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Accelerating Clinical Trials trough Multi-Stakeholder Collaborations

The World Congress Summit on Accelerating Clinical Trials focuses on collaboration among pharma, government, and research institutions to address clinical trial challenges. The event will feature discussions on innovative practices and data-sharing initiatives to enhance clinical trial efficiency and patient experience. It is scheduled for September 22-23, 2014, in Princeton, New Jersey, with opportunities for sponsorship and networking.

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To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com Kald Abdallah, MD, PhD Vice President Immunology - North America Medical Affairs Sanofi Barbara Bierer, MD Faculty Co-Director and Co-Chair, MRCT Executive Committee Senior Vice President, Research, Brigham & Women’s Hospital Professor of Medicine Harvard Medical School Cindy Geoghegan Chief Executive Officer Patient and Partners, LLC Sheryl Jacobs Vice President, Global Study Operations, Amgen Ülo Palm, MD, PhD, MBA Senior Vice President, Drug Development and Research Operations Forest Research Institute; Operations Committee Member TransCelerate BioPharma Jessica Scott, MD, JD Director, North America Medical Policy and Advocacy GlaxoSmithKline Ronit Simantov, MD Vice President and Head of Global Medical Affairs Pfizer Oncology featured speakers include : • Alliance for Clinical Research Excellence and Safety (ACRES) • Center for Information and Study on Clinical Research Participation (CISCRP) • Clinical Trials Transformation Initiative (CTTI) • Education Network to Advance Cancer Clinical Trials (ENACCT) • FasterCures • Multi-Regional Clinical Trials Center (MRCT) • Orion Bionetworks • Project Data Sphere • The Critical Path Institute • TransCelerate BioPharma S ave u p t o $ 3 0 0 i f y o u re g ister be f o re a u g u st 1 5 , 2 0 1 4 Join the Discussion and Get Involved with these Leading Clinical Research Initiatives: Supporting Organizations: TheWorldCongressSummiton AcceleratingClinicalTrials through Multi-StakeholderCollaborations CTTI • TransCelerate • Project Data Sphere • ACRES • C-Path • MRCT S e p t e m b e r 2 2 - 2 3 , 2 0 1 4 | T h e W e s t i n a t F o r r e s t a l V i l l a g e | P r i n c e t o n , N J Organized by:@wrldhealthcare #WCcollaboration
To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com CONSIDER A SPONSORSHIP PACKAGE • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site CAPTURE A TRUE ROI Through Sponsorship of the Following: Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks To inquire about Sponsorship, Exhibit, and Executive Networking Opportunities, Contact David Capobianco, Vice President, Business Development, World Congress • Call 781-939-2635 or email David.Capobianco@worldcongress.com Dear Colleague, In the past few years, pharma has made unprecedented moves as an industry to team up and collaborate with private, public, and government organizations in an effort to solve common clinical research challenges that never would have been a possibility a decade ago. Eliminating inefficiencies and standardizing processes, criteria, and templates, all while reducing the patient’s burden of participating in clinical trials, are initiatives actively being investigated across the industry and these efforts are beginning to pay-off with shortened timelines and lower costs. The World Congress Summit on Accelerating Clinical Trials through Multi-Stakeholder Collaborations offers the clinical research community a forum to share their work and an opportunity to build on collective knowledge and experiences in order to create safer, more efficient clinical trials. With so many initiatives underway, it can be easy to duplicate efforts and dilute the impact of change. Compare notes, join the discussion, and align your strategies with these leading clinical research initiatives: • Alliance for Clinical Research Excellence and Safety (ACRES) • Center for Information and Study on Clinical Research Participation (CISCRP) • Clinical Trials Transformation Initiative (CTTI) • Education Network to Advance Cancer Clinical Trials (ENACCT) • FasterCures • Multi-Regional Clinical Trials Center (MRCT) • Orion Bionetworks • Project Data Sphere • The Critical Path Institute • TransCelerate BioPharma If you are open to adopting new practices and committed to improving the clinical trial process, you don’t want to miss this Summit. I look forward to meeting you on September 22-23 in Princeton, New Jersey. Sincerely, Nancy Felsheim Conference Producer, Pharmaceutical Events Division World Congress P.S. Don’t forget about the team discount! Find out more about special group package discounts by calling 800-767-9499 or emailing wcreg@worldcongress.com Summit Objective: This conference offers delegates an in-depth view of the latest initiatives that are simplifying and improving the clinical trial experience for the patient through data-sharing and setting industry standards. Leading individuals from biopharma partnerships, alliances and other multi-stakeholder collaboratives come together to share the results and impact of their projects, as well as insights on areas ripe for future collaboration. The conference provides delegates with opportunities to learn from one another in regard to what works now and a forum to discuss how to leverage and build on collective experiences to advance innovation across the wider community. Who Should Attend: • Pharmaceutical industry — Clinical Research — Clinical Operations — Clinical Development — Clinical Innovation — Strategic Alliances — Research & Development — Strategic Projects • CROs • Government • Academic Medical Centers • Patient Advocacy Groups
DAY ONE – Monday, September 22, 2014 • Pre-Summit workshop 7:30 am – 8:30 am Workshop Registration and Morning Coffee 8:30 am – 11:45 am P r e - S u mm i t Wo r k s h o p Orion Bionetworks — An Open Innovation Alliance to Accelerate Research in Brain Disorders Orion Bionetworks is a Cooperative Alliance founded to accelerate time to cure for brain disorders by harnessing the power of big data and predictive analytics to build systems models of brain diseases, starting with multiple sclerosis and prodromal schizophrenia. The workshop functions as a forum for key stakeholders (i.e., the pharmaceutical and technology industries, academia, and patient advocacy organizations) to evaluate the role of systems biology and computational modeling in overcoming roadblocks and driving future progress in brain disorder research and treatment. Within the workshop, three sessions will be offered that focus on key approaches adopted by Orion Bionetworks to fill the Brain Disease Knowledge Gap by taking advantage of advances in computational science, bioinformatics, biomarkers and social media and integrating these platforms to develop refined models of disease. The agenda is as follows: I. Alliance Introduction & Quantifying Brain Health a. Orion Bionetworks: A Cooperative Alliance Model Magali Haas, MD, PhD, MSE, Founder and Chief Executive Officer, Orion Bionetworks b. Phenomics of Brain Health Gabriel Eichler, PhD, General Manager, PatientsLikeMe c. Patient Powered Networks Hollie Schmidt, MS, Vice President, Scientific Operations, Accelerated Cure Project for MS d. Panel Discussion with Audience Q&A Moderator: Julie Bryant, Chief Executive Officer, Rancho BioSciences II. Knowledge Engineering a. Extracting Knowledge through Visualization David King, Founder and Chief Executive Officer, Exaptive Inc. III. Systems Modeling and Computational Analytics a. Systems Modeling: Reinvented Iya Khalil PhD, Executive Vice President and Co-Founder, GNS Healthcare b. What Can Neuroscience Learn from a Worm? Stephen Larson, Chief Executive Officer, MetaCell c. Knowledge-Driven Big Data Analytics for MS Lee Lancashire, PhD, Bioinformatician, Thomson Reuters d. Panel Discussion with Audience Q&A Moderator: Keith Elliston, PhD, Chief Executive Officer, tranSMART Foundation President, Seneca Creek Research, Inc. Consulting Scientific Director, Orion Bionetworks For biographies on all the workshop presenters, please visit http://www.worldcongress.com/Collaboration Workshop Leader: Magali Haas, MD, PhD, MSE, Founder and Chief Executive Officer, Orion Bionetworks Dr. Haas is Founder and CEO of Orion Bionetworks. She also serves as Chief Science and Technology Officer for One Mind for Research, a nonprofit organization launched in May 2012, which seeks to advance the development of preventions and cures for brain disorders in this decade. Dr. Haas has over 15 years of pharmaceutical executive and clinical research experience, predominantly at Johnson & Johnson, where she assumed broad end-to-end development leadership roles in medical marketing, full clinical development, early development, and translational and biomarker sciences in psychiatry and neurology. As an “intrapreneur” at J&J she established the first NS Integrative Solutions department, and co-founded the first Companion Diagnostics Center of Excellence as well as the first Healthcare Innovation team. She serves on several advisory boards including the Irish Health Review Board, International Neuroinformatics Coordinating Facility, IMEC for nanoelectronics, and Guardian Angels for biosensors. Dr. Haas earned her bachelor of science degree in bioengineering from the University of Pennsylvania, a master of science degree in biomedical engineering from Rutgers University, New Jersey, and a medical degree and doctorate in neuroscience from Albert Einstein College of Medicine, New York. 11:45 am – 1:00 pm Lunch on Your Own/Main Summit Registration To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com Thereisa15minutecoffeeandnetworkingbreak from10:00am–10:15am
DAY ONE – Monday, September 22, 2014 • Main Summit agenda 1:00 pm – 1:15 pm Chairperson’s Welcome and Opening Remarks 1:15 pm – 1:45 pm How Can Collective Knowledge and Experiences be Leveraged for Next Gen Collaboration? This session discusses: • The barriers to multi-stakeholder collaboration • What can be done to put ideas into action • New models for innovation and collaboration that will emerge • What’s working now and can be applied across any multi-stakeholder collaboration Martha A. Brumfield, PhD President and Chief Executive Officer Critical Path Institute 1:45 pm – 2:45 pm Responsible Clinical Trials Data Sharing — Maximize the Benefits While Minimizing the Risks • Gain an understanding of the PhRMA and EFPIA joint Principles for Responsible Clinical Trial Data Sharing on a global basis and your ethical and legal responsibilities • Determine what’s confidential commercial information and what’s not, and what the procedures will be for providing and requesting data • Discuss barriers and challenges sharing results and clinical trial summaries with patients – What research results should be returned and how? • Evaluate methods for measuring the impact of data sharing Barbara Bierer, MD Faculty Co-Director and Co-Chair MRCT Executive Committee Senior Vice President, Research Brigham & Women’s Hospital Professor of Medicine Harvard Medical School Jessica Scott, MD, JD Director, North America Medical Policy and Advocacy GlaxoSmithKline Marcia Levenstein Vice President, Statistics Global Innovation, Pfizer Arti Rai, JD Elvin R. Latty Professor of Law Duke University School of Law 2:45 pm – 3:15 pm Networking and Refreshment Break 3:15 pm – 4:15 pm The Project Data Sphere Initiative — A New Data Sharing and Analytics Model for Cancer Research • Discuss the accomplishments and obstacles encountered when building a framework to share, integrate, and analyze collective cancer clinical trial data on one platform from the perspectives of a project lead, patient advocate, data provider, technology partner, and clinician * developing a proof of concept * securing executive management support on the benefits of providing datasets * privacy concerns and the sensitivity of the data issues • Learn how