Increase Compound Efficacy with an Integrated Approach


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

What to Look for When Recruiting Patient Arms for Phase I


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

Combine Compounding and Analytical Support for Speed, Efficiency, Safety, Quality and Consistency


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.

Here’s how.

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

5 Uses for Muscle Biopsies in Early Research Studies

muscle-biopsyRunning along the side of your thigh, the vastus lateralis muscle works with three other muscles within your “quad,” permitting actions crucial for forward movement. In the laboratory, clinicians are also relying on muscles like the vastus lateralis to move their research forward in the study of neuromuscular agents.

Muscle biopsies hold the key to understanding many aspects about a potential treatment or therapeutic agent. From pharmacokinetics to stem cell therapy, there are several intriguing areas of interest in the field. Continue reading