How to Best Integrate Patients into your Strategies and Operations in Clinical Development – Step III
Important milestones are reached for patient-oriented trials!
The third Patient Partnering in Clinical Development (PPCD) conference will present and discuss approaches with patients, their advocates, study nurses, physicians, industry partners and all stakeholders involved on 2-3 March 2020 at Berlin.
Strong awareness about the need of patient engagement was built up in the last decade. Now we have the first implementation of regulations at the FDA, the European Medicines Agency and the National Institute for Health and Care Excellence. We have to learn to execute clinical research at its best with patients in mind in the first place. We have new roles in pharma and the CRO industry who help to put in place the requirements to streamline and optimize all the efforts around the trials.
Important changes are linked to the voice of patients who become experts of their disease and to the digital technologies that needs to be created around the patients and physicians.
The new trials very often include hand-held data capture where applicable, home nursing and logistic support keeping in mind that in some diseases and pediatric indications very often the whole family is involved in the successful participation in the trial.
Therefore, the motto of the future is “Bring the trial to the patient instead of making the patient come to the trial”.
The 2020 edition of PPCD is offering a training workshop on blockchain applications in clinical research as part of the agenda to see how it is improving transparency, traceability and quality.
Speaker presentations, panel discussions and the interactive workshop will share thoughts on:
- Blockchain applications
- Early phase development
- Clinical development and operations
- Regulatory aspects
Nancy Meyerson-Hess - Expert Advisor admedicum Business for Patients and Chief Compliance and Regulatory Officer eMQT
Raphaela Schnurbus - Clinical Research Solutions Management and Business Development Director at Premier Research
Doris Christiane Schmitt - Consultant for patient communication and Member of the leading team EUPATI, Germany
Who should attend?
The conference is addressed to all Professionals working around the clinical trial from early onset up to late stage development and market authorization: Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centres, Hospital Centres, Patient Associations and Clinical Technology companies with a strong interest in integrating patient experts into their strategies and operations in healthcare development.
Pegasus Networking Reception
LS Academy and admedicum Business for Patients are pleased to invite you to the Pegasus Networking Reception on Monday 2 March from 18.00 - 20.00.
2 March 2020
The interactive workshop will focus on:
- Use of blockchain in transforming healthcare
- What you need to consider in setting up blockchain for pharmaceutical and healthcare use case
- A demo on Patient Data Use case and exploring example use cases from attendees
The National Institute for Health and Care Excellence (NICE) was established in 1999, and now has a reputation as an international leader in evidence synthesis, guideline development and technology evaluation. We will build and enhance this reputation with an new offer that integrates our advice along care pathways, accessible to users whenever and wherever they need it, which is always up to date. To achieve this, we will make effective use of digital technologies and artificial intelligence, with the aim of improving care and facilitating the use of new, cost effective technologies. Traditionally our recommendations have been based on the best available research evidence, supported by an economic analysis. Over the past 20 years, however, the availability of data – alongside research studies – has rapidly increased. Now some of our work is based on an analysis of real world data, such as for selected new cancer drugs. To build on this work, we have set up a new programme to routinely inform our guidance with analyses of relevant data. This will be particularly useful for answering questions where there is no published research, and to determine the effect of new interventions in day to day practice.
Patients are experts in their own experience of their condition and in the effect of using a medical product. Therefore, they should be meaningfully involved throughout the medical product development process, and their views and experiences should be taken into consideration by regulators.
Both in the United States (US) and in the European Union (EU), the authorities are focused on getting better patient experience data included in applications submitted for their assessment and decision-making regarding new medicines and/or the extended clinical use of approved medicines.
The US Food and Drug Administration (FDA) recently set up a guidance framework for gathering patient experience data in a systematic and evidence-based manner, as mandated by the 21st Century Cure Act Law from 2016.
This session will provide a brief update on current and future plans that applicants need to be aware of in relation to the US as proposed by the FDA, and in the EU by the European Commission (EC)/European Medicines Agency (EMA).
Participants will be taken through the process and systems to capture patient experience data in clinical trials. Examples will be presented illustrating how patient experience data can add value throughout the drug development process and may be included in a label claim.
Patient Engagement in Global Alliance (PEGA-SUS) networking events gather interested patients and patient organizations with industry (pharma, biotech, medtech) and any other potentially interested stakeholders within healthcare around the subject of patient engagement in an informal way. Pegasus events happened in Berlin, Cologne, Barcelona, and Leiden in 2019 and brought together over 120 people.
