Case Studies: Marketing Authorization & post-approval
Co-creation: Solving Issues of Patients with Product Packaging
This case study has been co-created with
Dr. Lode Dewulf
Managing Director of Corvalus
Rachel Jones
Associated Partner of admedicum® Business for Patients
Project brief
Dr. Lode Dewulf has relevant experience as patient, carer, practising physician and also industry executive. He has been among the thought leaders of patient-industry collaboration since several years, and contributed to this study case as co-founder and managing partner of Corvalus. Lode is currently working as Chief Patient Officer at Servier Group and previously worked as Chief Medical Affairs Officer and then Chief Patient Affairs Officer at UCB.
Rachel Jones is Associated Partner of admedicum® Business for Patients. She is the former Global Lead Patient Centricity at Astra Zeneca and has been instrumental in co-leading PACES, a renowned role model program of Astra Zeneca for how to integrate patients as key stakeholders across the value chain.
Situation
After launching a patch for the treatment of painful rheumatoid arthritis, a company learns from social media and physician feedback that patients experience difficulties opening the outer package. Patients with arthritic fingers need help lifting the corner to open the pouch containing the patch. More and more patients start asking for another treatment, because opening the package is a burden to them.
Objective
To interact with patients to fully understand the issue, discuss possible solutions and test the solution with patients before market implementation.
Challenge
To identify patients that struggle most with the product package, who are able and willing to be involved in re-shaping the product’s package. To set up and manage an efficient collaboration with high value outcome for patients and the company alike.
Procedure
Approach
- A cross-functional team led by marketing is formed including compliance, medical, technical, manufacturing and regulatory functions.
- Social media are being screened for more detail on the issue. The marketing team asks the sales team to discuss the challenge with physicians based on a list of specific questions.
- Medical affairs requests a personal meeting with one of the largest patient organizations for rheumatoid arthritis on the subject.
- At first the non-profit patient organization is reluctant to help, as they are concerned that supporting a commercial pharma company with the sale of a product would damage their reputation. With the help of a trusted physician and legal support, a collaboration framework is established to allow for the process, which ultimately benefits all parties involved. The patient organization starts identifying patients familiar with the issue, who would like to support the company in finding solutions.
- The team sets up a “patient engagement plan” with the objectives, actions and responsibilities. The compliance team takes part in all discussions of the planning process.
- As a first step, the company performs a number of individual interviews, packaging tests and distributes a survey among patients that have difficulties opening the pouch.
- Based on the findings, the technical and manufacturing team reconfigures its package design and adds round cut-outs on the corner that are easier for people to slip their fingers into.
- As a second step, the pouch prototype is tested in practice by patients. This results in further suggestions for improvement, that the company decides to adopt accordingly.
- Shortly following the first supply of the product with new packaging, patients start to share positive experiences on Twitter and other social media channels. Reports from physicians to the sales team also reflect the improvement.
Evaluation
What went well
The company used best practices to address the issue:
- They set up a clear plan before contacting patients.
- They asked patients about the problem in detail to fully understand the practical issues (the patient journey) before working on solutions.
- They made sure to be compliant, by having compliance representatives as integral team members from the start. This is critical for solution-oriented planning, especially when the product is already close to or on the market.
What can be improved?
If the packaging had been developed and tested right from the start, the issue could have been avoided and may have conferred some cost savings to the development team. In addition, many patient organizations are much more open to support early during R&D than once the product is close to or already on the market.
Considerations and recommendations
Preparing for a collaboration
A project plan, with objectives, milestones and timelines should be developed. Everybody in and outside the organization should be able to understand it. Be very clear on what is committed to and communicate this transparently. Please see also the case study "First Time Contact to Patients from the Industry's View" and checklist "Preparing a Collaboration" by EUPATI.
From a legal and procedural point of view, there is little difference in the approach of patients for interactions, as compared to health care practitioners. The differences mainly relate to wording, compensation and process in interactions with non-profit organizations, private people collaborating in their free-time and special needs of patients. Teams need clear compliance guidance and training about interactions with patients. There is no “one size fits all” approach. Each interaction with patient organizations and patients is different. In regard of creating the framework for a larger collaboration with a patient organization like in this case, the tools "10 Questions for Building a Patient Advisory Board" and "Draft Charter Patient Advisory Board" may be useful.
