Selecting the right candidate to take through clinical trials, picking the most promising indication and building a robust target product profile (TPP) will all help you to pick the right direction for your product development. The next step is to begin to build the data package that will get your drug through regulatory approval and on to the market where it will be prescribed to patients and reimbursed by payers. However, this next step is where the real investment comes into play and as an emerging biopharma company, you will need to convince investors that your approach is worth investing in.
This post, the second of the three posts based around our webinar Capturing the attention of investors, will help you think through the most important considerations in choosing the right path for the development of your clinical candidate.
Choosing the right path
The target product profile (TPP) is an important tool in shaping the route to take through clinical development. In other words, once you know where you are going, the TPP will help to define how you get there. Remember that the TPP forms the basic framework of your commercial goals and value, and the clinical development requirements needed to deliver that value. The next step, creation of a clinical development plan, expands on the clinical data requirements needed to deliver the commercial goals laid out in the TPP, and lays out the clinical development strategy in more detail. As you create your development plan, there will be a lot of decisions to make that will impact time cost and risk, and these will be important at both the program level and study level.
Drug development planning isn't a linear process, and the variables are almost always time, cost and risk driven. Different companies will have unique sets of priorities that will be used to balance these trade-offs in time, cost and risk in order to make decisions. For example, one drug development company may want the shortest route to market, so the development team may need to spend more in order to shrink timelines, or take on increased risk in the event that their Phase 2 program may be shorter and potentially less informative, with less risk mitigation prior to Phase 3. On the other hand, another company may be driven by shortest time to positive proof-of-concept, particularly if they have key business goals to achieve following a positive PoC. This may mean considering an interim analysis for PoC assessment, planning a study in the most responsive population (even if this may ultimately increase time to market), or with a costly endpoint assessment for robust data generation.
Finding the optimal development plan
To optimize the development plan, you will need to have an understanding of what’s important to your organization. These variables may include:
- Level of unmet need
- Time to proof-of-concept
- Cost constraints
- Time to approval
- Level of risk
- Required return on investment
For example, a development team from a well-funded company that values both fast development and low risk would see the following route as optimal, even though this path doesn’t lead to the highest possible value:
In contrast, a company who is willing to take on additional risk to try to get a drug on the market faster, and with a maximal possible return on investment would choose a different path.
Robust data facilitates confident decision making
Making decisions on development pathways becomes easier when more real-world data is available, as you can see trade-offs with regard to cost, time, risk and return and have confidence in the data informing these. Using robust real world data will help you to defend your decisions in front of investors and other key stakeholders, which will bolster your credibility and cement internal support.
Be sure to check out the third and final blog in this series to learn how you can convince key stakeholders to join you. To hear experts talk in more depth, and to listen to them answer audience questions, go to Capturing the attention of investors for the recorded webinar and accompanying slide presentation.
About the Authors
Tara Rheault, Ph.D., MPH
Senior Therapeutic Strategy Director, Drug Development Lead
Tara Rheault has over 16 years of cross-functional leadership experience across drug discovery and development. Dr. Rheault started her career as a medicinal chemist at GlaxoSmithKline where she was the inventor of the now marketed drug Tafinlar. Dr. Rheault then moved on to global project leadership for early development projects, including portfolio and governance management. She then transitioned into late stage clinical development as a clinical program and study leader. Dr. Rheault has continued to build her expertise at IQVIA in the development of integrated commercial and R&D strategies, helping clients articulate their differentiated value story along with a robust plan to achieve their product goals.
Senior Scientific Advisor
Bruce has worked as a biostatistician in the pharmaceutical industry for over 20 years across numerous therapeutic areas. One of his areas of expertise is leading development teams through scientific evidence generation plan strategy and optimization workshops. He is also a specialist in technical due diligence and asset value estimation using net present value.