Real-World Data & Life Science Analytics Congress

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1 25 th -26 th October 2018, Boston Real-World Data & Life Science Analytics Congress Event Overview As healthcare organizations move forward into the bold new world of value-based payments, they need to jump into advanced analytics to reduce inefficiencies, focus on quality and improve clinical performance. However, the uncertainty of where to start, which experts to trust, how to meaningfully use analytics and what tools to use are some of the critical challenges that persist. On the other hand, the use of real-world evidence (RWE) by clinicians and drug manufacturers is rapidly unfolding as it has the potential to provide renewed insights into treatment decisions. Drug manufacturers are now expanding their use of RWE through risk contracting with payers, in drug discovery, and to identify unmet therapy needs. It is also coming into play in pharma s health economics and outcomes research. The 21st Century Cures Act requires the FDA to develop a program for incorporating RWE into its activities but since RWE is relatively new it has its own real-world challenges. How exactly will it fit into the complicated world of drug testing, approval, regulation, and marketing is uncertain. Two of the most important reservations for RWE being study design and analytics, there is a need to overcome significant biases w.r.t. raw data that can make its rendering into evidence difficult. Our aim at the Real-World Data & Life Science Analytics Congress is to bring these two worlds together to understand how to leverage traditional data sets and layer that in with RWE and the operating models for both. events.marketsandmarkets.com

2 At the congress, you will meet Pharma, Bio-pharma, Payers, regulators, hospitals, insurance companies Head of informatics Chief Information Officer Chief Medical Officer Brand strategists Marketing Corporate strategy departments Computational Biologist Computational Chemistry Informatics Scientific Computing R&D and IT We seek to cover Future of Real World Evidence Fit-for-Purpose Evidence Robotics and Artificial Intelligence Use of Data & Technology Use of Repeated Health Measures Integrating Everyday Data into Decision Making AI and machine learning in RWE Implementing RWE research Institutionalizing RWE and RWD across your organization Real-World Data and Analytics Unlocking the Patient Journey Through RWE Advisory Panel Rachel Twardowski,Senior Manager, Specialty Analytics and Reporting, Specialty Decision Support and Reporting, Takeda Pharmaceuticals U.S.A., Inc. Jessica Smith, Vice President, Healthcare Analytics & Risk Adjustment Solutions, Gorman Health Group, Florida John Picconne, Principal, ZS Associates, Philadelphia Rolin (Ron) Wade, Senior Principal, Real World Evidence, HEOR, IMS Health, Greater New York City Area Jeff Messer, Director, Analytics, GSK, Boston Mary Jo, Senior Research Fellow, Tufts University, Boston Tom Haskell, Global Head of Data Analytics, Kantar Health, Philadelphia Josh Ransom, Head of Clinical Products, SHYFT Analytics, Boston

3 Meet our ESTEEMED SPEAKERS Shailendra Singh (Shelly) COO MarketsandMarkets Pvt. Ltd. Christopher Boone Vice President, Real World Data & Analytics Center of Excellence, Patient & Health Impact Pfizer Inc, New York Prasun Mishra Founder and CEO Agility Pharmaceuticals, San Fransisco Sebastian Schneeweiss Professor of Medicine and Epidemiology, Harvard Medical School, Vice Chief, Division of Pharmacoepidemiology, Department of Medicine Brigham and Women s Hospital, Boston Rachel Twardowski Senior Manager, Pharmaceutical Data Analytics, Takeda, Greater Chicago Area Kevin Haynes Director of Clinical Epidemiology HealthCore, Inc., Philadelphia Jesse Fishman Associate Director, Population Health Research-Real World Value & Evidence, Janssen Pharmaceuticals, Georgia Tom Haskell Global Head of Data Analytics Kantar Health, Greater Philadelphia Area Andrew Rosner Vice President, Real-World & Late Phase Syneos Health, Canada Robert Zambon Real World Innovation Lead, Janssen Scientific Affairs, LLC, Philadelphiav Peter Henstock Senior Manager Tech Analyst, Pfizer, Boston Tom Davis Principal Consultant End-to-End Analytics, Boston Julie Locklear Managing Director Genesis Research, New Jersey Amine Ouazzani Associate Director, Data strategy and analytics Bristol-Myers Squibb, New Jersey Oksana KaidanovichBeilin Evidence Generation Manager Takeda, Canada Nneka Onwudiwe Senior Scientific Reviewer FDA and Founder and CEO PECA LLC., Maryland John Piccone Principal ZS Associates, Philadelphia Vijay Mohan VP Strategy, Products, and Customer Success RxDataScience, Inc., North Carolina Qin Ye, MD, MS Associate Principal, ZS Associates Princeton, N.J. Lou Brooks Vice President, Commercial Analytics Optum, Rhode Island Daniel Weinstein CEO Oshi Health, New York

