collaboration with cooperative groups - CBI

CBI’s 3rd Annual Forum on Industry 

Collaboration with 

Cooperative Groups 

Understand Changes in Group Structure 

Improve Operations • Adhere to Critical Timelines 

M a r c h 2 7 - 2 8 , 2 0 1 2 • D o u b l e t r e e C e n t e r C i t y • P h i l a d e l p h i a , P A 

Attend the only event that provides a forum for learning and networking 

between industry, NIH and Cooperative Groups 

graphics courtesy of Getty Images 

NIH Perspectives: 

• Meg Mooney, Chief, Clinical Investigations Branch, 

CTEP, DCTD, NCI 

• Donna Shriner, Senior Clinical Research Pharmacist, 

Pharmaceutical Management Branch, CTEP, DCTD, NCI 

Distinguished Industry Faculty: 

• Karen Bartels, Investigator Sponsor Study Lead, 

AstraZeneca Pharmaceuticals LP 

• Jeffrey Humphrey, Executive Director, External Research, 

Oncology Global Clinical Research, Bristol-Myers Squibb 

• Coleman Obasaju, Senior Medical Director, US Medical 

Division, Oncology, Eli Lilly 

• Arthur Cannon, Medical Science Director, External Affairs, 

Genentech BioOncology 

• Ionel Mitrica, Director, Clinical Development, 

GlaxoSmithKline Oncology 

• Jocelyn Ulrich, Senior Project Manager, Medical Affairs, 

Human Genome Sciences 

• Benedetta Campanelli, Global IIR Senior Associate, 

External Medical Communications, Pfizer Inc 

• Donna Stocker, Manager, Global Investigator-Initiated 

Research, Pfizer Inc 

Global Address: 

“Explore Global Intergroup Collaborations” 

Yeul Hong Kim, President, 

Korean Cancer Study Group (KCSG); 

Professor, Department of Internal Medicine, 

Korea University College of Medicine 

Cooperative Group Representatives: 

NRG Oncology 

• Joan (Kip) Beyer Goldberg, Chief Executive Officer, 

NSABP 

• Elaine Junio, Business Development Officer, NSABP 

• Sharon Hartson-Stine, Senior Director of 

Clinical Trials, Group Administrator, RTOG 

• Laura Reese, Executive Director of Operations, GOG 

ECOG 

• Bruce Giantonio, Executive Officer, ECOG 

SWOG 

• Nathan Eriksen, Chief of Administration, SWOG 

• Dana Sparks, Director of Operations and Protocols, SWOG 

Alliance for Clinical Trials in Oncology 

• Linda Bressler, Director of Pharmaceutical 

and Regulatory Affairs, CALGB 

• Angie Patterson-LaBaw, Coordinator — 

Research Operations, NCCTG 

Lead Sponsor: 

Lead Media Partner: 

Additional Media Partners: 

www.cbinet.com/coop

“The conference was invaluable for sharing an incredible amount of 

information and learning from colleagues in the groups and other pharma.” 

— Previous Attendee, Jocelyn Ulrich, External Partner Liaison, Pfizer Inc 

M a i n c o n f e r e n c e 

Day One — Tuesday, March 27, 2012 

7:30 Main Conference Registration 

8:30 Chairman’s Opening Remarks 

Jeffrey Humphrey, M.D., Executive Director, External Research, 


Dr. Humphrey is an oncologist and currently serves in a newly-created 

role to facilitate external research with Cooperative Groups, the NCI and 

academic research organizations. He previously served as Vice President 

of Oncology, U.S. Medical Strategy, overseeing launch preparations 

for Erbitux ® , Sprycel ® and ipilimumab, and as Vice President of U.S. 

Medical Sciences at Bayer HealthCare Pharmaceuticals where he oversaw 

the launch of Nexavar ® in renal cell carcinoma and approval and launch 

in hepatocellular carcinoma. From 2003 to 2005, he served as Senior 

Director and Clinical Exploratory Head of phase I and phase II 

oncology drug development at Pfizer’s Groton/New London research. 

Dr. Humphrey served as Chief Oncology Fellow at the National Cancer 

Institute where he was a fellow and research officer from 1990 until 1997. 

N C I K e y n o t e A d d r e s s 

8:45 Cooperative Group Consolidation and Implications 

for Industry Collaborations 

Over the last few years, Cooperative Groups have been 

re-organizing to meet NCI and IOM recommendations 

to increase efficiency. In this address, hear how OEWG 

timelines instituted in January of 2011 have affected 

group operations and explore the status of consolidation 

and other changes to the program. 

