PHST » Topics » General

This excerpt taken from the PHST DEF 14A filed Jul 25, 2008.

General

The Company’s Amended and Restated Certificate of Incorporation and Bylaws, as amended, provide that the Board of Directors shall be divided into three classes, with each class having a three-year term when the Company is a “listed” corporation within the meaning of Section 301.5 of the California General Corporation Law (the “CGCL”). A listed company within the meaning of Section 301.5 of the CGCL includes companies with outstanding securities listed on the National Market System of the Nasdaq Stock Market (or any successor entity). The Company’s common stock was listed, and began trading on, the Nasdaq Capital Market on November 27, 2007. Consequently, the Company is a listed corporation within the meaning of Section 301.5 of the CGCL.

The Company’s Board of Directors is currently comprised of six directors. In accordance with the Company’s Amended and Restated Certificate of Incorporation and Bylaws, the Board of Directors has designated three classes of directors for election, with each class comprised of two directors. This year, all of the nominees to the Board of Directors will be subject to election. Thereafter, each class of directors will serve for a three-year term and will be subject to election every third year.

The two Class I directors will be elected initially for a one-year term expiring at the 2009 Annual Meeting of Stockholders or until such director’s successor has been duly elected and qualified. Upon the recommendation of the Nominating and Corporate Governance Committee of the Board of Directors, the Board of Directors has nominated Shawn M. O’Connor and John J. Schickling for re-election as Class I directors.

The two Class II directors will be elected initially for a two-year term expiring at the 2010 Annual Meeting of Stockholders or until such director’s successor has been duly elected and qualified. Upon the recommendation of the Nominating and Corporate Governance Committee of the Board of Directors, the Board of Directors has nominated Dean O. Morton and Douglas E. Kelly for re-election as Class II directors.

The two Class III directors will be elected for a three-year term expiring at the 2011 Annual Meeting of Stockholders or until such director’s successor has been duly elected and qualified. Upon the recommendation of the Nominating and Corporate Governance Committee of the Board of Directors, the Board of Directors has nominated Arthur H. Reidel and Howard B. Rosen for re-election as Class III directors.

Unless otherwise instructed, the proxy holders will vote the proxies received by them for the Company’s nominees named below. In the event that any nominee is unable or declines to serve as a director at the time of the Annual Meeting, the proxies will be voted for any nominee who shall be designated by the present Board of Directors to fill the vacancy. It is not expected that any nominee will be unable or will decline to serve as a director. The name, age and principal occupation of each nominee as of July 15, 2008, are set forth below. There are no family relationships among directors or executive officers of the Company.

This excerpt taken from the PHST DEF 14A filed Jun 29, 2007.

General

The Company’s Certificate of Incorporation and Bylaws provide that the Board of Directors shall be divided into three classes, with each class having a three-year term; provided, however, that if the Company ceases to be a “listed corporation” within the meaning of Section 301.5 of the California General Corporation Law, as amended (the “CGCL”), the Board of Directors shall cease to be divided into classes and all directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting of stockholders. On November 8, 2002, the Company ceased trading on The Nasdaq Stock Market and began trading on the Over-The-Counter Bulletin Board system. As a result, the Company is not currently a “listed corporation” within the meaning of Section 301.5 of the CGCL, and therefore, all directors of the Company shall be elected at each annual meeting of the stockholders to hold office until the next annual meeting of stockholders.

The Company’s Board of Directors is currently comprised of seven directors. The Board of Directors has selected six nominees for election to the Company’s board of directors, all of whom have been recommended for nomination by the Nominating and Corporate Governance Committee of the Board of Directors and all of whom are currently serving as directors of the Company. All nominees were elected by the stockholders at last year’s annual meeting, with the exception of John J. Schickling. Arthur H. Reidel, a director of the Company and member of the Nominating and Corporate Governance Committee, recommended Mr. Schickling as a member of the Board of Directors. After conducting an evaluation, including interviews with Mr. Schickling, the Nominating and Corporate Governance Committee recommended his election to the Board of Directors. In June 2007, the Board of Directors appointed Mr. Schickling as a director. The term of office of each person elected as a director will continue until the next annual meeting of stockholders or until a successor has been duly elected and qualified. Philippe O. Chambon, a current member of the Board of Directors, is not standing for re-election and his term will end at the Annual Meeting. Pursuant to the Company’s certificate of incorporation, the Board of Directors intends to reduce the size of the board to six directors following the Annual Meeting.

