preparing the biotech supply chain for 2025

“PREPARING THE BIOTECH
SUPPLY CHAIN FOR 2025“
BIO SUPPLY MANAGEMENT ALLIANCE
Building Supply Chain Excellence End to End
PLATINUM sponsor
GOLD sponsors
bronze sponsors
association sponsors
San Francisco Roundtable
Council of Supply Chain
Management Professionals
OCTOBER 15, 2015 CROWNE PLAZA FOSTER CITY, CALIFORNIA
www.biosupplyalliance.coM
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BIO SUPPLY MANAGEMENT ALLIANCE
MissionStatement
ExecutiveCommittee
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.
Devendra Mishra
EXECUTIVE DIRECTOR & CO-FOUNDER
Dave Malenfant
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
Pamela Gardner
VICE PRESIDENT, SPONSOR SALES
Dotti Yells
VICE PRESIDENT, MARKETING , WEBMASTER & DBA
Wayne McDonell
INDUSTRY LEADER, PwC
John Mitch
LEGAL COUNSEL
AdvisoryBoard
Anderson
Aphale
Buck
Curry
Dawe
Paul Anderson, Sr. Director, Toll Manufacturing & Supply
Chain, Illumina
Jayant Aphale, Senior Vice President, Technical Operations,
Serepta Therapeutics
Mark Buck, Global Supply Chain and Procurement Leader,
Bio-Rad Laboratories
Prentice Curry, VP Quality & Operations, Kite Pharma
Dr. Richard L. Dawe, Director of the Operations & Supply
Chain Management Program and the Center of Operations
Management, Golden Gate University
Johan Denecke Global Assurance Sr. Director, Life Sciences
Solutions, Thermofisher Scientific
Mary Kachinsky, VP Strategic Sourcing, Forma
Therapeutics
Phil Kaminsky, Associate Professor, School of Industrial
Engineering & Operations Research, University of
California, Berkeley
Nancy Nix, Ph.D, Director, Executive MBA Program,
Professor, Texas Christian University Board Chair, Elect
Council Supply Chain Management Professionals
Kevin Pegels, Vice President, Global Supply Chain USA,
Bayer Healthcare - PS Biotech
Paul Seaback, Head of Global Supply Chain, Gilead Sciences
paGe
3/
Denecke
Kachinsky
singh
Somerville
Kaminsky
Nix
Pegels
Sutherland Suryanarayanan Tenerowicz
seaback
SharpDonaldson
Waller
Yadav
Sophia Sharp-Donaldson, Head of Global Source &
Procurement, Baxalta US Inc.
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)
Joel Sutherland, Managing Director, SCM Institute, University
of San Diego
Shankar Suryanarayanan, Director, Manufacturing Strategy,
Baxter International
Rob Tenerowicz, Vice President, Supply Chain Management,
BioMarin
Rayne Waller, Vice President, Global Supply Chain, Amgen
Prashant Yadav, Director, Health Care Reserach Initiatiave,
William Davidson Institute
bio supply ManaGeMent alliance 2015
www.biosupplyalliance.com
October 15, 2015
BIO SUPPLY MANAGEMENT ALLIANCE
CONFERENCE PROGRAM
9:00am - 1:50pm PLENARY SESSION
9:00 –9:15am WELCOME ADDRESS
Devendra Mishra, Executive Director, BSMA
11:45 - 12:30 pm PANEL: "Industry 360° - Advancing the
Efficacy and Integrity of the Global Supply Chain"
9:15 - 9:45am “Genomics Innovations: Shaping the Future of
Medicine”
Insights into how Genomics is leveraged to produce next generation
medicine. The technology of using Genomics data for product
invention will be presented. The science, knowledge and data will be
nalyzed to enable greater efficacy in the overall supply chain. The
Illumina Accelerator program provides funding, equipment, lab
facilities and coaching on how to take a novel idea for use of genomics
and build it into a business that is pitched to venture investors. Results
of the effort will be presented.
