2015 ASA Biopharmaceutical Section Statistics Workshop

LUNCHEON ROUNDTABLE DISCUSSIONSAdaptive DesignTL1 Logistics and Implementation of AdaptiveTrial Designs — Eva Miller, inVentiv Health ClinicalTL2 Enriching Patient Population byResponse: Placebo Run-In, RandomizedWithdrawal, Sequential Parallel ComparisonDesign (SPCD), and Twice-Enriched Design(TED) — Anastasia Ivanova, The University of NorthCarolina at Chapel HillTL3 Key Characteristics in Bayesian AdaptiveDesign — Xin Fang, FDA/CDRHTL4 Challenges and Opportunities forStatisticians in Planning/ImplementingAdaptive Trial Designs — Nan Shao, Covance, Inc.TL5 H0 P-Value–Based Futility Decision andOther Seemingly Inappropriate Methods —Stan Lin, FDA/CBERTL6 Adaptive Designs in Unblinded Studies? —Jie (Jack) Zhou, FDA/CDRHTL7 Are Statisticians Ready to ImplementIncreasing Number of Platform Trials? —Emelita de Leon-Wong, PPDITL8 Adaptive design in Medical Device Trials— Peter Lam, Boston ScientificBioequivalence, Generics, andBiosimilarsTL9 Statistical Issues and Methods inBiosimilar — Jin Xu, MerckBiomarkersTL10 Precision Medicine: Statistical Issues,Trial Design, and Regulatory Aspects — AmirHandzel, AstraZenecaComparative EffectivenessTL11 Relevance and Data Accessibility forNetwork Meta-Analyses for ComparativeEffectiveness Research Using Patient-LevelRandomized Clinical Trial Data — Leiya Han,PPDTL12 Statistical Assessment of ComparativeEffectiveness in Clinical Trials — Isaac Nuamah,Janssen R&DDiagnosticsTL13 Precision Studies for In-Vivo Devices —Bipasa Biswas, FDA10 Program Book 2015DSMB/InterimAnalysis/Advisory CommitteeTL14 Incorporating Futility into a Phase 3Outcomes Trial Governed by a DataMonitoring Committee — Richard Davies, GSKEarly Phase TrialsTL15 Robust Decision-Making in Early-StageClinical Development — Yanli Zhao, MedImmune/AstraZeneca; Erik Pulkstenis, MedImmuneHigh-Dimensional Data (e.g.,Pharmacogenomics)TL16 Best Practices in Next-GenerationSequencing Methodology with Impact onHigh-Dimensional Findings — Justin Davis,AbbVieMedical DevicesTL17 How to Treat Site in Clinical Trials: Fixedor Random? — Chul Ahn, FDA-CDRHTL19 Making Sense of Sensors — VadimZipunnikov, The Johns Hopkins UniversityMeta-AnalysisTL20 Bayesian Meta-Analysis andMeta-Analysis for Stroke and Myeloma —Xiaoping Liu, Zhongnan Hospital of Wuhan UniversityMissing DataTL21 The Prevention and Treatment ofMissing Data in Clinical trials: How Far HaveWe Come? — Gosford Sawyerr, JanssenPharmaceuticalsTL22 Practical Issues with MMRM — DalongHuang, Takeda Development Center Americas, Inc.TL23 Impact of Missing Data and Their Imputations in Long-Term Treatment ofChronic Auto-Immune Diseases — AchimGuettner, Novartis Pharam AGTL24 Missing Data Analysis Planning in LateState Clinical Trials: A Check-Up on CurrentPractices — Davis Gates, MerckTL25 Investigating Product Complaints:Pitfalls of Working with Manufacturing Data —Aaron Spence, BIOVIA

