Hugh Davis CV Mar 2015

Hugh M. Davis, Ph.D.

1106 Aurora Drive Home: 610-873-9681West Chester, PA 19380 Cell: 484-431-8137Email: [email protected]

SUMMARY:

Over thirty years of Research, Development, Management, and Leadership Experience in the Pharmaceutical and Biotechnology Industries in Discovery Research, Toxicology, Biomarker & Translational Research, Clinical Pharmacology, and Project and People Management. Established Record in Building Organizations and Teams, Making Decisions and Executing Research and Clinical Programs with Creativity, Vision and Always with Attention to Efficiency, Quality and Productivity.

PROFESSIONAL EXPERIENCE:

JANSSEN RESEARCH & DEVELOPMENT, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson. Formerly, CENTOCOR RESEARCH & DEVELOPMENT, INC. (2001-Present)

Vice President and Head, Biologics Clinical Pharmacology and China Biologics Leader, Biotechnology Center of Excellence (Jan 2015- Present)

In addition to the responsibilities of the Head of Biologics Clinical Pharmacology position indicated below, also leading the development of biologics in China and Emerging Markets for the Biotechnology CoE and Janssen R&D.

Functionally, Co-Chair, with the Head of Asia R&D, the Emerging Biologic Markets Strategy Governance

Board within Janssen R&D, responsible for portfolio, budget, personnel and alliance strategy Developing biologics expert workforce in China to support New Molecular Entity portfolio Alliance partner assessment for establishing a domestic development plan network

Vice President and Head of Biologics Clinical Pharmacology (Jan 2008 – Dec 2014)

Reporting to the Chief Biotechnology Officer of Johnson & Johnson in the Biotechnology Center of Excellence, manage all aspects of the Biologics Clinical Pharmacology department, including Pharmacokinetics (PK) Bioanalysis, Immune Response Assessment and Research, PK Modeling and Simulation. GLP Compliance, and Scientific Systems, Process and Project management. Responsible for all administrative aspects of the department including people management, budget setting and review, objective setting, and project management. Responsible for a department budget of more than $35 MM and for management and leadership of approximately 130 employees.

Functionally, Chair, First-in-Human Readiness Committee, composed of members from Discovery Research, Toxicology, Clinical Pharmacology Translational Medicine and Pharmaceutical Development,

proactively designing and executing late Discovery/early Development programs to generate high quality FIH regulatory packages.

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Vice Chair, Clinical Pharmacology Center of Expertise Co-Chair, Global J&J Bioanalytical Leadership Team

Additionally, member of: Biotechnology Advisory Council Joint Discovery and Early Development Council Drug Safety Sciences Global Leadership Team Quantitative Sciences Global Leadership Team Scientific Advisory Board, Centyrex, Inc. Ad Hoc Member of Immunology and Oncology Review Boards Heart Failure and Diabetes Disease Area Leadership Teams Protocol Review Committee, Oncology & Immunology Therapeutic Areas Joint Discovery and Early Development Council Japan Development Management Committee

AWARDS AND RECOGNITION:

Standard of Leadership Awards:

For Outstanding Contribution to the Development and Approval of Stelara, nominated by Jerry Boscia, Head of Immunology Clinical Development, March 2010

For the Contribution to the Analysis and Design of the New Model-Based Drug Development Group, nominated by Martin Fitchet, Chief Operating Officer, J&J, July 2011

For Outstanding Leadership, Preparation and Participation in the FDA Advisory Committee Meeting which Resulted in the Approval of Remicade in the Treatment of Pediatric Ulcerative Colitis, nominated by Jerry Boscia, Head of Immunology Clinical Development, Sept., 2011

For the Vision, Drive and Execution of the Biologics Program for China R&D, nominated by Jay Siegel, Chief Biotechnology Officer, J&J, February 2012

Leadership Activities and Programs:

Ambassador for the Biotechnology Center of Excellence for the Leadership Imperatives Initiative in Janssen R&D, 2012

Nominated to and currently enrolled in the Accelerate Enterprise Leadership cross-sector program to enhance leadership capabilities, develop global partnerships, lead change internally that engages the broad organization and deliver growth and stimulate innovation, 2013

Vice President, Clinical Pharmacology & Experimental Medicine and Clinical Project Management Office (Feb 2006-Jan 2008)

Reporting to the Sr. Vice President, Clinical R&D, managed all aspects of the Clinical Pharmacology & Experimental Medicine Department and Clinical Project Management Organization, including clinical trial design and execution of experimental medicine approaches and early phase clinical studies including first-in-human and proof-of-principle studies, evaluation and analysis, immune response assessment and all administrative issues such as people management (~185 staff), budgeting (over $25 MM department budget), objective setting, human resourcing, project management, and compliance. Managed all aspects of project and resource management for Clinical Research and Development.

AAPS, National Biotechnology Conference, Biotec Section Programming Committee

Vice President, Clinical Pharmacology & Experimental Medicine(Feb 2005-Jan 2006)

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Executive Director, Clinical Pharmacology (Mar 2004-Feb 2005)Pharmacokinetics, Pharmacodynamics and Immune Response

Senior Director, Clinical Pharmacology (Mar 2002-Feb 2004) Pharmacokinetics and Pharmacodynamics

Director, Clinical Pharmacology (Feb 2001-Feb 2002)

GLAXOSMITHKLINE (2000-2001)SMITHKLINE BEECHAM PHARMACEUTICALS (1996-2000)

Global Head of the Pharmacodynamics and Exploratory Research Laboratory (PERL)

Associate Director, Clinical Pharmacology (Aug 2998-Feb 2002)

Assistant Director, Clinical Pharmacology (Jun 1996-Aug 1998)

Directed a staff of sixteen Doctorate and Master’s level scientific staff in the development and validation of pharmacodynamic biomarker assays to be used in the evaluation of compounds in early and late-phase clinical studies in the therapeutic areas of cardiovascular, inflammation, bone metabolism and pulmonary medicine.

SELECTED ACCOMPLISHMENTS: Provided justification to senior management groups that resulted in funding for capital

buildingexpansion/renovation of existing site, for capital equipment purchases totaling over $800,000 and to obtain headcount to initiate laboratory studies. Maintain operating budget of approximately $.25 million.

Established a Worldwide pharmacodynamics group within SmithKline Beecham involving sites within both the US and UK Clinical Pharmacology Units and the R&D sites in the US.

Developed collaborations within and outside of SmithKline Beecham that expanded the scope of the projects within the PERL to include both early phase and phase II/III clinical development in the US, UK and Belgium vaccines group

Extended Discovery-Development Interfacing to allow for a more efficient transfer of projects from Discovery into Clinical Development

Developed collaborations with the National Esoteric Testing Center and diaDexus for the commercial development of assays developed with the PERL

Maintained the PERL to GLP Standards Was responsible for determining budgets for 22 multiple competing projects from all therapeutic

disciplines within the US Discovery group, including cardiovascular, inflammation, bone metabolism, anti-infectives pulmonary, obesity and diabetes

RHONE-POULENC RORER (1991-1996)

Section Manager, Bone Metabolism Department

Directed the In VitroBone Metabolism Research group of five people in the identification of novel mitogenic and differentiation factors for cells in the osteoblastic lineage.

SELECTED ACCOMPLISHMENTS: Evaluated and recommended collaborations for the Bone Research Group.

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Served on a panel for the evaluation of in-licensing new technologies/products. Contributing author on a manuscript describing the discovery of a novel human calcium sensor protein associated with parathyroid carcinoma that has the potential for signal transduction that

may be involved in hyperparathyroidism and osteoporosis. Product support of Monoclate® and Mononine® helped result in heat-treated and pasteurized

product line extensions. Administered a $1.7 million operating budget and a capital budget of $140,000. Supervised Radiation Safety office.

RHONE-POULENC RORER (1988-1990)

Senior Research Scientist, Immunochemistry

Directed the Immunochemistry Group Research and In-process Deelopment projects. Supported clinical studies of Monoclate® and Mononine® . Developed whole-cell assays and immunoassays for the support of projects such as calcitonin, bisphosphonate-estrogen conjugates and recombinant von Willebrand factor peptide.

