# PHMSCI 763: The Drug Development Process From Fih to Bla/nda | UW–Madison [View on UW Courses](https://uwcourses.com/courses/PHMSCI_763) ## Dataset ### revision e243353dcb7d79b7247ced91d69443ef4c2a6349 ### repository twangodev/uwcourses ### schema version 6 ### importer version 7 ### projection id 52a78527ff09011d88cb04c7d43867d9fbfec2930bf1dd2ec359ebd2844e0b07 ### observed at 2026-09-07T15:55:43.033547+00:00 ### built at 2026-09-10T19:50:42.743001+00:00 ### courses 8951 ### current instructors 5754 ### limited false ### terms * 1272 * 1264 * 1262 * 1254 * 1252 * 1244 * 1242 * 1234 * 1232 * 1224 * 1222 * 1212 * 1204 * 1202 * 1194 * 1192 * 1184 * 1182 * 1174 * 1172 * 1164 * 1162 * 1154 * 1152 * 1144 * 1142 * 1134 * 1132 * 1124 * 1122 * 1114 * 1112 * 1104 * 1102 * 1094 * 1092 * 1084 * 1082 * 1074 * 1072 ### term 1272 ### departments | subject | count | | --------- | ----- | | AAE | 90 | | ABT | 20 | | ACCTIS | 36 | | ACTSCI | 14 | | AFAERO | 10 | | AFRICAN | 87 | | AFROAMER | 71 | | AGROECOL | 21 | | AMERIND | 53 | | ANAT\&PHY | 7 | | ANATOMY | 2 | | ANESTHES | 8 | | ANSCI | 57 | | ANTHRO | 95 | | ART | 125 | | ARTED | 10 | | ARTHIST | 121 | | ASIALANG | 129 | | ASIAN | 109 | | ASIANAM | 28 | | ASTRON | 38 | | ATMOCN | 69 | | BIOCHEM | 51 | | BIOCORE | 10 | | BIOLOGY | 14 | | BIOMDSCI | 18 | | BME | 66 | | BMI | 41 | | BMOLCHEM | 10 | | BOTANY | 69 | | BSE | 44 | | C\&ESOC | 73 | | CBE | 48 | | CHEM | 101 | | CHICLA | 52 | | CIVENGR | 133 | | CLASSICS | 47 | | CNP | 10 | | CNSRSCI | 50 | | COMARTS | 137 | | COMPBIO | 15 | | COMPLIT | 11 | | COMPSCI | 138 | | COUNPSY | 78 | | CRB | 19 | | CS\&D | 71 | | CSCS | 40 | | CURRIC | 193 | | DANCE | 93 | | DERM | 8 | | DS | 88 | | DYSCI | 35 | | ECE | 155 | | ECON | 145 | | EDPOL | 114 | | EDPSYCH | 97 | | ELPA | 70 | | EMA | 53 | | EMERMED | 17 | | ENGL | 206 | | ENTOM | 40 | | ENVIRST | 148 | | EP | 15 | | EPD | 67 | | ESL | 16 | | F\&WECOL | 60 | | FAMMED | 22 | | FINANCE | 50 | | FOLKLORE | 40 | | FOODSCI | 43 | | FRENCH | 63 | | GEN\&WS | 145 | | GENBUS | 72 | | GENECSLR | 17 | | GENETICS | 60 | | GEOG | 113 | | GEOSCI | 83 | | GERMAN | 82 | | GLE | 48 | | GNS | 38 | | GREEK | 27 | | HDFS | 41 | | HEBR-BIB | 13 | | HEBR-MOD | 10 | | HISTORY | 233 | | HISTSCI | 56 | | HONCOL | 13 | | ILS | 43 | | INFOSYS | 9 | | INTEGART | 7 | | INTEGSCI | 22 | | INTER-AG | 18 | | INTER-HE | 11 | | INTER-LS | 22 | | INTEREGR | 16 | | INTLBUS | 21 | | INTLST | 50 | | ISYE | 83 | | ITALIAN | 53 | | JEWISH | 56 | | JOURN | 88 | | KINES | 128 | | LACIS | 26 | | LANDARC | 61 | | LATIN | 24 | | LAW | 120 | | LEGALST | 48 | | LINGUIS | 35 | | LIS | 89 | | LITTRANS | 78 | | LSC | 52 | | M\&ENVTOX | 7 | | MARKETNG | 62 | | MATH | 153 | | MDGENET | 8 | | ME | 130 | | MEDHIST | 43 | | MEDICINE | 60 | | MEDIEVAL | 32 | | MEDPHYS | 39 | | MEDSC-M | 29 | | MEDSC-V | 41 | | MHR | 68 | | MICROBIO | 45 | | MILSCI | 16 | | MM\&I | 22 | | MOLBIOL | 6 | | MS\&E | 59 | | MUSIC | 165 | | MUSPERF | 126 | | NAVSCI | 20 | | NE | 44 | | NEURODPT | 11 | | NEUROL | 7 | | NEURSURG | 4 | | NTP | 11 | | NURSING | 111 | | NUTRSCI | 65 | | OBS\&GYN | 18 | | OCCTHER | 39 | | ONCOLOGY | 14 | | OPHTHALM | 5 | | OTM | 43 | | PATH | 34 | | PATH-BIO | 29 | | PEDIAT | 26 | | PHARMACY | 31 | | PHILOS | 77 | | PHMCOL-M | 11 | | PHMPRAC | 45 | | PHMSCI | 60 | | PHYASST | 37 | | PHYSICS | 88 | | PHYSIOL | 3 | | PHYTHER | 37 | | PLANTSCI | 52 | | PLPATH | 35 | | POLISCI | 192 | | POPHLTH | 58 | | PORTUG | 33 | | PSYCH | 101 | | PSYCHIAT | 22 | | PUBAFFR | 54 | | PUBLHLTH | 23 | | RADIOL | 11 | | REALEST | 41 | | RELIGST | 90 | | RHABMED | 9 | | RMI | 24 | | RP\&SE | 102 | | S\&APHM | 17 | | SCANDST | 73 | | SLAVIC | 89 | | SOC | 149 | | SOCWORK | 87 | | SOILSCI | 46 | | SPANISH | 83 | | SRMED | 21 | | STAT | 94 | | STDYABRD | 52 | | STS | 8 | | SURGERY | 25 | | SURGSCI | 33 | | THEATRE | 91 | | URBRPL | 60 | | UROLOGY | 5 | | ZOOLOGY | 89 | ## course ### run id 20260907T155543-ce3781c4 ### semester 1272 ### observed at 2026-09-07 15:55:43.033547+00:00 ### record version id ba5f1ea43fbd75baa388ed7fe49ee45cbb5b1fdbcdbd5df71a084fc673984f7c ### course id PHMSCI 763 ### course uid course\_b7da72aecf53dbf40a363e61 ### catalog version id 9175f1759595135dffb4d3a74fa30fbc555bdc5afa3f29449dd1c84a8a860282 ### course number 763 ### subjects * PHMSCI ### title THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA ### description Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed. ### requirements text Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development ### credit offering ids None recorded. ### llm job id enrich-8b774950c2b6adfdc46d1b82 ### llm output id d2e417dcf56ac41578787954ca4185d0f53f17dff00d090bdb096d53f031fee1 ### llm model nvidia/Qwen3.6-35B-A3B-NVFP4 ### llm model revision 1355db6a052410cfd62085d94b58866fd0f2c3c5 ### llm task version 14 ### llm search status valid ### llm summary PHMSCI 763 covers the drug development process from first-in-human trials to NDA/BLA submission, addressing clinical phases, biomarkers, and therapeutics. ### llm topics * Phases of clinical development * Biomarkers, companion diagnostics, statistical analysis, and CMC * Small molecule and protein therapeutics ### llm skills * Understanding the end-to-end drug development lifecycle from initial human trials to regulatory submission * Analyzing the roles of biomarkers, diagnostics, statistics, and CMC within clinical trial phases ### llm assumed background None recorded. ### llm search phrases * drug development process * clinical trials phases * biomarkers diagnostics * CMC clinical trials * small molecule protein therapeutics * NDA BLA submission ### llm requirements status valid ### llm student summary status valid ### llm experience status insufficient\_evidence ### catalog variants None recorded. ### student summary #### context hash 98146676635ec80db84182ced9d35014301fbf1d31eadae7d8e49782de53db13 #### course id PHMSCI 763 #### current instructors None recorded. #### difficulty workload None recorded. #### errors None recorded. #### historical context None recorded. #### message No course-specific reviews available #### offered false #### profile hash 5cb4dabf887cdbcd8c00d5a1312e10828b95c63f30bc3ea76aea199565390d02 #### quick take 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). ```json { "citations": [ { "course_id": "PHMSCI 763", "run_id": "20260907T155543-ce3781c4", "source_record": { "entity_id": "0c4e1947-79bd-3097-93c6-dd701cfd65fb", "file": "tables/observations.parquet", "kind": "grades", "source": "madgrades" }, "table": "grades_latest", "term_id": "1252", "type": "grade" }, { "course_id": "PHMSCI 763", "run_id": "20260907T155543-ce3781c4", "source_record": { "entity_id": "0c4e1947-79bd-3097-93c6-dd701cfd65fb", "file": "tables/observations.parquet", "kind": "grades", "source": "madgrades" }, "table": "grades_latest", "term_id": "1254", "type": "grade" }, { "course_id": "PHMSCI 