Project Management Best Practices for Biotech R&D: From Concept to Commercialization

Jun 26, 2024 | Project Management

Project Management Best Practices for Biotech R&D: From Concept to Commercialization

The biotech and pharmaceutical industry is typically at the forefront of technological innovation, constantly pushing the boundaries of what is possible in medicine and science. This makes managing research and development (R&D) projects in this sector incredibly complex, especially when these projects involve sophisticated information technology (IT) systems. Ensuring these projects stay on time and within budget requires a strategic approach grounded in proven project management methodologies and best practices. This means focusing on the phase-gate process,tracking the correct milestones, as well as developing good risk management habits.

Understanding the Phase-Gate Process for Project Development

The phase-gate process, also known as the stage-gate process, is a project management technique in which a project is divided into distinct phases or stages separated by decision points (gates). At each gate, project stakeholders review progress and decide whether to proceed to the next phase, pivot, or halt the project. It is important to incorporate the correct leadership buy at each gate – as R&D projects involve stakeholders from multiple areas of any given biotech or pharmaceutical company. Usually project can be divided into five phases:

The initial phase, conceptualization involves identifying and defining the project idea, its feasibility, and its potential impact. For IT projects in biotech, this might include assessing the need for new software to manage clinical trials or data analysis tools for genomics research. Regardless, it is important to understand the need and “why” behind the project ask, and ensure that you have the correct users and stakeholders set up from this phase forward.


The second phase, the feasibility analysis is a detailed evaluation conducted to determine the project’s technical and economic feasibility for all impacted users and stakeholder groups. This includes defining technical requirements, identifying potential challenges, and estimating costs and evaluating them against potential beneficial outcomes of the project.


Once completed, the actual development work begins. For this third phase of R&D IT projects, this could involve coding, system integration, and creating prototypes that would require initial user feedback. In order to make this phase as successful as possible, key milestones, metrics, and key performance indicators (KPIs) to measure success or failure should be established to track progress.


Once the development work is complete, the fourth and perhaps most daunting phase can begin: testing and validation. This is the phase of the project where the new system or technology undergoes rigorous testing to ensure it meets all requirements the users and stakeholders had outlined initially, as well as performs reliably under user testing. This is crucial in biotech and pharmaceutical companies, where the accuracy and reliability of IT system performance can directly impact research and clinical outcomes.


Once the new system has passed initial user testing and been approved by leadership stakeholders, the final phase can begin. Whether being launched internal to the company, or developed as an external product, this final phase can be called commercialization. This the phase where those developing and driving the system can focus on deploying the technology in either a real-world or internal corporate setting, scaling up operations and onboarding new users, and monitoring performance to ensure it delivers the expected benefits.


The Need for Milestone Tracking Across Stakeholders:

While building out an effective stage gated project lays and important framework for any project, effective milestone tracking within those stages is critical for maintaining project momentum and ensuring accountability among stakeholders. This involves setting clear, measurable goals for each phase of the project and regularly reviewing progress against these goals. Due to the nuance of R&D IT projects in biotech and pharma, the milestones selected may be very unique to the project. However, there are certain things to keep in mind when building out an overall schedule

  • Communication Plans: Regular updates and transparent communication are essential. Ensure communications are planned and a scheduled is agreed upon with stakeholders in advance of each phase. Use these as ways to ensure that smaller tasks are kept on track to ensure all stakeholders are kept engaged, and informed
  • Responsibility Assignments: Asking for and assigning owners for each milestone and deliverable is a key component of project management. It is important to define and document the roles and responsibilities of each stakeholder, and what they will subsequently be responsible for in the project, to prevent confusion and ensure accountability.
  • Review Meetings: in addition to regular communication efforts, it is important to schedule regular milestone review meetings with both project and leadership organizations to evaluate progress, address any issues, and make informed decisions about the next steps.These conversations should be guided by the metrics and KPIs laid out at the start of the project

Effective Risk Management in R&D Information Technology Projects

Risk management is a proactive process aimed at identifying, assessing, and mitigating potential risks that could impact the project. For biotech and pharmaceutical IT projects, risks might include technological failures, data accessibility and security breaches, regulatory changes, and resource constraints. It is important to understand these different types of risks, many of which are unique to the biotech sector:

  1. Technical Risks: These involve potential issues with the technology itself, such as software bugs, hardware failure of lab instruments, or integration challenges with currently existing hardware on delicate assets.
  2. Operational Risks: These pertain to the day-to-day management of the project, including resource availability as leadership organizations fluctuate and change, internal historical knowledge silos, stakeholder engagement on a project that may not be their full time job , and reliable leadership buy-in in the face of the shifting technology environment around the biotech sector.
  3. Compliance Risks: In the highly regulated biotech industry, staying compliant with internal and external regulatory requirements is crucial. Changes in regulations or failure to comply can pose significant risks to any project working in this industry, so it is important to remain abreast of current and emerging regulations affecting the end goal or product of the project.

Risk Mitigation Strategies:

  • Risk Assessment Matrix: It is important to implement risk assessment matrix at the start of the project to evaluate the likelihood and impact of each identified risk. Prioritize risks that are both highly likely and have significant potential impacts against those that are lower risk and less likely to happen. It is then important to develop mitigation strategies for each potential risk as the project progresses.
  • Contingency Planning: Develop contingency plans for high-priority risks. This might include alternative technical solutions, additional training for team members, or backup resources. It helps to have an experienced stakeholder for these contingency plans, as they can help ensure that any blindspots can be brought to light.
  • Regular Monitoring: Continuously monitor risks throughout the project lifecycle. Use the KPIs defined at the start of the project and regular risk reviews to stay ahead of potential issues.


Managing biotech R&D IT projects is inherently dynamic and complex, but by employing the phase-gate process, building out data-driven milestones, and robust risk management practices organizations can enhance their chances of success. These best practices help ensure that projects stay on track, meet budget constraints, and deliver valuable outcomes.

We invite you to share your experiences and insights on managing biotech R&D projects. What challenges have you faced, and how have you overcome them? Join the conversation in the comments below or reach out to discuss how we can help your organization excel in project management.

Dana Karen

About the Author

Shannon Browne

Shannon Browne is a senior program management consultant at Kalleid Consulting. With a background as a bench scientist in neuroscience and experience as a business manager for a global pharmaceutical research unit, Shannon brings deep expertise in project management for R&D-facing projects at leading pharmaceutical companies.

About Kalleid

Kalleid, Inc. is a boutique IT consulting firm that has served the scientific community since 2014. We work across the value chain in R&D, clinical, and quality areas to deliver support services for software implementations in highly complex, multi-site organizations. At Kalleid, we understand how effective project management plays a key role in ensuring the success of your IT projects. Kalleid project managers have the right mix of technical know-how, domain knowledge and soft skills to effectively manage your project over its full lifecycle. From project planning to go-live, our skilled PMs will identify and apply the most effective methodology (e.g., agile, waterfall, or hybrid) for successful delivery. If you are interested in exploring how Kalleid project managers can benefit your organization, please don’t hesitate to contact us today.