SELECTED ACCOMPLISHMENTS: Performed GLP safety studies in the development of a novel anti-thrombotic protein. Member of a biotechnology project team that facilitated the release of a clinical hold by the

FDA.

CENTOCOR (1985-1988)

Research Scientist (1986-1988)

Developed immunodiagnostic serum assays for cancer antigens and virus envelope proteins. Responsible for expanding the Immunochemistry section to include whole-cell assays to measure analyte activity.

SELECTED ACCOMPLISHMENTS: Acted as liaison to the FDA during PMA submission. Conducted the transfer of the CA125 Immunodiagnostic assay from Research and Development

into production Supervised the training of technical staff and writing of documents to bring a new antibody manufacturing facility on-line in Leiden, Netherlands. Patent application: Purified anti-Endotoxin antibody filed August 1987,

Post-doctoral Research Fellow (1985-1986)

Performed independent research leading to the characterization of the ovarian tumor associated antigen CA-125 that led to the FDA approval of the CA 125 Immunodiagnostic assay for the second-look monitoring for ovarian cancer.

SELECTED ACCOMPLISHMENTS: Performed immunoassay kit development and validation under GLP guidelines. Approved patent (October 22, 1991): Method of isolating CA 125 antigen, Number 5,059,680

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TEACHING EXPERIENCE:

VILLANOVA UNIVERSITY (1984-present)

Adjunct Faculty, Chemistry Department

Conduct lecture and laboratory instruction in General, Organic and Biochemistry for students in Allied Health majors.

IMMACULATA UNIVERSITY (1988-1990)

Part-time Faculty, Chemistry Department

Taught lecture and laboratory section of Chemistry to Allied Health students

THOMAS JEFFERSON UNIVERSITY (1985)

Part-Time Faculty, Allied Health Department

Taught lecture and laboratory section of Chemistry to Allied Health majors, including Medical Technology, Nursing, and Nutrition.

DELAWARE COUNTY COMMUNITY COLLEGE (1983-1986)

Part-time Faculty, Science Department

Taught Chemistry lecture and laboratory sections and College Physics

EDUCATION:

Ph.D., Biochemistry, Villanova University, Villanova, PA (1985)Thesis Title: Structural Elucidation of a water-insoluble glucan produced by the glucosyltransferase of Streptococcus mutans 6715, by Chemical and Instrumental methods.

M.S., Biochemistry, Villanova University, Villanova, PA (1983)

B.S., Chemistry, Gannon University, Erie, PA (1979)

REVIEWER:

British Journal of PharmacologyClinical Pharmacology and TherapeuticsInvestigational New Drugs

MEMBERSHIPS:

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ASCPT, ACCP, AAPS, and DIA

U.S. PATENTS:

Hugh M. Davis, Thomas L. Klug and Vincent R. Zurawski, Jr., Method of Isolating CA 125 Antigen, Approved October 22, 1991, No. 5,059,680.

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PUBLICATIONS

Y Zhu, G Shankar, N Yeilding, P Szapary, H Zhou and HM Davis, Ustekinumab: Immunogenicity Assessment and Clinical Relevance in Patients with Moderate-to-Severe Plaque Psoriasis, Brit. J. Pharmacol, (in preparation).

Xu Z, Davis HM and Zhou H. Clinical impact of concomitant immunomodulators on biologic therapy:  pharmacokinetics, immunogenicity, efficacy and safety. J Clin Pharmacol, 2015; in press.

Nnane, I, Xu, Z, Zhou, H and Davis, HM, Nonclinical Pharmacokinetics, Prediction of Human Pharmacokinetics and First-in-Human Dose Selection for CNTO 5825, an Anti-Interleukin-13 Monoclonal Antibody, Basic & Clin. Pharmacol & Toxicol., Accepted for publication, Feb 2015.

Xu Z, Marciniak SJ Jr, Frederick B, Kim L, Zhuang Y, Davis HM, Zhou H. Pharmacokinetic Bridging Approach for Developing Biologics-Delivery Devices: A Case Study With a Golimumab Autoinjector. Clin Ther. 2014 Oct 29. pii: S0149-2918(14)00604-3. doi: 10.1016/j.clinthera.2014.09.012.

Adedokun OJ, Sandborn WJ, Feagan BG, Rutgeerts P, Xu Z, Marano CW, Johanns J, Zhou H, Davis HM, Cornillie F, Reinisch W. Association Between Serum Concentration of Infliximab and Efficacy in Adult Patients with Ulcerative Colitis. Gastroenterology. 2014 Aug 27. pii: S0016-5085.

Han C, McIntosh TS, Geist BJ, Jiao T, Puchalski TA, Goldberg KM, Yang TY, Pendley CE, Zhou H, Davis HM. A novel approach to evaluate the pharmacokinetic biocomparability of a monoclonal antibody derived from two different cell lines using simultaneous crossover design. AAPS J. 2014 Jan;16(1):125-8.

Wang W, Wang X, Doddareddy R, Fink D, McIntosh T, Davis HM, Zhou H. Mechanistic pharmacokinetic/target engagement/pharmacodynamic (PK/TE/PD) modeling in deciphering interplay between a monoclonal antibody and its soluble target in cynomolgus monkeys. AAPS J. 2014 Jan;16(1):129-39.

OJ Adedokun, Z Xu, L Damaraju, M Blank, J Johanns, A Griffiths, J Ford, H Zhou, C Guzzo, HM Davis and J Hyams, Pharmacokinetics of Infliximab in Children with Moderate-to-Severe Ulcerative Colitis,: Results from a Randomized, Multi-Center, Open-Label, Phase 3 Study, Inflam.Bowel Diseases, 2013; 19(13), 2753-62.

Y Zhuang, S Lyn, Z Xu, E Bouman-Thio, T Masterson, JA Ford, M Keen, Y Li, KJ Petty, HM Davis and H Zhou, Pharmacokinetics and Safety of Golimumab in Healthy Chinese Subjects Following a Single Subcutaneous Administration, Clin Drug Invest, DOI: 10.1007/s40261-013-0124-7, August 2013.

BJ Geist, D Davis, T McIntosh, T-Y, Yang, K Goldberg, C Han, C Pendley and HM Davis, A Novel Approach for the Simultaneous Quantification of a Therapeutic Monoclonal Antibody in Serum Produced from Two Distinct Host Cell Lines, mAbs, 5(1), 150-161, 2013.

Zhu Y, Wang Q, Frederick B, Bouman-Thio E, Marini JC, Keen M, Petty KJ, Davis HM, Zhou H. Comparison of the Pharmacokinetics of Subcutaneous Ustekinumab between Chinese and Non-Chinese Healthy Male Subjects across Two Phase 1 Studies. Clin Drug Investig. DOI 10.1007/s40261-013-0072-2, 2013.

Y. Zhuang, Z. Xu, D.E. de Vries, Q. Wang, A. Shishido, C. Comisar, J.A. Ford, M. Keen, M. Achira, Y. Tsukamoto, K.J. Petty, H.M. Davis and H. Zhou, Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects, Int. J of Clin Pharmacol and Ther, DOI 10.5414/CP201785, Jan 29, 2013.

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Xu, Z, Davis, HM and Zhou, H, Rational Development and Utilization of Antibody-Based Therapeutic Proteins in Pediatrics, Pharmacology and Therapeutics, 137, 225-247, 2013.

Y Zhu, Q Wang, B Frederick, E Bouman-Thio, JC Marini, M Keen, KJ Petty, HM Davis and H Zhou, Comparison of the Pharmacokinetics of Subcutaneous Ustekinumab between Chinese and Non-Chinese Healthy Male Subjects across Two Phase 1 Studies, Clin Drug Invest, DOI 10.1007/s40261-013-0072-2, March 20, 2013.

B van Hartingsveldt, IP Nnane, E Bouman-Thio, MJ Loza, A Piantone, HM Davis and KJ Petty, Safety, tolerability and pharmacokinetics of a human anti-IL-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study, Br. J. Clin Pharmacol, 2012 Oct 8 doi: 10.1111/j.1365-2125.2012.04477.x, 75 (5), 1289-1298, 2013.

