Graduate School of Biomedical Sciences Department of Pharmaceutical Sciences Course Number: Course Name: Course Director: GPSC 5301-004

Drug Development and Discover !ame: 'itle: (ffice: Phone: ,mail: (ffice hours: "a#hrul $hsan% Ph&D& $ssociate Professor School of Pharmac % )oom 441 35*-4015 +335 fa#hrul&ahsan-ttuhsc&edu (pen door

Course Description: 'he steps and processes involved in drug development and discover & Course Mission: 'he process of drug development and discover has to go through multiples steps and re.uires involvement of e+perts from a variet of disciplines& 'he drug development process also varies significantl depending on the development of /rand% generic and ('C products& 0ith the aging of a drug% pharmaceutical companies e+plore ne1 avenues to e+tend the life-time of the drug& Similarl % pharmaceutical companies ma adopt various strategies to identif the need of a ne1 drug& 'his 3-SC2 course is designed to give students an understanding of the steps and processes involved in drug development& Course Prerequisite:$dmission to Pharm& Sci& Graduate Program& Tech's Top Ten: Drug Development and Discover 1ill stress the follo1ing concerns from the 'ech3s 'op 'en Competencies: $dvancing of the profession and promoting good health Pro/lem prevention and planning 4se of /asic science in drug development and discover &

Course Objectives and Expected Learnin Outcomes: $t the end of the course% the Doctoral Candidate is e+pected to #no1: 1& 5ethods and processes in drug discover and design 6& 5odels and tests that are performed for preclinical evaluation of a candidate drug 3& "undamentals of clinical evaluation of a drug candidate that sho1ed promise in preclinical studies including clinical trials and regulator re.uirements 4& Scale up from clinical /atch to commercial manufacturing 5& 'he drug approval processes: 7!D% !D$ and $!D$ *& 'he process of generic drug development 8& 'he process of conversion from prescription to ('C drug development and orphan drug development 9& Strategies and approaches to identif the need for a ne1 drug and increase drug lifespan

:& Post drug approval and commerciali;ation activities 10& (vervie1s of pharmaceutical companies and contract research organi;ation Course !ssessments: 'here 1ill /e t1o ma<or assessments: ,+am 7 and ,+am 77& ,+am dates 1ill /e set upon discussion 1ith the students& Students 1ill /e reminded of the date% time and place of e+ams t1o to three da s /efore the e+ams& ,+am 7: 5id (cto/er ,+am 77: 5id Decem/er

"equired Text: Guide to Drug Development: =ert Spil#er% >ippincott 0illiams and 0il#ins Drugs: "rom Discover to $pproval: )ic# !g% 0ile -=lac#1ell Drug and =iological Development: )onal P& ,vans% Springer !e1 Drug Development% $ )egulator (vervie1: 5ar# 5athieu% Pare+el "D$ )egulator $ffairs: D&?& Pisano and D&S& 5antus% 7nforma 2ealthcare 'he (rganic Chemistr of Drug Design and Drug $ction% Second ,dition: )ichard =& Silverman Ph&D& Principles and Practice of Clinical 'rial 5edicine% )ichard Chin and =ruce @ >ee !ttendance: $ttendance to all graduate courses is re.uired& Students 1ill not receive an points for attending classes% the 1ill rather /e penali;ed for missing classes& "or that matter% the team 1ill ta#e attendance for ever class& 0or# and personal travel plans do not constitute valid reasons for missing course activities& #radin : Presentations 30A of the course grade ,B$5 735A of the course grade ,B$5 7735A of the course grade $n average cumulative grade 80A or a/ove is re.uired to pass this course& $ grade of 80 to 8:% 90-9:% and :0 to 100 1ill receive a C% =% and $% respectivel & $ student 1ill receive C"3 if heDshe receives a grade of less than 80A& #rade$Exam "evie% and Dispute: 'he final grade of the course 1ill /e calculated using the average of actual grades received in presentations and t1o /ig e+ams& 'here 1ill /e no curving or magical change in the final course grade& Students are as#ed to #eep trac# of their grades& Students should verif that the grade posted on 0e/C' matches the actual grade received& 7n case of an discrepanc /et1een the posted grade and actual grade received% students should contact the team leader and confirm their actual grades andDor grade calculation method 1ithin one /usiness da follo1ing posting of a grade& 7f an error is found in calculation of the grade% the student 1ill al1a s receive the accurate grade% regardless 1hether the erroneousl posted grade 1as higher or lo1er than the true grade&

