Advancing Supply Chain Management in the Biopharma Industry

Transcription

1 Advancing Supply Chain Management in the Biopharma Industry BIO SUPPLY MANAGEMENT ALLIANCE Because life depends on us gold sponsor track sponsors silver sponsor bronze sponsors participating sponsors association sponsors San Francisco Roundtable Council of Supply Chain Management Professionals ISM Northern California, Inc. OCTOBER 23-24, 2014 CROWNE PLAZA FOSTER CITY, CALIFORNIA

2 BIO SUPPLY MANAGEMENT ALLIANCE MissionStatement To build effective and efficient supply chain STRATEGY for the biotech, biopharma, pharma and biomedical device industries by developing, advancing, and disseminating best practices, knowledge, and research. To encourage and promote supply chain INNOVATION within the biotech, biopharma, pharma and biomedical device industries for the highest quality and clinical outcomes in patient care and welfare. To create a supply chain COMMUNITY of thought and practice leaders from the business, professional association and academic sectors for information exchange, shared services, and collaboration. ExecutiveCommittee Devendra Mishra EXECUTIVE DIRECTOR & CO-FOUNDER Dave Malefant EXECUTIVE VICE PRESIDENT, INDUSTRY LIAISON & TALENT DEVELOPMENT Shankar Suryanarayanan VICE PRESIDENT, STRATEGIC PLANNING & INTERNATIONAL Bill Coakley VICE PRESIDENT, STRATEGIC ALLIANCE Vishal Singal VICE PRESIDENT, COLD CHAIN & EMERGING MARKETS Deborah Rice VICE PRESIDENT, SPONSOR SALES & MEMBERSHIP Dotti Yells VICE PRESIDENT, MARKETING, WEBMASTER & DBA Wayne McDonell INDUSTRY LEADER, PwC John Mitch LEGAL COUNSEL AdvisoryBoard Anderson Aphale Buck Dawe Kachinsky Kaminsky Malenfant Nix Pegels seaback singh Paul Anderson, Vice President of Global Procurement, Life technologies Jayant Aphale, Senior Vice President, Technical Operations, Serepta Therapeutics Mark Buck, Global supply chain and Procurement Leader, bio-rad Laboratories Dr. Richard L. Dawe, Director of the Operations & supply chain Management Program and the center of Operations Management, Golden Gate University Mary Kachinsky, sr. Director of strategic sourcing, cubist Phil Kaminsky, Associate Professor, school of industrial engineering & Operations research, University of california, berkeley Dave Malefant, Executive Vice President, Industry Liaison and Talent Development, BSMA Nancy Nix, Ph.D, Director, executive MbA Program, Professor, texas christian University board chair, elect council supply chain Management Professionals Somerville Suryanarayanan Kevin Pegels, Vice President, Global supply chain UsA, bayer Healthcare - Ps biotech Paul Seaback, Head of Global supply chain, Gilead sciences Mahender Singh, Ph.D., research Director, center for transportation and Logistics, Massachusetts institute of technology Susanne Somerville, Vice President, supply chain North America region, Genentech (A roche company) Shankar Suryanarayanan, Director, Manufacturing strategy, baxter international Rob Tenerowicz, Vice President, supply chain Management, biomarin Rayne Waller, Vice President, Global supply chain, Amgen Tenerowicz Waller page 2 / bio supply ManaGeMent alliance

3 BIO SUPPLY MANAGEMENT ALLIANCE CONFERENCE PROGRAM October 23, :00 11:00am PLANT TOURS Bio-Rad Instrument Assembly & Distribution Center, Hercules Genentech, South San Francisco 12:00pm REGISTRATION 1:00-5:30pm PLENARY SESSION 1:00-1;15pm WELCOME ADDRESS: "Manufacturer- Supplier Collaboration: New Rules of Engagement" Technology in a Flat World is enabling collaboration for productivity in ways that are unprecedented. Best practices from other industries will be presented for consideration in the biopharma industry. New rules of engage ment will be described to meet the emerging challenges of ensuring global supply chain integrity while achieving system-wide cost minimization. Devendra Mishra, Executive Director, BSMA 1:15-2:00pm Industry 360 : "Advancing the Efficacy and Integrity of the Biotech Supply Chain The subjects of supplier relations development, contract manufacturing and clinical trials management, governmental compliance, collaboration for efficiency, cold chain technology challenges, IT deployment, Big Data and analytics, integrity in the global supply chain, emerging markets and best practices from other industries will be discussed to generate solutions for the young biotech industry. Panelists: Kevin