4 Meet our ESTEEMED SPEAKERS Slava Akmaev Chief Analytics Officer, Senior VP BergHealth, Massachusetts Gillis Carrigan Principal Data Scientist, RWD Oncology Genentech, San Francisco Naomi Sacks Director, Evidence Strategy and Generation Precision Xtract, Boston Dana Teltsch Director of Science Aetion Inc., Boston Stephanie Reisinger VP of Life Sciences, Data and Analytics Allscript, San Fransisco Eric Schultz President Cota, Inc., New York Ajay Khanna Founder and CEO Tellius, Washington D.C. Media Partner

5 Gold sponsor Silver Sponsors Sponsors/Exhibitors

6 AGENDA 2018 DAY 01 25th October Thursday 08:00 Registration and Coffee 08:40 Welcome note by MarketsandMarkets 08:45 Shailendra Singh (Shelly), COO, MarketsandMarkets Pvt. Ltd. 08:55 Opening remarks by the chair Chair: Christopher Boone, Vice President, Real World Data & Analytics Center of Excellence, Patient & Health Impact, Pfizer Inc, New York 09:00 Key note address I: Institutionalizing real-world evidence and real-world data across your organization Defining key components of a RWD strategy and governance structure that aligns with organizational goals and priorities Identifying enablers and barriers to build a real-world insight-driven culture Assessing the readiness and effectiveness for institutionalizing real-world data across the organization Christopher Boone, Vice President, Real World Data & Analytics Center of Excellence, Patient & Health Impact, Pfizer Inc, New York 9:30 Panel discussion: Bringing two worlds together Sciences of epidemiology, biostatics, outcomes research with analytics, machine learning and big data Moderator: -Dana Teltsch, Director of Science, Aetion Inc., Boston -Rachel Twardowski, Senior Manager, Specialty Analytics and Reporting, Specialty Decision Support and Reporting, Takeda Pharmaceuticals U.S.A., Inc -Tom Haskell, Global Head of Data Analytics, Kantar Health, Philadelphia -Robert Zambon, Real World Innovation Lead, Janssen Scientific Affairs, LLC, Philadelphia -Kevin Haynes, Director of Clinical Epidemiology, HealthCore, Inc., Philadelphia 10:00 TBA Julie Locklear, Managing Director, Genesis Research, New Jersey 10:30 Role of Real World Data in improving the lives of patients Making every patient journey count Deriving precise longitudinal patient records combining clinical, genomics and cost Using a proprietary method of classifying patients to enable meaningful analytics Eric Schultz, President, Cota, Inc., New York 10:45 Morning refreshments One to one meetings Networking break 11:35 Use of Real World Data to Understand Burden of Disease This talk will discuss use of large commercial and Medicare claims data sets, electronic health records, and qualitative analyses to evaluate the burden of disease. Case studies include examples of estimating: Healthcare costs and use associated with a difficult-to-diagnose cardiac rhythm disorder (claims data); Healthcare resource use associated with advanced Type 2 Diabetes (EMR data); Prevalence of a rare, autoimmune disorder (claims data, EMR data, qualitative analyses) Naomi Sacks, Director, Evidence Strategy and Generation, Precision Xtract, Boston 11:50 Planning for the Life Sciences: Applying Analytics We will summarize important supply chain planning challenges facing life sciences firms We will describe how to overcome the challenges by combining analytics, technology, and sound business practice We will share cases illustrating how data can be effectively used to improve decision making Tom Davis, Principal Consultant, End-to-End Analytics, Boston 12:20 Applying AI-driven analytics to life sciences and real world data Accelerating time to market with intelligent analytics Using automated machine learning to discover insights from vast amounts of clinical, marketing, and operational data Simplifying use of real world data with unified data preparation and natural language search Ajay Khanna, Founder and CEO, Tellius, Washington D.C.