763", "run_id": "20260907T155543-ce3781c4", "source_record": { "entity_id": "0c4e1947-79bd-3097-93c6-dd701cfd65fb", "file": "tables/observations.parquet", "kind": "grades", "source": "madgrades" }, "table": "grades_latest", "term_id": "1264", "type": "grade" } ] } ``` #### student experience None recorded. #### task hash 74fb0997943e888960bbc9e47db8c4fd12e4292d55c20509d8d89db6a9910f68 #### teaching history None recorded. #### term id 1272 #### term name 2026 Fall #### version 2 ### requirements #### nodes ```json [ { "children": [], "condition": "Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development", "course": null, "evidence": "Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development", "id": "n0", "kind": "condition" } ] ``` #### notes None recorded. #### root n0 #### status parsed ### instructors None recorded. ### offerings None recorded. ### sections None recorded. ### grade instructors ```json [ { "instructor_uid": "instructor_46f340847a199ca64aca4502", "source": "madgrades", "source_instructor_id": "804013", "identity_basis": "source_id", "identity_status": "source_identified", "name": "LESLIE DICKMANN", "email": null, "first_observed_at": "2026-09-06 23:14:58.172943+00:00", "last_observed_at": "2026-09-07 15:55:43.033547+00:00", "grade_statistics": { "gpa": 3.82, "graded": 898, "counts": [ 694, 139, 45, 8, 6, 1, 5 ], "sections": 51 }, "instructor_url": "/instructors/LESLIE_DICKMANN--instructor_46f340847a199ca64aca4502" } ] ``` ### grades ```json [ { "run_id": "20260907T155543-ce3781c4", "semester": "1272", "observed_at": "2026-09-07 15:55:43.033547+00:00", "course_id": "PHMSCI 763", "course_uid": "course_b7da72aecf53dbf40a363e61", "term_id": "1244", "term_name": "Spring 2024", "instructors": [ "Leslie Dickmann" ], "a": 9, "ab": 6, "b": 1, "bc": 1, "c": 0, "d": 0, "f": 0, "satisfactory": 0, "unsatisfactory": 0, "credit": 0, "no_credit": 0, "passed": 0, "incomplete": 0, "no_work": 0, "not_reported": 0, "other": 0, "total": 17, "source_aliases": [ "PHMSCI 763" ] }, { "run_id": "20260907T155543-ce3781c4", "semester": "1272", "observed_at": "2026-09-07 15:55:43.033547+00:00", "course_id": "PHMSCI 763", "course_uid": "course_b7da72aecf53dbf40a363e61", "term_id": "1252", "term_name": "Fall 2024", "instructors": [ "Leslie Dickmann" ], "a": 7, "ab": 2, "b": 0, "bc": 0, "c": 0, "d": 0, "f": 0, "satisfactory": 0, "unsatisfactory": 0, "credit": 0, "no_credit": 0, "passed": 0, "incomplete": 0, "no_work": 0, "not_reported": 0, "other": 0, "total": 9, "source_aliases": [ "PHMSCI 763" ] }, { "run_id": "20260907T155543-ce3781c4", "semester": "1272", "observed_at": "2026-09-07 15:55:43.033547+00:00", "course_id": "PHMSCI 763", "course_uid": "course_b7da72aecf53dbf40a363e61", "term_id": "1254", "term_name": "Spring 2025", "instructors": [ "Leslie Dickmann" ], "a": 22, "ab": 4, "b": 1, "bc": 0, "c": 0, "d": 0, "f": 1, "satisfactory": 0, "unsatisfactory": 0, "credit": 0, "no_credit": 0, "passed": 0, "incomplete": 0, "no_work": 0, "not_reported": 0, "other": 0, "total": 28, "source_aliases": [ "PHMSCI 763" ] }, { "run_id": "20260907T155543-ce3781c4", "semester": "1272", "observed_at": "2026-09-07 15:55:43.033547+00:00", "course_id": "PHMSCI 763", "course_uid": "course_b7da72aecf53dbf40a363e61", "term_id": "1264", "term_name": "Spring 2026", "instructors": [ "Leslie