This event will feature an interactive parliamentary-style debate moderated by Paola Kruger, EUPATI Italy, and Roger Legtenberg, Upstrong, former CEO of PSR Clinical Research, where participants will be guided through a lively debate of current issues in patient engagement in research and development.
This is the first Pegasus event of 2020 and is taking place alongside the larger Patient Partnering in Clinical Development conference and both attendees of that conference and local stakeholders interested in patient engagement will join us for the evening. admedicum Business for Patients is the initiator and administering entity and joins with other interested patient organizations and companies to create the events. PEGASUS events are not for marketing or commercial purposes. Events are a platform for networking between industry and patients and knowledge exchange.
3 March 2020
In the search for new medicines and improved treatment methods there is an ever-increasing pressure to enhance both effectiveness and efficiency of the drug and the drug development process. In order to meet these expectations it is of vital importance that stakeholders/participants are much more aligned and work closely together, that administrative hurdles are reduced and that patients, being the end-users, are consulted and included throughout the different stages of the development chain, from discovery until market introduction of the drug. It is claimed that active patient participation in the various stages of new medicines development projects will increase the (average) success rate of projects and will enhance the level of acceptance of a drug upon introduction in the market.
Having said this, it is not an easy task for the professionals who are active in the chain to realise these desired improvements. In addition, investigators and project managers are often struggling with the concept of patient involvement in their projects and how to ‘operationalise’ this. This holds true for both the earlier (pre-clinical and clinical) stages but and even more for the later (peri- and post-clinical) stages of the development process. In order to be fully convinced, some doctors and investigators feel the need to have the concept of active patient participation supported by some scientifically sound evidence that it does really add value to include this in their new way of working.
A more in-depth evaluation of the matter adds further complexity, as it reveals not just the above issue, but also numerous other roadblocks that need to be recognised, addressed and removed on the road to a successful implementation of full patient involvement.
In this lecture, some considerations, new insights and promising developments around patient involvement and participation (why/what/how) will be shared. The earlier mentioned roadblocks will be discussed, and suggestions will be given on how to overcome or remove them. Furthermore, a few successful examples will be given of approaches that enhance collaboration and active patient involvement in The Netherlands. These best practices will be used to postulate some of key success factors that contribute to realising a successful drug development chain.
Seeking feedback from patients on informed consent and support from patient organisations in patient recruitment initiatives is frequent practice by pharma companies and CROs. However, patients can and should be involved in many more processes of the new treatment development process to ensure that the new treatments are meaningful to their needs. Why is it not happening to a much larger degree? There is a multitude of reasons for the different stakeholders involved in the process reaching, e.g., from lack of interest or willingness for collaboration in patient organisations to obstacles in company/CRO structures and processes on involving patients to not being able to find each other and lack of clarity on the rules for collaboration. This presentation will provide an overview over recent developments in educating and engaging patients in different steps of the new treatment development and access to treatment processes as well as guidance on ground rules and governance infrastructure for collaboration.
Moderator: Philipp Gallwitz - Founding Partner of admedicum Business for Patients
The role of patients is more important than ever, and an empowered patient likes to engage more with its health and has rising needs for trusted information. They are taking greater control of the treatment of their disease. Getting used to modern technologies patients’ expectations on good communication are rising and easy access to reliable and understandable information becomes a must. Providing product information electronically is a first step towards better communication.
The session will talk about the benefits of changing from static product information into its electronic form, it will touch upon the current discussion on European level and highlight some ongoing initiatives.
The role of Patient Advocacy Organizations (PAOs) has been evolving over the past few decades and the impact that PAOs can have in the planning, design and execution of clinical research trials has been expanding. It is not unusual for PAOs or even individual patients and/or their care network members to be involved in the identification or refinement of disease-specific endpoints, to offer insights on protocol design or to offer advice on enrollment or retention obstacles and how to overcome them. Indeed, the industry has come to realize the benefits of engaging with patients and their care partners at almost every step of the clinical development process.
In this presentation we will explore how a CRO’s engagement with a specific PAO impacted the country and site mix in a rare disease trial, resulting in a complete change in site selection strategy. This engagement resulted in the first ever trial in this indication being placed in this specific country, all as a result of the efforts of the PAO and the CRO to dig deeper and work together to understand the treatment landscape in that country.