7 AGENDA 2018 DAY 01 25th October Thursday 12:50 Lunch One to one meetings Networking break REAL WORLD DATA Chair: Rachel Twardowski, Senior Manager, Specialty Analytics and Reporting, Specialty Decision Support and Reporting, Takeda Pharmaceuticals U.S.A., Inc 14:00 Unlocking the Patient Journey Through Real World Evidence Real World Evidence data allows for the development of a longitudinal patient journey The identification of patient diagnosis, line of therapy and patient outcomes can be used to identify new patient segments to target or optimal uses for therapy Rachel Twardowski, Senior Manager, Specialty Analytics and Reporting, Specialty Decision Support and Reporting, Takeda Pharmaceuticals U.S.A., Inc 14:30 From real world data to insight, what s holding us back? From development to market, companies are infusing data into decision making process Payers, HCPs, and Regulator are increasingly looking at RWE to inform product selection, usage, and reimbursement decisions Although investments in data and technology are accelerating, industry has yet to realize the full potential of RWD. John Picconne, Principal, ZS Associates, Philadelphia Qin Ye, MD, MS, Associate Principal, Princeton, N.J. 15:00 Operating model for real world evidence and analytics Role of data standards Provenance of data in EMRs Strategies for linking data sets Privacy issues Stephanie Reisinger, VP of Life Sciences, Data and Analytics, Allscript, San Fransisco 15:50 Collection of real world patient data through digital health: the key to personalized treatments Many diseases are characterized by an individualized nature, (e.g., cancer, asthma, Inflammatory Bowel Disease), where symptoms and treatment response vary from patient to patient There are new digital health tools to that collect real-world patient data, including symptoms, medication adherence, lifestyle factors The insights collected from such real-world data sets will power a new era of personalized medicine Daniel Weinstein, CEO, Oshi Health, New York ANALYTICS Chair: Robert Zambon, Real World Innovation Lead, Janssen Scientific Affairs, LLC, Philadelphia 14:00 Case Study- Effective use of Real World Data Analytics across the Life Cycle: Data, Analytics, People, Organizations Strategic use of RWD analytics Pipeline discussions, trial planning, market access preparation, value-based contracting, secondary approvals and regulatory responses Sebastian Schneeweiss, Professor of Medicine and Epidemiology, Harvard Medical School, Vice Chief, Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women s Hospital, Boston 14:30 Using EHR as external controls for single arm ansclc clinical trials Single arm Phase 1B oncology trials are becoming more common in drug development Interpretation of these early phase single arm oncology trials can be challenging due to a lack of internal comparator External control arms derived from Electronic Health Records (EHR) may provide a way to contextualize early phase single arm oncology trials Gillis Carrigan, Principal Data Scientist, RWD Oncology, Genentech, San Francisco 15:00 Linking Data to Better Understand the Patient as a Person Methods for linking and how it drives patient centricity Case studies on how linking clinical and patient reported outcomes drives new insights The future of linking globally Tom Haskell, Global Head of Data Analytics, Kantar Health, Philadelphia 15:50 AI and machine learning in RWE and population management AI has been widely used in healthcare. The opportunity awaits in RWE Can we drive true precision medicine approaches based on post-market RWE? What about evidence for value-based care? Slava Akmaev, Chief Analytics Officer, Senior VP BergHealth, Massachusetts