Pegels, Vice President Global supply Chain, Bayer Healthcare Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Jayant Aphale, Senior Vice President, Technical Operations, Serepta Therapeutics Susanne Sommerville, Vice President, Supply Chain North America, Roche/Genentech Franck Toussaint, Managing Director, Biolog Europe, Belgium Johan Denecke, Sr. Director, Global Quality Assurance, Life Sciences Solutions, Thermofisher Moderator: Jennifer Parkhurst, Partner, PwC 2:00-2:30pm Are you Ready for Supply Chain Segmentation for Greater Profits and Service? Early lessons learned from this strategy of supply chain segmentation will be highlighted to find the best supply chain processes and policies to serve each customer and each product at a given point in time while also maximizing both customer service and company profitability. A framework will be discussed to drive such a process while giving consideration to company s capabilities and the challenges throughout the entire lifecycle. Rayne Waller, Vice President, Global Supply Chain, Amgen 2:30-3:00pm "Contract Manufacturing: Establishing a Core Competency" Realizing the strategic value of contract manufacturing in a marketplace of uncertainty and volatility of demand, risk of performance to schedule, capital investment constraints and product quality considerations is a long and difficult journey that Gilead Sciences has undertaken successfully. As a result, Virtual Supply Chain Management has become a core competency. Presentation will include 2:30-3:00pm "Contract Manufacturing: Establishing a Core Competency" ~ continued he impediments to be overcome and how transparency and collaboration is achieved with people, processes and technologies. Paul Seaback, Vice President, Global Supply Chain, Gilead Sciences 3:00-3:30pm Building Information Systems to Support Strategic Sourcing from Scratch" A case study of how the challenges faced when the executive first joined Cubist with no systems and tools to understand our spend and to be able to identify opportunities for strategic sourcing, cost reduction, supplier optimization and/or supplier management, etc. A customer driven, low cost solution was successfully implemented with extraordinary results. Mary Kachinsky, Senior Director, Strategic Sourcing, Cubist 3:30-4:00pm NETWORK BREAK 4:00-4:30pm Emerging Trends with Medical Devices in Biotech There is an emerging trend of drug delivery/medical devices being integrated with the packaging of biotechnology products. When manufacturers add drug delivery devices as part of their primary packaging, it is classified as a combination product. The presentation will highlight some of the reasons why and benefits to the patient community. The latest regulatory and compliance requirements for combination products will also be outlined. Kevin Prosise, Operations Manager, Bayer Healthcare 4:30-5:00pm The Drug Supply Chain Security Act: At the Cross Hair" Last November, President Obama signed the Drug Quality and Security Act. Title II, the Drug Supply Chain Security Act (DSCSA), requires the Secretary to establish federal guidelines for licensing wholesalers and third-party logistics providers (3PLs) and the development of an interoperable Track and Trace system that pre-empts existing state pedigree laws. Presentation will provide an informative update and timeline assessment for these new requirements, focusing on the initial efforts with FDA, supply chain stakeholders, and Congress to achieve the interoperable Track and Trace system as well as touch on an International perspective and global challenges. Chip Meyers, Vice-President, Corporate Public Affairs, UPS 5:00-5:15pm SCM INNOVATION AWARDS 5:15-6:30pm COCKTAIL RECEPTION bio supply ManaGeMent alliance 2014 / PAGE 3

