8th BSMA Conference – Foster City, CA 2015

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PLENARY SESSIONS

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Welcome Address
Speaker: Devendra Mishra, Executive Director, BSMA

“Genomics Innovations:  Shaping the Future of Medicine”:  Insights into how genomics is leveraged to produce next generation medicine. The technology of using genomics data for product invention will be presented. The science, knowledge and data will be analyzed to enable greater efficacy in the overall supply chain. Illumina Accelerator provides selected startups with funding, equipment, lab facilities, and coaching on how to advance downstream applications in genomics. Success stories in genomics will be presented.
Speaker:  Amanda Cashin, PhD, Head of Illumina Accelerator, Illumina

“Accelerated Product Lunch with FDA: Integrating Clinical and Commercial Supply Chains”:  Planning for commercial launch, especially with Breakthrough Therapy designation, introduces special supply chain challenges due to high demand and timing uncertainties. In this presentation, Genentech will share how a collaborative partnership between our clinical and commercial supply chain organizations and the FDA successfully enabled the accelerated launch of GAZYVA in 2013.
Speakers:  David Volk, Clinical Supply Chain Management (PTDS), Hoffmann-La Roche 

“Biologics Drug Substance Quality Management:  Integrating the Global Supply Chain”:  Provides an insight into the importance of Quality Operations Management across the product supply chain to realize productivity, customer service and governmental compliance, while achieving risk mitigation and manufacturing advancement. The case study will provide an example of the impact of a quality-driven culture. The implication of having responsibility across the supply chain (end-to-end) will be discussed along with Health Authority expectations for quality to ensure patient safety and integrity in the global supply chain.
Speaker: Andrea Goddard, Vice President & Head of Global Quality Biologics Drug Substance, Genentech

NETWORK BREAK

“Balancing Cost, Service and Risk to Achieve Operational Effectiveness”:  Presentation of the development of a new capability for the life science industry where the Operational Effectiveness Index is a powerful measure, visualization and communication approach, operations decision framework, and a benchmarking tool. 
Speaker: Carl Finamore, Director, PwC

PANEL: “Industry 360° – Advancing the Efficacy and Integrity of the Global Supply Chain”:  Senior SCM executives of the bio-pharma industry will address the subjects of supplier relations development, contract manufacturing and clinical trials management, cold chain technology challenges, IT deployment, Big Data and analytics, integrity in the global supply chain, emerging markets and collaboration for efficiency. Pursuit of SCM Excellence will be the objective in terms of Issues and Answers.
PANELISTS:  Andrea Goddard, Vice President & Head of Global Quality Biologics Substance, Genentech; Kevin Pegels, Vice President, Global Supply Chain USA, Bayer Healthcare; Paul Seaback, Head of Global Supply Chain, Gilead Sciences; Elizabeth Brady, Vice President, Global Supply Chain, Illumina (Not yet confirmed);  George O’Sullivan, Sr. Director os Supply Chain & Strategic Sourcing, Kite Pharma; Moderator: Wayne McDonnell, Leader, Life Sciences Advisory, PwC

NETWORK LUNCH

KEYNOTE ADDRESS: “Trends and Meeting Challenges in Today’s Global Supply Chains: A Road Map”:  Global trends and challenges are driving significant change which produce huge opportunities for individuals and supply chain organizations alike. Presentation highlights what it takes to get the job done in terms of personal skills, trust in relationships, consensus building, communication, leadership, technology, and building a sustainable community of supply chain professionals striving in a risk-laden marketplace. The outcome can be transformational in providing customer service from end to end of a supply chain.  
Keynote Speaker: Rick Blasgen, President and CEO, CSCMP – Council of Supply Chain Management Professionals

“PANEL: “Biotech Meets Hi-Tech: Driving Innovation””:  The cross-pollination of experience and knowledge between executives of the Hi-tech and the Biotech industry will crystallize variations in supply chain best practices from the end-to-end supply chain perspective. The mature global nature of Hi-tech, with its challenges of reducing cost while achieving manufacturing yields and overall quality, will be discussed for ‘leap-frog’ improvements in biotech.
PANELISTS:Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories; David Ginsberg, Vice President, Supply Chain, Sonic Manufacturing; Tim Jordan, Senior Global Commodity Manager, Siemens Healthcare; Jim Latimer, Director of Purchasing, Medivation; Moderator: Rick Blasgen, President and CEO, Council of Supply Chain Management Professionals (CSCMP)

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TRACK 1 : CLINICAL SUPPLY CHAIN MANAGEMENT