• Hear updates on the Cooperative Group 

System restructuring 

* changes in working with industry 

* how may restructuring affect contracts 

(existing and future agreements)? 

• How well are Cooperative Groups meeting 

OEWG timelines? 

• Explore updates on implementation of a common 

clinical data management system for the program 

Meg Mooney, M.D., MBA, Chief, Clinical Investigations Branch, 

CTEP, Division of Cancer Treatment and Diagnosis, 

National Cancer Institute (NCI) 

The Impact of Data Requirements and 

Operational Initiatives on Study Conduct 

9:45 Defining Minimum Data Submission Standards 

and Evidence Requirements in Clinical Trials 

Data collection and management is a complex and 

resource-intensive part of the clinical trial process. 

Industry and Cooperative Group practices and 

thinking around data collection often vary widely, with 

industry collecting large amounts of data to fulfill all 

potential regulatory requirements and Cooperative 

Groups collecting sufficient information to assess 

risks and benefits. The FDA is currently working 

on a draft guidance document to further define data 

submission standards and evidence requirements in 

clinical trials which may help inform practices for both 

industry and Cooperative Group trials. Publications 

and presentations over the past several years have 

indicated areas where fewer data may be collected in 

trials conducted to support supplemental registration 

without compromising the collection of data most likely 

to inform clinical practice. Circumstances where fewer 

data can be collected without compromising regulatory 

use of Cooperative Group trials are reviewed. 

Jeffrey Humphrey, M.D., Executive Director, External Research, 


10:30 Networking and Refreshment Break 

11:00 Overcome Challenges in Setting Accurate Budgets 

Early in Collaborations 

Budgeting for Cooperative Group-Industry collaborations 

is a complex process and depends heavily upon good 

communication and setting expectations up front (e.g., 

knowing if a study is intended for filing purposes and 

what level of data should be collected). This session 

provides an in-depth discussion of the factors that can 

impact the bottom line for conducting collaborative 

clinical research. Walk through budgeting scenarios 

and obstacles including what is truly involved in a “drug 

only” study. Understand when industry may be asked to 

provide supplemental funding for patient costs and what 

types of data collection may require additional support. 

Attendees examine potential methods to allow planning 

on both sides and avoid frustration. 

• Discuss factors that impact the bottom line in 

collaborative research 

• Walk through budgeting scenarios and obstacles 

* what study components may require 

additional support? 

• Explore ways to plan on both sides and 

avoid frustration 

Jocelyn Ulrich, Senior Project Manager, Medical Affairs, 


11:45 Facilitate Contracting — Develop Common 

Terminology and an Understanding of 

External Pressures 

P Contract negotiations can cause serious delays to study 

start times, compromising efforts to meet OEWG 

A 

and study timelines. There is need for a common 

N understanding of the overarching pressures facing both 

parties before they come to the table with unrealistic 

E expectations. For example, bio/pharmaceutical 

L companies must comply with regulatory (e.g., OIG) 

requirements and enter into IP and other agreements 

that provide an acceptable amount of risk/benefit to

each franchise within a company. When providing 

support for a trial, they must understand the mechanism 

behind how that trial is conducted and also have 

visibility and confidence that those processes meet 

requirements. This session examines pressures that 

complicate contracting and strategies to overcome them. 

• Examine the need for common terminology 

• Understand the regulatory and business requirements 

that industry must meet 

* how are companies asking Coops to help them 

meet their obligations? 

• Explore the legal identity of Cooperative Groups and 

relationships to membership sites 

* legal identity and binding of investigative sites in 

both the U.S. and ex-U.S. 

* site standards, monitoring and oversight 

• Examine Cooperative Group views on how to get 

collaboration agreements completed in an expedient 

manner, owning IP and use of biological samples 

• Devise a detailed plan for communication of 

trial progress and data, including ownership, 

use and publication 

Moderator: Jeffrey Humphrey, M.D., Executive Director, External Research, 


Panelists: Nathan Eriksen, Chief of Administration, SWOG 

Arthur Cannon, JD, Medical Science Director, External Affairs, 


Linda Bressler, Director of Pharmaceutical and Regulatory Affairs, 

CALGB, Alliance for Clinical Trials in Oncology 

12:45 Luncheon 

2:00 Understand Logistics for Drug Distribution in 

Cooperative Group Studies 

Cooperative Group Studies involve multiple sites 

and/or countries and therefore drug distribution can 

become complex. There are various options available 

P 

to furnish a drug in these studies — bio/pharmaceutical 

A companies can furnish the drug to CTEP which 

N distributes the drug to sites, bio/pharmaceutical 

supporters can agree to supply the drug using in-house 

E teams or third-party distributors or the Cooperative 

L Group can undertake drug distribution with a thirdparty 

distributor. This session discusses how the 

responsible party should establish proper processes for 

logistical and other challenges including: 