Unless otherwise instructed, the proxy holders will vote the proxies received by them for the Company’s nominees named below. Your proxies cannot be voted for a greater number of persons than the number of nominees named in this proxy statement. In the event that any nominee is unable or declines to serve as a director at the time of the Annual Meeting, the proxies will be voted for any nominee who shall be designated by the present Board of Directors to fill the vacancy. It is not expected that any nominee will be unable or will decline to serve as a director. The name, age and principal occupation of each nominee as of June 20, 2007, are set forth below. There are no family relationships among directors or executive officers of the Company.

This excerpt taken from the PHST 10-K filed Jun 27, 2007.

General

Pharsight Corporation develops and markets software and provides consulting services that help pharmaceutical and biotechnology companies improve drug development decision making by reducing the costs and time of drug development and commercialization. Our products include proprietary software for clinical trial simulation and computer-aided trial design, the statistical analysis and mathematical modeling of data, the automation of scriptable pharmacokinetic data analysis, the storage, management, and regulatory reporting of derived data and models in data repositories, the validation of regulatory workflows, and the visualization of drug-disease simulations. Pharsight uses expertise in the sciences of pharmacology, drug and disease modeling, biostatistics and strategic decision-making. Our service offerings use this expertise to interpret and improve the design of scientific experiments and clinical trials and to optimize clinical trial design and portfolio decisions. By integrating scientific, clinical, and business decision criteria into a dynamic model-based methodology, we help our customers to optimize the value of their drug development programs and portfolios from discovery to post-launch marketing

Our goal is to enable pharmaceutical and biotechnology companies to reduce the time, cost and risks of drug development activities and improve the value of approved medicines. Our products and services are designed to help our customers use a more rigorous scientific and statistical process to identify earlier drug candidates that will not be successful, to enhance the likelihood that the remaining candidates will successfully complete clinical trials, and to maximize marketing impact upon approval. This process is significant because clinical development time has remained lengthy and unpredictable while the productivity of molecule discovery research has accelerated dramatically in recent years.

Our Strategic Consulting Services are used by 20 of the world’s largest 50 pharmaceutical companies. In addition, all of the world’s largest 50 pharmaceutical companies use our software products. Our software products are currently licensed for use on more than 6,700 researcher desktops.

 

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We believe our products and services provide the following benefits to customers:

 

   

Reduced time required for the validated transformation, analysis, and reporting of information required for drug approval;

 

   

More effective trial designs with higher probability of success and greater information yield;

 

   

More rapid, robust and objective decision-making with wider data availability and quantified assessment of value versus risk;

 

   

Improved workflow and organizational efficiency with faster regulatory acceptance of trial results;

 

   

Faster, more cost-effective validation of analysis and reporting workflows;

 

   

More efficient development programs requiring fewer clinical trials and patients, less time and lower cost to reach the market; and

 

   

Strengthened competitive position due to improved product labels and earlier opportunity to establish a competitive franchise.

The following illustrates several typical customer applications of our software products and services:

 

   

In designing phase II clinical trials, companies often face significant uncertainty in selecting the appropriate doses to test. Our products and services integrate information from phase I and pre-clinical activities, information concerning related drugs that have been developed by the customer, information in scientific literature about other drugs in the same therapeutic area, and knowledge of the relevant physiological and disease processes. This information, along with carefully identified assumptions, is used to develop a mathematical model enabling a computer simulation of the proposed trial. Using this approach, customers are often able to identify proposed doses that have little chance of success and should be excluded, or to identify additional doses that are more likely to yield important information.

