collaboration with cooperative groups - CBI

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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,

Oncology Global Clinical Research, Bristol-Myers Squibb

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,

Oncology Global Clinical Research, Bristol-Myers Squibb

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,

Human Genome Sciences

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,

Oncology Global Clinical Research, Bristol-Myers Squibb

Panelists: Nathan Eriksen, Chief of Administration, SWOG

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

Genentech BioOncology

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

3:00 Networking and Refreshment Break

3:30 Factors to Consider when Working with

Cooperative Groups

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,

AstraZeneca Pharmaceuticals LP

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

Human Genome Sciences

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

Genentech BioOncology

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,

AstraZeneca Pharmaceuticals LP

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)

10:00 Networking and Refreshment Break

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,

Alliance for Clinical Trials in Oncology

Angie Patterson-LaBaw,

Coordinator – Research Operations, NCCTG,

Alliance for Clinical Trials in Oncology

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,

NSABP Foundation, Inc

Panelists: Elaine Junio, Business Development Officer,

NSABP Foundation, Inc

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

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

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

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

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

2-Day Conference $2,095 $1,795 $995

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.

Verification may be required for Coop/Gov’t/Non-profit rate.

• Team Discount:

Your organization may send 1 executive free for every 3 delegates registered.

All registrations must be made at the same time to qualify.

• Accommodations:

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

• Online: www.cbinet.com/coop

• Phone reservations: (800) 222-8733 and mention CBI’s Collaboration with

Cooperative Groups.

Cut-off date is Monday, March 12, 2012. Reservations made after the cut-off date or

after group room block has been filled (whichever comes first) will be accepted

on a space and rate availability basis. Rooms are limited so please book early.

All travel arrangements are subject to availability.

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Your registration may be transferred to a member of your organization up to 24 hours

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prior to the start date of the event will be refunded, less a $295 administrative charge.

No refunds will be made after this date; however, the registration fee less the $295

administrative charge can be credited to another CBI conference if you register within

30 days from the date of this conference to an alternative CBI conference scheduled

within the next six months. In case of conference cancellation, CBI’s liability is limited to

refund of the conference registration fee only. CBI reserves the right to alter this program

without prior notice. Please Note: Speakers and agenda are subject to change. In the

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

without notice. The opinions of the conference faculty do not necessarily reflect those of

the companies they represent or CBI.

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