FLEMINGTON, N.J., June 5, 2002 (PRIMEZONE) -- Strategic-Pharma announced today that it has developed a management tool designed to streamline and accelerate the development of new drugs and biologics. The knowledge-based process focuses the activities of multiple disciplines into one integrated objective -- namely, to obtain marketing approval as quickly as possible.
Development of a drug or biologic is complex and multifaceted, requiring highly specialized input from several scientific disciplines and business groups. Consequently, divisional barriers naturally separate the development process and create functional boundaries. Strategic-Pharma's knowledge-based technique removes these traditional boundaries from the development process by incorporating all the key elements into an integrated gap analysis.
"Due to the labyrinthine nature of drug development, the process is often conducted in an isolated and fragmented manner," said Dr. Richard Williams, Founder and President of Strategic-Pharma. "All too often, something crops up late in the day to delay the development of promising drugs ... our knowledge-based process provides senior management with a technique to proactively identify potholes and thus bring potentially life-saving therapies to patients more quickly."
Strategic-Pharma's gap analysis relies on integrating the various disciplines involved in drug development -- such as chemistry, manufacturing, biopharmaceutics, clinical, regulatory, and business development -- and then identifying the gaps in the strategy or process. By utilizing the knowledge of proven experts, Strategic-Pharma can quickly provide proactive solutions to these gaps, thereby not only preventing delays but actually accelerating the development process. The flexible technique can be applied to early stage ventures requiring advancement of their product to "proof-of-concept" as well as more advanced companies striving for worldwide marketing approval.
Dr. Williams continued: "Drug development costs hundreds of millions of dollars. Shortening development time can have an enormous impact on the return of investment as well as accelerating the availability of new drugs for patients."
Strategic-Pharma is a privately held consulting firm providing strategic drug development services for biopharmaceutical companies on a worldwide basis. The services include devising strategies to rapidly advance new therapies toward registration, providing integrated gap analysis (and solutions) for ongoing programs, and performing regulatory due diligence for licensing opportunities.