Students can revie1 and dispute their grades 1ith the concerned instructor& 7t is encouraged that students resolve all grade related issues 1ith the instructor& 7n case of unresolved issues% students can contact the team leader EDr& $hsanF and as# for revie1ing the grade& 7n such cases% team leader3s decision 1ill /e final& Students can also revie1 their tests 1ith the instructors& 2o1ever% students cannot ta&e an' %ritten notes 1hile revie1ing a test& "urther% students 1ill not be a((o%ed to revie% their tests just the da' be)ore an' ma<or assessments& $ student must revie% his$her test and$or dispute rades %ithin one business da' follo1ing a test or release of the grade&

Missed Examination Po(ic': Students 1ho are tard to an assessment 1ill onl have the remaining time in the e+am period to complete the assessment& (nl ,B'),5, emergencies such as the death of an immediate famil mem/er% an accident or serious illness 1ill /e considered as an e+cuse for missing an e+am& Schedule for an ma#e up e+am 1ill /e made at the convenience of the facult & !ssessment Methods: 'he t1o-hour e+am 1ill cover lectures% reading and case-/ased learning material& ,+ams 1ill consist of short .uestions and fill-in-the-/lan#s& *econd Chance Po(ic': 'here is no second chance for this course& 7f a student receives a grade of G90A% heDshe must reta#e the course& +ncomp(etes: $ grade of H7H 1ill /e a1arded onl / permission of the instructor prior to the end of the semester and onl 1hen a small amount of 1or# remains to /e completed for the course& $ grade of H7H is a1arded onl in case of emergenc Esee a/ove procedures on notes and verificationF and 1hen class performance at the time of the re.uest is satisfactor & Poor planning or e+cessive a/sences are not valid reasons for re.uesting a grade of incomplete& Course *chedu(e: Date 9D63D16 9D69D16 9D30D16 :D4D16 :D*D16 :D11D16 :D13D16 'ime 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 >ecture 7ntroduction to the process of drug development and discover 'arget identification and validation Discover of large and small molecular 1eight drugs $pproaches to lead discover >ead modification and design Pharmaco#inetics and to+icological evaluation of a candidate drug 5odels for preclinical >ecturer $hsan >iu >iu >iu >iu >iu >iu )oom S(P =03$ S(P =03$ S(P =03$ S(P =03$ S(P =03$ S(P =03$ S(P

:D19D16 :D60D16 :D65D16

3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5

:D68D16 10D6D16 10D4D16 10D:D16 10D11D16 10D1*D16 10D19D16 10D63D16 10D65D16 10D30D16 11D1D16 11D*D16 11D9D16 11D13D16

3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5

evaluations "ormulations and deliver s stems 7n silico models for stud ing $D5, Clinical evaluation of a drug candidate that sho1ed promise in preclinical studies and preparation of a /io-/atch $n overvie1 of clinical trials in drug development EPhase 7 to Phase 7J trialsF Design and implementation of clinical trials Dose response and relevant studies performed in a clinical trial Data management and statistics in clinical trials )egulator re.uirement for clinical trials and good clinical practice Scale up from clinical /atch to commercial manufacturing: Good practices ,+am $n overvie1 of 4S% ,uropean and ?apanese regulator $gencies 7!D !D$ $!D$ )evie1 process / the "D$ $n overvie1 of generic drug development 'he theor and practice of in vitro and in vivo correlation and its application in generic drug development =iopharmaceutical classification and /io-1aivers in generic drug development Computational models for stud ing in vitro and in vivo correlation

