World 2015Conference

Clinical ResearchInformatics

May 6 - 7, 2015 Seaport Hotel | Boston, MA

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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

COVERAGEINCLUDES:

DINNER WORKSHOP

SPONSORSPremier Sponsors

Corporate Sponsors

A Look at What’s Next for Clinical Trials

11:00 Mining Big Data for Translational & Clinical InsightsAnastasia Christianson, Head, Translational R&D IT, Bristol-Myers SquibbThe 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.

11:30 The Greatest Threats Opportunities to the Clinical Trial Industry: A Look at What’s NextLeonard D’Avolio, Director, Informatics, Ariadne Labs; Assistant Professor, Harvard Medical SchoolA 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)

PLENARYKEYNOTESESSION

WEDNESDAY, MAY 6, 2015

Rethinking the Clinical Trial Paradigm7:00 am Registration and Morning Coffee

8:00 Organizer’s Welcome and Chairperson’s RemarksLee Yuan, Associate Conference Producer, Cambridge Healthtech Institute Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and Company

8:10 Transforming Clinical Trials with Big Data and New TechnologyBarbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, PfizerPersonalized 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 Long TailTomasz Sablinski, M.D., Ph.D., Founder and CEO, Transparency Life SciencesClinical 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 ResearchHoward L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen CompanyThe 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 Clinical Trial Paradigm: What Is on the Horizon for Clinical Trials?Moderator to be AnnouncedPanelists:Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and CompanyBarbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, PfizerHoward L. Golub, M.D., Ph.D., Vice President, Clinical Research, Walgreen CompanyTomasz Sablinski, Founder and CEO, Transparency Life Sciences

CONFERENCEAGENDA

12:30 Diving Down the Wormhole of Unstructured Clinical Trial Data: Going from “How” and “Why” to “Eureka!” in 60 Seconds

Sponsored by

Melissa Chapman, Principal, The Riverhead GroupJohn Felahi, Chief Strategy Officer, Content Analyst CompanyUnderstanding, analyzing and visualizing critical relationships across massive amounts of unstructured proteomic and metabolite data, gene pathway data, mechanisms of action and adverse event data can be key to driving your development pipeline with reduced risk and lower costs. But navigating these large repositories of unstructured content can be a nightmare. Learn how recent advancements in web-based machine learning technology now make it possible to discover breakthrough insights buried within vast, disparate collections of unstructured content at speeds never possible before.

1:15 Session Break

THURSDAY, MAY 6, 2015

FOCUSEDBREAKOUTSESSIONSBig Data for Clinical Trials:Harnessing & Unlocking the Potential of Existing Data Sources

Establishing & Using a Big Data Strategy for Clinical Trial Insights

1:40 Chairperson’s RemarksAnastasia Christianson, Head, Translational R&D IT, Bristol-Myers Squibb

1:45 Clinical Research Continuum: Big Data FOR and FROM Clinical TrialsAlexander Sherman, Director, Strategic Development and Systems, Neurological Clinical Research Institute at MGH, Massachusetts General HospitalIn 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 DevelopmentFrancis Kendall, Global Head, Statistical Programming and Analysis, RocheThis 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 Clinical Trial Planning: Strategy, CER and Real World PatientsMichael Liebman, Managing Director & Co-Founder, IPQ Analytics LLCClinical 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 AnalyticsNirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research & Development Information, AstraZeneca PLCClinical 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 Clinical Trials: A Mayo Clinic-IBM InitiativeNicholas LaRusso, M.D., Director, Center for Innovation, Mayo ClinicCombining 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 Clinical Trials:New Tools and Analytics to Advance Clinical Research

Leveraging Technology to Bring Patient Centricity to Clinical Trials

1:40 Chairperson’s RemarksDevin Trejo, Director, Oncology Feasibility Lead, Development Operations, Pfizer

1:45 Clinical Trials: Responsive and Considerate Care for PatientsKatherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and CompanyImagine 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 CentricitySally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient Safety, PatientsLikeMePatient 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 Before and After the Honeymoon: The Criticality of Process Implementation Design to the Success of Innovation

Sponsored by

Ronald S. Waife, MS, President and Founder, Waife & Associates, Inc.Innovation in Clinical Informatics is dependent on many factors coming together successfully, and the technical component is only one of them. Besides vision, creativity, energy and timing, successful execution of Informatics innovation in clinical research requires understanding the existing and desired operational context of new technologies, even if the goal is to disrupt it. Barriers to clinical research innovation are not necessarily typical to those in other industries. In our experience innovation fails because of the gap between ideas and execution – not execution of the technical solution but execution by the intended users for the intended advantage. This presentation covers common unanticipated barriers and how to overcome them.