LUNCHEON ROUNDTABLE DISCUSSIONSModeling and SimulationTL40 We the People of the Biopharm Section Chat with the Chair-Elect — B. Christine Clark, QDSTL26 Validation of Predictive Modeling inObservational Studies — Rui Li, Quintiles;Zahouhui Su, QuintilesPatient-Reported Outcomes andPatient PreferencesTL27 The Interface Between Statistical andPKPD Modeling and Simulation — MatthewRotelli, Eli Lilly and CompanyTL41 Patient-Reported Outcomes in Oncology— Laura Fernandes, FDATL28 Analyses of Longitudinal Clinical Data withTime-Varying Covariates — Rong Liu, Eli Lillyand Company; Qianyi Zhang, Eli Lilly and CompanyTL42 Incorporating Patient PreferencesEvidence into Regulatory Considerations —Martin Ho, FDA/CDRHNoninferiorityTL43 PRO and COA Experiences: Regulatoryand Patient Priorities and Processes — LauraJohnson, FDATL29 Bayesian and Frequentist Approaches toNoninferiority Clinical Trials — Carl DiCasoli,Bayer Healthcare PharmaceuticalsTL30 Noninferiority Trial with Survival Endpoints — Mengdie Yuan, FDA; Elena Rantou, FDA/CDERObservational StudiesRegulatory Topics/GuidancesTL44 Pathway for Antibiotics: RevisitingEndpoints and Designs — Prasanna Ambati, PPDTL45 Next-Generation Sequencing DiagnosticTests — Peggy Wong, MerckTL31 The Impact of EU Post-Approval SafetySurveillance Studies (PASS) — Charles Liss,AstraZeneca PharmaceuticalsTL46 Challenges and Good Practices toImprove the Quality of Therapeutic DeviceSubmissions — Manuela Buzoianu, FDA/CDRHTL32 Statistical Considerations for HandlingTreatment Switches in Observational Studies— William Hawkes, Quintiles RWLPRRole of StatisticiansOncologyTL33 PFS: Central vs. Local — Lihui Zhao,NovartisTL34 Noninferiority in Cancer Trials — TingtingYi, NovartisTL35 Challenges and Opportunities ofStatistics in Oncology Immunotherapy — Yi He,Celldex TherapeuticsOtherTL36 Statistical Intellectual Property — PhilipLavin, Lavin Consulting LLCTL37 A Comprehensive Review of the Multiple-Sample Tests for the Three General DataTypes — Ying Yang, FDA/CDRHTL38 Leadership and Career Development forJunior Statisticians Working on Clinical Trials— Lei Gao, SanofiTL39 Crossover Design in Clinical Studies —Tao Wang, Eli Lilly and CompanyTL47 Promotion of Involvement of Statisticianand Statistical Analysis of Risk-BasedMonitoring in Clinical Trials — Xiaoqiang Xue,QuintilesSafetyTL48 Blinded and Unblinded Evaluationof Aggregate Safety Data During ClinicalDevelopment — Bill Wang, MerckTherapeutic Area Specific TopicTL49 Risk Stratification Strategies to IdentifyLow-Risk Patients in Cardiovascular ClinicalTrials — Juliana Ianus, Janssen R&D; CV Damaraju,Janssen R&DTL50 Suicidal Ideation and Behavior: Designand Analysis of Clinical Trials — Pilar Lim,Janssen R&D; Rosanne Lane, Janssen R&DQuality/ValidationTL51 IWRS: Interactive Web Response System:Looking Beyond Randomization andMedication Kit Assignment — Rama Melkote,Janssen, R&D ; Kim Cooper, Janssen, R&DASA Biopharmaceutical Section Statistics Workshop 2015 11