Amanda Cashin PhD, Director of the Accelerator Program, Illumina
9:45 - 10:15am “Accelerated Product Lunch with FDA:
Integrating Clinical and Commercial Supply Chains”
Planning for commercial launch, especially with Breakthrough
Therapy designation, introduces special supply chain challenges due
to high demand and timing uncertainties. In this presentation,
Genentech will share how a collaborative partnership between
our clinical and commercial supply chain organizations and the
FDA successfully enabled the accelerated launch of GAZYVA in 2013.
David Volk, Clinical Supply Chain Management (PTDS), HoffmannLa Roche
10:15 - 10:45am “Biologics Drug Substance Quality
Management: Integrating the Global Supply Chain”
Provides an insight into the importance of Quality Operations
Management across the product supply chain to realize productivity,
customer service and governmental compliance, while achieving risk
mitigation and manufacturing advancement. The case study will
provide an example of the impact of a quality-driven culture. The
implication of having responsibility across the supply chain (end-toend) will be discussed along with Health Authority expectations for
quality to ensure patient safety and integrity in the global supply
chain.
Andrea Goddard, Vice President & Head of Global Quality
Biologics Drug Substance, Genentech
10:45 - 11:15am NETWORK BREAK
11:15 - 11:45am "Balancing Cost, Service and Risk to
Achieve Operational Effectiveness"
Presentation of the development of a new capability for the life science
industry where the Operational Effectiveness Index is a powerful
measure, visualization and communication approach, operations
decision framework, and a benchmarking tool.
Carl Finamore, Director, Healthcare Industry Advisory, PwC
m
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 challenges, IT
deployment, Big Data and analytics, integrity in the global supply chain,
emerging markets and collaboration for efficiency. Pursuit of SCM
Excellence will be the objective in terms of Issues and Answers.
PANELISTS:
Andrea Goddard, Vice President & Head of Global Quality Biologics
Substance, Genentech
Kevin Pegels, Vice President, Global Supply Chain USA, Bayer
Healthcare
Paul Seaback, Head of Global Supply Chain, Gilead Sciences
George O'Sullivan, Sr. Director of Supply Chaain & Strategi Sourcing
Kite Pharma
Moderator: Wayne McDonnell, Partner, Life Sciences Advisory, PwC
12:30 -1:00pm NETWORK LUNCH
1:00 1:20pm KEYNOTE ADDRESS: “Meeting Challenges in
Today’s Global Supply Chains: A Personal Road Map” Global
trends and challenges are driving significant change which produce
huge opportunities for individuals and supply chain organizations alike.
Presentation highlights what it takes to get the job done in terms of
personal skills, trust in relationships, consensus building,
communication, leadership, technology, and building a sustainable
community of supply chain professionals striving in a risk-laden
marketplace. The outcome can be transformational in providing
customer service from end to end of a supply chain.
KEYNOTE SPEAKER: Rick Blasgen, President and CEO, CSCMP Council of Supply Chain Management Professionals
1:20 - 1:50pm PANEL: "Biotech Meets Hi-Tech: Driving
Innovation"
The cross-pollination of experience and knowledge between executives
of the Hi-tech and the Biotech industry will crystallize variations in
supply chain best practices from the end-to-end supply chain
perspective. The mature global nature of Hi-tech, with its challenges of
reducing cost while achieving manufacturing yields and overall quality,
will be discussed for ‘leap-frog’ improvements in biotech.
PANELISTS:
Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad
Laboratories
David Ginsberg, Vice President, Supply Chain, Sonic Manufacturing
Tim Jordan, Senior Global Commodity Manager, Siemens Healthcare
Jim Latimer, Director, Purchasing, Medivation
Moderator: Rick Blasgen, President and CEO, Council of Supply
Chain Management Professionals (CSCMP)
bio supply ManaGeMent alliance 2015 / PAGE
4
2:00 - 5:30pm TRACK 1: CLINICAL SUPPLY CHAIN MANAGEMENT
2:00 - 2:40pm PANEL: "Reducing Waste, Maximizing
Efficiency and Streamlining Your Global Clinical Supply
Chain"
This panel will address how data is captured and used for managing
clinical studies. Topics covered will include forecasting, tracking
shipments, managing inventory, production planning and MRP,
and performing drug accountability and reconciliation. A wide range of
solutions will be discussed, ranging from manual processes, to
automated ERP systems, to hybrid solutions that reflect combining
multiple tools and solutions.
