APRIL 26, 2017 BOSTON CAMBRIDGE MARRIOT BOSTON, MA www.biosupplyalliance.coM

association sponsors

San Francisco RoundtableCouncil of Supply Chain Management Professionals

BIO SUPPLY MANAGEMENT ALLIANCE

"DRIVING INNOVATIONS IN THE GLOBAL BIO-

PHARM SUPPLY CHAIN"

Building Supply Chain Excellence End to End

paGe 2 / bio supply ManaGeMent alliance 2017 www.biosupplyalliance.coM

MissionStatementto 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.

AdvisoryBoard

Chattioadhyay

Seaback Tenerowicz

HammanDawe PegelsAnderson Kachinsky KaminskyBuck

ExecutiveCommitteeDevendra MishraEXECUTIVE DIRECTOR & CO-FOUNDER Dave MalefantEXECUTIVE VICE PRESIDENT, INDUSTRY LIAISON & TALENT DEVELOPMENTShankar SuryanarayananVICE PRESIDENT, STRATEGIC PLANNING & INTERNATIONALBill Coakley VICE PRESIDENT, STRATEGIC ALLIANCEVishal SingalVICE PRESIDENT, COLD CHAIN & EMERGING MARKETSPamela GardnerVICE PRESIDENT, SPONSOR SALES Dotti YellsVICE PRESIDENT, MARKETING , WEBMASTER & DBA Wayne McDonellINDUSTRY LEADER, PwCJohn MitchellLEGAL COUNSEL

BIO SUPPLY MANAGEMENT ALLIANCE

Kevin Pegels, Vice President, Global Supply Chain, IlluminaPaul Seaback, Head of Global Supply Chain, Gilead SciencesSophia Sharp-Donaldson, Head of Global Source & Procurement, Baxalta US Inc.Joel Sutherland, Managing Director, SCM Institute, University of San DiegoShankar Suryanarayanan, Director, Manufacturing Strategy, Baxter InternationalRob Tenerowicz, Vice President, Supply Chain Management, BioMarinPrashant Yadav, Director, Health Care Reserach Initiatiave, William Davidson Institute

Aphale

Paul Anderson, Sr Director, Toll Manufacturing & Supply Chain, IlluminaJayant Aphale, VP, Technical Operations, Serepta TherapeuticsNevada Blair, Director, Supply Chain Management, Bayer Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad LaboratoriesSom Chattopadhyay, Vice President, Global Supply Chain, AmgenPrentice Curry, VP Quality & Operations, Kite PharmaDr. Richard L. Dawe, Director of the Operations & Supply Chain Management Program and the Center of Operations Management, Golden Gate UniversityLisa Hamman, VP & Region Head, NA Supply Chain, GenentechMary Kachinsky, VP, Strategic & Sourcing Ops, Forma TherapeuticsPhil Kaminsky, Associate Dean for Academic Planning & Development, University of California, Berkeley

