World 2015
Conference
Clinical Research
Informatics
May 6-7, 2015
Seaport Hotel | Boston, MA
KEYNOTE SPEAKERS:
REGISTER BY MARCH 20
TO SAVE UP TO $200
Reshaping Clinical Trials with
New Technologies and Analytics
Organized by:
Cambridge Healthtech Institute #CLIN15ClinicalInformaticsWorld.com
FINAL AGENDA
Real World Data Visualization Tools for End
Users across Clinical Development
•	 Establishing & Using a Big Data Strategy
for Clinical Trial Insights
•	 Leveraging Technology to Bring Patient
Centricity to Clinical Trials
•	 Innovating Existing Clinical Trial Processes and
Systems via New Tech Approaches
•	 Case Studies: Using Existing Data Sources for
Advancing Clinical Trials
•	 Cross-Industry Data Sharing to Advance
Clinical Trials & Data Privacy Issues
Barbara Tardiff, M.D.
Vice President, Development Operations;
Global Head, Clinical Innovation and Informatics,
Worldwide Research & Development, Pfizer
Howard L. Golub, M.D., Ph.D.
Vice President, Clinical Research,
Walgreen Company
Tomasz Sablinski, M.D., Ph.D.
Founder and CEO,
Transparency Life Sciences
COVERAGE
INCLUDES:
DINNER WORKSHOP
A Look at What’s Next for ClinicalTrials
11:00 Mining Big Data forTranslational & Clinical Insights
Anastasia Christianson, Head, Translational R&D IT, Bristol-Myers Squibb
The emergence of new technologies and continued exponential growth of data
and information generated daily in the clinic and in laboratories have led to a surge
in translational research opportunities for new clinical insights and treatment
paradigms. Pharma, Biotech, academic and medical research centers are all facing
the arduous task of finding and mining overwhelming quantities of efficacy, safety,
biomarker, and outcomes data accumulated from decades of preclinical studies
and clinical trials. Despite years of focusing on information management and
integration strategies, we still have less than optimal technical solutions for mining
our data. Our current strategy is to utilize expert data, information science, and
analytics skills, alongside scientific, medical, and technical experts to work together
as a team in defining questions, finding relevant data, analyzing, and interpreting
results into sustainable short term and long term solutions. Examples of how this
approach is enabling translational research will be presented, as will opportunities
for cross-functional and cross-organizational collaboration.
11:30The Greatest Threats Opportunities to the ClinicalTrial
Industry: A Look at What’s Next
Leonard D’Avolio, Director, Informatics, Ariadne Labs; Assistant Professor,
Harvard Medical School
A perfect storm of change is washing over the pharmaceutical industry thanks to
payment reform, low-cost high-throughput sequencing, and an explosion of digital
healthcare data. Combine enormously expensive trials with high failure rates and
rampant under-enrollment, and it becomes clear that change is coming. While
some are battening down the hatches, the real winners will be those that refuse
to let a crisis go to waste. We’ll explore who are those opportunists, what are they
doing, and what does it mean for the clinical trial industry.
12:00 pm Sponsored Presentation (Opportunity Available)
12:30 Luncheon Presentation (Sponsorship Opportunity Available)
or Enjoy Lunch onYour Own
1:15 Session Break
PLENARY
KEYNOTE
SESSION
WEDNESDAY, MAY 6, 2015
Rethinking the
ClinicalTrial Paradigm
7:00 am Registration and Morning Coffee
8:00 Organizer’s Welcome and Chairperson’s Remarks
8:10Transforming ClinicalTrials with Big Data and NewTechnology
Barbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical
Innovation and Informatics, Worldwide Research & Development, Pfizer
Personalized Medicine is based on digital data and Precision Medicine is enabled by big data.
Advances in technology along with new data sources and channels are changing the drug
development paradigm, and collaborations between non-traditional partners will drive further
innovations. We must learn to manage and be successful at understanding new types of data
and evidence, in order to realize the power of new types of data and evidence.
8:40 Opening up Clinical Study Design to the LongTail
Tomasz Sablinski, M.D., Ph.D., Founder and CEO, Transparency Life Sciences
Clinical research is in a crisis of existential proportions. Failure rates are unchanged from, or
worse than, in prior decades while costs have skyrocketed. We are implementing, a systemic
solution to this problem in the form of a new kind of drug development company, Transparency
Life Sciences LLC (TLS). Using the TLS approach, the design of a clinical trial is crowdsourced
via our transparent web-based Protocol Builder®, which invites participation of a broad range
of researchers, patients, health care providers, etc. Clinical studies are conducted in a patient-
friendly manner, with collection of data largely managed remotely with the use of digital
technology through video visits, and/or telemonitoring devices.
9:10 Leveraging Data from One of the Largest Pharmacy Chains in the
World in Order to Achieve Efficient, Cost-Effective Patient Recruitment for
Clinical Research
Howard L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen Company
The creation of Walgreens Boots Alliance (a recent merger between Walgreen Co., and
Alliance Boots Ltd.) establishes the first global pharmacy-led health and wellbeing enterprise.
Together, Walgreens Boots Alliance spans more than 25 countries, with over 12,800 stores.
In addition, there are primary-care clinics located in over 425 U.S. stores that can be used
for subject study visits. In the U.S. alone, 40M people visit our 8200 stores a week. The
prescription database contains over 70M active customers at any one time. In addition,
Walgreens U.S. has one of the largest specialty drug support services in the country. Use of
our customer data uniquely facilitates the contacting of potential study patients in order to
determine if they would like to opt-in for any of the studies which we are currently recruiting.
