PROGRESSION ON USES OF REAL-WORLD DATA ACROSS THE ECOSYSTEM |
Opening Remarks from the Chairman
Angela Ibald-Mulli , Head, Medical Evidence Generation Primary Care , Sanofi
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09:05 - 09:10 |
Keynote Presentation: Building and scaling organizational RWE capabilities to maximize return
Charles Makin , Global Head of HEOR and RWE, Global Head of Pipeline Value & Access, Biogen
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09:10 - 09:40 |
Multiple sclerosis outcomes database
Guru Rao KS, Senior Vice President, Molecular Connections Private Limited
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09:40 - 10:10 |
Real-World Evidence in Drug Development: The FDA Experience
Nneka Onwudiwe, Former PRO/PE Regulatory Review Officer, FOOD AND DRUG ADMINISTRATION
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10:10 - 10:40 |
Using Real World Clinical NGS Data for Precision Oncology
Sheryl Krevsky Elkin , Chief Scientific Officer , QIAGEN Digital Insights
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10:40 - 11:15 |
One-to-One Networking Meetings | Networking break
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11:15 - 11:35 |
ARTIFICIAL INTELLIGENCE, BLOCKCHAIN AND BIG DATA: GAMECHANGER IN REAL-WORLD EVIDENCE GENERATION |
Advanced real-world evidence as a competitive advantage
Dan Riskin , Founder and CEO, Verantos
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11:35 - 12:05 |
Considerations and challenges around AI enabled clinical decision support
Angela Ibald-Mulli , Head, Medical Evidence Generation Primary Care , Sanofi
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12:05 - 12:35 |
BigData & Artificial Intelligence: separating facts from fiction
Ignacio Hernandez Medrano, Founder, Savana Medica
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12:35 - 13:05 |
Challenges and opportunities on generating “regulatory grade” Real World Evidence
David Miller, Executive Director, Head of RWE- Patient Safety, Sarepta Therapeutics, USA
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13:05 - 13:35 |
Closing remarks from the Chairperson
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13:35 - 13:40 |
One-to-One Networking Meetings | Networking break
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13:40 - 14:30 |
IMPLICATIONS OF MARKET ACCESS AND PATIENT ACCESS TO MEASURE IMPACT |
Opening Remarks from the Chairman
Tao Fan , Senior Director, US HEOR US Medical Office , Takeda Pharmaceuticals
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09:05 - 09:10 |
Market Access & Pricing / What do you need to consider for a success drug launch?
Raymond Frost, Vice President, Market Access & Health Policy, Melinta
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09:10 - 09:40 |
Innovative Payment Models: Practical Learnings from the US Launch of the First Gene Therapy for a Genetic Disease
Jay Newman, Head of US Commercial, Spark Therapeutics
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09:40 - 10:10 |
Integrating Real-World Datasets to Understand Socio-Economic Disparities in Access to Healthcare
Tom Haskell, Managing Director, RWExperts LLC
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10:10 - 10:40 |
Generating Real World Evidence in Medical Affairs: Challenges and New Opportunities
Andrei Pikalov, Vice President, Head of Global Medical Affairs, Sunovion Pharmaceuticals
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10:40 - 11:15 |
One-to-One Networking Meetings | Networking break
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11:15 - 11:35 |
GLOBAL REGULATORY PERSPECTIVE ON REAL-WORLD EVIDENCE GUIDANCE |
RWE for regulatory and HTA decision-making: latest precedent and what’s ahead
Ashley Jaksa, VP of Science , Aetion
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11:35 - 11:50 |
Panel discussion- Assessing the upcoming changes in the regulatory landscape in terms of Real-World Data- FDA, EMA, PMDA & industry perspective
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11:50 - 12:35 |
Comprehensive real-world evidence generation strategy to support reimbursement and market access
Eliza Kruger, Associate Director, Global HEOR, Ultragenyx Pharmaceuticals
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12:35 - 13:05 |
Closing remarks from the Chairperson
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13:05 - 13:10 |
One-to-One Networking Meetings | Networking break
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13:10 - 14:30 |
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