The document provides information about an upcoming conference on clinical data disclosure and transparency taking place on January 28-29, 2015 in Philadelphia, PA. It lists the conference sponsors and over 30 speakers from 20+ companies that will discuss approaches to data sharing and ensuring compliance with regulations. Attendees will include chief medical officers, general counsels, and clinical professionals involved in disclosure, clinical operations, and regulatory affairs. The conference will explore implications of increased transparency requirements and navigating public disclosure on platforms like ClinicalTrials.gov and EudraCT.

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January 28-29, 2015 • Doubletree by Hilton Philadelphia Center City • Philadelphia, PA
Clinical Data
Ben Rotz,
Advisor,
Office of Medical
Transparency Initiatives
Eli Lilly and Company
Robin Jenkins, MBA,
Senior Director,
Medical Affairs
Innovation,
Sanofi
Anh Phung, Ph.D.,
Head,
Data Disclosure,
Novartis Vaccines
(Italy)
Jessica Scott, M.D., JD,
Director, NA Medical
Advocacy and Policy,
GlaxoSmithKline
North America,
R&D Chief Medical Office
Joanne Waldstreicher, M.D.,
Chief Medical Officer,
Johnson & Johnson; Committee Member,
Institute of Medicine (IOM) Committee on Strategies
for Responsible Sharing of Clinical Trial Data
30+ Speakers • 20+ Companies • 1 Choice for Disclosure Dissemination
BMJ • CISCRP • EFPIA • FDA • Harvard Medical School • Project Data Sphere
Parent Project Muscular Dystrophy • Lupus Foundation of America
Yale University School of Medicine
The Most Comprehensive Meeting of its Kind Including Perspectives from:
Jennifer Van Ekelenburg,
Head Clinical Transparency
and Submissions, PCPS, Study
Capabilities and Transparency,
GlaxoSmithKline
Justin McCarthy,
Senior Vice President,
Global Policy and International Affairs,
Pfizer Inc
CONFERENCE CO-CHAIRS
Navigating Patient-Level Data Disclosure, EudraCT and International Registries
ELITE INDUSTRY FACULTY:

2. Conference Sponsors:
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Following the success of the inaugural event, CBI’s Clinical Data Disclosure and
Transparency is back for its second year! As the most comprehensive event of its
kind, senior level executives convene to discuss implications of and approaches for
data sharing, ensuring compliance with regulations, navigating disclosure requirements
and releasing patient-level data. Don’t miss the opportunity to ensure your organization
is prepared to meet the requirements and pressures of increased disclosure and
transparency of clinical trial data.
WHO SHOULD ATTEND
You will benefit from attending this event if you are a chief medical officer,
chief compliance officer, general counsel or a clinical professional within the life sciences
with responsibilities or involvement in the following areas:
Disclosure and Transparency • Clinical Operations • Trial Disclosure • Regulatory Affairs/Disclosure
Clinical Transparency • Clinical Trial Registration • CRS Publications • Medical Writing • Biostatistics
Biometrics and Reporting • Data Management • Data Standards
This conference will also benefit consultants, technology vendors and companies providing
services to the above audience.
“This forum is critical to my planning,
provides information I need and is
where I meet an collaborate with the
disclosure community.”
– Past Attendee,
Disclosure Specialist,
Gilead
“An opportunity for beneficial exchange
and sharing of best practices and tools to
accomplish public disclosure and
clinical data sharing initiatives.”
– Past Attendee,
Senior Compliance and Process Specialist,
Ferring Pharmaceuticals
PLUS! DON’T MISS
HIGHLIGHTED SESSIONS:
• FDA’s Current Plans for their
Role in Data Disclosure
• The YODA Project’s Role with
Third-Party Data Sharing
• Patient Advocacy Perspectives
on How and Why Sponsors
Should Share Data
CHOOSE FROM TWO SYMPOSIA:
Practical Applications —
Navigate Regulatory Disclosure,
Public Disclosure and EudraCT
Executive Summit —
Implications of Data Sharing on
Business Objectives, Compliance
Strategies and Corporate Image
A
B
PAST ATTENDEE ACCLAIM:
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 more information on how to position your company as a sponsor or exhibitor,
contact Karen Hanover at 339-298-2184 or email karen.hanover@cbinet.com.