9:40 Coffee Break with Exhibit Viewing
10:30 PANEL DISCUSSION: Rethinking the ClinicalTrial Paradigm:What Is
on the Horizon for ClinicalTrials?
Moderator to be Announced
Panelists:
Barbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical
Innovation and Informatics, Worldwide Research & Development, Pfizer
Howard L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen Company
Tomasz Sablinski, Founder and CEO, Transparency Life Sciences
CONFERENCEAGENDA
FOCUSEDBREAKOUTSESSIONS
Big Data for ClinicalTrials:
Harnessing & Unlocking the Potential of Existing Data Sources
Establishing & Using a Big Data Strategy for
ClinicalTrial Insights
1:40 Chairperson’s Remarks
1:45 Clinical Research Continuum: Big Data FOR and FROM
ClinicalTrials
Alexander Sherman, Director, Strategic Development and Systems,
Neurological Clinical Research Institute at MGH, Massachusetts General
Hospital
In the world of Big Data in clinical research, there are bidirectional flows of
information: data from clinical trials may be aggregated and analyzed to better our
understanding of the disease, while information from the “bedside” combined
with data from clinical research helps companies to make better decisions
on disease progression models, outcomes selection, eligibility criteria tuning
and patient recruitment. In rare diseases such information may bring us to
personalized intervention tracking, with so-called “virtual lead-in” modeling.
2:15 Considerations in Building a Data Hub to Support Clinical
Trial Development
Francis Kendall, Global Head, Statistical Programming and Analysis, Roche
This talk will give an overview of how Roche is developing a Process and
Systems framework to store and manage Clinical Trial Data and Real World data
and how the Biometrics organization is changing to maximize the potential of
these data sources. Part of the talk will focus on the Data Hub Team who are the
curators of the data and how this team was formed and its current remit. The
final part of the talk will look at several ways we intend to use the Data Hub to
support our Portfolio.
2:45 Sponsored Presentation (Opportunity Available)
3:15 Refreshment Break with Exhibit Viewing
3:50 ClinicalTrial Planning: Strategy, CER and RealWorld Patients
Michael Liebman, Managing Director & Co-Founder, IPQ Analytics LLC
Clinical trials are considered the gatekeeper for attaining regulatory approval for
therapeutics and diagnostics, but the actual goal of commercial success (and
improved patient outcomes) may not be adequately addressed because of the
gap between clinical trials and real world patients and medicine. Examples of
how to objectively evaluate the gaps to provide decision support early in the
process will be presented in several disease areas.
4:20 Deriving Insight and Value from Clinical Data Using Large-
Scale Analytics
Nirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research &
Development Information, AstraZeneca PLC
Clinical data, whether derived from EHRs or actual clinical trials, provides a
valuable resource to analyze the outcomes and efficacy of clinical treatments and
therapeutic interventions. Classification and prediction algorithms can benefit
from novel representations of large populations of clinical data. In this talk we
address the challenge of deriving value from clinical data using analytics that can
benefit many parts of the drug development process. The ability to scale analyses
to increasingly large populations will also be discussed.
4:50 Using Watson to Improve ClinicalTrials: A Mayo Clinic-IBM
Initiative
Nicholas LaRusso, M.D., Director, Center for Innovation, Mayo Clinic
Combining the functionality of IBM Watson and leveraging the expertise of
Mayo clinicians, the Watson Clinical Trials Matching solution uses natural
language processing, machine learning and probabilistic computing to compare
individual patient attributes to complex eligibility criteria for multiple clinical trials.
Supporting clinician decisions at the point of care, it quickly provides a list of
trials that are most likely matched to the patient’s needs and an analysis of how
well the patient matches the criteria for those trials. Initial experience with three
cancers has been positive.
Tech Innovation in ClinicalTrials:
New Tools and Analytics to Advance Clinical Research
LeveragingTechnology to Bring Patient
Centricity to ClinicalTrials
1:40 Chairperson’s Remarks
1:45 ClinicalTrials: Responsive and Considerate Care for
Patients
Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli
Lilly and Company
Imagine being diagnosed with a new illness or chronic condition after a lifetime
of perfect health...would you feel embarrassed? What if existing treatments failed
to help you effectively treat your illness…would you feel vulnerable? What if your
condition prevented you from doing what you wanted to do, from living life to the
fullest?...would you be frustrated, even angry? Now, imagine consulting with your
doctor to determine a clinical trial to be your best course of treatment…could you
imagine that? Lilly Clinical Innovation believes that you should. Join us to learn
more about our vision for making responsive and considerate clinical research a
reality for vulnerable and embarrassed patients - like all of us - who need them.
2:15 Bringing Science to Patient Centricity
Sally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient Safety,
PatientsLikeMe
Patient engagement in research has been increasing in recent years, enabled
in part by attention to patient-focused drug development, online patient
communities and rapidly emerging technologies. Patients are no longer just
subjects in trials but partners in all phases of the process. This session explores
insights from PatientsLikeMe about patient preferences, motivations, barriers,
and concerns for participation in clinical trials. The resulting data can be used
to inform clinical development program decisions most consistent with patient
perspectives and study objectives.
