SURG 5100 · Section A · CRN 96270
Biopharmaceutical Drug Development: From Target to Product
Every week teaches one stage of the pipeline, then puts three real companies against it — two that died at that stage and one that lived because of it. The stage is the variable. The company is the readout.
To enrol
CRN 96270
Search the CRN in the UVM Registrar’s Schedule of Courses, or add SURG 5100 A in myUVM. Open to undergraduates and graduate students; elective credit for most departments — ask your advisor.
The pipeline this course walks
Where the 45 cases landed
Every company in this course, placed at the stage that decided it. Failures below the axis sit where they actually died; survivors above sit at the stage their week is about. Read it as the course's argument: attrition is not uniform — it clusters late, where it is most expensive.
Poster
A one-page recruitment poster, 11×17 in, ready to print and put on a board.
The QR code on the poster points back to this site.
Instructors
Larner College of Medicine & Biomedical Engineering · Dev.Majumdar@uvm.edu
R&D, Prolytix Technologies · Matthew.Whelihan@uvm.edu
Schedule
Tue & Thu, 11:40 a.m.–12:55 p.m. Home room is HSRF 200. Seven meetings, 17 Sep – 8 Oct, are in HSRF 400 — HSRF 200 is unavailable.
| Week | Topic | Date | Room |
|---|
Add, drop, withdrawal
| Last day to add | September 4, 2026 |
| Last day to drop | September 14, 2026 |
| 50% refund | September 21, 2026 |
| 25% refund | September 28, 2026 |
| Last day to withdraw | November 2, 2026 |
Download
The full syllabus as a printable document — course facts, expectations by level, assessment, the fifteen-week schedule and the University standard components.
Everything below is the same content, laid out for the screen.
Description
Biopharmaceutical Drug Development provides a practical overview of the end-to-end process of bringing a therapeutic from concept to clinic and market: target identification, lead optimization, preclinical development, formulation, clinical trial design, regulatory strategy, and manufacturing. Emphasis is on translational science, risk management, and decision-making across development stages — how scientific, regulatory, and commercial factors intersect in both small- and large-molecule programs.
Guest speakers from industry present periodically; optional site visits to local pharmaceutical companies are offered (Vermont pharmaceutical and biotechnology operations are on the contact list).
Prerequisites — enforced: MMG 2010, MMG 2040, BCOR 2300. In practice: intro microbiology, biochemistry, genetics and/or cell biology, or instructor permission. Cross-listing with Chemistry, BME, and MMG is in progress.
Objectives
- Describe the end-to-end drug development lifecycle from discovery to product release.
- Explain the roles of CMC, GxP, quality systems, and regulatory oversight.
- Evaluate analytical assays for fitness, validation, and decision-making.
- Interpret preclinical and toxicology data in the context of IND-enabling studies.
- Distinguish phases of clinical development and key trial design considerations.
- Understand the structure and purpose of FDA regulatory submissions.
- Apply industry perspectives to career paths in biopharma and regulatory science.
Grading
Attendance, participation, and preparation. A PhD course requires active engagement.
Five-minute quiz at the start of each class.
One cumulative in-class exam; an end-of-term report synthesizing the material and proposing novel strategies.
Letter scale
Curve. If >50% of the class answers a question correctly, the question is fair and we taught it. If <50% do, the problem is the question or our coverage — so points deducted per item scale with how many classmates got it right.
Attendance
Attendance folds into the participation grade. We expect everyone will miss up to three classes per semester; points come off only after more than three. Scientific conference travel is an excused absence.
Use of AI
Pedagogical. You are here to learn to think about cellular, molecular, and biomedical science and to express it precisely. Using AI for that defeats the purpose of taking the course.
Functional. LLMs hallucinate and confuse concepts. The quizzes turn on data interpretation and include hypothetical or invented phenotypes — AI is unlikely to help and very likely to invent.
Use it for grammar, nothing more. We will not deduct specifically for apparent AI use, but confused science is penalized regardless of who wrote it.