a series of research challenges will work starting with a prostate cancer-focused project to engage and stimulate the research community’s knowledge, expertise, and capabilities • Hear about planning for Phase 2 which will be based on feedback from the community and where they see value Kald Abdallah, MD, PhD Vice President Immunology - North America Medical Affairs Sanofi Cindy Geoghegan Chief Executive Officer Patient and Partners, LLC Robin Jenkins, MBA Project Lead, Project Data Sphere, LLC; Senior Director, Medical Affairs Innovation, Sanofi Ronit Simantov, MD Vice President and Head of Global Medical Affairs, Pfizer Oncology Gail Stephens Vice President SAS Health and Life Sciences 4:15 pm – 5:00 pm Clinical Trials Transformation Initiative — Advancing Central IRBs, IND Safety, and a Quality-by-Design Approach to Clinical Trial Operations This session outlines results and recommendations from CTTI projects that include: • Steps to remove barriers to the use of Central IRBs for multicenter clinical trials • Best practices that provide for greater oversight of safety for pre-market products consistent with the intent of the FDA IND Safety Rule • QbD Principles to implement in the clinical trials planning process Cynthia Hahn Vice President, Clinical Research North Shore-LIJ Health System Ann Meeker-O’Connell Senior Director, QA Clinical Strategy Team Lead Janssen Pamela Tenaerts, MD, MBA Executive Director Clinical Trials Transformation Initiative To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com
DAY ONE – Monday, September 22, 2014 (continued) 5:00 pm – 5:45 pm ROUNDTABLE DISCUSSION: Consortium Sandbox — Measure the Impact of a Consortium to Provide Maximum Value to Stakeholders Mark Lim will share FasterCures’ recent global findings on a research-by-consortium study that highlights trends from 369 multi-stakeholder consortia. One of the greatest challenges of any consortium is to determine if it’s on-track to realize its value proposition. Very few consortia have implemented some level of value assessment and one of the main reasons is that expectations are different depending on the specific stakeholder. This session will offer attendees an opportunity to explore and discuss ways that consortia can demonstrate and communicate the value of their partnership models in a small group, interactive format. Questions to be discussed: • Who are the stakeholders in a consortium? (government, industry, patients) What are each stakeholder’s expectation (what do they want to achieve through their participation/contribution)? • How can a consortium demonstrate that they are on-track for meeting each stakeholder’s ROI? What should they measure? How should they report? • What are the challenges for making these types of measurements? Roundtable Facilitators include: Mark D. Lim Associate Director, Medical Research Innovation FasterCures 5:45 pm – 6:45 pm Cocktail and Networking Reception DAY t wo – T u esday, S e p t em b e r 23, 20 1 4 7:30 am – 8:30 am Morning Coffee 8:30 am – 8:45 am Chairperson’s Welcome and Review of Day One 8:45 am – 9:45 am Lessons Learned from Pilot Studies on Risk-Based Monitoring Methodology to Ensure Data Quality • Insight into the FDA guidance on clinical trial oversight and its implications from a former FDA official • Utilize Functional Service Providers (FSP) for implementing RBM with a corresponding reduction in queries and cycle time • Discuss a TransCelerate approach to RBM methodology and one of the member’s views on two of the eight implementation pilots Ann Meeker-O’Connell Senior Director, QA Clinical Strategy Team Lead Janssen Sheryl Jacobs Vice President, Global Study Operations Amgen Reb Tayyabkhan Executive Director, Global Development Operations, Bristol-Myers Squibb Operations Committee Member and Work Stream Lead for Risk-Based Monitoring TransCelerate BioPharma 9:45 am – 10:30 am A Model to Create, Share, and Re-Use Structured Content throughout the Clinical Trial Life Cycle — The Sanofi-TransCelerate Collaboration • Improve the quality of clinical trial documentation • Speed the production of documentation through automation • Implement standards to facilitate re-use throughout the clinical trial life cycle for asthma and diabetes Joan Affleck Associate Vice President, Clinical Sciences and Operations Sanofi 10:30 am – 11:00 am Networking and Refreshment Break 11:00 am – 11:45 am Collaborative Efforts to Improve Cancer Clinical Trial Accrual for Under-Represented Populations • Increasing clinical trial participation among minority populations can lead to faster drug development and address disparities in care • Identify and remove accrual barriers related to ineffective pre-screening to enhance accrual (ENACCT National Cancer Clinical Trials Pilot Breakthrough Collaborative) • Implement new pre-screening/screening organizational processes prior to physician consultation Margo Michaels, MPH Principal, Health Access & Action Consulting; Adjunct Clinical Assistant Professor Boston University School of Public Health; Former Executive Director Education Network to Advance Cancer Clinical Trials (ENACCT) Karen Brooks Senior Director, Therapeutic Area Lead, Oncology and Early Phase Clinical Operations, Development Operations, Pfizer To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com
