6th BSMA Conference – Foster City, 2013

“MANAGING GOVERNMENTAL COMPLIANCE FOR GLOBAL
QUALITY, SAFETY & RELIABILITY”

The world’s leading community of biopharma supply chain management professionals will come together on October 8 for the annual conference of
the Bio Supply Management Alliance (BSMA) in Foster City, California. The conference will enable supply chain professionals engaged in clinical
operations, commercialization, manufacturing, logistics, information
technology and government compliance in managing governmental compliance for global quality,
safety and reliability.

Business leaders will address the strategic and tactical management of
global sourcing, entry into the emerging markets, clinical operations
management, information transfer from R&D to clinical trials to commerciali-
zation, manufacturing excellence, environmentally controlled distribution,
supply chain risk mitigation, and supply chain management talent and
career development, while ensuring compliance with expanding government regulations.

 

BSMA 6th ANNUAL CONFERENCE PROGRAM

     

BSMA WELCOMES
 OUR SPONSORS

listed below. 

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to visit each sponsor site by clicking on their respective logos.
   Learn and share their information.

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2013 Conference Program


GOLD SPONSOR

PwC

PricewaterhouseCoopers

 

SILVER SPONSORS

Therapak

Therapak

 

TRACK SPONSORS

Clarkston Consulting

Clarkston Consulting

Fisher Clinical Services

Fisher Clinical Services

 

BRONZE SPONSORS

Teradata

Tracelink

Tracelink

 

PARTICIPATING SPONSORS

APICS Santa Clara Valley Chapter

APICS SCVC

Envirotainer

Envirotainer

McKesson

McKesson

VWR

VWR

 

ACADEMIA SPONSORS

GGU-SF

Golden Gate University

Pepperdine

Pepperdine University

UC Berkeley

 

ALLIANCE SPONSORS

APICS

APICS GGC

AZ BIO

BAYBIO

BioTechnology Industry Organization

Biocom

Biocom Purchasing Group

CSCMP

ISM

Supply Chain Brain

SupplyChainBrain

WIL

WIL

 

Highlights of the Program

 

8:00am-

9:00am

Registration, Breakfast, Meet & Greet

 

9:00am-

9:15am

Welcome Address: “Convergence of Science, Technology & Business: Biotech Industry Reality!

Devendra Mishra, Executive Director, BSMA

 

9:15am-

10:00am

SCM EXECUTIVE PANEL: 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.

Moderator: Wayne McDonnell, Director of Advisory, PwC

Panelists:

Kevin Pegels, Vice President – Global supply Chain, Bayer Healthcare – Biotech

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

Rob Tenerowicz, Vice President, Supply Chain Management, Bio-Marin

 

10:00am-

10:30am

Keynote Address: “CA ePedigree Law 2015: Call to Action!

Presentation of game plan for adoption of California’s e-Pedigree requirements for tracking prescription drugs to take effect on a staggered basis from January 1, 2015 until July 1, 2017. Enacted to safeguard the state’s prescription drug supply, the law requires all owners and buyers of prescription drugs to append an electronically created and maintained record (or pedigree) to track every sale and purchase as the drug moves through the supply chain from the manufacturer through wholesalers to the pharmacy or physician.

Virginia Herold, Executive Officer, California Board of Pharmacy

 

10:30am-

11:15am

NETWORK BREAK

 

11:15am-

11:45am

Big Data and Analytics: The Transformative Powerhouse for Biotech Industry Advancement

A big-data revolution is under way in health care. Start with the vastly increased supply of information. Over the last decade, pharmaceutical companies have been aggregating years of research and development data into medical databases, while payors and providers have digitized their patient records. Meanwhile, the US federal government and other public stakeholders have been opening their vast stores of health-care knowledge, including data from clinical trials and information on patients covered under public insurance programs. In parallel, recent technical advances have made it easier to collect and analyze information from multiple sources—a major benefit in health care, since data for a single patient may come from various payors, hospitals, laboratories, and physician offices.

