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Why the FDA Loves Complex Generic Drug Products

Key Points FDA Commissioner Scott Gottlieb has initiated multiple policy actions to simplify the approval pathway for generic drug products Commissioner Gottlieb hopes these efforts will improve access to medications and lower healthcare costs The FDA has placed special focus on “complex” generic drug products, which have traditionally been difficult to “genericize” New policies are […]

Pharmacovigilance and Pharmacogenomics in the Digital Age: the EU General Data Protection Regulation (GDPR)

Pharmacogenomics: A Brief Introduction Pharmacogenomics is the study of the role of the genome in drug responses. That is, it identifies genetic loci associated with known drug responses on a population-level. Some of the current pharmacogenomic approaches used include multigene analysis and whole-genome single nucleotide polymorphism profiles. Subsequently, the genetic variants affecting an individual’s drug […]

The Role of Human-Centric Design Thinking in Healthcare

By Karin Bauer, VP Client Services, SGK Health Healthcare is an empathy-driven industry. But as healthcare consumers seek to become more empowered, changes in healthcare information gathering and sharing across systems have created a disconnect between the quantity of information available to empower care choices and the quality of care that patients receive. To win consumer confidence […]

Intellectual Property Protections for the Algorithms Used by the Healthcare Industry to Decode Big Data

Background As healthcare stakeholders begin to embrace real world evidence, along with many other forms of big data applications, there remains the issue of how to protect the underlying algorithms that derive meaning from this data. An algorithm is a very broad term that typically refers to the equations and/or a series of steps for […]

Tactical war games/competitive simulations to gain share

Tactical war games are generally used for strengthening detailing in product launches and to develop successful counter-messages to competitors that are gaining share. Definitions and main hypothesis: A tactical war game is a simulation of a typical sales visit to get a thorough knowledge and understanding of the competition’s sales approach to develop own alternatives […]

Real-world Data, Drug Access, and Digital

What are “Real-world Data”? “Real-world data” (RWD) refer to data collected in a real-life setting within a heterogeneous population. That is, not in a randomized controlled trial (RCT). In turn, analysis of these multi-source data provides real-world evidence (RWE) supporting the value of a product. This is especially important to confirm its long-term safety and […]

Unlearning Old Programming

Albert Einstein is widely credited with saying, “The definition of insanity is doing the same thing over and over again, but expecting different results.” While I do not view that choice as insane, I do see it as a common trap that most, if not all, in pharmaceutical sales seem to make. Here is how […]

In Pharma…Without Digital, It’s not a Strategy

LIFE SCIENCES FORCES OF CHANGE New and often asymmetrical competition is reshaping the market. Disruption is the new normal, the pace of innovation is accelerating, and data more important than ever. Furthermore, we have entered the era of the Millennial healthcare providers (HCPs) & patients with technology-dependent expectations and empowerment regarding care treatment, research and […]