DAY t wo – T u esday, S e p t em b e r 23, 20 1 4 (continued) 11:45 am – 12:30 pm CISCRP Recommendations — Communicate Trial Results to Participants to Improve Experience and Build Support for the Clinical Research Enterprise • Results from implementation of the CISCRP program for Communicating Trial Results to Study Volunteers at several major biopharmaceutical companies • Considerations when implementing the program on a global scale • Compliance with the EMA legal requirement to post a summary of study results to the EMA database Zachary Hallinan Director of Patient Communication and Engagement Center for Information and Study on Clinical Research Participation (CISCRP) Joseph Kim Senior Advisor, Clinical Development Innovation Eli Lilly and Company 12:30 pm – 1:30 pm Luncheon 1:30 pm – 2:15 pm Increase the Productivity of Biomedical Research in Drug Development to Reduce Waste • Understand the magnitude of the reproducibility problem in biomedical research • Discuss the consistent use of quality standards for planning, conducting, and reporting scientific work • Evaluate the potential to expand the TransCelerate model to pre-clinical research including discovery Ülo Palm, MD, PhD, MBA Senior Vice President, Drug Development and Research Operations, Forest Research Institute Operations Committee Member, TransCelerate BioPharma 2:15 pm – 3:00 pm CLOSING KEYNOTE: Build a Global System for Safer, More Efficient Clinical Research — The ACRES Mega-Collaboration • Develop standards and processes with input from all stakeholders to recognize and reward outstanding research sites • Create an integrated IT platform for a global clinical research network to amplify the impact of technology by working together • Deploy innovative Smart Monitoring technology that utilizes sensors to improve risk management • Discuss what next gen collaboration will look like Greg Koski, PhD, MD Co-Founder and President / Chief Executive Officer, Alliance for Clinical Research Excellence and Safety Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital Associate Professor of Anesthesia, Harvard Medical School 3:00 pm Close of Summit To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com WH Y YO U S H O U L D S P O N S O R POSITION your company as a leading solutions and service provider MEET your market SHOWCASE new technology innovations INCREASE brand awareness GENERATE leads and new business DEVELOP new and current client relationships CONSIDER A SPONSORSHIP PACKAGE • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site CAPTURE A TRUE ROI Through Sponsorship of the Following: Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks To inquire about Sponsorship, Exhibit, and Executive Networking Opportunities, Contact David Capobianco, Vice President, Business Development, World Congress • Call 781-939-2635 or email David.Capobianco@worldcongress.com
Registration Fee: Register By 8/15/2014 Register By 9/22/2014pharma / biotech Conference $ 1295.00 $ 1595.00 Conference Plus 1 Workshop $ 1595.00 $ 1895.00 standard Conference $ 1895.00 $ 2195.00 Conference Plus 1 Workshop $ 2195.00 $ 2495.00 academic / Government / associations Conference $ 395.00 $ 495.00 Conference Plus 1 Workshop $ 495.00 $ 595.00 Fee for conference includes welcome coffee, lunch, reception, refreshments, and web-based conference documentation available pre- and post-event, accessible through password-protected website. Checks in U.S. funds drawn from U.S. bank payable to: WC Research Inc. No personal checks accepted. Verification may be required for rate approvals. Please contact us should you have any special needs. SPECIAL TEAM DISCOUNTS: With so much great content, you can’t possibly cover it alone. Sign up your team and save. Find out more about special group package discounts by calling 800-767-9499 or emailing wcreg@worldcongress.com. Participant Substitution and Cancellations: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 30 days prior to the start of the event will be refunded, less a $395 administrative charge. No refunds will be made after this date; however, the registration fee less the $395 administrative charge can be credited to another World Congress conference if you register within 6 months from the date of this conference. In case of conference cancellation, World Congress’ liability is limited to refund of the conference registration fee only. World Congress reserves the right to alter this program without prior notice. Satisfaction guaranteed: World Congress stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable World Congress conference of your choice. WEBSITE WorldCongress.com/ Collaboration Register Now! E-MAIL wcreg@worldcongress.com Best Value PRSRT STD U.S. Postage PAID Gallery World Congress 500 West Cummings Park, Suite 5200 Woburn, MA 01801 PB14014 Venue: The Westin Princeton at Forrestal Village 201 Village Blvd, Princeton, NJ 08540 (609) 452-7900 www.westinprinceton.com Room Rate: $159 • Cut-off Date: 8/22/14 Mention World Congress when booking to receive our special rate. PHONE 800-767-9499 • 781-939-2400 outside the U.S. S ave u p t o $ 3 0 0 i f y o u re g ister be f o re a u g u st 1 5 , 2 0 1 4 CTTI • TransCelerate • Project Data Sphere • ACRES • C-Path • MRCT TheWorldCongressSummiton AcceleratingClinicalTrials through Multi-StakeholderCollaborations S e p t e m b e r 2 2 - 2 3 , 2 0 1 4 | T h e W e s t i n a t F o r r e s t a l V i l l a g e | P r i n c e t o n , N J To Register, please visit www.worldcongress.com/collaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com • The only forum that convenes 10 leading alliances and collaborative partnerships in clinical research to build on collective knowledge and experience • A panel discussion format conducive to audience engagement and interaction • An opportunity to meet peers who are taking collective action to improve clinical trials for sponsors, sites and patients top reasons to attend:featured speakers include: Joan Affleck Associate Vice President, Clinical Sciences and Operations Sanofi Zachary Hallinan Director of Patient Communication and Engagement, Center for Information And Study on Clinical Research Participation (CISCRP) Greg Koski, PhD, MD Co-Founder, President, and Chief Executive Officer Alliance for Clinical Research Excellence and Safety Marcia Levenstein Vice President, Statistics Global Innovation Pfizer Reb Tayyabkhan Executive Director, Global Development Operations Bristol-Myers Squibb Operations Committee Member and Work Stream Lead for Risk-Based Monitoring TransCelerate BioPharma @wrldhealthcare #WCcollaboration

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Accelerating Clinical Trials trough Multi-Stakeholder Collaborations

  • 1.