2:45 Sponsored Presentation (Opportunity Available)
3:15 Refreshment Break with Exhibit Viewing
Innovating Existing ClinicalTrial Processes and
Systems via NewTech Approaches
3:50 Re-Use of Electronic Health Records:The IMI EHR4CR
Project
Johann Proeve, Ph.D., Global Strategy and Development Advisor, Bayer
Healthcare, Leverkusen, Germany
The EHR4CR (electronic health records for clinical research) as part of the
Innovative Medicines Initiative in Europe looks into the re-use of electronic health
records for protocol feasibility, patient recruitment and eventually study conduct.
A consortium of 10 university clinics across Europe, 11 pharma companies and
several small businesses worked together for the past 4 years to a.) improve
clinical trial protocol design by accessing the electronic health records b.) support
study investigators in identifying suitable patients and c.) identify the most
common data items used in clinical trials and check those vs the data available in
the electronic health records of the participating hospitals. The presentation will
provide an insight into the challenges, the accomplishments and the next steps
of this 5 year program.
4:20 Case Study: Merging EDC and CTMS without aTraditional
Data Warehouse
Kesha Rodgers, Associate Director, Clinical Systems, BioMarin
When conducting and managing trials, the information in EDC systems and the
operational data in CTMS are critical to making fast, accurate decisions. Blending
the data, though, is typically either highly manual or requires expensive data
warehouse solutions. This talk follows BioMarin’s experience finding alternative
ways to merge CTMS and EDC data for reporting purposes.
4:50 Presentation to be Announced
WEDNESDAY, MAY 6, 2015
5:20 Welcome Reception with Exhibit Viewing
6:20 End of Day
6:30 – 9:00 Dinner Workshop: Real World Data VisualizationTools for End Users across Clinical Development (Separate Registration Required)
MEDIA PARTNERS
OFFICIAL
PUBLICATIONS
OFFICIAL
MEDIA PARTNER
LEAD SPONSORING
PUBLICATIONS
SPONSORING PUBLICATIONS WEB PARTNERS
FierceBiotechTHE BIOTECH INDUSTRY’S DAILY MONITOR
7:30 am Morning Coffee
Case Studies: Using Existing Data Sources
for Advancing ClinicalTrials
8:00 Chairperson’s Remarks
8:05 Banking Biospecimens for Exploratory Research
Catherine Marshall, Director, Information Strategy & Analytics, Clinical
Informatics and Innovations, Pfizer
Many pharmaceutical companies have established processes for collecting, banking,
and using clinical trial biospecimens consented for research purposes. Until recently,
the decision to collect these specimens has generally been made at the level of
the individual clinical teams. As the value of biospecimen-derived research data is
increasingly realized, it is important to take a more proactive and strategic approach
to routinely collecting and banking of biospecimens from our clinical trials. This talk
highlights the strategic imperative as well as some examples of key research needs
and the key challenges we face around cost and patient consent. Linkage back to
clinical phenotypic data will also be explored.
8:35 ImmPort: Open-Access Individual-Level ClinicalTrials Data-
Sharing, Dissemination and Meta-Trial Analyses
Sanchita Bhattacharya, Scientific Project Lead, ImmPort; Senior Bioinformatics
Research Specialist, Division of Systems Medicine, Stanford University School
of Medicine
Broad public access to individual-level clinical trials data is on the rise. In this
presentation, we will discuss the reasons and various ways of effective data sharing
including issues surrounding it. Few case studies on data re-use, reproducibility
and cross-trial meta-analyses for gaining insight to the multiple clinical studies will
be presented.
9:05 Sponsored Presentation (Opportunity Available)
9:35 Coffee Break with Exhibit Viewing
Cross-Industry Data Sharing to Advance
ClinicalTrials & Data Privacy Issues
10:30 Co-Presentation: De-Mystifying Data De-Identification (the
Why and the How)
Muzafar Mirza, Director, Information Strategy and Analytics, Clinical Informatics
and Innovation, Pfizer, Inc.
Stuart Pearce, Director, Information Strategy and Analytics, Development
Operations, Worldwide Research & Development, Pfizer, Inc.
With the increased value of sharing clinical data for secondary discovery and novel
analyses, the question of informed consent and patient privacy is being debated
and discussed at length. There are different schools of thought as to whether data
should be de-identified and when, and also, if this practice should be used for
certain data applications. This talk seeks to de-mystify some of the confusion, offer
up some suggestions, as well as provoke discussion about the issue.
11:30 Global Clinical DataTransparency
Speaker to be Announced
12:00pm Close of Conference
Clinical Research Informatics World provides
actionable takeaways to benefit those involved in:
•	 ClinicalTrial Management
•	 Clinical Operations
•	 Data Analysis
•	 Data Management
•	 ClinicalTrial Informatics
•	 Clinical Research IT
•	 Site Monitoring
•	 Clinical Innovation
•	 Patient Recruitment
•	 Trial Design
•	 Clinical Information Systems
WHO SHOULD
ATTEND?
THURSDAY, MAY 7, 2015
Companies A-K
Katelin Fitzgerald
Sr Business Development Manager
781-972-5458
kfitzgerald@healthtech.com
Companies L-Z
Elizabeth Lemelin
Business Development Manager
781-972-1342
elemelin@healthtech.com
For more information, please contact:
SPONSOR & EXHIBIT INFORMATION
ABOUT THE EVENT
DINNER WORKSHOP*
Complementing their exceptional series of informatics programming in Boston this spring, Cambridge Healthtech Institute and Clinical Informatics News are proud to
launch Clinical Research Informatics World.The event brings together industry leaders, innovative thinkers and decision makers in the areas of clinical operations, clinical
trial management, clinical innovation, data analysis, clinical trial informatics, data management, clinical research IT, and clinical information systems for two days of
dynamic discussions, expert-led presentations and invaluable networking.
The 2015 program, featuring a plenary keynote session and two concurrent conference tracks,
provides coverage on such topics as big data use and analytics for advancing clinical research,
data visualization and analysis trends, new technologies in use for clinical trials (including mobile
technology, wearables and social media), and cross-industry data sharing.
HOTEL & TRAVEL
CHI offers comprehensive sponsorship packages which include presentation opportunities,
exhibit space, branding and networking with specific prospects. Sponsorship allows you
to achieve your objectives before, during, and long after the event. Any sponsorship can be
customized to meet your company’s needs and budget. Signing on early will allow you to
maximize exposure to qualified decision-makers.
Podium Presentations – Available Within the Main Agenda!
Showcase your solutions to a guaranteed, targeted audience. Package includes a 15- or
30-minute podium presentation within the scientific agenda, exhibit space, on-site branding,
access to cooperative marketing efforts by CHI, and more.
Luncheon Podium Presentations
Opportunity includes a 30-minute podium presentation. Boxed lunches are delivered into the
main session room, which guarantees audience attendance and participation. A limited number
of presentations are available for sponsorship and they will sell out quickly. Sign on early to
secure your talk!
Invitation-Only VIP Dinner/Hospitality Suite
Sponsors will select their top prospects from the conference pre-registration list for an evening
of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver
prospects, helping you to make the most out of this invaluable opportunity. Evening will be
customized according to sponsor’s objectives i.e.:
•	 Purely social
•	 Focus group
•	 Reception style
•	 Plated dinner with specific conversation focus
Exhibit
Exhibitors will enjoy facilitated networking opportunities with qualified delegates. Speak face-to-
face with prospective clients and showcase your latest product, service, or solution.
Additional branding and promotional opportunities are available, including:
•	 Hotel Room Keys
•	 Staircase Ads
•	 Conference Tote Bags
•	 Literature Distribution (Tote Bag Insert or Chair Drop)
•	 Badge Lanyards
•	 Program Guide Advertisement
Conference Venue and Hotel:
Seaport Hotel
One Seaport Lane
Boston, MA 02210
Phone: 617-385-4514
Discounted Room Rate:
$259 s/d
Discounted Room Rate Cutoff:
March 26, 2015
For reservations and additional
information, please visit the travel page
of ClinicalInformaticsWorld.com
Real World Data Visualization
Tools for End Users across
Clinical Development
Data visualization tools offer a profound way
to enhance our understanding of clinical trial
data. This workshop will demonstrate real
world visualizations of safety, efficacy, and
operational data that empower end users
across clinical development. We will provide
tips about the best ways to get started, share
some lessons learned, and suggest keys for a
successful implementation.
Instructors:
Ted Snyder, Lead Senior Analyst, Informatics,
Infinity Pharmaceuticals
Additional Instructors to be Announced
Wednesday, May 6, 2015
6:30-9:00 pm
#CLIN15CONNECT WITH US
*Separate Registration Required
DINNER WORKSHOP PRICING
(Includes access to Workshop only)
Real World Data Visualization Tools for End Users across Clinical Development 	 $699	 $399
MAIN CONFERENCE PRICING
(Includes access to conference, excludes Dinner Workshop)
Advance Registration Rate Until March 20, 2015	 $1,449	 $679
Standard Registration Rate After March 20, 2015 and On-Site	 $1,649	 $759
CONFERENCE DISCOUNTS
Exclusive Offer to Attend Bio-IT World Conference & Expo and Medical Informatics World
Cambridge Healthtech Institute presents a series of informatics programs in Boston this spring with the goal of bridging the healthcare and life
science worlds. Paid attendees of Clinical Research Informatics World can attend Bio-IT World Conference (April 21-23) and Medical Informatics
World Conference (May 4-5) for a special discounted rate (20% discount off the registration fee for the main conference).To receive this exclusive
20% discount, mention keycode 1571CLNXP when registering for Bio-IT World Conference (Bio-ITWorld.com) and/or Medical Informatics World
(MedicalInformaticsWorld.com). Discount applies to paid attendees of the 2015 Clinical Research Informatics World Conference. Applies to new
registrations only and cannot be combined with other discount offers, except poster discount. Discount does not apply to workshops and will be
taken off lowest priced item(s).
Poster Submission - Discount ($50 Off): Poster abstracts are due by March 20, 2015. Once your registration has been fully processed, we will
send an email containing a unique link allowing you to submit your poster abstract. If you do not receive your link within 5 business days, please
contact jring@healthtech.com. *CHI reserves the right to publish your poster title and abstract in various marketing materials and products.
REGISTER 3 ­- 4th IS FREE: Individuals must register for the same conference or conference combination and submit completed registration form together
for discount to apply.
Additional discounts are available for multiple attendees from the same organization. For more information on group rates contact David Cunningham at +1-781-972-5472
If you are unable to attend but would like to purchase the Clinical Research Informatics World Conference CD for $750 (plus shipping), please visit
ClinicalInformaticsWorld.com. Massachusetts delivery will include sales tax.
Please refer to the Registration Code below:
Cambridge Healthtech Institute
250 First Avenue, Suite 300, Needham, MA 02494
www.healthtech.com • Fax: 781-972-5425
How to Register: www.ClinicalInformaticsWorld.com
reg@healthtech.com • P: 781.972.5400 orToll-free in the U.S. 888.999.6288
Please use keycode
1571 F
when registering!