Curry

Sharp-Donaldson

Sutherland Suryanarayanan Yadav

Blair

bio supply ManaGeMent alliance 2017 / PAGE 3www.biosupplyalliance.coM

April 26, 2017

8:00 - 9:00am REGISTRATION9:00 –9:15am WELCOME ADDRESS Devendra Mishra, Executive Director, BSMA9:15 - 10:00am PANEL: “Industry 360° - Advancing the Efficiency and Intelligence of the Biotech 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, Big Data and analytics and emerging markets. Approaches will be discussed to achieve disruption in traditional practices through technology and collaboration for efficiency and less onerous compliance with governmental regulations.PANELISTS: Yashwant Aphale, Vice President, Technical Operations, Sarepta Therapeutics; Ken Duval, Director Procurement Operations and Supply Risk, Shire; Mary Kachinsky, Vice President, Strategic Sourcing and Operations, Forma Therapeutics; Iris Stammberger, CEO, Talbok Consulting; Prashant Yadav, Director, Healthcare Research, William Davidson Institute, University of Michigan; MODERATOR: Devendra Mishra, Executive Director & Co-Founder, BSMA10:00 - 10:30am KEYNOTE ADDRESS: "Patient-centric Supply Chain in the Disruptive Digital World of Healthcare: Seizing the Potential!"The healthcare value chain is an extremely fragmented, multi-layered system of trading partners and intermediaries. This fragmentation makes it challenging for biopharma organizations to keep the end user, the patient, at the center of their supply chain strategies. The presentation will cover the ways supply chain and digital technologies can disrupt this fragmentation and create a more patient-centric supply chain organization. KEYNOTE SPEAKER: Barry Blake, Vice President, Program Director, SCM World10:30 - 11:00am  KEYNOTE ADDRESS: "Pharmaceutical and Biotech Company Practices and Strategies that Create Efficient Global Clinical Supply Logistics"Global clinical supply professionals are driven by a simple credo: to provide the highest possible quality clinical trial supplies in a fast and efficient manner. Tufts CSDD will present data not previously revealed from a clinical supply logistics study on key distribution metrics and strategies for success as well as improved efficiencies organizations are reporting across top pharmaceutical and biotech companies. Strategies for managing returns and the use of pooled supplies, as well as global approaches to expiry dates and temperature monitoring strategies globally will be examined as well as their impact. Organizational training and communication approaches will also be shared as well as measures that have improved training effectiveness. KEYNOTE SPEAKER: Mary Jo Lamberti, Senior Research Fellow, Tufts Centre for the Study of Drug Development

11:00 - 11:30pm NETWORK BREAK

BIO SUPPLY MANAGEMENT ALLIANCE

CONFERENCE PROGRAM

11:30 - 12:15 pm PANEL: "Meeting the Formidable Challenges of Strategic Sourcing for Developing a Virtual Infratructure for Drug Development and Commercialization"For small and medium-sized biotech companies, the tasks of procuring the services required to support drug discovery, development and commercialization are overwhelming. They are often underserved because of misaligned experience, limited resources, investment constraints, and incomplete knowledge of what options are available on the market. In this context, the role of strategic sourcing becomes vital to ensuring the success of the enterprise: meeting quality and regulatory requirements, accelerating speed to market and delivering compelling financial results. Identifying, qualifying, and establishing outsourcing relationships contributes to enterprise strategy, innovation, and collaboration. Given the rising importance of digital technology in procurement, a supplier discovery and knowledge management platform will be presented that centralizes information and instantly connects supplier capabilities with specific requirements. This dynamic session will highlight how to supplement scarce internal resources and overcome organizational constraints with the full capabilities of suppliers for synergy creating value beyond cost savings.PANELISTS: John Napoli, Director, Information Services, Perkin Elmer; Kimberly Lounds Foster, Corporate Vice President, Global Supply, Celgene; Stephany Lapierre, Founder and CEO, Tealbook; Matt Weinberg, Director, Strategic Sourcing and Procurement, Agios; MODERATOR: Mary Kachinsky, Vice President, Strategic Sourcing and Operations, Forma Therapeutics12:15 - 1:00pm PANEL: "Unleashing the Trapped Value in the Supply Chain Management Process by Starting at the Beginning of the Sourcing Process - Drug Discovery & Development CROs and CMOs” The intrinsic nature of a biotech company has the CROs and CMOs providing extraordinary value in discovery, development and delivery of drugs under the umbrella of cost efficiency, scalability and time to market. The consequent challenges of achieving total alignment of strategic objectives, seamless integration of services, capability to monitor the process and ensuring governmental regulatory compliance are enormous. The executives of small to large biotech companies from both the buy and sell sides will address how management, systems and technology are being deployed to optimize drug R&D programs that maximize success of drug delivery to the market in a speedy and efficient manner.Introduction: Shelly Amster, Founder and Principal, ShellyCO; PANELISTS: Andy Nichols, PhD. CSO, Catabasis Pharmaceuticals, Inc.; Liz O’Day, PhD, CEO & Founder, Olaris Therapeutics, Inc.; Roya Khosravi-Far, PhD, Co-Founder & Chief Scientific Officer, BiomaRx; Paul Wengender, CEO, Crow’s Nest Bio; MODERATOR: Michael Luther, CEO and President, Bantam Pharmaceuticals