3. 7:00 Conference Registration and
Continental Breakfast
8:00 Co-Chairs’ Welcome and Opening Remarks
JenniferVanEkelenburg,HeadClinicalTransparency
andSubmissions,PCPS,StudyCapabilitiesandTransparency,
GlaxoSmithKline
JustinMcCarthy,SeniorVicePresident,GlobalPolicyandInternational
Affairs,Pfizer Inc
Prepare for the Next
Steps in Data Disclosure
8:15 IOM ADDRESS
Strategies for Responsible Sharing of
Clinical Trial Data — The View from the
Institute of Medicine Committee
• Examine the IOM’s study conducted to develop
guiding principles and a framework for the
responsible sharing of clinical trial data, including
the decision to perform the study, who was involved
and what this means for industry
• Review the Institute of Medicine (IOM) report on
Strategies for Responsible Sharing of
Clinical Trial Data
• Consider the guiding principles and
final recommendations
• Analyze the Johnson & Johnson approach
to clinical trial data sharing
JoanneWaldstreicher,M.D.,ChiefMedicalOfficer,
Johnson & Johnson;CommitteeMember,
Institute of Medicine (IOM) Committee
on Strategies for Responsible Sharing
of Clinical Trial Data
8:55 EFPIA ADDRESS
Implementation of Industry
Commitments to Responsible Data
Sharing — What Might Be Next?
• Update on disclosure and transparency initiatives
and industry implementation
* how has industry employed the
five codes released in 2014?
• Discuss industry methods for
standardization, including CDISC
• Create processes and standards for
returning results to patients
AndrewPowrie-Smith,DirectorofCommunications,EFPIA
9:35 TransCelerate ADDRESS
TransCelerate’s Global Clinical Data
Transparency Initiative — How Industry
has Collaborated to Share Information
While Protecting Patient Privacy
• Discuss industry participation in developing a
position on the best and most efficient methods for
redacting privacy information found in clinical trials
• Share collaboration efforts with other trade
organizations’, including EFPIA and PhRMA
• Examine TransCelerate’s identification of the
instances and methods for redaction in order to
preserve the privacy of patients, investigators and
clinical trial staff
• Consider the future for principles of writing future
CSRs, as well as anonymization and de-identification
of patient-level data shared with the broader
healthcare community
BenRotz,Advisor,OfficeofMedicalTransparencyInitiatives,
Eli Lilly & Co
HelleGawrylewski,MA,SeniorDirector,HeadMedicalAffairs&Alliance
Management,MedicalWritinginQuantitativeSciences,
Janssen Research & Development
LizRoberts,MS,BS,Director,HeadU.S.Biostatistics,
GlobalStatisticalSciences,UCB BioSciences Inc
10:15 Networking and Refreshment Break
10:45 Consider the Future of Sharing Access
to Clinical Trial Data for Secondary
Research — Where are We and Where
are We Headed?
• Review industry commitments and the PhRMA/
EFPIA Principles
• Discuss current data progress and data use
• Look at the data sharing horizon
JessicaScott,M.D.,JD,Director,NAMedicalAdvocacyandPolicy,
GlaxoSmithKline North America,
R&D Chief Medical Office
11:25 KEYNOTE ADDRESS
Prepare for the Future of Transparency
• Examine what is next for transparency —
What is the 15-year vision for industry disclosure?
• Benchmark against industry leaders to remain on
the forefront of transparency
• Review what processes are working well and what
needs to be changed
* what can we learn from the past year’s
experiences with increased transparency?
* is industry moving toward a consolidated
database or will companies continue to share
data individually?
* what does the future hold? how can we
anticipate and react to the ever-changing
transparency landscape?
JustinMcCarthy,SeniorVicePresident,GlobalPolicyandInternational
Affairs, Pfizer Inc
DAY ONE Wednesday, January 28, 2015
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4. Snapshots of Transparency
Commitments
12:05 INDUSTRY PODIUM DISCUSSIONS
Facets of Disclosure — Showcasing
Various Industry Perspectives
These back-to-back 15-minute talks provide
the regulatory perspective on stakeholder
data disclosure and transparency.
I. FDA
What’s the FDA’s current perspective on the
advancement of clinical data disclosure and
transparency requirements? What the FDA current
plan is for their role in data disclosure? What is the
FDA perspective on lay summaries?
RichardMoscicki,M.D.,DeputyDirector,ScienceOperations,
CenterforDrugEvaluationandResearch(CDER),
U.S. Food and Drug Administration FDA
II. BMJ
What are the requirements for ICMJE
trial registration? What are the data sharing policies
of the BMJ and other medical journals? What does
industry need to know proactively
for clinical trial journal publication?