4 BIO SUPPLY MANAGEMENT ALLIANCE CONFERENCE PROGRAM October 24, :30am-4:45pm TRACK 1: STRATEGIC SOURCING - Track Coordinator: Jim Latimer, Sourcing Leader, Lawrence Berkeley National Laboratories 8:30-9:15am PANEL: "Leveraging Strategic Sourcing for Startups, Small and Mid-Sized Companies in Biotech, Pharma and Medical Devices" Sourcing for R&D, Clinical Trials and Commercialization is a formidable challenge for small and large companies. The global market place, inter-dependence of trading partners in the supply chain, emerging markets of suppliers, IT connectivity and stringent requirements of agility, cost reduction, quality, sustainability of the environment and safety have added challenges to management responsible for strategic sourcing. Panelists: Isaac Young, Sr. Director Supply Chain Operations, BioMarin Mary Kachinsky, Sr. Director, Strategic Sourcing, Cubist Sophia Sharp-Donaldson, Head of Strategic Sourcing & Global Logistics, Baxter Healthcare Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Moderator: Jim Latimer, Sourcing Leader, Lawrence Berkeley National Laboratories 9:15-9:45am "Rx-360 Upstream Supply Chain Security: A Supplier Collaborative Approach to Mitigate Risk and Enhance Transparency" Presentation on best demonstrated practices (BDPs) in the areas of Supply Chain Security Awareness, Supply Chain Mapping, Risk Assessment Tools and Risk Assessment Approaches, the Importance of Intended Use of the Product, Supplier Questionnaires / Surveys and Change Control and Change Notification. The content was developed after assessing the Rx-360 membership survey on upstream supply chain security business practices of over 80% of the top 15 largest global pharmaceutical manufacturers. The presentation will focus on BDPs to improve quality through supplier and industry collaboration. Rob Welsh, VP, Category Management, Production Chemical Operations, VWR International 9:45-10:15am NETWORK BREAK 10:15-10:45am "A New Perspective on Mentoring: Peer Mentoring at Cubist " The traditional mentoring relationship, pairing a junior employee with one senior colleague, is not enough in today s rapidly changing, increasingly complex work environments. No one mentor can be expected to provide all the necessary knowledge, guidance, and opportunities for career advancement and professional development. Based on the thought leadership of Kathy E. Kram, Professor of Organizational Behavior at Boston University s School of Management, and Monica C. Higgins, Professor of Education at Harvard University s Graduate School of Education, Cubist has embraced a new approach to mentoring Peer Mentoring. Claire Joyce, Senior Manager of Learning and Development, will discuss the genesis and implementation of Cubist s two peer mentoring programs, together with the response from employees. Claire Joyce, Senior Manager, Learning and Development, Cubist 10:45-11:45am "Town Hall Meeting for Interactive Solution Development" The attendees will be assigned to groups for Supplier Relations Management, Systems, HR Development of Executives, Risk Management and other burning issues so that issues and answers can be addressed. The individual teams will present their findings and initiatives to the general assembly. Leaders: Jim Latimer, Sourcing Leader, Lawrence Berkeley National Laboratories Mary Kachinsky, Sr. Director, Strategic Sourcing, Cubist Claire Scarborough Joyce, Manager, Learning & Development, Cubist Christelle Laot, Technical fellow, Life Sciences & Specialty Services. FedEx 11:45-12:30pm "Report from the Town Hall Meeting" Spokespersons: Supplier Relations Management: Jim Latimer Systems and Technology: Mary Kachinsky HR Development: Claire Scarborough Joyce Risk Management: Christelle Laot 12:30-1:30pm NETWORK LUNCH 1:30-2:30pm The DNA of Source-to-Pay: Cracking the Code on a Business Case for Procurement Transformation Driving transformational change across Source-to-Pay processes requires a formula that consists of these key elements: 1) Rock solid business case analytics, 2) Transformational technology and robust implementation planning, and 3) a Vision of the To Be end state process. This session will highlight best practice strategies, relevant benchmarks, and a methodology for developing the right formula for a winning business case and successful execution of transformational change. The key takeaways include Sample Business Case Analytics for S2P ROI Justification, Benchmarks for Monitoring and Measuring Performance and Vision of Future State Procurement Transformed. Richard Waugh, Vice-President, Corporate Development, ZYCUS 2:30-3:00pm Developing Transformative Biotech Strategies The Technology Way! Truly transformative change is hard, but innovative companies are doing it today at an ever-increasing pace. Explore some of the information, technologies, personnel and paradigm shifts that are allowing bio-companies to re-model their cost-side strategies in ways which optimize their potential for growth and innovation. John Lark, Senior Director, Solutions Marketing, Ariba 3:00-3:30pm NETWORK BREAK page 4 / bio supply ManaGeMent alliance

