4th BSCA Conference – Foster City, 2011

8:00am – 7:00pm

REGISTRATION

8:00am – 1:00pm

STEERING COMMITTEE OPEN FORUMS

Strategic Sourcing (Room:  SYRACUSE)

SCM Talent Development (Room:  DRAKE I)

Information Systems (Room:  STANFORD)

11:00am-12:00pm

STEERING COMMITTEE OPEN FORUMS

Clinical Operations (Room:  SYRACUSE)

Risk Management & Healthcare Policies (Room:  STANFORD)

Environmentally Controlled Logistics (Cold Chain) (Room:  DRAKE I)

12:00pm-1:00pm

OPEN LUNCH

GENERAL CONFERENCE (Room:  ALEXANDRIA-BALBOA)

1:00pm – 1:05pm

WELCOME

Devendra Mishra, Conference Co-Chairman, Executive Director, BSMA

1:05pm-1:30pm

“Life Sciences & Healthcare Vision 2020: Building a Solid Supply Chain Foundation”By 2020, the healthcare marketplace will demand more value in the form of improved patient outcomes.  In response, the pharmaceutical and life sciences industry will manufacture more specialized products that target specific diseases and subsets of patients based on their genetic makeup.  The industry will bundle medicines with services to help patients adhere to treatment plans. This shift in focus from product to patient will require manufacturing and distribution techniques radically different from those used to mass-produce the small-molecule drugs more prevalent today. Supply chains will have to evolve within the context of a much deeper understanding of patients and their healthcare needs. The management of information transfer among pharmaceutical and life sciences companies, patients, and healthcare providers will become as important as the movement of products.

Wayne McDonnell, Pharma & Life Sciences Advisory, PricewaterhouseCoopers

1:30pm-2:15pm

“Supply Chain Management: 360”: PANEL The first annual AMR Research Healthcare Top 25 for 2009 recognized those life sciences and healthcare companies – manufacturers, distributors, pharmacies and hospitals, which have demonstrated leadership in developing and leveraging supply chain capabilities. Executives will discuss challenges faced, collaborate and exchange solutions required to impact the supply chain in terms of productivity, quality, customer service, regulatory compliance and patient care.

Chris Horan, VP, Supply Chain, Region North America, Genentech

Grant Hodgkins, Strategy Standards & Process Manager, Global Supply Chain, Alcon Laboratories

Kevin Pegels, Vice President, Global Supply Chain USA, Bayer Healthcare – PS Biotech

Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories

Rob Tenerowicz, Vice President, Supply Chain Management, BioMarin

Moderator: Wayne McDonnell, Pharma & Life Sciences Advisory, PwC

2:15pm- 2:45pm

“Learning from the CPG Industry:  A Results Oriented Perspective” The consumer packaged goods industry is considered a leader in identifying and implementing supply chain management best practices. P&G, Pepsi, Coca-Cola, and Clorox are consistently ranked among the top 20 supply chains globally. This presentation will discuss some of those CPG best practices that have been or could be implemented in the Bio-Pharma industry.

Kevin Pegels, Vice President, Supply Chain – North America, Bayer

2:45pm- 3:15pm

“3rd Party Linkage with Contract Manufacturing” The role and relationship with contract manufacturers will be scrutinized in an environment of unpredictable product launch, lead time to generate manufacturing capacity, global demand and optimization of risk-reward tradeoff. Solution will address the needs of small to large bio-pharma companies trying to maximize fulfillment of market demand.

Shabbir Dahod, CEO, TraceLink

3:15pm- 3:45pm

NETWORK BREAK

3:45pm- 4:15pm

“The time is right:  why global price transparency, rapidly evolving reimbursement models and onerous healthcare reform can be positive forces for the value chain.”Biopharma and Medical Device/technology competitiveness remains under fire as regulatory regimes, customer cost drivers and channel consolidators converge to pressure life sciences companies. Understanding how these forces impact sales channels, market access dynamics as well as pricing, sales and contracting practices is the first step in engaging upstream organizations for highly integrated and nimble response. A practical presentation covers the trends in reimbursement, government pricing, healthcare reform and channel management, their impact and how companies address challenges.

