Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals. Obstacles along each path can lead to increased turnaround time and drive script abandonment. Technology brings advancements for removing these barriers, but buyer beware.
For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.
The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.
In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.
Identifying appropriate dose ranges for pivotal trials remains a major drug development challenge, particularly for new molecular entities (NMEs). Multiple Comparison Procedure – Modelling (MCP-Mod) is a powerful statistical tool that greatly improves the design and analysis of dose finding studies for more accuracy on the targeted dose range. Combined with the adaptive study design, simulation and modelling capabilities of ICON’s ADDPLAN® neo, adaptive MCP-Mod may significantly enhance drug development efficiency.
There is a shift in the pharmaceutical and CRO industries to improve the efficiency, effectiveness and quality of clinical trial research and the data generated together with improving patient safety. Read how Patient Centric Monitoring enables faster data access and quality checks, enabling early detection of errors and risks and ensuring improved patient safety plus data quality and integrity.
The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.
Cross-sectional studies (CSS) serve as an effective study design option to gather pertinent epidemiological data quickly to support drug development across the lifecycle. Here we explore how a hybrid MCR combined CSS can be an advantageous study design for real world evidence (RWE) generation, and how gaining a better understanding of the implementation of these designs can allow for better future planning, as well as to guide the development of the next generation of real world studies.
The rapid shift to VBHC is reshaping markets for medical and diagnostic devices in several important ways. Its incentives significantly affect the purchasing behavior of payers, clinicians and patients – and what device makers must do to win their business. Generally, this includes determining how these various stakeholders define value, and gathering evidence to build a value based purchasing case early in the product development cycle. In this paper, we examine some of the major factors that influence how different stakeholders define value. We then describe a model for mapping stakeholder value that can help drive profitable device development programs in increasingly value driven markets.
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