With so much information readily available companies have lost a significant level of control over how and when details about their progress in drug development and planning related to approval, launch, and commercialization are disseminated.
External stakeholders, including patient advocates, physicians, payers, and other healthcare providers, have access to a wide range of business information about pharmaceutical and life sciences companies, including details about progress in drug development, clinical data, pricing strategies, patient access strategies, and even company earnings. Most of this information is available in digital format and can be shared electronically. Not surprisingly, stakeholders are using this information advantage to exert influence over important goals and decisions for the industry – including efforts to advance drug development programs and strategies related to pricing, market access, and many other issues. This scenario requires new strategic approaches in effective stakeholder engagement.
With so much information readily available – often in real time – companies have lost a significant level of control over how and when details about their progress in drug development and planning related to approval, launch, and commercialization are disseminated. They also have less control over how dissemination of information might affect their goals for commercialization and business development. The explosion of online connectivity also means that external stakeholders can now organize, share information, and take action with lightning speed. The situation is made more complex by the fact that there are often multiple stakeholders established within many disease states, who often have conflicting priorities and interests.
In this environment, industry must take steps to identify and carefully assess the influence and interests of all the stakeholders within their target disease state. This includes efforts to analyze the often complex interrelationships and overlapping priorities among stakeholders. Industry must develop a cohesive and flexible strategy for engagement that reflects the full range of communities, opinions, and priorities. Only after developing a strategy should a company consider executing a plan in stakeholder engagement. While stakeholder engagement plans must always be customized to address unique factors associated with a drug development program and disease state, we outline below six steps that can help maximize the prospects for success in light of the evolving dynamics in stakeholder relationships:
1. Set clear goals for engaging with stakeholders right from the beginning.
2. Identify the appropriate contacts for engagement and confirm whether there are any existing relationships established with contacts from your company.
3. Use your assessment of each organization’s areas of interest, expectations, concerns and current positions as the foundation for dialogue and to integrate each relationship into an overall strategic approach to stakeholder engagement.
4. Test your company’s position on the issues important to stakeholders, including those that may not be internal priorities. Take steps to coordinate external relationships across all relevant internal functions to take account of your positions and maintain consistency in messaging.
5.Plan a targeted and relevant program around core objectives and stakeholder interests that is designed to improve understanding and drive actions.
6. Be clear about what your company hopes to get out of the engagement at every stage and commit to regular long-term interaction.
By following these steps, your engagement with communities of well-informed stakeholders will consistently be relevant, impactful, and integrated across all groups. Given the speed of communication and information sharing, industry must deliver information to stakeholders rapidly and comprehensively. Concurrently, insights from target groups must be continually acknowledged and addressed.
Working with third parties
The complexities and challenges in stakeholder engagement has led to the emergence of third-party organizations that are positioned to help both industry and stakeholders streamline and maximize the benefit of these relationships. For example, Alliance for Patient Access (AfPA) is a nonprofit physician-led advocacy group that often serves as a platform where external stakeholders collaborate in developing advocacy initiatives focused on issues impacting patient access. In that role, AfPA can act as a bridge that permits industry to engage effectively with relevant stakeholder communities including clinicians and patients. While working with external groups like AfPA can require industry to relinquish some control, it can bring a level of objectivity and balance to stakeholder relationships that can be critical to success.
Even with the involvement of third-party facilitators, all stakeholder engagement programs require pharmaceutical and life sciences companies to invest both time and resources in the process. This investment will expand as the development program progresses. It is generally advisable for companies to engage with advocates and other stakeholder groups early in the clinical development process, even when these efforts might not deliver tangible results for several years. By recognizing that stakeholders are typically very well-informed and able to mobilize quickly, careful strategic planning and a responsive approach in building and managing relationships can help companies better navigate the evolving stakeholder landscape in the years ahead.
Andrew Butcher is a vice president in the Life Sciences Practice of CRA (Charles River Associates) and Brian Kennedy is executive director of the Alliance for Patient Access, a national network of physicians focused on policy matters impacting patient access.
The views expressed herein are the authors’ and not those of Charles River Associates or any of the organizations with which the authors are affiliated.