SEND is Here. Are you Ready for Data-Driven Decision Making?

SEND-Blog-image-0215There’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

Establishing Control Over the Manufacturing Process and the Quality of your Biologic

101679_Large-Molecule_1575263331When 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

Integrated Solutions: Combining Multiple Endpoints into a Single Study Delivers Greater Confidence

covance_knife“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

The Growing “Need for Speed” in Food Pathogen Testing

102050_AB Still C1091It 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

The CiPA Debate: What You Should Know

ecg-printoutH1Debate 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

Market Access in Asia: What Role for Health Economics?

market-access-in-asiaThe 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

Increase Compound Efficacy with an Integrated Approach

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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

Detecting and Quantifying Mycotoxins with LC-MS/MS

mycotoxinWith the availability of sensitive mass selective instruments, such as tandem mass spectrometers and high-resolution mass spectrometers, today’s food safety chemists have the ability to accurately analyze multiple classes of mytotoxins simultaneously with minimal sample preparation. Mycotoxins, which are low-molecular weight, chemically diverse toxins, are produced naturally by molds commonly found in grains and fruit and have been linked to a wide range of negative health effects. Continue reading

Multi-Criteria Decision Analysis in Health Technology Risk-Benefit Analysis: The Future?

health-technology-risk-benefit-analysis

Current trends in health technology assessment (HTA) indicate a shift away from the use of cost-effectiveness to value-related measures. A suite of analysis methods, collectively referred to as “risk-benefit analysis”, can be used to address these requirements. Of these, multi-criteria decision analysis (MCDA) is considered a leading candidate for practical application in HTA.

Limitations of cost-effectiveness analyses
The quality-adjusted life-year (QALY), frequently used in cost-effectiveness analyses and once the gold-standard outcome measure for economic evaluation in healthcare, is coming under heavier criticism than ever before. While appropriate in certain situations, the instruments used to generate QALYs have been shown to lack the required sensitivity to capture all benefits of interventions in some therapy areas, including hearing loss and schizophrenia. Continue reading

What to Look for When Recruiting Patient Arms for Phase I

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A five-point checklist for early, positive studies

Now more than ever, there is increasing pressure to bring new drugs to market more efficiently. With so much at stake when introducing a drug into the human body for the first time, you need to consider safety and efficacy and an ability to make a decision whether and how to proceed at every turn. As a result, you want to improve the earlier stages of drug development to enhance the quality of compounds that progress to Phase III. The end goal? To increase the success rate of molecules in Phase III. Continue reading