Legal compliance in interaction with patients
A good general information source for orientation regarding compliance is Patient Engagement by Pharma—Why and How? A Framework for Compliant Patient Engagement.
Preparing co-creation and user tests of packaging with patients
- Start engaging patients as end-consumer experts early in the development process for the product design - including packaging. This provides you with the opportunity to approach product design more strategically. Good guidance can be found at:
- ‘Packaging for Patient Engagement’ in PharmaExec.com focuses on how ‘adherence packaging’ helps patients be compliant to their treatment regimes.
- ‘Research through the Product Lifestyle’ by EphMRA (European Pharmaceutical Market Research Association, see 3.3.3 Sources) (registration required)
- 'Innovations in Pharmaceutical Packaging - An Update'
- ‘A Guide to the Graphic Design of Medication Packaging’- on the National Patient Safety Agency (NPSA) website – has some useful tips for ‘user testing‘, particularly on page 12.
- Identify patients that should be involved in the interaction: Tool “Patient Identification” by EUPATI.
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Tool
Considerations for Implementing Expert Patient/Patient Group Input
Recommended Contributors :
- Program leaders
- Patient liaisons
- Sponsor representatives
- Clinical investigators
- Research team
- Trial site staff
- IRB
- Expert patient(s)/Patient Group representatives
Communicating with Patients throughout the Program
- How does the phase of drug/biologic/device development process covered by this program impact communication with patients?
- What translation and/or cultural adaptions?
- Wat language will be used to communicate with and about the patients?
- Are research questions and procedures culturally sensitive and appropriate?
- How will patients be referred to (e.g. “subject” vs. “patient” vs. “participant”)?
- What is the communication plan for patients throughout the program?
- Message content
- Audience
- Messenger
- Delivery mechanisms
- Timing
- Feedback mechanisms
- What feedback mechanisms and processes are in place for the patients to comment on sites, investigators, and the study participant experience?
- What role will social media play in the communications?
- How is social media defined?
- What restrictions should there be, if any?
- How can social media be used to advantage (e.g. for trial recruitment, to educate patients)?
- What limits should be placed on use of social media, if any? Why?
- How will those limits be communicated and enforced?
- What methods will be used to interact with patients and other stakeholders?
- Focus groups
- Interviews
- Surveys
- Inclusion on advisory councils
- Inclusion in meetings with researchers
- What data/information can and will be shared with the patients and when?
- Aggregate (de-identified)
- Patient-specific
- What are the restrictions (propieratry and regulatory) constraining the release of data?
- How do we ensure that this information is shared in patient-friendly language? How will that be determined/monitored?
Additional resources
Communication Handbook for Clinical Trials.
Guidance for Biomedical HIV Prevention Trials, p 37-38: “Stakeholder education plan.”
Checklist
Preparing a collaboration
Defining the interaction
Patients, patient representatives and industry should take responsibility to ensure interactions are meaningful by clearly defined processes and actions, progressed to timelines. In addition, all participants should be prepared for the interaction.
Prior to each interaction, agree mutually on (where applicable):
- The objective of project involving patients and/or areas of common interest to establish agreed structured interaction, providing all parties with necessary protection with regards to independence, privacy, confidentiality and expectations (see section 11. written agreement)
- The type of input and mandate of the involved person
- The tools and methods of interaction, e.g. types and frequency of meetings, ground rules, conflict resolution, evaluation
- Desired patient / patient partner organisation to foster long-term working partnerships, with independence ensured (in scope)
- The profile of the type of patient/s or patient representatives/s to be involved and their number
- How activity outputs will be used and ownership of outputs
- How and when the patient/s involved will be informed of outcomes
- Contractual terms and conditions including consent and compensation (see section 11, written agreement).
- Other elements according to the specific project
Source
Checklist
Preparing a collaboration
The four key principles for collaboration:
1. Clarity of Purpose
Each party should be clear about the reason for and the planned outcome of the collaboration – and the ultimate benefit for patients
2. Integrity
Each party should act and be seen to act honestly and with integrity at all times
3. Independence
Each party should maintain their independence
4. Transparency
Each party should be open and honest about the purpose of the collaboration and be able to account publicly for the associated activities and any exchanges of funding
Using this guide: a checklist
- Has there been a frank discussion about the purpose and expected benefits of the collaboration, and any risks, addressing all the issues in this guide?
- Are the objectives and planned outcomes of the collaboration specified?
