2nd BSCA Conference – SSF, CA 2009

BIO SUPPLY MANAGEMENT ALLIANCE: 

Forging Progress For
Life Depends On Us!

By Devendra Mishar, Executive Director, Bio Supply Management Alliance (BSMA)

“The global economy is transforming the way we all do business – it favors organizations that reach across boundaries effectively.  It rewards those that can collaborate smoothly with their partners and customers.  As a result, business excellence is no longer about individual players – it’s about effortless coordination and orchestration across your value chain.  To thrive I this environment, you must optimize the performance of your entire business community – from your smallest supplier to your largest customer.”

Source:  Sterling Commerce

The biotech industry is on the verge of a historic transition into the Age of Biotechnology as a result of the convergence of life sciences and information technology in the marketplace.  However, after its inception four decades ago, we find extreme fragmentation where silos exist within the business at large, as well as across the various enterprises that comprise this young industry.  Many of you have expressed your firm belief that a coordinated effort among the trading partners to establish an industry consortium, with a holistic supply chain mandate, is essential for a successful future. 

The complex nature of the biotech industry requires collaboration to improve quality.  Such cooperation further guarantees the safety of drugs and compliance with government regulations, maximizes patient care, eliminates redundancies of effort and waste, reduces costs, and helps gain a competitive advantage while delivering world-class affordable healthcare.

We at the Bio Supply Management Alliance (BSMA) are committed to bringing together the players in the biotech industry and believe the producers of healthcare products (drug, device, and medical/surgical manufacturers and universities), the purchasers of those products (wholesales/distributors/group purchasing organizations), the providers of services (hospitals, physician, IDNs and pharmacies), the fiscal intermediaries of the industry (insurers, HMOs, pharmacy and benefit managers), and the consumers (government, employers and individuals) are all pivotal to reaching this goal.

Driven by the vision and consensus of the Advisory Board of BSMA, this Conference focuses on the major issues facing our industry.  Topics covered include:

  • Development of Supply Chain Management Talent and Career;
  • Ensuring Visibility in the Supply Chain From End to End;
  • Risk Management – Strategic, Operational and Random;
  • Achieving Efficiencies and Customer Satisfaction in the Industry Supply Chain.

During the two-day conference, presenters cover the full spectrum of the industry, with executives from biotech and pharma companies, universities, distributors, technology and service providers, as well as management consultants providing solutions for building an alliance among the stakeholders of the supply chain.

We invite you, the leaders of the life sciences and healthcare industries, to participate, network and take away demonstrated solutions at the 2nd Annual Conference of the Biotech Supply Chain Academy.

2009 Conference Program

DAY 1 MONDAY, OCTOBER 19, 2009

8:00-8:30

Registration and Continental
Breakfast

8:30-8:40

Welcome Address Devendra Mishra, Executive Director, Bio Supply Management
Alliance

8:40-9:20

Keynote Address: “Regulatory Influences in Biogenerics: The Next
Horizon”
Recognized as one of the world’s leading expert on follow-on protein products and follow on
biologics (“biosimilars” in the European Union), Dr. Woollett will address an array
of scientific and science policy issues in connection with legislative, regulatory, public
affairs, and communications initiatives involving the government, industry, the research
community, in the biologics and biotechnology areas in the USA and Europe. The presentation
will also focus on the effectiveness of collaboration of biopharma companies’ with regulatory
agencies in multiple aspects of discovery, development, and manufacture of biotechnology-based
medicines. Speaker: Dr. Gillian R. Woollett, Chief Scientist, Engel
& Novitt, LLP

9:20-9:50

Keynote Address: “Why
Collaborate in the Biotech Industry”
Until recently, as long as the average biotech company?s pipeline was productive, the
warehouse was full and the underlying cost structure was manageable; these companies realized
very healthy profit margins and sustained top-line growth. So what happened to cause so many
biotech companies to reconsider their supply chain strategy? Global competition to reach
emerging markets, increased pressure on pricing and reimbursement, under-utilized capacity of
large manufacturing facilities and expensive stocks of inventory are all calling the biotech
supply chain executive to action. Operational excellence in supply chain and collaboration
across the value chain, every biotech executive?s keys to unlocking sustainable value, will be
discussed. Furthermore, a preview of AMR Research?s development of their first annual
Healthcare Top 25 ranking will be presented. Speaker: Wayne McDonnell, Research Director, Health &
Life Sciences, AMR Research

