Pharmaceutical Strategy Workshops
The two pharmaceutical strategy workshops are the Innovative Medicines Initiative (IMI) - Patient Engagement Strategy Workshop conducted in Brussels, Belgium and the DIA - Value, Access & Regulatory Strategy Workshop conducted in Basel, Switzerland.
1. Innovative medicines initiative (Imi) - Patient engagement strategy workshop
- IMI is considered as the "world's biggest public-private partnership (PPP) in the life sciences".
- It is a partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations).
- The IMI - Patient Engagement Strategy Workshop was conducted on April 27-28, 2016 in Brussels, Belgium.
- Participants include representatives of patient organizations, foundations, consumer organizations, regulatory bodies, the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), and non-profit organizations.
- This strategy workshop is conducted to identify 1) appropriate levels and mechanisms of involvement of patients in IMI and its projects; 2) strategy for optimizing and coordinating patient engagement practice; and 3) possible future research projects for IMI on enabling patient involvement in the medicines' life cycle.
- The workshop is discussion-based and there was no detailed information on the tools used but brochures and printed copies of the presentations were available based on the downloadable files in their website.
- The workshop started with a networking dinner.
- Discussions (advancing patient engagement in IMI)
- Presentation of case studies
- Discussion of themed topics and reporting for session 2 of the workshop
- Stakeholder views and open-floor discussion
METRICS OF SUCCESS/EFFECTIVENESS
- Effectiveness of the workshop was reflected in the summary report where outcomes of the discussions pointed to ways of ensuring meaningful and successful patient engagement in research projects.
- Its success was manifested in the development of an infrastructure/solution for the European/international landscape and training on the content and processes of medicines development (building on EUPATI) including patient groups not previously covered (pediatrics, geriatric, and elderly among others).
- The KPIs employed by IMI include the number of relevant priority areas in the WHO "Priority Medicines for Europe and the World 2013 Update", the total number of project-developed assets which complete a significant milestone, new or improved guidelines, methodologies, tools, technologies or solutions accepted by regulatory authorities for use in the context of R&D, contribution (in-kind or in-cash) from nonpharma actors (e.g. non-pharma industries, foundations, charities, professional organizations), and share of IMI projects whose resources/outputs are made accessible beyond the consortia partners, among others.
2. DIA — Value, Access & Regulatory StrategY Workshop
- This strategy workshop was conducted on October 25-26, 2017 at Basel, Switzerland.
- Participants include professionals working in regulatory affairs and HTA/market access, professionals involved in drug development (e.g. clinicians, epidemiologists, and biostatisticians), patient organizations, Biotech companies, drug developers including SMEs and decision makers (e.g. Ministries of Health).
- Concepts learned in this workshop include acceptance of RWD by HTA bodies/payers, early access to market, definition of unmet medical needs, alignment on evidence requirements across EU and between regulators and HTA, methodologies for HTA and pricing of products in combination or several indications, multi-stakeholder dialogue that optimized market access and product affordability, and patient’s role in the regulatory and HTA process.
- The next schedule is on October 24-25, 2019 at Basel, Switzerland.
- For the 2019 strategy workshop, featured topics include patient role/involvement, post-licensing evidence generation, regulatory vs. access views, and unmet medical need and evidentiary standard, among others.
- The workshop started with registration and welcome coffee.
- Discussion/Presentation from different stakeholders' perspective
- Four to five sessions per day with panel discussion and question and answer portion after the presentations
METRICS OF SUCCESS/EFFECTIVENESS
- The effectiveness of the strategy workshop was measured through an evaluation form available online.
- Another strategy workshop with the same title will be conducted again in October 2019, indicating that it has been successful and has met its goal to be repeated.
We were not able to provide pre-compiled case studies (with success metrics) of strategy workshops in the pharmaceutical industry but we have provided information on two strategy workshops with details regarding its overview, structure, and materials. We initially searched on pharmaceutical industry-specific websites, organizations, and associations for case studies of their strategy workshops but it was unavailable. We only get schedules, overviews, and reports of the available workshops. We also searched for scholarly articles on websites for pharma industry strategy workshops but we were not able to find one.
On Choosing IMI - Patient Engagement Strategy Workshop:
Although this was conducted in 2016, we chose this workshop because it is a strategy-focused workshop around business operations addressing issues such as the regulatory environment concerning its participants like representatives of patient organizations and foundations. IMI's Patient Engagement Strategy Workshop is the latest strategy workshop conducted under its 2014-2020 program.
On Tools and Success Metrics:
There was limited information we can pull out for the tools used and success metrics for the workshop since the organizations did not publicly provide them. For IMI, we tried to look for available metrics in IMI annual report but the report of the effectiveness of the workshop was not detailed. Based on IMI's report that the goal/objective of the workshop was achieved, the workshop can be considered successful. For the DIA strategy workshop, we also tried to look for the success of the workshop by looking through its annual report but there was no specific mention of the effectiveness of the strategy workshop. The available information was the success of the whole organization. But since the specific workshop (same title) will be conducted again in 2019, it indicates that it has been successful and has met its goal to be repeated.