• Identification and communication of shelf life, 

temperature excursion and contamination issues 

• Stock recovery — Drug destruction and/or returns 

• Shelf life determinations/documentation 

• Drug shortages/resupply/packaged material or bulk 

• Secondary distribution 

• International shipping/importing or exporting supplies 

• Shipping dangerous goods (as declared by IATA) 

• Examining the limitations and benefits of various 

mechanisms for distributing drug in a Cooperative 

Group-Industry collaboration 

Moderator: Joan (Kip) Beyer Goldberg, Chief Executive Officer, 

NSABP Foundation, Inc 

Panelists: Donna A. Shriner, Pharm.D., MPH, Senior Clinical Research Pharmacist, 

Pharmaceutical Management Branch (PMB), CTEP, 

Division of Cancer Treatment and Diagnosis (DCTD), 

National Cancer Institute (NCI) 

Dana B. Sparks, Director of Operations and Protocols, SWOG 

Donna L. Stocker, Manager, Global Investigator-Initiated Research, 

Pfizer Inc 


3:30 Factors to Consider when Working with 


Industry panelists discuss the perceived benefits and 

challenges involved in working with Cooperative 

Groups, including what situations represent a win-win, 

why they might forego a project and how to streamline 

communications. Panelists discuss: 

• How industry should categorize/approach these 

P trials keeping in mind that they are neither 

A 

investigator-initiated nor company-sponsored 

• Analysis of risk/benefit 

N • Globalization of clinical trials 

E • IP challenges and freedom to operate 

• Data considerations 

L 

* ownership/rights 

* 21 CFR Part 11 and data transfers 

• Timelines — LOI to CSR 

Moderator: Karen L. Bartels, Investigator Sponsor Study Lead, 


Panelists: Jocelyn Ulrich, Senior Project Manager, Medical Affairs, 


Arthur Cannon, JD, Medical Science Director, External Affairs, 


Benedetta Campanelli, Global IIR Senior Associate, 

External Medical Communications, Pfizer Inc 

4:30 Update on Group Collaboration Initiatives 

and the Path Forward 

Learn about initiatives including plans to draft guidance 

discussed at a recent NCI and industry working group. 

Attendees hear about progress and best practices for 

collaborative trials. 

Karen L. Bartels, Investigator Sponsor Study Lead, 


5:15 Close of Day One 

5:15–6:15 • Networking, Cocktail Reception 

Join colleagues and friends in a relaxed setting. 

hosted by: 

To Register Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) or visit www.cbinet.com/coop •

Day Two — Wednesday, March 28, 2012 

7:30 Continental Breakfast 

8:15 Chairman’s Review of Day One 

Jeffrey Humphrey, M.D., Executive Director, 

External Research, Oncology Global Clinical Research, 

Bristol-Myers Squibb 

Increase Patient Diversity in Cooperative 

Group Research — Encourage Minority 

Enrollment and Global Intergroup Work 

8:30 Diversity in Clinical Trial Enrollment — 

What can Cooperative Groups Offer? 

The importance of increasing minority enrollment 

in clinical trials is a current focal point for the FDA 

which is already suggesting that clinical trial results, 

in terms of patients accrued, should better reflect the 

U.S. population. While industry organizations may 

focus on engaging investigators who work in inner-city 

populations and areas with large ethnic populations, 

Cooperative Groups can also encourage diversity 

within their networks of clinical trial sites. This session 

examines the shared challenge of enrolling minorities 

in trials and the opportunities that Cooperative Groups 

have, as a non-industry model, to increase diversity. 

• Explore how industry and Cooperative Groups can 

work together to overcome challenges in recruiting 

minorities for clinical trials 

• Discuss how Cooperative Groups can encourage 

diversity within their networks 

* what measures help cultivate membership from 

institutions that have not traditionally participated 

in Cooperative Groups? 

* how can the Cooperative Group System leverage 

minority-based clinical oncology programs? 

* how can we increase the number of minority 

investigators? 

Coleman Obasaju, M.D., Ph.D., 

Senior Medical Director, US Medical Division, Oncology, 

Eli Lilly 

9:15 Globalization to Facilitate Patient Accrual 

NCI CTEP has identified global patient accrual as 

an objective for its Cooperative Group network. Timely 

accrual has always been a challenge in these studies 

and now delays in accrual can render a trial irrelevant. 

A larger, global network can facilitate efficient accrual. 

