The Drug Development Process: A Unique And Evolving Model

By James Weston, senior VP of regulatory affairs and quality, and Susan Flint, senior VP of drug development, Talaris Advisors, LLC

There are far too many companies and far too few resources today in biotech. The day has passed when “companies” can be built around a candidate that is really just a project. The investment to create a drug development infrastructure, the time lost, the cost of assembling teams, and need to keep that team busy diminish returns.  Traditional CRO solutions using task-oriented project management are not effective with many of the challenging programs in the current biopharm pipeline. The typical biotech “build-it” strategy is simply too time-consuming and costly to implement.

In today’s complex development environment, an optimal solution requires a far more strategic approach that promotes integrated execution, continuous project evaluation, rapid responses to new conditions and data, and ongoing contingency/alternatives planning. Thus, there is a need to innovate the model by providing a unique drug development approach. This leaves an opportunity for a new breed of strategic drug development organization that offers on-demand, turn-key service backed by experienced leaders with expertise and skills that cover the entire development process.

Long And Winding Road
In drug development, the path, independent of the stage, is complex and constantly changing. To mitigate the risk that development slows, becomes too expensive, or is inappropriately terminated, several key needs must be met. Foremost, the program requires strategic management and expert guidance that integrates all key functional disciplines. There must be strong control of costs and timelines. Losing propositions must be terminated early, and milestones must be accelerated to create maximum value.

Weakness In The Contract Model
Today’s most conventional model utilizes the CRO. However, most are unable to meet the challenges of current drug development programs, and very few can integrate the multiple disciplines necessary. Most CROs are focused on tactics and lack integrated solutions to the nuances and hurdles of development. There is little or no emphasis on strategy. Projects are generally staffed by junior personnel with limited oversight from senior managers. There is an overall lack of ownership as reflected by the prevailing time/materials contracts used in the industry.

“Build It” Model Drains Value
The traditional biotech model has been to recruit executives in all major functional disciplines (preclinical, medical, clinical, regulatory, manufacturing). This approach requires infrastructure and integration, which slow progress and do not inherently add value. Value creation is further reduced by the wind-down costs and the “tails” associated with building a company.

The Time For A New Drug Development Model Is Now
There is an alternative drug development model that is both more cost-and time-effective than the “build-it” and CRO models. This model proposes the engagement of an expert, turnkey team of leaders to direct the drug development efforts using strategic, integrated approaches without the ramp-up, wind-down, or carrying costs typically associated with the other approaches. This model’s agility and flexibility promote the adaptability required for efficient and effective drug development today. Services are provided only as needed, so team members transition into and out of the project as required. With the emphasis on goals and outcomes, the interests of sponsors and investors are aligned. The culmination is a reduction of risk across disciplines increasing the probability of success, maximum efficiency, and ROI. This, in turn, leads to enhanced value, the realization of exits and liquidity, and maximization of portfolio return for the biotech and the investors.