3rd Annual MarketsandMarkets Real-World Data, Life Sciences Analytics and Market Access Virtual Conference ( Time Zone

WHAT TO EXPECT

Progression on uses of Real-World Data across the ecosystem
Global regulatory perspective on Real-World Evidence Guidance- FDA & EMA
Applications of Artificial Intelligence & Blockchain for Real-World Data Analysis
Market Access and Pricing
COVID-19 impact- Identifying and overcoming challenges in Real-World Evidence space

From pharmaceutical and Biopharmaceutical companies-

Chief executives, VP’s, Directors, Global heads, Heads, Leaders, Senior Managers, Researcher, Analysts, Investigators, Scientists, Bio-Statisticians, Epidemiologist, within the following departments

Real-World Evidence
Health Economics & Outcomes Research
Patient Access
Value Access
Clinical Operations
Clinical Development
Center for Observational and Real-World Evidence

Understand the impact of innovative real-world evidence partnerships for better data
To explore the capabilities of using Artificial Intelligence & Machine Learning for better Data Analysis
Learn about global regulatory perspective on Real-World Evidence Guidance
Learn about best practices for the commercial structure of drugs, from development to market access strategy
Opportunity to network and exchange scientific knowledge with expert speakers from leading manufacturers, global regulators, and solution providers

CONFERENCE AGENDA

Registration

08:30 - 09:00

Welcome note from MarketsandMarkets

09:00 - 09:05

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	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	09:10 - 09:40
Multiple sclerosis outcomes database Guru Rao KS, Senior Vice President, Molecular Connections Private Limited	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	10:10 - 10:40
Using Real World Clinical NGS Data for Precision Oncology Sheryl Krevsky Elkin , Chief Scientific Officer , QIAGEN Digital Insights	10:40 - 11:15
One-to-One Networking Meetings \| Networking break	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	11:35 - 12:05
Considerations and challenges around AI enabled clinical decision support Angela Ibald-Mulli , Head, Medical Evidence Generation Primary Care , Sanofi	12:05 - 12:35
BigData & Artificial Intelligence: separating facts from fiction Ignacio Hernandez Medrano, Founder, Savana Medica	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	13:05 - 13:35
Closing remarks from the Chairperson	13:35 - 13:40
One-to-One Networking Meetings \| Networking break	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	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	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	09:40 - 10:10
Integrating Real-World Datasets to Understand Socio-Economic Disparities in Access to Healthcare Tom Haskell, Managing Director, RWExperts LLC	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	10:40 - 11:15
One-to-One Networking Meetings \| Networking break	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	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	11:50 - 12:35
Comprehensive real-world evidence generation strategy to support reimbursement and market access Eliza Kruger, Associate Director, Global HEOR, Ultragenyx Pharmaceuticals	12:35 - 13:05
Closing remarks from the Chairperson	13:05 - 13:10
One-to-One Networking Meetings \| Networking break	13:10 - 14:30

Registration	08:30 - 08:55
Welcome note from MarketsandMarkets	08:55 - 09:00
Opening Remarks from the Chairman Eliza Kruger, Associate Director, Global HEOR, Ultragenyx Pharmaceuticals	09:00 - 09:05
NEW FORMS OF REAL-WORLD DATA
What are Registries for Rare Diseases? Rafael Ioschpe, Associate Director, RWE Strategic Operations Lead, Rare Disease, , Sanofi Genzyme	09:05 - 09:35
Impact of COVID-19 on the generation and use of real-world data and evidence Nirosha Lederer , Managing Associate, Real World Evidence, Duke Margolis Center for Health Policy, Duke University	09:35 - 10:05
Best Practices in Long-Term Safety Follow-Up Studies – Using technology to ensure safety and lighten site and patient burden Noolie Gregory, Executive Director, Client Engagement Solutions, Real World Late Phase, Syneos Health	10:05 - 10:35
Generating Real-World Evidence For Stakeholders Including Physicians, Patients, and Payers Shaum Kabadi, Director of Global Real-World Evidence in Oncology, AstraZeneca	10:35 - 11:00
Causal Inference Methods for Real World Evidence: a Case Study of a Target Trial Emulation Xabier Garcia de Albeniz Martinez , Director, Epidemiology , RTI Health Solutions	11:00 - 11:30
One-to-One Networking Meetings \| Networking break	11:30 - 11:50
BREAKTHROUGH TO EXCELLENT DATA EVALUATION
Real-World Data Hubs - technology platforms to enable clinical outcome & RWE collaborations between hospitals and Life Sciences Industry Georges De Feu, Founder & CEO, Lynxcare	11:50 - 12:20
Real World Data in a pandemic: Making sense of EHR data for COVID-19	12:20 - 12:50
Closing remarks from the Chairman	12:50 - 12:55