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3RD ANNUAL INVESTIGATOR INITIATED AND SPONSORED RESEARCH
2015
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
R E G I S T E R BY N OV E M B E R 1 4 , 2 0 1 4 A N D S AV E $ 3 0 0 !
Media Partners:
JANUARY 21-22, 2015 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA
GAIN INSIGHTS FROM INDUSTRY LEADERS INCLUDING:
	Karen Bartels,
Business Area Lead –
Externally Sponsored
Research Operations,
AstraZeneca; Investigator
Research Interest Group
Leader, ACRP
	Neda Bell,
Former Senior Director,
Cooperative and Corporate
Alliances, Celgene
	Ben Cadieux,
Director,
Medical Affairs,
Raptor Pharmaceuticals
	Alexander Kostek, 	
Team Global IIR Group
Leader, Pfizer Inc;
Investigator Research
Interest Group Leader,
ACRP
	Kari Loeser, Esq.,
Senior Director &
Senior Compliance Counsel,
Jazz Pharmaceuticals
	Meg Mooney, M.D.,
Chief, Clinical Investigations
Branch, Cancer Therapy
Evaluation Program,
Division of Cancer
Treatment and Diagnosis,
National Cancer Institute
	Craig A. Sponseller, M.D.,
Vice President
of Medical Affairs,
Kowa Pharmaceuticals
America, Inc.
Building Industry Standards for FMV, Transparency and Reporting
With a robust and customizable agenda, this year’s program is
the perfect resource, regardless of your therapeutic area or focus.
Genentech, Janssen Research & Development, LLC,
Massachusetts General Hospital, SWOG and Many More!
ALSO HEAR FROM:
COOPERATIVE GROUPS AND
ONCOLOGY RESEARCH HIGHLIGHTS:
•	 In-depth discussions on the transition
to master protocols
•	 Insights on utilizing umbrella and
bucket studies
•	 Strategies for better collaborations
with cooperative groups and the
National Cancer Institute	
IIS, IST, IIR AND IIT HIGHLIGHTS:
•	 Insights from academic medical centers
on negotiating IST/IIS agreements
•	 Tactics for identifying and overcoming
intellectual property disputes over
data ownership
•	 A deep dive into executing global
research/IIS programs
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
Who Should Attend:
You will benefit from attending this event if you are a senior-level executive, director or manager from the
pharmaceutical or biotech industry with responsibilities or involvement in the following areas:
This conference will also benefit consultants, technology vendors, law firms and
companies providing services to the above audience.
•	 Investigator Initiated Studies (IIS, IIR or IITs)
•	 Cooperative Group and Academic
Investigator Research and Management
•	 Medical Affairs
•	 Research Grants
•	 Medical/Clinical Operations
•	 External Research and Partnerships
•	 Clinical Trial Monitoring and Management
Conference Sponsor:
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 more information on how to position your company as a sponsor or
exhibitor, contact Robert Boucini at 333.298.2150 or e-mail robert.boucini@cbinet.com.
Brand new content, interactive discussions and critical updates including:
•	 Insights on the NCI’s reporting practices including their reasoning on what they do
and do not report
•	 Strategies for meeting the standards and expectations of Corporate Integrity
Agreements while maintaining research studies
•	 Best practices for FMV analysis and insights on whether to report FMV by total
budget or by line item
•	 Tactics for determining ownership of research and negotiating research agreements
with external research partners
This groundbreaking event creates a platform for developing standards for FMV analysis,
transparency and reporting practices for IIS, IST and Cooperative Group Research.
CHOOSE FROM IN-DEPTH WORKSHOPS, BREAKOUTS AND THINK TANKS:
WORKSHOPS:
Optimize the Globalization
of Research
OR
FMV Analysis Boot Camp
BREAKOUTS:
Utilize Master Protocols
to Improve Clinical Trial
Effectiveness
OR
Develop Tactics for
Negotiating IIS Agreements
THINK TANKS:
Build Industry
Position Statements
OR
Create Research
Standard Operating
Procedures
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
Workshop Objective:
As research studies continue to go global it becomes
critical to understand how to initiate, maintain and
execute a global trial. This workshop takes a deep dive
into strategies for collaborating with affiliate offices to
optimize the effectiveness of globalized research.
Key Questions to Be Addressed:
•	 How do we make global decisions when key
decisions including FMV and budgeting are
left to the discretion of the affiliate office?
•	 What are best practices for ensuring foreign
investigators adhere to internal and external
reporting and transparency requirements?
•	 How can strategic planning be leveraged to reach
a consensus at the local and global level on study
design and protocol.
Workshop Outline:
I.	 Develop Global Standards
for Research Protocols
•	 Understand the role of a clear SOP on IST
concept review process and approval with
buy-in from affiliates
•	 Create strategies to limit redundancy
at the regional level
*	industry tactics for selecting a proposal
among similar competing concepts
*	implement fair and transparent competition
for prospective investigators
•	 Discuss the role of IT in consolidating and
organizing centralized reviews with each
affiliate membership
II.	 Optimize Collaborations
with Affiliate Offices
•	 Develop strategies for working with affiliate
offices to make decisions on a global scale,
instead of on a case-by-case basis
•	 Understand how to manage affiliate interests
in partnering with regional investigators on
concepts that meet regional and specific data
needs (e.g. label variations and/or varying dose
schedules, HEOR, etc.)