 

   

In designing phase III clinical trials, companies often face significant uncertainty concerning the most appropriate treatment strategy, patient inclusion/exclusion criteria and/or clinical measurements. Our products and services for phase III clinical trials use an information gathering and modeling approach similar to that described for the phase II clinical trials above, but incorporate phase II data and detailed mathematical models of the intended patient populations. Our products and services are often able to identify patient groups unlikely to show efficacy, or groups with an unacceptable chance of demonstrating side effects, prior to conducting the actual trial. In addition, we may be able to predict which clinical measurements will be most likely to provide conclusive results in the proposed trial.

 

   

In making drug portfolio decisions, companies need to integrate scientific and clinical results, such as those described above, with market and financial information for all of the drug candidates in the development pipeline. We believe that our products and services help companies make better decisions concerning “go/no-go” criteria, prioritization of potential label objectives to be pursued and optimal sequencing of clinical trials within a development program. Our products and services can also help customers adopt a more quantitative and scientific approach to resource allocation among programs within their drug portfolios.

 

   

The production of industry standard pharmacokinetic, or PK, reports required by the United States Food and Drug Administration, or FDA, for a new drug submission are often time consuming, costly, and effort intensive. Much of an individual scientist’s time in a typical client organization may be involved with tasks such as data preparation needed for analysis, display of PK analysis in reports, and the quality control measures needed to ensure correct information is presented to the FDA. These tasks may reduce time available to focus on the quality and impact of the scientific decisions that drive compound development. The lack of industry standards and an integrated software platform to drive the adoption and automation of standards can often lead to lengthy report cycles and delays in regulatory submissions. By deploying our Pharsight Knowledgebase Server, or PKS, suite of applications and services (WinNonlin, IVIVC Toolkit for WinNonlin, WinNonlin Validation Suite, PKS Reporter, PKS

 

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Validation Suite, WinNonlin AutoPilot, and PK Automation), we believe our clients can achieve sustainable productivity improvements in their regulatory submission process. Our PKS data repository affords integration to legacy laboratory and clinical data sources, reducing the time needed for data preparation prior to analysis by our clients’ scarce scientific resources. The PKS suite seamlessly integrates PKS with WinNonlin, PKS Reporter, and third-party applications and provides the opportunity to automate a majority of the standard PK reports required by the FDA.

 

   

We believe many of our clients have achieved significant productivity improvements in creation of standard PK reports, including significant reductions in report cycle time, along with improvements in quality and consistency of analysis and display of analytical results. As a result of these increases in productivity, we believe our clients are able to reallocate resources to other aspects of the drug development process.

 

   

Drug Model Explorer, or DMX, supports quantitative decision making when evaluating the benefit and risk of a potential new drug in a pharmaceutical company’s versus competing therapy. Pharsight collaborated with a pharmaceutical company to build model-based projections of the competitive landscape. The modeling effort combined internal study data with published trials and FDA submissions on competing compounds to generate an integrated and quantified assessment of the drug’s likely performance. The client’s clinical development project team used DMX to evaluate and communicate the modeling results. Through DMX, the team explored clinical effects and associated uncertainty for the drug and competitors across multiple endpoints, treatments, and patient populations based on pre-simulated responses from the model-building effort. The results showed that the new drug was unlikely to outperform its main competitor, and development was discontinued in the target patient population. The modeling project supported a more confident decision without investment in additional trials, and allowed team members to re-deploy earlier to other programs. It also provided an enduring, evolving knowledge database to support future development decisions.

The use of our software and leading edge methodology developed by our strategic consulting group greatly enhances the traditional drug-development process, which is heavily dependent upon clinical trials. Although our methodology does not displace the use of human trials in drug development, we believe our software and methodology renders human trials more efficient and relevant. The continued growth of our customer base, the importance ascribed to “Model-Based Drug Development” by the FDA in its Critical Path whitepaper, the increase in the number of contracts with our existing customers, and the increase in our average contract value over time have shown a trend that we believe demonstrates increased acceptance of our methodology and an increased demand for its use. This demand can be met by increased deployment of our software and services, by proprietary solutions developed by our clients, or by increased internal resources within our customers. We believe that these trends, in addition to increasing regulatory requirements from the FDA, demonstrate a potential for increased revenue growth resulting from increased demand for our current products and services, as well as long-term opportunities to expand the breadth and coverage of both our software products and services.