Engaging patients in clinical research decisions and activities seems a logic step when developing new drugs for patients. However, engaging patients is still not happening in all clinical trials as much as it could be done. This presentation will give an insight into Pfizer’s journey identifying challenges and opportunities involving patients in clinical research. A cross functional team has enabled study teams to effectively use patient insights to optimize protocol development and study conduct. Some examples of patient engagement and outcomes will be included in the presentation.
Patients say they want trusted relationships with clinical research staff based on clear, transparent communications. Yet too often patents are left feeling like they are not a valued partners in the research process. In response, Janssen developed HealthCaring Conversations for Clinical Research™, an initiative to help improve the trial experience for both patients and professionals. Based on an evidence-based communications framework, Health Caring Conversations:
- provides a universal platform for sites to forge deeper connections with all patients in all phases of the clinical trial journey
- ensures a consistent structure for sites to understand and address individual patient needs
- facilitates empowering patients via consistent, structured, and personalized conversations
There is no question about the value of patient involvement in clinical research. Depending on development phase and type of input needed, patients with specific expertise and knowledge, at least with a basic understanding of the development process for medicinal products, with own experiences as patient/parent (in case of pediatric development) in the condition to be discussed and/or foundation in patient advocacy or patient advisory groups are sought. The EUPATI competency model, for example, provides a good basis for selecting patients. Even though clinical development proceeds on a global level, standard of care varies across countries. In Germany, involvement is increasingly desired by national patient representatives. Concurrently, existing relationships between local patient relations experts of pharma companies with national patient/parent representatives and patient advisory groups can simplify interaction and attract participation, strengthen the relationship and yield additional activities for treatment-accompanying health care optimization. Using the example of a multinational patient involvement project, the two speakers will discuss how, in addition to personal competencies, choosing the right geographical representation can be relevant and value enhancing.
Presentation on the feasibility and benefits of creating a vendor/pharma independent, open source, Blockchain network to keep the real identity of the patients protected while allowing the possibility to:
- Inform patients on the outcome of the research they participated in and inform them on how their data is supporting novel medical research;
- Seek additional patient consent;
- Seek additional information from patients on treatment outcome;
- Empower the patients to choose which of their data can be used for what medical research;
- Link different anonymized datasets for more powerful advanced analytics;
- Link real world data with clinical trial data and diagnostics data;
- Avoid dual enrollment in clinical trials.
In this very early phase of the PEPS project, the purpose of the presentation is to obtain early feedback from patient engagement specialists to build the project on strong foundation.
Patients need their health data.
Pharma need PRO and RWE for new clinical trials.
Hospitals need access to patients for continuity of care.
How can all these actors of the health of tomorrow work better together while respecting their roles and values?
Vincent Keunen, CEO and founder of Andaman7, but also successful entrepreneur and cancer survivor, proposes a new paradigm: by empowering patients with their health data, they can feel safer, be more engaged in their health and contribute to the needs of hospitals and the research sector (pharmaceutical companies, medical device manufacturers, CROs and academic actors). Vincent will explain how the combination of the mobile applications and the peer-to-peer HIP (Health Intermediation Platform) can solve all three problems. In a very effective way, that reduces costs, while strictly respecting users privacy and augmenting data security.
By attending this talk, you will learn how patients, hospitals and medical researchers can work better together to find new cures and treat patients better.
Additional information available soon
Courtyard Berlin City Center, Axel Springer Strasse 55 - Berlin, Germany
Courtyard Berlin City Center is ideally located in the heart of downtown, in walking distance to many famous Berlin attractions such as Friedrichstrasse, Alexanderplatz, Brandenburg Gate, Checkpoint Charlie, Memorial of the Berlin Wall and Potsdamer Platz.
Spittelmarkt Underground Station is just a 4-minute walk from the hotel, providing connections to Alexanderplatz and Potsdamer Platz in just 10 minutes.
Spittelmarkt (270 mt.)
Berlin-Schönefeld Airport SXF (21 Km), Berlin-Tegel Airport TXL (12 Km)
Berlin Central Station, Hauptbahnhof (3,5 Km)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Cosmo Hotel Berlin Mitte (at 280 mt)
Titanic Comfort Hotel Berlin Mitte (at 450 mt)
Mercure Hotel & Residenz Berlin Checkpoint Charlie (at 500 mt)
Best Western Hotel am Spittelmarkt (at 550 mt)
On-site parking, fee: 2 EUR hourly, 20 EUR daily
La Banca Restaurant (1,1 Km), Cookies Cream (1,8 Km), Restaurant Maximilians Berlin (1 Km).
This hotel does not provide shuttle service.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.