“Pacific Pharma Group offers efficient product development through thoughtful design.”

Biologics

We see a large clinical need for our emerging biologic compounds, with their target specificity, unique mechanisms, and novel therapeutic potential. Fortunately, our increasing understanding and utilization of genomics, proteomics and molecular biology provides many promising compounds.

Yet as is generally recognized, our approach to clinical trials with biologics will be permanently affected by the very serious adverse events that occurred in connection with TGN412 during its first time in humans administration March 13, 2006. And rightfully so, as that experience illustrates important lessons regarding use of the Minimal Anticipated Biologic Effect Level (MABEL) as well as the No Observable Adverse Effects Level (NOAEL) in determining our starting dose, and more thorough scrutiny of the study design and safety precautions in general in relationship to the compoundís mechanism of action.

With respect for these principals, Dr. Ruckle's experience as Investigator includes 8 First Time In Humans clinical trials with biologics conducted safely since March 2006, and as a consultant for First Time In Humans studies for both large and small molecules. Pacific Pharma Group, LLC is prepared to assist with your protocol design, especially your First Time In Humans trial, and your product development strategy from IND through Proof of Concept.

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