•	 Discuss tactics for collaborating with affiliate
offices on building the budget and FMV
analysis on a global IIS
III.	 Overcome Challenges with Global
Regulatory Requirements
•	 Discuss tactics for ensuring the local FMV
practices of the foreign investigator site are
adapted to comply with internal requirements
•	 Understand the impact of foreign transparency
laws on multi-country research operations
	 Workshop Leaders:
	 BenCadieux,Director,MedicalAffairs,
Raptor Pharmaceuticals
Mr. Cadieux is a collaborative Medical Affairs (MA) professional with significant
Oncology, Immunology/Transplantation and Rare Disorders experience. Broad
experience in building and leading the MA platform aimed to facilitate the
generation of the cross-functional strategic plan, as well as identification
and execution of the global portfolio value drivers. Specific experience
include creating the Medical Plan, leading HECOR data generation initiatives,
Pharmacovigilance, Medical Communications and Publication strategies,
oversight of the global grants platform encompassing the evaluation of
investigator-initiated research (IIR) strategies, KOL engagement through
meaningful advisory boards and educational programs, relationship building
with advocacy group leadership, as well as the management of global field-based
MSL excellence in scientific exchange across various therapeutic areas and
throughout the life-cycle of the portfolio agents. Currently reporting to the CMO,
responsible for the global MA budget, the creation and maintenance of internal
guidelines and SOPs and successfully building the full scope of MA operations
platform through the company’s first product launch. Acting as cross-functional
internal medical expert (e.g., review PRC Sales and Marketing materials, sales
training, product monograph, etc.) and externally as an invited speaker on
behalf of the organization (medical meetings, advocacy groups).
AlexanderKostek,TeamGlobalIIRGroupLeader,Pfizer Inc;
InvestigatorResearchInterestGroupLeader,ACRP
Mr. Kostek started his career doing chemical research and development for
Hoffmann-La Roche, Inc. and later DuPont Merck Pharmaceuticals in 1996.
In 1999, he joined Merck Manufacturing Division, supporting the Rahway
manufacturing site before transitioning into Clinical R&D Project Management.
Having joined Pfizer in 2002, Mr. Kostek had a variety of responsibilities in Project
Management, supporting multiple products and working on cross-functional
initiatives like resource management forecasting. Mr. Kostek joined USP Medical
Finance in 2005, provided financial oversight for Phase IIIB/IV Medical Teams
and Administrative Groups, and worked with the implementation team for
Medical Education Grants (MEG). More recently, he served as Project Leader for
establishing Medical Business Operations, identifying and leveraging synergies
related to policies, processes, systems, and resources across functional groups in
CMO. He also served as the interim Director of a new MEG Operations Group and
led the Global IIR Transition Team in merging legacy US and legacy WW functions
into one global organization. He then became the Global IIR Group Leader for
Investigator Initiated Research located in the New York headquarters and led the
team for over five years within Pfizer Medical’s External
Medical Communications.
WORKSHOP A: OPTIMIZE THE GLOBALIZATION OF RESEARCH
DAY ONE WEDNESDAY, JANUARY 21, 2015
CHOOSE FROM TWO CONCURRENT IN-CONFERENCE WORKSHOPS (A & B)
	 There will be a 30-minute networking and refreshment break at 10:00 a.m.
12:00 	 Close of In-Conference Workshops
7:30 	 Workshop Registration and Continental Breakfast
8:30	 Workshop Leaders’ Welcome and Opening Remarks
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
Workshop Objective:
Transparency regulations are continuing to evolve
and FMV models including the proper analysis for FMV
could shift under changing regulations. It is crucial
to understand how to create an FMV analysis and
understand the impact FMV values have on negotiating
with investigator sites.
Key Questions to Be Addressed:
•	 How is “fair market value” determined?
• 	 Should an FMV analysis for research be done
by line item or by total budget?
• 	 What should a company do when an
investigator disputes the FMV of an expense?
Workshop Outline:
I. 	 Define What Is “Fair Market Value”
•	 Brainstorm measurable parameters for the
definition of fair that should be used in
building an FMV analysis
•	 Discuss what costs should be included
when creating a budget and FMV
II. 	 Establish a Standard FMV Analysis
•	 Assess implications of running an FMV by line
item compared to FMV by total budget
•	 Discuss how the method of analysis chosen
impacts reporting practices and
transparency obligations
•	 Share best practices on creating a standard
FMV analysis
III. 	 Negotiating FMV
•	 Analyze strategies for handling disagreements
with investigators regarding the FMV assigned
to an expense
	
	 Workshop Leaders:
	 LizCopeland,AssociateDirector,Contracts&Grants,
Janssen Research & Development, LLC
Ms. Copeland earned a Bachelor of Science degree in Business Economics from
the State University of New York and a Master of Business Administration in
Pharmaceutical Management from Drexel University. She has been employed by
Johnson & Johnson since 2001. Prior to J&J, Liz worked for Goldman Sachs as a Sr.
Analyst in the foreign exchange department. After initially supporting Sales &
Marketing, Liz became a charter member of the Janssen Research & Development
Contracts & Grants Group. She has held positions of increasing responsibility
across most functions within the group including most recently overseeing the
Fair Market Value Pricing function. In her current role, Liz oversees the Early
Development, Clinical Pharmacology and Investigator Initiated Contracts &
Grants function.
KristiVonderloh,SeniorContracts&GrantsAnalyst,
Janssen Research & Development, LLC
Ms. Vonderloh joined Janssen Research & Development through Research
Pharmaceutical Services in August, 2011 and became a fulltime employee in
June 2014. Kristi previously worked at Biogen Idec, Inc. as a Contract Manager
negotiating IIS agreements and company sponsored agreements for Phase I
oncology clinical trials. Prior to Biogen Idec, Kristi worked at Fred Hutchinson
Cancer Research Center as an Industry Sponsored Research Analyst negotiating
both sponsored CTAs and IIS agreements. She also worked at La Jolla Institute
for Allergy and Immunology as an Intellectual Property Specialist negotiating
confidentiality, consulting and material transfer agreements, as well as
processing invention disclosures and tracking patent applications. In her current
role within Janssen, Kristi is responsible for IIS contracting for all Janssen
Operating Company compounds. Kristi earned her Bachelor’s Degree in Business
Management in 2006. Prior to that, Kristi spent 4 ½ years in the United States
Navy as a Yeoman stationed at Naval Station Treasure Island in San Francisco, CA
where she worked in the Judge Advocate General’s Office processing Captains
Mass and Court Martial paperwork.
