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JOEL B. CORNACOFF, PH.D.

, DVM, DABT 2006 Blackbird Circle * Audubon, PA 19403 (610) 630-4804 * Cell: (610) 613-8061 * jc130e0e0@westpost.net SUMMARY OF QUALIFICATIONS Accomplished, dedicated professional with extensive experience in design, develo pment, and execution of nonclinical toxicology and safety pharmacology studies t o support discovery/development of small molecules, monoclonal anitbodies, pepti de agonists, and stem cells. Skillfully develop novel methodologies to assess sa fety of given molecule based upon mechanism of action (MOA). Utilize excellent writing abilities to prepare nonclinical sections of regulatory submissions, stu dy reports, and manuscripts to support key initiatives; present findings to seni or leadership. Extensive background managing contracts and studies with clinical research organizations (CROs), including placement of study, budgeting, coordin ation of pre-study activities, and review of study protocols. Dynamic leader able to leverage resources effectively and demonstrate flexibilit y, adaptability, and innovative approach to problem solving. Mentor, train, and supervise junior scientists and foster collaborative, productive, and supportive research environments. Recognized for numerous contributions to investigations, exemplary performance, and high professional standards. EDUCATION THE OHIO STATE UNIVERSITY, Columbus, OH * Doctor of Veterinary Medicine (DVM), 1985 * Doctorate in Immunology, 1979 * Master of Science in Immunology, 1976 * Bachelor of Science in Microbiology, 1974 PROFESSIONAL EXPERIENCE VIROPHARMA, Exton, PA * 2008-2010 Director of Toxicology Adeptly managed all toxicology activities within portfolio of company specializi ng in development of proprietary anti-infective agents and therapeutic proteins. Oversaw execution of nonclinical toxicology programs for drug development proje cts, including preparation of regulatory submissions. Supported multidisciplinar y project teams and coordinated studies executed at CROs; tracked project status and monitored validity, accuracy, and reliability of results. CENTOCOR R&D, Radnor, PA * 2001-2008 Associate Director - Toxicology and Investigational Pharmacology Managed nonclinical toxicology program in several therapeutic programs specializ ing in development of monoclonal antibodies. Created and instituted toxicology a nd safety programs, processes, and protocols. Reviewed potential in-licensing dr ug candidates and communicated recommendations to senior leadership. * Successfully completed five nonclinical toxicology programs and prepared regul atory documentation, allowing entrance into Phase I clinical trials in Europe or U.S. * Coordinated studies at CROs and monitored activities to ensure alignment with study protocols and core business objectives. * Prepared documents, such as pre-IND briefing documents, IND, CTA, and BLA, as well as summaries of nonclinical safety data, for submission to FDA and internat ional regulatory agencies. * Served as Chairman of IACUC, Chair of J&J Toxicology Interest Group, and on Ed itorial Board of Journal of Immunotoxicology. * Received two "Standards of Leadership" awards from J&J and six "Encore" awards from Centocor in recognition of innovation and achievement.

