Pharsight Presentations at the FDA Contribute to the Critical Path Initiative
Pharsight Corporation (OTC Bulletin Board: PHST), a leading provider of software and strategic services designed to optimize clinical drug development, today announced that two of its drug development consultants have given presentations to various divisions of the Food and Drug Administration (FDA) discussing the advantages of applying quantitative decision-making methodologies to the regulatory and drug development processes.
These invited presentations contribute to the FDA Critical Path initiative to improve the productivity of drug product development by the application of innovative approaches and emerging technological advances to assess the safety and effectiveness of potential new products. The FDA believes that efficiencies gained through these innovations will bring significant economic savings to the development process.
On March 16, 2004, the FDA released a report which addressed the slowdown in innovative medical therapies that have recently been submitted for approval. In that report, entitled “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products” the FDA outlined what it described as an “urgent need to modernize the medical product development process — the Critical Path — to make product development more predictable and less costly.” In response to this report, the FDA has begun sponsoring a series of workshops and meetings where renowned industry stakeholders are being invited to give presentations to members of the Center for Drug Evaluation and Research (CDER), a division of the FDA.
FDA Commissioner Mark B. McClellan, M.D., Ph.D. has said, “Today, as never before, we face a tremendous potential for new medicines to prevent and cure diseases, but fewer new products are actually reaching the FDA. With so much promising technology in development in the clinical labs … we need to turn the process of bringing these technologies to patients from a costly and time-consuming art form to a well-understood science.” According to Deputy FDA Commissioner Lester M. Crawford, “A new focus on updating the tools currently used to assess the safety and efficacy of new medical products will very likely bring tremendous public health benefits.”
“We are very encouraged by the FDA’s recognition of the need to streamline and strengthen the drug development process,” said Shawn O’Connor, president and chief executive officer of Pharsight. “By implementing quantitative decision-making approaches, pharmaceutical companies can greatly increase the efficiency of their drug development organization by optimizing many key decisions including those regarding dosing, go/no-go and clinical trial design. We are excited about this opportunity to address the FDA and expose industry thought-leaders, decision makers and other scientists to our state-of-the-art methods for quantitative modeling-based clinical drug development.”
R. Russell Wada, Ph.D., Vice President of Pharsight’s Drug Development Consulting Services for the western U.S. and Asia and William R. Gillespie, Ph.D., Vice President of Pharsight’s Drug Development Consulting Services forthe Eastern U.S. were both invited by the FDA Commissioner’s office to participate in a series of the lectures; the following is a synopsis of the talks that each presented:
- “Making Better Decisions in Cardio-Renal Drug Development: Application of Model-Based Drug Development” — this talk focused on models’ ability to enable better decisions because of integration, quantification, communication and accumulation.
- “Practical Approaches to Creating Drug and Disease Models” — this talk discussed 5 practical techniques for creating drug and disease models.
Both of these talks were presented by Dr. Wada.
- “Decision-focused Applications of Modeling and Simulation in CNS Drug Development” — this talk illustrated the role and value of modeling and simulation to support strategic decision-making in the clinical drug development process, including decisions relating to dose optimization, go/no-go decisions and clinical trial design.
- Integration of Pharmacodynamic Modeling and Bayesian Decision Analysis in Clinical Drug Development” — this talk illustrated how the integration of pharmacodynamic modeling and Bayesian decision analysis provides a powerful tool for optimization of many key decisions in clinical drug development.
Both of these talks were presented by Dr. Gillespie.
About Pharsight Corporation
Pharsight Corporation develops and markets products and services that help pharmaceutical and biotechnology companies improve their decision-making in drug evelopment and commercialization. By integrating scientific, clinical and business decision criteria into a dynamic, model-based methodology, Pharsight helps its customers optimize the value of their drug development programs and portfolios from discovery to post-launch marketing and any point in between. Pharsight uses computer-based drug-disease models, dynamic predictive market models, clinical trial simulation and advanced valuation models to create a continuously evolving view of its customers’ development efforts and product portfolios. This enables decision makers to make explicit value-driven trade-offs throughout the development and commercialization process. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available on the World Wide Web at http://www.pharsight.com .
NOTE: Pharsight is a registered trademark of Pharsight Corporation.