PARALLEL SESSIONSThursday, September 171:15 p.m. – 2:30 p.m.Chair(s): Michelle Detry, Berry ConsultantsSpeakers: Roger Lewis, Berry Consultants; GregCampbell, Consultant; Thomas Cook, University ofWisconsinPS1aStatistical Experiences on Subgroup-Stratified,Biomarker-Stratified, or Enrichment TrialsThurgood Marshall NorthOrganizer(s): Eva Miller, inVentiv Health Clinical;Liming Dong, FDA; Yuanjia Wang, Columbia University; Xiting (Cindy) Yang, FDA/CDRHChair(s): Xiting (Cindy) Yang, FDA/CDRHSpeakers: Bo Huang, Pfizer Inc.; Guoxing (Greg)Soon, FDA/CDER/OTS/OB; Richard Simon, NationalCancer InstitutePS1bCurrent and Future Role of the ClinicalStatistician in the World of Data TransparencyThurgood Marshall SouthOrganizer(s): Jeffrey Joseph, Theorem Clinical Research; Stephen Wilson, FDA/CDER/OTS/OB/DBIII;Vivian Shih, AstraZeneca; Yueqin Zhao, FDAChair(s): Stephen Wilson, FDA/CDER/OTS/OB/DBIIISpeakers: Michael Pencina, Duke Clinical ResearchInstitute; Marc Buyse, IDDI Inc.; Jeffrey Gardner,Janssen R&DDiscussant(s): Stephen Wilson, FDA/CDER/OTS/OB/DBIIIPS1cBig Data/Big Analytics: Challenges andOpportunities in Pre- and Post-Market MedicalProduct Evaluations Utilizing National/International RegistriesThurgood Marshall EastOrganizer(s): Yunling Xu, FDA/CDRH; Nelson Lu,FDA/CDRH; Charles Darby, Statistical Consultant;Rakhi KilaruPanelists: Jesse Berlin, J&J; Chunrong Cheng,CBER/FDA; Rima Izem, OB/CDER/FDA; Ted Lystig,Medtronic Inc.; Bram Zuckerman, CDRH/FDASpeakers: Donald Rubin, Harvard University; LillyYue, FDA/CDRH; Nelson Lu, FDA/CDRH; YunlingXu, FDA/CDRHPS1dAnalytical Similarity: Current Statistical Issuesin Biosimilar Product DevelopmentThurgood Marshall WestOrganizer(s): Meiyu Shen, FDA; Harry Yang,MedImmune LLCChair(s): Harry Yang, MedImmune LLCDiscussant(s): Yi Tsong, FDA/CDER; Rick Burdick,Amgen Inc.PS1eDMCs and Adaptive Clinical Trials: Considerations in Balancing Safety and Trial IntegrityLincoln 5Organizer(s): Michelle Detry, Berry Consultants;Jie (Jack) Zhou, FDA/CDRH; Greg Ball, AbbVie;Zhuang Miao, FDA12 Program Book 2015PS1fAdvanced Multiple Testing Methodologies forConfirmatory TrialsLincoln 6Organizer(s): Xuan Liu, AbbVie; Freda Cooner,FDA/CDER; Anthony Rodgers, Merck; Julia JingyuLuan, FDA/CDERChair(s): Xuan Liu, AbbVieSpeakers: Walter Offen, AbbVie; Frank Bretz,Novartis; Willi Maurer, Novartis; Xiaolei Xun,Novartis; Mohammad Huque, FDA/CDERDiscussant(s): Hsien-Ming James Hung, FDAThursday, September 172:45 p.m. – 4:00 p.m.PS2aLogical Inference on Treatment Efficacy inSubgroups and Their Combinations inPersonalized Medicine DevelopmentThurgood Marshall NorthOrganizer(s): Ying Ding, University of Pittsburgh;Xiang Ling, FDA/CDER; Jason Hsu, Eli Lilly and Company/Ohio State University; Thomas Birkner, FDAChair(s): Jason Hsu, Eli Lilly and Company/OhioState