    To register, pleasevisit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com Kald Abdallah, MD, PhD Vice President Immunology - North America Medical Affairs Sanofi Barbara Bierer, MD Faculty Co-Director and Co-Chair, MRCT Executive Committee Senior Vice President, Research, Brigham & Women’s Hospital Professor of Medicine Harvard Medical School Cindy Geoghegan Chief Executive Officer Patient and Partners, LLC Sheryl Jacobs Vice President, Global Study Operations, Amgen Ülo Palm, MD, PhD, MBA Senior Vice President, Drug Development and Research Operations Forest Research Institute; Operations Committee Member TransCelerate BioPharma Jessica Scott, MD, JD Director, North America Medical Policy and Advocacy GlaxoSmithKline Ronit Simantov, MD Vice President and Head of Global Medical Affairs Pfizer Oncology featured speakers include : • Alliance for Clinical Research Excellence and Safety (ACRES) • Center for Information and Study on Clinical Research Participation (CISCRP) • Clinical Trials Transformation Initiative (CTTI) • Education Network to Advance Cancer Clinical Trials (ENACCT) • FasterCures • Multi-Regional Clinical Trials Center (MRCT) • Orion Bionetworks • Project Data Sphere • The Critical Path Institute • TransCelerate BioPharma S ave u p t o $ 3 0 0 i f y o u re g ister be f o re a u g u st 1 5 , 2 0 1 4 Join the Discussion and Get Involved with these Leading Clinical Research Initiatives: Supporting Organizations: TheWorldCongressSummiton AcceleratingClinicalTrials through Multi-StakeholderCollaborations CTTI • TransCelerate • Project Data Sphere • ACRES • C-Path • MRCT S e p t e m b e r 2 2 - 2 3 , 2 0 1 4 | T h e W e s t i n a t F o r r e s t a l V i l l a g e | P r i n c e t o n , N J Organized by:@wrldhealthcare #WCcollaboration
  • 2.
    To register, pleasevisit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com CONSIDER A SPONSORSHIP PACKAGE • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site CAPTURE A TRUE ROI Through Sponsorship of the Following: Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks To inquire about Sponsorship, Exhibit, and Executive Networking Opportunities, Contact David Capobianco, Vice President, Business Development, World Congress • Call 781-939-2635 or email David.Capobianco@worldcongress.com Dear Colleague, In the past few years, pharma has made unprecedented moves as an industry to team up and collaborate with private, public, and government organizations in an effort to solve common clinical research challenges that never would have been a possibility a decade ago. Eliminating inefficiencies and standardizing processes, criteria, and templates, all while reducing the patient’s burden of participating in clinical trials, are initiatives actively being investigated across the industry and these efforts are beginning to pay-off with shortened timelines and lower costs. The World Congress Summit on Accelerating Clinical Trials through Multi-Stakeholder Collaborations offers the clinical research community a forum to share their work and an opportunity to build on collective knowledge and experiences in order to create safer, more efficient clinical trials. With so many initiatives underway, it can be easy to duplicate efforts and dilute the impact of change. Compare notes, join the discussion, and align your strategies with these leading clinical research initiatives: • Alliance for Clinical Research Excellence and Safety (ACRES) • Center for Information and Study on Clinical Research Participation (CISCRP) • Clinical Trials Transformation Initiative (CTTI) • Education Network to Advance Cancer Clinical Trials (ENACCT) • FasterCures • Multi-Regional Clinical Trials Center (MRCT) • Orion Bionetworks • Project Data Sphere • The Critical Path Institute • TransCelerate BioPharma If you are open to adopting new practices and committed to improving the clinical trial process, you don’t want to miss this Summit. I look forward to meeting you on September 22-23 in Princeton, New Jersey. Sincerely, Nancy Felsheim Conference Producer, Pharmaceutical Events Division World Congress P.S. Don’t forget about the team discount! Find out more about special group package discounts by calling 800-767-9499 or emailing wcreg@worldcongress.com Summit Objective: This conference offers delegates an in-depth view of the latest initiatives that are simplifying and improving the clinical trial experience for the patient through data-sharing and setting industry standards. Leading individuals from biopharma partnerships, alliances and other multi-stakeholder collaboratives come together to share the results and impact of their projects, as well as insights on areas ripe for future collaboration. The conference provides delegates with opportunities to learn from one another in regard to what works now and a forum to discuss how to leverage and build on collective experiences to advance innovation across the wider community. Who Should Attend: • Pharmaceutical industry — Clinical Research — Clinical Operations — Clinical Development — Clinical Innovation — Strategic Alliances — Research & Development — Strategic Projects • CROs • Government • Academic Medical Centers • Patient Advocacy Groups
  • 3.