H Zhou, Y Tsukamoto and HM Davis, Should Clinical Pharmacokinetic Bridging Studies Between Caucasian and Asian Populations Be Required for Approval of Monoclonal Antibodies?, J Clin Pharmacol, 52, 1273-1276, 2012.

Y. Zhuang, Z. Xu, B. Frederick, DE. de Vries, J. Ford, M. Keen, MK. Doyle, KJ. Petty, HM. Davis, H. Zhou. Golimumab Pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study. Clin Therapeutics 2012; Jan 34(1): 77-90.

JL Goldman, HM Davis, H Zhou and GL Kearns, Infliximab Plasma Clearance in Children: Potential Association with Resting Energy Expenditure, Annals of Paediatric Rheumatology, 1(2), 120-125, 2012.

Gerald J Fetterly, Urvi Aras, Patricia D Zagst, Chris Takimoto, Shobha Seetharam, Thomas McIntosh, Johann S de Bono, Shahneen K Sandhu, Anthony Tolcher, Hugh M Davis, Honghui Zhou, Thomas A Puchalski, Utilizing Mechanistic Pharmacokinetics/Pharmacodynamics Modeling to Simultaneously Examine Free CCL2, Total CCL2 and Carlumab (CNTO 888) Serum Concentration Time, J. Clin. Pharmacol, 2012; 52, 1755-1763.

Hu C, Yeilding N, Davis HM, Zhou H. Bounded outcome score modeling: application to treating psoriasis with ustekinumab. J Pharmacokinet Pharmacodyn. 2011 Aug;38(4):497-517. doi: 10.1007/s10928-011-9205-5. Epub 2011 Jun 18.

AA Fasanmade, OJ Adedokun, M Blank, H Zhou and HM Davis, Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn’s Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials, Clinical Therapeutics, 33 (7), 946-964, 2011.

C Hu, Z Xu, Y Zhang, M Rahman, HM Davis and H Zhou, A Population Approach for Exposure-Response Modeling of Golimumab in Patients with Rheumatoid Arthritis, J Clin Pharmacol, 51(5):639-48, 2011.

Z Xu, E Bouman-Thio, C Comisar, B Frederick, B Van Hartingsveldt, JC Marini,HM Davis and H Zhou. Pharmacokinetics, Pharmacodynamics, and Safety of a HumanAnti-IL-6 Monoclonal Antibody (Sirukumab) in Healthy Subjects in a First-in-Human Study, Br J Clin Pharmacol. Aug;72(2):270-81, 2011.

YW Zhu, A Mendelsohn, C Pendley, HM Davis and H Zhou, Population pharmacokinetics of ustekinumab in patients with active psoriatic arthritis, Int J Clin Phar Ther, 48 (12), 830-846, 2010.

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JF Rossi, S Ne’grier, ND James, I Kocak, R Hawkings, HM Davis, U Prabhakar, X Qin, P Mulders and B Berns, A Phase I/II Study of Siltuximab (CNTO 328), an Anti-Interleukin-6 Monoclonal Antibody, in Metastatic Renal Cell Cancer, Brit J Cancer, 1-9, 2010.

Z Xu, H Lee, T Vu, C Hu, H Yan, D Baker, B Hsu, C Pendley, C Wagner, H.M. Davis, and H Zhou, Population Pharmacokinetics of Golimumab in Patients with Ankylosing Spondylitis: Impact of Body Weight and Immunogenicity, Int J Clin Phar Ther, 48 (9), 596-607, 2010.

J Ling, S Lyn, Z Xu, M Achira, E Bouman-Thio, A Shishido, J Ford, G Shankar, C Wagner, KT Kim, HM Davis and H Zhou, Lack of Racial Differences in the Pharmacokinetics of Subcutaneous Golimumab in Healthy Japanese and Caucasian Male Subjects, J Clin Pharmacol, 50, 792-802, 2010.

T Puchalski, U Prabhakar, T Jiao, B Berns and HM Davis, Pharmacokinetic and Pharmacodynamic Modeling of an Anti-Interleukin 6 Chimeric Monoclonal Antibody (CNTO 328) in Patients with Metastatic Renal Cell Carcinoma, Clin Cancer Res, 16 (5), 1652-1661, 2010.

A Fasanmade, OJ Adedokun, A Olson, R Strauss and HM Davis, Serum Albumin Concentration: A Predictor of Infliximab Pharmacokinetics and Response Model in Patients with Ulcerative Colitis, Int J Clin Pharmacol Ther, 48 (5), 297-308, 2010.

H Zhou, Y Zhu, M Lu, C Hu, S Liao, N Yielding and HM Davis, Population-Based Exposure-Efficacy Modeling of Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis, J Clin Pharmacol, 50, 257-267, 2010

A Fasanmade, O Adedokun, J Ford, D Hernandez, J Johanns, C Hu, S Travers, HM Davis and H Zhou, Population Pharmacokinetics of Infliximab in Patients with Ulcerative Colitis, European J Clin Pharmacol, 65 (12), 1211-1228, 2010.

Z Xu, Q Wang, Y Zhuang, B Frederick, H Yan, E Bouman-Thio, JC Marini, M Keen, D Snead, HM Davis, and H Zhou, Subcutaneous Bioavailability of Golimumab at Three Different Injection Sites in Healthy Subjects, J Clin Pharmacol, 50, 276-284, 2010.

Q Lu, X Zheng, T McIntosh, HM Davis, JF Nemeth, C Pendley, S-L Wu and WS Hancock, The Development of Different Analysis Platforms with LC-MS for Pharmacokinetic Studies of Protein Drugs, Analytical Chem, 81, 8715-8723, 2009.

Z Xu, T Vu, H Lee, C Hu, J Ling, H Yan, D Baker, A Beutler, C Pendley, C Wagner, HM Davis and H Zhou, Population Pharmacokinetics of Golimumab, an Anti-Tumor Necrosis Factor- Human Monoclonal Antibody, in Patients with Psoriatic Arthritis, J Clin Pharmacol, 49, 1056-1070, 2009.

H Zhou and HM Davis, Risk-Based Clinical Pharmacology Strategy for the Assessment of Drug-Drug Interactions for Therapeutic Biologics, Drug Discovery Today, 14 (17/18, Sept), 891-898, 2009.

J Ling, H Zhou, T Jiao and HM Davis, Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look, J Clin Pharmacol, 49, 1382-1402, 2009.

JJ Perez-Ruixo, W Krzyzanski, E Bouman-Thio, B Miller, SA Bai, H Zhou, J Yohrling, A Cohen, K Burggraaf, K Franson, and HM Davis, Pharmacokinetics and Pharmacodynamics of Erythropoietic Mimetic Antibody Fusion Protein CNTO 528 in Healthy Subjects, J Clin Pharmacokinetics, 48 (9), 601-613, 2009.

Y Zhu, C Hu, M Lu, S Liao, J Marini, J Yohrling, N Yeilding, HM Davis and H Zhou, Population Pharmacokinetic Modeling of Ustekinumab, a Human Monoclonal Antibody Targeting IL-12/23p40, in Patients with Moderate-to-Severe Plaque Psoriasis, J Clin Pharmacol, 49, 162-175, 2009.

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E Bouman-Thio, K Franson, B Miller, J Getsy, A Cohen, S Bai, J Yohrling, B Frederick, S Marciniak, Q Jiao, H Jang, HM Davis and J Burggraaf, A Phase I, Single and Fractionated, Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of an Erythropoietin Mimetic Antibody Fusion Protein (CNTO 528) in Healthy Male Subjects, J Clin Pharmacol, 48, 1197-1207, 2008.

Z Xu, K Seitz, A Fasanmade, J Ford, P Williamson, W Xu, HM Davis, and H Zhou, Population Pharmacokinetics of Infliximab in Patients with Ankylosing Spondylitis, J Clin Pharmacol, 48, 681-695, 2008.

MA Mascelli, H Zhou, R Sweet, J Getsy, HM Davis, M Graham, and D Abernethy, Molecular, Biologic and Pharmacokinetic Properties of Monoclonal Antibodies: Impact of These Parameters on Early Clinical Development, J Clin Pharmacol, 45(5), 553-565, 2007.