...Continued... ...Page 2... JOEL B. CORNACOFF, PH.D., DVM, DABT (610) 630-4804 * Cell: (610) 613-8061 * jc130e0e0@westpost.net PROFESSIONAL EXPERIENCE (CONTINUED) WHITE EAGLE TOXICOLOGY LABORATORIES, Doylestown, PA * 2000-2001 Principle Research Scientist & Attending Veterinarian Conducted safety assessments of various chemical entities, including inhalation and surgically implanted access ports. Developed and implemented surgical models . Ensured welfare of small animals in lab. * Continuously investigated and pursued new business opportunities. THE UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA * 1999-2000 Fellow, University Laboratory Animal Resources Provided comprehensive care to multiple species, including rodents (nude, transg enic, and knockout), rabbits, guinea pigs, dogs, cats, primates, sheep, and swin e, used in medical research. Supported IACUC; assisted with protocol reviews and during site visits of University vivariums. NYCOMED AMERSHAM IMAGING / NYCOMED R&D, Wayne, PA * 1994-1999 Assistant Research Director - Toxicology, 1998-1999 Promoted to direct broad range of functions for toxicology unit, including strat egy development, resource management, protocol design, and data reporting. Achi eved considerable success in advancing novel drug candidates through all phases, from discovery through development, to meet regulatory filings; authored expert reports and pharmacology sections of regulatory filings. * Collaborated extensively with associates in toxicology, DMPK, chemical develop ment, analytical, pharmaceutical sciences, clinical research, and business devel opment units, coordinating efforts to ensure critical timelines were met. Provid ed updates on project status to senior management; communicated issues, roadbloc ks, challenges, and successes. * Contributed during pre-filing and critical phase meetings with FDA. * Served as member of Institutional Animal Care and Use Committee and served as relief veterinarian. Research Leader, 1994-1998 Oversaw drug development toxicology and safety pharmacology studies; managed tea m of Ph.D. scientists in fields of toxicology, reproduction, and genetic toxicol ogy. Conducted and monitored nonclinical safety trials and directed technical st aff members. * Appointed as toxicology representative for drug discovery and development team s. STERLING WINTHROP PHARMACEUTICAL R&D, Rensselaer, NY and Collegeville, PA * 1988 -1994 Principal Research Investigator Directed daily operations of Immunotoxicology Laboratory and served as staff tox icologist and veterinarian. Selected to serve as team representative to multiple discovery project teams. CHEMICAL INDUSTRY INSTITUTE OF TOXICOLOGY, Research Triangle Park, NC * 1985-198 8 Postdoctoral Fellow Awarded post-doc fellowship to investigate xenobiotic-induced immunotoxicity. THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, Columbus, OH * 1979-1985

Instructor of Medicine Taught immunology courses to first- and second-year medical students while manag ing all aspects of Renal Research Laboratory. Served as investigator on NIH-spon sored grant involving role of CR1 receptor on removal of pathogenic immune compl exes.

...Continued... ...Page 3... JOEL B. CORNACOFF, PH.D., DVM, DABT (610) 630-4804 * Cell: (610) 613-8061 * jc130e0e0@westpost.net BOOK CHAPTERS Dean, JH, Cornacoff, JB, Rosenthal, GJ and Luster, MI. Immune System: Evaluation of Injury. In: Principles and Methods of Toxicology, edited by A. Wallace Hayes , Raven Press, New York, 1994, pp.1065-1090. Dean, JH, Cornacoff, JB, and Luster, MI. Toxicity to the Immune System: A Review . In: Immunopharmacology Reviews, Vol. I, edited by J.W. Hadden and A. Szentiva nyi, Plenum Publishing Corporation, 1990, pp. 377-408. Dean, JH, Cornacoff, JB, LaBrie, T and Barbolt, TA. Assessment of Immune Respons es in Rodents and Non-Human Primates - Implications in Preclinical Evaluation of Proteins. In: Preclinical Evaluation of Peptides and Recombinant Proteins, edit ed by A. Sundwall, L. Ekman, H. Johansson, B. Sjoberg and I. Sjoholm, Skogs Graf iska AB, Sweden, 1990, pp. 23-34. Cornacoff, JB, and House, RV. T-Lymphocyte Assays. In: In Vitro Biological Syst ems: Preparation and Maintenance, edited by C.A. Tyson and J.M. Frazier, Academi c Press, 1993, pp. 467-481. Cornacoff, JB, Graham, CS and LaBrie, TK. Phenotypic Identification of Periphera l Blood Mononuclear Leukocytes by Flow Cytometry as an Adjunct to Immunotoxicity Evaluation. In: Methods in Immunotoxicology, Volume I., edited by G.R. Burleson , J.H. Dean and A.E. Munson, John Wiley & Sons, Inc., 1995, pp. 211-226. Working, PK, Newman, MS, Johnson, J and Cornacoff, JB. Safety of PEG and PEG De rivatives. In: Chemistry and Biological Applications of Poly(ethylene Glycol), edited by J. Milton Harris and S. Zalipsky, ACS Symposium Series 680, 1997, pp. 45-57. Cornacoff, JB and Giles-Komar, J. Humanized Monoclonal Antibodies. The Encycolo pedic Reference of Immunotoxicology. Springer-Verlag, 1005, pp. 296-298. Bugelski PJ, Sachs C, Cornacoff J, Martin P, Treacy G. Immunomodulatory Biopharm aceuticals and Risk of Neoplasia. In: J Cavagnaro ed. Preclinical Safety Evalua tion of Biopharmaceuticals. John Wiley & Sons, 2008, pp. 601-632 SELECTED PUBLICATIONS Cornacoff JB, Hebert LA, Smead WL, VanAman ME, Birmingham DJ and Waxman FJ. The primate erythrocyte-immune complex clearing mechanism. Journal of Clinical Inves tigation, 71:236, 1983. Cornacoff JB, House RV and Dean JH. Comparison of a radioisotopic incorporation method and the mouse ear swelling test (MEST) for contact sensitivity to weak s ensitizers. Fundamental and Applied Toxicology. 10: 40, 1988.

