Three questions on indication assessment

Recently, Principal Consultant, Iva Toudjarska spoke with Lisa Chontos of CenterWatch to discuss indication assessment.  The full text is only available to CenterWatch subscribers, but check out the first two questions below. 

 

Q: What role does indication assessment play in the development process?

A: When developing a new platform, technology, or therapeutic where multiple options for proof of concept exist, a critical review of the appropriate indications should be done early in the process. Indication assessment ensures a clear understanding of unmet medical needs, patient segmentation, and what the therapeutic profile—efficacy, safety, dosing, etc.—needs to look like to meet those needs. It is used to identify the end goal before starting the lengthy and costly process of drug development.

Indication assessment can be leveraged to lay the foundations of the development strategy—the path to creating a commercially viable and competitive molecule that will meet patients’ needs based on the current standard of care and other drugs in development. It can also be used to identify development activities and operational considerations. For example, what will clinical trials look like in different indications, size, recruitment environment, endpoints, timing, costs, and others? These core components can then be used to select the fastest, cheapest or most innovative path to clinic for proof-of-concept of the platform or therapeutic.

It is also a guiding point for building an integrated development plan, which closely follows the strategy laid out with operational considerations and Go/No-Go decisions. A continuous process, indication assessment, and development strategy involve multiple stakeholders and play a critical role in drug development today.

 

Q: What makes indication assessment such a powerful tool in the development arsenal?

Drug development has become increasingly competitive and costly. The rate of innovation is unprecedented; however, the attrition rates are still very high for certain diseases. The industry is also scrutinized by various parts of society, with a lot more visibility of cost and unwanted effects. As developers are focusing on their business goals, they strive to get to market the fastest, to be first-in-class and address indications that are uncharted territory.

Indication assessment is a way to de-risk the process, to validate the scientific hypotheses. Analog analysis can be very useful—looking at what’s already been done and what others have been able to achieve regarding clinical and regulatory milestones. A critical component is the on-the-ground perspective from key opinion leaders (KOLs), such as clinicians and researchers. KOLs are in a unique position to provide an in-depth perspective on crucial decisions, including targeted patient segments, clinical endpoints, unmet needs and ways to innovate to meet those needs. Payers are another very important player, as they determine how the drug will be reimbursed. KOLs can also be thought partners for drug developers throughout the entire lengthy process to ensure decisions are well-informed.

Creating the development strategy early in the development process and gathering support and understanding from various stakeholders results in competitive and commercially viable therapeutics that can significantly benefit patients.