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PANEL: “Reducing Waste, Maximizing Efficiency and Streamlining Your Global Clinical Supply Chain”:  This panel will address how data is captured and used for managing clinical studies. Topics covered will include forecasting, tracking shipments, managing inventory, production planning and MRP, and performing drug accountability and reconciliation. A wide range of solutions will be discussed, ranging from manual processes, to automated ERP systems, to hybrid solutions that reflect combining multiple tools and solutions.
PANELISTS: Malou Berdan, Senior Manager, Clinical Supply Chain, BioMarin ; Alyssa Bychowsky, Head, Clinical Supply Chain, Shire; Michael Dallmann, Director, Global Clinical Supply Chain, Merck; Matt Donnelly, Director, Clinical Supply Chain, Genentech; Luke Moyer, Project Group Manager, Project Services Liaison, Almac Clinical Services; Patty Overley, Clinical Supply Executive, Global BioPharm Solutions; Moderator: Bill Coakley, Director, Supply Chain Planning, Bio-Marin

“Ensuring Your Supply Chain Doesn’t Stop Until You Reach the End User: The Importance of the Investigator Site in Clinical Supply Chain Planning”:  In the high-stakes world of clinical development, sponsors develop protocols with a focus on testing clinical endpoints and, often, somewhat less appreciation for the practical implications of the designs on investigator sites and patients. At a time when the number and complexity of trials are escalating, sponsors stand to reap valuable benefits from the practical insights of investigator sites about the impact of clinical supplies in real-world care settings. The session will review the results of the global investigator site survey and the impact of clinical supplies on sites and patients, analyze challenges faced, identify opportunities to modify interactions with investigator sites to enable better site performance and higher patient retention strategies. Finally, current industry trends around patient centricity and how companies are taking action to address the paradigm shift to a patient-centric business model will be presented.
Speaker: Amy Musolino, Program Director, New Service Development, Fisher Clinical Services

“Trends and Technology innovations for Efficient Cold Chain Management and Distribution of Clinical Supplies”:  The panel will share what, in their opinion, is the very latest and most pertinent trends in terms of cold chain data management. Access to real-time data is particularly important, not only to secure the protection of IMP product, but also to optimize processes across, what can be, a complex supply chain. Inventory visibility alone is not enough. Sponsors today seek data to provide assurance that temperature specifications have been maintained within stipulated guidelines. In addition, the panel will share how fast-changing technology opens new possibilities to the industry enabling service providers to be more reactive with better visibility of clinical supplies as they are distributed across the globe. State-of-the-art technology combined with well-defined processes results in greater control, compliance and visibility across the supply chain.
PANELISTS:  Alex Guillen, Global Cold Chain Director, Fisher Clinical Services; Marsha Davis, Product Marketing Manager (Clinical Trials), Sensitech; Bill Rambo, Sales & Marketing Director, Priority Solutions; Tom Robinson, SVP of Strategic Business Development, Insync  Inc., (part of ORBCOMM); Julie Trulson, Director CMC Leader, OncoMed.

“ The Journey to Build a System for Managing Clinical Supplies”:  Presentation of a Case study of systems and tools deployed over two years for forecasting, tracking shipments, managing inventory, doing production planning and MRP, and  performing drug accountability and reconciliation. The solution includes a discussion about integration with ERP, Clinical Distribution, CTMS and IVR systems.
Speaker:Bill Coakley, Director, Global Supply Chain Planning, BioMarin Pharmaceutical

“Automated Inventory Control and Visibility: Streamlining the Clinical Supply Chain”:  Presenting a case study of automation and systematization of critical clinical supply chain functions to achieve efficacy, governmental compliance and streamlined commercialization. This is a journey of the Pilot Plants (API & Formulation) at Gilead Sciences to establish inventory control and visibility for GMP and R&D material leveraging their mainstream ERP systems. 
Speakers:  Arun Cavale, Supply Chain Process Designer, NexInfo; Scott Hebner, Sr. Manager FPD Pilot Plant, Gilead

“An Information System to Manage Clinical Operations – Achieving Cost Reduction, Speed to market and Compliance”:  Presentation of a focus on the challenges of forecasting, production planning, and drug accountability of clinical studies. A software solution is a protocol driven framework coupled with bidirectional integration to manufacturing systems (ERP), IVR services and B2B partners where clinical protocol requirements are translated into accurately packaged and distributed investigational drug products. The benefits realized are increased efficiency and accuracy and compliance of the clinical supply process in functions of Planning, Manufacturing, Packaging and Distribution, Management Control and Communication.
Speaker: Michelle Niles, Director, Business Development, CLINapps

“ID for Medicinal Products: Preparing for the EMA Regulation”:  EMA standard called IDMP created by ISO which takes 2017-18.  One of the purposes of this regulation is to establish standards (“controlled vocabularies”) across the industry for batch and lot identifiers, covering 243 attributes and 7 categories (e.g. drug substance, drug product, etc.).  This regulation will impact many functional groups within pharmaceutical companies (including Supply Chain), and applies to both clinical and commercial products. 
Speaker:  Franck Toussaint, Managing Director, Biolog Europe (Belgium)