- Are the roles of each partner and reporting mechanisms specified?
- Has a written agreement or contract been put in place, which sets out how each party will adhere to the four key principles?
- Is there a named senior individual accountable for managing and maintaining the relationship and monitoring adherence to the four key principles?
- Is information about the collaboration published on the company and charity websites?
- Can each party confidently explain the collaboration in public?
Source: National Voices, The Association of the British Pharmaceutical Industry (ABPI) (2015): Working
Tool
List of useful conferences
Conferences with and for patients
Rare diseases conferences with and for patients
The Global Orphand Drug Conference and Expo
Indication specific conferences with and for patients
Tool
Defining role patients
Although you may not have selected the expert patients or patient groups (EP/PGs) yet, outlining their roles and responsibilities at this stage helps to define your needs. Keep in mind that EP/PG roles may vary at different of the program or may evolve in response to new requirements. Once selected, discuss the roles with your EP/PGs to clarify what they can contribute based on their unique expertise and experience and avoid misunderstandings at the outset, e.g., if they’re expecting to have a partnership role but you’ve designed reactor role (see Types of Patient Roles chart below).
| Patient Role | Examples | Engagement Level |
| Partnership role |
| High |
| Advisor role |
| Moderate |
| Reactor role |
| Low |
| Trial or study participant |
| None |
Source: DIA (2017): Considerations Guide to Implementing Patient-Centric Initiatives in Health Care Product
Development. (02/06/17)
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Checklist
Preparing a collaboration
Defining the interaction
Patients, patient representatives and industry should take responsibility to ensure interactions are meaningful by clearly defined processes and actions, progressed to timelines. In addition, all participants should be prepared for the interaction.
Prior to each interaction, agree mutually on (where applicable):
- The objective of project involving patients and/or areas of common interest to establish agreed structured interaction, providing all parties with necessary protection with regards to independence, privacy, confidentiality and expectations (see section 11. written agreement)
- The type of input and mandate of the involved person
- The tools and methods of interaction, e.g. types and frequency of meetings, ground rules, conflict resolution, evaluation
- Desired patient / patient partner organisation to foster long-term working partnerships, with independence ensured (in scope)
- The profile of the type of patient/s or patient representatives/s to be involved and their number
- How activity outputs will be used and ownership of outputs
- How and when the patient/s involved will be informed of outcomes
- Contractual terms and conditions including consent and compensation (see section 11, written agreement).
- Other elements according to the specific project
Source
Download
TOOL
10 Questions for Bulding a Patient Advisory Board
This list of questions is non-exhaustive but may help with making a strong start. We recommend to discuss these questions with internal and external people you trust and may want to have on board.
- Why do you want to set up a Patient Advisory Board? (mission statement)
- What are the specific objectives and the anticipated outputs?
- Are you willing to share these objective, critically discuss and communicate them openly to all prospective board members? (If not, this may be prohibitive for setting up such board.)
- If confidentiality for content is required, how do you provide for it? E.g. will participants have to sign a Confidential Disclosure Agreement (CDA) prior to working with you? What does that mean to the process and selection of candidates?
- How often do you think the Patient Advisory Board needs to meet and how much time does the engagement require the patient advisor and your organization to dedicate to the Patient Advisory Board? Is that realistic?
- Do you have your management’s sponsorship for working with the Patient Advisory Board and for spending the time, resources and money on such an effort?
- What are the skills/profiles of the participating Patient Experts you want as advisors?
- Who from your organization and/or outside your organization should participate in the Patient Advisory Board meeting(s)?
- Who will chair the Patient Advisory Board and lead the meeting and follow up? Will you need an external facilitator?
- How will the logistics, compensation and legal compliance be provided for, including contractual arrangements? As you are working with patients, facilities may need to be adapted.
For more general guidance and detailed questions have a look at these sources:
EFPIA Guide “Working Together with Patient-Groups”
D.I.A. ConsiderationsGuide to Implementing Patient-Centric Initiatives
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Draft Charter for a Patient Advisory Board
This charter is designed for open communication with all potential Patient Advisory Board members inside and outside your organization and any other party interested in the purpose of the Patient Advisory Board and the nature of the attendees. Please note that Transparency Codes apply.
