The right prescription
BY LORNA PAPPAS
In the business world, pharmaceutical project managers are a breed apart due to the significant investment in drug development projects, the magnitude of risk in decisions made along the development cycle and the extensive involvement of senior management, often as a cross-functional committee. Science doesn't stop: Every day a new factor emerges in the development itself or from a competitor that can alter the project's course.
To steer these risky decisions, project managers must understand the best practices and concepts articulated by academic and government scientists, internal clinical research groups and other subspecialists involved in the project. They also must speak intelligently about these initiatives to the project team. Pharmaceutical project managers must gain approval by regulatory bodies, often in more than 100 countries, to deliver the product around the world, a cycle which averages 12 years and an investment of about $800 million, according to a study released by Tufts Center for the Study of Drug Development, Boston, Mass., USA.
“As pharmaceutical companies pursue growth objectives by pumping more drug candidates into the development pipeline, these increasingly costly projects are competing for more limited resources, and tough project trade-offs are being faced,” says Michael Goff, a Stamford, Conn., USA-based director of the Life Sciences Business Group of Pittiglio Rabin Todd & McGrath, a management consulting firm. “Pharmaceutical executives are turning to project managers to provide information on development costs, timelines, risks and overall project value to help make these decisions. Project managers are also expected to identify creative portfolio and resource management solutions to enable pharmaceutical companies to generate the most value from their drug development pipelines at a lower cost.”
Pharmaceutical executives are turning to project managers to provide information on development costs, timelines, risks and overall project value to help make these decisions.
DIRECTOR OF LIFE SCIENCES BUSINESS GROUP, PITTIGLIO RABIN TODD & MCGRATH, STAMFORD, CONN., USA
Co-development: The New Drug?
As larger pharmaceutical firms reach out to emerging biotech companies and smaller pharmaceutical organizations to add product to their pipelines, the project manager's role is magnified in the execution phase. The project manager moves from that of an integrator across various functions in a firm to these same roles across two or more co-developing companies. The use of contract research organizations and investigators to run preclinical surveys, for example, further increases the complexity of the project manager's job, as technology transfers from one company to another.
The demand for core project management skills will increase as more biopharmaceutical products enter the pipeline and clinical development cycle time is reduced, says Goff. These factors place functions not typically found on the critical path, like formulation development, process science and others, into the fray with clinical testing, regulatory compliance and marketing. The trade-offs in late-stage drug development will become more complex and the need for greater cross-functional understanding will make the role of the project manager even more critical.
For the project manager, balancing the requirements for speed to market vs. final product cost and quality is daunting, says Jim McDonough, a senior research scientist at Eli Lilly and Co., Indianapolis, Ind., USA. “The development of new therapeutic entities is a complex process characterized by high costs, extended timelines, extensive regulations, and extreme uncertainty and risk,” he says. “Large pharmaceutical companies manage significant portfolios of development projects, all competing for the same limited pool of resources. Relative priorities among the projects may change frequently as new toxicology, clinical or pharmaceutical data become available.
“Furthermore, given the years to bring a project to completion through regulatory submission and launch, project team membership may change many times over.”
McDonough adds that pharmaceutical project managers spend significant energy to ensure that all stakeholders understand the changing risk profile, progress, costs and likely deliverables performance of their projects. The fact that there is an ever-increasing adoption of a systematic, professional approach to managing pharmaceutical development projects indicates that the industry realizes the benefits that may accrue from effective pharmaceutical project management.
As in most projects, planning is the key element in the drug development cycle, and an intranet Web site designed around a particular project offers vitality to execution and communications.
Thorough planning smooths the path of a drug candidate from discovery to Phase 1 clinical trials, says Christine Hazelden, Zone 2 program management office leader at Eli Lilly and Co. Ltd., Basingstoke, U.K. “Planned, coordinated resources from numerous groups such as toxicology, pharmaceutical development, process chemistry, manufacturing and pharmacology in the United States, Europe and other major regions makes the difference between success and failure,” she says. “Delays in drug development could mean being second to market and lost sales of millions of dollars.”
Luis Cabassa, PMP, director of product development, project management, for Genentech Inc. of South San Francisco, Calif., USA, and chair of PMI's Pharmaceutical Specific Interest Group, asserts that the strategic planning process needs the right leader. “I know of no pharmaceutical company today attempting drug development without a project manager to oversee it.”