Gopkiran V. Rao, Senior Director, Global Marketing, Model N, Inc.

4:15pm- 4:45pm

“Supply Chain Management:  Resolving Problems, Mitigating Risks, and Capturing Opportunities” Most supply chain executives own a portfolio critical to the success of product supply– of problems, risks, and opportunities.  Managing and measuring problems, risks, and opportunities through different and sometimes conflicting processes skews focus and effort, undermining potential product quality, sales, and profit margins. An innovative, integrated approach for successfully identifying, measuring and managing the ever-changing portfolio of problems, risks, and opportunities will be presented.

Brian Hagen, Managing Director, Decision Empowerment Institute

4:45pm- 5:30pm

“Supply Chain Management Talent in Organizations of Bio-Pharma:  A Research Perspective”:  PANEL The results of the most comprehensive survey of the cross section of the bio-pharma industry will be reported to identify the current state and nature of supply chain management talent, scope of supply chain management, gap between need and degree of fulfillment, organization structures, career ladders, and services available, to name the basic dimensions. Opportunities will be presented to promote the professional development of executives with SCM knowledge and expertise.

Adam Zak, Founder and CEO, Adam Zak Executive Recruiter

Keith Launchbury, CFPIM, Past President, APICS

Kevin Pegels, Vice President, Global Supply Chain USA, Bayer Healthcare – PS Biotech

Nancy Nix, Executive Director, Executive MBA Program; Supply Chain Professor, Neeley School of Business, Texas Christian University

Phil Kaminsky, Associate Professor, School of IE&OR, University of California, Berkeley

Moderator: Muffie Dalton, Associate Director, Plant Operations Planning, Genentech

5:30pm 6:00pm

“Gartner (AMR Research)’s Healthcare Supply Chain Top 25: 2010” During this presentation, Gartner will use the Healthcare Supply Chain Top 25 to share insights into the capabilities companies are developing to drive high quality cost, effective healthcare.  Leaders in healthcare are developing patient centric supply chain strategies; they are sharing key information and collaborating more directly with key trading partners; they are differentiating their supply chain responses to distinct customer and channel segments; they are building cultures that can withstand the pressures that accompany transformation; and lastly, they are supporting these capabilities with a robust set of demand driven, foundational capabilities that enable an end to end value chain transformation.

Barry Blake, Research Analyst, Gartner

6:00pm – 7:00pm

COCKTAIL RECEPTION

8:00am-9:00am

BREAKAST

OPEN WORKSHOPS – KEY SUPPLY CHAIN CAPABILITIES

8:00am-9:00am

BIO-SERIALIZATION 101 – What is it and why should I care?

Serialization, Track and Track, GS1 Standards are among the many emerging regulatory requirements in the business of global pharmaceutical manufacturing, distribution and sales.  These new laws and regulations are aimed at securing the supply chain and improving patient safety. Additionally, there also have the potential to improve supply chain efficiency.  In this session, you will learn the basics of terms, concepts and principals of GS1 Standards, serialization and Track and Trace (TnT) how they will be used in the new business processes which are being written today in markets around the world. 

BIO-SERIALIZATION 201 – I hear the train a comin’……..

California Pedigree, EU Commission report on Falsified Medicines, Standardized Numerical Identifier (SNI), Authentication, Track and Trace. These are some of the many railcars (concepts) on the “Secure Pharmaceutical Supply Train” which is coming your way. They are just a few of the multiple rules, proposals, terms and laws which are being debated, written or have already been enacted in locations around the world.  What do they mean?  When will they start?  How will this affect my company?  What can I do to prepare?   In this session you will learn the basics of these initiatives, prospective timing and how you can begin to develop an action plan for your organization.

J. Michael Wallace, Director, Global Standards, & Serialization, Corporate Finance & Administration, Abbott Laboratories

8:30am-9:00am

“Transformation of Supply Chain in the Biopharma Industry“

External market forces – from the advent of biosimilars, to the potential for sales revenues in emerging markets, to the pressures of Healthcare Reform – are pulling the supply chain to center stage in many biopharma companies. To ensure future success, companies must achieve a balance between risk, cost and service.  No other function in a typical biopharma company is better prepared to help achieve that balance than supply chain.  Presentation will highlight how today’s supply chain function can help the entire corporate enterprise predict market events and be better prepared to respond, decrease costs without compromising service, and develop new operating models that increase service levels to a growing number of internal and external customers.