SinathLim,LeadContractsManager,
Genentech U.S. Site Contracts
Ms. Lim has over 13 years of experience in the biotech industry including
positions in Quality Assurance and Clinical Contracting. Currently she is a Lead
Contracts Manager in Genentech’s Global Pharma Procurement group. Sinath
also serves as Chair of the clinical study site Budget Review Committee in her
group within Strategic Realization & Operations where she provides experienced
budget and Fair Market Value analysis and negotiation expertise to teams
of contract managers. Sinath has also built a reputation for developing and
implementing efficient business process strategies in her role as Single Point of
Contact for the U.S. Medical Affairs function which supports investigative and
post market research. Sinath has a bachelors degree in Business Administration
and she holds Clinical Trials and Regulatory Affairs certificates and she has
completed extensive coursework in project management working towards PMP
certification. She currently resides in the San Francisco Bay Area with her husband
Vince and their dog Burton.
WORKSHOP B: FMV ANALYSIS BOOT CAMP
DAY ONE WEDNESDAY, JANUARY 21, 2015
7:30 	 Workshop Registration and Continental Breakfast
8:30	 Workshop Leaders’ Welcome and Opening Remarks
CHOOSE FROM TWO CONCURRENT IN-CONFERENCE WORKSHOPS (A & B)
	 There will be a 30-minute networking and refreshment break at 10:00 a.m.
12:00 	 Close of In-Conference Workshops
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
C 	 Utilize Master Protocols to Improve
Clinical Trial Effectiveness
1:30	 NCI Clinical Trials Network
Update — Implementing
Master Protocols
With the successful transition to a new system
and an integrated roster, the NCI continues to
look into innovative types of collaborations to
optimize the likelihood of clinical trial success.
This session discusses how the clinical trials
network has evolved and the impact of master
protocols on research.
•	 Understand how the integrated roster works
and how to utilize that roster to initiate a
research study
•	 Discuss funding challenges that have emerged
with implementation of master protocols
•	 Discuss the potential impact of new
collaborations and methods to gauge the
effectiveness of bucket and umbrella studies
MegMooney,M.D.,Chief,ClinicalInvestigationsBranch,
CancerTherapyEvaluationProgram,DivisionofCancer
TreatmentandDiagnosis,National Cancer Institute
2:15	 Precision Medicine —
Master Protocol Trial Design
and Implementation
Advancements in technology have led to
incorporating biomarkers as part of a master
protocol in clinical research. This session
discusses benefits and risks of conducting
umbrella and bucket trials and touches on the
operation complexity of these approaches.
•	 Understand how umbrella and bucket
trials work and identify the strengths and
weaknesses of each
•	 Discuss how the use of the master protocols
are being leveraged to improve patients
screening/enrollment
•	 Assess regulatory approval pathways
•	 Explore how best to bring various
stakeholders to collaborate under a single
master protocol and operational challenges
Moderator:	NedaBell,FormerSeniorDirector,CooperativeandCorporate	
	Alliances, Celgene
Panelists:	 DanaSparks,Director,OperationsandProtocol,SWOG
	 MaryRedman,LeadStatistician,Lung-MAP,
	 Fred Hutchinson Cancer Research Center;
	 LeadStatistician,LungMasterProtocol,SWOG
D 	 Develop Tactics for Negotiating
IIS Agreements
1:30 	 ACADEMIC MEDICAL CENTER PERSPECTIVE
Strategies for Negotiating
IIS/IST Agreements
When working with an investigator, it is critical to
determine ownership of the research, publication
rights and expectations and indemnification
policies. This session gives the academic
perspective on how to negotiate IIS agreements.
•	 Discuss ownership and patent issues that arise
when creating IIS agreements
•	 Understand the common stumbling blocks
investigators face with publishing research
and discuss strategies for setting reasonable
expectations for publication deadlines
and requirements
FernandoVallés,AssistantDirector,
Boston Children’s Hospital,
Clinical Trials Business Office (CTBO)
2:15 	 Assessing Compliance Risk and Fair
Market Value in IIS Grants
•	 Overview of enforcement trends in FMV and IIS
•	 Principles for assessing compliance risk and fair
market value in IIS grants
•	 Overview of Polaris methodology for
determining fair market value of IIS grants
LesleySlade,Consultant,Polaris
MarioProhasky,Manager,Polaris
N
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CHOOSE BETWEEN TWO CONCURRENT BREAKOUTS C & D
3:15	 Networking and Refreshment Break
P
A
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D
I
S
C
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12:00	 Luncheon
1:15	 Co-Chairs’ Opening Remarks
NedaBell,FormerSeniorDirector,CooperativeandCorporateAlliances,
Celgene
KarenBartels,BusinessAreaLead–
ExternallySponsoredResearchOperations,AstraZeneca
DAY TWO THURSDAY, JANUARY 22, 2015
7:30 	 Continental Breakfast
8:00 	 Co-Chairs’ Review of Day One
NedaBell,FormerSeniorDirector,CooperativeandCorporate
Alliances,Celgene
KarenBartels,BusinessAreaLead—ExternallySponsoredResearch
Operations,AstraZeneca
8:15	 Strategically Mitigate Risks for IISR
In the increasingly regulated life science industry,
is it increasingly difficult to support Investigator
Initiated Sponsored Research (IISR) and manage
risk effectively. Evidence generation in support
of safe and effective products has never been
more important. Regulatory bodies, healthcare
providers, payers and patients are all looking for
the latest data, good or bad to determine the
best, most cost effective therapies. This session
assesses potential risks and strategically mitigate
these risks through a well thought out plan to
optimize the performance of your IISR program.
•	 Identify common risks encountered while
managing IISR studies
•	 Discuss strategies to minimize risks and
improve performance
ScottCunningham,BusinessLead,Envision
9:00	 Best Practices for Maintaining IIS
Programs Under a CIA
With an increasing amount of industry operating
under a Corporate Integrity Agreement, it is
crucial to understand how to maintain investigator
initiated research/trials (IIR/IIT) programs while
adhering to the specifications of the CIA. This
session explores best practices for working within
the CIA requirements to maintain and improve
clinical research programs.