ADDITIONAL REGISTRATION DETAILS
Each registration includes all conference
sessions, posters and exhibits, food
functions, and access to the conference
proceedings link.
Handicapped Equal Access: In accordance
with the ADA, Cambridge Healthtech
Institute is pleased to arrange special
accommodations for attendees with
special needs. All requests for such
assistance must be submitted in writing
to CHI at least 30 days prior to the start
of the meeting.
To view our Substitutions/
Cancellations Policy, go to
http://www.healthtech.com/regdetails
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World 2015
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Clinical Research
Informatics
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Academic, Government,
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May 6-7, 2015 | Seaport Hotel | Boston, MA

Clinical Research Informatics World 2015

  • 1.
    World 2015 Conference Clinical Research Informatics May6-7, 2015 Seaport Hotel | Boston, MA KEYNOTE SPEAKERS: REGISTER BY MARCH 20 TO SAVE UP TO $200 Reshaping Clinical Trials with New Technologies and Analytics Organized by: Cambridge Healthtech Institute #CLIN15ClinicalInformaticsWorld.com FINAL AGENDA Real World Data Visualization Tools for End Users across Clinical Development • Establishing & Using a Big Data Strategy for Clinical Trial Insights • Leveraging Technology to Bring Patient Centricity to Clinical Trials • Innovating Existing Clinical Trial Processes and Systems via New Tech Approaches • Case Studies: Using Existing Data Sources for Advancing Clinical Trials • Cross-Industry Data Sharing to Advance Clinical Trials & Data Privacy Issues Barbara Tardiff, M.D. Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, Pfizer Howard L. Golub, M.D., Ph.D. Vice President, Clinical Research, Walgreen Company Tomasz Sablinski, M.D., Ph.D. Founder and CEO, Transparency Life Sciences COVERAGE INCLUDES: DINNER WORKSHOP
  • 2.
    A Look atWhat’s Next for ClinicalTrials 11:00 Mining Big Data forTranslational & Clinical Insights Anastasia Christianson, Head, Translational R&D IT, Bristol-Myers Squibb The emergence of new technologies and continued exponential growth of data and information generated daily in the clinic and in laboratories have led to a surge in translational research opportunities for new clinical insights and treatment paradigms. Pharma, Biotech, academic and medical research centers are all facing the arduous task of finding and mining overwhelming quantities of efficacy, safety, biomarker, and outcomes data accumulated from decades of preclinical studies and clinical trials. Despite years of focusing on information management and integration strategies, we still have less than optimal technical solutions for mining our data. Our current strategy is to utilize expert data, information science, and analytics skills, alongside scientific, medical, and technical experts to work together as a team in defining questions, finding relevant data, analyzing, and interpreting results into sustainable short term and long term solutions. Examples of how this approach is enabling translational research will be presented, as will opportunities for cross-functional and cross-organizational collaboration. 11:30The Greatest Threats Opportunities to the ClinicalTrial Industry: A Look at What’s Next Leonard D’Avolio, Director, Informatics, Ariadne Labs; Assistant Professor, Harvard Medical School A perfect storm of change is washing over the pharmaceutical industry thanks to payment reform, low-cost high-throughput sequencing, and an explosion of digital healthcare data. Combine enormously expensive trials with high failure rates and rampant under-enrollment, and it becomes clear that change is coming. While some are battening down the hatches, the real winners will be those that refuse to let a crisis go to waste. We’ll explore who are those opportunists, what are they doing, and what does it mean for the clinical trial industry. 12:00 pm Sponsored Presentation (Opportunity Available) 12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch onYour Own 1:15 Session Break PLENARY KEYNOTE SESSION WEDNESDAY, MAY 6, 2015 Rethinking the ClinicalTrial Paradigm 7:00 am Registration and Morning Coffee 8:00 Organizer’s Welcome and Chairperson’s Remarks 8:10Transforming ClinicalTrials with Big Data and NewTechnology Barbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, Pfizer Personalized Medicine is based on digital data and Precision Medicine is enabled by big data. Advances in technology along with new data sources and channels are changing the drug development paradigm, and collaborations between non-traditional partners will drive further innovations. We must learn to manage and be successful at understanding new types of data and evidence, in order to realize the power of new types of data and evidence. 8:40 Opening up Clinical Study Design to the LongTail Tomasz Sablinski, M.D., Ph.D., Founder and CEO, Transparency Life Sciences Clinical research is in a crisis of existential proportions. Failure rates are unchanged from, or worse than, in prior decades while costs have skyrocketed. We are implementing, a systemic solution to this problem in the form of a new kind of drug development company, Transparency Life Sciences LLC (TLS). Using the TLS approach, the design of a clinical trial is crowdsourced via our transparent web-based Protocol Builder®, which invites participation of a broad range of researchers, patients, health care providers, etc. Clinical studies are conducted in a patient- friendly manner, with collection of data largely managed remotely with the use of digital technology through video visits, and/or telemonitoring devices. 9:10 Leveraging Data from One of the Largest Pharmacy Chains in the World in Order to Achieve Efficient, Cost-Effective Patient Recruitment for Clinical Research Howard L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen Company The creation of Walgreens Boots Alliance (a recent merger between Walgreen Co., and Alliance Boots Ltd.) establishes the first global pharmacy-led health and wellbeing enterprise. Together, Walgreens Boots Alliance spans more than 25 countries, with over 12,800 stores. In addition, there are primary-care clinics located in over 425 U.S. stores that can be used for subject study visits. In the U.S. alone, 40M people visit our 8200 stores a week. The prescription database contains over 70M active customers at any one time. In addition, Walgreens U.S. has one of the largest specialty drug support services in the country. Use of our customer data uniquely facilitates the contacting of potential study patients in order to determine if they would like to opt-in for any of the studies which we are currently recruiting. 9:40 Coffee Break with Exhibit Viewing 10:30 PANEL DISCUSSION: Rethinking the ClinicalTrial Paradigm:What Is on the Horizon for ClinicalTrials? Moderator to be Announced Panelists: Barbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, Pfizer Howard L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen Company Tomasz Sablinski, Founder and CEO, Transparency Life Sciences CONFERENCEAGENDA
  • 3.