    DAY ONE –Monday, September 22, 2014 • Pre-Summit workshop 7:30 am – 8:30 am Workshop Registration and Morning Coffee 8:30 am – 11:45 am P r e - S u mm i t Wo r k s h o p Orion Bionetworks — An Open Innovation Alliance to Accelerate Research in Brain Disorders Orion Bionetworks is a Cooperative Alliance founded to accelerate time to cure for brain disorders by harnessing the power of big data and predictive analytics to build systems models of brain diseases, starting with multiple sclerosis and prodromal schizophrenia. The workshop functions as a forum for key stakeholders (i.e., the pharmaceutical and technology industries, academia, and patient advocacy organizations) to evaluate the role of systems biology and computational modeling in overcoming roadblocks and driving future progress in brain disorder research and treatment. Within the workshop, three sessions will be offered that focus on key approaches adopted by Orion Bionetworks to fill the Brain Disease Knowledge Gap by taking advantage of advances in computational science, bioinformatics, biomarkers and social media and integrating these platforms to develop refined models of disease. The agenda is as follows: I. Alliance Introduction & Quantifying Brain Health a. Orion Bionetworks: A Cooperative Alliance Model Magali Haas, MD, PhD, MSE, Founder and Chief Executive Officer, Orion Bionetworks b. Phenomics of Brain Health Gabriel Eichler, PhD, General Manager, PatientsLikeMe c. Patient Powered Networks Hollie Schmidt, MS, Vice President, Scientific Operations, Accelerated Cure Project for MS d. Panel Discussion with Audience Q&A Moderator: Julie Bryant, Chief Executive Officer, Rancho BioSciences II. Knowledge Engineering a. Extracting Knowledge through Visualization David King, Founder and Chief Executive Officer, Exaptive Inc. III. Systems Modeling and Computational Analytics a. Systems Modeling: Reinvented Iya Khalil PhD, Executive Vice President and Co-Founder, GNS Healthcare b. What Can Neuroscience Learn from a Worm? Stephen Larson, Chief Executive Officer, MetaCell c. Knowledge-Driven Big Data Analytics for MS Lee Lancashire, PhD, Bioinformatician, Thomson Reuters d. Panel Discussion with Audience Q&A Moderator: Keith Elliston, PhD, Chief Executive Officer, tranSMART Foundation President, Seneca Creek Research, Inc. Consulting Scientific Director, Orion Bionetworks For biographies on all the workshop presenters, please visit http://www.worldcongress.com/Collaboration Workshop Leader: Magali Haas, MD, PhD, MSE, Founder and Chief Executive Officer, Orion Bionetworks Dr. Haas is Founder and CEO of Orion Bionetworks. She also serves as Chief Science and Technology Officer for One Mind for Research, a nonprofit organization launched in May 2012, which seeks to advance the development of preventions and cures for brain disorders in this decade. Dr. Haas has over 15 years of pharmaceutical executive and clinical research experience, predominantly at Johnson & Johnson, where she assumed broad end-to-end development leadership roles in medical marketing, full clinical development, early development, and translational and biomarker sciences in psychiatry and neurology. As an “intrapreneur” at J&J she established the first NS Integrative Solutions department, and co-founded the first Companion Diagnostics Center of Excellence as well as the first Healthcare Innovation team. She serves on several advisory boards including the Irish Health Review Board, International Neuroinformatics Coordinating Facility, IMEC for nanoelectronics, and Guardian Angels for biosensors. Dr. Haas earned her bachelor of science degree in bioengineering from the University of Pennsylvania, a master of science degree in biomedical engineering from Rutgers University, New Jersey, and a medical degree and doctorate in neuroscience from Albert Einstein College of Medicine, New York. 11:45 am – 1:00 pm Lunch on Your Own/Main Summit Registration To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com Thereisa15minutecoffeeandnetworkingbreak from10:00am–10:15am
  • 4.
    DAY ONE –Monday, September 22, 2014 • Main Summit agenda 1:00 pm – 1:15 pm Chairperson’s Welcome and Opening Remarks 1:15 pm – 1:45 pm How Can Collective Knowledge and Experiences be Leveraged for Next Gen Collaboration? This session discusses: • The barriers to multi-stakeholder collaboration • What can be done to put ideas into action • New models for innovation and collaboration that will emerge • What’s working now and can be applied across any multi-stakeholder collaboration Martha A. Brumfield, PhD President and Chief Executive Officer Critical Path Institute 1:45 pm – 2:45 pm Responsible Clinical Trials Data Sharing — Maximize the Benefits While Minimizing the Risks • Gain an understanding of the PhRMA and EFPIA joint Principles for Responsible Clinical Trial Data Sharing on a global basis and your ethical and legal responsibilities • Determine what’s confidential commercial information and what’s not, and what the procedures will be for providing and requesting data • Discuss barriers and challenges sharing results and clinical trial summaries with patients – What research results should be returned and how? • Evaluate methods for measuring the impact of data sharing Barbara Bierer, MD Faculty Co-Director and Co-Chair MRCT Executive Committee Senior Vice President, Research Brigham & Women’s Hospital Professor of Medicine Harvard Medical School Jessica Scott, MD, JD Director, North America Medical Policy and Advocacy GlaxoSmithKline Marcia Levenstein Vice President, Statistics Global Innovation, Pfizer Arti Rai, JD Elvin R. Latty Professor of Law Duke University School of Law 2:45 pm – 3:15 pm Networking and Refreshment Break 3:15 pm – 4:15 pm The Project Data Sphere Initiative — A New Data Sharing and Analytics Model for Cancer Research • Discuss the accomplishments and obstacles encountered when building a framework to share, integrate, and analyze collective cancer clinical trial data on one platform from the perspectives of a project lead, patient advocate, data provider, technology partner, and clinician * developing a proof of concept * securing executive management support on the benefits of providing datasets * privacy concerns and the sensitivity of the data issues • Learn how a series of research challenges will work starting with a prostate cancer-focused project to engage and stimulate the research community’s knowledge, expertise, and capabilities • Hear about planning for Phase 2 which will be based on feedback from the community and where they see value Kald Abdallah, MD, PhD Vice President Immunology - North America Medical Affairs Sanofi Cindy Geoghegan Chief Executive Officer Patient and Partners, LLC Robin Jenkins, MBA Project Lead, Project Data Sphere, LLC; Senior Director, Medical Affairs Innovation, Sanofi Ronit Simantov, MD Vice President and Head of Global Medical Affairs, Pfizer Oncology Gail Stephens Vice President SAS Health and Life Sciences 4:15 pm – 5:00 pm Clinical Trials Transformation Initiative — Advancing Central IRBs, IND Safety, and a Quality-by-Design Approach to Clinical Trial Operations This session outlines results and recommendations from CTTI projects that include: • Steps to remove barriers to the use of Central IRBs for multicenter clinical trials • Best practices that provide for greater oversight of safety for pre-market products consistent with the intent of the FDA IND Safety Rule • QbD Principles to implement in the clinical trials planning process Cynthia Hahn Vice President, Clinical Research North Shore-LIJ Health System Ann Meeker-O’Connell Senior Director, QA Clinical Strategy Team Lead Janssen Pamela Tenaerts, MD, MBA Executive Director Clinical Trials Transformation Initiative To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com
  • 5.
