Public interest in participation in clinical trials for dementia is growing as governments become more vocal about the need to find treatments. A number of well-known organizations have well-established processes for linking patients with clinical trials. Alzheimer’s Association’s Trialmatch in the US and the United Kingdom’s Clinical Research Network (UKCRN) Study Portfolio allow patients to search for trials that they would like to participate in. In the case of dementia however, the disease may hinder a person’s ability to search for trials, potentially limiting access to experimental treatments. As research focuses more on prevention of Alzheimer’s it is important to include people interested in research who have no symptoms of memory loss. Continue reading
Testing drives drug development. From laboratory tests on patient specimens comes almost all of the clinical data needed for a new drug application. How and where those specimens are collected, transported, stored, and analyzed impacts the quality and usefulness of the data they produce. In the past, most tests were processed by local, academic, and specialized testing laboratories and coordinated by each investigator. However, centralized testing is becoming an accelerated trend – one that uses advanced technology and global operations to concentrate oncology clinical trial tests in a single, central laboratory.
The core value of a central lab is consistency. When local laboratories perform testing, their results will be different and results vary over the course of the trial. Central laboratory testing, on the other hand, offers ‘combinable data.’ The end product is that a result from a central laboratory is similar regardless of the global location where it originated from and the lab location where it is tested. At all of Covance’s central laboratories — in Indianapolis, Geneva, Singapore, Shanghai, and Tokyo — we generate data from the same analytical method platform, SOPs, equipment, reagents, and standards, eliminating variables that affect tests results. Continue reading
Over the last decade, the U.S. Food and Drug Administration (FDA), and other global regulatory agencies, have been placing increased scrutiny on clinical data quality. It has become clear that the traditional paradigms of sample testing management will not be sufficient in the future.
In order to avoid putting clinical trial programs at risk, the pharmaceutical industry will need to place a greater emphasis on meeting the new standards for testing data quality and documentation. The need to do so has become more pronounced with the increase in esoteric testing that has been seen in recent clinical trial programs. For example, the rise in genomics testing, immunohistochemistry (IHC) markers and flow cytometry panels has increased the volume of tests being sent out to referral laboratories. The frequency of warning letters from the U.S. FDA has also increased dramatically in the last few years. Continue reading
The gauntlet of oncology trial planning, investigation, and final approval can be daunting. Oncology is the largest, fastest-growing, and most research-intensive therapeutic area in drug development, yet the need for new agents is urgent. Plus, cancer patients are among the hardest to recruit for clinical trials.
Innovations in personalized medicine are also creating a dynamic environment presenting increased requirements for scientific and operational expertise; access to high-performing investigator sites with the right patients; and global combinable data. Continue reading
At Covance, we know that you, the pharmaceutical manufacturer, must deal with an increasingly complex marketplace. One of the current challenges is the 340B Drug Pricing Program (340B). In this article, we briefly review 340B and then discuss three aspects that affect you:
- The major challenges you face under this program
- Strategic recommendations for dealing with these challenges
- Important criteria to consider when selecting a partner to assist you with the 340B program
The 340B Drug Pricing Program
What is 340B?
The 340B program is a drug-pricing plan administered by the Health Resources & Services Administration (HRSA), a division of the Department of Health and Human Services (HHS). Eligible drugs include FDA-approved drugs, OTC written on a prescription, biological products that can be dispensed only by a prescription (excluding vaccines), and FDA-approved insulin. Continue reading
Multiple myeloma is a blood cancer that typically affects those aged 70 years and older. Although considered an uncommon disease, the American Cancer Society estimates that 24,050 new cases will be diagnosed in the United States this year. Global studies show a worldwide incidence of 86,000 cases per year.
The high five-year patient survival rate makes this type of cancer an ideal target for research and treatment studies. Pharmaceutical companies have also embraced the search for treatment of multiple myeloma, since the availability of a successful therapy would enable patients to live significantly improved and productive lives. Continue reading
The deadline to purchase insurance through the state and federal exchanges is March 31, 2014, which is less than two weeks away. From the start of open enrollment on October 1, 2013, to the end of February 2014, an estimated 4.2 million individuals have signed up for insurance through an exchange, while more than 4.4 million have signed up for Medicaid and the Children’s Health Insurance Program (CHIP). People who are not exempt from the individual mandate and fail to sign up by the deadline may face a penalty of $95 per adult and $47.50 per child up to a maximum of $285 per family or 1.0% of family income, whichever is greater. Despite the millions who have enrolled in an exchange or Medicaid, many people will remain uninsured. Many low-income people, some of whom would qualify for premium subsidies and cost-sharing assistance, have never held an insurance policy. They do not understand the concept of copayments, deductibles, and monthly premiums. In fact, many have chosen to forego enrollment this go-around. Continue reading
Under the Health and Human Services (HHS) 340B Drug Pricing Program, drug manufacturers who participate in the Medicaid Drug Rebate program must also provide covered outpatient drugs to eligible Covered Entities (CE) at considerably reduced prices. Manufacturers face several challenges when participating in the 340B program.
Covered Entities First, manufacturers need accurate accounting from Covered Entities (CE) for refund payments. Health Resources and Services Administration (HRSA) has increased scrutiny around the program and conducted targeted audits. CEs are performing internal audits to better understand any non-compliance, taking steps to “self disclose’ non-compliance activity, and proactively sending manufacturers refund payments. However, the supporting data provided by the CE may lack adequate information for manufacturers to accurately account and apply the refund payment. It is also possible that government pricing restatements will be required. Continue reading
When you think of a pathologist, you may picture a scientist peering through a microscope, viewing slides and making notes about a disease state, then moving on to the next sample. Indeed, the classic role of many contract pathologists is to evaluate large numbers of tissue slides and author pathology reports. However at Covance, the Lead Optimization Pathology group plays a much greater role in drug development.
The Lead Optimization Pathology group offers Project Pathologists—a staff pathologist with therapeutic area expertise who is assigned to a project and intimately involved in supporting the early drug development in both efficacy and non-GLP toxicity studies. As ACVP board certified veterinary pathologists with Ph.D. degrees and past experience working in large pharmaceutical companies, the staff can offer in-depth pathology support for both small and big clients. Continue reading
We are always on the lookout to apply the latest research to our work and contribute additional findings to the scientific community. This month we will present a poster studying the regulation of Tau phosphorylation at the upcoming 2013 Society for Neuroscience conference in San Diego.
The interest in this research was first sparked at last year’s 2012 Alzheimer’s Association International conference in Vancouver, Canada, where we heard discussions on the effects of anesthesia on Alzheimer’s disease (AD) patients. Continue reading