This excerpt taken from the PHST DEF 14A filed Jun 30, 2006.

General

The Company’s Certificate of Incorporation and Bylaws provide that the Board of Directors shall be divided into three classes, with each class having a three-year term; provided, however, that if the Company ceases to be a “listed corporation” within the meaning of Section 301.5 of the California General Corporation Law, as amended (the “CGCL”), the Board of Directors shall cease to be divided into classes and all directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting of stockholders. On November 8, 2002, the Company ceased trading on The Nasdaq National Market and began trading on the Over-The-Counter Bulletin Board system. As a result, the Company is not currently a “listed corporation” within the meaning of Section 301.5 of the CGCL, and therefore, all directors of the Company shall be elected at each annual meeting of the stockholders to hold office until the next annual meeting of stockholders.

The Company’s Board of Directors is currently comprised of seven directors. The Board of Directors has selected six nominees for election to the Company’s board of directors, all of whom have been recommended for nomination by the Nominating and Corporate Governance Committee of the Board of Directors and all of whom are currently serving as directors of the Company. All nominees were elected by the stockholders at last year’s annual meeting. Robert B. Chess, a current member of the Board of Directors, is not standing for re-election and his term will end at the Annual Meeting. Pursuant to the Company’s certificate of incorporation, the Board of Directors intends to reduce the size of the board to six directors following the Annual Meeting.

The term of office of each person elected as a director will continue until the next annual meeting of stockholders or until a successor has been duly elected and qualified.

Unless otherwise instructed, the proxy holders will vote the proxies received by them for the Company’s nominees named below. Your proxies cannot be voted for a greater number of persons than the number of nominees named in this proxy statement. In the event that any nominee is unable or declines to serve as a director at the time of the Annual Meeting, the proxies will be voted for any nominee who shall be designated by the present Board of Directors to fill the vacancy. It is not expected that any nominee will be unable or will decline to serve as a director. The name, age and principal occupation of each nominee as of June 20, 2006, are set forth below. There are no family relationships among directors or executive officers of the Company.

This excerpt taken from the PHST 10-K filed Jun 26, 2006.

General

 

Pharsight Corporation develops and markets software and provides strategic consulting services that help pharmaceutical and biotechnology companies improve the efficiency of the drug development decision making process by reducing the costs and time requirements of their drug discovery, development, and commercialization efforts. Our products include proprietary software for clinical trial simulation and computer-aided trial design, the statistical analysis and mathematical modeling of data, and the storage, management, and regulatory reporting of derived data and models in data repositories. Both our software products and our services utilize expertise in the sciences of pharmacology, drug and disease modeling, biostatistics and strategic decision-making. Our service offerings use this expertise to interpret and improve the design of scientific experiments and clinical trials and to optimize clinical trial design and portfolio decisions. By integrating scientific, clinical, and business decision criteria into a dynamic model-based methodology, we help our customers to optimize the value of their drug development programs and portfolios from discovery to post-launch marketing

 

Our goal is to enable pharmaceutical and biotechnology companies to reduce the time, cost and risks of drug development activities and improve the abilities of these companies to market the use of their pharmaceutical products once approved by governing regulatory agencies. Our products and services are designed to help our customers use a more rigorous scientific and statistical process to identify earlier drug candidates that will not be successful, to enhance the likelihood that the remaining candidates will successfully complete clinical trials and to maximize marketing impact upon approval. This process is significant because the process of clinical development has remained lengthy and unpredictable while the productivity of molecule discovery research has accelerated dramatically in recent years.

 

Our strategic consulting services are used by 20 of the world’s largest 50 pharmaceutical companies. In addition, all of the world’s largest 50 pharmaceutical companies use our software products. Our software products are currently licensed for use on more than 4,000 desktops.