H Zhou, H Jang, E Bouman-Thio, Z Xu, J Marini, C Pendley, Q Jiao, G Shankar, S Marciniak, RM Fleischmann, SB Cohen, MU Rahman, D Baker, MA Mascelli, DE Everitt, HM Davis, Pharmacokinetics and Safety of Golimumab, a Fully Human Anti-TNF Monoclonal Antibody, in Subjects with Rheumatoid Arthritis. J Clin Pharmacol, 47, 383-396, 2007.

S. Mullamitha, C. Ton, GJM Parker…HM Davis…and GC Jayson, Phase I Evaluation of a Fully Human Anti-v Integrin Monoclonal Antibody (CNTO 95) in Patients with Advanced Solid Tumors, Clinical Cancer Research, 13 (7), 2128-2135, 2007.

R Beckman, L.M. Weiner, and H.M. Davis, Antibody Constructs in Cancer Therapy: Protein Engineering Strategies to Improve Exposure in Solid Tumors, Target Journal: Cancer, 109 (2), 170-179, 2007.

J.A. Nemeth, M.T. Nakada, M. Trikha, Z. Lang, M.S. Gordon, G.C. Jayson, R. Corringham, H.M. Davis, and R.A. Beckman, v-Integrins as Therapeutic Targets in Oncology, Cancer Investigation, 25 (7), 632-646, 2007.

L. Yan and H.M. Davis, Pharmacogenetics and Pharmacogenomics of Therapeutic Monoclonal Antibodies; Pharmacogenomics Future Medicine, 7 (7), 961-964, 2006.

D. Geng, G. Shankar, A. Schantz, M. Rajadhyaksha, H.M. Davis and C. Wagner, Validation of Immunoassays Used to Assess Immunogenicity to Therapeutic Monoclonal Antibodies, J. Pharmaceutical and Biomedical Analysis, 39, 364-375, 2005.

PL Martin, Q Jiao, J Cornacoff, W Hall, B Saville, JA Nemeth, A Schantz, M Mata, H Jang, A Fasanmade, MA Graham, HM Davis and G Treacy, Absence of Adverse Effects in Cynomolgus Macaques Treated with CNTO 95, a Fully Human Anti-v Integrin Monoclonal Antibody, Despite Widespread Tissue Binding, Intl J of Cancer, 11 (19), 6959-6965, 2005.

D. Horninger, E. Eirikis, C. Pendley, J. Giles-Komar, H.M. Davis and B.E. Miller, A One-step, Competitive Electrochemiluminescence-based Immunoassay Method for the Quantification of a Fully Human Anti-TNF Antibody in Human Serum, J Pharmaceutical and Biomedical Analysis, 38, 703-708, 2005.

Uma Prabhakar, Terri M. Conway, Paul Murdoch, Jeff L. Mooney, Steve Clark, Elizabeth C. Jazwinska, Michael R. Barnes, Blanche Levitt, Hugh M. Davis, Diane K. Jorkasky and William V. Williams, Correlation of Protein and Gene Expression Profiles of Inflammatory Proteins After Endotoxin Challenge in Human Subjects, DNA and Cell Biology, 24(7), 410-431, 2005.

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James Illman, Robert Corringham, Don Robinson, Jr., Hugh Davis and Mohit Trikha, Are Inflammatory Cytokines the Common Link Between Cancer-Associated Cachexia and Depression?, J. of Supportive Oncology, 3 (1), 37-50, 2005.

M. Reddy, E. Eirikis, C. Davis, H.M. Davis and U. Prabhakar, Comparative Analysis of Lymphocyte Activation Marker Expression and Cytokine Secretion Profile in Stimulated Human Peripheral Blood Mononuclear Cell Cultures: An In Vitro Model to Monitor Cellular Immune Function, J. Immunol. Methods, 293, 127-142, 2004.

U. Prabhakar, E. Eirikis, M. Reddy, E. Silvestro, C. Pendley, III, H.M. Davis, and B.E. Miller, Validation and Comparative Analysis of a Multiplexed Assay for the Simultaneous Quantitative Measurement of Th1/Th2 Cytokines in Human Serum and Human Peripheral Blood Mononuclear Cell Culture Supernatants. J. Immunol. Methods, 291(1-2), 27-38, 2004.

BM Jucker, TR Schaeffer, RE Haimbach, TS McIntosh, D Chun, M Mayer, DH Ohlstein, HM Davis, SA Smith, AR Cobitz and SK Sarkar, Normalization of Skeletal Muscle Glycogen Synthesis and Glycolysis in Rosiglitazone-Treated Zucker Fatty Rats: An In Vitro Nuclear Magnetic Resonance Study, Diabetes, 51 (7), 2066-2073, 2002.

Uma Prabhakar, Edward Eirikis and Hugh M. Davis, Simultaneous Quantification of Proinflammatory Cytokines in Human Plasma Using the LabMAP Assay, Journal of Immunological Methods, 260 (1-2), 207-218, 2002.

Hugh M. Davis, Thomas S. McIntosh and Dwight E. Matthews, A liquid Chromatography-Mass Spectrometry Method to Measure Stable Isotopic Tracer Enrichments of Glycerol and Glucose in Human Serum, Analytical Biochemistry, 300, 163-169, 2002.

Hugh M. Davis, Donald C. Carpenter, Jocelyn M. Stahl, Wenyu Zhang, Weslia P. Hynicka, and Don E. Griswold, Human Granulocyte CD11b Expression as a Pharmacodynamic Biomarker of Inflammation, Journal of Immunological Methods, 240, 125-132, 2000.

Steven J. Kovacs, Karen L. Ramey, David E. Martin, Hugh M. Davis and Diane K. Jorkasky, Urine Drug Screening Methodologies, Journal of Clinical Pharmacology, 39, 425-427, 1999.

Jonathan Q. Tran, Steven J. Kovacs, Thomas S. McIntosh, Hugh M. Davis and David E. Martin, Morning Spot and 24 Hour Urinary 6--Hydroxycortisol to cortisol ratios: Intraindividual variability and correlation under Basal Conditions and Conditions of CYP 3A4 Induction, Journal of Clinical Pharmacology, 39, 487-494, 1999.

Hugh M. Davis, David W. Nash, Mark D. Clymer, Michele L. Frigo and Garrett E. Bergman, Lack of Immune Response to Mouse IgG in Previously Untreated Hemophilia A and Hemophilia B Patients Treated with Monoclonal Antibody Purified Factor VIII and Factor IX Preparations, Haemophilia, 3, 102-107, 1997.

G. Hjalm, E. Murray, G. Crumley, W. Herazim, S. Lundgren, I. Onyango, B. Ek, H. Davis, M. Larsson, C. Juhlin, P. Hellman, G. Akerstrom, L. Rask and B. Morse, Cloning and Sequencing of Human gp 330, a Ca+2 Binding Receptor with Potential Intracellular Signaling Properties, European Journal of Biochemistry, 239, 132-137, 1996

Joseph Haimovich, Hugh M. Davis and Alain B. Schreiber, Human Anti-Mouse Immunoglobulins in Sera of Patients Treated Chronically with Monoclonal Antibody Factor VIII:C, Seminars in Hematology, 27 (2), 11-15, 1990.

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Hugh M. Davis, Susan K. Brown, David W. Nash, Aniello Pennetti, Phyllis Salzman, Alain B. Schreiber and Joseph Haimovich, Lack of Immune Response to Mouse IgG in Hemophilia A Patients Treated Chronically with Monoclate®, A Monoclonal Antibody Affinity Purified Factor VIII Preparation, Thrombosis and Haemostasis, 63 (3), 386-391, 1990.

Vincent R. Zurawski, Jr., Hugh M. Davis, Neil J. Finkler, Cary L. Harrison, Robert C. Bast, Jr. and Robert C. Knapp, Tissue Distribution and Characteristics of the CA 125 Antigen, Cancer Review, 11, 102-118, 1989.

J.J. Quak, G.A. Van Dongen, J. Brakkee, H.M. Davis, R.J. Scheper, A.J. Balm, C.J. Meijer and G.B. Snow, Expression and Characterization of Two Differentiation Antigens in Stratified Squamous Epithelia and Carcinomas. In: Monoclonal Antibodies to Squamous Cell carcinomas of the Head and Neck. Barier-Ruinen, Amsterdam, The Netherlands, 59-75, 1989.

