Thomas P. Lawler III, Sr. Director-Global Project Management, Ardea Biosciences
Today, health care reform combined with an upturn in pharmaceutical R&D provides an opportunity to develop a more agile system for drug discovery, development, licensing and usage. To meet this demand many pharmaceutical companies look for partners to help establish unique deal structures.
To maximize the return on investment, pharmaceutical companies need to be mindful of how they are leveraging these partnerships in order to foster innovation, including smarter drug or study design.
What can often happen is that pharmaceutical companies place a strong focus on cost reduction. This zero-sum approach can be short-sighted, and usually leads to increasing delivery risk, or the perception of reduced quality. When companies enter into large partnerships with this mentality, it limits the ability for both partners, and ultimately projects, to all win.
Project management is an area that can facilitate and enable true collaboration that can greatly benefit the R&D process and bring a drug to market more quickly. With the pressures to help decrease health care costs, pharmaceutical companies should be turning to their partners to help increase effectiveness that will ultimately increase efficiency.
Building True, Lasting Collaborations
Pharmaceutical companies must find ways to embrace change and find creative solutions where partners work together and both sides benefit. This willingness to share risk and build trust is a key ingredient to a successful collaboration. While it doesn’t always come naturally, someone needs to be the first person to take the step required to establish a level of trust, and take the relationship to the next level. This can be a risk, yes, but ultimately the long term benefits can by far outweigh the short-term risks.
Leadership or sponsorship on both sides of the partnership is required to encourage this shift away from zero-sum and help overcome internal challenges. People receive cues on how to relate to their partners from the top down. Therefore, leadership needs to be equipped with the right messages, understand how to communicate these messages, as well as demonstrate them in their interaction with partners. In doing so, employees will not only hear how to work with partners, but they’ll have examples to serve as a reminder of how they can strengthen their own relationships.
In addition, the use of project management practices greatly increases the chance for success in relatively simple and pragmatic ways. Having a lead who understands the importance of strong project management will do wonders for the program, as well as the team, as this person will help keep the project on track, and the team strictly focused, despite the various hurdles that will inevitably surface.
Building valuable partnerships is dependent upon building strong relationships, as well as having a fit-for-purpose infrastructure to support the inevitable breakdowns that occur during project delivery.
First and foremost, working together with a mutual goal or at a minimum complimentary goal, can improve quality assurance, risk management and regulatory compliance. These goals should be established at the beginning of the program to ensure all parties are in alignment on the approach. The failure to align expectations at the beginning of a project can often be found as the root cause for failed outsourcing projects.
Defining, Delivering Quality Work Together
As noted, a common issue for project breakdowns is misalignment of expectations. Detailed planning and ongoing, open communications at the start of a project, and any relationship, are critical for success. As such, having a strong planning process is key. The scope, specific tasks, timing, accountabilities, risks and opportunities should all be outlinedat the beginning, and all parties should be in complete alignment before beginning work.
When the program begins, ongoing management will be essential. The team needs to be closely aligned on performance tracking, escalating issues rapidly for solutions, and actively managing risks. Actively benchmarking against goals for the relationship, for both sides, throughout the program is also important, as it allows people to course correct as needed, and ensure the relationship will remain completely positive through the end. Establishing and maintaining this regular cadence of oversight is a key accountability of project management.
Defining specifications for deliverables is also important, as it defines quality standards for the relationship. The scope of work must be clearly defined by the sponsor and accepted by CRO, or even defined together in partnership. Quality measures and metrics should support delivery of the scope. Additionally, delivery expectations for quality such as delivery to specifications (i.e. accuracy), as well as the delivery to project baseline (i.e. precision) should be considered in advance, and agreed upon by all parties prior to kick off.
Sustaining the Relationship
The final part of building a successful relationship is maintaining it through good times and bad. That said, one of the fastest ways to sabotage a relationship is to learn you are not in agreement on the program expectations, and even worse, learn you are not in agreement half way through the program at the first sign of something not going well within the project.
Since all projects encounter issues, building an environment of trust is essential. Open and honest communications should always be encouraged. People should know they need to behave as one team. A defined positive escalation approach with clearly and mutually understood triggers and pathways should be established, and a safe environment for conflict resolution built. Leadership should reinforce the importance of trust in their communication, and in daily interactions. The discipline of managing to plan and working together to resolve issues allows the team to own both successes and challenges across the partnership creating an environment that facilitates building trust rapidly.
To ensure successful delivery and continued innovation in pharmaceutical R&D, partnerships must continually be reimagined. Although cost drivers are critical, they do not necessarily drive the successful delivery of projects. To help ensure successful delivery and the development of true partnerships, it is important to build the proper frameworks and then be disciplined to support this framework. Project management practices can serve as this framework. Strong project management is critical at all levels, building an environment that encourages trust across teams. Building trust and effective teams focused on delivery will allow partnerships to out-perform cost-cutting expectations, and take sponsors to a place where projects are delivered as needed, and providers are profitable and viewed as a true extension of the sponsor.