Effectively Managing the Global Clinical Supply Chain to Maximize Efficiency, Meet Time Lines, reduce Costs, and Streamline Logistics

1. Proudly Presents:
Register by January 28, 2011 to
Receive our discounted Rate!
5 Forecasting and Optimizing
th
the Clinical Supply Chain
Effectively Managing the Global Clinical Supply Chain to Maximize Efficiency,
Meet Time Lines, Reduce Costs, and Streamline Logistics
March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA
Featured Sessions Include:
dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN
industry Formulating a Comprehensive Clinical Supplies Production Plan
Participants include: and distribution Strategy for Planning and Forecasting
aStRaZENECa Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK
allERgaN
dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialS
biOmaRiN utilizing Strategies to Predict and Supply the Correct amount of
EiSai Clinical Supply Kits in adaptive Clinical trials
F. HOFFmaN-la ROCHE ag Buz Hillman, Clinical Supply Manager,
JaNSSEN PHaRmaCEutiCal COmPaNiES of JOHNSON & JOHNSON
glaxOSmitHKliNE
glObal biOPHaRm CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCES
SOlutiONS
implementing an Effective Clinical Supply Chain Outsourcing Strategy
JaNSSEN PHaRmaCEutiCal Kevin Webb, Director of Supply Chain, biOmaRiN
mERCK
SuNOViON HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly
Optimizing Clinical Supply demands for global Studies using
SuPPly CHaiN iNStitutE
monte Carlo Simulation
Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag
SPONSOR
PRE-CONFERENCE Establishing and implementing a Clinical
Supply Chain in Emerging markets
WORKSHOP
To Register Call 866-207-6528 or Visit Us At www.exlpharma.com/Forecasting

2. Dear Colleague, Who Should Attend?
ExL Pharma is proud to introduce the new 5th This conference is designed for representatives from
Forecasting and Optimizing the Clinical Supply Chain pharmaceutical, biotechnology, and medical device
companies with responsibilities in the following areas:
event on March 8-9, 2011. This conference provides
participants with the tools and knowledge to effec- Departments
tively communicate and increase transparency to better • Clinical Trials Supply/ Clinical Supplies
forecast clinical supply demand, manage clinical supply • Clinical Trials Logistics, Planning and Distribution
in emerging markets, understand the regulatory guide- • Trial Materials Management/Planning
• Investigational Supplies
lines and expectations, increase operational efficiencies,
• Clinical Labeling and Packaging
and learn new emerging forecasting technologies for global • Clinical Manufacturing
clinical supply chain excellence. This is a must attend event • Clinical Pharmacy
for everyone involved in the clinical supply chain looking • Shipping and Distribution
to advance their knowledge and learn new strategies, while • Import-Export Trade Compliance
interacting with other pharmaceuticals, medical device, and • Clinical Operations/Development
• Drug Supply Management
biotechnology professionals. • Supply Chain Management
• IVRS/IWRS
We look forward to greeting you in March! • QA/QC
• Data Management & Statistics
Sincerely, • Regulatory Affairs
This conference is also of interest to:
• linical Services/ Clinical Process
C
Improvement Providers
Mary Ruggiero Kristen Hunter
• Clinical Technologies Companies
Conference Director Team Leader, Production • Forecasting and Simulation Technologies
mruggiero@exlpharma.com ExL Pharma • Clinical Packaging and Logistics Companies
• Contract Research Organizations
• Manufacturing Solution Providers
Hyatt at the Bellevue
200 South Broad Street, Philadelphia, Pennsylvania 19102
Tel: 215-982-4900 | Fax: 215.982.4922 | Email: conciergephlph@hyatt.com
D iscover true grandeur, unrivaled style and service at our iconic downtown Philadelphia hotel. Situated on
the famous Avenue of the Arts, Hyatt at The Bellevue (formerly Park Hyatt Philadelphia at the Bellevue)
blends old-world architecture with modern amenities. Unwind in our luxuriously oversized guestrooms with
posh amenities. Allow our European-style, Concierge to personally recommend and make arrangements at
top restaurants, shows and events. Dine at XIX (NINETEEN) atop our Philadelphia luxury hotel, with sweep-
ing city views. Peruse world-class shops within our landmark building. Work out in our remarkable 93,000
square foot health club. See why this elite Center City Philadelphia hotel has earned the Hyatt distinction..