Cornacoff JB, Lauer LD, House RV, Tucker AN, Thurmond LM, Working PK, Vos JG and Dean JH. Evaluation of the immunological effects of beta-hexachlorocyclohexane (B-HCH) in the B6C3F1 mouse. Fundamental and Applied Toxicology. 11:293, 1988. Cornacoff JB, Tucker, AN and Dean JH. Development of a human peripheral blood mo nonuclear cell model for immunotoxicity evaluation. In Vitro Toxicology. 2:81, 1 989 DiBartola SP, Reiter JA, Cornacoff JB, Kociba GJ and Benson MD. Serum amyloid A protein concentration measured by radial immunodiffusion in Abyssinian and nonAbyssinian cats. American Journal of Veterinary Research. 50:1414, 1989. ...Continued... ...Page 4... JOEL B. CORNACOFF, PH.D., DVM, DABT (610) 630-4804 * Cell: (610) 613-8061 * jc130e0e0@westpost.net SELECTED PUBLICATIONS (CONTINUED) Dean, JH, Cornacoff, JB, Barbolt, TA, Gossett, KA and LaBrie, T. Pre-clinical to xicity of IL-4: A Model for studying protein therapeutics. International Journal of Immunopharmocology. 14:391, 1992. Cornacoff JB, Gossett, KA, Barbolt, TA and Dean, JH. Preclinical evaluation of r ecombinant human interleukin-4. Toxicology Letters. 64/65:299, 1992. McIntire GL, Bacon ER, Toner JL, Cornacoff JB, Losco PE, Illig KJ Nikula KJ, Mug genburg BA and Ketai L. Pulmonary delivery of nanoparticles of insoluble, iodina ted CT X-ray contrast agents to lung draining lymph nodes in dogs. Journal of Ph armaceutical Sciences. 87:1466, 1998. Martin PL, Cornacoff J, Prabhaker U, Lohr T, and Treacy G. Preclinical safety an d immune-modulating effects of therapeutic monoclonal antibodies to interleukin6 and tumor necrosis factor-* in cynomolgus monkeys. Journal of Immunotoxicology . 1:131, 2004. Martin PL, Jiao Q, Cornacoff J, Hall W, Saville B, Nemeth JA, Schantz A, Mata M, Jang H, Fasanmade AA, Anderson L, Graham M, Davis HM, and Treacy G. Absence of adverse effects in cynomolgus macaques treated with CNTO 95, a fully human anti** integrin monoclonal antibody, despite widespread tissue binding. Clinical Can cer Research. 11:6959, 2005. Cornacoff JB, Howk K, Pikounis B, Mendenhall V, and Martin P. Development of a M ethod for the Evaluation of Wound Tensile Strength in Cynomolgus Macaques. Journ al of Pharmacological and Toxicological Methods. 57:74, 2008 Martin PL, Cornacoff nd Treacy G. Effects NFa During Pregnancy urine Immune System. JB, White KL, Peachee V, Hoberman A, Eirikas E, Marini J, a of Administration of a Monoclonal Antibody Against Murine-T and Lactation on the Pre and Postnatal Development of the M International Journal of Toxicology. 37:341-347, 2008.

Brodmerkel C, Zhu Y, Jiao T, Cornacoff J, Treacy G, Mascelli MA, and Gottlieb AB . Effects of Ustekinumab Administration on Primate/Human Antigen-Recall and Humo ral Immune Response Functions (Accepted - Journal of Drugs in Dermatology).

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