PANELISTS:
Alyssa Bychowsky, Head, Clinical Supply Chain, Shire
Luke Moyer, Supply Chain Solutions Manager, Almac Clinical Services
Malou Berdan, Senior Manager, Clinical Supply Chain, BioMarin
Michael Dallmann, Director, Global Clinical Supply Chain, Merck
Matt Donnelly, Director, Clinical Supply Chain, Genentech
Patty Overley, Clinical Supply Executive, Global BioPharm Solutions
Moderator: Bill Coakley, Director, Supply Chain Planning, Bio-Marin
2:40 - 3:00pm “Ensuring Your Supply Chain Doesn’t Stop
Until You Reach the End User: The Importance of the
Investigator Site in Clinical Supply Chain Planning” In the high-stakes world of clinical development, sponsors develop
protocols with a focus on testing clinical endpoints and, often,
somewhat less appreciation for the practical implications of the designs
on investigator sites and patients. At a time when the number and
complexity of trials are escalating, sponsors stand to reap valuable
benefits from the practical insights of investigator sites about the impact
of clinical supplies in real-world care settings. The session will review
the results of the global investigator site survey and the impact of clinical
supplies on sites and patients,analyze challenges faced, identify
opportunities to modify interactions with investigator sites to enable
better site performance and higher patient retention strategies. Finally,
current industry trends around patient centricity and how companies
are taking action to address the paradigm shift to a patient-centric
business model will be presented.
Amy Musolino, Program Director, New Service Development, Fisher
Clinical Services
3:00 -3:30pm “Trends and Technology innovations for
Efficient Cold Chain Management and Distribution of Clinical
Supplies”
The panel will share what, in their opinion, is the very latest and most
pertinent trends in terms of cold chain data management. Access to realtime data is particularly important, not only to secure the protection of
IMP product, but also to optimize processes across, what can be, a
complex supply chain. Inventory visibility alone is not enough. Sponsors
today seek data to provide assurance that temperature specifications
have been maintained within stipulated guidelines. In addition, the
panel will share how fast-changing technology opens new possibilities to
the industry enabling service providers to be more reactive with better
paGe
5/
visibility of clinical supplies as they are distributed across the globe.
State-of-the-art technology combined with well-defined processes
results in greater control, compliance and visibility across the supply
chain.
PANELISTS:
Marsha Davis, Product Marketing Manager (Clinical Trials), Sensitech
Tom Robinson, Senior Vice President, Strategic Business
Development, Insync (ORBCOMM)
Bill Rambo, Sales and Marketing Director, Priority Solutions
Julie Trulson, Director CMC Leader, OncoMed
Moderator: Alex Guillen, Global Cold Chain Director, Fisher Clinical
Services
3:30 - 4:00pm NETWORK BREAK
4:00 -4:20pm " The Journey to Build a System for Managing
Clinical Studies"
Presentation of a Case study of systems and tools deployed dover two
years for forecasting, tracking shipments, managing inventory, doing
production planning and MRP, and performing drug accountability
and reconciliation. The software solution has been successfully
integrated with ERP, Clinical Distribution, CTMS and IVR systems.
Bill Coakley, Director, Global Supply Chain Planning, BioMarin
Pharmaceutical
4:20 - 4:45pm “Automated Inventory Control and Visibility:
Streamlining the Clinical Supply Chain”
Presenting a case study of automation and systematization of critical
clinical supply chain functions to achieve efficacy, governmental
compliance and streamlined commercialization. This is a journey of the
Pilot Plants (API & Formulation) at Gilead Sciences to establish
inventory control and visibility for GMP and R&D material leveraging
their mainstream ERP systems.
Arun Cavale, Supply Chain Process Designer, NexInfo
Scott Hebner, Sr. Manager FPD Pilot Plant
4:45 - 5:10pm "An Information System to Manage Clinical
Operations - Achieving Cost Reduction, Speed to Market and
Compliance"
Presentation of a focus on the challenges of forecasting, production
planning, and drug accountability of clinical studies. A software
solution is a protocol driven framework coupled with bidirectional
integration to manufacturing systems (ERP), IVR services and B2B
partners where clinical protocol requirements are translated into
accurately packaged and distributed investigational drug products. The
benefits realized are increased efficiency and accuracy and compliance
of the clinical supply process in functions of Planning, Manufacturing,
Packaging and Distribution, Management Control and
Communication.