8 AGENDA 2018 DAY 01 25th October Thursday REAL WORLD DATA ANALYTICS 16:30 Challenges of integrating AI into drug discovery Potential for AI within pharma Why AI isn t yet mainstream in the industry Path forward with AI Peter Henstock, Senior Manager Tech Analyst, Pfizer, Boston 17:00 Data Science Applied to Real World Data Data Science Overview & Vision RWD/RWE Case Study Strategy and Implementation Considerations Vijay Mohan, VP Strategy, Products, and Customer Success, RxDataScience, Inc., North Carolina 15:45 Afternoon refreshments One to one meetings Networking break 16:30 PCORnet Health Plan Research Network, providing real-world data for real-world evidence Discuss the impact of health plan enrollment in a large pragmatic clinical trial demonstration project within PCORnet (ADAPTABLE Outline the utility of administrative data to longitudinally obtain outcomes across health systems Highlight data expansion opportunities to integrate clinical data with claims data Kevin Haynes, Director of Clinical Epidemiology, HealthCore, Inc., Philadelphia 17:00 Real World Data: Integrating Everyday Data into Decision Making How emerging data types (e.g., mhealth) and analytics (e.g., machine learning) are changing the way real world data is used Real world data and evidence is now playing a key role in decisions across organizations - it s not just HEOR anymore Capabilities that leverage RWD are expanding across the enterprise sales, marketing, analytics, data science, IT, etc., are all beginning to touch RWD and need support in understanding and using it appropriately. Robert Zambon, Real World Innovation Lead, Janssen Scientific Affairs, LLC, Philadelphia 17:30 Closing remarks by the chair 17:30 Closing remarks by the chair Drinks Reception End of Day 1

9 AGENDA 2018 DAY 02 26th October Friday 08:00 Registration and Coffee 08:45 Welcome note by MarketsandMarkets 08:50 Opening remarks by the chair Oksana Kaidanovich-Beilin, Evidence Generation Manager, Takeda, Canada 09:00 Future of Real World Evidence: we in RWE Outlining current gaps (perception about RWE) How to establish scientifically relevant and valuable projects (patient-focused and technologically innovative) Focusing on brining value to external stakeholders through RWE (building trust) Oksana Kaidanovich-Beilin, Evidence Generation Manager, Takeda, Canada 09:30 Real-World Data and Analytics: Innovative approaches to accelerate Precision Oncology clinical trials The promise of Precision Oncology Operational challenges and opportunities of Precision Oncology clinical trials Leveraging RWD and Analytics to support study design, site selection and patient enrollment Amine Ouazzani, Associate Director, Data strategy and analytics, Bristol-Myers Squibb, New Jersey 10:00 Panel discussion: Value and Value frameworks -Nneka C. Onwudiwe, Senior Scientific Reviewer FDA and Founder and CEO, PECA LLC., Maryland -Prasun Mishra, Founder and CEO, Agility Pharmaceuticals, San Francisco -Jesse Fishman, Associate Director, Population Health Research-Real World Value & Evidence, Janssen Pharmaceuticals, Georgia -Amine Ouazzani, Associate Director, Data strategy and analytics, Bristol-Myers Squibb, New Jersey 10:30 The Use of Repeated Health Measures to Better Understand the Patient Journey Learn how to achieve increased collaboration and value among stakeholders by understanding the patient journey from different perspectives See how the use of data from the practice of medicine rather than the billing of healthcare can enable greater engagement across stakeholders Develop an understanding of the growth of healthcare data from alternative sources and how it can power new and existing models Lou Brooks, Vice President, Commercial Analytics, Optum, Rhode Island 10:45 Morning refreshments One to one meetings Networking break 11:30 Optimizing Real World Research Through the Use of Data & Technology Real world data and insights and its use to inform study design and protocol development Addressing the pain points of site and patient identification and recruitment using data enabled approaches Leveraging fit-for-purpose technology to minimize site burden and drive towards efficient study execution Andrew Rosner, Vice President, Real-World & Late Phase, Syneos Health, Canada 12:00 Generating Fit-for-Purpose Evidence along a Medical Product Life-cycle Understand the current landscape for real world evidence generation Develop a Target Product Profile (TPP) that is informed and supported by real world evidence Learn how to communicate medical product value in drug advertising and promotional labeling Nneka C. Onwudiwe, Senior Scientific Reviewer FDA and Founder and CEO, PECA LLC., Maryland 12:30 Augmenting Drug Discovery and Development through Robotics and Artificial Intelligence Big-data analytics & cloud computing: Players, collaborative models, data integration and representation Implications of AI in digital health, medical devices and wearables Robotics technology & its applications to drug discovery and development Running intelligent clinical trials: Accelerating trials using advanced analytics, machine learning and AI Prasun Mishra, Founder and CEO, Agility Pharmaceuticals, San Fransisco 13:00 Closing remarks by the chair End of conference 13:05 Lunch One to one meetings Networking break