In this session, the Eastern Cooperative Oncology Group 

(ECOG) discusses the development of its international 

program and the contribution its international members 

have made to ECOG. 

• Understand how Cooperative Group-led, ex-U.S. 

partnerships can benefit industry collaborators 

• Learn how ECOG is partnering with groups outside 

of the U.S. 

• Analyze the structure of intergroup collaborations 

Bruce J. Giantonio, M.D., FACP, Associate Professor of Medicine, 

Abramson Cancer Center of the University of Pennsylvania; 

Executive Officer, The Eastern Cooperative Oncology Group (ECOG) 


g l o b a l A d d r e s s 

10:30 Explore Global Intergroup Collaborations — 

The Korean Cancer Study Group (KCSG) 

More and more, Cooperative Groups and 

bio/pharmaceutical companies are collaborating directly 

with foreign networks whose structures and funding may 

differ from the NCI system. The Korean Cancer Study 

Group (KCSG) joined as a special member of ECOG 

in September 2011 and has collaborative efforts with 

the EORTC, CIRG and Asian Cooperative Groups. 

This address from the President of the KCSG describes 

the organization and how it interacts and partners with 

Cooperative Groups to further research. In addition, 

learn about the hurdles of investigator-initiated 

international cooperative clinical work efforts — such as 

national health insurance reimbursement systems, study 

drug import systems, routine practice in each country 

and funding for clinical study organizations. 

Yeul Hong Kim, President, Korean Cancer Study Group; 

Professor, Department of Internal Medicine, 

Korea University College of Medicine 

To Register Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) or visit www.cbinet.com/coop

Consolidation and Restructuring 

of Cooperative Groups 

11:30 Formation and Current Status of the New “Alliance” 

Cooperative Group 

In light of the previously-discussed NCI initiative to 

consolidate the number of Cooperative Groups, three 

groups proactively merged to form “The Alliance.” 

Comprised of CALGB, NCCTG and ACOSOG, the 

Alliance is the furthest along in consolidation and 

potentially the most complex. This co-presentation 

provides an opportunity to understand how this new 

group operates and what, if any, changes industry should 

expect. In addition, attendees hear perspective on how 

groups are meeting OEWG timelines. 

• Hear from the newly-formed Alliance 

Cooperative Group 

• Understand how group structure differs due to merger 

* NCI grant support 

• Examine changes for industry collaborators 

* changes in capabilities, contracting 

and communications 

• Explore lessons-learned in consolidation and 

current organizational structure 

• Learn how ACOSOG, NCCTG and CALGB have 

harmonized and where each group maintains some autonomy 

• Hear Alliance perspective on how groups are 

meeting OEWG timelines 

* when to submit concepts to CTEP relative to the 

status of talks with industry 

Linda Bressler, 

Director of Pharmaceutical and Regulatory Affairs, CALGB, 


Angie Patterson-LaBaw, 

Coordinator – Research Operations, NCCTG, 


12:30 Luncheon 

1:45 New “Energy” in Clinical Trials — 

Introducing NRG Oncology 

In this panel discussion, hear about the newly-formed 

NRG Oncology, which combines the synergistic expertise 

P of three Cooperative Groups (NSABP, RTOG and GOG) 

and its transition to a single grant mechanism. Explore 

A NRG Oncology’s approach to parallel project planning 

N for grant preparation/operational changes and corporate 

restructuring. In addition, learn how this consolidated 

E 

group will leverage complementary modalities from the 

L three entities and interact with industry collaborators 

through unique organizational structures. Attendees have 

the opportunity to ask questions of representatives from 

the three original groups. 

Moderator: Joan (Kip) Beyer Goldberg, Chief Executive Officer, 


Panelists: Elaine Junio, Business Development Officer, 


Sharon Hartson-Stine, 

Senior Director Clinical Trials, Group Administrator, RTOG 

Laura Reese, Executive Director of Operations, GOG 

2:45 Key Learnings from Collaborations between 

Cooperative Groups and a Pharmaceutical Company 

In this session, hear examples of how one large 

organization has interacted with different Cooperative 

Groups over multiple studies. Understand how the 

company thinks about and manages these partnerships 

as part of an overall company strategy, including 

considerations such as risk management. Hear about 

collaborations that worked well and why. In addition, 

learn what issues arise and how the company has evolved 

its approach to better address challenges in the future. 