ROOM RESERVATIONS:
If you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s
Forecasting & Optimizing conference by Sunday, February 6, 2011. We encourage conference participants
to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate.
To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

3. Pre-Conference Workshop Day One – Tuesday, March 8, 2011
8:00 Registration and Continental breakfast for Workshop Participants
PRE-CONFERENCE WORKSHOP:
9:00 EStabliSHiNg a RObuSt CliNiCal SuPPly CHaiN iN EmERgiNg maRKEtS
implementing a Clinical Supply Chain in Emerging markets
Barriers for getting clinical supplies into emerging markets is incredibly complex and requires a depth of knowledge and understanding that has become critical
with the expansion of global clinical trials. In this workshop attendees will:
• earn the regulatory and global clinical supply requirements and how to overcome hurdles for shipping into emerging clinical supply markets
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• lan for and be ready to handle the challenges of importing and exporting clinical supplies
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• earn how to leverage shipping lanes to reduce the cost and time associated with the clinical supply chain
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• aintain clinical supply on time delivery by understanding and adapting to the demands and limitations at locations
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Steve A. Jacobs, MBA, PRh, President, glObal biOPHaRm SOlutiONS
10:30 30-minute Networking & Refreshment break
12:00 Workshop Concludes; luncheon for Workshop Participants
Main Conference Begins Day One
1:00 CHaiRPERSON’S WElCOmE aNd OPENiNg REmaRKS the temperature of supplies during transport, monitoring the
Rick Mann, Associate Director, Clinical Trial Material Management, delivery status to meet on time metrics, and ensuring products
SuNOViON PHaRmaCEutiCalS are safe and meet environmental requirements
1:15 imPROViNg tHE CliNiCal SuPPliES ExECutiON tHROugH Javad Seyed, PhD, Adjunct Professor, Operations Management, Performance
COllabORatiON aNd COmmuNiCatiON and Risk Analysis, Principal Founder, SuPPly CHaiN iNStitutE
building and Optimizing inter-departmental Communications
3:30 Networking and Refreshment break
and Collaborations to better Forecast Clinical Supply demand
• ncreasing transparency by developing communication and knowl-
I 4:00 PaNEl diSCuSSiON- CONtROl COSt aNd maximiZE tHE EFFiCiENCy OF
edge transfer with QA, regulatory, supply and clinical team members tHE CliNiCal SuPPly CHaiN tHROugH tHE uSE OF NEW tECHNOlOgy
• roactive and early engagement techniques that increase com-
P Enhancing the Clinical Supply Chain through the use and
munication and best practices for exchanging information and application of New technology Programs to Reduce Costs and
adjusting clinical supply projections meet time lines
• apping the clinical supply process to best identify where to
M • hy it is important to show the base line before implementing
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implement better supply and demand management the new technology to clearly show the return on investment of
• nderstanding the leader’s corporate responsibility to effectively
U the new systems
communicate up and down the chain • ow you can ensure consistent on time delivery with the highest
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Kathie Sweeney, Investigational Products, aStRaZENECa quality by partnering with your stakeholders
2:00 dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN • he future of forecasting services and applications of the clinical supply chain
T
Formulating a Comprehensive Clinical Supplies Production Plan Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag
and distribution Strategy for Planning and Forecasting Rick Mann, Associate Director, Clinical Trial Material Management,
• egin with the end in mind to comprehensively manage the clinical
B SuNOViON PHaRmaCEutiCalS
supply chain and establish an efficient distribution strategy Are you interested in speaking on this session? If so please call
• ssessing key areas of improvement, reducing waste, and control-
A Mary Ruggiero at (212) 400-6242 mruggiero@exlpharma.com
ling costs in clinical supply chain management
4:45 ROuNdtablE diSCuSSiONS
• ffectively managing change in the clinical supply chain to adapt to
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new clinical trial demands Choose from one of the following roundtable sessions:
Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK 1) RElatiONSHiP buildiNg: Identifying and selecting clinical supply
third party logistics (3PL) and CROs, and building the relationship to
2:45 uNdERStaNdiNg aNd imPROViNg tHE lOgiStiCS imPaCtiNg tHE optimize delivery
CliNiCal SuPPly CHaiN 2) mid-Study mOdiFiCatiONS: Challenges and considerations when
Enhancing demand and Supply Forecasts by aligning Supply modifying the clinical supply chain mid study
Operations to Ensure a Robust delivery 3) gREEN CliNiCal SuPPly CHaiN: The application and value of a
• nderstanding the newest concepts in packaging to include an
U “green” clinical supply chain solution
overview of new packing systems and their mobile environment,
best packaging methods to guarantee stability and study execution, 4) PREdiCtiVE mOdEliNg tOOlS: Risk-based predictive modeling
and ensuring temperature control across the entire supply chain tools to best assist with clinical demand planning scenarios
• ays to get the most out of labeling operations through: language
W 5) imPORt/ExPORt REgulatiONS: Understanding US import/export
libraries, investigator-specific labeling for kits, just-in-time labeling regulations and hurdles
• ow to improve shipping control and transparency by tracking
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5:30 Close of day One
To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

4. Main Conference Day Two – Wednesday, March 9, 2011
8:00 Continental breakfast for Conference Participants 12:45 luncheon
9:00 CHaiRPERSON’S RECaP OF day ONE aNd KEy POiNtS FROm 1:45 CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCES
ROuNdtablE diSCuSSiONS implementing an Effective Clinical Supply Chain Outsourcing
Rick Mann, Associate Director, Clinical Trial Material Management, Strategy
SuNOViON PHaRmaCEutiCalS • dentifying what aspects of clinical supply should be outsourced,
I
and finding the best outsourcing partners
9:15 maximiZiNg tHE ValuE OF iNtERaCtiVE RESPONSE tECHNOlOgy
• he pros and cons of working with local or foreign clinical supply
T
using Either interactive Voice Response (iVR) or interactive
vendors
Web Response (iWR) Systems to Control Cost and Optimize
Production of Clinical Supplies • anaging expectations, deliverables, and the long term relationship
M
• nderstanding when to employ IVR and IWR Independently or in com-
U between sponsor companies and vendors
bination, how to clearly show the cost benefit of using these systems • echniques for managing escalating clinical supplies work load and
T
• earning how IVR/IWR can streamline clinical supply operations
L how outsourcing can be a solution
and reduce overage Kevin Webb, Director of Supply Chain, biOmaRiN
• electing an Interactive Response Technology (IRT) system, estab-
S
lishing what IRT functions will improve the efficiency of the clinical 2:30 CliNiCal labEliNg SyStEmS
supply chain Optimizing the Clinical Supply Chain through the use of New
• valuating the benefits of managing use-by dates using IRT technology
E labeling technology
• ew labelling technology that enhances global clinical studies
N
10:00 HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal through the use of a language library that can be used for rapid
SuPPly design
Optimizing Clinical Supply demands for global Studies using
• earn the methods of new electronic routing of labels for rapid
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monte Carlo Simulation
approvals
• ow to understand and deal with the unequal allocation to treat-
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ment and optimization of site’s supply strategy • nderstanding new labeling technology that enhances accountabil-
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ity of clinical supplies through bar code scanning
• Know how to indentify key blinding considerations when setting up IVRS
• ow to better understand the impact of randomization balancing
H Steve A. Jacobs, MBA, R.Ph, President, glObal biOPHaRm SOlutiONS
on a clinical trial’s supply 3:15 REgulatiON VS iNtERPREtatiON
Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag identifying unclear international Regulations and the Potential
10:45 Networking and Refreshment break impact of Varying interpretations on global Clinical Supplies
• here to find clinical supply regulations and understanding how
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11:15 dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialS interpretation can vary
utilizing Strategies to Predict and Supply the Correct amount • ow to obtain an interpretation of the regulation with the right
