CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, Lisa Chontos spoke with Iva Toudjarska, Ph.D., MBA, Principal Consultant for Biopharma Strategy at Halloran Consulting Group.

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?

A: 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.

Q: What are the other top components of an effective development arsenal?

A: As drug developers, we start with a scientific and therapeutic hypothesis. Assessing the relevant indications early on aids in platform development and optimizing the performance of individual molecules. It’s imperative to ensure no work is done in a vacuum. When making development decisions, it is essential to interact early and often with the scientific and clinical leaders and payers. Interacting with patients and patient advocacy groups is also beneficial. Devising a solid roadmap early in the process is key, but it’s just the beginning. The ability to iterate on this plan when new information comes in ensures the company can stay competitive and relevant to the unmet medical needs and drug development environment. A well-known strategy in the industry is to “kill early and kill quick,” asking the most important questions first. Making termination decisions earlier in the development process increases R&D productivity, and reduces the cost of failure as well as any negative public exposure.

The iterative process of evaluating all these questions across a company’s entire portfolio determines the drug developer’s competitive advantage. By ensuring that the development strategy opportunities and operational hurdles align with the business goals held by both the company and its investors, a company can achieve the long-term success and sustainability they seek.  

This article was reprinted from Volume 21, Issue 37, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »