Spring 2027

The Drug Development Process From Fih to Bla/nda

Overview of drug development from first-in-human to NDA/BLA submission, covering clinical phases, biomarkers, companion diagnostics, statistical analysis, CMC, and both small molecule and protein therapeutics.

offering recorded3 credits
Recorded instructors · Spring 2027 Leslie Dickmann

Summary

1 / 3

Recent recorded grades — Fall 2024: 3.89 GPA, 100.0% A/AB (n=9 letter grades); Spring 2025: 3.75 GPA, 92.9% A/AB (n=28 letter grades); Spring 2026: 3.93 GPA, 100.0% A/AB (n=27 letter grades).

What you’ll be able to do

  • Describe the phases of drug development from first-in-human (FIH) studies to NDA/BLA submission and the different functional areas involved.

  • Explain the goals, expectations, and objectives for the different phases of clinical development and describe innovative trial design

  • Define a biomarker, a companion diagnostic, and a statistical analysis plan (SAP) and describe the important elements of all three.

  • Explain the chemistry, manufacturing, and controls (CMC) activities that take place during clinical phases of drug development and pre-launch.

  • Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions.

  • Evaluate how clinical trial design and execution might differ between different therapeutic areas and between small molecule drugs and protein therapeutics.

  • Create a clinical development strategy for a specific drug modality and disease combination.

Source: UW Guide

Grade history

↗
average GPA
letter grades
A
AB
B
BC
C
D
F

All recorded terms · compare terms & instructors

Prerequisites

Course map

Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development

    • Declared in MS Pharmaceutical Sciences: Applied Drug Development
    • Capstone Certificate in Applied Drug Development
    take one
PHMSCI 763 used by

“Used by” includes alternatives; linked courses may have other requirements. This is a best-effort interpretation; check the catalog requirements above.

Prerequisite text tree
  • Any of
    • Declared in MS Pharmaceutical Sciences: Applied Drug Development
    • Capstone Certificate in Applied Drug Development

Professors

Spring 2027

Recent recorded grades — Fall 2024: 3.89 GPA, 100.0% A/AB (n=9 letter grades); Spring 2025: 3.75 GPA, 92.9% A/AB (n=28 letter grades); Spring 2026: 3.93 GPA, 100.0% A/AB (n=27 letter grades).

Historical instructors & teaching patterns

LESLIE DICKMANN is recorded teaching in Spring 2024, Fall 2024, Spring 2025, Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

Recorded history may be incomplete and does not establish a future schedule.

Calendar & sections

Spring 2027

Schedule loads here as you scroll.

SectionModeEnrolled / capacityWaitlist
LEC 001Online Only0 / 300
LEC 002Online (some classroom)0 / 100

Times are Central. Select a meeting for details; export includes recorded dates for the selected sections. Enrollment reflects scan time.

Meeting source records
Download part 1

Student experience

the class

Recent recorded grades — Fall 2024: 3.89 GPA, 100.0% A/AB (n=9 letter grades); Spring 2025: 3.75 GPA, 92.9% A/AB (n=28 letter grades); Spring 2026: 3.93 GPA, 100.0% A/AB (n=27 letter grades).

difficulty & workload

No workload feedback recorded.

Topics

  • Phases of clinical development, biomarkers, companion diagnostics, statistical analysis, and CMC.
  • Small molecule and protein therapeutics.
  • New drug application (NDA) and biologics license application (BLA) submission.

Skills

  • Describe phases of drug development from FIH to NDA/BLA submission and functional areas.
  • Explain goals and objectives of clinical development phases and describe innovative trial design.
  • Define biomarkers, companion diagnostics, and SAPs, describing their important elements.
  • Explain CMC activities during clinical phases and pre-launch.
  • Apply course knowledge to address drug development challenges and propose novel solutions.
  • Evaluate differences in trial design and execution across therapeutic areas and modalities.
  • Create a clinical development strategy for a specific drug modality and disease combination.

Grades

Latest available · Spring 2026— not enough history to project Spring 2027.

average GPA
A / AB grades
letter grades
Instructor

Grade distribution · % of letter grades

A
AB
B
BC
C
D
F

Grades over time

Through Spring 2026

More grade details Grade mix, volume & source data

Not enough comparable courses for Spring 2027 in UW–Madison.

Sources & history

UW–Madison

Catalog & offerings

Descriptions, prerequisites, and recorded course offerings.

Catalog observation history

Observations at scan time; dates do not imply when a catalog change took effect.

Download part 1
Selected offering source records
PHMSCI 763 · Spring 2027

The Drug Development Process from FIH to BLA/NDA

Recorded 2026-10-14
Raw records 
[
  {
    "run_id": "20261014T203208-0851c9a1",
    "semester": "1274",
    "observed_at": "2026-10-14 17:50:09.728220+00:00",
    "offering_id": "1274:718:026624",
    "course_id": "PHMSCI 763",
    "course_uid": "course_b7da72aecf53dbf40a363e61",
    "term_id": "1274",
    "source_course_id": "026624",
    "source_subject_id": "718",
    "title": "The Drug Development Process from FIH to BLA/NDA",
    "credits_min": 3,
    "credits_max": 3,
    "typically_offered": "Not Applicable"
  }
]
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Student reviews

Original comments behind the course and instructor summaries.

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Madgrades

Grade history

Recorded grade distributions by term, section, and instructor.

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Dataset & model

Recorded 2026-10-14

View the dataset on Hugging Face
Model outputs & technical records
Qwen/Qwen3.8-27B
LLM outputs across runs
Download part 1
Full model traces

Recorded model configuration, reasoning, and tool conversations.

Download part 1
Model & dataset provenance 
{
  "model": "Qwen/Qwen3.8-27B",
  "model_revision": "1d4bf0f2ff6012fd82039f2fa52739d0dd7c60c0",
  "task_version": "17",
  "output_id": "06495b4916a89dc388ab11d56ff3ff07c12917046513c651c95302e3c9f4a070",
  "requirements_status": "valid",
  "dataset_revision": "fc1811fa52e581ea57a35c0cf3343f8740a8ffbf",
  "observed_at": "2026-10-14 17:50:09.728220+00:00"
}