9:50-10:10

NETWORKING BREAK

10:10-10:50

Operations Executives
Panel: “Managing the Enterprise in Turbulent Times”
Executives of biotech companies will discuss the biggest challenges they have already
conquered, are addressing now, and will potentially face. The opportunities, impediments and
risks from end-to-end are multi-faceted, such as commercialization of innovations, clinical
trials global outsourcing, lean and contract manufacturing, information sharing, visibility
and asset management in the supply chain. The panelists will also answer questions – How has
the economy changed sourcing and delivery? What will their supply chain look like in five
years? This important session provides a forum for an informative Q&A about collaboration
along the entire supply chain. Panelists:

Allison Moore, VP, Corporate Manufacturing, Amgen

Andrew Ramelmeier, VP, Manufacturing and Process Development, BioMarin
Pharmaceutical

Dave Malenfant, VP, Global Supply Chain, Alcon Laboratories

Franklyn Hathaway, Director, Supply Chain Excellence, Bayer Healthcare

Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories Moderator: Devendra Mishra, Adjunct Professor, Graziadio School of
Business & Management, Pepperdine University

10:50-11:20

“Rx 360: Global QA for
Suppliers”
A non-profit consortium from the pharmaceutical industrial complex has been
established to develop operating standards, share data and create an independent supplier
audit function to improve the efficiency, oversight and accountability of the bio-
pharmaceutical supply chain. The Deming-based approach promises the benefits of cost reduction
in the supply chain, standardization of best practices, monitoring of quality and security,
and establishment of world-class suppliers will be analyzed. In addition, the necessary
interface with the Government will be highlighted. Speaker: Eric L. Berg, Director, Supplier Quality, Amgen

11:20-12:00

Panel: “Launch and
Commercial Management: Overcoming the Achilles’ Heel”
The commercialization of new products faces significant obstacles in terms of
organizational structure, cross-functional collaboration for launch, transfer of knowledge,
capacity planning under uncertainty, process control and optimization, and interface with
distribution and the market place. Panelists:

Shankar Suryanarayanan, Co-Chairman, Biotech Supply Chain
Academ
y

Fred Gvillo, Entrepreneur Biotechnology

Lee Schruben, Professor, Industrial Engineering and Operations Research, University of California, Berkeley Moderator: Wayne McDonnell, Research Director, Health & Life
Sciences, AMR Research

12:00-1:00

LUNCH

 

SUPPLY CHAIN RISK
MANAGEMENT TRACK

Laura Langone, JD, Former Director of Risk Management, Genentech

Chair, BSMA Risk Management Steering Committee

1:00-1:40

Keynote Address: “The 5 Risk
Management Mistakes”
Projects are hard enough to manage without making the same mistakes others make. How much
would it be worth to you to learn the biggest mistakes others make related
to project risk? Join this humorous and informative workshop and take home pointers you can
use right away. Participants will learn the top 5 mistakes people make when it comes to Risk
Management; understand why these mistakes are being made and better understand the risk
management process as it is used in the real world. Speaker: Rita Mulcahy, PMP, President, RMC Project
Management

1:40-2:20

Panel: “Supply
Chain Risk Management: Safeguarding The Enterprise and Making It
Resilient”
The strategic, financial, operational and hazard risks in the industry supply chain, from
end to end, will be analyzed and current practices will be discussed with
emphasis on information, systems, procedures and collaboration to achieve security, quality assurance. Panelists:

Phil Kaminsky, Industrial Engineering and Operations Research, UC Berkeley

Dave Malenfant, SVP, Global Supply Chain and Head of Risk Management Committee, Alcon Laboratories