UniversitySpeakers: Yi Liu, Takeda Pharmaceuticals; YingDing, University of PittsburghDiscussant(s): Hsien-Ming James Hung, FDAPS2bSubgroup Analysis Under Rising RegulatoryEmphasis: Fundamentals and ChallengesThurgood Marshall SouthOrganizer(s): Yijie Zhou, AbbVie; Bo Yang, AbbVie;Weiya Zhang, FDA; Yifan Wang, FDASpeakers: Lu Cui, AbbVie; Shufang Liu, AbbVie;Janet Wittes, Statistics CollaborativeDiscussant(s): Bob Temple, FDAPS2cLarge Trials for Major Adverse CardiovascularEventsThurgood Marshall EastOrganizer(s): Aloka Chakravarty, FDA/CDER; BretMusser, Merck; Olga Marchenko, QuintilesChair(s): Richard Zink, JMP Life Sciences, SASInstituteSpeaker(s): Olga Marchenko, QuintilesPanelists: Aloka Chakravarty, FDA/CDER;Qi Jiang, Amgen; José Pinheiro, J&J; EstelleRussek-Cohen, FDA/CBER

PARALLEL SESSIONSPS2dQuality and Quality MetricsThurgood Marshall WestOrganizer(s): Stan Altan, J&J; Liang Zhao, FDASpeakers: Lawrence Yu, FDA/CDER/OPQ; HelenStrickland, GSKPS2eCurrent Statistical Issues in BiosimilarProduct DevelopmentConsultants; Liz Krachey, Berry Consultants; GenePennello, FDA/CDRHDiscussant(s): Ravi Varadhan, The Johns HopkinsCenter on Aging and HealthPS3cTown Hall Session: Roles of Statisticians inAcademia, Regulatory, and PharmaceuticalsIndustryThurgood Marshall EastLincoln 5Organizer(s): Bo Jin, Pfizer Biotechnology ClinicalDevelopment; Sungwoo Choi, FDA/CDER; JasonLiao, Novartis; Xin Gao, FDA/CDERChair(s): Joshua Chen, Sanofi Pasteur; Eric Chi,Amgen Inc.Speakers: Bo Jin, Pfizer Biotechnology ClinicalDevelopment; Kerry Barker, Pfizer Inc.; Cassie Dong,FDA; Gregory Levin, FDAPS2fAdaptive Enrichment Design: A Way toAchieve the Goal of Personalized Medicine?Lincoln 6Organizer(s): Min (Annie) Lin, FDA/CBER;Zhiwei Zhang, FDA/CDRH; Feng Liu, GSK; InnaPerevozskaya, Pfizer Inc.Chair(s): Meijuan Li, FDA; Feng Liu, GSKSpeaker(s): Cong Chen, Merck; Nicole Li, Merck;Zhiwei Zhang, FDA/CDRH; Michael Rosenblum,Johns Hopkins Bloomberg School of Public HealthOrganizer(s): Yulan Li, Novartis; Guoxing (Greg)Soon, FDA/CDER/OTS/OB; Yanming Yin, FDA/CDER/OTS/OB; Keaven Anderson, MerckChair(s): Yulan Li, Novartis; Guoxing (Greg) Soon,FDA/CDER/OTS/OBSpeaker(s): Janet Wittes, Statistics Collaborative;Robert Califf, FDA; Lisa LaVange, FDA; JeffreyHelterbrand, RochePanelists: Robert Califf, FDA; Lisa LaVange, FDA; Jeffrey Helterbrand, Roche; Janet Wittes, Statistics Collaborative; Bob Temple, FDA; Tom Fleming, University ofWashington; Sonia Davis, University of North Carolinaat Chapel Hill; Ramachandran Suresh, GSKPS3dContinuing Discussion: Statistical Considerations for Continuous Manufacturing ProcessesThurgood Marshall WestOrganizer(s): David Christopher, Merck; Yi Tsong,FDA/CDER; Helen Strickland, GSKPS3eNew Statistical Methods for Risk AssessmentThursday, September 174:15 p.m. – 5:30 p.m.Lincoln 5PS3aConcerns with Reanalysis for Ongoing DataTransparency InitiativesThurgood