 

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We believe our products and services provide the following benefits to customers:

 

    Reduced time required for transforming, analyzing, and reporting information required for drug approval;

 

    More effective trial designs with higher probability of success and greater information yield;

 

    More rapid, robust and objective decision-making with wider data availability and quantified assessment of value versus risk;

 

    Improved workflow and organizational efficiency with faster regulatory acceptance of trial results;

 

    More efficient development programs requiring fewer clinical trials and patients, less time and lower cost to reach the market; and

 

    Strengthened competitive position due to improved product labels and earlier opportunity to establish a competitive franchise.

 

The following illustrates several typical customer applications of our software products and services:

 

    In designing phase II clinical trials, companies often face significant uncertainty in selecting the appropriate doses to test. Our products and services integrate information from phase I and pre-clinical activities, information concerning related drugs that have been developed by the customer, information in scientific literature about other drugs in the same therapeutic area, and knowledge of the relevant physiological and disease processes. This information, along with carefully identified assumptions, is used to develop a mathematical model enabling a computer simulation of the proposed trial. Using this approach, customers are often able to identify proposed doses that have little chance of success and should be excluded, or to identify additional doses that are more likely to yield important information.

 

    In designing phase III clinical trials, companies often face significant uncertainty concerning the most appropriate treatment strategy, patient inclusion/exclusion criteria and/or clinical measurements. Our products and services for phase III clinical trials use an information gathering and modeling approach similar to that described for the phase II clinical trials above, but incorporate phase II data and detailed mathematical models of the relevant patient populations. Our products and services are often able to identify patient groups with low chance of demonstrating efficacy, or an unacceptable chance of demonstrating side effects, prior to conducting the actual trial. In addition, we may be able to predict which clinical measurements will be most likely to provide conclusive results in the proposed trial.

 

    In making drug portfolio decisions, companies need to integrate scientific and clinical results, such as those described above, with market and financial information for all of the drug candidates in the development pipeline. We believe that our products and services help companies make better decisions concerning “go/no-go” criteria, prioritization of potential label objectives to be pursued and optimal sequencing of clinical trials within a development program. Our products and services can also help customers adopt a more quantitative and scientific approach to resource allocation among programs within their drug portfolios.

 

    The production of industry standard pharmacokinetic, or PK, reports required by the United States Food and Drug Administration, or FDA, for a new drug submission are often characterized by lengthy cycle times, increasing both expense and required resources along with potential variability and quality issues regarding the display of results within a clinical development organization. Much of an individual scientist’s time in a typical client organization may be involved with tasks such as data preparation needed for analysis, display of PK analysis via report creation, and the quality control measures needed to ensure correct information is presented to the FDA. These tasks may reduce time available to focus on the quality and impact of the scientific decisions that drive compound development. The lack of industry standards and an integrated software platform to drive the adoption and automation of standards can often lead to lengthy report cycles and delays in regulatory submissions.

 

   

By deploying our Pharsight® Knowledgebase Server™, or PKS™, suite of applications and services (PKS, WinNonlin®, PKS Reporter™, PKS Validation Suite™ and PK Automation), we believe our

 

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clients have succeeded in delivering sustainable productivity improvements to their regulatory submission process. Our PKS data repository affords integration to legacy laboratory and clinical data sources, reducing the time needed for data preparation prior to analysis by our clients’ scarce scientific resources. The PKS suite seamlessly integrates PKS with WinNonlin, PKS Reporter, and third-party applications and provides the opportunity to automate a majority of the standard PK reports required by the FDA.

 

    We believe many of our clients have experienced significant productivity improvements in creation of standard PK reports, including significant reductions in report cycle time, along with improvements in quality and consistency of analysis and display of analytical results. As a result of these increases in productivity, we believe our clients are able to reallocate resources to other aspects of the drug development process.

