Building the case for developing a medical affairs patient-centric framework collaboratively.

Within the biopharmaceutical environment there are increased expectations for medical affairs to serve as a patient understanding facilitator, engagement champion and empowerment enabler. The collaborative development of a medical affairs patient-centricity framework to characterize avenues of medical affairs patient-centric activity could enhance transparency of objectives, input and outputs of medical affairs interactions with the patient. This article presents an initial opinion regarding how medical affairs interacts with patients to advance patient centricity. The proposal: medical affairs engages and collaborates with patients through strategic leadership, medical communication, evidence generation, patient engagement and experience of patient care. Once validated, such a framework's implementation could help clarify medical affairs competencies and behaviors necessary to optimize associated effort.

PAUSE: A Patient-Centric Tool to Support Patient-Provider Engagement on Menopause.

There are powerful demographic, political, and environmental trends shaping women's health. Increases in life expectancy, literacy, and empowerment are fueling expansions in education and advocacy. Research and development focuses on women's health and fertility across an expanded age spectrum. There is also a cultural emphasis on antiaging and aesthetics. In parallel, the digital revolution is changing how health care is accessed by and delivered to women. A women's journey through menopause is at the crossroads of these transformations. Medical and social platforms encourage women to embrace menopause as a pivotal life stage. Yet, many women are reticent to discuss "the transition" due to embarrassment about its symptoms, lack of awareness of its physical manifestations, or fear of aging. We introduce a patient-centric framework to support patient-provider engagement on menopause: prevention, anxiety, urogenital symptoms, vasomotor symptoms, and education. Although not comprehensive, PAUSE represents an acronym and reminder to focus a portion of the medical interaction on menopause.

Precision medical communication to optimize stakeholder information exchange: a '4M-Quadrant' approach.

Personalized and precision medicine concepts have transformed the healthcare delivery environment from research and development to commercialization. Precision medical communication (PMC) represents a strategy to maximize personalized healthcare elements in medical-related exchanges to optimize value from the activity for the associated stakeholders. It is a discipline of developing the right message through the right mechanism at the right moment to the right healthcare member. PMC enhances the value of information exchange among stakeholders because it integrates data, analytics, and environmental and medical insights to efficiently disseminate more precise content to specified audiences in a balanced and compliant manner.

A Patient Centricity Team Tool to Enable Patient-Focused Drug Development.

In order to better understand and advance the field of patient-focused drug development, a multifunctional patient affairs team developed and piloted a Patient Centricity Team Tool (PCTT) within a large pharmaceutical organization. The tool is a computer-based survey designed to interrogate the frequency of team efforts in 20 areas of patient centricity across 4 dimensions: people, purpose, process, and actions. Results from a pilot with a Phase III product team indicate a spectrum of team activity of different frequencies related to patient-focused drug development. Given the lack of tool validation, interpretation of results remains a reflection of the team, asset, and lifecycle stage as opposed to a diagnostic of activities. Over time and with increased use across teams, tool implementation and associated learnings may yield organizational, product, and ultimately patient benefits.

Will biomedical innovation change the future of healthcare?

Healthcare costs in all industrial nations have increased and payors are starting to look at new ways to contain costs and at new funding models. The business model of pharmaceutical companies is also undergoing rapid changes - potentially disruptive new modalities, such as RNAi, therapeutic vaccines, and cell therapy are emerging, R&D costs have increased year on year, pressures on drug pricing and the efficacy and safety of medicines are mounting. Change is therefore inevitable and already ongoing in healthcare systems and pharmaceutical companies alike. This paper presents several major forces which could drive different future scenarios including: R&D costs, the source of payments for medicines and the emergence of new modalities.