Michael Mitchell, Director, Global Supply Chain Management, SAFC Bioscience
Mohinder Sikka, CEO, Sensitel Moderator: William Coakley, Senior Director, Supply Chain Management, SciClone Pharmaceutical

2:20-2:50

“Supply Chain Risk Management: A
Supplier Perspective”
One supplier’s development in supporting biopharma industry response to
China origin concerns and the broader implications for risk management collaboration. By
including the supplier, the relationship can discern risks specific to the biopharma raw
material supply chain. Speaker: Michael Mitchell, Director, Global Supply Chain
Management, SAFC Bioscience

2:50-3:10

NETWORKING BREAK

 

SUPPLY CHAIN TALENT MANAGEMENT TRACK

Dave Malenfant, Vice-President,

Global Supply Chain, Alcon Laboratories

Chair, BSMA Talent Management Steering Committee

3:10-3:40

“Development of Supply Chain
Management Talent: The Intel Story!”
Starting in the 1980’s, Intel – The world’s largest manufacturer of micro-
electronic parts, discovered that to compete, having the best technology was no longer good
enough. It was required to build products at the right cost and the right volume, and then
deliver them to customers at the right time. Intel embarked upon the development of supply
chain expertise in its ranks by setting up a special career track. The results have fulfilled
the strategic objective of Intel. Its program later inspired CSCMP’s Supply Chain Management
Professional designation. Intel also has the largest number of APICS CSCP professionals. Speaker: K C Quah, CSCP, Supply Chain Master, Intel
Corporation

3:40-4:10

“Developing Talent Beyond the
APICS Supply Chain Manager Competency Model”
APICS developed the Supply Chain Manager Competency Model to guide
individuals considering careers in supply chain management, supply chain professionals seeking
to advance their positions, and human resource managers who are hiring in this fast-growing
field. In addition to discussing the competency model, this session will also identify how to
extend supply chain manager capabilities beyond the APICS competency model to organizational
vision and leadership; to alignment of supply chain initiatives to enterprise objectives; and
to driving global strategy and relationships. Speakers: Tim Salaver, President, APICS Golden Gate
Chapter
and Executive Vice-President, Bio Supply Management
Alliance

Andre Alves, Sr. Supply Chain Analyst, VSP Vision Care; Member, Future
Leaders of APICS The Association for Operations Management

4:10- 4:50

Panel: “Supply Chain Talent
Management – A Biotech Industry Prerogative!”
Proven solutions will be presented by leaders of the biotech and semi-conductor industry in
conjunction with academia for the development of supply chain management professionals for all
rungs of the ladder in a biotech enterprise. Development programs range from tactical to
strategic management training of professionals. Panelists:

Laura Meade, Associate Professor, Texas Christian
University

Phil Kaminsky, Associate Professor, University of California,
Berkeley

Nabil Rageh, Director, DBA Program, Golden Gate
University

Adam Zak, Founder and CEO, Adam Zak Executive Search Moderator: K C Quah, CSCP, Supply Chain Master, Intel

4:50-5:10

“Alcon Laboratories Partnership
with Texas Christian University: A Model of Talent Development”
For over eight years Alcon and TCU have partnered to develop supply chain
talent by mentoring students and projects which has resulted in over 100 projects with
positive results. Several students have been placed at Alcon after successful projects. Speaker: Dave Malenfant, Vice President, Global Supply
Chain, Alcon Laboratories

Laura Meade, Associate Professor, Texas Christian
University

5:15-6:30

COCKTAIL RECEPTION

DAY 2

TUESDAY, OCTOBER 20, 2010

8:00-8:30

Registration and Continental
Breakfast

8:30-9:20

Panel: “Distribution &
Fulfillment: Ensuring Agility, Adaptability and Alignment”
Discussion to enhance the value added services between the manufacturer of the drug and the
hospitals, doctors and patients. Solutions and best practices will be addressed, such as,
collaborative planning, IT linkage, data synchronization, warehousing, transportation,
fulfillment services, sustainability of the environment, etc. Panelists:

Ronald Bone, Senior Vice President, Distribution Support, McKesson

Laurel Junk, Vice President, Procurement and Supply Chain, Kaiser
Permanente

Jim Burleigh, CEO, SmartTurn

Dave Zaleski, Industry Manager, Dematic Moderator: Robert Bowman, Senior Editor, SupplyChainBrain.com

9:20-10:00

Keynote Address: “The
Building Blocks of a World-Class Distributor”
Distribution in the biopharma industry has expanded its services with extraordinary
results. The information-driven service provider will highlight how customer-centricity can be
achieved while reducing costs, decreasing lead times, and improving asset utilization. Speaker: John Figueroa, President, McKesson U.S.
Pharmaceutical

10:00-10:20

NETWORKING BREAK

10:20-10:50

“Enabling Visibility and Effective
Collaboration Across the End-to-End Demand-Supply Network”
This presentation will discuss the strategic importance for life sciences
companies to achieve visibility and collaboration with upstream and downstream trading
partners. Participants will learn how they can leverage best practices from supply chain
leaders in the high-tech industry to achieve better alignment between customer demand and
supply, thereby improve revenue and shareholder value, while reducing inventory and operating
cost. Speaker: Richard McCluney, General Manager, International
Business, E2Open

10:50-11:20

“Creating Supply chain
Transparency and Security”
Through extensive industry research and the development of mechanisms to
ensure the safety and integrity of the supply chain this session will define methods and
techniques used to make global issues more transparent through greater and secure
information. Speaker: Bill McBeath, Chief Research Officer, ChainLink
Research

11:20-12:00

Panel: “Visibility in The
Supply Chain: Building The Holy Grail”
Address the issues of achieving visibility in the supply chain from end-to-end, utilizing
ePedigree and the current Government legislation, technology solutions, legal framework and
best practices. A framework for Track-and-Trace being adopted by the food industry consisting
of a technology-based infrastructure and software will also be discussed. Panelists:

Angela Watson, Corporate Vice President, Strategic Accounts, Healthcare Sector, UPS

Dina Bunn, Director, Customer Service and IT, LifeConEx

Laurel Junk, VP, Procurement and Supply Chain, Kaiser Permanente

Colin Finn, VP, Sales and Co-Founder, Pelyco Systems Moderator: Tom Magill, Executive Consultant, Judgment Index

12:00-1:00

LUNCH

1:00-1:45

Keynote Address: “The
Biotech Industry: $$$ and Sense”
The biotech industry has thrived as a new drug incubator for big pharma companies, which
have poured money into acquisitions and partnerships to build up their biotech product line.
An authoritative analysis will take stock of the economic performance and outlook of the
sector in terms of the therapeutic areas, companies, products, technologies, investments,
consolidations, and the competitive environment and governmental regulations. Speaker: J. Casey McGlynn, Partner, Wilson, Sonsini,
Goodrich & Rosati

1:45-2:25

Panel (SALON E): “4Ts of
Cold Chain – Technology, Panel Tracking, Temperature-Controlled
Transportation”
An innovator in Cold Chain, an RFID provider with hosted offerings, industry standards
organization and a leading BioPharma company will address how to move the industry to more
consistent, better understood and ultimately lower cost temperature assurance transport
solutions. Solutions will be presented and discussed for expanded deployment of the technology
from the clinical and bulk arenas to the commercial environment. The transfer of knowledge on
scalable platforms is a large piece of the puzzle when looking to reduce total cost of
ownership. Panelists:

Ed Church, Executive Director, International Safe Transit
Association

Frank Newman, Managing Director, Enterprise & Regional Account
Management, FedEx

Garry Hutchinson, Director, Global Transportation, Amgen

Jim Cox, CEO, Temp Trip Moderator: Rodney Derifield, President and Founder, EnviroCooler

1:45-2:25

Panel (SALON F): “Clinical
Trials Supply Chain Through Demand And Operations Planning”
The ability to map clinical trial demand streams, understand demand variability, and
developing segmented clinical trial supply responses would yield significant benefits for life
sciences companies. In this session clinical supply chain demand forecasting will be examined
within the broader clinical trial resource alignment and a new, highly accurate demand
forecasting platform. This session will also introduce Demand Rationalization &
Operations Planning (DR&OP) adopted from the traditional S&OP process and how to use
DR&OP within your clinical trial to balance demand and supply to achieve peak
performance. Panelists:

Andrew Ramelmeier, VP, Manufacturing and Process Development, BioMarin
Pharmaceutical
s

Arun Cavale, CEO, Nexinfo Moderator: Wayne McDonnell, Research Director, Health & Life
Sciences, AMR Research

2:30-3:00

“Profiting From Lean Six Sigma in
Biotech: Experiences of The Best”
(SALON E)
A Case Study of the successful evolution of lean six sigma principles from the automotive
to discrete manufacturing to biotech will be analyzed to demonstrate contribution to the
bottom line and customer satisfaction. Speaker: Edgar Sur, Head of Operational Excellence, Bayer Healthcare

2:30-3:00

“Supplier Collaboration For Sales
and Operations Planning”
(Salon F)
This session will define a solution that help companies implement a collaboration process
to maximize the effectiveness of their S&OP process. The session will lay out the S&OP
Process and it?s informational needs from suppliers. It will highlight some of the facets of
the process that make it complex like demand striping and other demand level information like
partial fulfillment; distinguishing existing contractual commitments; establishing other
product level information like ‘lot expiry’, ‘minimum shelf life’, ‘required product grade’;
identifying cost impacts of changes to supply during iterative simulations; and visibility to
safety stock and demand variability. Speaker: Arun Cavale, CEO, Nexinfo

3:05-3:45

Panel (SALON E): “Developing
Flexible Manufacturing Capabilities”
The panel will identify proven approaches for producing multiple products in a flexible
manufacturing environment. The challenges to be addressed – segregation, quick changeover,
inventory management, disparate cells or product types, operator costs and ease of technology
transfer.  The pros and cons of building in a single site versus diversifying to multiple
sites will be analyzed. Key considerations include business continuity risks, availability of
diverse expertise and capabilities, such as bulk production versus fill finish activities and
business incentives. Panelists:

Andrew Ramelmeier, Vice-President, Manufacturing & Process Development, BioMarin Pharmaceuticals

Robert Bottome, Head of Operational Excellence, Genentech

Nabil Rageh, Director, DBA Program, Golden Gate
University

Dave Zaleski, Industry Manager, Dematic Moderator: Tim Salaver, EVP, Operations and Technology, Bio Supply Management Alliance

3:05-3:45

Panel (SALON F): “Leveraging
Partner Networks to Meet Supply Chain Challenges of Biotech Companies”
Increasing globalization and complexity in today?s biotech development and commercial
supply chains creates opportunities for CROs and CMOs to partner with their biotech clients.
Effective partnerships create significant value by providing supplemental competencies and
capacity to accelerate time to market and maintain commercial supplies. Hear industry thought
leaders discuss the strategic and tactical secrets to successful partnering. Panelists:

Alison Moore, VP, Corporate Manufacturing Amgen

Gustavo Mahler, President, C/M/C ICOS Biologics

Shabbir Anik, President and CEO, Althea Technologies

Shankar Suryanarayanan, Co-Chairman, Biotech Supply Chain
Academy
Moderator: Jay Vora Ph.D, Principal PRTM

3:50-4:00

CLOSING REMARKS and End of
Conferenc
e

Devendra Mishra, Executive Director, Bio Supply Management Alliance

 

 

EVENT SPONSORS

 

APICS Golden Gate Chapter

 

Bio Supply Management Alliance

 

Cornerstone Systems Solutions

SILVER SPONSORS

E2Open

 

McKesson

 

BRONZE SPONSORS

 

Dematic

 

 

EnviroCooler
Green Mountain Consulting

 

LifeConEx

 

Pelyco Systems
NexInfo
UPS

 

MEDIA SPONSOR

 

SupplyChainBrain

 

ACADEMIC SPONSORS

 

Golden Gate University

 

Pepperdine University

 

PRESENTING SPONSOR

 

ChainLink Research