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BARRY H. SCHWAB, PH.D.
EDUCATION
Ph.D. Biostatistics, Medical College of Virginia, Richmond, Virginia, 1984
B.A. Statistics, State University of New York, College at Oneonta, 1980
Undergraduate Study Abroad, Tel Aviv University, Israel (1978 – 1979) EMPLOYMENT HISTORY
1984-present
Janssen Research & Development, LLC (a J&J company)

Vice President, Clinical Biostatistics Head-Neuroscience, Pain, Established Products; additionally responsible for support from Shanghai, China office Vice President, Statistics Head – Neuroscience, Pain, Anti- Infectives/Metabolism, CV/Urology, Established Products Vice President, TA Head of Statistics – CNS, Pain & Established Products Executive Director, TA Head of Statistics – CNS & Pain Executive Director, Clinical Biostatistics & Statistical Programming Associate Director, Medical Biostatistics Assistant Director, Medical Biostatistics Manager, Medical Biostatistics, PRI-Zurich, Switzerland CURRENT JOB RESPONSIBILITIES
Responsible for statistical support of clinical programs under development for the Neuroscience, Pain, and Established Products areas of Janssen R&D. Direct a staff of approximately 50 statisticians. Provide strategic input into development plans, NDAs and WW regulatory submissions, product labeling and publications. Participate in licensing and acquisition activities. Responsible for strategy and biostatistics support from 15 staff located in our Shanghai, China office. KEY J&J ACCOMPLISHMENTS
Provided statistical expertise and strategic direction to many of J&J's investigational compounds
(contributing to numerous product approvals), including: CNS: RISPERDAL, INVEGA,
INVEGA SUSTENNA, CONCERTA, REMINYL/RAZADYNE, TOPAMAX;
Pain: NUCYNTA; Dermatology: RETIN-A, RENOVA, SPECTAZOLE; Anti-infectives:
FLOXIN, LEVAQUIN; Hem/Onc: PROCRIT/EPREX; Metabolic: REGRANEX.
BARRY H. SCHWAB, PH.D.
CURRENT PROFESSIONAL AFFILIATIONS
American Statistical Association (Corporate Member)
International Biometric Society
Drug Information Association

PROFESSIONAL ACTIVITIES/COMMITTEES

Editorial Advisory Board Member of Pharmaceutical Statistics, The Journal for Applied Statisticians in the Pharmaceutical Industry, 2002-present. Provide peer review of articles submitted for publication. FDA/DIA Statistics Forum Served as the Pharmaceutical Industry Co-Chair for the 1st (March 2007) through 6th (April 2012) annual meetings of the FDA/DIA Statistics Forum. Worked closely with my FDA Co-Chair (Dr. Steve Wilson) and DIA to create this forum to address statistical and regulatory issues associated with the development and review of therapeutic drugs and biologics. Past program topics focused on: emerging draft guidances per PDUFA-IV (multiplicity, non-inferiority and adaptive designs); missing data; statistical graphics; drug safety evaluation; regulatory and statistical challenges in the design and analysis of clinical trials. DIA Workshops on “Statistical Methodology in the Biopharmaceutical Sciences” 2004-2006: Program Committee Member and Session Chair (topics included Proof-of-Concept Studies; Missing Data). American Statistical Association – FDA/Industry Workshops, Washington D.C. 2004-2006: Steering Committee Member and Session Chair (topics included Data Monitoring Committees; Bridging Studies; Evolving Data Standards). BASS Applied Statistics Symposium, Savannah, GA 2005-present: Organizing Committee Member and Session Chair. PhRMA/FDA Biostatistics & Data Management Workshops 2003 – Served as the Meeting Chair for the workshop entitled: “Risk Detection, Management and Communication: Quantitative Perspectives.” The keynote speaker for the workshop was FDA Commissioner Mark McClellan. 2002 - Roundtable facilitator on IDMCs at visitation with FDA’s Office of Biostatistics 2001 - Session Chair on IDMCs and Adaptive Clinical Trial Designs 2000 - Session Chair on Randomization Methods PhRMA Biostatistics and Data Management Technical Group (BDMTG) Served 3-year term as an elected member (2000-2002); served as Recorder and BDMTG liaison to other groups including: Information Management Policy & Affairs Coordinating Committee (IMPACC), Japanese Pharmaceutical Manufacturers Association Statistics Working Group and VFA Biometrics Project Group (Germany). BARRY H. SCHWAB, PH.D.
PUBLICATIONS

Liu, Q., Lim, P., Singh, J., Lewin, D., Schwab, B., and Kent, J. (2012). Doubly-randomized
delayed-start design for enrichment studies with responders or non-responders. Manuscript submitted
for publication.