Thomas L. Klug, Paul J. Green, Vincent R. Zurawski, Jr. and Hugh M. Davis, Confirmation of a False-Positive Result in CA 125 Immunoradiometric Assay Caused by Human Anti-Idiotype Immunoglobulin. Clinical Chemistry, 34, 1071-1076, 1988.

Hugh M. Davis, Vincent Zurawski, Jr., Robert C. Bast, Jr. and Thomas L. Klug, Characterization of the CA 125 Antigen Associated with Human Epithelial Ovarian Carcinomas, Cancer Research, 46, 6143-6148, 1986.

Hugh M. Davis, Harry B. Hines and John R. Edwards, Structural Elucidation of a Water-Insoluble Glucan Produced by a Cariogenic Oral Streptococcus, Carbohydrate Research, 156, 69-77, 1986.

Hugh M. Davis, Walter J. Boyko and John R. Edwards, Structural Determination of a Water-Insoluble Glucan from Streptococcus mutans 6715 by Carbon-13 Nuclear Magnetic Resonance Spectroscopy, Carbohydrate Research, 152, 279-282, 1986.

BOOK CHAPTERS:

M Reddy, C Davis, HM Davis, C Pendley and U Prabhakar, T-Cell Surface Markers in Human Peripheral Whole Blood Using Flow Cytometry, in A Practical Guide for Validating Cell-Based Assays in the GLP Setting, J. Wiley, NY, NY, 2007.

M Reddy, J Wong, C Davis, HM Davis, C Pendley and U Prabhakar, IL-5 ELISPOT Assay Validation, in A Practical Guide for Validating Cell-Based Assays in the GLP Setting, J. Wiley, NY, NY, 2007.

U. Prabhakar, E. Eirikis, B.E Miller and H.M. Davis, Multi-Plexed Cytokine Sandwich Immunoassays: Clinical Applications. “Microarrays in Clinical Diagnostics” for the series Methods in Molecular Medicine, Eds. T. Joos and P. Fontina, Humana Press, Totowa, New Jersey, 2005.

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SYMPOSIA, INVITED SPEAKER:

Chairperson and Presenter, Utilization of Novel Pharmacodynamic Approaches in Clinical Drug Development, Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, March 1999.

Drug Development of Monoclonal Antibodies as Anti-Cancer Agents; Pharmacokinetics and Pharmacodynamics of a Novel Anti-IL-6 Monoclonal Antibody, Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, March 2004.

The Effect of Infliximab Plus Methotrexate Therapy on the Modulation of Inflammatory Disease Markers in Patients with Early Rheumatoid Arthritis, Medicine in the Twenty First Century, Tri-Conference & Bio-Forum 2004, Shanghai, July 2004.

Phase I Study of CNTO 95: A Fully Human Mab to v Integrins in Patients with Solid Tumors, G. Jayson, S. Mullamitha, H.M. Davis, Z. Lang and R. Beckman, 4th International Symposium on Translational Research in Oncology, Dublin, Ireland, 2004.

Selection of a Safe Starting Dose for First-in-Human Studies; Case Studies from Industry, H.M. Davis, 44th DIA Annual Meeting, Atlanta, GA, June 2007.

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ABSTRACTS:

Serum Golimumab Exposure and the Incidence of Selected Safety Events in Patients With Ulcerative Colitis Following Treatment With Golimumab: An Exploratory Analysis of the PURSUIT Study Data. Adedokun OJ, Xu Z, Marano C, Strauss R, Zhang H, Johanns J, Ford J, Zhou H, Davis HM, Liao S, Colombel JF, Reinisch W, Feagan B, Rutgeerts P, Gibson P, Sandborn W. Abstract presented at Disease Digestive Week, Chicago, IL, May 2014.

"Application of a Novel Bioanalytical Method for Pharmacokinetic Biocomparability Assessment of a Therapeutic Monoclonal Antibody"; Geist BJ , Davis D, McIntosh T, Yang T-Y, Goldberg K, Han C, Pendley C, and Davis HM. 8th Workshop on Recent Issues in Bioanalysis, March 11 – 13th 2014, Universal City, CA.

The Impact of Anti-drug Antibodies on the Pharmacokinetics of a Human Therapeutic Monoclonal Antibody in Non-naïve Monkeys. Jiao Q, Han C, Gunn G, Gopi S, Marini J, Hsu H, Davis H. Abstract/poster presented at National Biologic Conference, San Diego, CA, May 2014.

Long-term pharmacokinetics of body surface area- adjusted doses of golimumab following repeated subcutaneous administrations in pediatric patients with polyarticular juvenile idiopathic arthritis. Leu JH, Mendelsohn A, Ford J, Davis HM, Zhou H, Xu Z. Abstract presented at the Pediatric Rheumatology Symposium (PRSYM), Orlando, FL and American College of Rheumatology Annual Meeting, Boston, MA, April 2014.

Pharmacokinetics and PK-Efficacy Analyses for Body Surface Area-Adjusted Doses of Golimumab Following Repeated Subcutaneous Administrations in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis. Leu JH, Mendelsohn A, Ford J, Davis HM, Zhou H, Xu Z. American College of Clinical Pharmacology Annual Meeting, Atlanta, GA, September 2014.

Evaluation of the Relationship between CNTO 5825 Pharmacokinetics and IgE Suppression to Support Dose Selection in Patients with Severe Asthma. Nnane IP, Xu Z, Zhou H and Davis HM. Abstract accepted for poster presentation at the 2014 AAPS Annual Meeting and Exposition, November 2-6, 2014, San Diego, CA, November 2014.

Evaluation of Disease-Mediated Therapeutic Protein-Drug Interactions Between an Anti-Interleukin-6 (Anti-IL-6) Monoclonal Antibody (Sirukumab) and Cytochrome P450 (CYP) Activities in Patients with Rheumatoid Arthritis (RA) Using a Cocktail Approach, Zhuang Y, de Vries DE, Xu Z, Marciniak S, Chen D, Leon F, Davis HM, Zhou H. Abstract presented at ACCP, Atlanta, GA, September 2014.

Impact of Immunomodulators on the Pharmacokinetics and Efficacy of Golimumab in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase 2/3 PURSUIT –SC Induction and Maintenance Studies, Omoniyi J Adedokun, Zhenhua Xu, Colleen Marano, Richard Strauss, Hongyan Zhang, Jewel Johanns, Joyce Ford, Honghui Zhou, Hugh M Davis, JF Colombel, Walter Reinisch, Brian Feagan, Paul Rutgeerts, William Sandborn, UEGW, 2013

Sirukumab Pharmacokinetics Following Multiple Subcutaneous Administrations in Patients with Rheumatoid Arthritis despite Methotrexate Therapy, Yanli Zhuang, Benjamin Hsu, Zhenhua Xu, Joyce Ford, Monica Keen, Hugh M. Davis, Honghui Zhou, ACCP, 2013.

Body Surface Area-Based Dosing Approach Produced Comparable Golimumab Exposure Across Different Age Ranges After Subcutaneous Administration of Golimumab in Pediatric Patients with Juvenile Idiopathic Arthritis, JH Leu, A Mendelsohn, J Ford, HM Davis, H Zhou, Z Xu, ACCP, 2013.

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Biocomparability Assessment of Subcutaneous Delivery of Golimumab by a SmartJect Autoinjector or a Needle and Syringe in Healthy Subjects, Zhenhua Xu, Stanley Marciniak, Bart Frederick, Lilianne Kim, Joyce Ford, Kevin Petty, Hugh M. Davis, Honghui Zhou, ACCP, 2013

Pharmacokinetics and Exposure-Response Relationship of Golimumab in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase2/3 Induction and Maintenance Studies, O.J. Adedokun,1 Z. Xu,1 C. Marano,1 R. Strauss,1 H. Zhang,1 J. Johanns,1 J. Ford,1 H. Zhou,1 H.M. Davis,1 J.F. Colombel,2 W. Reinisch,3 B. Feagan,4 P. Rutgeerts,5 W. Sandborn6, DDW, 2013.