JoseG.Merino,M.D.,U.S.ClinicalResearchEditor,BMJ
III. Patient Advocacy; Parent Project
Muscular Dystrophy
Patients are the beginning and end of the industry
thought process throughout clinical trials, as they
are the stakeholders that are most crucial for clinical
trial success. What does industry need to know
about patient advocacy organizations in regards to
increased data disclosure? In addition to learning
more about the disease to better create a compound
or biologic to treat patients, how can industry
strengthen partnerships with advocacy groups? How
can you manage and engage an advocacy/industry
relationship over time? Are there best practices that
sponsors can utilize to understand the disease state,
design trials that are inclusive of the population and
test the patients that are impacted by a
specific disease?
PatriciaFurlong,PresidentandCEO,
Parent Project Muscular Dystrophy
1:15 Networking Luncheon
2:15 KEYNOTE PANEL
Experiences to Date with Increased
Data Sharing
This panel shares the perspectives of three
pharmaceutical companies that have committed to
sharing patient-level data with third-party researchers
upon reasonable request.
• What have their experiences been with
increasing disclosure?
• What has the effect been on company resources
and infrastructure?
• What internal teams and members of teams are
involved with data sharing?
• What are the various ways companies are receiving,
processing and fulfilling requests?
• How many requests have they experienced?
• Does the process differ if the request is
for data from multiple sponsors? What progress has
been made for fulfilling multi sponsor requests?
How many have companies received?
• What approach is being used in the
de-identification of data? Are there any tools or
resources that can be utilized for removing
patient identifiers?
• How are they handling competitor requests
for access to their data?
• What internal teams, members of teams and
functional expertise are involved with data sharing?
Moderator: JenniferVanEkelenburg,HeadClinicalTransparency
andSubmissions,PCPS,StudyCapabilitiesandTransparency,
GlaxoSmithKline
Panelists: WendyWimmer,ClinicalProcessInnovation&Excellence(CPIE),
Merck
KarlaChilders,Director,StrategicProjects,
Johnson & Johnson,
Office of the Chief Medical Officer
Hanns-GeorgLeimer,Ph.D.,HeadofProcesses
andSystemsCoordinationinCorporateRegulatoryAffairsincl.
ClinicalTrialInformationDisclosure(CTID),
Boehringer Ingelheim (Germany)
3:00 Networking and Refreshment Break
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5. 3:30 - 5:15 CHOOSE BETWEEN TWO SYMPOSIA
Practical Applications —
Navigate Regulatory
Disclosure, Public
Disclosure and EudraCT
Executive Summit —
Implications of Data Sharing
on Business Objectives,
Compliance Strategies and
Corporate Image
3:30 Symposium Chair Opening Remarks
JenniferVanEkelenburg,HeadClinicalTransparency
andSubmissions,PCPS,StudyCapabilitiesandTransparency,
GlaxoSmithKline
3:45 Industry Experience and
Challenges with EudraCT
• Discuss EudraCT version 10 reporting results
• Examine issues encountered with disclosing
results via EudraCT version 10
• Inspect differences in data fields
from ClinicalTrials.gov
* will registries be open to harmonization?
• Review common validation errors experienced
and strategies for resolution
AnhPhung,Ph.D.,Head,DataDisclosure,
Novartis Vaccines(Italy)
ChristinaZackiewicz,AssociateDirector,ClinicalRegistry
Janssen, Pharmaceutical Companies of
Johnson & Johnson(TheNetherlands)
4:30 Utilizing Technology to Post
to ClinicalTrials.gov
• Consider the use of technology and tools
to aid with posting information more easily
and efficiently, as Allergan has done
with PharmaCM
* what were the decisions made to
utilizing this tool?
* what pitfalls did Allergan face?
* is Allergan doing anything further
with the system?
* what processes is Allergan changing to
manage international requirements?
SukhChugh,Director,R&DInformaticsServices,Allergan
3:30 Symposium Chair Opening Remarks
JustinMcCarthy,SeniorVicePresident,GlobalPolicy
andInternationalAffairs,Pfizer Inc
3:45 Proactively Plan for Data
Re-Analysis Inaccuracies
• Avoid unnecessary public fear when
third-party re-analysis of data is inaccurate
• Correct inaccurate re-analysis
• Work toward appropriate patient use during
times of confusion
KristieC.Kuhl,ExecutiveVicePresident,Cohn & Wolfe
4:30 Addressing Transparency of Clinical
Data while Preserving Confidential
Commercial and Patient Information
• Review transparency guidelines and privacy
obligations and ascertain which information,
if maintained confidential, has
commercial importance
• Strategize how to protect confidentiality of
commercially important information and
maintain privacy
• Formulate corporate transparency interests
relative to guidelines
• Design clinical trials to align with corporate
transparency interests to abide by transparency
guidelines and privacy obligations
• Ascertain implications of changes to transparency
guidelines and privacy obligations
RaymondParker,Ph.D.,J.D.,
SpecialCounsel,Cooley LLP
A B
5:15 Close of Day One
Networking, Wine and Cheese Reception immediately following the final session on day one
CASE
STUDY
CASE
STUDY
CASE
STUDY
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“Expanded my knowledge and awareness of the complex
environment of clinical disclosure.”