David Wiggin, Program Director, Healthcare & Life Sciences, Teradata

 

11:45am-

12:15pm

Supply & Distribution Risks: Assessment and Mitigation for the Virtual Supply Chain

A comprehensive and systematic solution will be presented to determine the risks faced by a company, known and unknown, in the global marketplace of a drug owner/developer that has internal or external relationships with businesses providing research, clinical trials management, manufacturing, information technology and distribution services. Proven solutions will be provided to mitigate the risk and ensure the strategic growth of the IP holder with relevance to mid-sized and small companies.

Friedhelm Lotz, Partner and Audit Practice Leader, Global Risk Experts, AG.

12:15pm-

1:30pm

LUNCHEON BREAK

 
 

TRACK 1: SERIALIZATION, TRACEABILITY & TEMPERATURE-CONTROLLED DISTRIBUTION

 

1:30pm-

2:00pm

One Way or Another, Serialization and Track & Trace Will Transform the Pharma and Biolog Supply Chains

Significant supply chain transformation is nearly upon us with serialization and track & trace regulatory requirements popping up here at home and around the globe.  In just a few years, the value of pharmaceuticals and biopharmaceuticals in the supply chain will not only be determined by the price set by the manufacturer or payers, it will depend on how accurate and “clean” their documented supply chain history is.  Without a clear supply chain pedigree, drugs and biologics will have no value.  The maintenance and use of the new supply chain IT systems that will be needed to ensure that this documentation is not inadvertently lost or garbled will require new skills and great care.  This session will examine some of the regulatory requirements and the problems that these new systems must address so that users will have confidence in the value of their inventory.

Dirk Rogers, CEO & Founder, RxTrace 

 

2:00pm-

2:30pm

The Global Network Service for Product Safety, Quality and Reliability

Responding to the end-to-end Supply Chain initiative of the U.S. Food and Drug Administration, a network service solution will be presented to ensure product safety, quality and reliability in order to move from a posture of intercepting harmful products to anticipating and preventing the arrival of such goods in order to ensure maximum patient care in the world.

Shabbir Dahod, CEO, TraceLink

 

2:30pm-

3:30pm

PANEL: “Driving Serialization and ePedigree for Business Growth and Profitability

Listen to experts from across the pharmaceutical distribution chain (manufacturers, wholesalers, pharmacies, third party logistics providers) as they discuss supply chain security. A distinguished panel will review current practices to track medicines, the California law on e-pedigree and efforts to establish a federal standard. Other topics to be addressed include patient safety, use of new technologies, and feasibility of requirements. Panelists will highlight these issues from their stakeholder perspectives to provide a comprehensive analysis of supply chain security issues.

Moderator: Mark Ginestro, Partner, Clarkston Consulting

Panelists:

Bethany Hoover,Director, Supply Chain Integrity, BioMarin

Chris Chandler, Senior Director – Healthcare, GS1 US 

Shabbir Dahod, CEO, TraceLink

John Johnson, Director – Pharmacy, Sharp Memorial Hospital

Dirk Rodgers, Founder, RxTrace & CEO, Dirk Rodgers Consulting

Steve Tadevich, Director, Serialization Technologies, McKesson

Glenn Abood, CEO & President, rfXcel Corporation

 

3:30pm-

4:00pm

NETWORK BREAK

 

4:00pm-

5:15pm

PANEL:  “The Evolution of the Cold Chain and How Technology is Playing a Role in Product Integrity

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.

Moderator: Doug Wettergren, Regional Sales Manager, Envirotainer

Panelists:

Sophia Sharp Donaldson, Senior Director, Global Supply Chain, Baxter Bioscience

Gary Hutchinson, CEO, Modality Solutions

Lisa Fuller-Howard, Global Product Manager, UPS

Chris Amber, Executive Vice President, Unitrans International Corp

Marissa Johnson, Sales Manager-North America, LifeConEx

 

5:15pm-

5:30pm

Wrap Up: Furthering Progress!

Mark Ginestro, Partner, Clarkston Consulting

 
 

TRACK 2: STRATEGIC SOURCING & CLINICAL SUPPLY CHAIN

 

1:30pm-

2:00pm

PANEL: “Strategic Management of Suppliers:  Maintaining Efficienct Manufacturing Operations

Learn how industry experts address Supplier Relationship Management (SRM), Suppliers in Emerging Markets, Supplier Qualification, Total Cost of Acquisition, Life Cycle Management, Talent Development and How to Measure Success.