•	 Understand the fundamental requirements and
expectations for conducting IIR/IITs under a CIA
•	 Explore current trends and recent CIA
obligations and expectations
•	 Explore best practices for research within
the parameters of a CIA
•	 Share sample methods and practices for
conducting monitoring (and end of year
auditing) regarding research as required by CIAs
•	 Highlight operational insights for conducting
clinical trial research (policies, SOPs and
transparency reporting)
KariLoeser,Esq.,SeniorDirector&SeniorComplianceCounsel,
Jazz Pharmaceuticals
5:15 	 Close of Day One
	 Networking, Wine and Cheese Reception immediately following the final session on day one
3:45 - 5:15 CHOOSE BETWEEN TWO CONCURRENT THINK TANKS E & F
F 	 Create Research Standard
Operating Procedures
This think tank focuses on creating SOPs to
implement at the operational level in the midst
of regulatory uncertainty. Work through critical
issues including timely review and approval,
providing protocol, guidance, negotiating
agreements, tracking to research completion
as intended.
The content for this summit is driven by the
participants, who are surveyed ahead of time
about the topics they wish to discuss.
Facilitator:	 KarenBartels,BusinessAreaLead—
	 ExternallySponsoredResearchOperations,
	 AstraZeneca
E 	 Build Industry Position Statements
In an era with unclear guidance surrounding
how researchers handle FMV, reporting and
transparency, this unique think tank provides
a platform for senior level executives within
pharma to engage in open discussion and
determine the industry’s position on what
processes should be followed in an effort to
create an industry standard.
The content for this summit is driven by the
participants, who are surveyed ahead of time
to identify one or two key areas within FMV,
transparency and reporting they want to develop
a position statement for.
Facilitator:	 CraigA.Sponseller,M.D.,VicePresidentofMedicalAffairs,
	 Kowa Pharmaceuticals America, Inc.
Developing Industry Standards and Best Practices
REGI STER AT WWW.CBINET.COM/IISR • 800-817-8601
REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601
9:45	 Benchmark Against NCI
Reporting Practices
As the implementation of transparency and
open payments continues, there are still no SOPs
for reporting research expenses and payments.
This session gives insights on the NCI’s reporting
practices and discusses strategies and best
practices for reporting.
•	 Understand the NCI’s reasoning on what
they do and do not report
MegMooney,M.D.,Chief,ClinicalInvestigationsBranch,
CancerTherapyEvaluationProgram,DivisionofCancerTreatment
andDiagnosis,National Cancer Institute
10:30 	 Networking and Refreshment Break
11:00	 EXTENDED SESSION
Determine How to Classify
Research Studies
The definition of what exactly an IIS is and
how different research formats fit into that
classification is unclear. This session navigates
the various aspects of research studies
to determine what an IIS is and what the
boundaries of that classification are.
•	 Identify the boundaries of an IIS and when
it transitions into “something else”
•	 Outline the delegation of responsibilities
in an IIS
•	 Discuss strategies for determining reporting
and transparency processes
•	 Develop classifications for research studies
that do not fit the definition of IIS/IIR/IST
LoriBarrentine,MS,PA-C,Director,ClinicalandMedicalAffairs,
Nestlé Health Science- Pamlab
12:15 	 Luncheon
1:30	 Create a Strategy to Overcome
Publication Challenges
When working with multiple authors, creating
a publication strategy can become very
challenging. This session focuses on overcoming
obstacles of developing and executing a
successful publication plan when working with
external research partners.
• 	 Discuss what it takes to develop a
successful publication plan for IIS/IST and
cooperative groups
• 	 Understand when the process is different for
external research partners and how to adapt
your publication plan to those differences
• 	 Identify who should drives the
publication process
NamitGhildyal,Ph.D.,AssociateDirector,
Janssen Research & Development, LLC
2:15 	 Breaking the Grey Zone —
Where Do We Go From Here?
As the regulations concerning Sunshine and
open payments continue to evolve with no sign
of official guidance on how these regulations
apply to research studies, understanding how
to break free of the regulatory gray zone is the
key to clinical research success. This interactive
discussion analyzes strategies to maintain study
progress during regulatory uncertainty.
•	 Develop strategies for effectively operating
research studies during the evolution of open
payments and global transparency laws
•	 Discuss industry best practices for adapting
to open payment regulations over the next
five years
CraigA.Sponseller,M.D.,VicePresidentofMedicalAffairs,
Kowa Pharmaceuticals America, Inc.
3:15 	 Close of Conference
Feedback from Previous Attendees:
“It’s been great to hear from colleagues and their own struggles in the field.”
– Clinical Research Associate, Millennium
“The opportunity to network and share best practices is unique.”
– Director of Operations, SWOG
“It’s interesting hearing how other pharma companies handle their processes
such as IISR and IIT’s and how they handle FMV.”
– Medical Grants Coordinator, Lundbeck
3RD ANNUAL INVESTIGATOR INITIATED AND SPONSORED RESEARCH
2015 SCAN HERE
CBI
70 Blanchard Road
Burlington, MA 01803
4WAYS TO REGISTER NOW!
PHONE
800-817-8601
339-298-2100 outside the U.S.
E-MAIL
cbireg@cbinet.com
WEBSITE
www.cbinet.com/iisr
LIVE CHAT
www.cbinet.com/iisr
IISR2015			 				 			 PC15147
VENUE:
DoubleTree by Hilton Philadelphia Center City
237 South Broad Street
Philadelphia, PA 19107
Phone Reservations: 1-800-222-8733
Hotel Direct Line: 1-215-893-1600
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate online or by phone, please go to:
• Online: www.cbinet.com/iisr
• Phone reservations: 1-800-222-8733 and mention CBI’s IISR conference
Book Now! The DoubleTree by Hilton Philadelphia Center City is accepting
reservations on a space and rate availability basis. Rooms are limited,
so please book early. All travel arrangements subject to availability.
REGISTRATION FEE:
	 ADVANTAGE PRICING	Standard
Conference 	 $1899	 $2199
Register by November 14, 2014 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 full, Standard Rate.
