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.
This white paper is about why—and how—a commitment to functional integration can help management navigate the often-unforgiving transition from registration to the real-world battle for clinical acceptance and market share. It draws on a recent Executive Roundtable hosted by Pharmaceutical Ex- ecutive and facilitated by Editor-in-Chief William Looney that included UMT Consulting Group along with four big Pharma practitioners in the art of commercial effectiveness
This whitepaper provides an overview and best practices for success when implementing access programs for patients with unmet medical needs. Programs described expanded access, compassionate use, named patient programs which are allowed by regulatory authorities around the world.
The ability to capture, connect, and extract value from laboratory asset data is critical to a company's ability to run its business efficiently. Decision makers are hard pressed to answer fundamental questions about laboratory assets: asset census and density, laboratory service event information, instrument downtime and asset utilization. Given this reality, knowing what your optimized asset footprint should be, much less the real total cost of ownership is a challenge. "Bringing Business Analytics to the Lab" discusses overcoming these challenges.
This Improving Lab Efficiency Through New Mobility and Data Visualization Techniques whitepaper explores the impact of mobile applications and visualizing instrument performance using new techniques with the objective of creating a more interactive and informative lab environment.