Moderator: Jim Latimer, Chairman, Strategic Sourcing Steering Committee, BSMA

Panelists:

Dan Ambrose, Director, Customer Logistics, VWR International

Paul Anderson, Vice President, Global Procurement, Life Technologies

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

Mike Mayo, Director, Materials & Procurement, Olympus Biotech 

 

2:00pm

2:20pm

Back to Basics: 7 Focus Areas for Supply Chain Improvements

Facing complexity, uncertainty and competition is the new normal in the global delivery of goods and services. A comprehensive framework will be presented, consisting of the focus areas of core information systems, operational excellence, electronic integration with trading partners, customer segmentation, expanded value add services, segmentation of the supply chain and collaboration with customers.

Dan Ambrose, Director, Customer Logistics, VWR International

 

2:20pm-

2:40pm

Consortium Prchasing: Crrent Benefits & Future Opportunities

Are GPOs part of your strategic sourcing? Come join us for a Biotech Group Purchasing Organization State of the Union led by the two life science industry leaders, Biocom Purchasing Group and BIO Business Solutions. Learn more about the power of leveraging life science spend across 3,000+ companies nationwide and join in on the discussion with senior business leaders to further enhance the value of these programs for members and the entire industry. Together we can set the pace for what’s next in the world of life science procurement.

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

Rick Fultz, Managing Director, BIOCOM Purchasing Group

 

2:40pm-

3:00pm

“Trials & Tribulations of HR: Developing Sourcng Management Executives”

To attract, retain and develop top talent in biotech strategic sourcing supply chain management has never been more strategic a demand than ever before. The global market place, inter-dependence of trading partners in the supply chain, emerging markets for sourcing, 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. Finally, the value of team work in a continuous improvement environment remains undisputed. The presentation will address these requirements of Human Resource as met successfully at Bio-Rad. Knowing that employees represent the majority of company value, maximizing that value requires truly knowing your talent and continuously developing it to influence and drive change across all departments, both local and global where “hard” technical and “soft” people skills are blended.

Guadalupe “Lupe” Leon, Division Global HR Manager, Bio-Rad Laboratories

 

3:00pm-

3:30pm

Clinical Supply 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..

Moderator:   Devendra Mishra,Executive Director, BSMA

Panelists:

Amy Penticoff, Director, Clinical Supply Management, Intarcia Therapeutics

Elizabeth Gallagher, Global Logistics, Fisher Clinical Services

Bill Coakley, Director, Supply Chain Planning, BioMarin

Lisa Fuller-Howard, Temperature True Product Manager, UPS

Michelle Foust, Director of New Product Development, Almac Clinical Services

 

3:30pm

4:00pm

NETWORK BREAK

 

4:00pm-

4:30pm

3rd Party Blinding Case Study: Best Practices for Achieving and Maintaining Site Compliance

Maintaining blind and achieving maximum site compliance are essential to conducting a successful clinical trial in which 3rd party blinding is required. Site education, clear instructions and a close partnership with the clinical team are all necessary components for success. In this case study presentation attendees will learn: Techniques to achieve and maximize site compliance; Necessary components for maintating blind; How to leverage site pharmaceutical expertise; and, Best practices in site education.

Michelle Foust, Director of New Product Development, Almac Clinical Services

 

4:30pm-

5:30pm

Challenges in Managing Clinial Supply Chains: Workshop

The complexity of clinical trials and clinical supply chains continues to increase as clinical teams reach to new geographies and approach trial execution with an even greater sense of urgency.  At the end of every clinical supply chain is a patient that is counting on their medication.  What are the critical decisions that must be made when setting up and managing a clinical trial, and how can the inherent risks be identified and mitigated early on?  What are some of the best strategies for making the supply chain robust?  This session will explore the key risk factors, decisions, and implications of those decisions when managing a global clinical supply chain.