– Past Attendee, Vice President Clinical Operations, Acorda Therapeutics

6. DAY TWO
Thursday, January 29, 2015
8:00 Continental Breakfast
8:30 Chairperson’s Review of Day One
JenniferVanEkelenburg,HeadClinicalTransparencyandSubmissions,
PCPS,StudyCapabilitiesandTransparency,GlaxoSmithKline
Optimize Standardization and
Automation Processes to Alleviate
Data Disclosure Challenges
8:45 Establish Standards to Support
Transparency Planning, Scope
and Resource Management
• Learn ways to determine what is needed for
transparency planning, when it should be done,
who is responsible and why it is necessary
• Improve standards and efficiencies while supporting
the scientific nature of clinical research
• Create regulatory submissions that allow for
flexibility in scientific content and are easily
interpreted, understood and navigated by
regulatory reviews
• Examine how results are reported in multiple
registries and countries, including identifying tools
that can scan data and metadata for easier upload
JackYeager,CEO, Sylogent
KathleenOrmiston,DirectorofTrialTransparency,Sanofi
9:25 BIOSTATISTICIAN PANEL
Do We Have Enough Information
to Effectively Analyze Data?
Questions to be addressed during this panel include:
• User side — Are we meeting the needs for providing
information and CSRs? Are there additional
analytical tools/software that should be provided?
• Provider side — What are the approaches for
providing information? Are there any items that need
to be considered when performing analysis and
meta-analysis? How do we consider sub-groups?
What is statistically meaningful?
• Automation — Are there ways of getting data into a
structure easily? Can we enable measurement of all
data automatically?
• What is the impact of data anonymization/
de-identification on the ability to perform
statistical analyses?
• What is needed for a well designed clinical trial?
• What constitutes the totality of evidence?
• Does the information (data and documents)
provided facilitate endpoint identification and
creation of SAPs?
• What is critical to include in your strategy?
• Compared to colleagues in other areas, for example
financials, we are only scratching the surface with
data analysis and statistics — How can we learn from
them and apply to data disclosure?
Moderator: MarciaLevenstein,VicePresident,Statistics,GlobalInnovative
PharmaceuticalBusinessUnit,Pfizer Inc
Panelists: JenniferAngell,Director,Biostatistics,Genzyme
PaulMcSorley,Director,NeurosciencesClinicalStatistics,
GlaxoSmithKline
Examine Innovative Industry
Solutions for EMA Policy
70 Compliance
10:05 CISCRP ADDRESS
Establishing a Standard Practice
to Communicate Trial Results to
Study Volunteers
A growing number of pharmaceutical and
biotechnology companies have implemented
programs to communicate trial results to their study
volunteers in anticipation of regulatory reform and
the necessity to engage patients as research partners.
During the past four years, the Center for Information
and Study on Clinical Research Participation
(CISCRP) has assisted more than two dozen sponsor
organizations in developing and establishing clinical
trial results communication programs.
In this address, CISCRP discusses:
• Data characterizing the impact of communicating
trial results on study volunteer expectations and
participation satisfaction
• Evolving regulatory guidelines in the EU and US to
drive higher levels of transparency
• Establishing a trial results communication capability
within sponsor organizations that includes internal
functions as well as investigative site personnel
• Scaling a trial results communication capability
across the sponsor’s portfolio of clinical trial activity
ZachHallinan,Director,PatientCommunicationandEngagement
Programs,The Center for Information and Study on
Clinical Research Participation (CISCRP)
10:45 Networking and Refreshment Break
11:15 Operational Planning for Plain Language
Summaries and Return of Results to
Patients and Other Stakeholders
• Review the purpose and scope of return of
general research summaries to trial participants,
including operational preparedness and
logistical considerations
* nature of information to be included in
plain language summaries
* methods of delivery
* timing of return
* special considerations, including trials that close
early, third-party notification, etc.