After the milestones and breakdown of specifics for discovery, preclinical studies and the development phases have been identified, Cabassa recommends a focus on the elements you can control over the short term rather than activities years in the future, when there is a lower level of certainty. “By concentrating on the specifics you can control within the next 12 to 18 months and moving forward on a rolling basis as you shift to the next phase, from a strategic point of view, you will gain a greater level of certainty and higher probability of hitting your deliverables than if you work now on issues six years down the road,” says Cabassa.
Pharmaceutical project managers often mediate between various business units, such as strategic marketing, clinical and regulatory organizations, which typically have a preferred strategy for the initial drug filing. “Good project management ensures that the right things are delivered to the right place at the right time using the right people,” says Eli Lilly's Hazelden.
For example, marketing may want upfront the broadest possible product profile requiring extensive additional clinical studies during development. The clinical organization may want a narrower product profile based on focused clinical data to speed the drug to market.
“Project management demonstrates what can be delivered according to the cost, resource and time constraints of a project,” says Hazelden. “If marketing wants a pediatric granule or several formulations or strengths for an initial new drug launch, project management tools can expound on the extra development time or resources, such as the need to use universal excipients, manufacturing resources, extra clinical trials and registration activities required, which can differ by country. These information tools can achieve a compromise of what can be delivered within the project constraints, for example, three strengths of one formulation using universally accepted excipients, while still meeting the key market needs.”
Goff agrees: “Project management can be very effective in translating between business and scientific needs to develop a time-based product profile of successive claims that will optimize the product life cycle, including subsequent studies to follow initial submissions. Without the effective mediation and translation capabilities good project managers provide, conflicting issues can create an impasse that can cause significant drug development delays.”
It is crucial to relay information between internal and external sources and integrate the data so team members can obtain it easily, because even the best ideas and practices are useless if not shared with the right people at the right time. At many pharmaceutical companies, communications are streamlined with internal access from an intranet to a Web site designed around each drug development project. The site serves as the project management team's central communications point, with each team member inputting and accessing data on a regular basis.
Documents are knowledge, and most drug development project Web sites include real-time project document files. Each morning, team members learn the precise status of the project, and, with the proper clearance, can review up-tothe-minute reports, milestones, objectives, agendas, status of protocols and trials, decision-making documents, project plans, major deliverables, schedules, presentations and other pertinent project data. In most cases, the project manager even works together with the Webmaster to design and maintain this core communications tool.
At Wyeth Research of Collegeville, Pa., USA, Jann Nielsen, director of project management, employs user-friendly Web sites for centralized communications. In a previous position, he was involved with co-developing, along with a Japanese drug company, a product that had sales of almost $1 billion last year. Through the Web, both firms in the alliance accessed the same up-to-date clinical information about animal toxicology, drug efficacy and safety, competitive information, relevant manufacturing data, timelines and other development strategies.
“The key to our success in establishing and maintaining the alliance, which several other companies also were attempting to do, was recognizing the importance of the scientific achievement early, getting buy-in from our company to pursue the effort and showing the Japanese firm that we would be the best partner,” says Nielsen. “Having a robust system facilitated this, permitting us to be faster—and first—which is key in the pharmaceutical industry.”
With entire new drug application submissions built on drug development Web sites, flexibility is key, says Robert Sturm, senior director of pharmaceutical applications at MAJARO InfoSystems, a San Jose, Calif., USA-based clinical data management CRO. “For example, the site should not maintain one structure for a U.S. Food and Drug Administration submission, another for European concerns and another for the Japanese,” he says. “All elements must be common to each country involved.”
With entire new drug application submissions built on drug development Web sites, flexibility is key.
SENIOR DIRECTOROF PHARMACEUTICAL APPLICATIONS, MAJAROINFOSYSTEMS, SAN JOSE, CALIF., USA
Managing the documents on a company's intranet allows easy tracking using metadata, or key information about each document. Sturm says that, with metadata, authorized personnel can pull up specific documents from a previous trial, an entire product plan or all protocol data for a specific drug in a certain timeframe.
Sturm suggests that the documents should be scanned and stored as PDF files, so no changes can be made. Only the project team should have access to the site, with project managers controlling the level of access by designating different security codes to various sets of documents.
In establishing an intranet project Web site, endorsement from senior management is key, but so is acceptance from the bottom up. Nielsen explains: “If the system isn't easy for the IT team, scientists and other people in the trenches to input data, the right information won't make it onto the Web site. Likewise, if extracting data is onerous, people won't use the Web site, and your phone will never stop ringing with questions.” PM
Lorna Pappas is a freelance writer based in Andover, N.J., USA. She has worked on projects within the pharmaceutical industry.
PM NETWORK | OCTOBER 2002 | www.pmi.org