Importance of Steady-State Trough Concentrations After Intravenous Golimumab with Concomitant Methotrexate in Patients with Active Rhematoid Arthritis, JH Leu, Z Xu, C Hu, A Mendelsohn, J Ford, HM Davis and H Zhou, EULAR, 2013.

Pharmacokinetics and Exposure-Response Relationship of Golimumab in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase2/3 Induction and Maintenance Studies, Omoniyi J Adedokun, Zhenhua Xu, Colleen Marano, Richard Strauss, Hongyan Zhang, Jewel Johanns, Joyce Ford, Honghui Zhou, Hugh M Davis, JF Colombel, W. Reinisch, B Feagan, P Rutgeerts,and W Sandborn, DDW, 2013.

Population Pharmacokinetic and Pharmacodynamic Modeling of an Anti-Interleukin-6 Chimeric Monoclonal Antibody, Siltuximab (CNTO 328), in Patients With B-Cell Non-Hodgkin’s Lymphoma, Multiple Myeloma, or Castleman’s Disease. Lanyi Xie, Lilian Y Li, Razelle Kurzroch, Frits van Rhee, Xiang Qin, Majula Reddy, Ming Qi,Hugh M Davis, Honghui Zhou, and Thomas A Puchalski, ASH, 2012.

A Novel Preclinical Study in Cynomolgus Monkeys Examing CCL2 Production Rate and Kinetic Profile After Escalating Dose Administration of Anti-CCL2 Human Monoclonal Antibody Carlumab (CNTO 888). T. Puchalski, C. Han, T. McIntosh, E. Brenner, D. Fink, K. Graham, Q. Jiao, S. Seetharam, C. Takimoto, H.M. Davis, H. Zhou. AACR, 2012.

Infliximab Concentration and clinical outcomes  in patients with ulcerative colitis, Omoniyi J Adedokun, Zhenhua Xu, Lakshmi Damaraju, Marion Blank, Jewel Johanns, Anne Griffiths, Joyce Ford, Honghui Zhou, Cynthia Guzzo, Hugh M Davis, Jeffrey Hyams, DDW, 2012.

Mechanism-Based Exposure-Efficacy Relationship after Intravenous (IV) Golimumab with Concomitant Methotrexate in Subjects with Active Rheumatoid Arthritis (RA), C Hu, Z Xu, A Mendelsohn, HM Davis and H Zhou, ACCP, 2012.

Pharmacokinetics and Safety of Golimumab in Healthy Chinese Subjects Following a Single Subcutaneous Administration, Y Zhuang, S Lyn, Z Xu, E Bouman-Thio, T Masterson, JA Ford, M Keen, KJ Petty, HM Davis, H Zhou, ACCP, 2012

Pharmacokinetics of Infliximab in Pediatric Patients with Moderate to Severe Ulcerative Colitis: Results from a Randomized, Multicenter, Open-Label Phase 3 Study. O. Adedokun, Z. Xu, L. Damaraju, M. Blank, J. Johanns, A. Griffiths, J. Ford, H. Zhou, C. Guzzo, HM. Davis, J. Hyams. DDW, 2012.

Population pharmacokinetic analysis of infliximab in pediatrics using integrated data from six clinical trials. Xu Z, Mould DR, Hu C, Ford J, Keen M, Davis HM, Zhou H., ACCP, 2012.

Population Pharmacokinetic and Pharmacodynamic Modeling of an Anti-Interleukin-6 Chimeric Monoclonal Antibody, Siltuximab (CNTO 328), in Patients with B-Cell Non-Hodgkin’s Lymphoma, Multiple Myeloma, or Castleman’s Disease, L Xie, H Zhou, HM Davis and T Puchalski, ASH, 2012.

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A Population-Based Pharmacokinetic Meta-Analysis of Infliximab in Pediatrics, Z Xu, D Mould, C Hu, J Ford, M Keen, H M Davis, and H Zhou, ACCP, 2012.

Importance of Steady-State Trough Concentrations after Intravenous (IV) Golimumab with Concomitant Methotrexate in Subjects with Active Rheumatoid Arthritis, J.H. Leu, Z. Xu, C. Hu, A. Mendelsohn, J. Ford, H.M. Davis, and H. Zhou., ACCP, 2012 and ACR 2012.

A Novel Preclinical Study Examining CCL2 Production Rate and Kinetic Profile following Administration of Escalating Doses of the anti-CCL2 Antibody Carlumab (CNTO 888), T Puchalski, C Han, D Fink, Q Jiao, S Seetharam, C Takimoto, H Zhou and HM Davis, ASCO, 2012.

Lack of Ethnic Effect on the Pharmacokinetics of Subcutaneous Ustekinumab in Adult Chinese and Non-Chinese Healthy Male Subjects, Y Zhu, Q Wang, B Frederick, E Bouman-Thio, JC Marini, M Keen, KJ Petty, HM Davis and H Zhou, ACCP, Sept 2011.

Utilizing Mechanistic PK/PD Modeling to Simultaneously Examine Free CCL2, Total CCL2 and CNTO 888 Serum Concentration Time Data, GJ Fetterly, TA Puchalski, C Takimoto, DE Mager, S Seetharam, T McIntosh, JS De-Bono, A Tolcher, HM Davis and H Zhou, ASCO 2010.

Association of Infliximab Clearance and Resting Energy Expenditure in Children, GL Kearns, JL Goldman, HM Davis, and H Zhou, Oral presentation, ASCPT 2010.

Immunogenicity Assessment of Ustekinumab in Phase 3 Studies in Patients with Moderate to Severe Plaque Psoriasis, Y Zhu, G Shankar, N Yeilding, P Szapary, H Zhou and HM Davis, ASCPT 2010.

Pharmacokinetics and Safety of Golimumab, a Human Anti-TNF- Monoclonal Antibody, Following a Single Subcutaneous Administration to Healthy Caucasian and Japanese Subjects, J Ling, S Lyn, Z Xu, M Achira, E Bouman-Thio, A Shishido, J Ford, G Shankar, C Wagner, KT Kim, HM Davis and H Zhou, ASCPT 2010.

Bioavailability of Golimumab, an Anti-Tumor Necrosis Factor-Human Monoclonal Antibody, Administered Subcutaneously at Three Different Injection Sites in Healthy Subjects, Z.H. Xu, Q.M. Wang, Y.L. Zhuang,….. H.M. Davis and H. Zhou, ASCPT, March 2009.

Population-Based Exposure-Efficacy Modeling of Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis, H Zhou, Y Zhu, M Lu, , C Hu, S Liao, N Yielding and HM Davis, ACCP 37th Annual Meeting, Phila, 2008.

Population Pharmacokinetics of Golimumab, a Human Anti-Tumor Necrosis Factor- Monoclonal Antibody, in Patients with Rheumatoid Arthritis, Z Xu, H Lee, T Vu, C Hu, J Ling, D Baker, MU Rahman, C Pendley, CL Wagner, HM Davis and H Zhou, ACCP 37th Annual Meeting, Phila, 2008.

Population Pharmacokinetics of Golimumab, a Human Anti-Tumor Necrosis Factor- Monoclonal Antibody, in Patients with Psoriatic Arthritis, Z Xu, T Vu, H Lee, J Ling, C Hu, D Baker, A Beutler, C Pendley, CL Wagner, HM Davis and H Zhou, ACCP 37th Annual Meeting, Phila, 2008.

Z Xu, T Vu, H Lee, C Hu, A Beutler, C Pendley, CL Wagner, HM Davis and H Zhou, Population Pharmacokinetics of Golimumab, a Human Anti-Tumor Necrosis Factor- Monoclonal Antibody, in Patients with Ankylosing Spondylitis, ACCP 37th Annual Meeting, Phila, 2008.

Population Pharmacokinetic Modeling of Ustekinumab, a Human Anti-IL-12/23p40 Monoclonal Antibody (mAb), in Two Phase 3 Studies in Patients with Moderate to Severe Plaque Psoriasis, Y.W. Zhu, H. Zhou, S. Liao, C. Hu, M. Lu, L. Wang, J. Yohrling, J.C. Marini, N. Yielding, and H.M. Davis, IXth World Congress of Clinical Pharmacology and Therapeutics, Quebec, 2008.