 

    A typical example of the use of Drug Model Explorer™, or DMX®, to support quantitative decision making is in the area of analyzing a potential new drug in a pharmaceutical company’s key therapeutic area franchise. To this end, we collaborated with a pharmaceutical company to build model-based projections of the competitive landscape. The modeling effort combined internal study data with published trials and FDA submissions on competing compounds to generate an integrated and quantified assessment of the drug’s likely performance. The client’s clinical development project team used DMX to evaluate and communicate the modeling results. Through DMX, the team explored clinical effects and associated uncertainty for the drug and competitors across multiple endpoints, treatments, and patient populations based on pre-simulated responses defined and prepared as part of the model-building effort. The results showed that the new drug was unlikely to outperform its main competitor; development was discontinued in the target patient population. The modeling project supported a more confident decision without investment in additional trials, and allowed team members to re-deploy to other programs. It also provided an enduring, evolving knowledge database to support future development decisions.

 

The use of our software and leading edge methodology developed by our strategic consulting group greatly enhances the traditional drug-development process, which is heavily dependent upon clinical trials and patient testing. Although our methodology does not displace the use of human trials in drug development, we believe our software and our methodology renders human trials more efficient and relevant. The continued growth of our customer base, the increase in number of contracts with our existing customers, and the increase in our average contract value over time have shown a trend that we believe demonstrates increased acceptance of our methodology and an increased demand for its use. This demand can be met by increased deployment of our software and services, by proprietary solutions developed by our clients, or by increased internal resources within our customers. We believe that these trends, in addition to increasing regulatory requirements from the FDA, demonstrate a potential for increased revenue growth resulting from increased demand for our current products and services, as well as long-term opportunities to expand the breadth and coverage of both our software product offerings and strategic consulting services.

 

This excerpt taken from the PHST DEF 14A filed Jul 7, 2005.

General

 

The Company’s Certificate of Incorporation and Bylaws provide that the Board of Directors shall be divided into three classes, with each class having a three-year term; provided, however, that if the Company ceases to be a “listed corporation” within the meaning of Section 301.5 of the California General Corporation Law, as amended (the “CGCL”), the Board of Directors shall cease to be divided into classes and all directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting of stockholders. On November 8, 2002, the Company ceased trading on The Nasdaq National Market and began trading on the Over-The-Counter Bulletin Board system. As a result, the Company is not currently a “listed corporation” within the meaning of Section 301.5 of the CGCL, and therefore, all directors of the Company shall be elected at each annual meeting of the stockholders to hold office until the next annual meeting of stockholders.

 

The Company’s Board of Directors is currently comprised of eight directors. The Board of Directors has selected seven nominees for election to the Company’s board of directors, all of whom have been recommended for nomination by the Nominating and Corporate Governance Committee of the Board of Directors and all of whom are currently serving as directors of the Company. All nominees were elected by the stockholders at last year’s annual meeting, with the exception of Howard B. Rosen. In 2004, a third-party search firm engaged by the Company recommended Mr. Rosen as a member of the Board of Directors. After conducting its evaluation, including interviews with Mr. Rosen, the Nominating and Corporate Governance Committee recommended his election to the Board of Directors. In October 2004, the Board of Directors appointed Mr. Rosen as a director. Steven D. Brooks, a current member of the Board of Directors, is not standing for re-election and his term will end at the Annual Meeting. Pursuant to the Company’s certificate of incorporation, the Board of Directors intends to reduce the size of the board to seven directors following the Annual Meeting.

 

The term of office of each person elected as a director will continue until the next annual meeting of stockholders or until a successor has been duly elected and qualified.

 

Unless otherwise instructed, the proxy holders will vote the proxies received by them for the Company’s nominees named below. Your proxies cannot be voted for a greater number of persons than the number of nominees named in this proxy statement. In the event that any nominee is unable or declines to serve as a director at the time of the Annual Meeting, the proxies will be voted for any nominee who shall be designated by the present Board of Directors to fill the vacancy. It is not expected that any nominee will be unable or will decline to serve as a director. The name, age and principal occupation of each nominee as of June 20, 2005, are set forth below. There are no family relationships among directors or executive officers of the Company.

 

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