4 REASONS TO ATTEND:

  1. Appreciate how to combine external data with advanced technology, to develop RWE that provides value to KOLs, payers & regulators
  2. Benchmark how technologies like AI, Big Data, Cloud, EDC, PROs, Mobile Apps or EHR can maximise the potential, evidence & insights from RWE
  3. Learn how to turn big messy data, into structured evidence that provides insights and value.
  4. Find out how industry leaders are collaborating with a myriad of diverse external stakeholders to generate robust, quality evidence 

Speakers List

INDUSTRY EXPERTS

Global Head, HEOR, HTA & RWE and Global Head, Value & Access, Pipeline 
Biogen

Patricia Dorling

Head of Global HEOR & RWE
Chiesi 

Alexander Cole

Executive Director, Head Epidemiology and Real-World Science 
Alexion 

Dhaval Patel

Global RWE Head, Applied and Advanced Analytics
Novartis 

Director of Biostatistics, HEOR
Pfizer

Associate Director, Worldwide RWE & US HEOR 
Eisai

Danielle Bargo

Director, Worldwide RWE & US HEOR
Eisai

 

 

Event Structure

Event Program

Login & Registration
07:30 LA/10:30 NYC
Chairperson’s opening remarks
08:00 LA/11:00 NYC
Patricia Dorling

Head of Global HEOR & RWE
Chiesi 

Getting to answers that matter: Deploying Real-World Evidence for the maximum impact
08:10 LA/11:10 NYC
Keynote Presentation

Global Head, HEOR, HTA & RWE and Global Head, Value & Access, Pipeline 
Biogen

How to leverage registries & external data to develop RWE that can best provide value to external stakeholders?
08:40 LA/11:40 NYC
Patricia Dorling

Head of Global HEOR & RWE
Chiesi 

How to turn big messy data into structured evidence?
09:10 LA/12:10 NYC
Danielle Bargo

Director, Worldwide RWE & US HEOR
Eisai

 

 

Break
09:40 LA/12:40 NYC
The value of external data to inform R&D: How can this impact the future of healthcare?
10:00 LA/13:00 NYC
  • Regulatory perspectives on RWE in clinical development
  • Challenges and opportunities in the rare disease space
  • Understanding the challenges in leveraging RWD to generate evidence
Alexander Cole

Executive Director, Head Epidemiology and Real-World Science 
Alexion 

The role of registries in overcoming lack of data in oncology and rare diseases
10:30 LA/13:30 NYC
  • Regulatory guidance on using external control data, including registries
  • Acceptability of using registries in oncology and rare disease
  • Considerations for the design and analysis of externally controlled studies
  • Impact of unmeasured confounders in externally controlled studies

Director of Biostatistics, HEOR
Pfizer

Strategies to maximize ROI of big data in the pharma value chain
11:00 LA/14:00 NYC
  • Types of RWDs and relevance of the derived RWE to various stakeholders
  • Current challenges to generating fit-for-purpose RWE
  • Roadmap to establish value of scalable RWD at regional and global levels

Associate Director, Worldwide RWE & US HEOR 
Eisai

Panel Discussion: Novel approaches to Real-World Big Data, Registries & AI
11:30 LA/14:30 NYC
  • Artificial intelligence & Machine Learning: What can we realistic expect and when?
  • Retrospective data analysis: How best to combine & mine internal & external data sets?
  • Data analysis: Making sense of the deluge of structured and unstructured real world data
  • How to turn big data into big insights?

Global Head, HEOR, HTA & RWE and Global Head, Value & Access, Pipeline 
Biogen

Alexander Cole

Executive Director, Head Epidemiology and Real-World Science 
Alexion 

Patricia Dorling

Head of Global HEOR & RWE
Chiesi 

Director of Biostatistics, HEOR
Pfizer

Associate Director, Worldwide RWE & US HEOR 
Eisai

Dhaval Patel

Global RWE Head, Applied and Advanced Analytics
Novartis 

Danielle Bargo

Director, Worldwide RWE & US HEOR
Eisai

 

 

End of Day
12:00 LA/15:00 NYC

Speaker Biographies

Charles Makin

Global Head, HEOR, HTA & RWE and Global Head, Value & Access, Pipeline 
Biogen

Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products.

Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies.

In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles, and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU.

Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.

Jinma Ren

Director of Biostatistics, HEOR
Pfizer

 

Jinma Ren is a director of biostatistics at Pfizer Inc., where he has provided statistical support to oncology and other areas on Health Economics & Outcomes Research projects, mainly for health technology assessment. He has 15+ years of outcomes research experience from both academia and industry, and he serves on the editorial board of two major journals. Dr. Ren has his PhD degree in epidemiology and health statistics, and MD degree in preventive medicine.

Anandaroop Dasgupta

Associate Director, Worldwide RWE & US HEOR 
Eisai

Anandaroop Dasgupta, PhD is an Associate Director in the Worldwide RWE & US HEOR team at Eisai Inc. He is responsible for development and execution of RWE and HEOR strategy in NSCLC and other oncology pipeline indications. Dr. Dasgupta has a strong background in outcomes research with 10+ years of experience and has contributed to multiple RWE and HEOR projects across the product life cycle, including drug development, launch and commercial phases. His domain knowledge in oncology covers multiple solid tumors including lung, bladder, breast, prostate, and melanoma. In addition, his experience encompasses several hematological malignancies. He has received his PhD in Outcomes Research from University of Texas at Austin and an MS in Pharmacy Administration from University of Houston. He has published extensively in RWE and HEOR field.

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