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William Sharbaugh, Chief Operating Officer, PPD, INC.Mitchell Katz, PhD, Vice President, Global Clinical Operations, EISAI
This presentation focused on the partnership that has been established and developed between PPD and Eisai Pharmaceutical Company.
Opening comments were that the patent expiration cliff is now. It is incumbent for companies to strengthen their pipeline as soon as possible. It was also noted that there are changes occurring with respect to the relationship between the CRO and sponsor.
The PPD/Eisai relationship has been in existence since 1995. As evidenced by this example, a good strategic relationship takes a long time to develop and with much effort.
Past relationships have been tactical in nature. This means that the previous interactions have been a fee for service, preferred partnership or a price for volume for services provided. The past model is one in which the sponsor gives responsibility/accountability for a function or service to the CRO.
The new model is structured such that value is created for both organizations. It is a matter of the sponsor stating the desired business outcome and the CRO developing the processes to achieve the stated outcome. A good working relationship will take up to 3 – 5 years to build that will result in mutual confidence and respect for both parties. The new strategic Partnership should move from transactional to portfolio partnering and to make the necessary investments to grow and thrive.
Issues associated with selecting the correct CRO include key core competencies, sponsor needs to leverage outsourcing goals, to achieve greater operational efficiencies, higher quality, improved performance and shorter timelines.
Eisai trimmed down their service providers from many down to 2 global providers. The understanding by this arrangement was that each CRO was given one specific area of development and they were treated as equal partners in therapeutic development efforts. The continuation of this working arrangement was based upon the understanding that the contract was the CROs to lose based upon their own efforts/activity (performance) as well as maintaining a clear cut team for all activities leading up to registration.
The selection criteria for this process was based upon therapeutic expertise of the CRO, assessment of Eisai processes by PPD, performance, creative accounting, partnering experience, good presentation, CTMS experience real time, EDC capabilities/experience.
Benefits to Eisai – increase in pipeline throughput, faster drug development programs, reduction in Contract to work Order Time, Access to data in real time, reduction in CRO oversight.
PPD benefits – greater team empowerment, internal job satisfaction, dedicated team sequential to project roll over, increased staff retention, joint process and process improvement, decreased project start up time, decreased investment and guarantee investment stream.
The Eisai short term strategy used to prepare for this dynamic shift required an internal cultural change. The partnership was introduced internally by using presentations, conducting internal surveys, baseline data for blending of services was obtained and held many internal training meetings.
The success of PPD and Eisai working together has created a movement to shared visions and values, higher level of trust, aligned goals and incentives, derived greater values in working together, brought about senior management engagement and could possibly serve as model to industry.
Opening comments were that the patent expiration cliff is now. It is incumbent for companies to strengthen their pipeline as soon as possible. It was also noted that there are changes occurring with respect to the relationship between the CRO and sponsor.
The PPD/Eisai relationship has been in existence since 1995. As evidenced by this example, a good strategic relationship takes a long time to develop and with much effort.
Past relationships have been tactical in nature. This means that the previous interactions have been a fee for service, preferred partnership or a price for volume for services provided. The past model is one in which the sponsor gives responsibility/accountability for a function or service to the CRO.
The new model is structured such that value is created for both organizations. It is a matter of the sponsor stating the desired business outcome and the CRO developing the processes to achieve the stated outcome. A good working relationship will take up to 3 – 5 years to build that will result in mutual confidence and respect for both parties. The new strategic Partnership should move from transactional to portfolio partnering and to make the necessary investments to grow and thrive.
Issues associated with selecting the correct CRO include key core competencies, sponsor needs to leverage outsourcing goals, to achieve greater operational efficiencies, higher quality, improved performance and shorter timelines.
Eisai trimmed down their service providers from many down to 2 global providers. The understanding by this arrangement was that each CRO was given one specific area of development and they were treated as equal partners in therapeutic development efforts. The continuation of this working arrangement was based upon the understanding that the contract was the CROs to lose based upon their own efforts/activity (performance) as well as maintaining a clear cut team for all activities leading up to registration.
The selection criteria for this process was based upon therapeutic expertise of the CRO, assessment of Eisai processes by PPD, performance, creative accounting, partnering experience, good presentation, CTMS experience real time, EDC capabilities/experience.
Benefits to Eisai – increase in pipeline throughput, faster drug development programs, reduction in Contract to work Order Time, Access to data in real time, reduction in CRO oversight.
PPD benefits – greater team empowerment, internal job satisfaction, dedicated team sequential to project roll over, increased staff retention, joint process and process improvement, decreased project start up time, decreased investment and guarantee investment stream.
The Eisai short term strategy used to prepare for this dynamic shift required an internal cultural change. The partnership was introduced internally by using presentations, conducting internal surveys, baseline data for blending of services was obtained and held many internal training meetings.
The success of PPD and Eisai working together has created a movement to shared visions and values, higher level of trust, aligned goals and incentives, derived greater values in working together, brought about senior management engagement and could possibly serve as model to industry.
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