Date

6 October 2020

Location

Virtual

Language

English

European Epidemiological Forum Virtual

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European Epidemiological Forum Virtual

All times indicated on the Agenda are Central Europe Summer Time.

The value of Real-World Evidence in Drug Life Cycle: promises, barriers and pathways to success


Regulators, health technology assessment (HTA) bodies, academics, bio-pharmaceuticals companies, payers, and patients are presently rethinking the healthcare ecosystem and facing diverse and increasing challenges at different levels. In this conceptual modelling of the healthcare ecosystem, the potential value of Real-World Data (RWD) for decision making has never been more relevant.
Real-World studies seek to provide complementary evidence to that provided by randomized controlled trials. While the latter provide evidence of efficacy, Real-World Data provide information on therapeutic effectiveness in a real-world practice setting.

Pharmaceutical companies need to focus on innovative and targeted therapies both due to the increased competition in the sector, and of the number of better structured and demanding patients’ groups or associations. Pharmaceutical companies are presently discussing on:

  • How does RWD contribute to translational research?
  • Whether there are any companies optimally leveraging RWD and how its application to biobanks can better advance innovation and discovery of targeted therapies?
  • What are the structural and logistical needs for this to be effective?
  • What have we already learned about the process?


Regulatory bodies face the challenge of ensuring that only safe and effective medicines reach patients; a decision which so far has only been substantiated upon data from RCTs. They actually need to know:

  • Whether other stakeholders can help them in the process and how?
  • Where and how do we using RWD in the drug development and approval process?
  • What has already been achieved in the field and what the success factors are? 


Payers, and HTA bodies want to make sure that the most innovative and novel medicines reach patients who need them most as quickly as possible; and that these medicines provide value for money to all parties: patients and health care systems. They may ask themselves:

  • How can sponsors better demonstrate the value of their innovative medicines using RWD?
  • How can they work with decision-makers to establish agreed upon standards for RWE research?
  • How do recent frameworks (FDA, NICE, etc) help advance RWE research?   

What brings all stakeholders at the same level is the need for new paradigms for a more performing healthcare ecosystem that reduce the gap between its representation and its implementation. Emerging e-health models and applications can greatly contribute to it, particularly, if hand-in-hand with Real-World Data Studies.

The European Epidemiological Forum will review the progress and perspectives on the value of RWD in the drug life cycle, will discuss what RWD promises, what the barriers may be and what a successful story may look like. 


Scientific Board:

Christian Agboton - Sr Global Brand Medical Director at Takeda
Maurille Feudjo Tepie - Observational Research Director at Amgen
Michele Intorcia - HEOR Senior Director at Apellis Pharmaceuticals


Who should attend?

The conference is addressed to professionals with a deep interest in drug development, healthcare decision making, academia and healthcare research, belonging to department such as: Medical Affairs, R&D, HTA/Market access, Medical Informatics, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics and Data Management from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.


For sponsorship opportunities, please contact events@lsacademy.com

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6 October 2020

This session will present an overview on the value of Real-World Data (RWE) and Real-World Evidence (RWE) going beyond data and evidence themselves!
Bearing in mind the recent COVID-19 crisis, we will address the importance of open long-term collaborations between private and public stakeholders to collect and use RWD and RWE. These may benefit from the healthcare ecosystem and help build trust among the public and end-users of health advancements. We need a change of mentality that brings together innovative approaches and intensive analytics!

Maurille  Feudjo Tepie Maurille Feudjo Tepie – Observational Research Director at Amgen

Evidence needs are increasing and evolving. Ideally, one may start local strategic Real-World Evidence (RWE) planning at the Drug Development Program (DDP)/end of phase 1 (launch –5 years) and should continue during all drug development phases and after launch. This enables a successful collaboration and discussion with National Health Services (NHS), which leads to a better impact on public health. RWE is crucial to better understand how drugs perform in broader patients groups. 

We are nowadays asked to produce all of the clinical, epidemiological, organizational evidence that may support adopting a health value-based approach. Partnerships between Pharma companies and NHS are the only solution to face the complex present challenges in health care, which are increasing more and more.

The pandemic of Sars-CoV-2 has accelerated this process, highlighting the need for timely, valuable evidence, better data, and registries, open collaboration between all the stakeholders, flexibility, and the ability to make decisions based on RWE.

Are we ready?
Do we have the right mindset? Do we have the needed know-how? Are we fast and smart enough in conducting studies? Are we focusing on real gaps? Are we able to reach patients,  pharmacies, GPs, and caregivers also to understand how a new therapeutic approach can properly work? Are we capitalizing on the experiences of other countries?
Are we able to partner with the Health System early on and in a collaborative way?

