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.
POSTOPERATIVE CARE INSTRUCTIONS FOR: _____________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________ Date: The following medications might have been prescribed and are to
Evaluation of media and test kits for the detection and isolation of Escherichia coli O157 from cattle faeces A.V. Tutenel, L. De Zutter and J. Van Hoof Department of Veterinary Food Inspection and Public Health, Faculty of Veterinary Medicine, RUG, Salisburylaan 133, B-9840, Belgium Presented at the symposium: ”Escherichia coli: friend and foe” at the University of Yor