Vitaly Glozman, Partner, PricewaterhouseCoopers

9:00am-9:45am

“Consortium Purchasing: Unlocking the Value of Collaboration”: PANEL 

Learn about the group purchasing agreements offered by BIO, BayBio, and BIOCOM and how they are negotiated and managed.  Panelists will also discuss the merits of consortium purchasing and explain why such programs can benefit all companies, regardless of size. 

Rick Fultz, Director of Purchasing Group, BIOCOM

Tom Heebink, Business Development & Strategic Alliances, Western Region, BIO

Vita Blake, Associate Director Membership, BayBIO

Bill Coakley, Senior Director, Supply Chain Management, SciClone Pharmaceuticals

9:45am- 10:15am

“Risky Business – Today’s Worldwide Operations Supported by Global Supply Chains”

The earthquake in Japan, volcano in Iceland, and other types of disasters and unexpected events have created immense challenges for supply chain.  Hear how experts in the industry identify major supply chain threats and actions they take to mitigate catastrophes and disasters. 

Dale Dwier, Strategic Sourcing Manager, Bayer

Ken Duval, Associate Director- Supply Chain, Shire Pharmaceuticals

Erika Banks, Procurement Manager, Supply Chain Risks, Life Technologies

Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories

10:15am-10:45am

NETWORK BREAK

10:45am-11:30am

“Securing the Supply Chain for Patient Care: The California State Regulatory Game Plan”

The California laws of Pedigree, scheduled to go into effect in 2015-17, is designed to enable the healthcare and life sciences industry achieve the highest levels of patient care by minimizing the inherent risk in the end-to-end supply chain. Serialization, in addition to authentication of drugs at the distributor and pharmacy levels, and track and trace of the pedigree are essential to ensuring the safe delivery of drugs to patients. The presentation will provide an update of the proposed legislation, the value proposition, implementation phases, manufacturer’s notification requirements of the designated drugs and the methods employed to achieve the serialized electronic pedigree requirements.

Virginia “Giny” Herold, Executive Officer, California State Board of Pharmacy

Moderator: Wayne McDonnell, Pharma & Life Sciences Advisory, PwC

11:00am- 4:30pm

TRACK 1 of 4: STRATEGIC SOURCING AND CLINICAL OPERATIONS

11:00am-11:30am

“Unlocking the Value of Distributors”

Discussion will be centered on how to engage with distributors at various levels to leverage knowledge of suppliers, market, and similar customers.  Further, how industries differ depending upon the complexity of the products and services provided by distributors will be scrutinized and suggestions will be offered for engaging resources to improve planning, collaboration, and value.

Ed Borger, Vice President Operations, VWR Scientific

Moderator: Rick Fultz, Director, Purchasing Group, BIOCOM

11:30am-12:00pm

“Supplier Lean: A Successful Supplier Relations Management Strategy”

The “Supplier Lean” approach has proven to be a valuable focus area within an overall Supplier Relationship Management (SRM) program.  It enables Companies to collaboratively engage Suppliers to leverage their expertise to drive out waste from current practices, thereby improving productivity and achieving year-over-year cost reductions.  Learn how this approach was piloted and the concept proven for Facilities Maintenance Services at a manufacturing site. 

Marc Lampron, Senior Director, Procurement, Genentech

Moderator: Vita Blake, Associate Director – Membership, BayBIO

12:00pm- 12:30pm

“Vision for World Class Purchasing: Translating Into Results” 

This session will cover numerous facets that should be considered in defining a World Class Purchasing function with the goal of providing a compass for developing procurement organizations.  A means of presenting current state against the desired end state will be reviewed as well.

Isaac Young, Senior Director, BioMarin Pharmaceutical Inc.

Moderator: Tom Heebink, Business Development & Strategic Alliances, Western region – BIO

12:30pm-1:30pm

LUNCH NETWORK BREAK

1:30pm- 2:15pm

“Purchasing & Supply Management: Meeting the Operational Challenges”: PANEL

Hear how to organize Purchasing for success; Ideas for process and system improvements;   Strategic goals for Purchasing; and Strategic sourcing process.