Course policies
Classroom environment. We build a learning community that is inclusive and respectful, in the spirit of Our Common Ground. Constructive dialogue requires mutual respect, willingness to listen, and open-mindedness toward opposing views. Conduct that repeatedly disrupts teaching or engagement may result in being asked to leave temporarily.
Lived name and pronouns. The UVM Directory has fields for your lived name and pronouns. Entering pronouns is strongly encouraged and propagates to Teams and Brightspace.
Accommodations. Students with a documented disability should contact Student Accessibility Services. SAS identifies reasonable accommodations and communicates them to faculty in an accommodation letter. A170 Living/Learning Center · 802-656-7753 · access@uvm.edu
Religious holidays. Submit dates in writing at least one week before the observance; make-up work is permitted.
Intellectual property. Do not publicly share or sell materials you did not author, or share assessments.
Course evaluation. Conducted through Blue; anonymous and confidential.
Materials. No textbook. Primary literature and reviews, posted on Brightspace. Brightspace and the ability to produce PDFs are required. There is no Teams page.
Student resources
How the case cards were built — and what to distrust
Bottom line: the three-company panels are teaching drafts, not vetted course content. Every card carries an evidence class and links out. Verify before you lecture from one.
Evidence classes used on every card
| Badge | Means | Trust it for |
|---|---|---|
| REGULATORY RECORD | FDA / EMA / DOJ / SEC documents and warning letters. | Dates, findings of fact, dollar figures in settlements. |
| PEER-REVIEWED | A published trial or analysis. | Endpoints, n, effect sizes. |
| COMPANY DISCLOSURE | Press release, 10-K, earnings call. | What the company said. Not why. |
| REPORTED | Trade or general press. | Chronology. Treat numbers as approximate. |
| INFERRED | Our reading of the causal chain. | Nothing. This is the argument, not the evidence. |
The six questions, asked identically of all 45
Every company — failure and survivor alike — gets the same protocol, in the same order. That is the point of numbering them: it is a fixed instrument, not a narrative. A survivor's page is not a victory lap; it asks what bottleneck they actually solved, what their money did relative to their science, how much was execution versus being in the right place, and what they still got wrong.
- The specific technical or biological bottleneck.
- Cash timing relative to publicized scientific wins and losses.
- Lost a contest, or self-inflicted — as a percentage split.
- Platform flaw, or wrong target for the platform — as a percentage split.
- External forces: funding shifts, regulatory change, patent litigation.
- What we would have done differently.
Why the source links are searches, not deep links
Deep links to agency documents rot within a year or two, and a plausible-looking dead PMID is worse than no citation. Every source button resolves through a live search on the issuing body's own site — PubMed by exact title, FDA site search, DOJ press-release search, SEC EDGAR by company. The link works in 2030; the target is the primary record, not a summary.
Missing here on purpose: photographs, logos, and figures from papers. This page can load nothing from an outside host, and using a company's mark on a card about its failure would be its own problem. Every graphic is drawn from the case data instead — so the picture cannot say something the data doesn't.
Known gaps
- Week 6's topic is ours, not the department's. Both documents jump Week 5 → Week 7. We filled it with Formulation and Drug Delivery — named in the catalog description and covered by no other week. It is flagged as proposed everywhere it appears, and is the first thing to swap if the department has a different plan.
- Lecture bullets, speakers, readings are placeholders where the planning doc has X / Y. Empty slots render as empty slots.
- Dollar figures mix write-offs, market cap loss, settlements, and raised capital. The unit is printed on every bar. Do not add them together.
- Week 12 is "Roles and Jobs in the Food Chain" per the planning doc, replacing "Clinical Trials 2" from the syllabus draft. The two documents disagree; the planning doc wins here.
- Course number differs across documents: the syllabus draft says SURG 5990, the catalog says SURG 5100. Catalog wins. Final title in the planning doc is "Pharmaceutical Drug Development."