TEAM DISCOUNT:
For every three paying registrations from your company, you will receive a fourth complimentary*
registration to the conference (must register four at same time to qualify). To receive the team discount
you must register with our customer service department by calling 339-298-2100.
* Advantage pricing rates do apply when applicable. Offer may not be combined with any other
special pricing promotions. Offer may be used at CBI co-located events.
SATISFACTION GUARANTEED:
CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference,
a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-
8601 for further information. Advanced preparation for CBI conferences is not required.
SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organization up to 24 hours in advance of the
conference. Cancellations received in writing on or before 14 days prior to the start date of the event
will be refunded, less a $399 administrative charge. No refunds will be made after this date; however,
the registration fee less the $399 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.
R E G I S T E R AT W W W. C B I N E T. C O M / I I S R • 8 0 0 - 8 1 7 - 8 6 0 1
R E G I S T E R BY N OV E M B E R 1 4 , 2 0 1 4 A N D S AV E $ 3 0 0 !
JANUARY 21-22, 2015 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA
Building Industry Standards for FMV, Transparency and Reporting
ANY QUESTIONS OR TO REGISTER
CALL Heather Munnell 339-298-2141
OR FAX TO MY ATTENTION 781-939-2459
email: heather.munnell@cbinet.com

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pc15147_brochure

  • 1. 3RD ANNUAL INVESTIGATOR INITIATED AND SPONSORED RESEARCH 2015 REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 R E G I S T E R BY N OV E M B E R 1 4 , 2 0 1 4 A N D S AV E $ 3 0 0 ! Media Partners: JANUARY 21-22, 2015 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA GAIN INSIGHTS FROM INDUSTRY LEADERS INCLUDING: Karen Bartels, Business Area Lead – Externally Sponsored Research Operations, AstraZeneca; Investigator Research Interest Group Leader, ACRP Neda Bell, Former Senior Director, Cooperative and Corporate Alliances, Celgene Ben Cadieux, Director, Medical Affairs, Raptor Pharmaceuticals Alexander Kostek, Team Global IIR Group Leader, Pfizer Inc; Investigator Research Interest Group Leader, ACRP Kari Loeser, Esq., Senior Director & Senior Compliance Counsel, Jazz Pharmaceuticals Meg Mooney, M.D., Chief, Clinical Investigations Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute Craig A. Sponseller, M.D., Vice President of Medical Affairs, Kowa Pharmaceuticals America, Inc. Building Industry Standards for FMV, Transparency and Reporting With a robust and customizable agenda, this year’s program is the perfect resource, regardless of your therapeutic area or focus. Genentech, Janssen Research & Development, LLC, Massachusetts General Hospital, SWOG and Many More! ALSO HEAR FROM: COOPERATIVE GROUPS AND ONCOLOGY RESEARCH HIGHLIGHTS: • In-depth discussions on the transition to master protocols • Insights on utilizing umbrella and bucket studies • Strategies for better collaborations with cooperative groups and the National Cancer Institute IIS, IST, IIR AND IIT HIGHLIGHTS: • Insights from academic medical centers on negotiating IST/IIS agreements • Tactics for identifying and overcoming intellectual property disputes over data ownership • A deep dive into executing global research/IIS programs
  • 2. REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 Who Should Attend: You will benefit from attending this event if you are a senior-level executive, director or manager from the pharmaceutical or biotech industry with responsibilities or involvement in the following areas: This conference will also benefit consultants, technology vendors, law firms and companies providing services to the above audience. • Investigator Initiated Studies (IIS, IIR or IITs) • Cooperative Group and Academic Investigator Research and Management • Medical Affairs • Research Grants • Medical/Clinical Operations • External Research and Partnerships • Clinical Trial Monitoring and Management Conference Sponsor: 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 more information on how to position your company as a sponsor or exhibitor, contact Robert Boucini at 333.298.2150 or e-mail robert.boucini@cbinet.com. Brand new content, interactive discussions and critical updates including: • Insights on the NCI’s reporting practices including their reasoning on what they do and do not report • Strategies for meeting the standards and expectations of Corporate Integrity Agreements while maintaining research studies • Best practices for FMV analysis and insights on whether to report FMV by total budget or by line item • Tactics for determining ownership of research and negotiating research agreements with external research partners This groundbreaking event creates a platform for developing standards for FMV analysis, transparency and reporting practices for IIS, IST and Cooperative Group Research. CHOOSE FROM IN-DEPTH WORKSHOPS, BREAKOUTS AND THINK TANKS: WORKSHOPS: Optimize the Globalization of Research OR FMV Analysis Boot Camp BREAKOUTS: Utilize Master Protocols to Improve Clinical Trial Effectiveness OR Develop Tactics for Negotiating IIS Agreements THINK TANKS: Build Industry Position Statements OR Create Research Standard Operating Procedures
  • 3. REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 Workshop Objective: As research studies continue to go global it becomes critical to understand how to initiate, maintain and execute a global trial. This workshop takes a deep dive into strategies for collaborating with affiliate offices to optimize the effectiveness of globalized research. Key Questions to Be Addressed: • How do we make global decisions when key decisions including FMV and budgeting are left to the discretion of the affiliate office? • What are best practices for ensuring foreign investigators adhere to internal and external reporting and transparency requirements? • How can strategic planning be leveraged to reach a consensus at the local and global level on study design and protocol. Workshop Outline: I. Develop Global Standards for Research Protocols • Understand the role of a clear SOP on IST concept review process and approval with buy-in from affiliates • Create strategies to limit redundancy at the regional level * industry tactics for selecting a proposal among similar competing concepts * implement fair and transparent competition for prospective investigators • Discuss the role of IT in consolidating and organizing centralized reviews with each affiliate membership II. Optimize Collaborations with Affiliate Offices • Develop strategies for working with affiliate offices to make decisions on a global scale, instead of on a case-by-case basis • Understand how to manage affiliate interests in partnering