By Michael Guarciaro, Ph.D.
The average cost of bringing a new molecule to FDA approval has risen precipitously during the last 10 years. In order to control costs, improve efficiencies, and streamline the timeline from discovery to approval, life sciences companies participate in outsourcing collaborations with CROs. Organizations from large pharmaceutical and agricultural companies to virtual companies with no scientific staff make use of CROs in the areas of R&D and manufacturing. In the area of discovery services, all phases are outsourced. Outsourcing also extends through the preclinical development and clinical/manufacturing phases of drug development.
In recent years, clients have begun to take advantage of capabilities and partnering opportunities with CROs at multiple sites across the globe in order to take advantage of cost benefits and regional expertise. Clients have come to expect a comprehensive offering of chemistry and biology services from CROs in North America, Europe, and Asia. The chemistry services can include the synthesis of building blocks and custom libraries, custom synthesis, process research, medicinal chemistry, computational chemistry, and scale-up chemistry, transitioning to cGMP support and manufacturing. The biology services may include protein expression, target validation, bioinformatics, assay development, high-throughput screening, secondary screening, in vitro ADME (absorption, distribution, metabolism, and excretion)-tox, in vivo pharmacology, and in vivo ADME-tox.
Along with the advantages of global outsourcing also comes a unique set of challenges for the client and the CRO. The challenges are generally either of a technical nature, logistical nature, or communications-related, and are described in more detail further on in this article.
This has led to the utilization of integrated global project management practices in global collaborations. These unique management protocols provide a way to effectively lead a client’s outsourcing projects that are worked on at multiple sites in different parts of the world. The project’s chemistry and/or biology may be performed at one or more sites, and the project may be coordinated or managed from a separate location or from one of the sites where research is being performed. The collaboration is ultimately integrated by the CRO to provide a single point of contact in order to maximize communication efficiencies with the client.
BENEFITS AND CHALLENGES OF GLOBAL OUTSOURCING
The consideration of offshore outsourcing and the utilization of global project teams offer a number of benefits to the client, including cost advantages, access to global talent and technologies, compressed timelines, increased production, and the potential of having projects conducted on a 24/7 basis. Equally important are the concerns and potential issues associated with offshore outsourcing to the client. From the client’s perspective, project or program deadlines must be met. Technical expertise and time management skills are crucial to affording acceptable productivity metrics in this regard, and the client pays particular attention to assessing these skills when making a site selection. Can the site being considered handle the degree of difficulty and complexity of the project? Will any improvement in cost be offset by lower metrics? IP protection is also crucial to the client in making a CRO and site decision. The client will also study the ability of the CRO to effectively handle technology transfer between global sites, as well as internal communications and external communications to the client. Logistics issues will also be of high importance to the client in the areas of sourcing of raw materials, shipping times, and delays, as well as customs issues and how they are handled by the CRO. Other challenges that are confronted include ethics, meeting regulatory compliance demands, access to talent and technologies, and quality control. In addition, communication breakdowns may occur between sites, as well as with the client, in setting and following of the project objectives, changes in objectives during the project, prioritization of goals, deadlines, and documentation. Cultural barriers may also contribute to breakdowns in communications. Project management and coordination at remote global sites as well as between global sites are also critical to the success of a collaboration, and the client should study the past record of a CRO in this regard.
ADDRESSING INTEGRATED GLOBAL PROJECT MANAGEMENT ISSUES
Coordination And Management
Within organizations that utilize the integrated global project model extensively, a global project manager (GPM) is responsible for coordinating the work performed at all locations. The GPM is someone who possesses outstanding communications and technical skills as well as experience and sensitivity in dealing with diverse cultures. This individual should be responsible for remotely managing, coordinating, and facilitating the successful progress and completion of the project and should be well-versed in the techniques of matrix management.
The GPM acts as the primary contact for the client. This will save the client time and labor, since the CRO handles the collection of reports, data, and samples through a centralized location and contact. The GPM should be responsible for communicating information and directions from the client to the sites, conducting the work, and vice versa. Included in this crucial communications area are the collection and review of project updates and their transfer to the client. The GPM functions as the central communication link between the CRO project teams and the client. This allows the client to communicate with the CRO in one time zone with one contact.
The presence of employees with training in the core values and corporate culture of the CRO, who are on the ground at the various global sites, also acts as an aid in addressing communication breakdown issues before they occur. An understanding of how things are done at a particular site due to the culture of the host country and due to corporate cultures is essential in being able to recognize the capabilities and limitations of the staff at a particular site.
Logistics And Quality Control
The CRO should have a global project coordination team, which can coordinate the sourcing of raw materials with the global sites. This experienced group provides a centralized sourcing point for the CRO’s global sites and works closely with the GPM to quickly find sourcing solutions for a particular client’s project. Sourcing can be arranged with outside vendors or with internal synthesis groups at the CRO’s global sites. The GPM might coordinate the shipments of raw materials to the various global sites, as the project’s needs dictate. The centralization of a shipping point, either solely via the GPM or with the help of a project coordination team, allows the CRO to provide another point of quality control. The groups who receive samples from the global sites will routinely check the documentation and analytical data and act as an additional pair of eyes in the CRO’s quality control process.
Technical And Problem-Solving Skills
The technical skills of individual teams and sites should be taken into consideration by the client when choosing a particular site(s). Support in this area should be available to all teams from senior scientists to managers at the global sites who can be utilized as consultants on various projects. The GPM and technical consultants within the CRO should also be utilized to help contribute intellectual input in synthesis strategy/tactics and in analogue design.
The GPM or project coordinator should also regularly track the metrics of the project teams at all sites, paying attention to problem-solving skills, success rates, targets completed, and effective multitasking. These results should be made available to the client.
IP Protection and Security
Organizations that offer integrated global project models must also guarantee the same diligence towards protecting the IP of the client at all of their global sites that the client expects from one of their own sites. The employees at global sites are trained in this area to ensure they will protect IP and also conform uniformly to a corporate culture that values confidentiality and ethics. While it is not possible to change cultures related to the country at which a research site is located, it is possible to teach the employees to follow and practice the corporate culture. Utilization of secure email and secure websites may be specified by the client or recommended by the CRO.
THE ADVANTAGES OF THIS APPROACH
Integrated global project management practices offer a number of advantages to a client over a situation where the client has to independently do business with the multiple sites of one CRO. These advantages include flexibility and centralization of communications, thus allowing the client to communicate efficiently in whatever time zone is most convenient. The system also allows for the rapid identification of critical technical and logistical issues, efficient problem-solving, and the application of global technical expertise in chemistry, biology, and pharmacology across multiple sites via coordinators and consultants. Logistical issues, including sourcing and shipping, are handled by the CRO; this allows for the most rapid delivery of raw materials at the most competitive price. The client is also assured that IP will be completely protected. Coordination and management of the projects at multiple global sites should be handled by an experienced project manager, who may act as a central contact point for the client.
For the extended version of this article that includes a section on the advantages of this approach, click on the “magazine” tab on our homepage (LifeScienceLeader.com) and navigate to the January 2010 issue.
About the Author
Michael Guaciaro, Ph.D. is director of medicinal chemistry at AMRI. He has led and coordinated integrated global projects since 2000 and is highly experienced in dealing with the unique challenges associated with such projects. He received his Ph.D. in organic chemistry from the University of Pennsylvania.