• Examine how Cooperative Group collaborations are 

integrated into company strategy 

• Hear about successes and challenges in 

these partnerships 

• Understand what changes the company made to address 

challenges and maximize the opportunities these 

partnerships present 

Ionel Mitrica, Ph.D., Director, Clinical Development, 

GlaxoSmithKline Oncology 

3:30 Close of Conference 

T o R e g i s t e r C a l l T o l l F r e e 8 0 0 - 8 1 7 - 8 6 0 1 

( 3 3 9 - 2 9 8 - 2 1 0 0 o u t s i d e t h e U . S . ) 

o r v i s i t w w w . c b i n e t . c o m / c o o p

Who Should Attend: 

You will benefit from attending this event if you are a senior-level 

professional at a bio/pharmaceutical company, Cooperative Group, 

cancer center or academic medical center with responsibilities or 

involvement in the following areas: 

• Clinical Development 

• Clinical Affairs 

• Clinical Operations 

• Clinical Research/Investigation 

• Medical/Scientific Affairs • Medical Science Liaison (MSL) 

• Legal/Counsel 

• Clinical Integration 

• Investigator-Initiated Research • Research Grants and Contracts 

• Program/Project Management • Regulatory Affairs 

• Study Delivery 

• Cooperative Group Research and Management 

• Clinical Trial Monitoring and Management 

• Extramural/External Research and Partnerships 

This conference will also benefit consultants, technology and service 

providers and companies providing services in drug distribution, image 

capture, clinical data management, clinical data safety reporting, 

clinical trial management, compliance and tracking to the above 

audience. 

Top 10 Reasons to Attend: 

• Understand the status of Cooperative Group Consolidation 

from NCI 

• Hear from newly-merged groups — 

The Alliance and NRG Oncology 

• Simplify contracting with common terminology and a shared 

understanding of external pressures 

• Consider how FDA’s working draft guidance on data submission 

standards and evidence requirements in clinical trials can inform 

practices for both industry and Cooperative Groups 

• Learn about global intergroup work and hurdles in international 

investigator-initiated trials from The Korean Cancer Study Group 

(KCSG) 

• Hear how industry, NCI’s Pharmaceutical Management Branch (PMB) 

and Cooperative Groups address drug distribution challenges in 

multi-site, multi-country studies 

• Walk through budgeting scenarios to explore how both sides may 

improve planning and ease frustrations throughout the process 

• Explore how ECOG is partnering with groups outside of the U.S. to 

facilitate patient accrual 

• Discuss perceived benefits and challenges of working with 

Cooperative Groups from the industry perspective 

• Understand how Cooperative Groups can assist in increasing 

diversity in clinical trial enrollment 







Attend the only event that provides a forum for learning and networking 

between industry, NIH and Cooperative Groups 

A Great Place to Meet Your Market! 

Take advantage of the best opportunity to meet 

potential clients face-to-face. Build relationships 

while demonstrating thought leadership and 

sharing expertise. 

For additional information on sponsorship or exhibitor 

opportunities, please call Lauren Moras at 

(339) 298-2172 or email lauren.moras@cbinet.com. 

Lead Sponsor: 

To Register 

Call Toll Free 

800-817-8601 

(339-298-2100 

outside the U.S.) 

or visit 

www.cbinet.com/coop

graphics courtesy of Getty Images 

www.cbinet.com/coop 







Scan Here 

Leverage a Unique Opportunity 

to Engage with Leaders from 

Cooperative Groups, NCI 

and Industry 

Hear Cooperative Group perspectives from... 

Alliance for Clinical Trials in Oncology, 

NRG Oncology, SWOG, Korean Cancer 

Study Group, ECOG, RTOG and GOG 

...and network with industry leaders from... 

AstraZeneca Pharmaceuticals LP, 

Bristol-Myers Squibb, Eli Lilly, Genentech 

BioOncology, GlaxoSmithKline Oncology, 

Human Genome Sciences, Pfizer Inc 

The Next Best Thing to Being There… 

Order the Online Compendium if you would like to capture what you’ve missed 

at the conference. It couldn’t be easier. The link to the online compendium is 

available for only $298 and includes the conference agenda, presentations and 

speakers’ biographies. Don’t miss out on this valuable information presented 

by industry leaders exclusively at this event. Simply fill out the order form 

and submit via phone, fax or website and you’ll receive the link to the 

Online Compendium within 2 weeks after the conference. 

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• Registration Fee: Standard Advantage Pricing Coop/Gov’t/Non-Profit 

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Advantage Pricing — Register by January 20, 2012 and SAVE $300. 

Fee includes continental breakfast, lunch, wine and cheese reception, 

refreshments and conference documentation. Please make checks (in U.S. 

funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) 

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate. 

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To receive CBI’s special discounted hotel rate online or by phone, please go to: 

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event of a speaker cancellation, every effort to find a suitable replacement will be made 

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