What are the most innovative project management practices for biotechnology drug development?

Thankfully, there is no one project management method that is superior to the others in drug development. Each has its place in the heterogeneous workflows of drug development. For example, your manufacturing teams may find lean the best tool for program initiation and then switch to CCPM during production, your regulatory teams will often require waterfall methodologies with some Monte Carlo simulation to estimate durations, and your discovery teams will by default often run agile or semi-agile methods that are most akin to the scientific method. Building your PM team with the flexibility to implement and change processes to suit the situation is most often better than searching for The One Right Method.

Here are some innovative and most likely ignored project management practices for clinical drug development in my experience: - Utilizing real-time data montioring tools to track project progress, enabling data driven-making and ensuring the project stays on courses. - Patient centric approach-Involving patient advocacy groups early, designing more patient friendly clinical trials, and addressing the needs of target population. - Digital project management tools: Leverage cloud based platforms and virtual project management tools to facilitate seamless communication across global teams - Post launch monitoring: Implement post launch monitoring system to track drug’s performance in the market, patient outcomes, and AEs.

Operational or project methodology needs to be selected based on the specific situation for the company or project. Traditionally Agile was developed for computer software projects because speed and iteration works for this type of product development. Six Sigma was developed for large scale manufacturing because precision was needed. Plus the approach is repetitive. It's easier to map out processes and cut them or reshape them for efficiency. Lean Six Sigma is a broadening of Six Sigma for team based situations like startups. I developed a merged approach specific for biopharma called AgiLean. Over several decades in the industry, I honed my innovative approach to fit biotechnology. It has sound structure plus flexibility.

While Agile methodology is useful for project management given that the only constant in a project is that it will continue changing, it isn't maximally effective when used alone. What I do is combine Six Sigma methodology with Agile to provide both flexibility as well as efficiency. You can think of it as building a strong structure that can withstand an earthquake because it's strong but also flexible. Six Sigma cuts out inefficiencies. Agile allows adjustment. I pioneered this approach over 2 decades ago for biopharma project management. I call it AgiLean.

In my experience managing global program teams CCPM is the most common process used in drug development, but it isn't the sole answer. Managing large cross-functional teams requires an ability to adapt as new data emerges, without losing sight of the ultimate end goal, improving patient lives. Like every competitive field, we are always battling the triple constraints of time, budget, and quality; however, any time I need to reorient myself to what is most critical in the moment, I remind myself why I am doing this, and that is always for the patients. This helps me keep myself and my team motivated as plans change and helps us all adapt.

Strategic portfolio management begins with a constant monitoring of the competitive environment. Over the lifespan of an asset, market conditions may change regardless of the intrinsic value of the asset. Understanding if programs need to or can be accelerated or should be discontinued in favor of more attractive assets is key. Value can be captured from partnering or other business development initiatives and internal resources reallocated.

In AI/CADD-driven biotech companies focused on drug discovery, it is common practice to develop a technology platform while simultaneously applying it to discover and develop novel drugs. This dual focus requires project management practices that integrate both the structured, phase-based Waterfall approach for drug development and the flexible, iterative Agile approach for technology platform development. By combining these methodologies, companies can ensure that the platform evolves in parallel with drug discovery efforts, aligning the timelines and objectives of both joint asset development and tech innovation.

I've been applying hybrid Agile and Six Sigma management techniques to operations for decades. This is the best approach to use in a highly regulated industry that also experiences constant regulatory change and technological innovation. I call my methodology AgiLean. It's a way to keep costs low, reduce overwhelm in staff plus remain compliant with global biotechnology regulations. It also substantially increases speed to market for product development. There are many other methods that can be used in specific situations for example methods for risk management or analysis for acquisitions or licensing opportunities. I recommend getting an MBA if you want to have a tool belt full of management analysis methods.

Integrating QMS elements & tools into the drug development project can be very beneficial. A very useful tool is risk assessment. This can be used for all stages of development and can help identify potential risk areas as well as assist in identifying priorities. Using electronic document & data management tools will ensure better collaboration with outsourcing partners as well as prevent delays due to lost or incorrect data/documents.