I don’t have all of the answers, however, I would be happy to share some experiences about: 

- Partnering with NHS: the implementation research
- Innovation and operational aspects in RWE generation
- How to better listen to patients’ voice

Elena Peruzzi Elena Peruzzi – Evidence Generation & Data Analytics Head at Novartis

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. In January 2020 we published a Statement of Intent to increase and extend the use of data in the development and evaluation of our guidance. This explores:

  • What kind of evidence does NICE currently use to develop guidance
  • What broader types of data are available
  • When and why should broader types of data be considered
  • Practical considerations associated with data analytics

We have since defined the programme to develop a methods and standards framework for activities involving broader sources of data and applied analytics. We accelerated some aspects of this to ensure fit-for-purpose analysis during the COVID-19 pandemic. It can be summarised into five key topics, which are crucial to address to ensure best practice in conducting high quality analyses of data. These are Research Governance; Data; Analysis; Results and Dissemination. In addition to these topics, the programme will consider some cross cutting issues ranging from transparency and public trust, to the validation and evaluation of artificial intelligence [AI] in digital technology.

The presentation will give an overview of the transformational journey to increase the use of broader data and applied analytics in NICE Guidance. It will also touch on the some of the issues we are considering with Standards; which will be crucial for any organisation seeking to ensure their approach is suitable for regulatory assessment/evaluation.

Adrian Jonas Adrian Jonas – Associate Director for Data and Analytics at National Institute for Health and Care Excellence (NICE)

In the past couple of years, development of IT systems and IT capacity have brought a huge amount of data that could be potentially used to support clinical, managerial and policy decision-making. However, so far the utilisation of RWD or RWE in the approval or reimbursement of drugs is very limited. There may be some reasons behind it notwithstanding the methodological concerns. HTA is a formal process to review structured evidence, but HTA has never been designed to evaluate neither systematic RWD nor RWE, in spite of major transformations in healthcare stem at RWE.

The objective of this presentation will be to review both the methodological and non-methodological concerns from payers and decision makers regarding the use RWE, and how can we try to overcome those limitations, with particular focus on non-methodological concerns. Equally we will try to build on some examples of submissions that have been used in the past in country-specific jurisdictions to approve/reject the usage of a new drug.

Main takeaways for the audience should be understanding how to better use the data available to support their submissions.

Oriol Solà-Morales Oriol Solà-Morales – CEO at HITT - Health Innovation Technology Transfer

Summary of the first part of the meeting

Christian Agboton Christian Agboton – Sr Global Brand Medical Director at Takeda

Regulators, health technology assessment (HTA) bodies, academics, bio-pharmaceuticals companies, payers, and patients are presently rethinking the healthcare ecosystem and facing diverse and increasing challenges at different levels. With ever increasing demands on healthcare costs and considerable focus on drug pricing across global markets, conceptual modelling within value-based agreements between drug manufacturers and payers has never been more important.

 The potential for Real-World studies to provide complementary evidence to that provided by randomized controlled trials are becoming more established within formal assessment and appraisal processes across the globe. Whilst RCTs provide evidence of efficacy, Real-World Data provide information on therapeutic effectiveness in a real-world practice setting. Pharmaceutical companies need to focus on innovative and targeted therapies both due to the increased competition in the sector, and of the number of better structured and demanding patients’ groups or associations. 

 Payers, and HTA bodies want to make sure that the most innovative and novel medicines reach patients who need them most as quickly as possible; and that these medicines provide value for money to all parties: patients and health care systems. They will need to address the following:

  • How can sponsors better demonstrate the value of their innovative medicines using RWD?
  • How can they work with decision-makers to establish agreed upon standards for RWE research?
  • How do recent frameworks (FDA, NICE, etc) help advance RWE research?
  • How does RWE address critical issues such as cost effectiveness, budget impact and uncertainty ?

 What brings all stakeholders at the same level is the need for new paradigms for a more performing healthcare ecosystem that reduce the gap between its representation and its implementation. Emerging e-health models and applications can greatly contribute to it, particularly, if hand-in-hand with Real-World Data Studies. The European Epidemiological Forum will review the progress and perspectives on the value of RWD in ensuring access and reimbursement of new innovative medicines, will discuss what RWD promises, what the barriers may be and what a successful story may look like.

Omar Ali Omar Ali – Visiting Lecturer Value Based Pricing at University of Portsmouth & Former Adviser to NICE

We live in a data-driven environment. As clinical researchers, epidemiologists and scientists, we generate, use, and share data on a daily basis.

The current drug regulatory landscape supports the use of non-conventional clinical data sources to compensate for the lack of generalisability of data from clinical trials. Recent guidelines are encouraging the use real-world data (RWD) collected outside the controlled environment of clinical trials as clinical evidence to support efficacy and safety of health products. Real world evidence (RWE) is collected in many different ways, including patient registries, mobile devices, geolocation information and wearables, and is largely technology driven.

Any data we collect needs to be used appropriately and responsibly. Two key aspects in data use that we need to consider are data transparency and data privacy. Though these may be contradictory first glance, these two principles are actually complementary.

The new EU regulations and updated ICH guidelines are pushing for public disclosure of data through many different platforms, such as publicly accessible clinical trial databases and open access biomedical publications. The aim of transparency is to promote innovation and trust in the healthcare industry.

Coupled to data sharing is maintaining data privacy of the individual. The General Data Protection Regulation was adopted to harmonise data protection across the EU, provide better protection to data subjects, and clarify the responsibilities of data controllers and processors. 

Taken together, these regulations and guidelines provide researchers and scientists a solid framework to perform research that is scientifically sound, fair, and patient-centric.