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Pharmacokinetics and Exposure-Response Relationship of Ustekinumab, a Human Monoclonal Antibody to Interleukin-12/23 in Patients with Moderate to Severe Crohn’s Disease, A. Fasanmade, O. Adedokun, J. Johanns, H. Zhou, H.M. Davis and M. Blank, DDW, 2008.

Z Xu, H Lee, T Vu, C Hu, J Ling, D Baker, MU Rahman, C Pendley, CL Wagner, HM Davis and H Zhou, Population Pharmacokinetics of Golimumab, a Human Anti-Tumor Necrosis Factor- Monoclonal Antibody, in Patients with Rheumatoid Arthritis, EULAR, Paris, France, June 2008.

Z Xu, T Vu, H Lee, J Ling, C Hu, D Baker, A Beutler, C Pendley, CL Wagner, HM Davis and H Zhou, Population Pharmacokinetics of Golimumab, a Human Anti-Tumor Necrosis Factor- Monoclonal Antibody, in Patients with Psoriatic Arthritis, EULAR, Paris, France, June 2008.

Population-based Assessment of Concomitant Methotrexate on Infliximab Pharmacokinetics in Patients with Psoriatic Arthritis, S. Zhang, K. Seitz, A. Fasanmade, Z. Xu, C. Pendley, A. Beutler, H. Davis and H. Zhou, ASCPT, 2007.

Use of Phage Display and Selection Criteria to Design Human Anti-Idiotypic Antibodies that Mimic a Polyclonal Primate Immune Response, A. Schantz, M. Tornetta, D. Fisher, K. O’Neil, D. Knight, H. Davis, R. Sweet and P. Tsui, AAPS Biotechnology National Conference, 2007.

Exposure-Efficiency Assessment of Golimumab in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Application of Population Pharmacokinetic/Pharmacodynamic Modeling, H. Zhou, M.U. Rahman, C. Wagner, J. Han, D. Baker, H. Jang and H.M. Davis, ACR, 2007.

A Phase I, Single Ascending Dose Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of an Erythropoeitic Mimetic Antibody Fusion Protein (CNTO 528) in Healthy Male Subjects, E. Bouman-Thio, K. Franson, J. Burggraaf, … and H.M. Davis, ASCPT, March 2007.

Population Pharmacokinetics of Infliximab, An Anti-tumor Necrosis Factor-Monoclonal Antibody, in Patients with Ankylosing Spondylitis: A Randomized, Double-Blind, Phase III Trial, Zhenhua Xu, Adedigbo Fasanmade, Charles Pendley, Paul Williamson, Haishan Jang, Hugh M. Davis, Honghui Zhou, EULAR, 2006.

Immunohistochemical Characterization of Signaling Responses Following v Integrin Antibody Therapy with CNTO 95, U. Prabhakar, JA Nemeth, M. Munteanu, HM Davis, M. Mata, Z. Lang, MT Nakada, G. Jayson, R. Corringham and R. Beckman, 17th EORTC-NCI-AACR Symposium, 2005.

Phase I study of CNTO 95, a Fully Human Monoclonal Antibody (mAb) to v integrins, in Subjects with Solid Tumors, GC Jayson, S. Mullamitha, C. Ton, J. Valle, M. Saunders, MC. Munteanu, Q. Jiao, HM. Davis, Z. Lang and RA. Beckman, 29th ESMO Congress, 2004.

Pharmacokinetics of CNTO 328 in a Three Month Intravenous Dose Toxicity Study in Cynomolgus Monkeys with Concomitant IL-2 Therapy, Q. Jiao, U. Prabhakar, M. Frigo, T.A. Lohr, J. Cornacoff, H.M. Davis and M.A. Graham, 16th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics, September 2004.

Pharmacokinetics of CNTO 95, a Fully Human Mab to Human Integrin Receptors Following Single or Multiple IV Injections to Cynomolgus Monkeys, Q. Jiao, A. Fasanmade, U. Prabhakar, J. Cornacoff, H.M. Davis, ASCPT, 2004

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A Rational Approach for a phase I Clinical Study Design to Evaluate CNTO 95, a Novel, Fully Human Anti-v Monoclonal Antibody (Mab), in Patients with Solid Tumors, HM Davis, U Prabhakar, H Jang, Q Jiao, M Trikha, J Cornacoff, J Ford, A Fasanmade and MA Graham, ASCO, 2004.

Phase I Study of CNTO 95, a Fully Human Monoclonal Antibody to v Integrins, in Patients with Solid Tumors, G Jayson, S Mullamitha, C Ton, M Munteanu, H Jang, M Trikha, HM Davis and RA Beckman, ASCO, 2004.

Pharmacokinetic/Pharmacodynamic Modeling and Trial Simulations to Guide Dose Selection with CNTO 328, a Chimeric Anti-IL-6 Monoclonal Antibody, in Patients with Renal Cell Carcinoma, H Jang, U Prabhakar, Q Jiao, J Ford, B Miller, HM Davis and MA Graham, ASCO, 2004.

Correlation of Serum CNTO 328 [Anti-IL-6 Monoclonal Antibody] Concentrations and Biomarker Expression in Renal Cell Carcinoma Patients, U Prabhakar, H Jang, Q Jiao, J Ford, BE Miller, MA Graham and HM Davis, ASCO, 2004.

Phase I Study of CNTO 328, a Chimeric Murine-Human Monoclonal Antibody to Interleukin-6 in Patients with Metastatic Renal Cell Cancer, P Mulders, JF Rossi, F Debruyne, J Cooper, HM Davis, L Zhang and R Corringham, ASCO, 2004.

A Methodological Approach to Evaluating a Human Anti-v Monoclonal Antibody, CNTO 95, In Patients with Solid Tumors: Rationale for Phase I Clinical Study Design, U Prabhakar, H Jang, Q Jiao, M Trikha, J Cornacoff, J Ford, A Fasanmade, MA Graham and HM Davis, 6th International Symposium on Anti-Angiogenic Agents, January 2004.

Phase I Study of CNTO 95, A Fully Human Monoclonal Antibody to v Integrins, in Patients with Solid Tumors, G Jayson, S. Mullamitha, L Broughton, M Munteanu, H Jang, MT Nakada, M Trikha, HM Davis and RA Beckman, 6th International Symposium on Anti-Angiogenic Agents, January 2004.

Pharmacokinetics, Pharmacodynamics and GP IIb/IIIa Receptor Blockade of Abciximab in Stable Angina Pectoris, AA Fasanmade, E Barnathan, MA Graham, CL Wagner, HM Davis and R Jordan, Clinical Pharmacology and Therapeutics, 75 (2), p89, 2004.

PK Modeling and Simulations of an Anti-IL-6 Monoclonal Antibody in Patients with Renal Cell Carcinoma, H. Jang, U. Prabhakar, J Ford, B Miller, HM Davis and MA Graham, ASCPT, March 2004.

PK/PD of a Human Anti-TNF- Monoclonal Antibody in Patients with Rheumatoid Arthritis, H. Jang, JC Marini, C. Pendley, Q. Jiao, SJ Marciniak, S. Cohen, R. Fleischmann, DE Everitt, HM Davis and MA Graham, ASCPT, March 2004.

Pharmacokinetics of a human monoclonal antibody to IL-12 p40 following single intravenous infusion in patients with moderate to severe plaque-type psoriasis, YW Zhu, JP Zhang, J Marini, C Pendley, B Frederick, MA Mascelli, AB Gottlieb, CL Kauffman, C Guzzo, HM Davis, DE Everitt and MA Graham, ASCPT, March 2004.

Pharmacokinetics of a Human Antibody to Interleukin-12 Following Multiple Subcutaneous Doses to Cynomolgus Monkeys, Q. Jiao, Y. Zhu, B. Miller, G. Treacy, H. Davis, and MA Graham, AAPS, Oct. 2003.

Infliximab Pharmacokinetics and Improvement in Fistulizing Crohn’s Disease, A. F. Fasanmade, P. Marsters, E. Munsanje, M.A. Graham, H.M. Davis, S. J. van Deventer, Gastroenterology, 124, PA-61, 2003.

