The partnership model This model was developed over several years and initially implemented by Actelion Pharmaceuticals (see sidebar). It has been
successfully reproduced after adaptation to the specific needs of each sponsor. For instance, if the sponsor cannot frequently
attend project team meetings, the sponsor reserves a desk for the partner's project manager to spend several days or weeks
at the sponsor's office on a regular basis. The advantage of having a project manager from the clinical partner is to increase
communication. Both parties can fully benefit from a complete under- standing of the processes involved and direct contact
with field and biometric department colleagues. It is easy to see the advantages of having a project manager working closely
with the sponsor organization. From this viewpoint, it will be easier to filter information back into the service provider
organization, which is a known territory.
Other advantages to this model are Web-based status and data reporting systems. Data can be made available to sponsors at
any time. Systems interfaced with validated data management systems can be updated daily to manage and track the project and
be accessible through secured Internet connections from virtually anywhere.
Thus, as depicted in Figure 1, this model creates a point of intense sponsor-CRO interaction, which radiates within the clinical
development organization and its suppliers or partners.
Opportunities Small biopharmaceutical companies are evolving fast. Most of the time they would prefer to internalize key functions within
the company, but the need for activities typically performed by these functions may arise before internal resources and their
related ICH/GCP processes have been implemented. A typical example may be the handling of serious adverse events and their
reporting to health authorities. There is a constant exchange of process know-how and a flexible adaptation of each partner
to the progress of the sponsor's infrastructure when flexibility exists within the partnership. Thus, certain tasks may be
taken over by the sponsor along the way, in particular for programs of long duration. This gives time for the sponsor to set
up an internal organization, which will then be able to operate with the same or very similar processes estab-lished with
the experienced partner.
The same principles may be applied to biometrics services. The use of validated systems meeting regulatory requirements is
paramount to any clinical development program aimed at obtaining registration under ICH regulations. The setup of such systems
is expensive and requires much time and experience. Therefore, the sponsor may decide to leave the database with the partner,
yet progressively develop their own statistical expertise for data analysis and reporting as well as establish independent
access to high-quality data.
Emerging biopharmaceutical companies make great efforts to build and maintain their image within the life science investment
community. They should also not miss the early opportunity to build their name recognition and image within the clinical research
community. The better their image, the more likely study investigators will develop loyalty and support for the company. Investigators
prefer working directly with a sponsor rather than dealing with representatives of a large CRO.5 Due to limited staff and geographic presence, this is difficult for small biopharmaceutical companies. Through a clinical
development partnership, the sponsor and its partner create a combined entity dedicated to the project, "the partnership,"
whose interest is to develop the sponsor's name recognition.
Conclusions Co-management and integration of key resources to ensure flexibility, commitment, project focus, and full control by the sponsor
has been tested for over three years and has shown excellent results.
This partnership solution-based on mutual trust, transparency, and synergies of expertise-allows the sponsor to keep full
control of the development program despite employing external resources. It has the potential to provide key long-term benefits
to the biopharmaceutical company, such as guarantees of meeting regulatory requirements and opportunities to develop its own
operations progressively according to proven and established processes.
The achievements in time savings are substantial, although always difficult to calculate accurately. The best evidence is
provided by the record time achieved by Actelion Pharmaceuticals with its Tracleer" pulmonary hypertension product, which
went from start of Phase II to product launch in the U.S. market in only 30 months. The time saved was estimated at approximately
six months, with savings per month estimated between $10 million and $30 million.
Thus, this approach may represent the option of choice for emerging and growing biopharmaceutical companies facing a need
for experienced clinical development resources and which do not wish to fully outsource this critical investment due to an
expected lack of pricing and control strategy.
References 1. J.R. Vogel and N. Resnick, "Achieving Results with Contract Research Organizations: A Case Study in Evaluating and Selecting
a CRO," Applied Clinical Trials, June 1996, 30-36.
2. M. Cuddigan and M. Driver, "Keeping Score in Clinical Outsourcing," Scrip Magazine, October 2002, 51-53.
3. T. Hill, "Can CROs Measure Up to Their Claims?," Scrip Magazine, March 2002.
4. M. Bowden and S. Mckenzie-Lawrie, "Looking to the Next Generation of CROs," Scrip Magazine, March 2002, 36-37.
5. CenterWatch 2001 Survey of 405 Investigative Sites (CenterWatch, vol. 8(7), pp. 4-7, July 2001).
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