*

CURRICULUM VITAE

Date Prepared: November *, **23

Name: Eiji Ishida

Home Address: **** ********** **, ********, ** 75071 Contact Phone: 703-***-**** (Mobile)

Contact Email: ad0t2h@r.postjobfree.com

SUMMARY

• 7+ years of pharmaceutical industry experience in registration clinical trials early and late phase o CRO and internal management experiences

• 13+ years of FDA primary reviewer and regulatory researh experience

• Therapeutic areas include (not limited to): Psychiatry, Neurology, Immunology, Nephrology, Cardiology, Respirology

• Strong skills in multiplicity adjustment methods, regulatorily applicable in clinical trial designs

(including adaptive design, group sequential design in the context of accelerated approval)

• Solid backgrounds in innovative design for a challenging trial in pediatric and/or rare diseases

• Specific Research areas of interest: Treatment Switch (including crossover and re-randomization), constrained Longitudinal Data Analysis (cLDA), An extension of Enhanced Mixture-based Multiplicity Adjustment method for accelerated approval scheme, Estimand and Causal Inference

• More than a decade of regulatory NDA/BLA review experience (very recent rare disease

(immunology) review experiences included) at FDA

• IND review experience to provide sponsors with regulatory guidance on proposed design and analysis, over a decade as primary statistical reviewer at FDA

• 4+ years of project statistician experience

• Excellent interpersonal skills, written and presentation HIGHLIGHTS ON RECENT CONTRIBUTIONS

• Amended Multiplicity Adjustment Method by increasing success chance using Enhanced Mixture- based Gatekeeping approach (uniformly less conservative multiple testing procedure than its Stepwise Testing Algorithm application) for a pivotal Phase 3 trial

• Supported FDA regulatory decision by providing a new application of Bayesian method for BLA trial of mixed rare disease populations of Juvenile Idiopathic Arthritis PROFESSIONAL EXPERIENCE

2

Director (Biostatistics)

Insmed Incorporated

• Serving as project statistician for first-in-patient phase 2 trial o Improve design and analysis (propose phase 2 adaptation and increase power with enhanced mixture method)

o Increase success chance using a less conservative approach using enhanced mixture method for a pivotal phase 3 registration trial o Manage CRO management (randomization, eCRF, DMC, data management edits, other biometrics operations)

o Manage CRO service budget approval process

• Developing regulatorily applicable innovative design for phase 3 trials February 2023

– present

Senior Director (Biostatistics)

Sunovion Pharmaceuticals Inc

• Served as project statistician for first-in-patient phase 2 trial o Provided statistical responses to FDA’s comments regarding estimand and primary analysis

o Provided leadership in methodological and analysis development for NDA submission (SAP)

o Managed CRO management (randomization, eCRF, DMC, data management edits. Other biometrics operations)

• Provided supervisory guidance for early phase trials such as QT study, PK/PD studies

o Developed primary analysis for estimand with composite variable strategy

o Gave guidance to project company and CRO statisticians for randomization, analysis, etc

• Developed regulatorily applicable innovative design March 2022

– February 2023

Mathematical Statistician (Staff Fellow)

Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Biostatistics

Primary Statistical Reviewer, Division of Biometrics II (Pediatric Team), Division of Biometrics I (Psychiatry Products Team), Division of Biometrics VI (Carcinogenicity, QT and Drug Safety Review Teams)

• Served 10 years as Primary Statistical Reviewer for NDAs/BLAs and IND Applications (Phases 2 & 3 Efficacy and Safety Trials) o Reviewed NDA in Psychiatry and Neurology (9 years) and BLA in Pediatric Immunology Rare Disease (1 year)

o Reviewed IND Applications for efficacy and safety clinical trials of disease areas above mentioned

• Served 1+ year as Safety Statistical Reviewer for New Drug Safety

• Served 2 years as Primary Statistical Reviewer for Animal Carcinogenicity, QT

(Thorough QT and concentration QT)

• Conducted research in statistical methodologies in multiplicity adjustments, missing data and estimand, crossover design

September 2008

– March 2022

3

Biostatistician/Manager

Otsuka Pharmaceutical Co. Ltd. Japan & Otsuka Pharmaceutical Development Company USA

• Served as Project Statistician in Parkinson’s Disease project (phase 2 trial conducted in Japan) and in early phase studies

• QC statistician for NDA submission

• Evaluated clinical trial data of a company to assist license in of a compound

• Provided statistical method for bridging efficacy data from US to Japan February 2002

– August 2008

Data Manager, SAS Programmer and Statistician

University of Iowa College of Medicine Psychiatric Research (Collaborative Study on Genetics of Alcoholism)

August 2000

– July 2002

Graduate Teaching Assistant

University of Iowa, College of Liberal Arts and Sciences and College of Business September 1996

– July 2000

Advisory Committee Meetings

• Advisory Committee Cardiology and Nephrology Drugs, December 8, 2021

• Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM), October 9, 2020

• Advisory Committee PDAC Meeting, March 29, 2016

• Joint Meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committee, December 8, 2009