We strongly recommend to use this only as a proposal for clarifying your own thinking first and then ask all other involved stakeholders (patient experts, Key Opinion Leaders, others) to comment and add as appropriate. You may even start with an open discussion before drafting with some of the potential advisors you know you want to have on the board. The final charter should be the reflection of the major points agreed upon between the collaborators about why to collaborate on what and how to do that.
Purpose / Mission and Objectives
The “insert Name of the Board” shall contribute to (specify)…
- Describe what your company is currently doing, why this requires patient advice and what you hope to achieve from it.
- Describe the specific objectives the Board should strive to to achieve in as much detail as possible (“to learn / get insight / discuss…”). Try to put yourself into the shoes of the potential patient advisory board member reading this who shall make a judgement call on whether to join or not based on this charter.
- Input from (already) appointed members of the board, both inside and outside your organization, is valuable to improve the charter.
Members and Responsibilities
The “insert Name of the Board” consists of (specify)…
Describe the desired profile of the external and internal board members and their expected roles:
- Who should chair the Board? Is an independent, external chair required? And what are this person’s responsibilities? e.g. The Board will be chaired by “insert name and function”. The Chairperson is responsible for preparation of the meeting including draft agenda for input by the Board, final agenda, moderation of the Meeting itself, Meeting Minutes and any follow-up items.
- Describe the Patient Advisors on the board and their roles, names and backgrounds/functions:e.g. “There will be 5 Patient Advisors on the board:
- a Patient Advocate on behalf of Patient Organization A
- a Patient Advocate on behalf of Patient Organization B
- 2 patients diagnosed with (specify indication), who have experience with (specify, e.g. specific treatment, a specific patient support program or more general “clinical development in disease X”)
- an experienced patient nurse / a social worker / a caretaker
- Describe the employees of your organization who should be on the board and their expected roles, names and functions: e.g. “There will be 5 Company Representatives on the board:
- The Head of Clinical Development
- The International Project Lead
- The Head of Market Access
- etc.
- an experienced patient nurse / a social worker / a caretaker
- Describe any other external Advisors (e.g. physicians) you may want to have on your board and their expected roles
Organization and Logistics of the Patient Advisory Board
The “insert Name of the Board” will meet (specify)…
- Describe in detail the frequency of meetings, whether they are in person or via phone/web conference, the duration and location
- Clarify whether confidentiality agreements are in place and provide for the board members’ freedom to communicate about the confidential information between each other: e.g. “The board meetings will be subject to confidentiality as agreed individually in written form between the company and the board members.”
- Make sure provisions are taken to ensure all Board members “speak the same language”, hereby taking into account not everyone may be fluent in English and avoiding misinterpretations. Also, local boards can be in a different language: e.g. “All board materials and the board meetings will be in English language. Where needed translation of materials and during meetings will be provided for.”
- Make sure all participants agree on time needed for preparation, e.g.: "Board members shall prepare for the board meetings based on the material provided by the Chair, which shall not exceed more than (…specify estimated time…) per board session.”
- Provide for detailed loops before, during and after each session regarding possibly required adaptations.
Source: This charter has been developed by admedicum® Business for Patients GmbH
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Checklist
Patient identification/interaction
Patient identification/interaction
There are many ways to identify patients to be involved in an interaction. The main routs are through:
- existing patient organisations
- EUPATI or similar project
- advertising opportunities for patient participation
- existing relationships with healthcare providers, hospitals and researchers and other agencies
- unsolicited requests previously made by interested parties
- existing advisory boards / groups (e.g. EFPIA Think Tank, Patients and Consumers Working Party at the EMA)
- this party agencies
Source: European Patients’Academy on Therapeutic Innovation (EUPATI) (2016): Guidance for patient involvement for industry-led medicines R&D. (12/06/17)
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Checklist
Patient identification
There are many ways to identify patients to be involved in an interaction. The main routes are through:
- Existing patient organizations
- EUPATI or similar project
- Advertising opportunities for patient participation
- Medical Key Opinion Leaders. healthcare providers, hospitals and researchers and other institutions
- Systematic social media search for patient exchange platforms
- Unsolicited requests previously made by interested parties
- Existing advisory boards / groups (e.g. EFPIA Think Tank, Patients and Consumers Working Party at the EMA)
- Specialized patient engagement agencies
Source: European Patients’Academy on Therapeutic Innovation (EUPATI) (2016): Guidance for patient involvement for industry-led medicines R&D. (12/06/17)
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