Most founders get to it too late, when restructuring means losing the work of years.
Indication selection is the process of choosing which disease or condition a drug, biologic, or medical device will be developed to treat, diagnose, or prevent.
This white paper is written for biotech and medtech/IVD teams at the pre-clinical stage who want to build towards an IND submission, a first-in-human study or CE mark but have no regulatory strategy yet.
Here we show you the framework and two examples of projects delayed due to lack of indication selection.
WHAT WE ANSWER
The answer is: a strong indication selection and a clinical development plan.
Beyond the science, investors want to see that you understand the path from where you are to a proof of concept and that you have made deliberate, defensible choices along the way. That includes knowing what is your drug or device for, what the regulatory pathway looks like, what a realistic first-in-human trial design would be, and what data you need to get to the next funding round.
This white paper is the first in a series on the foundations of successful drug and medical device development.
Usually because the development strategy was not built early enough. Late-stage course corrections are expensive. Preclinical models built around the wrong indication need to be redesigned, timelines stretch, and budgets run out before there is ever a proof of concept.
Reach out for drug development consulting.
Most founders assume the obvious indication is the right one. It rarely is. The right indication is not the one closest to your mechanism of action. It is the one where there is a real unmet need, a clear regulatory pathway and a clinical trial that is actually executable. This white paper gives you the framework to evaluate it before committing resources to the wrong studies.
If you find out late, preclinical models need to be redesigned, endpoints do not align with regulatory expectations and require new studies. The direct consequence is delayed timelines, significant resource loss, and a declining probability of reaching proof of concept. Late-stage course correction is costly but early indication selection is not.
Stating that no cure exists is not sufficient. Regulators want to see a clear understanding of where current therapies fall short and how your product addresses that gap specifically. Investors want confidence that the addressable population is real and the competitive landscape leaves room for differentiation. Reach out for regulatory strategy consulting.
They want to see that your indication choice is grounded in biology, supported by translatable preclinical evidence, and aligned with a feasible trial design. Arriving with an underdeveloped indication rationale or gaps in your nonclinical package compromises your credibility early in the regulatory process.
The answer depends on four dimensions: where the biological rationale is stronger, where the unmet need is greater, where a clinical trial is operationally feasible, and where the competitive landscape allows meaningful differentiation. This white paper provides a structured framework for making that comparison.
Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials
