intelligence from industry peers. The solution utilizes machine learning and AI to deliver actionable supplier intelligence across the enterprise. Insights will also be shared how C-level buy-in of the platform with its value proposition was achieved. The broad range of benefits for operations, finance, and IT will be enumerated that small to large companies can realize.
SPEAKER: Dana Small, Sourcing Manager, BioMarin Pharmaceutical
04:50pm-05:30pm PANEL: “Integrating Planning, Packaging, Logistics to Maximize Effectiveness of Clinical Trials”: This panel will address how operations planning, packaging, information systems, business practices and collaboration will improve accountability and visibility in the supply chain linking clinical drug discovery, clinical operations and clinical supply with trials management and service providers. Topics covered will include patient enrollment forecasting and real time updating, managing inventory with MRP, and performing drug accountability and reconciliation, including returns.
PANELISTS: Arun Cavale, Principal and CEO, NexInfo; Kevin Shea, Senior Label Program Director, Clintrak Clinical Labeling; Inder Makin, Associate Professor, A.T. Still University; Bill Coakley, Senior Director, Supply Chain, BioMarin; MODERATOR: Ravi Kiron, Head, BioPharma External Innovation, EMD Serono
TRACK 2: TECHNOLOGY TO REWIRE THE SUPPLY CHAIN
03:30pm-04:00pm “Are You Truly Prepared for Blockchain Within Your Cold Chain?” The product release process involved in the distribution of temperature controlled products requires distributed parties to share information necessary to determine the stability of products. Distributed ledger technologies (aka blockchain) could facilitate the process of product release, however, these efforts are hampered by proprietary/encrypted temperature logger formats. A central tenet of blockchains is for each party in a distributed ledger to be able to validate the transactions independently. Proprietary and encrypted formats on a ledger are antithetical to this purpose. This talk will focus on the value of aggregating product release (temperature) data and how the industry must push its logger vendors to pursue open data formats that would enable blockchains to deliver on their true potential of distributed, verifiable supply chain integrity.
SPEAKER: Rich Kilmer, CEO, CargoSense
04:00pm-04:40pm PANEL: Temperature Controlled Ecosystem: Overcoming the Achilles Heel” : The extreme challenges of having robust temperature controlled solutions are being met with innovations in technology, systems and business processes. Major inroads have been made with delivering extremely temperature sensitive products through demanding environments across U.S., EU 5, Brazil and Japan. The solutions have been fast evolving and keeping pace with increased regulatory requirements, number of drugs and complexity of serving diverse group of stakeholders. Insights will be provided for avoiding the Achilles Heel of the temperature controlled supply chain. The stakeholders of the industry will present solutions for the successful deployment of the emerging temperature-controlled logistics and cold chain technology. An assessment will also be made of packaging, engineering standards, business processes, information systems and monitoring mechanisms.
PANELISTS: Doug Wettergren, Global Key Account Manager, Envirotainer; Richard Ettl, CEO, Skycell; Des Charlery, Cold Chain Specialist, Fisher Clinical Services; Sophia Sharp-Donaldson, CEO, SophWiz Consulting; Tammy Orr, Global Account Manager, FedEx Custom Critical; MODERATOR: Vishal Singal, Principal Commercial Services, QuintilesIMS
04:40pm-05:05pm “Increasing Demand Visibility in Clinical Supply Chain Forecasting. How performing routine maintenance and information upkeep with trial variables leads to an improved and clarified picture of clinical supplies management, in turn driving down costs and overhead in inventory manufacturing and storage. Study Managers and Planners approach to updating protocols can make or break program level aggregation and analysis.
SPEAKER: Jason Dean, Director of Product Management, Bracket Global
05:05pm-05:30pm “Collaborating to Create Confidence in your Cold Chain Management” The connection between customer and provider is as important as ever. Collaborating with your providers allows you to navigate through the requirements of your product and the intricacies of your supply chain. This presentation will cover the benefits of collaborating to overcome supply chain challenges and find innovative solutions, as well as topics related to temperature control, quality management, enhanced security and more.
SPEAKER: Tammy Orr, Global Account Manager, FedEx Custom Critical
SCM EXCELLENCE AWARD CEREMONY