About AAPS PharmSci 360
The American Association of Pharmaceutical Scientists (AAPS) ↗ Annual Meeting (PharmSci 360) is the world's foremost pharmaceutical sciences conference. It convenes industrial scientists from DMPK, formulation, CMC, and regulatory affairs alongside academic pharmacokineticists, drug delivery researchers, and regulatory scientists from FDA, EMA, and Health Canada.
AAPS publishes the Pharmaceutical Research ↗, AAPS Journal ↗, and AAPS PharmSciTech ↗ — where much of the PharmSci 360 research is published. Meeting abstracts are published in the AAPS Journal.
2026 scientific tracks
BCS classification, biorelevant dissolution media (FaSSIF/FeSSIF), in vitro–in vivo correlation (IVIVC), permeability testing (Caco-2, PAMPA), and FDA biowaivers guidance ↗. BCS-based bioequivalence waivers for Class I/III drugs. See also: bioavailability glossary ↗.
Regulatory use of PBPK for DDI prediction, hepatic/renal impairment labelling, paediatric extrapolation, and bioequivalence waiver support. Platforms: GastroPlus, Simcyp, PK-Sim. FDA PBPK guidance (2018) ↗ and EMA PBPK guideline ↗. Related guide: PK basics.
Nanoparticle drug delivery, lipid nanoparticles (LNPs, mRNA delivery), amorphous solid dispersions for BCS Class II drugs, hot-melt extrusion, long-acting injectable formulations (LAIs), and advanced delivery systems review (NCBI) ↗.
CYP enzyme inhibition/induction screening, transporter DDI assessment (P-gp, BCRP, OAT, OCT), FDA DDI guidance (2020) ↗, and reaction phenotyping. Relevance to labelling: how in vitro data translate to clinical DDI sections in prescribing information. Related guide: Drug interactions guide.
LC-MS/MS method development and validation per FDA bioanalytical method validation guidance ↗ and ICH M10 ↗. Immunogenicity testing for biologics, PD biomarker qualification, digital biomarkers.
FDA regulatory roundtables, continuous manufacturing, real-time release testing (RTRT), quality by design (QbD), ICH Q8-Q12 implementation, and FDA regulatory science strategic priorities ↗. Generic drug development (ANDA, product-specific guidances, complex drug products). Related: Generic vs brand drugs guide.
Model-Informed Drug Development (MIDD) spotlight
MIDD is a rapidly expanding area at PharmSci 360, reflecting FDA's MIDD Pilot Programme ↗ launched in 2017 and now in its expanded phase. MIDD uses quantitative models to inform:
Dose selection
Population PK (PopPK) and PK/PD models replace or augment Phase 2 dose-finding studies. Exposure-response analysis supports dose selection for registration. NCBI MIDD review ↗.
Labelling support
PBPK models support dosing recommendations in special populations (renal/hepatic impairment, paediatrics, pregnancy) in prescribing information sections 8.x. See our guide: Renal dosing adjustments.
Clinical trial optimisation
Optimal sampling design, adaptive trial designs, and simulation-based power calculations. Reduces patient exposure and accelerates regulatory timelines. Relevant tool: NONMEM, Monolix, PUMAS.
Frequently asked questions
What is AAPS PharmSci 360?
AAPS PharmSci 360 is the annual meeting of the American Association of Pharmaceutical Scientists (AAPS) — the world's largest pharmaceutical sciences organisation. PharmSci 360 spans drug discovery, formulation development, PK/PD modelling, biopharmaceutics, regulatory science, and manufacturing. It draws approximately 5,000–7,000 attendees including industrial scientists, academic researchers, and regulatory scientists from FDA, EMA, and other agencies.
How does PharmSci 360 differ from ASHP Midyear or ACCP?
PharmSci 360 is primarily a pharmaceutical sciences and drug development conference — not a clinical pharmacy meeting. Its attendees are predominantly from industry (formulation, DMPK, regulatory affairs, CMC) and academia (pharmacokinetics, drug delivery, analytical chemistry). ASHP and ACCP are clinical pharmacy-oriented. PharmSci 360 is highly relevant for those working in early drug development, ANDA/NDA preparation, biopharmaceutics classification (BCS), and model-informed drug development (MIDD).
What is the BCS (Biopharmaceutics Classification System) and why is it important?
The BCS classifies drugs into four classes based on aqueous solubility and intestinal permeability: Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability), Class IV (low solubility, low permeability). BCS is used by FDA and EMA to grant waivers for in vivo bioequivalence studies for Class I drugs (and sometimes Class III). BCS is a major topic at PharmSci 360's biopharmaceutics track. FDA guidance on BCS-based biowaivers is published on the FDA website.
What is PBPK modelling and what role does it play at PharmSci 360?
Physiologically-based pharmacokinetic (PBPK) modelling builds a mechanistic mathematical model of drug disposition using organ volumes, blood flows, and drug-specific parameters (permeability, solubility, protein binding, metabolic rates). PBPK models are used to predict drug-drug interactions, paediatric doses, effect of hepatic/renal impairment, and formulation changes — often replacing in vivo studies. FDA and EMA accept PBPK model submissions in regulatory dossiers. PharmSci 360 dedicates multiple symposia to PBPK qualification and regulatory use.
Are there regulatory scientist sessions at PharmSci 360?
Yes — FDA, EMA, and other regulatory agencies regularly participate in PharmSci 360 through symposia, regulatory roundtables, and poster presentations. Sessions cover current FDA guidance priorities (e.g. model-informed drug development, complex drug products, continuous manufacturing), regulatory submissions for generics (ANDA, the Orange Book), and EMA scientific advice procedures. The AAPS Regulatory Science Section organises many of these sessions.