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 TRACK 2: WORKSHOP – TALENT & CAREER DEVELOPMENT FOR YOUNG PROFESSIONALS SEEKING CAREER IN SUPPLY CHAIN MANAGEMENT

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DESCRIPTION: Young professionals in the biotech industry, who have aspirations for a SCM career with advancement to the top of the organization, are seeking Leadership Skills for navigating their paths for career fulfillment. The traditional career path for many has been to rise vertically in the organization in the function of their choosing. The extraordinary opportunities to impact an enterprise by having an integrated experience in SCM remain largely overlooked. Cross-functional integration of experience in the horizontal functions of an enterprise is necessary for career growth. Training in soft skills, in addition to education and experience, will enable them to meet the challenges of an enterprise to grow profitably and compete globally. This program is to further develop professionals who may have acquired the technical training of APICS, CSCMP or ISM. The workshop is designed to help an individual achieve career growth in the organization based on self assessment and goals.  

“SCM as a Competitive Edge in Biotech: The Practitioner’s Perspective”: The presentation will discuss how Supply Chain Management needs to serve as the key integrator of functions across the company in order to drive critical business results. To fulfill this key role, supply chain managers need to develop skills and experience in supply chain fundamentals, business acumen, and leadership.
Speaker: Kevin Pegels, Vice President, Global Supply Chain, Bayer Healthcare

“From a Warehouse Supervisor to the Global Head of Supply Chain: The Zigzag Journey”:  It is the Journey of a Supply Chain Executive who created a Global SCM Group with over 900 employees at Alcon Laboratories as its Vice President, after assuming advancing responsibilities in warehousing, manufacturing, purchasing and materials management over 20 years. He shares his experience in leadership and performance excellence through new business opportunities captured, best-in-class processes established, operational innovations implemented, costs eliminated, inventory optimized and teams engaged and inspired. Lessons learned from Systems Thinking-by embracing cross-functional connections and interdependencies across procurement, logistics, manufacturing, sales, and marketing will be included. Implementation of a comprehensive mentoring and talent development program for all supply chain professionals is a legacy for others to emulate.
Speaker: Dave Malenfant, Executive Vice President, Industry Liaison and Talent Development, BSMA, and, Former Vice President, Global Supply Chain, Alcon Laboratories

“Supply Chain Professional Development Program at Intel: A Blue Print for Action”:  Presentation of the program of the “Supply Chain Master” professional development implemented at Intel with success and enduring value. Intel created a job ladder to supplement their managerial and engineering job ladders that is specifically focused on supply chain professional development from a career growth perspective. He will also discuss how Intel used an interdepartmental project to help train the new supply chain masters across the many areas of the supply chain.
Speaker: Jim R. Kellso, Professor of Practice, ASU Supply Chain Management and Intel Supply Chain Master (Retired) 

“Development of the Low Cost Supply Chain Master Program at Intel – The Mechanics for Change”:  In her role as the supply chain master, a step-by-step insight into leading the final design and deployment of the “Low Cost Supply Chain” for the Atom Microprocessor for Intel across the world. Unique focus on how that cross functional project both added in project management skills in a multi-cultural environment and the soft skills of influence and risk taking.
Speaker: Cindie Blackmer, Former Supply Chain Master, Intel 

WORKSHOP: “Mapping Your Own Career Path in SCM”:  The group of professionals from various companies, serving different functions of Planning and Forecasting, Purchasing, Manufacturing, Quality Assurance, Distribution, Logistics. Customer Service, Business Process Management, Project Management, Governmental Regulations, will be split into small groups of less than 8 to enable interaction. Questionnaire-based fact-finding will be utilized to gather individual’s career details, educational background, organizational characteristics, career goals over a time frame, strengths and weaknesses, and constraints to yield an assessment of a personal profile. Interaction among participants will be professionally facilitated to analyze the self-assessment. The management skills required to navigate career goals will be analyzed and the participants will be navigated to develop individual career paths in terms of the overall journey with milestones, resources, networking, reaching out to professional associations and mentorship.
Facilitators: Richard Dawe, Director, Operations and Supply Chain, Center of Operations Management, Golden Gate University; Dave Malenfant, Executive Vice President, Industry Liaison and SCM Talent Development, BSMA; Susanne Somerville, Former Vice President, Supply Chain North America, Genentech; Prashant Yadav, Senior Research Fellow and Director of the Health Care Research Initiative, William Davidson Institute (WDI)

