About Marina Ness

Director of Research, Inspire, Public health and policy researcher with experience in pharmaceutical market research, healthcare data management, and health policy analysis. 5+ years expertise in a wide range of health domains, including: clinical trials, addiction medicine, public health emergency management, health security, rare disease, mental health, women’s health, infectious disease, and vaccination. Background involves both qualitative and quantitative data analysis and visualization.

FDA Finalizes First of Four PFDD Industry Guidances

FDA Finalizes First of Four PFDD Industry Guidances By Marina Ness, MA On June 16th, the FDA released the final version of “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” This document, referred to as Guidance 1, advises industry on methodologies they can use to collect patient input that will be considered scientifically valid for the drug and device regulatory approval process -- including guidance on using input from social media. It is the first finalized version of the set of four planned guidances for making the patient perspective part of FDA regulatory approval. All of the [...]

Diversity in Clinical Trials: Being Left Out

Diversity in Clinical Trials: Being Left Out By Marina Shayevich Why do African Americans develop breast cancers with significantly higher basal gene expression? 1 Why do Hispanics develop type II diabetes at an earlier age than other groups? 2 Understanding the functional reasons for disease processes is necessary to develop targeted treatments. Yet because clinical research lacks sufficient diversity, reasons for and mechanisms of disease development are not fully understood. Some reasons for minority patient under-representation in clinical trials are known. For example, strict eligibility criteria, like chronic kidney disease,3 hypertension or diabetes exclusions, leave out many groups, [...]

Social Listening to Understand the Unmet Needs of Patients

Social Listening to Understand the Unmet Needs of Patients By Marina Shayevich and Sara Ray Across healthcare, patients lament the imperfection of pharmaceutical treatment. Although grateful to have life saving and life improving medications, patients are often met with frustration at the limitations of their medications. Nowhere is that more evident than in rare diseases, where the rarity of the illness may lead to a scarcity of available, approved pharmaceutical treatment options. Many patients are left to turn to off-label medication use in the effort to get the best solution possible. Even then, these treatments do not [...]