Drug candidate selection

Drug candidate selection

From scientific potential to development-ready assets

Selecting the right drug candidate is where potential becomes progress. It’s the moment when promising science must prove its worth — clinically, technically and commercially. At this stage, the risks are high. And the cost of getting it wrong is even higher.

KLIFO helps you navigate this transition with precision and senior-level guidance, turning potential into development-ready assets.

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Klifo, Glostrup. 07/10-2025

What is drug candidate selection?

Drug candidate selection is the decision point where one lead compound is chosen to advance from discovery into preclinical development. The selection is based on multiple layers of data, ranging from pharmacological potency and selectivity to safety, stability and manufacturability.

It’s more than a scientific checkpoint. It’s a strategic milestone.

A well-chosen candidate must:

  • Be supported by a defensible intellectual property position
  • Show robust and selective pharmacological activity
  • Demonstrate a favorable ADME and PK/PD profile
  • Exhibit a preliminary safety profile with no red flags
  • Be chemically and physically stable
  • Be synthetically feasible and manufacturable at scale
  • Align with a clear, commercially viable Target Product Profile (TPP)
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What makes KLIFO different?

Unlike traditional CROs, we are not just a service provider. We are a development partner who brings:

  • Highly experienced senior consultants with decades of drug development insight
  • Cross-functional expertise, including CMC, toxicology, regulatory and IP
  • Integrated project leadership that ensures strategy and execution are aligned
  • A critical, constructive perspective to challenge assumptions and strengthen decisions

We don’t just ask whether your compound can move forward. We help you decide if it should — and how to make it succeed.

About KLIFO

A structured approach to reduce risk and increase confidence

The handover from discovery to development is where many drug candidates are less well managed. At KLIFO, we ensure that your lead is not only scientifically sound but also strategically aligned and practically viable for the next phase.

The objective is to build a realistic picture of your compound’s development readiness.

Our approach includes:

Definition of a preliminary TPP aligned across functions

Scientific evaluation of early safety  and efficacy data

ADME/DMPK profiling to assess absorption, distribution, metabolism and excretion

Early toxicology screening to flag potential safety concerns

Physicochemical and preformulation assessment (solubility, stability, bioavailability)

Formulation feasibility and manufacturability (CMC readiness, scalability)

Intellectual property and commercial assessment

Key considerations in selecting the right candidate

Overlooking any of these areas can lead to delayed regulatory approvals, failed studies or unnecessary resource drain.

To make a confident development decision, you need to evaluate several domains in parallel:

Pharmacology

Is the compound potent, selective and efficacious in relevant models?

PK/PD and ADME

Does it reach the right tissues, at the right dose, for long enough?

Safety

Are there early signs of toxicity?

Developability

Can it be produceded, formulated and scaled effectively?

TPP alignment

Does the candidate match the intended indication, route of administration and differentiation towards competition?

IP position

Is the innovation protected and competitive in the market landscape?

Common pitfalls we help our clients avoid

Without experienced guidance, many teams face challenges such as:

  • Advancing compounds with poor solubility or stability
  • Proceeding without full freedom-to-operate or a strong IP strategy
  • Underestimating formulation and bioavailability challenges 
  • Misalignment between preclinical, CMC, clinical, regulatory and commercial goals
  • Defining a weak or unrealistic TPP

KLIFO helps avoid these missteps by providing early, cross-functional evaluation with a clear development perspective.

Klifo, Glostrup. 07/10-2025

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How we help

Many biotech teams encounter similar challenges at the candidate selection stage. KLIFO typically responds by conducting targeted gap analyses, coordinating additional preclinical studies, and facilitating cross-functional workshops to align the Target Product Profile.

This structured approach enables clients to move from uncertainty to a validated candidate, a clear development roadmap, and a strong foundation for both regulatory interaction and investor engagement.

Deliverables you can expect

KLIFO typically supports this phase through a combination of strategic and technical deliverable.

We tailor these based on your specific situation and integrate input from our Drug Development Counselling, CMC Development and Non-Clinical teams.

Non-clinical gap analysis

Strategic roadmap for preclinical advancement

Early CMC feasibility evaluation

Target Product Profile (TPP)

Due diligence report for internal or investor purposes

Guidance through every phase

Drug development is a multifaceted process shaped by scientific, operational, and regulatory demands. At KLIFO, we provide clear, actionable guidance to help you move forward with confidence at every stage.

Make the right decision now — save time later

At KLIFO, we believe that good medicines deserve to reach the market. But to get there, you need more than a promising compound. You need strategy, senior insight and practical execution.

Whether you’re a biotech company preparing your first IND or an established player seeking specialist support, we help you move from uncertainty to clarity — with confidence in your candidate and your development plan.

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