    FOCUSEDBREAKOUTSESSIONS Big Data forClinicalTrials: Harnessing & Unlocking the Potential of Existing Data Sources Establishing & Using a Big Data Strategy for ClinicalTrial Insights 1:40 Chairperson’s Remarks 1:45 Clinical Research Continuum: Big Data FOR and FROM ClinicalTrials Alexander Sherman, Director, Strategic Development and Systems, Neurological Clinical Research Institute at MGH, Massachusetts General Hospital In the world of Big Data in clinical research, there are bidirectional flows of information: data from clinical trials may be aggregated and analyzed to better our understanding of the disease, while information from the “bedside” combined with data from clinical research helps companies to make better decisions on disease progression models, outcomes selection, eligibility criteria tuning and patient recruitment. In rare diseases such information may bring us to personalized intervention tracking, with so-called “virtual lead-in” modeling. 2:15 Considerations in Building a Data Hub to Support Clinical Trial Development Francis Kendall, Global Head, Statistical Programming and Analysis, Roche This talk will give an overview of how Roche is developing a Process and Systems framework to store and manage Clinical Trial Data and Real World data and how the Biometrics organization is changing to maximize the potential of these data sources. Part of the talk will focus on the Data Hub Team who are the curators of the data and how this team was formed and its current remit. The final part of the talk will look at several ways we intend to use the Data Hub to support our Portfolio. 2:45 Sponsored Presentation (Opportunity Available) 3:15 Refreshment Break with Exhibit Viewing 3:50 ClinicalTrial Planning: Strategy, CER and RealWorld Patients Michael Liebman, Managing Director & Co-Founder, IPQ Analytics LLC Clinical trials are considered the gatekeeper for attaining regulatory approval for therapeutics and diagnostics, but the actual goal of commercial success (and improved patient outcomes) may not be adequately addressed because of the gap between clinical trials and real world patients and medicine. Examples of how to objectively evaluate the gaps to provide decision support early in the process will be presented in several disease areas. 4:20 Deriving Insight and Value from Clinical Data Using Large- Scale Analytics Nirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research & Development Information, AstraZeneca PLC Clinical data, whether derived from EHRs or actual clinical trials, provides a valuable resource to analyze the outcomes and efficacy of clinical treatments and therapeutic interventions. Classification and prediction algorithms can benefit from novel representations of large populations of clinical data. In this talk we address the challenge of deriving value from clinical data using analytics that can benefit many parts of the drug development process. The ability to scale analyses to increasingly large populations will also be discussed. 4:50 Using Watson to Improve ClinicalTrials: A Mayo Clinic-IBM Initiative Nicholas LaRusso, M.D., Director, Center for Innovation, Mayo Clinic Combining the functionality of IBM Watson and leveraging the expertise of Mayo clinicians, the Watson Clinical Trials Matching solution uses natural language processing, machine learning and probabilistic computing to compare individual patient attributes to complex eligibility criteria for multiple clinical trials. Supporting clinician decisions at the point of care, it quickly provides a list of trials that are most likely matched to the patient’s needs and an analysis of how well the patient matches the criteria for those trials. Initial experience with three cancers has been positive. Tech Innovation in ClinicalTrials: New Tools and Analytics to Advance Clinical Research LeveragingTechnology to Bring Patient Centricity to ClinicalTrials 1:40 Chairperson’s Remarks 1:45 ClinicalTrials: Responsive and Considerate Care for Patients Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and Company Imagine being diagnosed with a new illness or chronic condition after a lifetime of perfect health...would you feel embarrassed? What if existing treatments failed to help you effectively treat your illness…would you feel vulnerable? What if your condition prevented you from doing what you wanted to do, from living life to the fullest?...would you be frustrated, even angry? Now, imagine consulting with your doctor to determine a clinical trial to be your best course of treatment…could you imagine that? Lilly Clinical Innovation believes that you should. Join us to learn more about our vision for making responsive and considerate clinical research a reality for vulnerable and embarrassed patients - like all of us - who need them. 2:15 Bringing Science to Patient Centricity Sally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient Safety, PatientsLikeMe Patient engagement in research has been increasing in recent years, enabled in part by attention to patient-focused drug development, online patient communities and rapidly emerging technologies. Patients are no longer just subjects in trials but partners in all phases of the process. This session explores insights from PatientsLikeMe about patient preferences, motivations, barriers, and concerns for participation in clinical trials. The resulting data can be used to inform clinical development program decisions most consistent with patient perspectives and study objectives. 2:45 Sponsored Presentation (Opportunity Available) 3:15 Refreshment Break with Exhibit Viewing Innovating Existing ClinicalTrial Processes and Systems via NewTech Approaches 3:50 Re-Use of Electronic Health Records:The IMI EHR4CR Project Johann Proeve, Ph.D., Global Strategy and Development Advisor, Bayer Healthcare, Leverkusen, Germany The EHR4CR (electronic health records for clinical research) as part of the Innovative Medicines Initiative in Europe looks into the re-use of electronic health records for protocol feasibility, patient recruitment and eventually study conduct. A consortium of 10 university clinics across Europe, 11 pharma companies and several small businesses worked together for the past 4 years to a.) improve clinical trial protocol design by accessing the electronic health records b.) support study investigators in identifying suitable patients and c.) identify the most common data items used in clinical trials and check those vs the data available in the electronic health records of the participating hospitals. The presentation will provide an insight into the challenges, the accomplishments and the next steps of this 5 year program. 