1:00 - 2:00pm LUNCHEON NETWORK

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4:00 -4:45pm PANEL: “Optimizing and Integrating (Cont'd) The practical opportunities to significantly reduce cost, time and failures in Clinical Trials of drugs, while ensuring regulatory compliance, will be addressed through the deployment of automation of clinical protocol request process; a patient-centric approach to overcome logistics impediments to patient enrollment; demand planning and inventory management with drug expiry; integration of labeling, packaging, delivery and returns with governmental regulations in mind; and, enhanced integration of the IRT links based on transparency and trust. In addition, the unique opportunities in Latin America will be explored for patient enrollment.PANELISTS: Arun Cavale, CEO, NexInfo; Sara Tylosky, President & CEO, Farmacon; Maggie A. Pax, Vice President, Strategy and Marketing, Thermo Fisher Scientific BioPharma Services; MODERATOR: Jim Shuman, Principal, JMB Consulting4:45 - 5:15pm PANEL: “Are You Ready for Serialization 2017 Mandate of DSCSA?”An interactive panel discussion will cover how to prepare for the November 2017 deadline for DSCSA serialization. Serialization can involve manufacturing implementation of unit level bar coding, case and pallet level aggregation, system management of product movement, warehousing and distribution processes to ship product. This panel will address topics such as: pharmaceutical manufacturers/CMO collaborations and integration, line management upgrades, serialization readiness, and discuss how to overcome these operational challenges while achieving compliance with the least cost, time and risk to your organization. Finally, the panel will provide an overview of global serialization requirements with first-hand experience of how support of these regulations may benefit from early lessons learned in US implementation of serialization.PANELISTS: Brian Daleiden, VP Industry Marketing, TraceLink; Franco Pasquale, Sr Director of Supply Chain, Technical Operations, Agios; Jaclyn Bissonnette, Sunovion Pharmaceuticals; John Kuczek, Sr Director, Supply Chain, Flexion Therapeutics; MODERATOR: Greg Cathcart, CEO, Excellis Health Solutions5:15 - 5:45pm PANEL: “Disruptive Technology Rewiring the Supply Chain with Real Time Intelligence?”This insightful, technology-driven panel of executives will explore how machine learning algorithms and artificial intelligence are being deployed today to identify specific patterns from environmental sensor data such as light, pressure, humidity, shock and temperature to visually segment supply chain shipments into their parts (truck, warehouse, tarmac, flight, rail, boat). Combination of these insights on a global scale, generates highly accurate handling and excursion benchmarks for airports, shippers, lanes, and seasons. From these benchmarks, pharmaceutical companies quickly and accurately project the optimal shipping method to minimize risk, reduce product damage, and cut transportation costs. The capabilities emerging from IoT will be presented.PANELISTS: Rich Kilmer, CEO, Cargo Sense; Ken Cottrill, Research Principal, Chain Business Insights LLC; Dave Bang, CEO, LifeConEx (DHL Global Forwarding); Pat Luisi, Regional Manager, Healthcare Group North America, Expeditors International; David Windsheimer, Vice President, Global Supply Chain, Bio-Rad Laboratories; MODERATOR: Vishal Singal, Prinicipal, Real World Insights, QuintilesIMS

