Project Assistants’ Case Studies

Life Sciences Company Implements Resource Planning Tool to Enhance Proven Clinical Trial Methodology

Description of Client

Biogen, Inc., is a global biopharmaceutical company principally engaged in discovering and developing drugs for human health care through genetic engineering. The world’s oldest independent biotechnology company, Biogen was founded in 1978 and currently employs more than 1,500 people worldwide. With headquarters in Cambridge, Massachusetts, the Company’s revenues are generated from worldwide sales of drugs for treating relapsing forms of multiple sclerosis and from the worldwide sales by licensees of a number of products, including Intron® A and hepatitis B vaccines. Biogen has built a global operating biopharmaceutical company with the capabilities to research, develop, manufacture, and market products to treat inflammatory and autoimmune diseases, neurological diseases, cancer, fibrosis and congestive heart failure.

The Biopharmaceutical Industry Challenge

The major challenge for the entire biopharmaceutical industry is to speed up the delivery of high quality innovative new drugs for human health care with limited human and financial resources. The process to develop new medicines is both lengthy and expensive. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), it takes 12 to 15 years on average and $500 million for an experimental drug to travel from research in the labs to use by patients. For every 5,000 compounds that enter pre-clinical testing, only five will continue on to clinical trials in humans, and only one will be approved for marketing in the United States. Several phases of clinical trials are required prior to FDA approval for the release of any drug.

The Biogen Challenge

Biogen recognized the need to improve their process for the initiation, management, and reporting of the resourcing requirements for all clinical trial projects world-wide. The Biogen Business Analysts have the need to identify the resources across the organization that are assigned to all phases of clinical trials.

Biogen has developed well documented algorithms for the level of effort required from each type of generic resource based upon several parameters of any specific clinical trial. The use of pre-resourced templates was shown to be inadequate because of the maintenance requirements for the large number of templates required to cover the many types of clinical trials.

The Biogen Clinical R&D Department identified the need to adopt a standard project management tool for assigning, tracking and forecasting resources, and sought the help of Project Assistants to assist with this effort. Several meetings took place between Project Assistants and Biogen to help identify the requirements for an effective Census Planning Tool.

Solution

  1. Project Assistants and Microsoft helped Biogen to achieve the desired future state by developing and implementing a Resource Planning Tool to enhance Biogen’s proven clinical trial methodology as part of their Project Management Infrastructure. This involved creation of a tool that would:
    • facilitate project initiation through a wizard that uses a central database for resource algorithms (by position, by level, by phase and in-house or out-sourced). By providing menu-driven responses (a checklist of stages, levels, positions, etc.), this database is accessed by the initiation wizard for assigning resources and their appropriate level of effort. Any changes or additions to this database are reflected in the “outputs” (fte’s/time)
    • provide an administrative procedure that allows Biogen to update resource algorithms and add database parameters such as resources, categories, stages and resource options and assumptions
    • include functionality that allows Biogen to apply newly updated algorithms to existing project plans
    • support storage of project plans in a central database that could be accessed for future analysis and report generation

    Project Assistants assisted Biogen to reach the desired future state by following a proven methodology.

    • Project Assistants assisted Biogen with executing the plan by building the processes, guidelines, tools, training, communications, and associated change management required to implement the work management and Project Management Infrastructure.
    • The solution also included mentoring of the Business Analyst function to retrofit all project plans into the new Infrastructure

    Business Benefits

    • Ensure success by engaging experts with a proven track record for these types of initiatives.
    • Follow a proven methodology for achieving your work management and project management objectives.
  2. Microsoft Project providing the following functions:Standard process and Project Management repository for initiation of all clinical trial plans. By implementing a standard system to initiate all new clinical trials at Biogen, the resource data can be stored along with project tasks so that it would be possible to view a resource’s allocation across all activities they have been assigned to in the organization.
    • View a resource’s total scheduled and actual work by time period
    • View a resource’s total remaining availability by time period
    • View a resource’s utilization by time period
    • View future resource needs

    Business Benefits

    • Single source of data for management reporting
    • All resources are accounted for
    • Single source for assigning and managing resources
    • Easier to spot unnecessary duplication of effort
    • Provide tool to assist the Business Analysts to project resource allocations and to forecast additional resource needs
  3. Load all clinical trial project information into common resource management tool:The robust, flexible and scalable architecture of Microsoft Project and Project Central provide the required platform to store all resource project data for active Clinical Trials at Biogen.

    Business Benefits

    • Leverage the organization’s current investment in Microsoft Project
    • Microsoft Project is only needed by project managers and project leaders; all others are able to access needed project information directly from Project Central.
    • Microsoft Project data is integrated with other key business applications, such as accounting and human resource systems.
    • Ad hoc management requests reports are developed and published using industry standard report writing tools.