Module 2: Target Identification, Validation & Druggability

Every other module in this course assumes you already have a target. This one asks the question that comes first — and is the single highest-leverage decision in the entire pipeline: which protein should we drug at all?


Learning outcomes

  • State the three independent conditions a genuine therapeutic target must satisfy.
  • Assemble an evidence chain for target validation and rank the strength of its links.
  • Compare geometric, energetic, and knowledge-based binding-site detection methods.
  • Compute and interpret a SiteMap Dscore, and explain why PPI interfaces score badly.
  • Explain how polypharmacology turns target prediction into a similarity search.

1. What Is a Therapeutic Target?

A therapeutic target is a biomolecule — almost always a protein — whose activity can be modulated by a drug to produce a desired clinical effect. To be a genuine target it must satisfy three independent conditions, and failing any one of them is fatal:

1. Disease-linked

Modulating it must actually change the disease. This is a question about biology, and it is where most drugs die.

2. Druggable

It must have a binding site that a drug-like molecule can actually occupy with high affinity. This is a question about structure — and it is what the rest of this module measures.

3. Safely modulable

Hitting it must not cause unacceptable harm — which depends on where else it is expressed and what else the drug touches (Module 12).

2. Why Target Selection Dominates Everything Downstream

The human genome encodes roughly 20,000 proteins. Estimates of the druggable fraction and approved-drug target counts depend on database date, definitions, and modality. A pocket score is not a universal census of what can be therapeutically modulated.

~20,000

protein-coding genes

the whole proteome

Context-dependent

therapeutic tractability

Depends on modality and evidence

Date-dependent

approved-drug target counts

Specify source, date, and definition

The uncomfortable truth about attrition

Lack of efficacy is a major cause of clinical attrition, but it does not uniquely diagnose a wrong target. Inadequate tissue exposure, insufficient functional modulation, patient selection, compensatory biology, and endpoint choice can all contribute. Target validation should test these alternatives.

3. Target Classes

Approved drugs cluster heavily into a handful of protein families, largely because those families happen to have well-formed binding pockets. Knowing the class tells you a great deal about which method to reach for.

ClassWhy it's druggableTypical approach
Enzymes (esp. kinases, proteases)Deep, enclosed catalytic/cofactor pockets evolved to bind small moleculesStructure-based docking; competitive inhibition
GPCRsOrthosteric site buried in the 7-TM helical bundleHistorically ligand-based (few structures); now structure-based
Ion channelsPore and gating sites; but selectivity across the family is hardOften ligand-based; heavy off-target screening (see hERG, Module 12)
Nuclear receptorsBuried hydrophobic ligand-binding domainStructure-based (see the estradiol pharmacophore, Module 7)
TransportersSubstrate sites, but large conformational cyclesEnsemble/state-specific modelling
PPIs & transcription factorsUsually not — flat, extended, solvent-exposed interfacesFragment-based, stabilizers/glues, or degradation (Module 6)

4. Target Validation: Building an Evidence Chain

Validation asks: if I modulate this target, does the disease change? No single experiment settles it. Confidence comes from stacking independent, orthogonal lines of evidence — the more independent the sources, the lower the risk. Module 17 covers where that evidence comes from: omics data, interaction networks, pathway context, and perturbation screens, and how to weigh them without fooling yourself.

1

Human genetic evidence

The strongest signal available. GWAS hits, rare loss-of-function variants, and Mendelian disease genes tie the target to human biology directly — not to a mouse. Targets with supporting human genetic evidence succeed in the clinic roughly twice as often, which is why genetics-led target selection has reshaped the industry.

2

Genetic perturbation in models

Knockout/knockdown (CRISPR, RNAi) shows whether removing the protein produces the desired phenotype. Caveat: removing a protein is not the same as inhibiting it — a knockout also deletes scaffolding functions a drug would leave intact.

3

Chemical/pharmacological evidence

A selective tool compound reproduces the phenotype. This is the closest proxy for what a drug will actually do — but only if the tool is genuinely selective. A promiscuous 'tool' validates nothing.

4

Clinical/translational precedent

Human data: an existing drug on the same pathway, or a biomarker that tracks target engagement in patients.

Target engagement vs. efficacy. These are different claims and conflating them is a classic error. Evidence supporting engagement (for example, a controlled CETSA experiment) is not proof of functional modulation or efficacy. A negative phenotype prompts checks of exposure, occupancy, modulation, model relevance, and timing before invalidating the target.

5. Druggability: Can a Small Molecule Actually Bind?

Tractability is modality-dependent. Pocket descriptors estimate one aspect of small-molecule ligandability, not therapeutic feasibility. Antibodies, degraders, oligonucleotides, and other modalities have different requirements, including accessibility, tissue delivery, and mechanism.