Marshall NorthOrganizer(s): Theodore Lystig, Medtronic, Inc.Chair(s): Michael Hale, AmgenSpeaker(s): Jonathan Hartzel, Merck; EstelleRussek-Cohen, FDA/CBER; Sara Hughes, GSKOrganizer(s): Zhiwei Zhang, FDA/CDRH; Mei-LingLee, University of Maryland; Mengdie Yuan, FDA;Greg Ball, AbbVieChair(s): Zhiwei Zhang, FDA/CDRHSpeaker(s): Yueqin Zhao, FDA; Lei Shen, Eli Lillyand Company; Mei-Ling Lee, University of MarylandPS3fPractical Experiences Using Meta-AnalysisLincoln 6PS3bBayesian Subgroup Analysis: Opportunitiesand Challenges in Unmet Medical NeedThurgood Marshall SouthOrganizer(s): Margaret Gamalo, FDA/CDER;David Ohlssen, Novartis; Helen Zhou; Freda Cooner,FDA/CDERSpeaker(s): Satrajit Roychoudhury, Novartis;Santosh Sutradhar, Novartis; Kert Viele, BerryOrganizer(s): Anna Nevius, FDA/CVM; StevenRadecki, ASA; Ed Luo; Lisa Rodriguez, FDA/CVMChair(s): Virginia Recta, FDA/CVMSpeaker(s): Laura Hungerford, FDA/CVM; EmilySmith, FDA/CVM; Steven Radecki, ASA; JunshanQiu, FDA/CDER; Anna Nevius, FDA/CVMASA Biopharmaceutical Section Statistics Workshop 2015 13

PARALLEL SESSIONSFriday, September 188:30 a.m. – 9:45 a.m.Discussant(s): Lindsay Renfro, Mayo Clinic; LeiNie, FDA/CDERPS4ePS4aAdvancing Personalized Medicine UsingInnovative Subgroup Identification MethodsThurgood Marshall NorthOrganizer(s): Qi Tang, AbbVie; Rong (Rachel) Chu,Agensys, Inc.; Yun Wang, FDA/CDER/OTS/OB/DB5;Anna Sun, FDAChair(s): Qi Tang, AbbVieSpeaker(s): James Chen, FDA/NCTR; Wei-Yin Loh,University of Wisconsin-Madison; Xin Huang, AbbVieDiscussant(s): Lei Shen, Eli Lilly and CompanyPS4bModeling and Simulation at the FDA and inIndustry: Collaboration Among Statisticians,Modelers and PharmacometriciansThurgood Marshall SouthOrganizer(s): Cristiana Mayer, J&J; Shiowjen Lee,FDA; Alan Hartford, AbbVie; Misook Park, FDAChair(s): Cristiana Mayer, J&JSpeaker(s): Tarek Haddad , Medtronic; Rajesh Nair,FDA/CDRH; Laura Thompson, FDA; Telba Irony,FDA; Adam Himes, Medtronic Inc.; José Pinheiro, J&J;Chyi-Hung Hsu, Janssen R&D; Vikram Sinha, FDAPS4cMessy Data Issues in Evaluationof BioequivalenceThurgood Marshall EastOrganizer(s): Wanjie Sun, FDA; Stella Grosser,FDA; Mark Shiyao Liu, Mylan Inc.; Charles DiLiberti,Montclair Bioequivalence Services, LLCChair(s): Julia Jingyu Luan, FDA/CDERSpeaker(s): Wanjie Sun, FDA; Aotian Yang, GWU;Stella Grosser, FDA; Carol Kim, FDA; Charles Bon,Biostudy Solutions, LLC; Lindsey Katz, BiostudySolutions, LLCPanelists: Lisa LaVange, FDA; Yi Tsong, FDA; SheinChong Chow, Duke; Pina D’Angelo, Noum Pharmaceutical Research ServicesPS4dMeeting the Ebola ChallengeLincoln 5Organizer(s): Estelle Russek-Cohen, FDA/CBER;Deepak Khatry, MedImmune; Dionne Price, FDA/CDER; James Lymp, GenentechChair(s): Deepak Khatry, MedImmuneSpeaker(s): Ivan Chan, Merck; Kenneth Liu, Merck;Lori Dodd, NIAID; Michael Proschan, NIAIDDiscussant(s): Estelle Russek-Cohen, FDA/CBER;Dionne Price, FDA/CDERPS4fMinimizing Bias