Mike Crowell, Senior Director, Supply Chain Management, Verinata Health

Tim Jordan, Associate Director, Supply Chain, MAP Pharmaceuticals

Moderator: Jim Latimer, Senior Director, Purchasing and Supply Management, Elan Pharmaceuticals

2:15pm-2:45pm

“Clinical Supply Chain Challenges & Solutions” ROUND TABLE

This will be a round table discussion where the audience will have an opportunity to seek answers to questions they have concerning Clinical Supply challenges.  Learn from those around you and share your experience with industry colleagues.  Bring any questions you would like the panelists and audience to address.

Phil Chou, Associate Director, Clinical Supplies, Elan Pharmaceuticals

Moderator:  Bill Coakley, Senior Director, Supply Chain Management, SciClone Pharmaceuticals

2:45pm-3:15pm

“Clinical Demand Planning”

These sessions will give specific examples for applying concepts usually used in commercial supply chains to a clinical development environment.  Topics include demand review and balancing, establishing and honoring lead times, and using ERP systems to manage clinical supply.

Randy Schwemmin, Clinical Demand and Supply Planning, Genentech

3:15pm-3:30pm

NETWORKING BREAK

3:30pm-4:00pm

“Necessary Skills for Success in Clinical Supply Management”

Learn what the most important skills are to insure success in Clinical Supply Chain, the similarities and differences in skill sets between commercial and clinical supply chain management, and the metrics used to measure success. 

Phil Chou, Associate Director, Clinical Supplies, Elan Pharmaceuticals

Daniel Ramos, Director, Clinical Supplies, Exelixis

Mike Dallman, Associate Director, Clinical Supplies, Cerexa

4:00pm-4:30pm

“Overcoming the Hurdles in Emerging Markets” – PANEL

This panel discussion will explore a wide range of pertinent questions for practitioners looking to conduct clinical trials in emerging markets such as China, India, Brazil, Russia and Ukraine.  Learn about challenges and potential pitfalls, including unique country requirements and guidelines, custom duty and taxes, labeling, etc. from industry leaders who have direct experience with trials in emerging markets.

Diana Vazquez, Sr. Manager Global Supply Chain & Logistics, Onyx Pharmaceuticals

Mathew Blume, Senior Director, Packaging & Logistics, Aptuit

Nathan Kohner, Distribution project Group Manager, Almac Clinical Services

Moderator: Jamin Eberhart, PRTM

11:30am-4:30;m

TRACK 2 of 4:  RISK MANAGEMENT & BIO- SERIALIZATION

11:30am-12:00pm

“Bio-Serialization: A Case Study”

BioMarin has been analyzing serialization/ePedigree requirements since early 2008 and plans to have all products serialized and in distribution by 2014. The presentation will cover the challenges to be overcome due to the fragmented nature of US state, potential federal and EU legislation, and the various country requirements either in place or in development, which make the regulatory environment uncertain and potentially extremely costly for implementation. Success is achieved through the anticipation of these changes and deliver of solution at the “intersection” of these two variables several years in advance. Furthermore as 2015 approaches, qualified third party resources to support a serialization/ePedigree implementation will become increasingly difficult and expensive to obtain. Small/mid-size companies need to be diligent and creative in securing project resources in an environment of increasing demand and shrinking supply of qualified support.

Kevin Webb, Sr. Director Supply Chain Planning & Logistics, BioMarin

12:00pm- 12:30pm

“Risk Management in Raw Material Procurement”

This presentation will review the approach to developing a risk-based strategy for raw materials sourced for biopharmaceuticals and consider the risk impact of materials and potential for adulteration. The product and processes for manufacturing small molecule drugs of biotech are inherently far more complicated, producing a severe risk profile. A significant concern arises from the sourcing, supply and inherent variability of raw materials in terms of the origin and potential for adulteration, adequacy of capacity and flexibility, manufacturing process control, and appropriate management of risk and disaster recovery. It is also relevant to consider whether the supplier’s business commitment to service and support for any troubleshooting are aligned.