with regional investigators on concepts that meet regional and specific data needs (e.g. label variations and/or varying dose schedules, HEOR, etc.) • Discuss tactics for collaborating with affiliate offices on building the budget and FMV analysis on a global IIS III. Overcome Challenges with Global Regulatory Requirements • Discuss tactics for ensuring the local FMV practices of the foreign investigator site are adapted to comply with internal requirements • Understand the impact of foreign transparency laws on multi-country research operations Workshop Leaders: BenCadieux,Director,MedicalAffairs, Raptor Pharmaceuticals Mr. Cadieux is a collaborative Medical Affairs (MA) professional with significant Oncology, Immunology/Transplantation and Rare Disorders experience. Broad experience in building and leading the MA platform aimed to facilitate the generation of the cross-functional strategic plan, as well as identification and execution of the global portfolio value drivers. Specific experience include creating the Medical Plan, leading HECOR data generation initiatives, Pharmacovigilance, Medical Communications and Publication strategies, oversight of the global grants platform encompassing the evaluation of investigator-initiated research (IIR) strategies, KOL engagement through meaningful advisory boards and educational programs, relationship building with advocacy group leadership, as well as the management of global field-based MSL excellence in scientific exchange across various therapeutic areas and throughout the life-cycle of the portfolio agents. Currently reporting to the CMO, responsible for the global MA budget, the creation and maintenance of internal guidelines and SOPs and successfully building the full scope of MA operations platform through the company’s first product launch. Acting as cross-functional internal medical expert (e.g., review PRC Sales and Marketing materials, sales training, product monograph, etc.) and externally as an invited speaker on behalf of the organization (medical meetings, advocacy groups). AlexanderKostek,TeamGlobalIIRGroupLeader,Pfizer Inc; InvestigatorResearchInterestGroupLeader,ACRP Mr. Kostek started his career doing chemical research and development for Hoffmann-La Roche, Inc. and later DuPont Merck Pharmaceuticals in 1996. In 1999, he joined Merck Manufacturing Division, supporting the Rahway manufacturing site before transitioning into Clinical R&D Project Management. Having joined Pfizer in 2002, Mr. Kostek had a variety of responsibilities in Project Management, supporting multiple products and working on cross-functional initiatives like resource management forecasting. Mr. Kostek joined USP Medical Finance in 2005, provided financial oversight for Phase IIIB/IV Medical Teams and Administrative Groups, and worked with the implementation team for Medical Education Grants (MEG). More recently, he served as Project Leader for establishing Medical Business Operations, identifying and leveraging synergies related to policies, processes, systems, and resources across functional groups in CMO. He also served as the interim Director of a new MEG Operations Group and led the Global IIR Transition Team in merging legacy US and legacy WW functions into one global organization. He then became the Global IIR Group Leader for Investigator Initiated Research located in the New York headquarters and led the team for over five years within Pfizer Medical’s External Medical Communications. WORKSHOP A: OPTIMIZE THE GLOBALIZATION OF RESEARCH DAY ONE WEDNESDAY, JANUARY 21, 2015 CHOOSE FROM TWO CONCURRENT IN-CONFERENCE WORKSHOPS (A & B) There will be a 30-minute networking and refreshment break at 10:00 a.m. 12:00 Close of In-Conference Workshops 7:30 Workshop Registration and Continental Breakfast 8:30 Workshop Leaders’ Welcome and Opening Remarks
  • 4. REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 Workshop Objective: Transparency regulations are continuing to evolve and FMV models including the proper analysis for FMV could shift under changing regulations. It is crucial to understand how to create an FMV analysis and understand the impact FMV values have on negotiating with investigator sites. Key Questions to Be Addressed: • How is “fair market value” determined? • Should an FMV analysis for research be done by line item or by total budget? • What should a company do when an investigator disputes the FMV of an expense? Workshop Outline: I. Define What Is “Fair Market Value” • Brainstorm measurable parameters for the definition of fair that should be used in building an FMV analysis • Discuss what costs should be included when creating a budget and FMV II. Establish a Standard FMV Analysis • Assess implications of running an FMV by line item compared to FMV by total budget • Discuss how the method of analysis chosen impacts reporting practices and transparency obligations • Share best practices on creating a standard FMV analysis III. Negotiating FMV • Analyze strategies for handling disagreements with investigators regarding the FMV assigned to an expense Workshop Leaders: LizCopeland,AssociateDirector,Contracts&Grants, Janssen Research & Development, LLC Ms. Copeland earned a Bachelor of Science degree in Business Economics from the State University of New York and a Master of Business Administration in Pharmaceutical Management from Drexel University. She has been employed by Johnson & Johnson since 2001. Prior to J&J, Liz worked for Goldman Sachs as a Sr. Analyst in the foreign exchange department. After initially supporting Sales & Marketing, Liz became a charter member of the Janssen Research & Development Contracts & Grants Group. She has held positions of increasing responsibility across most functions within the group including most recently overseeing the Fair Market Value Pricing function. In her current role, Liz oversees the Early Development, Clinical Pharmacology and Investigator Initiated Contracts & Grants function. KristiVonderloh,SeniorContracts&GrantsAnalyst, Janssen Research & Development, LLC Ms. Vonderloh joined Janssen Research & Development through Research Pharmaceutical Services in August, 2011 and became a fulltime employee in June 2014. Kristi previously worked at Biogen Idec, Inc. as a Contract Manager negotiating IIS agreements and company sponsored agreements for Phase I oncology clinical trials. Prior to Biogen Idec, Kristi worked at Fred Hutchinson Cancer Research Center as an Industry Sponsored Research Analyst negotiating both sponsored CTAs and IIS agreements. She also worked at La Jolla Institute for Allergy and Immunology as an Intellectual Property Specialist negotiating confidentiality, consulting and material transfer agreements, as well as processing invention disclosures and tracking patent applications. In her current role within Janssen, Kristi is responsible for IIS contracting for all