2:00 - 2:30pm KEYNOTE ADDRESS: "Global Supply Chains are ABout to Get Better, Thanks to Blockchain"A comprehensive view of the transformational potential of blockchain technology as it pertains to supply chain management of the healthcare and life science industry will be presented based on the ongoing research at the MIT Media Lab. Fundamental issue will be explored as how distributed ledger technology could allow suppliers with unaligned interests to selectively share vital information on production process and payment flows in a manner that all parties can trust and to extract value at different stages of the chain. The resulting transparency and market discovery capacity could significantly improve resource usage and give consumers, businesses and regulators greater confidence in the provenance of the goods and services we consume.KEYNOTE SPEAKER: Michael Casey, Senior Adviser, Blockchain Opportunities, Digital Currency Initiative, MIT Media Lab2:30 - 3:00pm "Leveraging Product Lifecycle Management (PLM) & Regulatory Information to Address the Complexity and Cost of Drug Portfolio"Product portfolio complexity in pharma and biotech continues to increase with the launch of new products and approval of variations post-launch. Complexity comes from the number of products and SKUs, and also in the ability to manage the pipeline, registration, launch, and post launch re-submission activities. Many companies have not developed the processes, organization and systems to address this complexity and manage the associated costs. Results of a bench marking study involving 20+ companies to characterize the current state of managing this complexity and the associated costs will be presented for the first time. Best practices will be discussed both within the life sciences industry as well as other sectors, and how tools such as Product life cycle management (PLM) and Regulatory Information management (RIM) can be leveraged to deliver significant advantages in cycle times and productivity. SPEAKERS: Wayne McDonnell, Principal, Pharmaceutical & Life Sciences Advisory, PwC; Shankar Iyer, Director, Pharmaceutical & Life Sciences Advisory, PwC3:00 -3: 30pm Data Management in the Cloud” 

PANEL: “Benefits and Best Practices for GxP

The ascension of the patient-centric supply chain, omni-channel e-commerce, mobile computing, and big data analytics promise significant business benefits; however, they rely more and more on an enterprise level approach to providing a single point of access and control and for your GxP-critical data. The strategic opportunity, best practices, technical roadmap and validation considerations of a cloud transformation of GxP data will be discussed on this panel. PANELISTS: John Danese, Sr. Director Life Sciences Strategy, KPIT; Chandra Pandey, Supply Chain & ERP Thought Leader, PO&T Technology and Business Solutions, Biogen; Deepak Gupta, Global Practice Director and Chief Architect, Oracle MDM Practice, KPIT; Sophia Hannay, Director, Global Supply Chain Master Data, Celgene; MODERATOR: Todd Hein, Sr. Director, Oracle Life Sciences3:30 - 4:00pm NETWORK BREAK4:00 -4:45pm PANEL: “Optimizing and Integrating the Fulfillment Process of the Clinical Supply Chain in the Global Territories: Technology, People and Processes” 

April 26, 2017BIO SUPPLY MANAGEMENT ALLIANCE

CONFERENCE PROGRAM

www.biosupplyalliance.coM bio supply ManaGeMent alliance 2017 / paGe 5

5:45- 6:00pm WRAP UP!SCM EXCELLENCE AWARD CEREMONY“SCM Innovation Awards” have been given since 2014 to the stakeholders of the Biotech industry – Manufacturers, Service and Material Providers, Technology Enablers, Academia, Management Consultants, Trade Associations and Governmental Regulators, in order to recognize exemplary contribution towards advancing the Global Supply Chain.6:00 - 7:00pm NETWORKING COCKTAIL RECEPTION

KEYNOTE SPEAKERS

Blake Casey Lamberti

PANELISTS

Amster Aphale Bang

Bissonnette Cathart Arun

Cottrill Daleiden Danese

Duval Foster Gupta

Hannay Hein Iyer

Kachinsky Kilmer

Kuczek LaPierre

Luisi Luther McDonnell NapoliMishra

Nichols O'Day

Pandey Pasquale

Pax Shuman Singal Stammberger Tylosky

Weinberg Wengender

Windsheimer Yadav

Khosravi-Far

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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.

• 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 partnerevents

• 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

BIO SUPPLY MANAGEMENT ALLIANCE

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Supply Chain Leadership & Excellence

Because life depends on us™