Michael Ward has over 15 years of experience in biomedical research and drug development. He currently works as a Senior Clinical Science Specialist at Genentech, where he helps develop clinical trial protocols and analyzes data from Alzheimer's disease studies. Prior to this role, he worked as a Senior Manager leading statistical analysis teams. Dr. Ward has extensive experience across multiple disciplines including neuropsychology, bioinformatics, data management, and clinical research.
FAIR and metadata standards - FAIRsharing and Neuroscience
MikeWard CV 7May2015
1. June 21, 2014
Michael Ward, Ph.D.
281 Cumberland St. • San Francisco, California 94114 • dharmaward@gmail.com • 415.341.3514
PROFILE
A multidisciplinary Life Science professional experienced in biomedical engineering, drug discovery and development, and
neuropsychological research. Strong aptitude and interest in bridging disciplines and work cultures, as well as promoting
interdisciplinary teamwork. Superb communication and interpersonal skills, adept at problem analysis and resolution.
o Drug discovery and development
o Clinical trial research
o Medical imaging
o Project management o Bioinformatics and DNA microarrays
o Statistics and data analysis, Scientific
Programing
o Neuropsychological evaluation and
assessment
EMPLOYMENT HISTORY
GENENTECH INC. South San Francisco, California 1999 – present
Senior Clinical Science Specialist, Clinical Science, Early Clinical Development, gRed (Sep 2012-present)
Clinical Scientist in the anti-ABeta Alzheimer’s program. anti-CMV program and other neurology programs.
• Initial development and updating of protocols, informed consent forms, investigator’s brochures, INDs, Regulatory Authority
briefing packages, internal safety reports, pharmacy manuals, safety monitoring plans, statistical analysis plans, guidances
and charters for site-level execution of protocols
• Develop and provide training to clinical sites on aspects of protocol execution and safety reporting
• Liaise with internal groups (Drug Safety, Imaging Science, Biometrics, PK/PD, Diagnostics, Toxicology, Regulatory,
Clinical Operations, Commercial; Late-stage counterparts) on tactical and strategic aspects of development programs and
protocol execution
• Develop strategy, Target Product Profiles, and Clinical Development Plans for overall drug develop programs
• Provide data management, analysis and interpretation of clinical trial and third-party data for protocol execution, program
development, and safety reporting purposes
• Monitor ongoing general safety and MRI based safety measures in clinical trials
• Processes and Initiatives: aligning with Biometrics processes, exploratory data analysis with SpotFire, Optimized and fast-to-
success Clinical Programs, Review of SOP changes
Senior Manager, Statistical Programming and Analysis (Aug 2008-Aug 2012)
Head of Genentech Early Development (gRed) group, member of gRed Biometrics Leadership Team and extended member of
Statistical Programming Analysis (SPA) Senior Leadership Team.
• Led a team of Statistical Programmer/Analysts in Phase I-Phase IV activities, including bringing new agents to humans,
multiple FDA filings, label enhancements, team building, training in biology, Journal Club, team development activities.
• Created behavioral criteria for an analyst competency within department job functions, and developed expanded role
definition for Senior SPA position.
• Key member leading creations/enhancement of department processes (machine-readable dataset specs, standard Phase I
reporting packages, standard lab data processing systems, tools for checking dataset correctness) and expanding SPA
capabilities (exploratory analysis, scientific understanding, writing of CSRs).
• Lead the Biometrics Functional Team (BFT) for the ocrelizumab MS indication.
• Recruited and managed a team of 8 experienced Statistical Programmers
Other recent initiatives and projects: Data Extraction Workgroup, Exploratory work in lymphoma, Flexible Analysis Solutions
Initiative, Biometrics PHC Goal, People & Culture Goal.
