GlaxoSmithKline

Goal: To define novel approaches to objectify and stratify patients suffering from a complex neurological disease. Create a rational program of work.

Result:

1. •Interviewed medical and drug discovery experts to understand how subjective clinical endpoints complicate patient stratification and increase late-stage drug attrition.
   

2. •Defined plausible scenarios for diagnosing, treating, and monitoring this disease in 10 year’s time.
   

3. •Identified early-stage innovations that would dramatically advance the detection and treatment of this disease and could be used in clinical and preclinical studies.
   

4. •Created a 5-year work plan that would confirm the clinical value of novel approaches to objectifying this disease, and establish strategic partnerships that would advance early-stage innovations necessary to deliver this capability routinely.
   

A Large Pharmaceutical Company

Goal: To design experiments and performed in vitro pharmacodynamics modeling of dose and schedule for a combination of two anti-HIV compounds with different modes of action.

Result:

1. •Modeled clinical pharmacology data to determine the in vivo pharmacokinetics of each antiviral agent.
   

2. •Performed an in vitro simulation of plasma concentration-time profiles of the individual agents using a hollow fiber pharmacodynamics system.
   

3. •Performed a series of experiments to compare the efficacy of the combination regimen to the efficacy of each individual agent.
   

4. •Determined the optimal dose and schedule for the combination regimen.
   

5. •Client used this work to design and implement clinical trails on the combination regimen.
   

6. •Presented and published this work in collaboration with client.
   

A Mid-Sized Pharmaceutical Company

Goal: To address pivotal data and analysis issues for an NDA in oncology

Result:

1. •Identified and characterized issues of non-randomly missing primary efficacy data.
   

2. •Defined overall strategy for communicating this issue to the FDA.
   

3. •Devised sensitivity analyses to assess possible impact of the data gaps on primary efficacy result.
   

4. •Summarized issues and results in Clinical Study Report.
   

5. •The U.S. NDA filing was successful and was approved in 1Q2008.
   

6. •Note:  A European company performed the submission for market authorization in Europe, but did not address this issue of non-randomly missing data. European regulators raised concerns over the issue and as a consequence, the European filing is still pending.

Clients