Duncan Low, Scientific Executive Director, Process Development, Amgen

12:30pm-1:30pm

NETWORK LUNCH

1:30pm-2:00pm

“Bio-Serialization: Road Mapfor implementation”

Presentation will be made of the game plan being adopted by the major wholesaler to be ready to meet the California mandate in the context of the challenging interfaces with drug manufacturers, pharmacies, hospitals, doctors and patients.

Steve Tadevich, Vice President, Distribution Support, McKesson

2:00PM-3:00pm

“Bio-Serialization: Supply Chain Efficacy & Patient Safety Imperative!”PANEL

Serialization and Pedigree present an unprecedented challenge and opportunity for the bio-pharma industry. Executives will discuss how to achieve the highest levels of patient care by minimizing the inherent risk in the end-to-end supply chain by ensuring governance, enterprise risk management and compliance with regulations in the overall development, manufacture and delivery of products and services in a global market place.

Jane Lavine, Insurance Executive

Mike Wallace, Director, Global Standards & Serialization, Enterprise Master Data, Abbott Laboratories

Steve Tadevich, Vice President, Distribution, McKesson

Vijay Chiruvolu, Director, Corporate QA, Amgen

Moderator: Mike Cleland, Vice President, Northhigland

3:00pm-3:30pm

NETWORK BREAK

11:00am- 4:30pm

TRACK 3 of 4: HI-TECH 7 INFORMATION SYSTEMS

11:30am-12:00pm

“System Development Evolution for the Biopharma Industry: A Blueprint for Implementation”

A proven framework for strategic planning for systems for small and medium-sized biotech companies will be presented in the context of total business requirements along with considerations of priorities, mode of implementation and potential economic benefits.

Lou Killian, Enterprise Systems for Technical Operations, Biomarin

12:00pm-12:30pm

“GS1 Standards, Key Work Streams and 2015 Readiness”

GS1 Healthcare US’s Secure Supply Chain Task Force has developed a pharmaceutical supply chain model as part of a program known as 2015 Readiness. The model is intended to prepare members of the U.S. pharmaceutical supply chain to use a standard serialized track-and-trace system (known as an electronic pedigree) related to the movements of items. Since January 2010, 50 companies have utilized a simulated supply chain to map out a supply chain and send items with unique ID numbers, either on RFID tags or on 2-D bar codes. The program aims to develop a model for anyone in the pharmaceutical industry who is responsible for IT, logistics or packaging, as well as manufacturers, retail pharmacies and wholesalers.

Bob Celeste, Director, Healthcare, GS1

12:30pm-1:30pm

LUNCH NETWORK BREAK

1:30pm- 3:00pm

“Hi-Tech Meets Biotech: Transfer of Technologies for Results”: PANEL

Biotech and High-tech supply chains share many similarities. This session brings together leaders from biotech, medical devices and high-tech industries to identify knowledge and best practice sharing opportunities in the areas from R&D to distribution, and the most effective ways to collaborate going forward.

Alex Brown,Senior Director, Supply Chain, Xilinx

Arun Kumar, Vice President, Global Sales, Capgemin

Frank Menkel,Associate Director, Supply Chain Strategic Planning, Genentech

Grant Hodgkins, Strategy, Standards and Process Manager, Alcon Laboratories

JasminaPavlin,Manager, Enterprise Data Systems, Technology Manufacturing Group, Intel

Joy King, Practice Lead, Life Sciences, Teradata

Lee W. Schruben, Professor & Chairman, IEOR, UC Berkeley

Mete Bayybit, Managing Director of Global Services Operations, Applied Materials

Mike Macri, Boston ScientificPaul Dennies, Program Director, Hi- Tech Manufacturing, Teradata

Rick Redd, Vice President, Siemens

VinayAsgekar, Vice President, Edward

Moderator: Blake Johnson, Consulting Assistant Professor, Management Science & Engineering, Stanford University

3:00pm-3:15pm

NETWORK BREAK

3:15pm-3:45pm

“Managing the Clinical Trials Supply Chain”

With the increased cost, complexity and global scale of clinical trials, a solution will be demonstrated for optimization of the clinical supply chain, based on “pull based” replenishment and better alignment with site enrollment levels, visit schedules and treatment arms to insure availability while minimizing waste. Presentation will include converting from long term program level planning to shorter- term study level plans using a formalized, closed-loop process that encompasses simulation, trial management, clinical forecasting, supply planning & collaboration, packaging and manufacturing thru integrated IVRS/IWRS and analytics.

