Drug Discovery and Development Accomplishments

 

InvestNI

Goal: To stimulate North American foreign direct investment in the Northern Ireland life sciences community. Provide R&D and commercialization advice to North Ireland Universities, Hospitals, and SMEs.

Results to date:

  • 180 assets screened, 72 inventors engaged, 47 projects under active advisement or on watching brief.
  • 600 unique organizations introduced to Northern Ireland, 45 active, 30 CDAs signed, 13 deals signed or under negotiation.
  • Value of portfolio estimated at $10-15 MM

 

GlaxoSmithKline

Goal: To define novel approaches and work plan to objectify and stratify patients suffering from a complex neurological disease.

Result:

  • Determined how subjective clinical endpoints complicate patient stratification and increase late-stage drug attrition.
  • Defined plausible scenarios for diagnosing, treating and monitoring this disease in 10 year’s time.
  • Identified early-stage innovations that would dramatically advance the detection and treatment of this disease and could be used in clinical and preclinical studies.
  • 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/ perform in vitro pharmacodynamics modeling of dose and schedule for a combination of two anti-HIV compounds with different modes of action.

Result:

  • Modeled clinical pharmacology data to determine the in vivo pharmacokinetics of each antiviral agent.
  • Performed an in vitro simulation of plasma concentration-time profiles of the individual agents using a hollow fiber pharmacodynamics system.
  • Performed a series of experiments to compare the efficacy of the combination regimen to the efficacy of each individual agent.
  • Determined the optimal dose and schedule for the combination regimen.
  • Client used this work to design and implement clinical trials on the combination regimen.
  • 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:

  • Identified and characterized issues of non-randomly missing primary efficacy data.
  • Defined overall strategy for communicating this issue to the FDA.
  • Devised sensitivity analyses to assess possible impact of the data gaps on primary efficacy result.
  • Summarized issues and results in Clinical Study Report.
  • The U.S. NDA filing was successful and was approved in 1Q2008.

 

GlaxoSmithKline’s Technology Investment Board

Goal: To establish and implement a strategic approach to investments in step-change Drug Discovery and Development technologies.

Result:

  • Identified short-term and long-term technology gaps across R&D.
  • Identified business opportunities aligned with corporate gaps.
  • Performed due diligence on business plans, potential ROI, technology development roadmaps and intellectual property estates.
  • Highlighted key challenges associated with technology and scientific validation.
  • Defined strategic partnership approaches.
  • Ensured that investment capital was allocated in a disciplined way.
  • Monitored and supervised portfolio companies.

 

Several Angel and Venture Capital Investors

Goal: To perform due diligence on investment candidates.

Result:

  • Provided feedback on business plans.
  • Assessed the immediate and long-term value of various start-up companies’ core capabilities to the biotechnology and pharmaceutical industries.
  • Identified early adopters and recommended strategic partnership approaches.
  • Evaluated and summarized the quality of candidate’s science, technology development and business plans. Highlighted additional challenges the candidate should address.
  • Evaluated candidate exit strategies and highlighted challenges to business models and financial projections.