3:15 Refreshment Break with Exhibit Viewing

Innovating Existing Clinical Trial Processes and Systems via New Tech Approaches

3:50 Re-Use of Electronic Health Records: The IMI EHR4CR ProjectJohann Proeve, Ph.D., Global Strategy and Development Advisor, Bayer Healthcare, Leverkusen, GermanyThe 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.

WEDNESDAY, MAY 6, 2015

FOCUSEDBREAKOUTSESSIONS4:20 Case Study: Merging EDC and CTMS without a Traditional Data WarehouseKesha Rodgers, Associate Director, Clinical Systems, BioMarinWhen 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 Maximizing Utilization of Claims/EHR during Clinical DevelopmentDevin Trejo, Director, Oncology Feasibility Lead, Development Operations, PfizerOpportunity exists to maximize the use of real-world patient data in order to incorporate into the clinical development process. Valuable insight can be gained by application of these data sets in order to realize cost and time savings while conducting quality clinical research. Successful utilization of these data sets have been used to optimize protocol design, minimize downstream amendments, improve the site identification process and enhance patient recruitment. This presentation will highlight case studies and discuss novel combinations of unique data sets in order to apply fact-based data to improve predictability, reduce time to reach clinical endpoints and target the correct patient population.

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 Visualization Tools for End Users across Clinical Development (Separate Registration Required)

7:30 am Morning Coffee

Case Studies: Using Existing Data Sources for Advancing Clinical Trials

8:00 Chairperson’s RemarksCatherine Marshall, Director, Information Strategy & Analytics, Clinical Informatics and Innovations, Pfizer

8:05 Banking Biospecimens for Exploratory ResearchCatherine Marshall, Director, Information Strategy & Analytics, Clinical Informatics and Innovations, PfizerMany 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 Clinical Trials Data-Sharing, Dissemination and Meta-Trial AnalysesSanchita Bhattacharya, Scientific Project Lead, ImmPort; Senior Bioinformatics Research Specialist, Division of Systems Medicine, Stanford University School of MedicineBroad 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 Clinical Trials & 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 The Yale Open Data Access (YODA) Project – An Academic-Industry Partnership towards Data TransparencyNihar Desai, M.D., MPH, Assistant Professor of Medicine, Cardiology, Yale School of MedicineThe talk will offer an overview of the push for data transparency broadly as well as the Yale Open Data Access Project specifically, which is an academic-industry project aimed at improving access to clinical trial data. The presentation will review results of the initial collaboration with Medtronic, Inc. as well as the recent announcements of partnerships with Johnson & Johnson/ Janssen.

12:00pm Close of Conference

Clinical Research Informatics World provides actionable takeaways to benefit those involved in:

• Clinical Trial Management• Clinical Operations• Data Analysis• Data Management • Clinical Trial Informatics• Clinical Research IT • Site Monitoring• Clinical Innovation• Patient Recruitment• Trial Design• Clinical Information Systems

WHO SHOULDATTEND?

THURSDAY, MAY 7, 2015

Companies A-KKatelin Fitzgerald Sr Business Development Manager 781-972-5458kfitzgerald@healthtech.com

Companies L-Z Elizabeth LemelinBusiness Development Manager781-972-1342elemelin@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 PresentationsOpportunity 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 SuiteSponsors 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

ExhibitExhibitors 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, Senior Solution Architect, Tamr

Timothy Swan, MS, PMP, Principal CDW Analyst, Clinical Data Sciences, Biogen

Balazs Flink, M.D., Global Development Analytics Lead, Bristol-Myers Squibb

Wednesday, May 6, 20156:30-9:00 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 WorldCambridge 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.

How to Register: www.ClinicalInformaticsWorld.comreg@healthtech.com • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288

Please use keycode 1571 F

when registering!

ADDITIONAL REGISTRATION DETAILSEach 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/regdetailsVideo and or audio recording of any kind is prohibited onsite at all CHI events.

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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.

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World 2015Conference

Clinical ResearchInformatics

PRICING AND REGISTRATION INFORMATIONAcademic, Government, Hospital AffiliatedCommercial

May 6 - 7, 2015 | Seaport Hotel | Boston, MA

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