The allegations came after testing initiated by the state’s Attorney General’s office found that supplements, such as ginseng and echinacea, apparently did not contain the labeled ingredients. Although dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before being sold to consumers, they must be labeled correctly and safe for consumption. They also must, according to current good manufacturing practice, be tested using scientifically valid methods–in other words, “accurate, precise, and specific for its intended purpose.”1
If you walk into a McDonald’s restaurant anywhere in the world, one thing is certain: your hamburger will taste the same. Ensuring that level of consistency in tens of thousands of restaurants is no small feat—and is a testament to the stringent quality and safety practices followed by their suppliers.
Today increasing numbers of food manufacturers seek to achieve that same consistency worldwide. Achieving consistency takes regular, global product testing. However, finding a partner that can providethis confidence, anywhere in the world, requires some investigation of its own.
So what do you look for in a lab? And how do you compare one to another? After more than 20 years of managing safety and quality programs, these are my top four suggestions:
In the effort to reduce attrition rates and improve approval rates of new molecular entities by regulatory agencies, there’s no doubt that biomarkers can make a big impact. But it’s not as simple as tacking on additional studies. Biomarker development requires an insightful strategy and consideration of specific opportunities and needs throughout the drug development pipeline.
A quality biomarker starts at the source—the sample itself. Sample collection and handling protocols must be standardized to specify the minimum volume requirement in the proper container along with the most optimal temperature during transportation and storage. These requirements should be backed and driven by validated processes. To further ensure biomarker stability, it’s equally critical to include the maximum allowed time in transportation. Continue reading
There’s no denying that studies are only as strong as their resulting data—and nonclinical studies produce a lot of data. A two-week study can easily generate more than 2 million results, while a two-year study can contain upward of 500 million data points. In an effort to process and easily interpret these massive data files, the FDA has developed SEND (Standard for Exchange of Nonclinical Data).
While it’s easy to think of SEND as another obstacle, it’s actually an opportunity to reveal new insights and gain efficiencies in data management. Exchanging information in a standard format can ease knowledge transfer between internal and external databases, as well as provide a common framework to support a more robust submission process. Coupled with the emergence of new tools for visualization and statistical analyses, SEND has the power to revolutionize the way data drive drug development decision making. Continue reading
When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.
For the development of biologic medicines, the process of generating a quality product is less straightforward than that of a small-molecule medicine, like pain relievers such as aspirin. Selecting the right partner, such as Covance and its ‘Central GMP Testing Laboratory’ model, can smooth the path to validation and consistent manufacturing quality for your biologic. Continue reading
“The whole is greater than the sum of its parts” is often quoted to inspire teamwork and synergy but it can also apply to drug development. Studies that assess endpoints in isolation have value and can achieve the desired outcome. Yet, many times a more complicated picture emerges and assessing multiple endpoints in a combined study reveals a more holistic view.
Inspired by the 3Rs—reduction, refinement and replacement of animals used in safety testing—the possibility of integrating multiple endpoints into one study is shaping new best practices in early drug development. Integrated solutions can maximize the value of each study to provide a better understanding, reveal earlier decision points and produce greater confidence in clinical outcomes.
While the concept seems straightforward, it’s not only a combination of otherwise standalone studies. Integrated solutions require a unique blend of fit-for-purpose experimental strategies tailored to each unique drug development program and the relevant endpoints. Continue reading
It seems every few months there’s another announcement about a new rapid method to test for pathogens. These developments have food manufacturers talking, but why the growing need for speed when it comes to food pathogen testing? And how do you know which method is right for you?
Faster answers, minimizing impact
The benefits of rapid testing are most obvious when you consider the investigation of a food-borne illness outbreak caused by a pathogen such as Listeria monocytogenes, E.coli O157:H7 or Salmonella. These methods allow investigators to quickly link case strains and screen more samples. They also can accelerate root cause investigations so manufacturers can get to a resolution more quickly. Continue reading
Debate around best practices for safety pharmacology continued on December 11, 2014 as global regulators, drug developers and scientists from contract research organizations gathered in Silver Spring, MD for a workshop on the Comprehensive in vitro Proarrhythmia Assay (CiPA) and the clinical QT testing initiatives that stand to create a new paradigm in cardiac safety testing and drug development.
So, what led to the proposal for this sweeping change and why the debate? Continue reading
The pharmaceutical, medical device and diagnostics industries are very interested in the changing market access landscape in South and East Asia because of the vast commercial potential of this area. This region has a large proportion of the world’s population (~60%), a 2011 gross domestic product (GDP) growth that is almost triple the average of Europe and North America, and a huge opportunity for improvements in healthcare.
Market access requirements
Current market access requirements vary considerably among the countries in South and East Asia. Many of them – including China and India – do not have any formal comparative effectiveness or health economic criteria for national pricing and reimbursement submissions. Health economics generally plays a minor role in their decision-making. Continue reading
Iteration is the key for earlier and better decisions
The great inventor Thomas Edison once said, “I have not failed. I’ve just found 10,000 ways that won’t work.” While he was not talking about compounds, he could have been. The likelihood of success for any given compound is less than one percent. Aggravating the situation are several other factors, including constant pressure on decreasing pricing, quickly diminishing point of return at the 20-year mark, and along the way, inherent risk and large investments.
Still, we persevere. But to be successful in today’s environment requires a different, non-linear approach. The status quo will not work. We recommend taking a holistic view of the drug development process and an integrated approach. Continue reading