4:20 Case Study: Merging EDC and CTMS without aTraditional Data Warehouse Kesha Rodgers, Associate Director, Clinical Systems, BioMarin When conducting and managing trials, the information in EDC systems and the operational data in CTMS are critical to making fast, accurate decisions. Blending the data, though, is typically either highly manual or requires expensive data warehouse solutions. This talk follows BioMarin’s experience finding alternative ways to merge CTMS and EDC data for reporting purposes. 4:50 Presentation to be Announced WEDNESDAY, MAY 6, 2015 5:20 Welcome Reception with Exhibit Viewing 6:20 End of Day 6:30 – 9:00 Dinner Workshop: Real World Data VisualizationTools for End Users across Clinical Development (Separate Registration Required)
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    MEDIA PARTNERS OFFICIAL PUBLICATIONS OFFICIAL MEDIA PARTNER LEADSPONSORING PUBLICATIONS SPONSORING PUBLICATIONS WEB PARTNERS FierceBiotechTHE BIOTECH INDUSTRY’S DAILY MONITOR 7:30 am Morning Coffee Case Studies: Using Existing Data Sources for Advancing ClinicalTrials 8:00 Chairperson’s Remarks 8:05 Banking Biospecimens for Exploratory Research Catherine Marshall, Director, Information Strategy & Analytics, Clinical Informatics and Innovations, Pfizer Many pharmaceutical companies have established processes for collecting, banking, and using clinical trial biospecimens consented for research purposes. Until recently, the decision to collect these specimens has generally been made at the level of the individual clinical teams. As the value of biospecimen-derived research data is increasingly realized, it is important to take a more proactive and strategic approach to routinely collecting and banking of biospecimens from our clinical trials. This talk highlights the strategic imperative as well as some examples of key research needs and the key challenges we face around cost and patient consent. Linkage back to clinical phenotypic data will also be explored. 8:35 ImmPort: Open-Access Individual-Level ClinicalTrials Data- Sharing, Dissemination and Meta-Trial Analyses Sanchita Bhattacharya, Scientific Project Lead, ImmPort; Senior Bioinformatics Research Specialist, Division of Systems Medicine, Stanford University School of Medicine Broad public access to individual-level clinical trials data is on the rise. In this presentation, we will discuss the reasons and various ways of effective data sharing including issues surrounding it. Few case studies on data re-use, reproducibility and cross-trial meta-analyses for gaining insight to the multiple clinical studies will be presented. 9:05 Sponsored Presentation (Opportunity Available) 9:35 Coffee Break with Exhibit Viewing Cross-Industry Data Sharing to Advance ClinicalTrials & Data Privacy Issues 10:30 Co-Presentation: De-Mystifying Data De-Identification (the Why and the How) Muzafar Mirza, Director, Information Strategy and Analytics, Clinical Informatics and Innovation, Pfizer, Inc. Stuart Pearce, Director, Information Strategy and Analytics, Development Operations, Worldwide Research & Development, Pfizer, Inc. With the increased value of sharing clinical data for secondary discovery and novel analyses, the question of informed consent and patient privacy is being debated and discussed at length. There are different schools of thought as to whether data should be de-identified and when, and also, if this practice should be used for certain data applications. This talk seeks to de-mystify some of the confusion, offer up some suggestions, as well as provoke discussion about the issue. 11:30 Global Clinical DataTransparency Speaker to be Announced 12:00pm Close of Conference Clinical Research Informatics World provides actionable takeaways to benefit those involved in: • ClinicalTrial Management • Clinical Operations • Data Analysis • Data Management • ClinicalTrial Informatics • Clinical Research IT • Site Monitoring • Clinical Innovation • Patient Recruitment • Trial Design • Clinical Information Systems WHO SHOULD ATTEND? THURSDAY, MAY 7, 2015
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    Companies A-K Katelin Fitzgerald SrBusiness Development Manager 781-972-5458 kfitzgerald@healthtech.com Companies L-Z Elizabeth Lemelin Business Development Manager 781-972-1342 elemelin@healthtech.com For more information, please contact: SPONSOR & EXHIBIT INFORMATION ABOUT THE EVENT DINNER WORKSHOP* Complementing their exceptional series of informatics programming in Boston this spring, Cambridge Healthtech Institute and Clinical Informatics News are proud to launch Clinical Research Informatics World.The event brings together industry leaders, innovative thinkers and decision makers in the areas of clinical operations, clinical trial management, clinical innovation, data analysis, clinical trial informatics, data management, clinical research IT, and clinical information systems for two days of dynamic discussions, expert-led presentations and invaluable networking. The 2015 program, featuring a plenary keynote session and two concurrent conference tracks, provides coverage on such topics as big data use and analytics for advancing clinical research, data visualization and analysis trends, new technologies in use for clinical trials (including mobile technology, wearables and social media), and cross-industry data sharing. HOTEL & TRAVEL CHI offers comprehensive sponsorship packages which include presentation opportunities, exhibit space, branding and networking with specific prospects. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on early will allow you to maximize exposure to qualified decision-makers. Podium Presentations – Available Within the Main Agenda! Showcase your solutions to a guaranteed, targeted audience. Package includes a 15- or 30-minute podium presentation within the scientific agenda, exhibit space, on-site branding, access to cooperative marketing efforts by CHI, and more. Luncheon Podium Presentations Opportunity includes a 30-minute podium presentation. Boxed lunches are delivered into the main session room, which guarantees audience attendance and participation. A limited number of presentations are available for sponsorship and they will sell out quickly. Sign on early to secure your talk! Invitation-Only VIP Dinner/Hospitality Suite Sponsors will select their top prospects from the conference pre-registration list for an evening of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver prospects, helping you to make the most out of this invaluable opportunity. Evening will be customized according to sponsor’s objectives i.e.: • Purely social • Focus group • Reception style • Plated dinner with specific conversation focus Exhibit Exhibitors will enjoy facilitated networking opportunities with qualified delegates. Speak face-to- face with prospective clients and showcase your latest product, service, or solution. Additional branding and promotional opportunities are available, including: • Hotel Room Keys • Staircase Ads • Conference Tote Bags • Literature Distribution (Tote Bag Insert or Chair Drop) • Badge Lanyards • Program Guide Advertisement Conference Venue and Hotel: Seaport Hotel One Seaport Lane Boston, MA 02210 Phone: 617-385-4514 Discounted Room Rate: $259 s/d Discounted Room Rate Cutoff: March 26, 2015 For reservations and additional information, please visit the travel page of ClinicalInformaticsWorld.com Real World Data Visualization Tools for End Users across Clinical Development Data visualization tools offer a profound way to enhance our understanding of clinical trial data. This workshop will demonstrate real world visualizations of safety, efficacy, and operational data that empower end users across clinical development. We will provide tips about the best ways to get started, share some lessons learned, and suggest keys for a successful implementation. Instructors: Ted Snyder, Lead Senior Analyst, Informatics, Infinity Pharmaceuticals Additional Instructors to be Announced Wednesday, May 6, 2015 6:30-9:00 pm #CLIN15CONNECT WITH US *Separate Registration Required
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    DINNER WORKSHOP PRICING (Includesaccess to Workshop only) Real World Data Visualization Tools for End Users across Clinical Development $699 $399 MAIN CONFERENCE PRICING (Includes access to conference, excludes Dinner Workshop) Advance Registration Rate Until March 20, 2015 $1,449 $679 Standard Registration Rate After March 20, 2015 and On-Site $1,649 $759 CONFERENCE DISCOUNTS Exclusive Offer to Attend Bio-IT World Conference & Expo and Medical Informatics World Cambridge Healthtech Institute presents a series of informatics programs in Boston this spring with the goal of bridging the healthcare and life science worlds. Paid attendees of Clinical Research Informatics World can attend Bio-IT World Conference (April 21-23) and Medical Informatics World Conference (May 4-5) for a special discounted rate (20% discount off the registration fee for the main conference).To receive this exclusive 20% discount, mention keycode 1571CLNXP when registering for Bio-IT World Conference (Bio-ITWorld.com) and/or Medical Informatics World (MedicalInformaticsWorld.com). Discount applies to paid attendees of the 2015 Clinical Research Informatics World Conference. Applies to new registrations only and cannot be combined with other discount offers, except poster discount. Discount does not apply to workshops and will be taken off lowest priced item(s). Poster Submission - Discount ($50 Off): Poster abstracts are due by March 20, 2015. Once your registration has been fully processed, we will send an email containing a unique link allowing you to submit your poster abstract. If you do not receive your link within 5 business days, please contact jring@healthtech.com. *CHI reserves the right to publish your poster title and abstract in various marketing materials and products. REGISTER 3 ­- 4th IS FREE: Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply. Additional discounts are available for multiple attendees from the same organization. For more information on group rates contact David Cunningham at +1-781-972-5472 If you are unable to attend but would like to purchase the Clinical Research Informatics World Conference CD for $750 (plus shipping), please visit ClinicalInformaticsWorld.com. Massachusetts delivery will include sales tax. Please refer to the Registration Code below: Cambridge Healthtech Institute 250 First Avenue, Suite 300, Needham, MA 02494 www.healthtech.com • Fax: 781-972-5425 How to Register: www.ClinicalInformaticsWorld.com reg@healthtech.com • P: 781.972.5400 orToll-free in the U.S. 888.999.6288 Please use keycode 1571 F when registering! ADDITIONAL REGISTRATION DETAILS Each registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link. Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting. To view our Substitutions/ Cancellations Policy, go to http://www.healthtech.com/regdetails Video and or audio recording of any kind is prohibited onsite at all CHI events. Complimentary news delivered to your inbox Subscribe to New Bulletins or the Weekly Update Newsletter at Bio-ITWorld.com Clinical Trials to the Clinic, subscribe at ClinicalInformaticsNews.com A series of diverse reports designed to keep life science professionals informed of the salient trends in pharmaceutical technology, business, clinical development, and therapeutic disease markets. For a detailed list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia, rlaraia@healthtech.com, +1-781-972-5444. Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit barnettinternational.com. World 2015 Conference Clinical Research Informatics PRICING AND REGISTRATION INFORMATION Academic, Government, Hospital AffiliatedCommercial May 6-7, 2015 | Seaport Hotel | Boston, MA