Agenda

The program for RWE 2022 is below, with speakers being announced regularly, please watch this space!

At this year’s event, you can expect core themes including:

Reimbursement and payer models
Regulatory tools and fairness
The impact of big data, artificial intelligence and machine learning
Exploring quality, registries and patient-first practices

RWE 2022 will be an engaging and accessible event:

The Collaboration and Mastery Zone will comprise panels and presentations, with ample time for questions and discussion, enabling participants to experience debates and learn about the latest developments.
The Debate and Dialogue Zone will subvert the traditional conference, and create a space for roundtables, fishbowl conversations, creating an environment to share, build relationships, and collaborate on future projects.

Day 1 Day 2

DAY ONE – Wednesday 29 June 2022

08:15	09:00	Registration, breakfast, coffee and exhibition
09:00	09:05	Welcome Laura Dormer, Future Science Group
09:05	09:15	Opening remarks Conference chair
09:20	09:50	Opening keynote fireside chat: understanding the human angle – the impact of rare diseases: my story Jean-Christophe Novelli
09:50	10:35	Regulator keynote 2025 vision: collaborating to enable use and establish value Delivering future visions through multi-stakeholder collaboration The future of RWE policy Latest updates from Europe, DARWIN EU and more
10:30	11:05	Morning coffee, speed networking and exhibition
		COLLABORATION AND MASTERY ZONE	DEBATE AND DIALOGUE ZONE
		Understanding reimbursement
11:05	11:35	Gaining clarity on RWE and payer models across Europe: managing the uncertainty of approving and reimbursing drugs Lotte Steuten, Office of Health Economics	Two parallel sessions: Fishbowl session – “moving panel” with participants stepping in and out to keep conversation going and fresh ideas flowingHow has access to RWD informed care pathways for patients? Roundtable conversation – kickstarted with opening remarks, this concurrent conversation is designed to encourage debate and collaboration Using RWE to support cell and gene therapies Reimbursement and outcome-based agreements to provide cell and gene therapies with the necessary RWD
11:35	12:05	Understanding the lifecycle approach to determining the value of treatments The need for a standardized, iterative scientific process for valuing treatments to support HTA and payers Amr Makady, Janssen
12:05	12:35	RWE for HTA payer decisions: the rare diseases perspective Overcoming the challenges of reimbursement decisions in rare diseases	Fishbowl session: TBA Roundtable conversation: Outcomes-based payment models
12:35	13:05	Economic modelling in rare diseases: how should we assess value? Christian Hill, MAP BioPharma
13:05	14:10	Lunch and exhibition
		COLLABORATION AND MASTERY ZONE	DEBATE AND DIALOGUE ZONE
		Achieving patient focus
14:10	14:30	Listen and learn: partnering with patient advocates and groups	Fishbowl session: Developing patient centrality in RWE Roundtable conversation: Using RWD to identify patients eligible for clinical trials Moderator: Tim Williams, CPRD, MHRA
14:30	15:00	How do you share real-world patient data? Andreas Hager, Patient Data Lawyer
15:00	16:30	Afternoon tea and exhibition
		Registries: curse or cure?
15:10	15:40	Should you trust Trusted Research Environments? Why? Why not? How to collect RWD while remaining GDPR-compliant Leveraging primary care data for planning and research Susheel Varma, HDR UK	Fishbowl session: Untapped opportunities in registries Treatment vs disease registries How does industry get access to registries? How do we achieve collaboration? Roundtable conversation: Developments in trial methodology Investigating the different hybrid study designs Determining the efficacy remote and decentralized trials?
16:10	16:40	How are registries learning and changing? Sofie Terwel, European Blood and Marrow Transplant registry
16:40	16:55	Closing questions
17:00	18:30	Drinks reception

DAY TWO – Thursday 30 June 2022

08:15	09:00	Registration, breakfast, coffee and exhibition
09:00	09:20	Welcome address Laura Dormer, Future Science Group
09:20	09:50	Harnessing partnerships to unlock data and creative collaborative learning systems
09:50	10:35	Accelerated regulatory approval in 2022 and beyond: managing uncertainty with the impact of Brexit and COVID How have regulators handled areas of unmet need Determining what is reasonable when approving and reimbursing drugs in times of Brexit and COVID Panelists: Alexander Shacht, Veramed Leslie Galloway, Ethical Medicines Industry Group
10:35	11:05	Morning coffee, speed networking and exhibition
		COLLABORATION AND MASTERY ZONE	DEBATE AND DIALOGUE ZONE
		Agility and collaboration
11:05	11:35	Achieving transparency in the generation and use of RWE Richard White, Oxford PharmaGenesis	Fishbowl session: Untapped opportunities in registries Treatment over disease registries Ensuring the industry can get access to registries Determining the steps needed to achieve collaboration Roundtable conversation: TBA
11:35	12:05	HTA-quality real world data – what quality is required? Clearly defining “regulatory-grade RWD” Ensuring that RWD submitted to regulators can meet expectations The benefits of collaboration in creating regulatory-grade RWD Catia Proenca, Alira Health
12:05	12:35	Is it fair? Understanding the healthcare disparities and fair access to treatment	Fishbowl session: TBA Roundtable conversation: Data and the patient: are there novel ways of generating patient-centric data?
12:35	13:05	Opportunity for a sponsored feature, if you’re interested in filling this slot please contact our Business Development Director, Ian Law, at [email protected]
13:05	14:10	Lunch and exhibition
		COLLABORATION AND MASTERY ZONE	DEBATE AND DIALOGUE ZONE
		Impact of data quality and artificial intelligence
14:10	14:40	Title TBC: Leveraging EHRs for trial recruitment and management Tim Williams, CPRD, MHRA	Fishbowl session: TBA Roundtable conversation: Who owns the data? How much are patients, the public and governments willing to share? Data access and data confidence
14:40	15:10	Leveraging artificial intelligence and machine learning for data quality Akrivia Health Speakers TBC	Digital health, cognition and decentralized and virtual trials What we can learn from digital health data and how to best analyse it Teaching from COVID about digital health, cognition and decentralized / virtual trials Current digital health projects underway (e.g., Duchenne Group)
15:10	15:40	Afternoon tea, speed networking and exhibition
15:40	16:10	How much uncertainty in the changing regulatory environment: what is the risk and benefit balance?	Fishbowl session: TBA Roundtable conversation: The challenges of data collection
16:10	16:40	Closing keynote fireside chat Topic: TBA
16:40	17:00	Closing keynote remarks Next steps in RWE and rare diseases