Mike Walker, Oracle Life Sciences

ArunCavale, Principal, NextInfo

3:45pm-4:30pm

“Information Systems and B2B Network: Enhancing Productivity across the Supply Chain”: PANEL

The best information and systems technology requirements to meet the complex technology needs of the biotech and pharma supply chain community consisting of the manufacturers, distributors, retail pharmacies and hospitals require synchronization, connectivity and sharing of information.

Grant Hodgkins, Strategy Standards & Process Manager, Global Supply Chain, Alcon Laboratories

Joy King, Practice Lead, Teradata Life Sciences

Kevin Riccoboni, IT Leader, Global Operations, Life Technologies

Tim Kvanvig, Business Unit Life Sciences, Oracle

R. Arun Kumar, VP, Global Sales, Capgemini

11:00am-4:30pm

TRACK 4 of 4:  ENVIRONMENTALLY CONTROLLED LOGISTICS (COLD CHAIN)

11:30pm- 12:00pm

“Designing a LTL Cold Chain Network for Pharmaceuticals”

Requirements for warehousing and transportation of LTL shipments of pharmaceutical products will be addressed in the design of the network to ensure compliance.

Jim Barnes, President, enVista

12:00pm-12:30pm

“Securing Your Controlled Environment Logistics Network”

The monitoring of critical parameters in ensuring compliance of environmental standard will be analyzed comprehensively in the overall network.

Matthew McDonough, Director of Business Development, LoJack SCI

12:30pm-1:30pm

NETWORK LUNCH BREAK

1:30pm-2:00pm

“Temperature Monitoring Through to the “Last Mile” With Visual Controls”

The temperature excursion events in the “Last Mile” impacting cost and patient safety will be examined. In addition, comparative study data on freeze indicator device performance will be analyzed with consideration for cost/value equation to aid in the selection process of monitoring devices.

Mike Montana, Business Development Manager, TempTime Corp

2:00pm-2:30pm

“High Reliability Performance in the ‘Last Mile’ of Cold Chain”

The challenge of assuring reliability of product quality in the last mile of delivery will be presented with solutions.

Josh Hobrick, Senior Vice President, Dawson Logistics

2:30pm-3:00pm

“Understanding Controlled Ambient Conditions – A Forwarder’s Perspective”

The variations in ambient conditions experienced in handling, storing and shipping product remains a formidable challenge and solutions will be discussed for safety and quality.

Mark Davis, Manager, Healthcare Logistics, UPS (TBC)

3:00pm-3:20pm

NETWORK BREAK

3:20pm- 3:45pm

“Managing for Profits in an Environmentally Controlled; Commoditized and Perishable Cold Chain – Lessons from the Ag Industry”

Have you ever wondered how businesses that have low consumer brand recognition; operate in a Nature Controlled Market setting and have products that a shelf life of 2 – 3 weeks are able to operate efficiently and profitably – Well in that case you will not want to miss this session in which two presenters began a Transformation journey about 4 years back, share the lessons learned…..

David Hostetter, Chief Administrative Officer, Sunworld International

Sumantra Sengupta, Managing Director, EVM Partners LLC

3:45pm-4:30pm

“End to End Cold Chain Supply Chain: Packaging, Warehousing, Transportation”: PANEL

Deployment of the emerging Cold Chain Technology, manifesting from end-to-end of the supply chain, requires packaging engineering standards, processes, systems, monitoring mechanisms. The stakeholders will discuss the solutions and outstanding challenges of manufacturing, warehousing and delivering materials and finished products globally that are sensitive to temperature, humidity, vibration and other factors.

Douglas Wettergren, Global Key Account Manager, Envirotainer

Rod Derifield, President, Envirocooler

Jim Barnes, President, enVista

Moderator: Gary Hutchinson, President, Modality Solutions LLC

END OF CONFERENCE PROGRAM