5 8:30am-4:45pm TRACK 1: STRATEGIC SOURCING - Track Coordinator: Jim Latimer, Sourcing Leader, Lawrence Berkeley National Laboratories 3:30-4:00pm Accelerating Beyond Post Market Surveillance Post Market Surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilane. In today s fast moving Medical device industry it is important to develop highly effective monitoring and cross functional decision making process to adapt quickly to the changing customer uses. Focus will be on establishing an effective cross functional collaboration across Sales, Field Service, Marketing, Product Management, Technical Service, and Operations to fully identify the changing voice of the customer and establish effective mechanisms to pro-actively evolve products and specifications. Several tools will be introduce to help this identification. Johan Denecke, Sr. Director, Global Quality Assurance, Life Sciences Solutions, Thermofisher 8:30am-4:45pm TRACK 2: CLINICAL SERVICES SUPPLY CHAIN & COLD CHAIN - Track Coordinator: Vishal Singal, Vice President, Cold Chain & Emerging Markets, BSMA 8:30-9:15am "Clinical Operations Management: Best Practices and Services for the Global Marketplace Presentation of how supply chain can support clinical development and help serve as a launching point for commercial success in the most economical and timely manner. Learn and share with your peers solutions and best practices to common challenges encountered in clinical supply chain. Hear how the experts perform forecasting, determine safety stock levels, manage inventory, reduce costs and lead times, satisfy labeling, packaging and cold chain requirements, and handle shipments to emerging markets. The IT Integration in the supply chain will be discussed. Panelists: Bill Coakley, Director, Supply Chain Planning, Bio-Marin Luke Moyer, Project Services Liaison, Almac Clinical Services Irene Ping Xie, Sr. Manager, Clinical Supply Management, Gilead Sciences Michael Moro, PMP, Senior Manager Clinical Trial Materials, Acadia Moderator: Devendra Mishra, Executive Director, BSMA 9:15-9:45am Global Clinical Supplies & The Road Less Traveled: Navigating the bumps, pot holes and detours that come with the development and delivery of Investigational Products. Commercial supply chains are characterized by efficiency, throughput, automation and real time tracking of goods. They are equivalent of a well paved, fast motorway. While clinical supply chains can learn a great deal from their commercial counterparts, they also must operate in an environment that is predictably ever changing, has added regulatory and distribution constraints, is subject to scientific "surprises", and on the critical path to new product launches. Perhaps the equivalent of an unpaved shortcut through the briar patch... Learn more about the differences in commercial and clinical supplies, regulatory drivers, operational challenges as well as strategies for delivering on time, every time. Lorna Briddick, Managing Partner, Brizzey LLC 9:45-10:15am NETWORK BREAK 10:15-10:45am New Technology Assisting & Empowering the Global Supply Chain New products types and movement of materials across temperature and time zones has spurred innovation across the clinical supply chain. Hear about some of the more interesting technology that has emerged and why it is making a difference to clinical supply chain professionals and investigator sites around the world. What are unmet needs that still exist today and are there any relevant possibilities from the commercial world that might be able to help clinical teams still facing challenges. Alex Guillen, Director, Global Cold Chain, Fisher Clinical Services Michael Moro, PMP, Senior Manager Clinical Trial Materials, Acadia 10:45-11:15am "Risk Management Methods Applied to Healthcare Transportation Solutions" Transportation providers are leveraging risk management methods used by the pharmaceutical and biotech industry to build a comprehensive risk-based approach towards shipping solutions, and in particular towards those dedicated to temperature-sensitive shipments. A few FedEx Express examples will be used to illustrate how robust risk management documents and protocols can be created for specific transportation products and services. Risk