Dickmann" ], "a": 23, "ab": 4, "b": 0, "bc": 0, "c": 0, "d": 0, "f": 0, "satisfactory": 0, "unsatisfactory": 0, "credit": 0, "no_credit": 0, "passed": 0, "incomplete": 0, "no_work": 0, "not_reported": 0, "other": 0, "total": 27, "source_aliases": [ "PHMSCI 763" ] } ] ``` ### statistics #### gpa 3.809 #### graded 81 #### counts * 61 * 16 * 2 * 1 * 0 * 0 * 1 ### grade conflicts None recorded. ### evidence #### history * [/data/e243353dcb7d79b7247ced91d69443ef4c2a6349/history/course\_b7da72aecf53dbf40a363e61-0.json](https://uwcourses.com/data/e243353dcb7d79b7247ced91d69443ef4c2a6349/history/course_b7da72aecf53dbf40a363e61-0.json) #### traces * 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departments ```json [ { "subject": "PHMSCI", "comparison": { "size": 26, "gpaPercentile": 56, "countPercentile": 40, "medianCount": 97.5, "histogram": [ { "range": "0.0–0.4", "count": 0, "current": false }, { "range": "0.4–0.8", "count": 0, "current": false }, { "range": "0.8–1.2", "count": 0, "current": false }, { "range": "1.2–1.6", "count": 0, "current": false }, { "range": "1.6–2.0", "count": 0, "current": false }, { "range": "2.0–2.4", "count": 0, "current": false }, { "range": "2.4–2.8", "count": 0, "current": false }, { "range": "2.8–3.2", "count": 0, "current": false }, { "range": "3.2–3.6", "count": 6, "current": false }, { "range": "3.6–4.0", "count": 20, "current": true } ] } } ] ``` ### terms #### 1244 ##### term 1244 ##### gpa 3.676470588235294 ##### count 17 ##### departments | subject | comparison | | ------- | ---------- | | PHMSCI | | #### 1252 ##### term 1252 ##### gpa 3.888888888888889 ##### count 9 ##### departments | subject | comparison | | ------- | ---------- | | PHMSCI | | #### 1254 ##### term 1254 ##### gpa 3.75 ##### count 28 ##### departments | subject | comparison | | ------- | ---------- | | PHMSCI | | #### 1264 ##### term 1264 ##### gpa 3.925925925925926 ##### count 27 ##### departments | subject | comparison | | ------- | ---------- | | PHMSCI | | ### benchmarks #### all ##### school ###### size 3039 ###### gpa 3.6809392869930226 ###### top Share 83.34668756564041 ###### count 89 ##### PHMSCI ###### size 26 ###### gpa 3.7315206559302285 ###### top Share 85.17105711166545 ###### count 97.5 #### terms ##### 1244 ###### school ###### size 1241 ###### gpa 3.5975573126929192 ###### top Share 78.29036874847135 ###### count 65 ##### 1252 ###### school ###### size 1333 ###### gpa 3.619494049739118 ###### top Share 79.71442190500672 ###### count 69 ###### PHMSCI ###### size 12 ###### gpa 3.728543154478551 ###### top Share 84.94017449057357 ###### count 65 ##### 1254 ###### school ###### size 1289 ###### gpa 3.6126423469389106 ###### top Share 79.48050408754871 ###### count 66 ##### 1264 ###### school ###### size 1283 ###### gpa 3.6229729166451925 ###### top Share 80.13669149396227 ###### count 66 ## instructor Trends ```json [ { "uid": "instructor_46f340847a199ca64aca4502", "name": "LESLIE DICKMANN", "count": 81, "terms": [ { "term": "1244", "count": 17, "sections": 2, "gpa": 3.676470588235294 }, { "term": "1252", "count": 9, "sections": 2, "gpa": 3.888888888888889 }, { "term": "1254", "count": 28, "sections": 2, "gpa": 3.75 }, { "term": "1264", "count": 27, "sections": 2, "gpa": 3.925925925925926 } ] } ] ``` ## following | code | title | | ---------- | -------------------------------- | | PHMSCI 764 | CASE STUDIES IN DRUG DEVELOPMENT |