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Is anti-MUC-1 Antibody Expression Prognostic of Survival in Patients with Breast Carcinoma?, J.A. Ford, N.K. Brown, M.L. Faircloth, H.M. Davis and U. Prabhakar, American Journal of Clinical Oncology, 22, p 988, 2003.

Infliximab levels in the Breast Milk of Nursing Crohns Patients Compared to Serum Concentrations in Crohns Patients, D. James, J. Ford, C. Wagner, H.M. Davis and S. Hanauer, presented to Federation of Clinical Immunology Societies (FOCIS), 2nd annual meeting, June, 2002.

Comparison of the Pharmacokinetics of Infliximab in Patients with Psoriasis and Crohn’s Disease Not Receiving Concomitant Immunosuppresants or Corticosteroids, A.A. Fasanmade, C.L. Wagner, H.M. Davis, M.A. Graham and A. Gottlieb, Journal of Investigational Dermatology, July, 2002.

Relationship Between Infliximab Pharmacokinetics and Improvement in Crohn’s Disease, A.A. Fasanmade, A. Olson, W. Bao, C. Pendley, H.M. Davis and L. Mayer, Gastroenterology, 122 (4), pa 617-618, 2002.

Comparative Pharmacokinetics of Single and Multiple-Dose Infliximab in Crohn’s Disease Patients, A.A. Fasanmade, R. Tawadros, Y. Zhu, A. Olson, H.M. Davis, G. Lichtenstein and L. Mayer, Gastroenterology, 122 (4), pA 614-615, 2002.

Population Pharmacokinetics of Single Dose Infliximab in Patients with Crohn’s Disease, A.A. Fasanmade, Y. W. Zhu, C. Wagner, C. Pendley and H.M. Davis, Clinical Pharmacology and Therapeutics, 71 (2), 2002.

Infliximab Levels in Breast-Milk of a Nursing Crohn’s Patient, Marilyn Peltier, Debra James, Joyce Ford, Carrie Wagner, Hugh Davis and Steven Hanauer, Presented at the American College of Gastroenterology annual meeting, Gastroenterology, 2001.

Characterization of Metabolic Intermediates and Fluxes in Rosiglitazone-Treated Zucker Fatty Rats, Beat M. Jucker, Thomas R. Schaefer, Thomas McIntosh, Hugh M. Davis, Susanta S. Sarkar, Presented at the 61st Scientific Session of the American Diabetes Association, Diabetologia, 44 (1), p. A27, 2001.

Human Granulocyte CD11b Expression as a Pharmacodynamic Biomarker of Inflammation, Hugh M. Davis, Donald C. Carpenter, Wenyu Zhang, Weslia P. Hynicka and Don E. Griswold, 10th National Conference of the Inflammation Research Association, Hot Springs, VA, Inflammation Research, 49 (S2), p. S101, 2000.

Activation of Pro- and Inflammatory Proteins in Endotoxin-Challenged Human Subjects: Correlation of Protein and Gene Expression Profiles, U. Prabhakar, T.M. Conway, P. Murdoch, J. Mooney, S. Clark, L. Jazwinska, M.R. Barnes, B. Levitt, H.M. Davis, D.K. Jorkasky and W.V. Williams, Scandinavian Journal of Immunology, 51 (1), p. 99, 2000.

Suppression of Ex Vivo Cytokine Production by SB 242235, A Selective Inhibitor of p38 MAP Kinase, T. Fullerton, A. Sharma, U. Prabhakar, M. Tucci, S. Boike, H.M. Davis, D. Jorkasky, W. Williams, Clinical Pharmacology and Therapeutics, 67 (2), p. 114, 2000.

P38 MAP Kinase Inhibition in Rheumatoid Synovium and ex vivo: Effects on Cytokine Production, WV Williams, U Prabhakar, T Fullerton, S Sharma, E Eirikis, JC Lee, S Boike, HM Davis, A Truneh and DK Jorkasky, FASEB Journal, 14 (6), pA 1211, 2000.

An Extensive Evaluation of Spot Urinary 6--Hydroxy Cortisol as a Biological Marker for CYP3A4 Induction, J. Tran, S.J. Kovacs, T.S. McIntosh, H.M. Davis and D.E. Martin, Clinical Pharmacology and Therapeutics, 65 (2), p. 157, 1999.

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Understanding Drug Activity in Early Phase Clinical Studies Using a Multi-Faceted Approach, H. M. Davis, Clinical Pharmacology and Therapeutics, 65 (2), 1999.

A(-) Variant Glucose-6-Phosphate Dehydrogenase Deficiency in African American Women, S.B. Sheth, W. Hynicka, D.J. Kazierad and H.M. Davis, Blood, 92 (10), p 2148, 1998.

Administration of a Humanized Monoclonal Antibody to Factor IX in Healthy Volunteers, S.B. Sheth, D. Wilson, H.M. Davis and D. Jorkasky, Blood, 92 (10), p 1491, 1998.

Comparison of Inhibition of Platelet Aggregation and GP IIb/IIIa Receptor Occupancy: Evaluation of the Effects of SB 214857, a Low Molecular Weight GP IIb/IIIa Receptor Antagonist, H.M. Davis, S.M. Hwang and M.I. Freed, Blood, 90 (10), p.299a, 1997.

Development of a Whole Blood Flow Cytometric Method Using LDS-751 to Evaluate LTB4-Induced CD11b Expression, H.M. Davis, D.C. Carpenter, J.M. Goodlavage, W.P. Hynicka and D.E. Griswold, Blood, 90 (10), p. 41b, 1997.

Lack of Immune Response to Mouse IgG in Previously Untreated Hemophilia A and Hemophilia B Patients Treated with Monoclonal Antibody Purified Factor VIII and Factor IX Preparations, H.M. Davis, M.D. Clymer, D.W. Nash and M.L. Frigo, Blood, 86 (10), 1995.

Fixed Platelets as a Defined and Convenient Alternative to Fresh, Washed Platelets for Studying GPIb Binding Activity, Zimmerman Conference: Progress in Vascular Biology, M.D. Clymer, F.V. Chu, V.L. Robinson, A Zilberstein and H.M. Davis, Hemostasis and Thrombosis, La Jolla, CA, 1992.

A Sensitive Radioimmunoassay for the Determination of the von Willebrand Factor Fragment RG 12986 in Human Acidified Citrate Dextrose (ACD) Plasma, Zimmerman Conference: Progress in Vascular Biology, H.M. Davis, D.W. Nash, R. Hensel, A. Saha and J. Miksic, Hemostasis and Thrombosis, La Jolla, CA, 1992.

Comparative Bioactivity of Calcitonins and Salmon Calcitonin Analogues as Determined by an In Vitro Whole Cell Assay and an In Vivo Rat Hypocalcemic Assay, Hugh M. Davis, Aniello Pennetti and Joseph Haimovich, FASEB Journal, 4 (7), A1830, 1990.Human Anti-Mouse Immunoglobulins in Sera of Patients Treated with Monoclonal Antibody Purified Factor VIII:C, Joseph Haimovich, Hugh M. Davis and Alain B. Schreiber, American Society of Hematology Inforum, Atlanta, GA, December 1989.

Isolation and Partial Characterization of an Antigen Associated with Human epithelial Ovarian Carcinomas, Hugh M. Davis, Thomas L. Klug and Vincent Zurawski, Jr., Fifth Annual Congress for Hybridoma Research, Baltimore, MD, January 1986.

The use of Carbon-13 NMR for the Determination of a Water-Insoluble Glucan Isolated from a Streptococcus Species, Walter J. Boyko, Hugh M. Davis and John R. Edwards, Eastern Analytical Symposium, New York, NY, October 1986.

Chemical and Instrumental Analysis of a Water-Insoluble Glucan Produced by the Cariogenic bacterium, Streptococcus mutans 6715, Hugh M. Davis, Harry B. Hines and John R. Edwards, 19th Middle Atlantic Regional Meeting of the American Chemical Society, South Orange, NJ, May 1985.

Structural Determination of Two Glucans from Streptococcus mutans 6715, Hugh M. Davis and John R. Edwards, 18th Middle Atlantic Regional Meeting of the American Chemical Society, Newark, NJ May 1984.

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