Considering the current level of extensive international food trade, food safety has become a significant global issue. Many people are increasingly concerned about chemical residues in their foods. Hundreds of pesticides, including herbicides, insecticides and fungicides, are among the most hazardous chemical compounds extensively applied in agriculture to increase food production. They are intended for destroying and controlling pests, weeds or plant diseases. Pesticide application is strictly regulated to protect consumers and the environment. However, the misuse of pesticides, lack of good agricultural management and/or cross-contamination during food processing, storage or transportation may result in unwanted or even illegal pesticide residues in foods. Some compounds, such as polychlorinated pesticides, have been banned for crop use but they are still present in the environment due to their long-term persistence and can bioaccumulate in the food chain. There is evidence that chronic exposure to pesticides can cause health risks to humans even at trace concentrations, for instance having adverse effects on endocrine system or causing behavior modification. Continue reading
As device technology significantly improves and becomes more reliable and user friendly, the range and quality of measurable modalities—from actigraphy (movement or sleep patterns) to respiration—continues to expand. Wearable medical devices are being depended on for gathering and transmitting objective, experiential data in real time. These devices could enable researchers to go from looking at a very small number of data points to analyzing hundreds of readings per second from thousands of patients. Continue reading
The lasting image of the initial health exchange roll out is that of persistent technical problems that plagued the federal government’s insurance exchange website Healthcare.gov. At the start of the 2014 open enrollment period in October 2013, the online marketplace for federally-facilitated insurance exchanges was overwhelmed with a volume of potential customers the website was not designed to handle. A handful of state-based exchanges (e.g., Maryland, Massachusetts and Nevada) also witnessed technical glitches that hampered the enrollment process for countless applicants. It took months to fully correct these technical issues, but at the end of the open enrollment period, an estimated 7.3 million people had enrolled in an exchange nationwide. This final tally, released by Politico, is comprised of the 8 million people who signed up in the regular enrollment period less those who did not pay their premiums in time or dropped out of the exchanges for some reason. An additional 6.7 million people also enrolled in Medicaid during the open enrollment period. Continue reading
The integrity of any Phase I clinical program relies heavily on the production, supply and analysis of quality dose formulations. Historically, drug doses have been formulated, manufactured and analyzed at the contract manufacturer, which typically adds significant time and expense given the small volume and the regulatory expectations at Phase I. One solution that is becoming widely practiced is combining extemporaneous preparations at the clinical research unit with independent dose analysis. It’s a one-two punch that not only saves time and money, it provides an extra assurance of quality.
Pharmacies are nimble
Contract manufacturers are built for the scale and regulatory requirements of a large Phase III clinical trial. Volume is their game. In Phase I, volume is overkill and leads to additional time and cost. Continue reading
Failures of Phase III programs after successful Phase II programs is probably the worst outcome of a clinical development program, as it failed in the most costly way. Nevertheless, these failures occur not infrequently. In psychiatry, highly publicized Phase II success stories ended in discontinuations of development programs, such as the NK1-antagonist program in depression several years ago. More recently, other examples have emerged. Some skip the Phase II process altogether with designs, which are supposed to provide “pivotal” data for regulatory purposes in large Phase III-like studies, which are just labeled as Phase II. These failures do not come out of the blue. Sometimes it is important to go back to basics and consider the purpose of Phase II trials.
What is the purpose of a Phase II trial?
The purpose of Phase II trials, besides gaining insights into the safety of a compound, is broadly exploratory, i.e. to generate data, which help with the design of the pivotal Phase III program. In a therapeutic area, a reasonably performed Phase II study can provide insights into clinical and biological patient characteristics, which match the properties of the drug under study. With an increased interest in personalized medicine, these boundaries between patient populations have to be understood in order to be successful. This approach is in direct contradiction to the urge to generate a “pivotal” Phase II outcome. Continue reading
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.
Challenges with pediatric trials
A number of factors work against studying pediatric populations. As a highly fragmented and dynamic population, children and infants undergo rapid developmental changes over time, complicating study design and interpretation.
In addition, small sample sizes and potentially low incidence rates can make it difficult to find a treatment group—as well as a suitable control group with an approved active control. Finally, ethical considerations, such as informed consent can be more complex in pediatric trials. Continue reading
The biologics sector continues to offer lucrative opportunities for future growth, but with relatively few contributions for the treatment of CNS indications. High-growth CNS market segments generally share one feature: biologics play a pivotal role in the treatment paradigm, or soon will. Neuromuscular-blocking biologics recently secured regulatory approval for chronic migraine. Alzheimer’s disease is a high unmet need indication currently addressed only by symptomatic treatments, with potential for disease modification biologic therapies to play an important future role.
The example of biologics’ success in the CNS market is highlighted largely by the success of therapies that target the multiple sclerosis (MS) disease process. This success has spurred some drug developers to increase their assets in this space and seek future opportunities for biologics in other CNS diseases. However, one important new reality that is slated to reshape the future landscape of this market is the introduction of biosimilars. Continue reading
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. Continue reading
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.
Yet, with such compelling numbers, why do only 6.7% of these trials lead to FDA approval from Phase 1?2 Possibly because of difficulties recruiting patients for oncology trials, but more likely due to the complexity of cancer as a disease. Continue reading
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.
Changes in Traditional Customers
Pharmacy Benefit Managers (PBM) are your primary contracting conduit into commercial and Medicare Part D plans to assure formulary market access. The FTC approved the $29.1 billion ESI-Medco merger, further consolidating the PBM group. If your new product is not granted preferential access on a national PBM, you may be losing access to 70 million patients. Continue reading