    DAY ONE –Monday, September 22, 2014 (continued) 5:00 pm – 5:45 pm ROUNDTABLE DISCUSSION: Consortium Sandbox — Measure the Impact of a Consortium to Provide Maximum Value to Stakeholders Mark Lim will share FasterCures’ recent global findings on a research-by-consortium study that highlights trends from 369 multi-stakeholder consortia. One of the greatest challenges of any consortium is to determine if it’s on-track to realize its value proposition. Very few consortia have implemented some level of value assessment and one of the main reasons is that expectations are different depending on the specific stakeholder. This session will offer attendees an opportunity to explore and discuss ways that consortia can demonstrate and communicate the value of their partnership models in a small group, interactive format. Questions to be discussed: • Who are the stakeholders in a consortium? (government, industry, patients) What are each stakeholder’s expectation (what do they want to achieve through their participation/contribution)? • How can a consortium demonstrate that they are on-track for meeting each stakeholder’s ROI? What should they measure? How should they report? • What are the challenges for making these types of measurements? Roundtable Facilitators include: Mark D. Lim Associate Director, Medical Research Innovation FasterCures 5:45 pm – 6:45 pm Cocktail and Networking Reception DAY t wo – T u esday, S e p t em b e r 23, 20 1 4 7:30 am – 8:30 am Morning Coffee 8:30 am – 8:45 am Chairperson’s Welcome and Review of Day One 8:45 am – 9:45 am Lessons Learned from Pilot Studies on Risk-Based Monitoring Methodology to Ensure Data Quality • Insight into the FDA guidance on clinical trial oversight and its implications from a former FDA official • Utilize Functional Service Providers (FSP) for implementing RBM with a corresponding reduction in queries and cycle time • Discuss a TransCelerate approach to RBM methodology and one of the member’s views on two of the eight implementation pilots Ann Meeker-O’Connell Senior Director, QA Clinical Strategy Team Lead Janssen Sheryl Jacobs Vice President, Global Study Operations Amgen Reb Tayyabkhan Executive Director, Global Development Operations, Bristol-Myers Squibb Operations Committee Member and Work Stream Lead for Risk-Based Monitoring TransCelerate BioPharma 9:45 am – 10:30 am A Model to Create, Share, and Re-Use Structured Content throughout the Clinical Trial Life Cycle — The Sanofi-TransCelerate Collaboration • Improve the quality of clinical trial documentation • Speed the production of documentation through automation • Implement standards to facilitate re-use throughout the clinical trial life cycle for asthma and diabetes Joan Affleck Associate Vice President, Clinical Sciences and Operations Sanofi 10:30 am – 11:00 am Networking and Refreshment Break 11:00 am – 11:45 am Collaborative Efforts to Improve Cancer Clinical Trial Accrual for Under-Represented Populations • Increasing clinical trial participation among minority populations can lead to faster drug development and address disparities in care • Identify and remove accrual barriers related to ineffective pre-screening to enhance accrual (ENACCT National Cancer Clinical Trials Pilot Breakthrough Collaborative) • Implement new pre-screening/screening organizational processes prior to physician consultation Margo Michaels, MPH Principal, Health Access & Action Consulting; Adjunct Clinical Assistant Professor Boston University School of Public Health; Former Executive Director Education Network to Advance Cancer Clinical Trials (ENACCT) Karen Brooks Senior Director, Therapeutic Area Lead, Oncology and Early Phase Clinical Operations, Development Operations, Pfizer To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com
  • 6.