TOWN HALL DIALOG: SCM Career Planning Q&A:  A Panel of SCM Experts from various segments of the industry will address the issues raised by the participants in the workshop to provide unique insights, guidance to detect iceberg-like organizational impediments and practical how-to suggestions to navigate in the turbulent waters.
PANELISTS: Richard Dawe, Director, Operations and Supply Chain, Center of Operations Management, Golden Gate University; Jim R. Kellso, Professor of Practice, ASU Supply Chain Management; Dave Malenfant, Executive Vice President, Industry Liaison and SCM Talent Development, BSMA; Jennifer Parkhurst, Partner, Life Sciences, PwC; Kevin Pegels, Vice President, Global Supply Chain, Bayer Healthcare; P. J. Shelton, Vice President, Academic Collaboration, CSCMP San Francisco; Susanne Somerville, Former Vice President, Supply Chain North America, Genentech; Prashant Yadav, Senior Research Fellow and Director of the Health Care Research Initiative, William Davidson Institute (WDI); representatiave from ISM

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TRACK 3: GLOBAL SUPPLY CHAIN INTEGRITY (TEMPERATURE-CONTROLLED DISTRIBUTION)

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“Logistics Strategies for New Products and New Markets: A Transformational Solution”:  Temperature sensitive biologics from CRT down to cryogenic, diverse regulations and growing global demand require supply chain transformation that challenges the linear “chain” metaphor. Learn how some of the top logistics leaders are insuring integrity in the global supply chain by creating systems more like mesh networks, fabric and webs.
Speaker:  Robin Hooker, Director, Healthcare Marketing, UPS 

“Leveraging Data to Drive Insight vs. Oversight: For Cost Reduction, Best Processes & Compliance”:  A solution will be presented of system-wide data capture, analysis and timely reporting to ensure quality of delivered goods while managing costs, in addition to maintaining compliance with regulations for biopharma products. Temperature monitoring and simple climate excursions provide historical insights of how transportation providers are handling goods within your end-to-end supply chain. You will learn how to reduce total cost of product, packaging and transportation, and how to optimize the overall quality control processes. Innovations from sensor deployments and Internet of Things will be discussed to bypass geo location and arrive at the detailed proximity events that allow you to understand the interrelationship of carriers within the supply chain itself. Insights will be presented on significantly improved response to compliance issues and establishment of best practices.
Speaker:  Rich Kilmer, CEO, CargoSense 

“Importance of Global Launch Sequence and its impact on Cold Chain”:  Launching a pharmaceutical product in the current environment is much more difficult that it was just a few years ago. Now it involves a truly cross functional involvement to optimize the launch effort. With more and more products (requiring cold chain) being launched in countries other than U.S, EU5 and Japan, it becomes all the more important to sequence the launch well and prepare for the complexities. A suboptimal launch with suboptimal readiness can have the company leave 10’s of millions of dollars on the table.
Speakers: Vishal Singal, Principal, Consulting Group, IMS

“Taking a Risk-Management Approach to Ensure Supply Chain Integrity”:  Presentation of the highest level of understanding of a complex logistic network so that efficiencies can be realized across a multi-service channel business by mining quality data through the creation of safety zones for product quality. Tools and applications to create supply chain visibility any time will be discussed along with best practices to apply active technologies across your global platform for results.
Speaker:  Brian Cooper, Head of Healthcare Sales, Envirotainer

PANEL: “Temperature-Controlled and Cold Chain Supply Chain: Proven Technologies and Practices for Compliance”: Deployment of the emerging temperature-controlled logistics and cold chain technology, manifesting from end-to-end of the supply chain, requires packaging engineering standards, business processes, information systems and monitoring mechanisms. The stakeholders will discuss the pitfalls and present a blueprint for the manufacturing, logistics and distribution of temperature-sensitive materials and finished products globally.
PANELISTS: Jim Peyton, Associate Director, Supply Chain, Gilead Sciences; Sophia Sharp-Donaldson, Sr. Director and Head of Global Sourcing & Procurement, Baxalta US Inc.; Doug Wettegren, Business Area Key Account Manager – Americas, Envirotainer; Moderator: Vishal Singal, Principal, Consulting Group,IMS.

“A Process Validation Guide for Cold Chain Logistics: Ensuring Compliance Globally”:  Strategies focused on the packaging qualification, without consideration for validation of the process of drug product transport and the potential impact on the potency, efficacy, or purity of the drug product as compared to the specification, will be challenged by regulatory agencies around the world. Process validation for cold chain logistics (packaging, storage, and distribution) is a required part of the Common Technical Document (CTD) for any Biologics License Application (BLA) for monoclonal antibodies. Any review of the submitted dossier and subsequent pre-approval inspection onsite will most likely review the areas of 1.Stability testing, 2. Thermal packaging qualification, 3. Process validation, and 4. Validation master planning. The best practices will be identified and current expectation of drug quality from regulatory agencies globally will be confirmed after transport.
Speaker:  Gary M. Hutchinson, President and CEO, Modality Solutions