Michelle Niles, Director, Business Development, CLINapps
bio supply ManaGeMent alliance 2015
www.biosupplyalliance.com
2:00 - 5:30pm TRACK 1: CLINICAL SUPPLY CHAIN MANAGEMENT (cont'd)
5:10- 5:30pm ID for Medicinal Products (IDMP): Meeting
the European Deadline"
EMA standard called IDMP created by ISO which takes effect July,
2016. One of the purposes of this regulation is to establish standards
(“controlled vocabularies”) across the industry for batch and lot
identifiers, covering 243 attributes and 7 categories (e.g. drug
substance, drug product, etc.). This regulation will impact many
functional groups within pharmaceutical companies (including Supply
Chain), and applies to both clinical and commercial products. Franck Toussaint, Managing Director, Biolog Europe (Belgium)
2:00 - 5:30pm TRACK 2: WORKSHOP: CAREER DEVELOPMENT FOR YOUNG PROFESSIONALS IN SUPPLY CHAIN
MANAGEMENT
2:00 - 2:20pm "SCM as a Competitive Edge in Biotech: The
Practitioner's Perspective"
Supply Chain Management is a cross-functional layer of management
which sits on top of vertical organizational functions of R&D, Clinical
Supply, Commercialization, Planning, Distribution, Customer
Service , QA, Risk Management and Governmental Compliance. The
role of the Global Supply Chain Officer is to establish collaboration so
that processes can be optimized across functions from supplier to
patient. The presentation deals with organizational framework,
intrinsic bottlenecks, integration of business elements, deployment of
IT and leadership acumen required to achieve greater profitability and
growth in the global marketplace.
Kevin Pegels, Vice President, Global Supply Chain, Bayer Healthcare
2:20 - 2:40pm “From a Warehouse Supervisor to the Global
Head of Supply Chain: The Zigzag Journey”
It is the Journey of a Supply Chain Executive who created a Global
SCM Group with over 900 employees at Alcon Laboratories as its Vice
President, after assuming advancing responsibilities in warehousing,
manufacturing, purchasing and materials management over 20 years.
He shares his experience in leadership and performance excellence
through new business opportunities captured, best-in-class processes
established, operational innovations implemented, costs eliminated,
inventory optimized and teams engaged and inspired. Lessons learned
from Systems Thinking-by embracing cross-functional connections
and interdependencies across procurement, logistics, manufacturing,
sales, and marketing will be included. Implementation of a
comprehensive mentoring and talent development program for all
supply chain professionals is a legacy for others to emulate.
Dave Malenfant, Executive Vice President, Industry Liaison and
Talent Development, BSMA, and, Former Vice President, Global
Supply Chain, Alcon Laboratories
2:40 - 3:10pm "Supply Chain Professional Development Program at
Intel: A Blue Print for Action"
Presentation of the program of the "Supply Chain Master" professional
development implemented at Intel with success and enduring value.
Intel created a job ladder to supplement their managerial and
engineering job ladders that is specifically focused on supply chain
professional development from a career growth perspective. He will
also discuss how Intel used an interdepartmental project to help
www.biosupplyalliance.com
2:40 - 3:10pm "Supply Chain Professional Development
Program at Intel: A Blue Print for Action" (cont'd)
train the new supply chain masters across the many areas of the supply
chain.
Jim R. Kellso, Professor of Practice, ASU Supply Chain Management
and Intel Supply Chain master (Retired)
3:10-3:30pm "Development of the Low Cost Supply Chain Master
Program at Intel - The Mechanics for Change"
In her role as the supply chain master, a step-by-step insight into leading
the final design and deployment of the "Low Cost Supply Chain" for the
Atom Microprocessor for Intel across the world. Unique focus on how
that cross functional project both added in project management skills in
a multi-cultural environment and the soft skills of influence and risk
taking.