Janssen Operating Company compounds. Kristi earned her Bachelor’s Degree in Business Management in 2006. Prior to that, Kristi spent 4 ½ years in the United States Navy as a Yeoman stationed at Naval Station Treasure Island in San Francisco, CA where she worked in the Judge Advocate General’s Office processing Captains Mass and Court Martial paperwork. SinathLim,LeadContractsManager, Genentech U.S. Site Contracts Ms. Lim has over 13 years of experience in the biotech industry including positions in Quality Assurance and Clinical Contracting. Currently she is a Lead Contracts Manager in Genentech’s Global Pharma Procurement group. Sinath also serves as Chair of the clinical study site Budget Review Committee in her group within Strategic Realization & Operations where she provides experienced budget and Fair Market Value analysis and negotiation expertise to teams of contract managers. Sinath has also built a reputation for developing and implementing efficient business process strategies in her role as Single Point of Contact for the U.S. Medical Affairs function which supports investigative and post market research. Sinath has a bachelors degree in Business Administration and she holds Clinical Trials and Regulatory Affairs certificates and she has completed extensive coursework in project management working towards PMP certification. She currently resides in the San Francisco Bay Area with her husband Vince and their dog Burton. WORKSHOP B: FMV ANALYSIS BOOT CAMP DAY ONE WEDNESDAY, JANUARY 21, 2015 7:30 Workshop Registration and Continental Breakfast 8:30 Workshop Leaders’ Welcome and Opening Remarks CHOOSE FROM TWO CONCURRENT IN-CONFERENCE WORKSHOPS (A & B) There will be a 30-minute networking and refreshment break at 10:00 a.m. 12:00 Close of In-Conference Workshops
  • 5. REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 C Utilize Master Protocols to Improve Clinical Trial Effectiveness 1:30 NCI Clinical Trials Network Update — Implementing Master Protocols With the successful transition to a new system and an integrated roster, the NCI continues to look into innovative types of collaborations to optimize the likelihood of clinical trial success. This session discusses how the clinical trials network has evolved and the impact of master protocols on research. • Understand how the integrated roster works and how to utilize that roster to initiate a research study • Discuss funding challenges that have emerged with implementation of master protocols • Discuss the potential impact of new collaborations and methods to gauge the effectiveness of bucket and umbrella studies MegMooney,M.D.,Chief,ClinicalInvestigationsBranch, CancerTherapyEvaluationProgram,DivisionofCancer TreatmentandDiagnosis,National Cancer Institute 2:15 Precision Medicine — Master Protocol Trial Design and Implementation Advancements in technology have led to incorporating biomarkers as part of a master protocol in clinical research. This session discusses benefits and risks of conducting umbrella and bucket trials and touches on the operation complexity of these approaches. • Understand how umbrella and bucket trials work and identify the strengths and weaknesses of each • Discuss how the use of the master protocols are being leveraged to improve patients screening/enrollment • Assess regulatory approval pathways • Explore how best to bring various stakeholders to collaborate under a single master protocol and operational challenges Moderator: NedaBell,FormerSeniorDirector,CooperativeandCorporate Alliances, Celgene Panelists: DanaSparks,Director,OperationsandProtocol,SWOG MaryRedman,LeadStatistician,Lung-MAP, Fred Hutchinson Cancer Research Center; LeadStatistician,LungMasterProtocol,SWOG D Develop Tactics for Negotiating IIS Agreements 1:30 ACADEMIC MEDICAL CENTER PERSPECTIVE Strategies for Negotiating IIS/IST Agreements When working with an investigator, it is critical to determine ownership of the research, publication rights and expectations and indemnification policies. This session gives the academic perspective on how to negotiate IIS agreements. • Discuss ownership and patent issues that arise when creating IIS agreements • Understand the common stumbling blocks investigators face with publishing research and discuss strategies for setting reasonable expectations for publication deadlines and requirements FernandoVallés,AssistantDirector, Boston Children’s Hospital, Clinical Trials Business Office (CTBO) 2:15 Assessing Compliance Risk and Fair Market Value in IIS Grants • Overview of enforcement trends in FMV and IIS • Principles for assessing compliance risk and fair market value in IIS grants • Overview of Polaris methodology for determining fair market value of IIS grants LesleySlade,Consultant,Polaris MarioProhasky,Manager,Polaris N C I A D D R E S S CHOOSE BETWEEN TWO CONCURRENT BREAKOUTS C & D 3:15 Networking and Refreshment Break P A N E L D I S C U S S I O N 12:00 Luncheon 1:15 Co-Chairs’ Opening Remarks NedaBell,FormerSeniorDirector,CooperativeandCorporateAlliances, Celgene KarenBartels,BusinessAreaLead– ExternallySponsoredResearchOperations,AstraZeneca
  • 6. DAY TWO THURSDAY, JANUARY 22, 2015 7:30 Continental Breakfast 8:00 Co-Chairs’ Review of Day One NedaBell,FormerSeniorDirector,CooperativeandCorporate Alliances,Celgene KarenBartels,BusinessAreaLead—ExternallySponsoredResearch Operations,AstraZeneca 8:15 Strategically Mitigate Risks for IISR In the increasingly regulated life science industry, is it increasingly difficult to support Investigator Initiated Sponsored Research (IISR) and manage risk effectively. Evidence generation in support of safe and effective products has never been more important. Regulatory bodies, healthcare providers, payers and patients are all looking for the latest data, good or bad to determine the best, most cost effective therapies. This session assesses potential risks and strategically mitigate these risks through a well thought out plan to optimize the performance of your IISR program. • Identify common risks encountered while managing IISR studies • Discuss strategies to minimize risks and improve performance ScottCunningham,BusinessLead,Envision 9:00 Best Practices for Maintaining IIS Programs Under a CIA With an increasing amount of industry operating under a Corporate Integrity Agreement, it is crucial to understand how to maintain investigator initiated research/trials (IIR/IIT) programs while adhering to the specifications of the CIA. This session explores best practices for working within the CIA requirements to maintain and improve clinical research programs. • Understand the fundamental requirements and expectations for conducting IIR/IITs under a CIA • Explore current trends and recent CIA obligations and expectations • Explore best practices for research within the parameters of a CIA • Share sample methods and practices for conducting monitoring (and end of year auditing) regarding research as required by CIAs • Highlight operational insights for conducting clinical trial research (policies, SOPs and transparency reporting) KariLoeser,Esq.,SeniorDirector&SeniorComplianceCounsel, Jazz Pharmaceuticals 5:15 Close of Day One Networking, Wine and Cheese Reception immediately following the final session on day one 3:45 - 5:15 CHOOSE BETWEEN TWO CONCURRENT THINK TANKS E & F F Create Research Standard Operating Procedures This think tank focuses on creating SOPs to implement at the operational level in the midst of regulatory uncertainty. Work through critical issues including timely review and approval, providing protocol, guidance, negotiating agreements, tracking to research completion as intended. The content for this summit is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss. Facilitator: KarenBartels,BusinessAreaLead— ExternallySponsoredResearchOperations, AstraZeneca E Build Industry Position Statements In an era with unclear guidance surrounding how researchers handle FMV, reporting and transparency, this unique think tank provides a platform for senior level executives within pharma to engage in open discussion and determine the industry’s position on what processes should be followed in an effort to create an industry standard. The content for this summit is driven by the participants, who are surveyed ahead of time to identify one or two key areas within FMV, transparency and reporting they want to develop a position statement for. Facilitator: CraigA.Sponseller,M.D.,VicePresidentofMedicalAffairs, Kowa Pharmaceuticals America, Inc. Developing Industry Standards and Best Practices REGI STER AT WWW.CBINET.COM/IISR • 800-817-8601
  • 7. REGISTER AT WWW.CBINET.COM/IISR • 800-817-8601 9:45 Benchmark Against NCI Reporting Practices As the implementation of transparency and open payments continues, there are still no SOPs for reporting research expenses and payments. This session gives insights on the NCI’s reporting practices and discusses strategies and best practices for reporting. • Understand the NCI’s reasoning on what they do and do not report MegMooney,M.D.,Chief,ClinicalInvestigationsBranch, CancerTherapyEvaluationProgram,DivisionofCancerTreatment andDiagnosis,National Cancer Institute 10:30 Networking and Refreshment Break 11:00 EXTENDED SESSION Determine How to Classify Research Studies The definition of what exactly an IIS is and how different research formats fit into that classification is unclear. This session navigates the various aspects of research studies to determine what an IIS is and what the boundaries of that classification are. • Identify the boundaries of an IIS and when it transitions into “something else” • Outline the delegation of responsibilities in an IIS • Discuss strategies for determining reporting and transparency processes • Develop classifications for research studies that do not fit the definition of IIS/IIR/IST LoriBarrentine,MS,PA-C,Director,ClinicalandMedicalAffairs, Nestlé Health Science- Pamlab 12:15 Luncheon 1:30 Create a Strategy to Overcome Publication Challenges When working with multiple authors, creating a publication strategy can become very challenging. This session focuses on overcoming obstacles of developing and executing a successful publication plan when working with external research partners. • Discuss what it takes to develop a successful publication plan for IIS/IST and cooperative groups • Understand when the process is different for external research partners and how to adapt your publication plan to those differences • Identify who should drives the publication process NamitGhildyal,Ph.D.,AssociateDirector, Janssen Research & Development, LLC 2:15 Breaking the Grey Zone — Where Do We Go From Here? As the regulations concerning Sunshine and open payments continue to evolve with no sign of official guidance on how these regulations apply to research studies, understanding how to break free of the regulatory gray zone is the key to clinical research success. This interactive discussion analyzes strategies to maintain study progress during regulatory uncertainty. • Develop strategies for effectively operating research studies during the evolution of open payments and global transparency laws • Discuss industry best practices for adapting to open payment regulations over the next five years CraigA.Sponseller,M.D.,VicePresidentofMedicalAffairs, Kowa Pharmaceuticals America, Inc. 3:15 Close of Conference Feedback from Previous Attendees: “It’s been great to hear from colleagues and their own struggles in the field.” – Clinical Research Associate, Millennium “The opportunity to network and share best practices is unique.” – Director of Operations, SWOG “It’s interesting hearing how other pharma companies handle their processes such as IISR and IIT’s and how they handle FMV.” – Medical Grants Coordinator, Lundbeck
  • 8. 3RD ANNUAL INVESTIGATOR INITIATED AND SPONSORED RESEARCH 2015 SCAN HERE CBI 70 Blanchard Road Burlington, MA 01803 4WAYS TO REGISTER NOW! PHONE 800-817-8601 339-298-2100 outside the U.S. E-MAIL cbireg@cbinet.com WEBSITE www.cbinet.com/iisr LIVE CHAT www.cbinet.com/iisr IISR2015 PC15147 VENUE: DoubleTree by Hilton Philadelphia Center City 237 South Broad Street Philadelphia, PA 19107 Phone Reservations: 1-800-222-8733 Hotel Direct Line: 1-215-893-1600 ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to: • Online: www.cbinet.com/iisr • Phone reservations: 1-800-222-8733 and mention CBI’s IISR conference Book Now! The DoubleTree by Hilton Philadelphia Center City is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability. REGISTRATION FEE: ADVANTAGE PRICING Standard Conference $1899 $2199 Register by November 14, 2014 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 full, Standard Rate. TEAM DISCOUNT: For every three paying registrations from your company, you will receive a fourth complimentary* registration to the conference (must register four at same time to qualify). To receive the team discount you must register with our customer service department by calling 339-298-2100. * Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at CBI co-located events. SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817- 8601 for further information. Advanced preparation for CBI conferences is not required. SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 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. R E G I S T E R AT W W W. C B I N E T. C O M / I I S R • 8 0 0 - 8 1 7 - 8 6 0 1 R E G I S T E R BY N OV E M B E R 1 4 , 2 0 1 4 A N D S AV E $ 3 0 0 ! JANUARY 21-22, 2015 • DOUBLETREE BY HILTON PHILADELPHIA CENTER CITY • PHILADELPHIA, PA Building Industry Standards for FMV, Transparency and Reporting ANY QUESTIONS OR TO REGISTER CALL Heather Munnell 339-298-2141 OR FAX TO MY ATTENTION 781-939-2459 email: heather.munnell@cbinet.com