Showing results 81 - 96 of 91813 for .
Showing results 81 - 96 of 91813 for .
Harnessing Public Involvement for Faster, Lower Cost Trials in Dementia
There should be no doubt that clinical trials in Alzheimer's disease and dementia need to be faster and more cost-effective if new treatments are to reach patients.
How to Proactively Avoid the Common Pitfalls in Biologics Development
When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product's potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product's development, can make the difference between success and failure.
Understanding the Clinical Impact of Having a Companion Diagnostics Strategy
As the pace of companion diagnostic innovation continues to accelerate, the drug development industry faces several headwinds. Numerous patent 'cliffs' are affecting the sales of blockbuster drugs; competition is increasing for a limited clinical trial population in increasingly global trials; and health outcomes pressures from patients, payers and healthcare providers are transforming the drug development process.
ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring
Over the past several years, the life science community has gained an improved understanding of the immune system-from B and T cells to molecular pathways.
Integrated Writing Services for the BioPharmaceutical Industry
Helping physicians and patients get access to new drugs and medical devices requires more than showing that a product works. In this article, we focus on the hurdles that the biopharmaceutical industry faces. Similar challenges face the medical device industry; however, as they say, the devil is in the details.
Is There a Case for Open-Label Extensions to Early Development Studies?
Balancing the need for early access to treatments for rare disorders and protecting patients' safety and the viability of promising novel treatments
Simple Strategies for Balancing Risks in CNS Drug Development
Drug discovery and development is inherently risky. Recent figures indicate that less than 11% of new pharmaceutical agents entering clinical development reach the marketplace across all therapeutic areas.
Biosimilars: The Commercial Challenge
With the implementation of the FDA's abbreviated biosimilar approval pathway, biosimilars have become one of the fastest-growing categories in the biopharmaceutical sector. While these lower-priced alternatives will offer value in terms of cost savings, many stakeholders have voiced concerns over switching to biosimilar products.
Reflections on the Placebo Response
Since the 1960s, much medical research has been conducted on placebo, an inert agent that does not contain any active therapeutic substances.
CNS Drug Development: Impact of Biosimilars
The biologics sector continues to offer lucrative opportunities for future growth, but with relatively few contributions for the treatment of CNS indications.
Your Customers and Your Market Access Are Changing!
US health care is exponentially more complicated today than just 5 years ago. Even the most competent, experienced marketing teams may not anticipate or clearly understand the complex forces that are changing how we select, dispense, and reimburse for drugs and devices.
FSMA Rules - Round Two
Signed into law in 2011, the Food Safety of Modernization Act (FSMA) is the most sweeping change to the way food safety is regulated in the U.S. since the adoption of the Food Drug and Cosmetic act itself in 1938. Due to the sheer size and magnitude of this legislation, the FDA is taking time to get the rules correct.
Harmonizing Anatomic Pathology and Histology Services: Constructive Steps Toward Greater Precision in Global Oncology Trials
In 2013, oncology represented the largest segment of the clinical trial market. In 2014, it is estimated to grow by 4.9%,1 reaching nearly $100 billion. The number of oncology clinical trials stands well above those in other therapeutic areas and most major biopharmaceutical companies are involved in oncology to some degree.
FDA Takes Final Step On Manufacturing Standards of Infant Formula
An estimated 1 million infants in the U.S. are fed formula from birth, and by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.
Considerations for Running an Effective Pediatric Clinical Trial
Treatments that are safe and effective for adults may be ineffective or even dangerous for children. But infants and children are often prescribed medications with "off-label" use, where the treatment's safety, dosage and efficacy are based solely on adult studies. To address this issue, both drug developers and regulators are working to boost clinical trials in children and include this underserved market in their studies.
Risk-Based Monitoring: Working Smarter, Not Harder
A six-step systematic, proactive approach to your study can help transform risks into returns