Cindie Blackmer, Former Supply Chain Master, Intel
3:30 - 5:00pm "WORKSHOP: "Mapping Your Own Career
Path in SCM"
The group of professionals from various companies, serving different
functions of Planning and Forecasting, Purchasing, Manufacturing,
Quality Assurance, Distribution, Logistics. Customer Service, Business
Process Management, Project Management, Governmental Regulations,
will be split into small groups of less than 8 to enable interaction.
Questionnaire-based fact-finding will be utilized to gather individual’s
career details, educational background, organizational characteristics,
career goals over a time frame, strengths and weaknesses, and
constraints to yield an assessment of a personal profile. Interaction
among participants will be professionally facilitated to analyze the selfassessment. The management skills required to navigate career goals will
be analyzed and the participants will be navigated to develop individual
career paths in terms of the overall journey with milestones, resources,
networking, reaching out to professional associations and mentorship.
FACILITATORS:
Richard Dawe, Director, Operations and Supply Chain, Center of
Operations Management, Golden Gate University
Dave Malenfant, Executive Vice President, Industry Liaison and SCM
Talent Development, BSMA
Susanne Somerville, Former Vice President, Supply Chain North
America, Genentech
Prashant Yadav, Senior Research Fellow and Director of the Health
Care Research Initiative, William Davidson Institute (WDI)
bio supply ManaGeMent alliance 2015 / paGe
6
2:00 - 5:30pm TRACK 2: WORKSHOP: CAREER DEVELOPMENT FOR YOUNG PROFESSIONALS IN SUPPLY CHAIN
MANAGEMENT (Cont'd)
5:00 - 5:30pm TOWN HALL DIALOG: SCM Career Planning
A Panel of SCM Experts from various segments of the industry will
address the issues raised by the participants in the workshop to provide
unique insights, guidance to detect iceberg-like organizational
impediments and practical how-to suggestions to navigate in the
turbulent waters.
PANELISTS
Richard Dawe, Director, Operations and Supply Chain, Center of
Operations Management, Golden Gate University
Jim R. Kellso, Professor of Practice, ASU Supply Chain Management
Dave Malenfant, Executive Vice President, Industry Liaison and SCM
Talent Development, BSMA
Jennifer Parkhurst, Partner, Life Sciences, PwC
Kevin Pegels, Vice President, Global Supply Chain, Bayer Healthcare
P. J. Shelton, Vice President, Academic Collaboration, CSCMP San
Francisco
Susanne Somerville, Former Vice President, Supply Chain North
America, Genentech
Prashant Yadav, Senior Research Fellow and Director of the Health
Care Research Initiative, William Davidson
Representative from ISM
2:00 - 5:30pm TRACK 3: GLOBAL SUPPLY CHAIN INTEGRITY (TEMPERATURE-CONTROLLED DISTRIBUTION)
2:00 - 2:30pm “Pain in the Supply Chain of Pharma, Biotech
and Medical Devices: Strategic and Tactical Issues in the
Global Market”
Presentation of the key findings on the business landscape of
healthcare logistics around the world, as well as healthcare logistics
executives’ top concerns and strategies for expansion. In collaboration
with TNS Global, over 440 executives were interviewed in the pharma,
biotech and medical device industries world-wide. Subjects have been
elevated which are of vital importance to small and large companies
alike. Considerable concern has been highlighted in temperaturecontrolled distribution and cold chain, for example.
Robin Hooker, Director of Global Strategy Healthcare Logistics, UPS
2:30 - 3:00pm “A Process Validation Guide for Cold Chain
Logistics: Ensuring Compliance Globally”
Strategies focused on the packaging qualification, without
consideration for validation of the process of drug product transport
and the potential impact on the potency, efficacy, or purity of the drug
product as compared to the specification, will be challenged by
regulatory agencies around the world. Process validation for cold chain
logistics (packaging, storage, and distribution) is a required part of the
Common Technical Document (CTD) for any Biologics License
Application (BLA) for monoclonal antibodies. Any review of the
submitted dossier and subsequent pre-approval inspection onsite will
most likely review the areas of 1.Stability testing, 2. Thermal packaging
qualification, 3. Process validation, and 4. Validation master planning.
The best practices will be identified and current expectation of drug
quality from regulatory agencies globally will be confirmed after
transport.
