Developing a new drug or biologics is quite a long journey and probably one of the most risky and exciting one within the industry. A careful preparation including a solid development plan is a must to reduce time to market and most significantly to maximize success rate. Developing a comprehensive biotech roadmap is part of this journey.
How to start the journey ?
Starting point of the biotech roadmap construction is the establishment of the Target Product Profile (TPP). As for all projects, defining specifications is key before developing any plan. TPP serves as a reference for decision-making throughout the development process and is regularly reviewed and updated as new data become available, such as product behavior, regulation changes, new comers…Biotech roadmap is therefore also lead to be amended many times along the way.
TPP typically includes information such as the intended use of the product, the patient population it is intended to treat, the route of administration, the dosage form, the efficacy and safety endpoints, and other specific requirements such as stability, packaging, and labeling. An exhaustive list and associated recommendations are described in the FDA Guidance: “Target Product profile – A Strategic Development Process Tool”.
As the biotech roadmap aims to describe all steps to go through for advancing the new compound to the market. Having established the objectives of the project and its attributes into TPP is essential to avoid drifting the project. Notably getting the market authorization is not the last step of the roadmap, reimbursement and post market surveillance are essential steps to anticipate and integrate early within the biotech roadmap.
While TPP is prepared early in the product development process and is a strategic document, the roadmap is a tactical tool translating the vision into plan.
Who is responsible of what ?
As for TPP, establishing a robust biotech roadmap requires an experienced cross-functional team. Indeed, various competences are needed to define and articulate the numerous phases and milestones the project will go through. All the activities that have to be described and articulated within the biotech roadmap requires careful coordination. This means that the activity of developing such a roadmap requires an experienced team leader with a comprehensive overview of drug development and business acumen.
Basically the biotech roadmap will contain the stages outlining the chemistry, manufacturing, and controls (CMC), formulation activities, key non-clinical studies, clinical trials, regulatory submissions, health authority interactions, market launch activities, and post market surveillance.
All these activities have specific context, planning, competencies and resources needs, costs, inputs and outputs that have to be defined and described. This precise work enables to spot interdependencies that are critical to dawn on before launching any activity. This will minimizing the risk of misunderstandings, delays, or costly mistakes. One can see these steps as consequential, but notably many are ran in parallel and some are transverse along the development.
Biotech roadmap is thus developed by a cross-functional team, experienced within drug development, including representatives from research and development, quality assurance, regulatory affairs, manufacturing and many other business areas.
While TPP is prepared early in the product development process as a strategic document, the roadmap is a tactical tool translating the vision into plan.
Why building a roadmap?
Building a roadmap has various roles and advantages. It first helps transcribing the vision into a route, it enunciates the necessary steps and by breaking down the project, highlight risks and opportunities.
This is an important tool for all project team members to be aligned and have a clear understanding of the project’s goals, milestones and expectations. It permits onboarding new team members pretty quickly. Biotech roadmap is also an important tool to navigate the financial rounds the biotech will necessarily go through. It demonstrates the understanding of the journey to develop the drug, anticipating and mitigating risks and the upcoming milestones to finance.
Developing the biotech roadmap will allow to focus on designing and developing a set of crystal-clear executable action plans the team can take ownership of.