The first step is finding the pocket at all. Tools fall into three families:

Geometric

Find concave cavities purely from shape, e.g. by rolling a probe sphere over the surface (fpocket, PockDrug). Fast and structure-only.

Energetic / probe-based

Computationally flood the surface with small organic probes and find where they cluster — "hot spots" (FTMap, SiteMap). Captures chemistry, not just shape.

Knowledge-based / ML

Learn what real ligand-binding sites look like from the PDB and predict new ones. Increasingly the default for large-scale proteome-wide assessment.

Once you have a pocket, you score it. The best-known scheme is SiteMap (Halgren, 2009), which reduces a pocket to three numbers and combines them linearly:

Dscore = 0.094·√n + 0.60·e − 0.324·p
SiteMap Druggability Score

n is the number of site points, capped at 100 in the published function. e is enclosure, from 0 to 1. p is hydrophilic character. Size and enclosure raise the score; polarity lowers it. Halgren fit the three coefficients to a set of known sites, so the equation describes that fit. A flat, polar protein–protein interface scores badly for the same algebraic reason. A low Dscore does not, by itself, decide that the protein is undruggable: hot spots, pocket motion, and whether a small molecule can compete with the partner are outside the regression.

Interactive Playground: Druggability Scorecard

Load a pocket type and move one descriptor at a time. Start from the flat protein–protein interface and raise enclosure: SiteMap’s Dscore can cross its druggable cut-off from that change alone. Enclosure is one fitted descriptor. Hot spots, pocket adaptability, and competition with the partner protein are outside this equation.

Pocket type

Deep, enclosed, largely hydrophobic — the archetypal druggable pocket.

n — site points (pocket size)100

Capped at 100 by the scoring function.

e — enclosure (how buried)0.78

0 = flat open surface, 1 = fully enclosed cavity.

p — hydrophilic character0.65

Higher = more polar/solvent-friendly = worse for binding.

Fitted-score interpretation Higher fitted pocket score

1.20

Dscore

This descriptor combination resembles higher-scoring sites in the fitted scheme; high affinity and therapeutic tractability remain untested.

SiteScore1.12

≥ 0.80 — above this scheme’s reference threshold. Inspect local structure and ligand evidence; this is not proof of a binding site.

Dscore thresholds
▶ Higher fitted score≥ 0.98
   Intermediate fitted score0.83 – 0.98
   Lower fitted score< 0.83
What the equation is telling you

Because enclosure carries a +0.60 coefficient and hydrophilicity a −0.324 one, a pocket earns its druggability mainly by being buried and greasy. A PPI interface fails not because it is small — it is usually enormous — but because it is flat and wet. This is exactly why the field invented PROTACs and molecular glues (Modules 1 and 6): alternative modalities change the requirements, but PROTACs still need target engagement, productive ligase geometry, ubiquitination, and suitable cellular exposure. Antibodies and other biologics take the same escape route from the opposite direction — they bind flat, polar epitopes precisely because they present a large complementary surface rather than filling a cavity; Module 16 covers modelling those interfaces.

6. The Inverse Problem: Target Fishing & Polypharmacology

So far we have gone target → molecule. The reverse question is just as important: given a molecule, what does it hit? This is target prediction(or "target fishing"), and it matters for three reasons:

  • Phenotypic hits need deconvolution. If a compound cures cells in a screen but you do not know its target, you cannot optimize it rationally.
  • Off-targets cause toxicity. Predicting secondary targets early feeds directly into the safety work in Module 12.
  • Polypharmacology is sometimes the point. Many effective drugs — notably kinase inhibitors and most CNS drugs — work because they hit several targets. Perfect selectivity is not always the goal.

The dominant computational approach rests on the similar property principle you will meet in Module 5: if your molecule is highly similar to a compound with a known target, it probably shares that target. This turns target prediction into a fingerprint similarity search against annotated bioactivity databases such as ChEMBL.

Ligand-Based Target Prediction by Similarity Search

Knowledge check

Checkpoint

Research decision checkpoint

Helpful background: Module 1: Introduction to Drug Discovery · Module 17: Bioinformatics & Systems Biology Foundations

A target has a high pocket score but weak functional perturbation evidence. Would you advance it?

Your output: Write a target evidence matrix with modulation direction, provenance, modality, and the next falsifying experiment.

Compare your reasoning

Keep pocket ligandability separate from disease causality. Seek selective perturbation and rescue in a relevant model; absent human genetics is not an automatic veto.

Evidence anchor: Open Targets: modality-specific tractability. A first reading and this prompt do not replace a validated practical exercise.

Knowledge checkQuestion 1 of 3

A protein-protein interaction interface has a very large surface area, yet SiteMap classifies it as undruggable. Why?