Managing Real World Data -





Published: October 2012 | Pages: 54 

Managing Real World Data 

Pharma companies are no longer the sole owners and controllers of the information that determines the maintenance and reimbursement of their products. An outpouring of real-world data (RWD) from every corner of the healthcare industry is putting new evidence into public and private domains. 

Many factors are driving this explosion of RWD, and its increasing value. Indeed, payers, regulators, providers and pharma companies have many different reasons for wanting to know more about real-world performance and outcomes. However, all of these stakeholders are discovering the substantial benefits of analysing data from a non-experimental setting. 

The strong shared interest in RWD is driving the centralisation of disparate data sources, and leading to revolutionary new kinds of healthcare partnerships. In this rapidly changing environment, pharma companies who move quickly to develop a clear RWD strategy will be at a considerable competitive advantage. 

 

Report Overview 

 

Managing Real-World Data 

 

This definitive report on RWD helps pharma companies navigate the complexities of developing, accessing, and using real-world data sources, and provides guidance on developing a successful RWD strategy. 

 

Key RWD concepts and terminology are clearly defined, and detailed descriptions of RWD trends give you a clear picture of RWD today, and an insightful look at what to expect tomorrow. 

 

Companies who are getting ready to think strategically about RWD will find step-by-step guidance on gaining internal strategic alignment, choosing an operating model, and gaining a seat at the policy-making table. This invaluable resource also examines the pros and cons, and other critical considerations, of many strategies, including buying vs. partnering. 

 

Pharma companies must evolve RWD strategies sooner rather than later. Managing Real-World Data provides the know-how you need to succeed. 

 

Key Report Features 

 

Overview of how Big Data is revolutionising healthcare 

Clarification of terminology and concepts 

Current look at how pharma companies are using RWD 

Review of the main sources of RWD 

Guide to observational research methodologies 

Organisational considerations to developing an RWD strategy 

Benefits and risks of in-house vs. external sources 

RWD’s important role in product life cycle management 

Who Should Read This Report? 

 

Pharma managers and executives in: 

Health economics/HEOR 

Pharmacovigilance 

Epidemiology 

Medical affairs 

Market Access 

R&D 

Branding and marketing 

 

Expert Views Include: 

 

Norman Rosenthal, head of scientific affairs, Johnson & Johnson North America 

 

Alex Thompson, head of epidemiology, PROs and healthcare data strategy, Roche UK 

Team leader of the “Epidemiology for Therapeutics” group, conducting large-scale observational studies to assess emerging risk factors in cardiovascular disease 

 

Rick Lones, executive medical director, Bristol-Myers Squibb UK 

Co-chair of the Association of the British Pharmaceutical Industry’s RWD working group 

 

Jamie Cattell, principal and leader, McKinsey & Co’s Global Healthcare Technology practice 

 

Jeff Trotter, executive vice-president of Phase IV development, PharmaNet 

 

Chris Easley, partner, Pope Woodhead 

 

Key Quotes 

 

“If you are in pain that is not something your doctor is necessarily best placed to assess for you. These are subjective experiences. … PROs [are] valuable because healthcare is about more than just hard outcomes.” Alex Thompson, head of epidemiology, PROs and healthcare data strategy, Roche UK 

 

“War is too strong a word but there is fierce competition in how companies are using RWD to demonstrate the real impact of their products.” Jamie Cattell, principal and leader, McKinsey &s Co’s Global Healthcare Technology practice 

 

“The beauty of RWD is that you don’t just have to study one product or one step in a disease pathway, but you can look at multiple aspects.” Rick Lones, executive medical director, Bristol-Myers Squibb UK 

 

“We want to develop standards for partnership selection and assemble the right internal people with the key capabilities to ensure a systematic approach. We are considering a ‘string of pearls’ approach because different payers will have different competencies.” Norman Rosenthal, head of scientific affairs, Johnson & Johnson North America  

 

 

Key Questions Answered 

What is RWD and why is it important? 

How are companies using RWD? 

How are observational research methodologies changing? 

How can RWD assist in market access and reimbursement? 

How should we structure our organisation to facilitate RWD collection? 

Should we build or buy? 

What are the advantages of working with external parties to obtain data? 

How can RWD support a product’s entire lifecycle? 

 

Key Benefits 

Eliminate confusion over what RWD is and does 

Prepare your organisation for the challenges of implementing an integrated RWD strategy 

Understand where to obtain different types of RWD 

Be aware of the strengths and weaknesses of primary data sources 

Gain an understanding of different study types and designs that can be used to fill data gaps 

Know how RWD helps fulfill regulators’ increasing demands for safety data in the non-clinical-trial setting 

Learn about ways in which RWD can be used, such as interpreting epidemiology trends 

Discover ideas for possible partnerships, and know how to bring them to fruition 

 

Content Highlights 

Executive summary 

Big data takes centre stage 

> Everyone wants RWD 

> Opportunities for partnership 

> Accelerating pace of change 

> Interfacing Rush 

> Risk-sharing agreements 

> Comparative benefit-risk assessment 

Observation in the real world 

> Patient-reported outcomes 

> Observational research rises in credibility 

> Pharma use of RWD 

> RWD throughout the product lifecycle 

> Who owns observational research? 

> Cross-functional approach 

> Organisational challenges of RWD 

> J&J seeks partners 

> Internal alignment 

> Appoint a champion 

> Establish bespoke SOPs 

> Strategic first steps 

Sources of RWD 

> Buying in RWD 

> National payer systems 

> Administrative data 

> Prospective RWD studies 

> Large simple trials 

> Registries 

> Strengths and weaknesses 

> ...of registries 

> ... of historical data 

> Validity of RWD 

> New methodologies 

> Changing regulatory environment 

RWD strategies: buy or partner? 

> Organic approach 

> Partnership with payers 

> AstraZeneca and HealthCore 

> Other pharma-payer data deals 

> Future of pharma-payer collaborations 

> The brave new real world 

> Entrenched resistance 

Acknowledgements