Gary M. Hutchinson, President, Modality Solutions
3:00 - 3:30pm “Wiring the Biotech Supply Chain for
Actionable Intelligence, Accountability & Overall Process
Improvement”
The presentation will demonstrate how a systematic deployment of
sensors at the critical nodes of the supply chain, gathering data
wirelessly and near real-time computing can produce actionable
intelligence to achieve cost reduction, asset utilization, safety, risk
mitigation and patient care. The Internet of things has been
successfully deployed to integrate all stakeholders for overall good and
compliance.
Rich Kilmer, CEO, CargoSense
3:30 - 4:00pm Network Break
4:00 - 4:30 m “Taking a Risk-Management Approach to
Ensure Supply Chain Integrity”
Presentation of the highest level of understanding of a complex logistic
network so that efficiencies can be realized across a multi-service
channel business by mining quality data through the creation of safety
zones for product quality. Tools and applications to create supply chain
visibility any time will be discussed along with best practices to apply
active technologies across your global platform for results.
Brian Cooper, Head of Healthcare Sales, Envirotainer
4:30 -5:30pm 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:
Gary Hutchinson, President, Modality Solutions
Jim Peyton, Associate Director, Supply Chain, Gilead Sciences
Sophia Sharp-Donaldson, Sr. Director and Head of Global Sourcing &
Procurement, Baxalta US Inc.
Doug Wettegren, Business Area Key Account - The Americas,
Envirotainer
Moderator: Vishal Singal, Vice President, Cold Chain & Emerging
Markets, BSMA, Director Healthcare Advisory, Double Helix
5:30 - 7:00pm SUPPLY CHAIN EXCELLENCE AWARD &
COCKTAIL RECEPTION
/PAGE 7 / bio supply ManaGeMent alliance 2015
www.biosupplyalliance.coM
Preview: PUTTING VOLUNTEERS FIRST
What Every Clinical Team Should
Consider Before Developing the Next Protocol
Some call it a buzz phrase, others a movement. Regardless of what it is, momentum continues to
build around “patient centricity”, a concept that is captivating the biopharmaceutical industry and
spawning everything from articles and conferences to surveys, webinars and lively LinkedIn
exchanges. And while everyone applauds the renewed focus on patients as a positive development,
some say it is time for biopharma companies to turn their attention to another audience without whom
drug development would be impossible – clinical trial participants.
For one thing, there is an important distinction between the two audiences, according to
representatives of investigator sites, who operate on the front lines of clinical research. “Although
individuals who participate in clinical trials are often referred to as patients, they really aren’t patients
– they’re actually volunteers,” said Therese Dayton, RN, CCRC, Director of Nursing and Operations at
Rochester Clinical Research (RCR) in Rochester, NY. “They volunteer their time and medical
treatment during a trial is not guaranteed,” she added, explaining, “Volunteers could receive a placebo
oran unproven or ineffective treatment. That’s the whole point of research.” As a result, investigator
sites eschew the phrase “patient centricity” in favor of “volunteer centricity”.
Semantics aside, an examination of the issues surrounding clinical trials appears to be long overdue.
Only about 5 percent of those eligible to participate in trials actually do so, even though the number
and size of studies have been escalating. Those who do volunteer to participate in trials can face
some frustrating experiences, thanks to what could be characterized as a combination of faulty
communication and protocol missteps. Among them: hard-to-open drug packaging, unclear directions
about following complex regimens, an escalating number of required medical procedures,
malfunctioning technology, and clinic appointments that must be cancelled – again – when supplies
fail to arrive.
The issues may be a consequence of a failure to consider the needs of volunteers during the protocol
development process. Beyond engendering frustration among volunteers and the site staff who
interact with them, such issues potentially endanger drug development by eroding the three
cornerstones of clinical research – adherence, retention and recruitment.
At a time when companies are readily embracing new opportunities to engage patients, they would do
well to dismantle barriers to clinical trial participation by making subjects the centerpiece of the
protocol planning process. “Volunteer-centric” trials engage subjects as partners in clinical research by
making participation easy, positive and comfortable experiences for them.