EDUCATION

George Mason University, Fairfax, VA

PhD Candidacy in

Statistical Science

2011

University of Iowa, Iowa City, IA MS in Statistics December 2000 University of New South Wales,

Kensington, Australia

Graduate Diploma in

Business Statistics

May 1996

Tohoku University, Sendai, Japan Bachelor of Economics March 1987 PUBLICATIONS

• Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges; Journal of Biopharmaceutical Statistics 2022 (Accepted 29 Nov 2022, Published online: 21 Dec 2022), Youn Jeong Choi, Nathalie Barbier, Sabine Fürst-Recktenwald, Jingjing Ye, Dalia Ballas Wajsbrot, Eiji Ishida and Margaret Gamalo 4

• Statistical power considerations in the use of win ratio in cardiovascular outcome trials; Contemporary Clinical Trials 2022 (Accepted 1 December 2022 Available online 5 December 2022), Bang Wang, Dali Zhou, Jialu Zhang, Yoonhee Kim, Ling-Wan Chen, Preston Dunnmon, Steven Bai, Ququan Liu, Eiji Ishida

• Mixture-Based Gatekeeping Procedures in Adaptive Clinical Trials; Journal of Biopharmaceutical Statistics 2018, Vol.28(1):129-145, George Kordzakhia; Alex Dmitrienko; Eiji Ishida

• An Enhanced Mixture Method for Constructing Gatekeeping Procedures in Clinical Trials; Journal of Biopharmaceutical Statistics 2018, Vol.28(1):113-128, George Kordzakhia; Thomas Brechenmacher; Eiji Ishida; Alex Dmitrienko; Winston Zheng; David Fuyuan Li

• Summary of Findings From the FDA Regulatory Science Forum on Measuring Sexual Dysfunction in Depression Trials (Review Article); J Clin Psychiatry 2015;76(8):1050–1059, Phillip D. Kronstein, Eiji Ishida, Ni A. Khin, Eric Chang, H. M. James Hung, Robert J. Temple, and Peiling Yang

• Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials (Consensus Statement); J Clin Psychiatry 2015;76(8):1060–1063, Ni A. Khin, Phillip D. Kronstein, Peiling Yang, Eiji Ishida, H. M. James Hung, Mitchell V. Mathis, Ellis F. Unger and Robert J. Temple

OTHER ACTIVITIES

Contributions to Academic Working Groups, Meetings and Presentations Contributions to Academic Working Groups, Meetings and Presentations: Life Time Data Science Conference, May 31 – June 2, 2023

• Invited Speaker (Topic: An illustrative application of an extended enhanced gatekeeping method in a two-stage design with a hierarchical testing structure “modified” after an interim analysis) ICSA Applied Statistics Symposium, June 11-14, 2023

• Organizer: Clinical Trial Designs Involving Multiple Stages and Re-Randomization Beyond Traditional Randomization

ISCTM Autumn Conference, September 2022

• Poster presentation (Topic: Baseline measurements in a study designed with Treatment Switch) Joint Statistical Meeting, August 8, 2021

• Invited Speaker (Topic: Missing data and Sensitivity Analysis) ASA Biopharmaceutical Section Scientific Working Group/Statistics in Pediatric Drug Development

• Activities in Research for Pediatric Efficacy and Safety Clinical Trial

• A coauthored article on Pediatric Safety Data Statistical Analysis to be submitted March 2022 5

ICSA Applied Statistics Symposium, December 15, 2020

• Invited Speaker (Topic: Treatment Switch and Crossover Design) ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, September 22-25, 2020

• Organizer: Novel methods of time-to-event analysis and clinical trial designs (Restricted Mean Survival Time and Use of Win Ratio in clinical trials) International Symposium on Biopharmaceutical Statistics, August 26, 2019

• Collaborated Presentation (Topic: An enhanced mixture method for constructing gatekeeping procedures in clinical trials) (Collaborated with George Kordzakhia, Thomas Brechenmacher, Alex Dmitrienko)

ICSA Applied Statistics Symposium, June 14, 2016

• Invited Speaker (Topic: Placebo Effects and Sequential Parallel Comparison Design) Joint Statistical Meeting, August 11, 2015

• Collaborated Presentation (Topic: General Mixture-Based Gatekeeping Procedures in an Adaptive-Design Setting) (Collaborated with George Kordzakhia, Thomas Brechenmacher, Alex Dmitrienko)

Qualitative and Quantitative Assessments, SCT/FDA Benefit-Risk Workshop, October 22, 2013

• Chairperson for Regulatory Background and Industry Response Session Regulatory Science Forum, August 2012

• FDA – Industry – Academia Research (Topic: Sexual Dysfunction in MDD trials) Journal Referees

• Served as referee of draft articles (requested by Statistics in Medicine/Journal of Biopharmaceutical Statistics), on the following topics: Sequential Parallel Comparison Design, Multi-regional clinical trials, Heterogeneity and Treatment-by-subset interaction, Individualized Minimal Clinically Important Difference, Power for Simultaneous assessment of Consistent Treatment Effect, 2-Stage Adaptive Design in Oncology trial, Win Ratio, etc.

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