Key Steps Toward a Promotional Communications Strategy: Collaboration Best Practices for Teams Creating Promotional Materials and Regulatory Colleagues.

A promotional communications strategy is considered early in prescription medical product development by commercial disciplines (e.g., commercial/marketing) and informs promotional materials to key stakeholders such as healthcare providers and patients. Health economics and outcomes research (HEOR) is a scientific discipline that is also responsible for the generation of promotional materials to other key stakeholders such as payors. The overarching promotional strategy benefits from consistent partnerships with regulatory affairs colleagues, culminating in cost savings and patient-centric promotional materials. Yet there is a paucity of published content that details effective collaboration between promotional teams and regulatory colleagues prior to medical/legal/regulatory (MLR) review. The following review aims to showcase such organizational innovation from the perspective of teams developing promotional materials (i.e., commercial and HEOR). Behind-the-scenes marketing activities are described in relation to the following key steps that build the strategy's foundation: insight gathering from key stakeholders; sub-strategy development; tactic identification; and promotional message development. Integration of regulatory colleagues with teams developing promotional materials is imperative to accomplish these key steps prior to any MLR review. Finally, four themes in best practices for collaboration with regulatory colleagues are shared from the perspective of commercial disciplines and HEOR, alongside a real-world example for each: (1) Alignment of Strategies; (2) Shared Process & Tools; (3) Creative Problem-Solving; and (4) Culture of Connecting.

An Evolved Approach to Advisory Boards in Rare Disease Drug Development: 5-Step Model to Finding and Engaging Patient Advisors.

Nearly all new product development teams at pharmaceutical companies will routinely conduct patient advisory boards. These board meetings will help collect and document the experience of patients and caregivers for medical product development and regulatory decision-making. Recently, in June 2020, The US Food and Drug Administration (FDA) published a final guidance on methodological patient-focused drug development (PFDD) to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers, and others) can successfully use these patient forums. In the process of developing this guidance, the FDA acknowledged that leading its own PFDD meetings, especially when limited to organized disease advocacy groups, cannot address the gaps in information on the patient perspective. So, it has expressed support for advancing the science and utilization of patient input other means. Because traditional methods of conducting patient advisory boards often do not achieve the full potential of patient centricity, the authors of this article share an approach to consider when selecting patient advisors, in order to gain the most actionable input to a product development team.

A seven-year experience in expedition medicine: the Juneau Icefield Research Program.

There have been relatively few attempts to document the optimal medical support for wilderness expeditions, and none of these previous reports includes physician-level providers. Here we document our experience with physician-level medical support to an annual wilderness expedition in Alaska. This report utilizes data collected from 1994 to 2000 as part of the medical response to the Juneau Icefield Research Project, an annual research expedition to the Alaskan wilderness involving up to 60 students and professors. Medical supplies and equipment were catalogued, and 7 years of medical logs were reviewed with data presented in descriptive fashion. The majority of diseases encountered included gastrointestinal illness, minor orthopedic injuries, urinary tract infections, illness related to sun exposure, and kidney stones. Several patients required evacuation by helicopter to the nearest medical facility. The logistical challenges of medical treatment in this setting are discussed.