assessment, risk quantification, and risk control will be addressed. Findings of the risk management exercise enable logistics departments to take advantage of analytical methods to prioritize activities, resources, and investments. Christelle Laot, Technical Fellow - Cold Chain Management, Life Sciences & Specialty Services, FedEx Irene Ping Xie, Sr. Manager, Clinical Supply Management, Gilead 11:45-12:30pm "Town Hall Meeting for Interactive Solution Development" The attendees will be assigned to groups for Supplier Relations Management, Information Systems and Technology, Regulatory Matters in Emerging Markets, Risk Management and other burning issues so that issues and answers can be addressed. Leaders: Bill Coakley, Director, Supply Chain Planning, Bio-Marin Vishal Singal, Vice President, Cold Chain & Emerging Markets, BSMA bio supply ManaGeMent alliance 2014 / page 5

6 8:30am-4:45pm TRACK 2: CLINICAL SERVICES SUPPLY CHAIN & COLD CHAIN - Track Coordinator: Vishal Singal, Vice President, Cold Chain & Emerging Markets, BSMA 12:30-1:30pm NETWORK LUNCH 1:30-2:15pm "Report from the Town Hall Meeting" Leaders of the individual teams will present their findings and initiatives to the general assembly. Spokespersons: CC Technology CC Best Practices CC Regulation CO Planning CO Best Practices CO Regulation 2:15-3:00pm 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 Wahiba Hall, Senior Manager Global Logistics/Cold Chain Management, Bayer HealthCare Karl Schlenker, VP Business Development, va-q-tec USA Doug Wettegren, Regional Sales Manager & Global Key Account Manager, Envirotainer Moderator: Vishal Singal, Vice President, Cold Chain & Emerging Markets, BSMA 3:00-3:30pm Track and Trace Solutions Available in the Industry: A Research Perspective How can track and trace technology be employed to improve supply chain security? This session review the development of track-and-trace services that are being offered by transport service providers and discuss what is new to the market. A demonstration of the technology will also be given. Chris Fore, Compliance Manager, Envirotainer 3:30-4:00pm NETWORK BREAK 4:00-4:30pm Qualification & Validation Best Practices Due diligence in cold chain means not simply using a qualified shipper, but qualifying the shipper to perform within the condition of the entire shipping process, whether overnight to the Midwest, or four days to the Far East. Commissioning a transit study to qualify your shipping system will lower costs in a number of ways. This includes dramatically reducing loss of material and the repetitive testing of suspect material. A transit study will allow you to identify when a more expensive shipper combined with a less expensive transport option, such as twoday ground vs. overnight, is more cost effective than a less expensive shipper, combined with occasional use of a specialized courier service. Jim Peyton, Associate Director, Supply Chain, Gilead Sciences 4:30pm WRAP UP page 6 / bio supply ManaGeMent alliance

7 BIO SUPPLY MANAGEMENT ALLIANCE 2014 speakers, presenters, & panelists thank you to our Aphale Briddick Buck Coakley Denecke Fore Jordan Joyce Kachinsky Laot Lark Latimer Marcus Meyers Parkhurst Pegels Peyton Prosise Seaback Somerville Toussaint Moro Guillen Hingst Mishra SharpDonaldson Waller Waugh Welsh Wettergren Moyer Singal Xie Young academic sponsors Because life depends on us m bio supply ManaGeMent alliance 2014 / PAGE 7

8 BIO SUPPLY MANAGEMENT ALLIANCE Because life depends on us Bio Supply Management Alliance membership is open to those who belong or have an interest in the operations and supply chain activities in the bio life sciences. The member dues cover all subsidiaries of the entity. BSMA is dedicated to increasing the capabilities and knowledge of bio life sciences supply chain management professionals worldwide. MEMBERSHIP APPLICATION COMPANY NAME WEBSITE HEADQUARTERS ADDRESS LATEST Y/E REVENUES TICKER SYMBOL CITY STATE/PROVINCE COUNTRY POSTAL CODE PRIMARY CONTACT NAME WORK PHONE FAX TITLE MOBILE PHONE ADDRESS CITY STATE/PROVINCE COUNTRY POSTAL CODE MEMBERSHIP CATEGORY (CHECK ONE) Member Category Member Description Annual Dues (select one) Executive Membership Level 1 Annual Revenues Greater than $1 Billion $12,500 Executive Membership Level 2 Annual Revenues Less Than or Equal to $1 Billion $6,500 Executive Membership Level 3 Emerging