Pam Osbourne, Senior Clinical Supply Chain Manager, Thermo Fisher Clinical

 
 

TRACK 3: MOLECULAR DIAGNOSTICS

 

1:30pm-

2:00pm

Molecular Diagnostics Testing Industry: An Overview

The market for molecular diagnostics testing, projected do reach $14 Billion in 2014, is fragmented with more than 500 companies, where 98% of them could benefit from the best practices of supply chain management. Molecular diagnostic tools have a vast base of end-users, which includes hospital-based laboratories, reference laboratories, and others (physicians’ labs, research laboratories, other healthcare clinics, and government agencies. The research will highlight the opportunities to achieve low product cost, high quality, compliance with governmental regulations, speed to market and customer service.

Mike Crowell, Sr. Director, Supply Chain Management, Verinata Health (Illumina)

Alan Wells, Vice President, Diagnostics Laboratory Operations, Life Technologies

 

2:00pm-

2:30pm

Supply Chain 101: Foundations for Success in the Molecular Diagnostics Testing

The presentation will answer the questions:

  1. How should supply chain leaders support the company’s growth mission over time?
  2. What key supply chain capabilities should leaders build over time?
  3. What are the key metrics that supply chain leaders should focus on to monitor performance and guide the supply chain?
  4. What are the regulations that supply chain leaders should prepare to comply with in the next few years (focus on UDI)?

Wayne McDonnell, Director of Advisory, PwC

 

2:30pm-

3:10pm

PANEL: “Molecular Diagnostics Testing: Opportunities for SCM Efficiency!

As scientists discover how to glean useful information from the human genome through sequencing and make that information clinically meaningful, this market will continue to grow rapidly from startup through to commercialization. These constituent would probably relish the opportunity to share the SCM tools and strategies used in this area. As you may know, the needs of a molecular diagnostic companies’ supply chains are just as critical to its success as it is to a larger pharma/biopharma commercial organization, but in many respects the strategies that are emerging are different from big pharma, or biopharma’ s needs (think a service delivery model supply chain vs. that of a drug manufacturer or distributor).

Moderator: Alan Wells, Vice President, Diagnostics Laboratory Operations, Life Technologies

Panelists:

Susan Jiang, Supply Chain Supervisor, Verinata Health (an Illumina Company)

Arbi Harootoonian, Vice President, Business Development, Therapak

Glen McHenry, Senior Manager SCM, Monogram Bioscience

Meserve Platt, Associate Director- Materials & Facilities, Crescendo Biosciences

Karel Hurka, Jr., Sr. Manager, SCM, Genomic Health

Christelle Laot, Technical Fellow, Cold Chain Management, Life Sciences & Specialty Services, FedEx

Winnie To, Procurement and Planning Manager, Natera, Inc.

 

3:10pm-

3:30pm

Case Study: “Managing Your 3-PL Partner”

Now that you have selected a partner – defined the kit and done the data dance to share addresses for deliveries, How do we manage this relationship? How do we keep our customers – internal and external happy? How do we ensure the ‘bang-for-the-buck’?

Meserve Platt, Associate Director Materials / Facilities, Crescendo Bioscience

 

3:30pm-

4:00pm

NETWORK BREAK

 

4:00pm-
4:30pm


Designing Solutions for Healthcare Shippers”

Healthcare shippers, and in particular those involved with molecular diagnostics, have unique transportation needs. Case studies illustrate how specific shipping solutions can be designed by close collaboration between shippers and shipping providers. Risk management practices put in place at FedEx in relation to cold chain logistics will also be presented.

Christelle Laot, Technical Fellow, Cold Chain Management, Life Sciences & Specialty Services, FedEx

 

4:30pm-

5:00pm

Case Study: “Drum, Buffer, Rope”

Using a pull based inventory replenishment model for variable process environments where Push/MRP does not easily fit.

Mike Crowell, Director Supply Chain, Verinata Health (Illumina)

 

5:00pm-

5:30pm

Case Study: “Rightsizing Your Client’s Kit Inventory”

Demonstration of tools that can help diagnostic companies ensure that their clients sites have the right amount of sample kits ready for use at the right time.

Arbi Harootoonian, Vice President, Business Development, Therapak

 

5:30pm-

6:30pm

COCKTAIL RECEPTION