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.
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
Debates are gripping Capitol Hill regarding the individual mandate of the Affordable Care Act (ACA). The mandate requires individuals to sign up for private insurance or Medicaid by March 31, 2014 or 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. Continue reading
Cardiovascular safety remains a leading cause of drug attrition during preclinical and clinical development, accounting for discontinuation of approximately one third of marketed drugs.
These liabilities, which pertain to both cardiovascular- and non-cardiovascular-targeted drugs, can be identified during early development by addressing cardiovascular safety endpoints prior to the selection of a drug candidate, a process known as ‘frontloading’. Although not mandated by the key regulatory guidance for safety pharmacology (ICH S7A; US FDA, 2001), an increasing number of companies choose to conduct early non-GLP cardiovascular safety studies in support of decisions on the progression of their compounds. Continue reading
Connect with your patient at every stage of their journey
Covance Patient and Provider Services understands the patient journey and provider needs. We bring you industry-leading consultative insight to help you maximize your product value as patients navigate their treatment journey. We keep patients connected to your product at every stage along the way.
Navigating the patient journey successfully takes a team effort
Learn more about Patient & Provider services.
Throughout my career at Aventis, Hoffmann-La Roche and Alcon (a Novartis company), we focused on the proof of concept (PoC) as the critical milestone when considering when to partner with or purchase a compound from a small biotech.
Your potential pharma partner is looking for answers to key development questions surrounding the mechanism of action and your compound, how your company has addressed those, the robustness of the results and the quality of the data. This drives their evaluation of the real stage of development and the valuation. Continue reading
Are your infrastructure, staff and processes up to the task of tracking today’s managed market contracts, chargebacks and rebates, and complying with government regulations?
Protect your revenue
Changes in managed markets are imposing the development of even more complex contracts with distributors, pharmacy benefits managers (PBMs), third-party payers and government agencies. Add to that the cost pressures that reduce available resources, and the required new investment in technology to track it, you’re facing a harder time achieving goals and staying profitable.
Learn more about protecting your revenue.
Emerging Markets in Clinical Trials: Romania Delivers Pivotal Boost in Enrollment in Challenging Indication
Intense competition for investigators and patients in traditional clinical research markets has enabled emerging regions such as Central and Eastern Europe, Russia and the former USSR to play an increasingly prominent role in the quest for high-quality clinical trial data. While well-established markets across Western Europe and the U.S. continue to play an important role in clinical research, it has become crucial to leverage the untapped patient and investigator potential of these emerging markets to ensure sufficient and timely enrollment. Continue reading
Parkinson’s Disease (PD) is a chronic neurodegenerative disease with no known cure, no certain cause, and no clinically available test for simple diagnosis. Research advances have been made, but there still remains a huge unmet need for diagnostic and disease progression biomarkers.
Research on this disease is focused on the changes that occur in the brain. Research has shown that the nerve cells in the brains of Parkinson’s patients have abnormal protein deposits that may disrupt normal brain function and cause Parkinsonian symptoms, such as tremor, slowness of movement, and rigidity, among others. Continue reading