and Startup Drug Companies $2,000 without a commercial product Affiliate Membership 1 Annual Revenues Greater than $250 million $6,500 Affiliate Membership 2 Annual Revenues Less than or Equal to $250 million $2,500 Academia Membership Any accredited academic institution that works in $500 support of the bio life sciences. Individual Membership Annual Revenues Greater than $1 Billion $500 PAYMENT Membership is effective upon receipt of dues payment and is active for twelve (12) months thereafter. If paying by check, make payable to BIO SUPPLY MANAGEMENT ALLIANCE. Send completed application to Devendra Mishra, Park Andorra, Calabasas, CA or fax to CREDIT CARD NUMBER or CHECK NUMBER EXPIRATION DATE CDC NAME ON CREDIT CARD SIGNATURE DATE

9 JOIN THE BIO SUPPLY MANAGEMENT ALLIANCE Supply Chain Leadership & Excellence Become a member of the world s leading organization for operations and supply chain management professionals in the bio life sciences industry. Because life depends on us, the Bio Supply Management Alliance supports continuous learning and development of bio supply management professionals and the enhancement and efficacy of the supply chain in the industry through collaboration. MembershipBenefits Advisory board membership Participation in industry-specific steering committees Passes to BSMA partner events Marketing and advertising in quarterly industry journal Upgrade on sponsorship and group registration packages to partner events Exclusive banner ad on newsletter and top rotation on Alliance website Company logo on organization communications Exclusive access to Alliance online community Discounts to Alliance events Exclusive access to online presentations from BSMA sponsored events FIND OUT MORE: Because life depends on us

10 JOIN THE BIO SUPPLY MANAGEMENT ALLIANCE STEERING COMMITTEES PROMOTING INDUSTRY SUPPLY CHAIN INITIATIVES! SUPPLY CHAIN INFORMATION MANAGEMENT (SCIM) STEERING COMMITTEE Identifying the best information and systems technology required to meet the complex technology needs of the biotech and pharma supply chain. CHAIRPERSON: Grant Hodgkins, Strategy Standards & Process Manager, Global Supply Chain, Alcon Laboratories R. Arun Kumar, VP, Global Sales, Capgemini Colin Finn, Founder and VP, Marketing, Pelyco Systems Kevin Riccoboni, IT Leader, Global Operations, Life Technologies Lou Killian, Enterprise Systems for Technical Operations, BioMarin Tim Kvanvig, Business Unit Life Sciences, Oracle SUPPLY CHAIN STRATEGIC SOURCING (SCSS) STEERING COMMITTEE Identifying and enabling the sharing of best practices in common areas of interest relating to strategic sourcing. CHAIRPERSON: Jim Latimer, Senior Director, Purchasing and Supply Management, Elan Dan Ambrose, Director Customer Logistics, VWR International Paul Anderson, VP, Global Procurement, Life Technologies Mark Buck, Global Procurement and Supply Leader, Bio-Rad Laboratories Ken Duval, Associate Director, supply chain, shire Dale Dwier, Manager, strategic sourcing, bayer Healthcare Rick Fultz, Director, Purchasing Group, biocom Tom Heebink, business Development & strategic Alliances, bio Tim Jordan, Associate Director supply chain, MAP Mary Kachinsky, senior Director, strategic sourcing, cubist Marc Lampron, senior Director, Procurement, Genentech Myles Marcus, Vice President, supply chain, Dendreon Mike Mayo, Director, Materials and Procurement, Olympus Biotech Mike Mitchell, Director, Supply Chain Management, SAFC Biosciences Isaac Young, sr. Dir., supply chain Operations, biomarin, inc. Yingming Yue, Associate Director, Nektar Therapeutics SUPPLY CHAIN TALENT MANAGEMENT (SCTM) STEERING COMMITTEE Developing leaders and programs that increase the capabilities and skills in the biotech and pharma supply chain community. CHAIRPERSON: Muffie Dalton, Associate Director, Operations Planning Genentech Don Wilson, Associate Manager, Amgen Keith Launchbury, cfpim, President, Keith Launchbury and Associates, Vice chair, bsma talent Development committee Devendra Mishra, founder & executive Director, bio supply Management Alliance Nancy Nix, Ph.D., Executive Director, Executive MBA Program; Supply Chain Professor, Neeley School of Business, Texas Christian University Dave Malenfant, VP, Global Supply Chain, Alcon Laboratories Inc. Phil Kaminsky, Ph.D., Professor, School of Industrial Engineering, University of California, Berkeley, Site