in Medical Device TrialsThrough Study Design and Data AnalysisLincoln 6Organizer(s): Laura Lu, FDA/CDRH; TheodoreLystig, Medtronic, Inc.; Chia-Wen Ko, FDAChair(s): Laura Lu, FDA/CDRHSpeaker(s): Yunling Xu, FDA/CDRH; Heng Li,FDA/CDRH/OSB; Vandana Mukhi, FDA/CDRH/OSB; Nelson Lu, FDA/CDRH; Lilly Yue, FDA/CDRH;Peter Lam, Boston Scientific; Thomas Love, CaseWestern Reserve UniversityFriday, September 1810:00 a.m. – 11:15 a.m.PS5aRecent Developments and Considerations forPersonalized Medicine: Follow-On ‘Me Too’Companion Diagnostic DevicesThurgood Marshall NorthOrganizer(s): Yuying Jin, FDA/CDRH; Laura Yee,FDA/CDRH; Alicia Toledano; Kuang-Lin He,Fujirebio Diagnostics, Inc.Chair(s): Qin Li, FDA/CDRHSpeaker(s): Xiao-Hua Zhou, University ofWashington; Yunqi Bu, University of Washington;James Ranger-Moore, Roche Tissue Diagnostics; Crystal Schemp, Roche Tissue Diagnostics; Meijuan Li, FDARecent Innovations in the Development andApplication of Statistical Designs forEarly-Phase Oncology TrialsPS5bOrganizer(s): Yuan Ji, NorthShore UniversityHealthSystem/The University of Chicago; AdamHamm, Theorem Clinical Research, Inc.; Hui Zhang,FDA; Xian ZhouChair(s): Sue-Jane Wang, FDASpeaker(s): Peter Thall, MD Anderson CancerCenter; Inna Perevozskaya, Pfizer Inc.; Linda Sun,Merck; Christine Gause, MerckOrganizer(s): Yeh-Fong Chen, FDA; HopeKnuckles, Abbott; Laura Johnson, FDA; JeffreyKrischer, University of South FloridaChair(s): Yeh-Fong Chen, FDASpeaker(s): Roy Tamura, University of SouthFlorida; Min Min, FDA; GQ Cai, GSKThurgood Marshall West14 Program Book 2015Innovative Designs and Advanced StatisticalMethodologies for Rare Disease Clinical TrialsThurgood Marshall South

PARALLEL SESSIONSPS5cRole of Statisticians in CDISC Data Standardsfrom Developers to UsersThurgood Marshall EastOrganizer(s): Weiya Zhang, FDA; Deborah Bauer,Sanofi; Stephen Wilson, FDA/CDER/OTS/OB/DBIII;Peter Mesenbrink, NovartisChair(s): Deborah Bauer, SanofiSpeaker(s): Peter Mesenbrink, Novartis; WeiyaZhang, FDAPanelists: Stephen Wilson, FDA/CDER; SusanKenny, Maximum Likelihood, Inc.; Chris Holland,Amgen; Deborah Bauer, SanofiPS5dICH E9 R1 Defining the Estimand and SensitivityAnalysisThurgood Marshall WestOrganizer(s): Estelle Russek-Cohen, FDA/CBER;Brent Burger, PAREXEL International; Guoying Sun,FDAChair(s): Joan Buenconsejo, AstraZenecaSpeaker(s): Devan Mehrotra, Merck; ThomasPermutt, FDAPS5eUsing Historical Data in Clinical Trials:Synthesis of Truth with UncertaintyLincoln 5Organizer(s): Kerri Schoedel, Alteros ResearchPartners, Inc.; Satrajit Roychoudhury, BDM Oncology,Novartis Pharmaceuticals; Pandurang Kulkarni, EliLilly and Company; Margaret Gamalo, FDA/CDERChair(s): Satrajit Roychoudhury, BDM Oncology,Novartis PharmaceuticalsSpeaker(s): Beat Neuenschwander, Novartis; JasonConnor, Berry Consultants; Kristine Broglio, BerryConsultants; Manuela Buzoianu, FDA/CDRHDiscussant(s): Sujit Ghosh, North