Medical Affairs Transformation in Specialty Pharma: Next-Level Collaboration at the Core.

Pharmaceutical companies with a medical mindset and an empowered Medical Affairs function are well equipped to meet the needs and expectations of patients and society. Yet, as capacity to understand and serve those needs accelerates, so too do expectations. Evidence-based practice, without delay, is expected throughout the development and delivery of medicine, healthcare, and information, and potential sources of evidence are legion. To keep pace and go beyond, to innovate, requires efficiencies. Not the disguised cutbacks of political language, but the collaborative constructive efficiencies of shared learning, forming new evidence bases for further progress. Here, we describe the first year of a medical transformation process at a global mid-sized pharmaceutical company. Beginning with a broad review designed to leverage collective intelligence and focus on meaningful outcomes for patients, this process examined and reshaped the structure, culture, and tools of the medical organization and its interactions within and outside the company. We report the findings of the diagnostic phase, outline the solutions implemented to date, and anticipate the next steps in this dynamic evolving journey.

Investigating muscle selection for botulinum toxin-A injections in adults with post-stroke upper limb spasticity.

BACKGROUND: Limited empirical information exists regarding botulinum toxin-A injector decision-making practices for adult upper limb post-stroke spasticity. The design of most studies prevents such an assessment, as injection sites and dosage are mandated by researcher protocols. This contrasts to usual injector practices, where individualized decision-making is the standard of care. DESIGN: Secondary data analysis from an Australian randomized controlled trial of 90 adults with upper limb post-stroke spasticity where experienced clinicians followed their standard clinical injecting practice rather than a mandated injection regimen. METHODS: Clinicians were hypothesized to tailor their injection practices according to the subject's degree of spasticity and/or the type of functional gain desired. Hypothesis testing was conducted using non-parametric analysis. RESULTS: Muscle selection and botulinum toxin-A dosage were not significantly associated with spasticity severity or with patient-identified goals. Between-site differences in injection practices suggested that injector beliefs, rather than patient characteristics, were the dominant feature driving botulinum toxin-A injection strategy for post-stroke upper limb spasticity. CONCLUSION: This result looks into the "black box" of rehabilitation, revealing significant variation in injector beliefs. Findings suggest that further scientific work is required to maximize the efficacy of botulinum toxin-A injections in post-stroke upper limb spasticity management.