March 12, 2007

Pharsight
Shawn O'Connor
President and CEO

How has your company adapted and responded to the changing economic climate in the past five years when so many others companies did not?

Pharsight has responded to the changing economic climate by building a diversified revenue stream including 1) software for analysis, data management, reporting, validation, and visualization of PK/PD data, 2) consultancy for optimizing decisions (e.g., dose selection) relying on PK/PD modeling and simulation, 3) literature-derived modeling data to support modeling engagements, 4) training in modeling and simulation techniques and methods, and 5) NCA and population PK/PD analysis and reporting. 

What is your vision for the future of the life sciences market over the next several years? 

The pressures on pharmaceutical and biotechnology revenues will increase as payers seek to limit reimbursement, many large patent expirations take their toll, the blockbuster business model becomes harder to sustain, and the industry comes to grips with the declining productivity of its R&D investments.  In this environment, making smarter decisions early in the life of a compound will become increasingly critical, and mathematical modeling and simulation will play an increasing and central role in clinical drug development.  This will drive demand for state-of-the-art data management and modern modeling software platforms to increase the capacity for timely, efficient analysis and sharing of models across the drug development enterprise.  

What products and services does your company provide and what special capabilities do they offer the life sciences market? 

Pharsight Knowledgebase Server (PKS )— Enterprise PK/PD data management software.  Used to dramatically improve data management and data access, increase productivity in analysis and reporting tasks, and support compliance with FDA requirements for electronic records and signature, CFR 21 part 11.

WinNonlin AutoPilot — Used to streamline routine clinical PK analyses and reporting.

WinNonlin —The industry gold-standard for pharmacokinetic (“PK”), pharmacodynamic (“PD”) modeling, and non-compartmental analysis. Used to simulate effects of different dosing regimens and changes in pharmacokinetic parameters required in regulatory submissions. Increases productivity in modeling, analysis and reporting activities.

Trial Simulator -- State-of-the-Art clinical trial design and simulation software.  Used to minimize risk of trial design, formalize assumptions, quantify uncertainty, and reduce the cost of clinical trials and drug development time-to-market.

Drug Model Explorer (DMX) - -Software-based communication technology, used to facilitate quantitative decision-making in drug development.

Strategic Consulting Services -- Optimize clinical development programs with respect to therapeutic potential, R&D productivity and commercial value, optimize clinical trial designs, support go/no-go decisions.

Training — Trains clients to make full use of software tools for modeling and simulation, and apply PK/PD modeling to clinical drug development.

Metadata -- Compiled therapeutic data and information from public-source scientific literature to provide a ready context for model based meta-analysis that can accelerate quantitative assessment of your compound's performance relative to competing treatments.

Partnerships are an effective way to track life science advances and ensure that your company delivers timely products and services. Which life sciences companies or organizations have you partnered with or invested in and why? 

CTC Life Sciences,(part of Itouchu Trading Group, for distribution of PKS and AutoPilot in Japan, and Bellkey Sciences for distribution of WinNonlin and Trial Simulator in Japan. We also partner with various leading suppliers of modeling software and lab data management software so our clients may achieve a higher degree of workflow integration and efficiency.

What are your most exciting products and initiatives in development, and how will they improve life science research? 

Pharsight has several new products in development — all reflecting our belief that the future will place a premium on the highest-quality decision-making and scientific productivity.  These include new, integrated software platforms to simplify analysis, reporting, model development, and reuse so that more scientists can take on complex modeling chores. Current PK/PD modeling efforts span multiple scientific disciplines (and pharma departments) including preclinical, biochemistry, pharmaceutical development, and use various modeling and simulation tools that are not integrated across departments and require separate acquisition and learning.  Our aim is to simplify collaborative modeling across departments through automation of repetitive tasks and reports, better use of parallel/grid computing structures, new GUIs, tool integration to shorten learning curves, and more powerful modeling languages.

Where do you see your company in five years? 

Pharsight will continue to lead in the provision of state-of-the-art modeling and simulation tools, together with data management infrastructure to enable a free flow of information and efficient analysis and reporting for development scientists in the laboratory, modelers, statisticians, pharmacologists, clinicians, and managers.  The analysis and visualization tools built on this platform will enable scientists to use all of the data at their disposal to optimize their development pipelines and maximize the chances for clinical success of their investigational compounds.  Pharsight will also provide strategic drug development consultancy and outsourcing of NCA and population PK/PD analyses and reporting.