Carolina StateUniversityPS5fAnalysis and Interpretation of Human AbusePotential Study DataLincoln 6Organizer(s): Yahui Hsueh, FDA; Hope Knuckles,Abbott; Kerri Schoedel; Chen Ling, FDAChair(s): Wei Liu, FDA/CDER/OTS/OB/DBVI;Marta Sokolowska, Grunenthal USASpeaker(s): Chen Ling, FDA; NaamaLevy-Cooperman, Altreos Research Partners; KerriSchoedel; Susan Spruill, Applied Statistics andConsultingFriday, September 1812:45 p.m. – 2:00 p.m.PS6aStatistical Considerations of DelayedTreatment Effects in Cancer Vaccine TrialsThurgood Marshall NorthOrganizer(s): Shenghui Tang, FDA; Zhenzhen Xu,FDA/CBER; Marc Buyse, IDDI Inc.; JonathanNorton, MedImmuneChair(s): Shenghui Tang, FDASpeaker(s): Zhenzhen Xu, FDA/CBER; JianliangZhang, MedImmune; Erik Pulkstenis, MedImmune;Daowen Zhang, North Carolina State UniversityPS6bDesigning Bioequivalence Studies for theEvaluation of Generic Drugs: AddressingChallenges Arising from Different Sources ofVariabilityThurgood Marshall SouthOrganizer(s): Elena Rantou, FDA/CDER; FairouzMakhlouf, FDA/CDER; CV Damaraju, Janssen R&D;Susan Huyck, MerckChair(s): Fairouz Makhlouf, FDA/CDERSpeaker(s): Charles DiLiberti, MontclairBioequivalence Services, LLC; Elena Rantou, FDA/CDER; Shein-Chung Chow, Duke UniversityPS6cSummarizing Case Studies to Learn andImprove Confirmatory Adaptive Trial Designand ImplementationThurgood Marshall EastOrganizer(s): Weili He, Merck; Paul Gallo,Novartis; Xuefeng Li, FDA/CDRH; Min (Annie) Lin,FDA/CBERChair(s): Paul Gallo, Novartis; Xuefeng Li, FDA/CDRHSpeaker(s): Eva Miller, inVentiv Health Clinical;Weili He, Merck; Paul Gallo, NovartisPanelists: Sue-Jane Wang, FDA; Greg Campbell,formerly of FDA/CDRH; Boguang Zhen, FDA/CBER;Jerry Schindler, Merck; Eva Miller, inVentiv HealthClinical; Weili He, MerckPS6dIncorporating Patient Perspectives in theMedical Product Life CycleThurgood Marshall WestOrganizer(s): Bennett Levitan, Janssen R&D; ScottBraithwaite, New York University; Telba Irony, FDA;Martin Ho, FDA/CDRHSpeaker(s): Telba Irony, FDA; Bennett Levitan,Janssen R&D; Scott Braithwaite, New YorkUniversityASA Biopharmaceutical Section Statistics Workshop 2015 15

PARALLEL SESSIONSPS6eCommon Statistical Issues FDA EncountersLincoln 5Organizer(s): Heng Li, FDA/CDRH/OSB; VandanaMukhi, FDA/CDRH/OSB; Brent Burger, PAREXELInternational; Adam Hamm, Theorem ClinicalResearch, Inc.Chair(s): Heng Li, FDA/CDRH/OSBSpeaker(s): Shiowjen Lee, FDA; Laura L.Fernandes, FDA/CDER/OTS/OB/DBV; Xu Yan, FDA/CDRH; Heng Li, FDA/CDRH/OSB; Vandana Mukhi,FDA/CDRH/OSBPS6fMissing Data in Diagnostic Device Studies:Methods and Case StudiesLincoln 6Organizer(s): Bipasa B

John Scott (FDA/CBER) Short Course Subcommittee Chris Holland (Amgen) Telba Irony (FDA/CDRH) Bret Musser (Merck) Mark Levenson (FDA/CDER) Camille Orman (Janssen) Yue Shentu (Merck) Yuqing Tang (FDA/CDRH) Roundtable Luncheon Subcommittee Freda Cooner (FDA/CDER) Rakhi Kilaru (PPD) Inna Perevozs