Perry, B.H., Sampson, A.R., Schwab, B.H., Karim, M.R. and Smiell, J.M. (2002). A Meta-Analytic
Approach to an Integrated Summary of Efficacy: A Case Study of Becaplermin Gel. Controlled
Clinical Trials 23, 389-408.
Smiell, J.M., Wieman, J., Steed, D.L., Perry, B.H., Sampson, A.R., and Schwab, B.H. (1999).
Efficacy and safety of becaplermin (rhPDGF-BB) in patients with non-healing, lower extremity
diabetic ulcers: a combined analysis of four randomized studies. Wound Repair and
Regeneration 7, 335-346.
Boateng, F., Sampson, A., and Schwab, B.H. (1996). Statistical analysis of possible bias of clinical
judgments due to observing an on-therapy marker variable. Statistics in Medicine 15, 1747-1755.
Bhawan, J., Olsen, E., Lufrano, L., Thorne, E.G., Schwab, B.H., and Gilchrest, B.A. (1996).
Histologic evaluation of the long-term effects of tretinoin on photodamaged skin. Journal of
Dermatological Science 11, 177-182.

Grove, G.L., Grove, M.J., Leyden, J.J., Lufrano, L., Schwab, B.H., Perry, B.H., and Thorne, E.G.
(1991). Skin replica analysis of photodamaged skin after therapy with tretinoin emollient cream.
Journal of the American Academy of Dermatology 25, 231-237.
Chinchilli, V.M., Schwab, B.H., and Sen, P.K. (1989). Inference based on ranks for the multiple-
design multivariate linear model. JASA 84, 517-524.
Abbey, L.M., Schwab, B.H., Landau, G.C., and Perkins, R.E. (1984). Incidence of second primary
breast cancer among patients with a first primary salivary gland tumor. Cancer 54, 1439-1442.
SELECT PRESENTATIONS
Liu, Q, Lim, P, Schwab, B, and Singh, J. Doubly-randomized delayed-start design with applications to anti-depressant drug development. Biopharmaceutical Applied Statistics Symposium (BASS) XVII , Hilton Head, SC, November. 8, 2010. Schwab, B.H. Technical and Soft Skills for Success. Presented at the Sino-American Pharmaceutical Professionals Association (SAPA) Clinical Programming Workshop, Princeton University, Princeton, NJ, October 10, 2009. Schwab, B.H. The Role of the Statistical Analysis Plan in Confirmatory Clinical Trials. Presented this tutorial as a member of the faculty of the American Course on Drug Development and Regulatory Sciences, University of California San Francisco’s Washington Center, Washington, D.C., September 9, 2008. BARRY H. SCHWAB, PH.D.
Schwab, B.H. Statistics in the Pharmaceutical Industry and Career Opportunities at Johnson &
Johnson. Invited talk given to the Graduate Statistics Department at The Ohio State University,
February 10, 2005.
Schwab, B.H. Data Monitoring Committees: Industry Perspectives. Presented at the PhRMA
Visitation at the U.S.FDA, Rockville, Maryland, October, 2002.
Schwab, B.H. Industry Perspectives on Data Safety Monitoring Boards. Presented at the PhRMA
Visitation at U.S.FDA, Rockville, Maryland, October, 2001.
Smiell, J.M., Perry, B.H., Sampson, A.R., Schwab, B.H., and Sullivan, D.J. The role of meta-
analysis in wound healing clinical research. First World Wound Healing Congress, Melbourne,
Australia, 2000.
Thorne, E.G., Lufrano, L., Boateng, F., Perry, B.H., Sampson, A.R., Pledger, G., Schwab, B.H., and
Bryant, E.C. The relationship between irritation and improvement in photodamaged skin in studies
of tretinoin emollient cream. American Academy of Dermatology 51st Annual Meeting, San
Francisco, California, 1992.
Thorne, E.G., Lufrano, L., Worobec, S.M., Schwab, B.H., Perry, B.H., and Shaw, S. Maintenance of
improvement in photodamaged skin with long-term topical tretinoin treatment. American Academy
of Dermatology 50th Annual Meeting, Dallas, Texas, 1991.
Schwab, B.H. Nonparametric analysis of the multiple design multivariate linear model. Biometric
Society Spring Meeting, Raleigh, North Carolina, 1985.
Schwab, B.H. The multiple design multivariate linear model. The Virginia Academy of Science 61st
Annual Meeting, Fairfax, Virginia, 1983.
Hamer, R.M. and Schwab, B.H. Analysis of effects on variances using GLM. The SAS Users group
International Annual Meeting, San Francisco, California, 1982.
Hamer, R.M. and Schwab, B.H. Hierarchical cluster analysis with multiple subjects. The
Psychometric Society Spring Meeting, Chapel Hill, North Carolina, 1981.

Source: http://www.biostatistics.vcu.edu/files/2012/10/Barry-CV-2012.pdf

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