Director, Center for Excellence in Logistics and Distribution Richard Dawe, Ph.D., Professor, Ageno School of Business, Golden Gate University Kevin Pegels, VP, Supply Chain Management, Bayer Healthcare Adam Zak, CEO, Adam Zak Executive Search SUPPLY CHAIN RISK MANAGEMENT (SCRM) STEERING COMMITTEE Identifying the best practices for the identification, measurement, and execution of managing risks in the end-to-end supply chain of the biotech and pharma industry. CHAIRPERSON, Vijay Chiruvolu, Director, Operations Risk Management, Amgen Adam Zak, founder and ceo, Adam Zak executive recruiter Laboratories Arun Cavale, Principal, NexInfo Carla Reed, Principal, Tunnell Consulting Chris Sam, Executive Director, Craigshannock Dave Malenfant, SVP, Global Supply Chain, Alcon Jane Lavine, Insurance Executive Lew Kontnik, Director of Brand Protection, Amgen Michael Mooney, Dir., Risk Management & Insurance - The Americas, Expeditors Mohinder Sikka, CEO, Sensitel Ron Bone, SVP, Distribution, McKesson Thomas Smith, Director, Supply Chain, Shire Yingming Yue, Associate Director, Nektar therapeutics page 10 / bio supply ManaGeMent alliance

11 STEERING COMMITTEES PROMOTING INDUSTRY SUPPLY CHAIN INITIATIVES! ENVIRONMENTALLY CONTROLLED LOGISTICS (BIOTECH COLD CHAIN MANAGEMENT) STEERING COMMITTEE Identifying the best practices for controlled environmental logistics to maximize patient safety and enhance its value chain. CHAIRPERSON: Gary Hutchinson, CEO, Modality Solutions Rod Derifield, President, Envicooler Don Wilson, Associate Manager, Amgen Douglas Wettergren, Regional Sales Manager, Western North America, Envirotainer Ed Church, Executive Director, ISTA Jim Cox, CEO, TempTRIP Paul Harber, Associate Engineering Consultant, Eli Lilly MOLECULAR DIAGNOSTICS TESTING STEERING COMMITTEE Establish a network and facilitate the sharing and building best practices, advancing the adoption of information systems and tools, and meeting the challenges of logistics in emerging markets of the Molecular Diagnostics Testing segment of the biopharma industry. The broad areas to be embraced are Sales & Operations Planning, Materials Management /Strategic Sourcing and Procurement, Logistics, Information Technologies, Emerging Markets and SCM in general. CHAIRPERSON: Mike Crowell, Sr. Director, Supply Chain Management, Verinata Health Alan Wells, Vice President, Diagnostics Laboratory Operations, Life Technologies, Andrea Fox, Sales Executive - Life Sciences, FedEx Arbi Harootoonian, Vice President, Business Development, Therapak Glen McHenry, Sr. Manager Supply Chain Management, Monogram Biosciences Jordan Myers, Sales Associate, VWR Healthcare Karel Hurka Jr, Sr. Manager Supply Chain Management, Genomic Health Scott Krhoun, Supply Chain Operations Manager, Tethys Biosciences Meserve Platt, Associate Director Materials / Facilities, crescendo Bioscience Rishi Kacker, Vice President, Engineering, Counsyl Diagnostics Susan Jiang, Health Supply Chain Supervisor, Verinata Health Tom Schoenherr, Vice President, Business Development, Counsyl Diagnostics Winnie To, Supply Chain Manager, Natera Health HEALTHCARE POLICY COMMITTEE Informing and educating the members about governmental regulations related to the Biopharma industry and serve as a resource for the governmental agencies as it develops and implements regulations. CHAIRPERSON: Ron Bone, SVP, Distribution, McKesson Karen Conway, Director, Healthcare, Global Health Exchange Lou Kontnik, Director of Brand Protection, Amgen Mike Wallace, Director, Global Standards & Serialization, Enterprise Master Data, Abbott Laboratories Wayne McDonnell, Pharma & Life Sciences Advisory, PricewaterhouseCoopers SUPPLY CHAIN CLINICAL OPERATIONS (SCCO) STEERING COMMITTEE Identifying and enabling the sharing of best practices, knowledge and experience in clinical supply chain and integrate clinical operations as a critical segment of the overall supply chain. CHAIRPERSON: Bill Coakley, Director, SC Planning, Biomarin Philip Chou, Associate Director, Clinical Supplies, Elan Michael Dallmann, Associate Director, Clinical Supplies, Cerexa Jaymin Eberhart, Principal, PRTM Richard Horn, Associate Director, Supplier Management, Nektar Therapeutics Theodore James Maylath, Manager, Clinical Supply, Abbott Amy Penticoff, Associate Director Pharmaceutical Sciences, NeurogesX, Inc. bio supply ManaGeMent alliance 2014 / page 11