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11D68D16 11D6:D16 16D4D16 16D*D16 16D11D16 16D13D16

3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5 3&00 P5 I 4:30 P5

=ioe.uivalence re.uirements for generic drug development 'he process of conversion of prescription drugs to ('C drugs (rphan drug development and "D$ regulations Pharmaceutical companies% t pes and personnel Contract research organi;ation and their roles in drug development Strategies to identif the need for a ne1 drug and life c cle management of a patented drug product Post drug approval and commerciali;ation activities Pharmaceutical Companies and contract research organi;ation ,+am

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Course ,acu(t':

-in(i Liu. Ph/D/ ,mail: +inli&liu-ttuhsc&edu (ffice: )oom $)= K1105 Phone: 90*-35*-4850 EB66*F (ffice hours: = appointment Nishi( Desai. Ph/D/ ,mail: nishil&desai-ttuhsc&edu (ffice: $=7 6*05 Phone: 365-*8*-8:49 (ffice hours: = appointment
!cademic +nte rit': $ll students are e+pected to su/scri/e to an honor s stem 1hich is implicit in accepting admission to the 2ealth Sciences Center& ,ach student shall /e responsi/le for hisDher conduct from the time of the application for admission through the actual a1arding of a degree% even though conduct ma occur /efore classes /egin or after classes end% as 1ell as during the academic ear and during periods /et1een terms of actual enrollment& Students are e+pected to a/ide / all of the rules for academic integrit % as specified in the ''42SC Student $ffairs 2and/oo# E111&ttuhsc&eduDstudentservicesDdocDhand/oo#&pdfF&

*tudents %ith Disabi(ities: $n student 1ho% /ecause of a disa/ilit % ma re.uire special arrangements in order to meet course re.uirements should contact the 'eaching 'eam 1ithin 1 1ee# of the /eginning of this course to ma#e the necessar accommodations& (ptional 7nformation Teachin Method: $ portion of the course 1ill /e delivered in interactive lectures% /ut

80A materials 1ill /e for self-stud & "or self-stud materials% the instructor 1ill provide student presenters 1ith materials for preparation of presentations& Graduate students are encouraged to spea# to the instructor if the need help& 7nstructors 1ill go over the materials /efore each session& Students 1ill then give a presentation on the assigned materials& $ll presentations should /e sent or posted one /usiness da /efore the da of presentation& Students 1ill prepare .uestions for discussion on each topic&
Late 0or& Po(ic': !ot applica/le Ethica( and Pro)essiona( *tandards: 'he ethical standards for the School of Pharmac and the $$PS Code of ,thics are in effect for all components of this course& Candidates found to /e in violation of ethical standards 1ill receive a ;ero E0F for the course in .uestion and 1ill /e reported to the Pharmaceutical Sciences Graduate Program Committee& Students are e+pected to interact professionall 1ith the instructors and fello1 students& Students are not to use iPods. ce(( phones% eat% drin# or sur) the internet during the class or e+ams& Students ma not 1al# in or 1al# out of the classroom during a lecture or e+am& ,aci(ities: $ll lectures 1ill /e held in =03$& $ll ma<or e+aminations 1ill /e conducted either in the scheduled classroom or as determined / the instructor& Candidate +nquiries: Students are as#ed to resolve all course related issues 1ith the concerned instructor& 2o1ever% students ma contact the team leader EDr& $hsanF for .uestions that are general in nature and issues that re.uire immediate attention& 7n case of an e+treme emergenc % Dr& $hsan ma /e contacted at his cell phone E90*-433-4*13F or / email at fa#hrul&ahsan-ttuhsc&edu& D+*CL!+ME": 'his document is a general guideline on ho1 the course 1ill /e conducted& 'his guideline of the course cannot /e used as a legal contract /et1een the students and instructors& 'he team can ma#e minor changes in the schedule% grade distri/ution and content of the course if there is an need&