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of Clinical Supply Kits in adaptive Clinical trials regulatory contact
• sing various tools and technologies to best forecast clinical supply
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• hat country regulation take precedent over other country regu-
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needs for adaptive trials
lations for clinical supplies
• reating accurate forecasts and estimates relating to adaptive
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• ow to perform regulatory risk management in the clinical supply
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adjustments
world where nothing is black or white
• xamining the likely level of necessary overage and solutions to
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increase efficiency Antonia Daniel, Director, Global Head & Clinical Research Support, EiSai
• eveloping a strategy to minimize the waste sometimes inherent
D Mark Kothapalli, Ph.D., Global Demand and Logistics,
with adaptive trial designs Investigational Material Supply, glaxOSmitHKliNE
Buz Hillman, Clinical Supply Manager, 4:00 Close of Conference
JaNSSEN PHaRmaCEutiCal COmPaNiES OF JOHNSON & JOHNSON
12:00 ENHaNCiNg CliNiCal SuPPly mEtRiCS
methods for identifying and developing appropriate metrics to
improve Clinical Supply Performance
• etermining the right metrics and data to collect in order to
D
increase efficiency in supply forecasting
• esign and development of clinical supply chain metrics to mea-
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sure and improve performance
• Leveraging metrics to forecast future clinical supply needs
Mark E. Apgar, Project Leader, Clinical Informatics, allERgaN Sponsorship and Exhibiting Opportunities
Do you want to spread the word about your organization’s solutions and services to Lucas Carrasco
potential clients who will be attending this event? Take advantage of the opportunity to Business Development Manager
exhibit, present an educational session, host a networking event, or distribute promotional
(212) 400-6231
items to attendees. ExL Pharma will work closely with you to customize a package that
will suit all of your needs. To learn more about these opportunities, please contact: lcarrasco@exlpharma.com
To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

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the Clinical
Supply Chain
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Effectively Managing the Global Clinical Supply Chain to Maximize
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Efficiency, Meet Time Lines, Reduce Costs, and Streamline Logistics
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March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA
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Featured Sessions Include:
industry dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN
Participants include: Formulating a Comprehensive Clinical Supplies Production Plan
and distribution Strategy for Planning and Forecasting
aStRaZENECa
Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK
Zip:
866-207-6528
888-221-6750
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biOmaRiN dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialS
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EiSai utilizing Strategies to Predict and Supply the Correct amount of
Clinical Supply Kits in adaptive Clinical trials
q I’m interested in marketing opportunities at this event
F. HOFFmaN- Buz Hillman, Clinical Supply Manager,
la ROCHE ag JaNSSEN PHaRmaCEutiCal COmPaNiES of JOHNSON & JOHNSON
State:
www.exlpharma.com/Forecasting
glaxOSmitHKliNE
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glObal biOPHaRm CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCES
SOlutiONS implementing an Effective Clinical Supply Chain Outsourcing Strategy
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Kevin Webb, Director of Supply Chain, biOmaRiN
555 8th Avenue, Suite 310
JaNSSEN
PHaRmaCEutiCal
New York, NY 10018
HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly
mERCK Optimizing Clinical Supply demands for global Studies using
ExL Events, Inc.
SuNOViON monte Carlo Simulation
SuPPly CHaiN iNStitutE Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag
To Register:
Please contact me:
PRE-CONFERENCE Establishing and implementing a Clinical
Supply Chain in Emerging markets
WORKSHOP
Telephone:
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To Register Call 866-207-6528 or Visit Us At
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