Pharma Drug Development Lifecycle Phase Summary
10 phases from target discovery through commercial launch and real-world evidence
1.
Discovery
Yrs 1–4
Identify biological targets, druggable binding sites, and develop screening assays to measure compound activity.
2.
Lead Optimization
Yrs 2–5
Optimize lead series for
ADMET
properties, selectivity, potency, and scalable synthesis using
PK/PD
modeling.
3.
Preclinical
Yrs 4–6
Conduct
GLP
toxicology studies, determine in vivo safety, efficacy dose, and prepare
IND
-enabling packages.
4.
Clinical Trial Supply (
CTS
) Scaleup
Yrs 5–13
Scale synthesis from lab to
GMP
, develop formulations, validate analytical methods, and manage clinical supply chain.
5.
Regulatory
1
Yrs 5–15
eCTD
submission, regulatory review, label negotiation, and post-marketing commitment planning.
6.
Phase I
Yrs 6–8
First-in-human trials to assess safety, tolerability,
MTD
, and human
PK
parameters.
7.
Phase II
Yrs 8–11
Proof-of-concept efficacy trials to determine optimal dose, biomarkers, and target patient subgroups.
8.
Phase III
Yrs 10–14
Large-scale pivotal trials to confirm efficacy vs. standard of care and build safety database for regulatory approval.
9.
Commercial Scale-Up
Yrs 13–16
Process validation at commercial scale (
PPQ
), tech transfer, serialization, and
ERP
/
MES
implementation.
10.
Commercial &
RWE
Yr 15+
Post-launch real-world effectiveness monitoring, pharmacovigilance, market access, and
HEOR
for payers.