    DAY t wo– T u esday, S e p t em b e r 23, 20 1 4 (continued) 11:45 am – 12:30 pm CISCRP Recommendations — Communicate Trial Results to Participants to Improve Experience and Build Support for the Clinical Research Enterprise • Results from implementation of the CISCRP program for Communicating Trial Results to Study Volunteers at several major biopharmaceutical companies • Considerations when implementing the program on a global scale • Compliance with the EMA legal requirement to post a summary of study results to the EMA database Zachary Hallinan Director of Patient Communication and Engagement Center for Information and Study on Clinical Research Participation (CISCRP) Joseph Kim Senior Advisor, Clinical Development Innovation Eli Lilly and Company 12:30 pm – 1:30 pm Luncheon 1:30 pm – 2:15 pm Increase the Productivity of Biomedical Research in Drug Development to Reduce Waste • Understand the magnitude of the reproducibility problem in biomedical research • Discuss the consistent use of quality standards for planning, conducting, and reporting scientific work • Evaluate the potential to expand the TransCelerate model to pre-clinical research including discovery Ülo Palm, MD, PhD, MBA Senior Vice President, Drug Development and Research Operations, Forest Research Institute Operations Committee Member, TransCelerate BioPharma 2:15 pm – 3:00 pm CLOSING KEYNOTE: Build a Global System for Safer, More Efficient Clinical Research — The ACRES Mega-Collaboration • Develop standards and processes with input from all stakeholders to recognize and reward outstanding research sites • Create an integrated IT platform for a global clinical research network to amplify the impact of technology by working together • Deploy innovative Smart Monitoring technology that utilizes sensors to improve risk management • Discuss what next gen collaboration will look like Greg Koski, PhD, MD Co-Founder and President / Chief Executive Officer, Alliance for Clinical Research Excellence and Safety Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital Associate Professor of Anesthesia, Harvard Medical School 3:00 pm Close of Summit To register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.comTo register, please visit www.worldcongress.comCollaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com WH Y YO U S H O U L D S P O N S O R POSITION your company as a leading solutions and service provider MEET your market SHOWCASE new technology innovations INCREASE brand awareness GENERATE leads and new business DEVELOP new and current client relationships CONSIDER A SPONSORSHIP PACKAGE • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site CAPTURE A TRUE ROI Through Sponsorship of the Following: Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks To inquire about Sponsorship, Exhibit, and Executive Networking Opportunities, Contact David Capobianco, Vice President, Business Development, World Congress • Call 781-939-2635 or email David.Capobianco@worldcongress.com
  • 7.
    Registration Fee: RegisterBy 8/15/2014 Register By 9/22/2014pharma / biotech Conference $ 1295.00 $ 1595.00 Conference Plus 1 Workshop $ 1595.00 $ 1895.00 standard Conference $ 1895.00 $ 2195.00 Conference Plus 1 Workshop $ 2195.00 $ 2495.00 academic / Government / associations Conference $ 395.00 $ 495.00 Conference Plus 1 Workshop $ 495.00 $ 595.00 Fee for conference includes welcome coffee, lunch, reception, refreshments, and web-based conference documentation available pre- and post-event, accessible through password-protected website. Checks in U.S. funds drawn from U.S. bank payable to: WC Research Inc. No personal checks accepted. Verification may be required for rate approvals. Please contact us should you have any special needs. SPECIAL TEAM DISCOUNTS: With so much great content, you can’t possibly cover it alone. Sign up your team and save. Find out more about special group package discounts by calling 800-767-9499 or emailing wcreg@worldcongress.com. Participant Substitution and Cancellations: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 30 days prior to the start of the event will be refunded, less a $395 administrative charge. No refunds will be made after this date; however, the registration fee less the $395 administrative charge can be credited to another World Congress conference if you register within 6 months from the date of this conference. In case of conference cancellation, World Congress’ liability is limited to refund of the conference registration fee only. World Congress reserves the right to alter this program without prior notice. Satisfaction guaranteed: World Congress stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable World Congress conference of your choice. WEBSITE WorldCongress.com/ Collaboration Register Now! E-MAIL wcreg@worldcongress.com Best Value PRSRT STD U.S. Postage PAID Gallery World Congress 500 West Cummings Park, Suite 5200 Woburn, MA 01801 PB14014 Venue: The Westin Princeton at Forrestal Village 201 Village Blvd, Princeton, NJ 08540 (609) 452-7900 www.westinprinceton.com Room Rate: $159 • Cut-off Date: 8/22/14 Mention World Congress when booking to receive our special rate. PHONE 800-767-9499 • 781-939-2400 outside the U.S. S ave u p t o $ 3 0 0 i f y o u re g ister be f o re a u g u st 1 5 , 2 0 1 4 CTTI • TransCelerate • Project Data Sphere • ACRES • C-Path • MRCT TheWorldCongressSummiton AcceleratingClinicalTrials through Multi-StakeholderCollaborations S e p t e m b e r 2 2 - 2 3 , 2 0 1 4 | T h e W e s t i n a t F o r r e s t a l V i l l a g e | P r i n c e t o n , N J To Register, please visit www.worldcongress.com/collaboration • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com • The only forum that convenes 10 leading alliances and collaborative partnerships in clinical research to build on collective knowledge and experience • A panel discussion format conducive to audience engagement and interaction • An opportunity to meet peers who are taking collective action to improve clinical trials for sponsors, sites and patients top reasons to attend:featured speakers include: Joan Affleck Associate Vice President, Clinical Sciences and Operations Sanofi Zachary Hallinan Director of Patient Communication and Engagement, Center for Information And Study on Clinical Research Participation (CISCRP) Greg Koski, PhD, MD Co-Founder, President, and Chief Executive Officer Alliance for Clinical Research Excellence and Safety Marcia Levenstein Vice President, Statistics Global Innovation Pfizer Reb Tayyabkhan Executive Director, Global Development Operations Bristol-Myers Squibb Operations Committee Member and Work Stream Lead for Risk-Based Monitoring TransCelerate BioPharma @wrldhealthcare #WCcollaboration