Doing so has the potential to launch a new era of volunteer-centric clinical trials that, aside from being
efficient and cost-effective, establish a cadre of research ambassadors – volunteers whose
experiences are so fulfilling that they join additional studies and encourage friends and family to do the
same.
The full paper was developed by Patricia S. Larrabee, RNNP, CCRC, who is Site Director, Founder and CEO of Rochester
Clinical Research and Amy Musolino, New Service Development Program Director at Fisher Clinical Services. Ms. Larrabee
and Ms. Musolino serve on the Investigator Site Panel on Clinical Supplies, a volunteer organization that has represented
clinical sites in North America, Europe and South America and others involved in the implementation of clinical trials since
2011. The 11-member panel includes two representatives of Fisher Clinical Services, a global leader in supply chain
management that is committed to participating in ongoing dialogue and improving clinical research.
You can view the full whitepaper at fisherclinicalservices.com/patient-centricity-white-paper/
We Supply Hope
SM
Helping our customers deliver an
efficient and risk controlled clinical
supply chain to investigators and
patients worldwide.
fisherclinicalservices.com
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.
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POSTAL CODE
MEMBERSHIP CATEGORY (CHECK ONE)
Member Category
Member Description
Annual Dues
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
without a commercial product
$2,000____
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
support of the bio life sciences.
$500____
Individual Membership
Annual Revenues Greater than $1 Billion
$500____
(select one)
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, 23681 Park Andorra, Calabasas, CA 91302 or fax to 513893-2107
_____________________________________________________________________________________________
CREDIT CARD NUMBER or CHECK NUMBER
EXPIRATION DATE
CDC
_____________________________________________________________________________________________
NAME ON CREDIT CARD
SIGNATURE
DATE
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:
www.biosupplyalliance.com
Because life depends on us™
You start
by listening
In times like these, knowing where to start the conversation in
helping to address complex issues is vital. So, there is a process
to everything we do and it starts with listening and identifying
the right questions. Knowing where to start and what to ask
comes from experience and discipline of thought. This is just the
beginning of what we provide to our clients.
Through our global network of firms with more than 195,000
people in 157 countries, we provide quality assurance, tax
and advisory services to many of the world’s most successful
companies. Tell us what challenges you face or find out more by
visiting us at www.pwc.com/us/pharma
Wayne McDonnell
[email protected]
(949) 437 5451
Jennifer Parkhurst
[email protected]
(650) 248 4380
© 2015 PwC. All rights reserved. PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity.
Please see www.pwc.com/structure for further details. This content is for general information purposes only, and should not be used as a substitute
for consultation with professional advisors.
87187-2016 BSMA Ad.indd 1
9/29/2015 5:55:07 PM
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
Committee Members:
• 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 Pharmaceuticals
Committee Members:
• Dan Ambrose, Director customer Logistics, VWr international
• Paul Anderson, VP, Global Procurement, Life technologies
• Mark Buck, Global Procurement and supply Leader, bio-rad Laboratories
• Tim Doran, Sr Director, Global Strategic Sourcing & Procurement, Jazz
Pharmaceuticals
• Ken Duval, Associate Director, supply chain, shire Pharmaceuticals
• Dale Dwier, Manager, Procurement-Driect Materials, Bayer Healthcare
• Jennifer Forte, Associates Contract Director, Purchasing Group,
BIOCOM
• Rick Fultz, Director of Purchasing Group, BIOCOM
• Tom Heebink, Business Development & Strategic Alliances, Western
Region, BIO
• Joseph Hopkins, Sr Strategic Sourcing & Procurement Consultant
• Tim Jordan, Associate Director supply chain, MAP Pharmaceuticals
• Mary Kachinsky, senior Director, strategic sourcing, cubist Pharmaceuticals
• Marina Kreculj, Director of Corporate Admin & Sourcing, Kite Pharma
• Marc Lampron, senior Director, Procurement, Genentech
• Mike Mayo, Director, Materials and Procurement, Olympus biotech
• Mike Mitchell, Director, supply chain Management, sAfc biosciences
• Sophia Sharp-Donaldson, head of Strategic Sourcing & Global Logistics,
Baxter Healthcare
• Isaac Young, sr. Dir., supply chain Operations, bioMarin Pharmaceuticals, inc.
