Thursday, April 30, 2009

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution

Harris Koffer, Pharm D, President and COO, RPS, INC.
James Dannemiller, Director, Site Research, WYETH RESEARCH


Harris Koffer and James Dannemiller started off discussing the understanding key trend and drivers for pharma. Over the last ten years, a peak of 50 drugs were approved in 1996, then dwindling to 22 drugs approved in 2006. The cost of developing drugs over this time as doubled. The market for Pharma products has continued to grow. The risks of drug development have continued to increase. Only one in five drugs for human testing actually reaches the market. Patent expirations on drugs has been putting pressure on the industry. Companies will loose significant revenue because of this between now and 2012. We’re also faced from external burden of a declining economy. Total health care expenditure was at slowest pace in 2007. Declining utilization of healthcare coupled with patients who can no longer to afford to medication will further decrease the productivity and profit of the Pharma industry. What is MMAX? Maximizing Monitoring, Availability and Excellence. Wyeth and RPS to make this program work. MMAX was established in 2005. The goal of this program was to reduce cost, improve quality, expedite clinical development process and improve site relationships. It operates under one global process. It includes one global structure reporting to Wyeth and one governance model. The strategic intent of MMAX was to implement structure that represented culture of Wyeth, structure to expand or contract with Wyeth’s portfolio, and to maintain Wyeth’s primary image.


Key objectives of MMAX:Quality – With activities, but also the quality from a site perspective, and to identify quality site that can perform the study based on the expectations.Speed – Ability for RPS to gear up for changes. Flexibility – ability to scale up or down as the needs of the organization mergeCost Effectiveness – Cost model that provides more streamline approach to cost.

Updated

Here is a brief clip from this keynote presentation


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