This presentation will discuss the interplay between data collection, data transparency and data protection and the regulations governing them in the context of RWE generation, use, and dissemination. The relevant guidelines and regulations will be discussed and case studies will be presented.

Raquel Billiones Raquel Billiones – Subject Matter Expert on Medical/Regulatory/Scientific Writing, Data Disclosure and Protection, Pharma/Medical Devices

A fully digital data collection system, including patient identification, would represent a substantial advance in how patient-reported outcomes (PRO) data are measured. Within the European Union, one way to identify patients without the involvement of healthcare professionals is to use the unique 2D matrix codes on the packaging of prescription medication. DePRO is an observational, multi-center, cross-sectional, digital, patient-driven study conducted in Germany. Patients with a prescription for a metformin-containing medication are given a postcard by their pharmacist, which includes a download link for the my ePRO app. Participants use their own mobile device to download the my ePRO app and access the DePRO study, for which they can register using the 2D matrix code on their medication. An electronic informed consent is collected. The PRO instruments used in the study are the summary of diabetes self-care activities scale, the diabetes treatment satisfaction questionnaire and the EQ-5D questionnaire. Patients are also asked to complete a questionnaire with items addressing demographics, patient characteristics, disease history, complications and concomitant medications. Enrollment of the first participants started in June 2020 (recruitment period, 3 months; planned sample size, 300 patients). The design of the DePRO study represents a substantial advance in scalability using digital capturing of PRO data.

Christian Müller Christian Müller – Teamleader Data Generation at Bayer

The COVID-19 pandemic provided a dramatic example of how big data can provide quick access to invaluable information and a unique opportunity for decision-makers to respond rapidly to a public health emergency while posing new challenges for the scientific community on data integrity and reliability. 

Some analyses and interpretations were controversial – leading to 3 retracted papers in 3 leading medical journals; public health authorities did contribute to misinformation (e.g. use of ibuprofen) and decision-makers were not prepared. 

During the workshop we will study the anatomy of a crisis that illustrates the need for specific approaches to big data and collaboration at different levels of the decision-making process.

Managed by 

Christian Agboton Christian Agboton – Sr Global Brand Medical Director at Takeda
Maurille  Feudjo Tepie Maurille Feudjo Tepie – Observational Research Director at Amgen
Michele Intorcia Michele Intorcia – HEOR Senior Director at Apellis Pharmaceuticals

Scientific Board

Christian Agboton
Christian Agboton Sr Global Brand Medical Director at Takeda
Maurille  Feudjo Tepie
Maurille Feudjo Tepie Observational Research Director at Amgen
Michele Intorcia
Michele Intorcia HEOR Senior Director at Apellis Pharmaceuticals

Speakers

Omar Ali
Omar Ali Visiting Lecturer Value Based Pricing at University of Portsmouth & Former Adviser to NICE
Raquel Billiones
Raquel Billiones Subject Matter Expert on Medical/Regulatory/Scientific Writing, Data Disclosure and Protection, Pharma/Medical Devices
Adrian Jonas
Adrian Jonas Associate Director for Data and Analytics at National Institute for Health and Care Excellence (NICE)
Christian Müller
Christian Müller Teamleader Data Generation at Bayer
Elena Peruzzi
Elena Peruzzi Evidence Generation & Data Analytics Head at Novartis
Oriol Solà-Morales
Oriol Solà-Morales CEO at HITT - Health Innovation Technology Transfer

Scientific Board

Christian Agboton
Christian Agboton Sr Global Brand Medical Director at Takeda
Maurille  Feudjo Tepie
Maurille Feudjo Tepie Observational Research Director at Amgen
Michele Intorcia
Michele Intorcia HEOR Senior Director at Apellis Pharmaceuticals

Conference Venue

European Epidemiological Forum Virtual

Virtual conference with presentations, slots for Q&A and discussion among delegates.

Useful information

LS Academy will provide the link to join the conference some days before the conference date.

All times indicated on the Agenda are Central Europe Summer Time.

Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.

Useful numbers

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager

Past Events

Conference Price

Ordinary

680.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager
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Participants' Feedbacks

Very focused and "hot topics" of RWE generation

Interesting topics. Speakers very well prepared and with interesting talks

Do this again! Superb agenda!

Nice combinations of theory and practical issues 

Deep insight of speakers during round table, nice discussion topics. Broad view with presentations/speakers, multiple relevant topics

Enough time for networking and discussion. Very well organized

Broad coverage of topic matter & subject matter experts from various countries backgrounds. Objective of conference achieved.

Mix of industry and academia/public. Good practical examples, illustrations to mark the point

Different point of view from HTA agency, interesting examples, NICE, to market access

Very interactive, focus, practical and very relevant

Perfect timing and location

Great presenters, lot of topics covered

Very good speakers!

I found EPI Forum latest conference very focus and targeted, yet still with the right amount of generalities that should better help appreciate the lessons that could be learned from these case examples. The size (not too big!) was also very conducive to interactions and thus some kind of brainstorming sessions.

Congratulations for the great organisation of the event and the high level of the speakers. I really enjoyed the meeting!

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