Michael Ward, Ph.D. dharmaward@gmail.com 415.341.3514 1
i.e xe
2. June 21, 2014
Neuropsychologist, Alzheimer’s Clinical Development Program (Dec 2006-present)
• Convinced the AD Clinical Development team of the need for a Neuropsychologist, and was involved in all aspects of
protocol development, clinical development plans, Intellectual Property development, and regulatory/commercial strategy
(TPP, PTS, payer perspective) for the crenezumab program
• Developed autosomal dominant program with Colombia Antioquia group, including relationship building with site and
partner, training, co-development efforts, contracts
• Developed neurocognitive measurement strategy; served as expert on suicidality measures; led instrument/training
development efforts with vendors and CROs; provided oversight on selection and training of raters
• Engaged with and contracted with KOLs, included Advisory Boards and key partners presenting crenezumab results at AAIC
and CTAD in 2014
• Developed initial bioimaging strategy for program
• Developed diagnostic verification process for ensuring appropriate patient enrollment
• Provided data management and analysis of clinical trial data for ongoing monitoring
• Lead development of programming and analysis efforts in the ADNI database
Senior Statistical Programmer/Analyst, Statistical Programming and Analysis (Jan 2006-Aug 2008)
• Programmed in SAS, Perl and other languages for data management and statistical analyses of clinical trial safety and
efficacy data
• Led efforts for departmental and Development initiatives including the creation of new job families, standardization of data
collection and analysis formats (e.g., CDISC),,production of cross-trial tumor burden datasets, development of the
Departmental User Manual, selection of the new SPA Data Model (CDISC SDTM), development of processes for DNA de-
identification, and development of databases to house clinical sample information (SPEAR).
• Developed dataset standards and TLG specification and programming standards for programming group
• Developed laboratory data analysis libraries for department; developed processes for Rave EDC data management system
• Interfaced with cross-functional teams to enhance and streamline data processes, develop new technologies and standards
• Developed methodologies for management and anonymization of genomic data
• Taught seminars on biomarkers, disease processes, and programming languages
• Served on Neurological Diagnostics team and biomedical Imaging Council
Bioinformatics Software Engineer/Analyst, Bioinformatics (Jul 1999-Mar 2005)
• Developed image processing and signal extraction systems for in-house microarray platform, validated platform with
TaqMan data
• Managed expression data (Affymetrix, Agilent, in-house platforms; managed Rosetta Resolver database) and developed
pattern extraction algorithms
• Developed and programmed algorithms for expression and sequence data: correlation analysis, entropy, clustering, multiple-
testing adjustments, supervised learning algorithms for protein receptor class predication, SNP analysis for drug response
• Created web-sites for expression data analysis and dissemination of signaling pathway information; trained scientists
Tools/Languages (partial list): BLAST, sim4, align, SNAP, genome viewers, Resolver, SpotFire, GeneSpring, SNP/mutation
analysis, multivariate/resampling/nonparametric statistics; Perl, Matlab, Partek, R, Splus, Xclust/TreeView, SAS, JMP, C, Java,
JavaScript, HTML, CGI, XML, Oracle, SQL, Unix shell scripting.
Molecular Biology databases (partial list): GeneLogic, RefSeq/Gene, LocusLink, GenBank, dbSNP, GEO, Gene Ontology,
Proteome, SwissProt, Affymetrix & Agilent annotation.
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO. San Francisco, California 2005 – 2006
Research Consultant, Department of Neurology, Memory and Aging Center
Development and scientific efforts in the analysis of structural brain changes underlying functional performance in various dementia diagnoses.
Work with volumetric-based morphology (VBM) and other structural protocols; use of SPM and other proprietary brain imaging packages.
HARVARD MEDICAL SCHOOL Cambridge, Massachusetts 1995 - 1999
Michael Ward, Ph.D. dharmaward@gmail.com 415.341.3514 2
3. June 21, 2014
BOSTON UNIVERSITY MEDICAL SCHOOL Boston, Massachusetts
Research Fellow in Psychiatry Scientific Computing System Administrator
Neuropsychological and neuroimaging (MRI, fMRI) studies in genetics of schizophrenia and alcoholism. Large-scale data collection
and management, software and methodology development, experimental design, image analysis, training. Specification, purchase,
configuration and maintenance of computer and network equipment; database design and administration; system and network
administration; software development; coordination and support of collaborations. Proprietary stimulus presentation and statistical
image processing software, C-shell, Perl, C, HTML. UNIX, Mac and PC.
