Product development alliances between global pharmaceutical giants and startup companies can be a win-win. They offer startups resources and reach, while larger entities gain access to innovative approaches and potential assets at an early stage. The mutual benefits are clear: acceleration in drug development and a higher probability of bringing new treatments to market.
However, they are not without challenges. Aligning the needs and operations of a small startup with a global corporation can lead to misunderstandings and missteps. Such issues, if not addressed in advance (or promptly), can jeopardize the shared goals of both parties.
Integrated Project Management Company, Inc. (IPM) supported a biopharma startup that established an alliance with a large pharmaceutical company to develop one of the small company’s lead assets. The pharma ultimately planned to acquire the asset for further development, which would be a successful outcome for both companies.
After significant internal resource and organizational changes, the startup company decided it would benefit from external knowledge. They sought help from IPM, and a program management consultant who had been leading discovery projects transitioned to take on the role of alliance manager.
The consultant encountered several challenges. The alliance document didn’t clearly define roles and responsibilities between the two organizations. This led to confusing and sometimes contentious decision-making and resource allocation. The companies hadn’t aligned on clinical strategy and study design in advance. Hindering resolution, they didn’t share information openly. For example, one company preferred not to share details about its budget or other companies it had alliances with.
The alliance also faced complicated governance. Each company had its own governance, but senior leadership also had a say in most decisions. Teams were frustrated that approvals took several steps and too much time.
Finally, resourcing was challenging. Staff turnover was high at both companies, and it was difficult to keep track of who was working on which workflow. Resources from the large pharma were also working on other major initiatives, so the alliance work wasn’t always their first priority.
Combined, the challenges slowed progress toward a new drug application (NDA) submission. If the problems continued, the larger company could have limited or even ended support of the asset and the alliance.
The IPM consultant took on a multifaceted role combining program and project management with alliance management. As a foundation, she developed an integrated project plan that included roles and responsibilities, timelines, milestones, and interdependencies. Creating the plan uncovered resource gaps and strategic differences. For example, the pharmacology lead wasn’t reporting when studies were scheduled to start and stop. Teams didn’t know when they would get data, so they couldn’t schedule their work in advance. This missing data stood out on the integrated plan, and he had to incorporate it.
Once set, the plan allowed both companies to make informed decisions and address ongoing needs. It also helped teams identify where they could accelerate their work or do some tasks in parallel to make up time.
Faced with urgent deadlines and busy resources, the consultant used soft skills to facilitate consensus-building both on working teams and with executive stakeholders. She ensured leadership had the information—and the rationale—they needed for faster decisions. Working with alliance and project managers from both companies, IPM’s consultant incorporated risk management planning to avoid potential problems.
When the companies began to trust they were reviewing the same information, they combined the governance structure and increased transparency. They aligned on budgets, resource planning, and priorities. The larger company even ensured that its resources prioritized the alliance projects over other work.
While the startup biopharma and large pharma companies continue to pursue the NDA, the alliance management skills of IPM’s consultant—program leadership, consensus-building, and executive communication among them—have helped set them up for success. Aligned, streamlined governance and transparent communication have sped up decision making. And an integrated project plan has connected functions, who are now following accurate timelines and budgets toward an accelerated NDA filing.
The alliance continues to support the shared goal that the large pharma will acquire the asset. That company will be able to market drugs for two indications, bringing life-enhancing drugs to the patients who need them. And the startup will be able to use the financial resources for the discovery of future drug candidates.
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