April 25, 2013

The CECON Group Announces Partnership with DESCA

The CECON Group is pleased to be partnering with The Delaware Sustainable Chemistry Alliance (DESCA). DESCA is an alliance of Delaware based businesses focused on  sustainable/green chemistry through the growth of emerging companies, creation of high quality jobs, and development and commercialization of innovative technologies to benefit the environment

CECON will be managing DESCA’s new Domain Expert Network. Experienced and highly skilled experts will be assisting emerging companies and universities in the region and generating income for DESCA.

Services include advising emerging companies on development and commercialization of their sustainable chemistry technologies, and assessing and marketing green chemistry intellectual property for university tech transfer offices.

Since 1985, CECON has developed a worldwide network of consultants specializing in science, engineering, and technical business issues. The company offers consultants with expertise in over 200 technical disciplines and provides customized search support to help clients find the experts they need. Typical services include technical due diligence, regulatory compliance, interdisciplinary design teams, and material properties and processing evaluations.

Please contact us if you have a project that requires the expertise of our consultants

April 12, 2013

What is a Biomarker & How Might Biomarkers Affect Legal Cases?

A biomarker, or biological marker, is a substance used as an indicator of a biological state. It is a characteristic that can be objectively measured and evaluated as an indicator of specific processes.

A biomarker can indicate a change that correlates with the risk or progression of a disease. Biomarkers can usually be detected and measured in parts of the body like the blood or other tissue. They may indicate either normal or diseased processes in the body.

For example, body temperature is a well-known biomarker for fever. Cholesterol values are a biomarker and also a risk indicator for coronary and vascular disease. It is also well known that blood sugar levels are a biomarker for diabetes.

In his article, “Biomarkers –Making the Appropriate Selection for Clinical Trials” a CECON consultant outlines the challenges in ensuring the appropriate biomarkers are chosen for clinical trials. Understanding these challenges and the many variables involved may add insight in legal cases involving pharmaceuticals.

Look for future articles discussing different ways biomarkers can be used in drug development and how the various testing factors that, if not carefully monitored, can lead to misleading results.

The author of the articles referenced is a Pharma consultant in The CECON Group network and has extensive experience in regulatory statistics in both clinical and preclinical areas. For 25 years, he was a statistical reviewer, supervisor, and manager in the Center for Drug Evaluation and Research (CDER) of the FDA. His expertise includes drug quality, stability, clinical trials, and data integrity. Click here to read more about this regulatory statistician consultant and expert witness