MASSACHUSETTS MENTAL HEALTH CENTER Boston, Massachusetts 1996 - 1998
HARVARD MEDICAL SCHOOL Cambridge, Massachusetts
BOSTON UNIVERSITY HOSPITAL Boston, Massachusetts
Extern in Clinical Psychology and Neuropsychology
Psychodiagnostic and neuropsychological assessment, individual and group intervention, and management of patients in psychiatric
and neurological settings. Wrote evaluative reports for referring physicians and other professionals.
Additional research experience at Boston University, Harvard Medical School in data acquisition/analysis and psychological
testing.
EDUCATION
Ph.D. Psychology (Clinical Neuropsychology) Boston University
Dissertation: “A Functional MRI Study of Working Memory and Attention in Non-psychotic First-degree Relatives of Schizophrenic Patients.”
Prior graduate training in Health Psychology at UCSF
M.S. Biomedical Engineering University of Miami
Thesis: “Microcomputer Based Assessment of Autonomic Cardiac Control Using Systolic Time Intervals and Spectral Analysis of Heart Rate
Variability.”
B.S. Electrical and Computer Engineering University of California, Santa Barbara
Additional training:
Certificate in Biotechnology, University of California, Santa Cruz Extensions.
Certificate in Bioinformatics, University of California, Santa Cruz Extensions.
Ph.D. training in Health Psychology, University of California, San Francisco.
M.S. training in Biomedical Engineering, Drexel University.
B.S. training in Electrical Engineering, Worcester Polytechnic Institute.
Recent management/finance coursework in: Crucial Conversations, Situational Leadership, Conflict Resolution, Transformational
Leadership, Managing within the Law, Fastrack to Management, Making Meetings Work, Corporate Finance, Options and Other
Financial Derivatives, Management, Organizational Development.
Recent science/drug development coursework in: Drug Discovery Principles, Drug Development, Personalized Medicine,
Regulation of Medical Devices and Diagnostics, Clinical Statistics, Intellectual Property Rights in Pharmaceuticals/Biotechnology,
Bioinformatics, Microarray Data Analysis, Data Modeling and Visualization, Molecular Cell Biology, Cancer Biology, Immunology,
Developmental Biology, Protein Fundamentals, Experimental Methods in Molecular Biology, Web Design/Information Architecture.
RECENT PUBLICATIONS
J Cummings, W. Cho, M. Ward, M. Friesenhahn, F. Brunstein, L. Honigberg, D. Clayton, D. Mortensen, C. Ho, and R. Paul (2014)
Crenezumab Phase 2 Studies in Mild to Moderate Alzheimer’s Disease Clinical Results from ABBY and BLAZE. Oral presentation,
AAIC, July 16, 2014, Copenhagen.
Michael Ward, Ph.D. dharmaward@gmail.com 415.341.3514 3
4. June 21, 2014
Stephen Salloway, William Cho, David Clayton, Lee Honigberg, Christina Rabe, Michel Friesenhahn, Michael Ward, Flavia
Brunstein, Shehnaaz Suliman, Carole Ho, Robert Paul (2014). Amyloid PET Imaging Results from a Study to Evaluate the Impact of
Crenezumab on Fibrillar Amyloid in Patients with Mild-to-Moderate Alzheimer’s Disease. Oral presentation, CTAD, November 20,
2014, Philadelphia.
OTHER SKILLS, PROFESSIONAL TRAINING, AND ACCOMPLISHMENTS
• Organizational and individual development; teaching, supervising and training
• Psychological testing, diagnosis and intervention
• Process improvement, leadership and management
• 15+ additional publications and scientific presentations; some fluency in French, knowledge of Spanish
• Tau Beta Pi, Eta Kappa Nu; At various times: IEEE, APS, American Statistical Association, INS
• Stanley Fellowship from the Stanley Scholars Program (Theodore and Vada Stanley Foundation Research Programs on
Schizophrenia and Bipolar Disorders), 1998.
• Regents Fellow, UC San Francisco, 1987-88
Michael Ward, Ph.D. dharmaward@gmail.com 415.341.3514 4