Novartis Corp.

Medical Information has a strategic role that extends beyond inquiry management. The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 35 US pharmaceutical companies was conducted to describe the current landscape and future opportunities of other services Medical Information could provide.

In July 2023, an electronic survey containing 57 closed and open-ended questions was distributed to phactMI member companies. The survey questions addressed demographics, medical review, development of materials, training, patient services, insights, and awareness.

Medical Information is a significant contributor to the medical review of promotional healthcare provider materials (51%), patient materials (52%), and non-promotional medical materials (45%). Medical Information ensures the accuracy of medical information, fact checks and validates claim accuracy. Fifty percent of the respondents are responsible for reviewing and/or contributing to Medical Affairs material for Field Medical. Additionally, Medical Information trains both Field Medical and Sales teams on the Medical Information function, and to a lesser extent, disease state information. The majority (75%) of Medical Information Departments offer patient information. The vast majority (85%) produce and identify insights. Medical Directors, Field Medical, and Scientific Communications/ Publications often receive shared insights. Fewer individuals integrate insights with Field Medical and Medical Directors. Since 2018, Medical Information activities have seen a rise in advisory board presentations, insights reporting, publications, competitive intelligence, disease state education, surveillance, pathway submission, and labelling activities. Building awareness is still an important aspect of Medical Information and most focus on the development of their Medical Information website.

The essential roles and activities of Medical Information Departments support products at every stage. Medical Information participates with multiple functions in evaluating medical materials and there is a growing trend of including Medical Information in the development and review of Medical Affairs materials. Medical Information has expanded its participation in pathway submissions, publications, and labeling activities. This benchmark for Medical Information can provide a potential best practice template for activities. For the future, the three areas to prioritize are: increasing the strategic value and KPIs of Medical Information, integrating and overseeing AI technology in the insights process, and improving internal visibility.

While high-sensitivity C-reactive protein (hs-CRP) is a marker of inflammation and higher cardiovascular risk, its association with health status (symptoms, function and quality of life) after acute myocardial infarction (AMI) is unknown.

Among 3410 patients with AMI from the TRIUMPH (N = 1301) and VIRGO (N = 2109) studies, we compared 1-year generic (Medical Outcome Study Short Form-12 and Euro Quality of Life Visual Analog Scale) and disease-specific (Seattle Angina Questionnaire) health status outcomes in those with hs-CRP ≥2 mg/L vs. <2 mg/L. In hierarchical linear regression models, we examined the association of 30-day hs-CRP levels with 1-year health status without adjustment, after adjusting for 30-day health status, and after adjusting for demographic, socioeconomic, disease severity/comorbidities and treatment characteristics.

The median (25th, 75th percentiles) 30-day hs-CRP was 2.6 (1.1, 6.1) mg/L and 59% had hs-CRP ≥2 mg/L. Statin therapy was used in 92% of patients at hospital discharge. Thirty-day hs-CRP ≥2 mg/L was inversely associated with all 1-year health status measures in unadjusted and partially adjusted models, but not in fully-adjusted models. Results were similar when hs-CRP was analyzed as a continuous variable.

While elevated hs-CRP 30 days after AMI was associated with worse health status in unadjusted analyses, this was not significant after adjusting for comorbidities, suggesting that hs-CRP may be a marker of comorbidities associated with worse health status. Whether reducing inflammation in AMI patients will improve health status should be tested in ongoing trials.

β2-Agonists are the most common form of treatment of asthma, but there is significant variability in response to these medications. A significant proportion of this responsiveness may be heritable.

To investigate whether a genome-wide association study (GWAS) could identify novel pharmacogenetic loci in asthma.

We performed a GWAS of acute bronchodilator response (BDR) to inhaled β2-agonists. A total of 444,088 single-nucleotide polymorphisms (SNPs) were examined in 724 individuals from the SNP Health Association Resource (SHARe) Asthma Resource Project (SHARP). The top 50 SNPs were carried forward to replication in a population of 444 individuals.

The combined P value for four SNPs reached statistical genome-wide significance aftercorrecting for multiple comparisons. Combined P values for rs350729, rs1840321, rs1384918, and rs1319797 were 2.21 × 10(-10), 5.75 × 10(-8), 9.3 × 10(-8), and 3.95 × 10(-8), respectively. The significant variants all map to a novel genetic region on chromosome 2 near the ASB3 gene, a region associated with smooth muscle proliferation. As compared with the wild type, the presence of the minor alleles reduced the degree of BDR by 20% in the original population and by a similar percentage in the confirmatory population.

These GWAS findings for BDR in subjects with asthma suggest that a gene associated with smooth muscle proliferation may influence a proportion of the smooth muscle relaxation that occurs in asthma.