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7. • Examine where regulators stand on communication
clinical trial plain language information
* EMA and EudraCT
* FDA and ClinicalTrials.gov
* other regulatory authorities
• Assess the additional resources that will be required
to create and communicate plain language
summaries for each trial
BarbaraE.Bierer,M.D.,ProfessorofMedicine,Harvard Medical
School;FacultyCo-Chair,Multi-Regional Clinical Trials
Center at Harvard (MRCT)
11:55 The Role of Artificial Intelligence in
Clinical Trial Transparency
• Assess the complexities and implications of clinical
trial disclosure and transparency for sponsors
• Review the pitfalls and risks associated with manual
redaction processes
• Learn how artificial intelligence and natural language
recognition and processing are significantly improving
the accuracy and efficiency of successfully redacting
personally identifiable information, patient protected
data, company confidential information and other
sensitive information from clinical trial documents for
public disclosure
KeithKleeman,President,Synchrogenix
12:35 Networking Luncheon
1:35 Sharing Data via a Third-Party,
Independent Academic Review Process —
Experiences from the YODA Collaboration
During this session, hear back to back presentations
from both a clinical trial sponsor that has committed
to a greater level of data sharing through a third-party
process and the third-party academic independent
review panel that has been engaged to review the
sponsor’s external requests for data. In this session, the
speakers will specifically examine:
• The YODA Project/J&J model for the review of data
requests from external investigators, including
the structure of the agreement, key features of the
arrangement, and policies/procedures
• Lessons learned during the establishment of the
data sharing model and associated processes
• Considerations for others contemplating
establishment of an agreement with a third-party
independent review panel
SandraMorris,Ph.D.,PMP,VicePresident,StrategyRealization,
Johnson & Johnson, Office of the Chief Medical Officer
JosephSolomonRoss,M.D.,AssistantProfessor,SchoolofGeneralInternal
Medicine,Yale University School of Medicine
2:15 MULTISPONSOR EXTENDED SESSION
Compare and Contrast Benefits
of Multisponsor and Single
Sponsor Websites
During this extended session, participants have the
opportunity to converse with multiple companies
that are taking steps to increase data availability upon
reasonable third-party researcher request.
• Discuss different company policies regarding how to
approach the disclosure operational process
* is there a standard process that can be
implemented industry-wide?
• Maximize impact within the increased volume of
disclosure requests
* what are the strategies different companies are
taking to make sure there is alignment with all
information that is being released?
* how can we manage regulatory submission
systems with clinical tracking systems?
how are these systems being
managed consistently?
• Review the evaluation for proposals, including an
evaluation framework
• Consider the evolution and evaluation of models
that are being piloted for sharing data in the
multisponsor environment
• Examine costs associated with the multi and single
sponsor environments
* what are the initial costs associated with launching?
* what infrastructure and personnel resource
expenses are required?
* who will ultimately pay the costs for increased
transparency?will it be the patients?
• Discuss the review process for each company
* for what purpose is the data being reviewed?
scientific merit, conflict of interest, etc.?
* what is the appropriate level of review?
* what controls are in place to ensure both parties
are meeting their requirements?
* what are the data standards?
* how can we combat data being collected
differently across manufacturers to allow
harmonized database communication?
* are requests coming through across different kinds
of drugs and companies?
* what kinds of questions and issues are arising?
* how are companies reporting metrics,
i.e., on requests received and those approved or
not? are the requestors’ information, including
statistical analysis plans going to be made public?
* how will the industry measure success of
data sharing initiatives?
Moderator: RobertAPaarlberg,Principa,Paarlberg & Associates LLC
Panelists: MarlaJoBrickman,Ph.D.,SeniorDirector/TeamLeader—
ClinicalTrialDisclosureGroup,Pfizer Inc
RobinJenkins,MBA,SeniorDirector,MedicalAffairsInnovation,Sanofi
JenniferVanEkelenburg,HeadClinicalTransparencyandSubmissions,
PCPS,StudyCapabilitiesandTransparency,GlaxoSmithKline
3:15 Close of Conference
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Register by November 21, 2014 and SAVE $300. Fee includes continental breakfast, lunch,
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PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.
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you must register with our customer service department by calling 339-298-2100.
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SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organization up to 24 hours in advance of the
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will be refunded, less a $399 administrative charge. No refunds will be made after this date; however,
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you register within 30 days from the date of this conference to an alternative CBI conference scheduled
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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
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January 28-29, 2015 • Doubletree by Hilton Philadelphia Center City • Philadelphia, PA
Clinical Data
R E G I S T E R BY N OV E M B E R 2 1 , 2 0 1 4 A N D S AV E $ 3 0 0 !
Navigating Patient-Level Data Disclosure, EudraCT and International Registries
ANY QUESTIONS OR TO REGISTER
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