• Yingming Yue, Associate Director, Nektar Therapeutics Pharmaceuticals
paGe
13 /
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
Committee Members:
• 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
Committee Members:
• 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 Pharmaceuticals
• Thomas Smith, Director, Supply Chain, Shire Pharmaceuticals
• Yingming Yue, Associate Director, Nektar therapeutics
bio supply ManaGeMent alliance 2015
www.biosupplyalliance.com
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: Vishal Singal, VP, Cold Chain Emerging
Markets, BSMA
Committee Members:
• Chris Amberg, EVP, Unitrans International
• Jim Cox, All QA Consulting, All QA Products
• Carli Derifield, CTO, Pharmour
• Rod Derifield, CEO, Pharmour
• Chris Fore, Compliance Manager, Envirotainer
• Alex Guillen, Global Cold Chain Director, Fisher Clinical Services
• Wahiba Hall, Sr Mgr Global Transportation & Cold Chain, Baxter
Healthcare
• Darold Hill, Director of Manufacturing & Validation, Gilead Services
• Lisa Howard, Temperature True Product Manager, UPS
• Gary M. Hutchinson, CEO, Modality Solutions
• Marissa Johnson, Temperature Management Solutions, Thermonet,
LifeConex (DHL Forwarding)
• Christelle Laot, Technical Fellow, Cold Chain Mgmt Life Sciences,
FedEx
• Dave Malenfant, EVP, Industry Liaison & Talent Development, BSMA
• Jim Peyton, Associate Director of Supply Chain, Gilead Sciences
• Karl Schlenker, Vice President, va-Q-tec USA
• Sophia Sharp-Donaldson, Sr Director, Global Supply Chain, Baxter
Healthcare
• Don Wilson, Associate Manager, Amgen
• Douglas Wettegren, regional sales Manager, Western North America,
envirotainer
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
Pharmaceuticals
Committee Members:
• Karen Conway, Director, Healthcare, Global Health exchange
• Lou Kontnik, Director of brand Protection, Amgen
• Mike Wallace, Director, Global Standards and Serialization,
Master Data, Abbott Laboratories
• Wayne McDonnell, Pharma & Life sciences Advisory,
Pricewaterhousecoopers
www.biosupplyalliance.com
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
Committee Members:
• Andrea Fox, VP, Diagnostics Laboratory Operations, Life
Technologies
• Arbi Harootoonian, Vice President, Business Development,
Therapak
• Karel Hurka Jr, Sr. Manager Supply Chain Management, Genomic
Health
• Susan Jiang, Health Supply Chain Supervisor, Verinata Health
• Scott Krhoun, Supply Chain Operations Manager, Tethys
Biosciences
• Rishi Kacker, Vice President, Engineering, Counsyl Diagnostics
• Glen McHenry, Sr. Manager Supply Chain Management,
Monogram Biosciences
• Jordan Myers, Sales Associate, VWR Healthcare
• Meserve Platt, Associate Director Materials / Facilities, crescen-do
Bioscience
• Tom Schoenherr, Vice President, Business Development, Counsyl
Diagnostics
• Winnie To, Supply Chain Manager, Natera Health
• Alan Wells, VP, Diagnostics Laboratory Operations, Life
Technologies
SUPPLY CHAIN CLINICAL OPERATIONS (SCCO)
STEERING
COMMITTEE
•
identifying and enabling the sharing of best practices,
knowledge and experience in clinical supply and integrate
clinical operations as a critical segmanet pf the overall supply
chain.
CHAIRPERSON: Bill Coakley, Director, Supply Chain
Planning, BioMarin
Committee Members:
• Philip Chou, Associate Director,Clinical Supplies, Elan
Pharmaceuticals
• Michael Dallmann, Associate Director, Clinical Supplies, Cerexa
• Jaymin Eberhart, Principal, PRTM
• Richard Horn, Associate Director Supplier Mgmt, Necktar
Therapeutics
• Theodore James Maylath, Manager, clinical supply, Abbott
• Amy Penticoff, Associate Director Pharmaceutical sciences,
NeurogesX, inc.
Bio Supply Management Alliance 2015 / Page
14
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