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Flexible Project Management for Pre-Clinical and Clinical Drug Development

Author Eric Knox

Flexible Project Management for Pre-Clinical and Clinical Drug Development - Clinical trial project manager with clipboard and laptop

Safely, quickly, and affordably bringing new drugs to market is key to the success of pharmaceutical companies. But keeping pace with today’s rapidly changing pharmaceutical landscape presents enormous challenges during the long product-development process. The effect is amplified when a company is developing multiple treatments addressing a broad range of therapeutic areas in parallel.

With a wealth of promising treatments in development at any given time, leading pharmaceutical companies need strong project managers who can maintain laser-focus on individual products and drive them through the pre-clinical and clinical development process. Timely and effective project management is key to overcoming inherent uncertainties in the process and moving forward in a cost-effective manner. But what happens when the company doesn’t have enough resources at hand to support its full pipeline of new assets?

The R&D Project Management group at one Fortune 500 pharmaceutical leader faced such an issue. Experiencing significant resourcing gaps to support various pre-clinical studies and clinical trials within the company’s oncology, fibrosis, cardiovascular, and immunology therapeutic areas, the group’s business leader reached out to BTG for help.

BTG provided the pharma company multiple project managers with deep experience in the drug development process for the group’s targeted therapeutic areas:

  • To support early development initiatives in the treatment of fibrosis, BTG deployed a skilled project and program manager with experience at Pfizer, Express Scripts, and Memorial Sloan Kettering Cancer Center. The talent assessed risks to development processes, developed an integrated cross-functional project plan and asset development-to-launch timeline, and coordinated functional sign-offs for all key activities.
  • For oncology assets in pre-clinical through phase I development, the company tapped a senior project manager with an extensive background at Fred Hutchinson Cancer Research Center and leading clinical research firms. With the help of the talent, the company was able to keep multiple workstreams on track and ensure smooth transitions for assets entering later development phases.
  • To assist with other early-stage development processes, BTG delivered a clinical scientist, Stanford University School of Medicine co-instructor, and former Chief Medical Officer for a precision microbiome engineering company. The talent worked with the early development program team and its leader to successfully shape and execute the project and drug development strategies, as well as lifecycle planning.
  • To support late-development R&D work within immuno-oncology (Phase II and III), the company selected a project and portfolio management leader with 30 years of experience in the pharmaceutical industry as a discovery scientist, and as leader and manager of discovery, preclinical, and clinical development programs.

With help from BTG and these highly skilled independent clinical project management talent, the R&D Project Management group was able to fill a significant resources gap and provide the company’s cross-functional teams with the flexible project management they needed to drive the development of multiple promising new drug candidates.