Pharmaceutical companies face compliance and reporting requirements of the Physicians Payments Sunshine Act of the Affordable Care Act. Many companies are trying to meet these requirements using highly inefficient tools. There is a better way.
As the healthcare landscape moves increasingly toward outcome-based treatment approaches, the need to gather and analyze real-world outcome data has become paramount to gauging medication effectiveness and subsequently recruiting prescribers as brand advocates. This study outlines a feedback program that provides prescribers with patient results of their treatment experience in order to better inform their therapy recommendations. The program is designed to offer a unique value proposition to both patients and physicians to drive increased participation in their treatment.
This report summarizes the results from a recent IDC Health Insights study to identify the top 10 software vendors serving the life science market. The report also breaks out the top 3 vendors serving the four key sub segments that make up the life science enterprise, namely research, development, manufacturing and supply chain, and sales and marketing.
The U.S. Sunshine law has traveled a turbulent road over the past couple of years. Over the course of the 2013-2014 submissions, some best practices have emerged in this dynamic environment. Download this whitepaper to learn eight key best practices for manufacturers to consider in their Sunshine Compliance programs.
The European Medicines Agency (EMA) released the first guidance for biosimilar production in 2005. It facilitated the initial wave of registrations for human growth hormone, epoetin, and filgrastim biosimilars. In the United States, the Biologics Price Competition and Innovation Act of 2009, which became law in 2010, provided an abbreviated biosimilars licensure pathway. It wasn’t until 2012, however, that the FDA issued three draft guidelines intended to bridge the gap and enable a biosimilar program across Europe and the U. S.
A simple, rapid and sensitive method for determination of raloxifene (RAL) and metabolites in human plasma, which outlines effective extraction, reversed-phase LC separation and detection on a triple quadrupole mass spectrometer.
This whitepaper discusses the importance of observational research and patient registries in evidence generation. The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs sub-serving different objectives … Increasingly central is the inclusion of observational studies, including registries, which provide insights missing from traditional interventional studies encountered in the course of drug development.
When it comes to supporting the clinical and marketing objectives of a pharmaceutical franchise, removing potential barriers for patients and providers is a primary focus for any brand team. How are manufacturers using hub model programs to maximize brand access and adherence?
Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen. Unfortunately, most methods for measuring medication adherence are inaccurate, which can result in costly phase III failures. This whitepaper focuses on a proven exception—automatic adherence measurement through electronic compilation of drug dosing histories. Electronic measurement enables a better understanding of drug safety and efficacy data, improving the likelihood of a successful trial outcome and more informed development decisions, leading to faster speed to commercialization.
CEOs of generic companies report they are considering a spectrum of solutions to bridge the revenue gap, but perhaps none are more valid than the U.S. FDA’s 505(b)(2) approval pathway, which can offer accelerated approval, reduced development costs, lower risk and, in certain cases, market exclusivity. In this podcast, readers will get an understanding of 505(b)(2), why developers are choosing it, how products are identified and models for development.