Clinical Trials Manager

Gamal E. Osman, Ph.D.

• *** Mill Street, Burlington, Massachusetts 01803 • 339-***-**** • ******@*****.***

SUMMARY

A senior immunologist with extensive experience in Clinical Trial Management and Clinical Data Management. Significant experience in managing Phase I, II, & III Clinical trials and adhering to Clinical Protocol Requirement, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOP). Experience in drafting Investigational New Drug, Device Exemption (IND, IDE), Investigator’s Brochure (IB), Clinical Study Protocol (CSP), Clinical Annual Report (CAR), and Clinical Evaluation Report (CER). Strong ability to analyze and solve problems creatively. Highly skilled in managing Clinical Research Associates (CRA), Clinical Coordinators, Contract Research Organizations (CRO), and Scientific Consultants.

EDUCATION

Ph.D., Immunology, Tufts University School of Medicine, Boston, MA 1989

M.S., Biochemistry, Rockefeller University, New York, NY 1979

B.Sc., Chemistry, Cairo University, Cairo, Egypt 1978

PROFESSIONAL CAREER

INDEPENDENT CLINICAL TRIAL CONSULTANT 2008 – Present

Provide expertise in clinical research (phases I –III), medical devices, oncology, infectious diseases, and related expertise such as Electronic Data Capture Systems to a wide variety of clients in USA, Europe, and Middle East.

• Advise in creating clinical protocol development, informed consent forms, case report forms, and related documents

• Assist in evaluating scientific literature regarding current clinical practice and diseases

• Recommending qualified investigators, conducting site selection, site initiation visits, and monitoring visits

• Advise in managing clinical study budgets and payments

• Help in initiating and monitoring clinical trial studies to ensure adherence to sponsor protocol/ICH guidelines, data integrity, and regulatory compliance

INTRINSIC THERAPEUTICS INC., Woburn, MA 2007-2008

Develops safe and effective therapies for soft- tissue injuries of the spine.

Clinical Operation Consultant

• Established and promoted good working relationships with Investigators and site research staff

• Developed and directed site training during site initiation phase

• Traveled to field sites, observed cases, provided support for site research staff, prepared written reports on procedures, and ensured proper collection of data

• Supervised patient screening and enrollment at clinical sites

• Monitored Investigators’ compliance to clinical protocols and ensured adherence to GCP/ICH Guidelines, IRB requirements, the company Standard Operating Procedure (SOPs), and applicable regulations

• Worked with investigators to quickly and effectively resolve discrepancies

• Reviewed source documentation, case report forms (CRF), and data reports for accuracy

• Identified, prepared written reports and follow-up for all serious or unexpected adverse events

• Recognized problems and implemented methods to improve conduct of clinical study

• Supported company goals, objectives, policies, and procedures

INTRINSIC THERAPEUTICS INC., Woburn, MA 2004-2007

Develops safe and effective therapies for soft- tissue injuries of the spine.

Clinical Trial Manager

• Developed all aspects of Clinical Trial Processes including initiation, planning, monitoring, reporting, and deliverables

• Selected, trained, and supervised Investigators/Doctors, Clinical Research Associates (CRA), Clinical Trial Coordinators (CTC) and Clinical Study Monitors (CSM)

• Managed and monitored seven Clinical Sites and ensured that clinical trials are conducted, recorded, and reported in accordance with the clinical protocol requirements, SOPs, and ICH GCP

• Established metrics, measurable time-lines, and developed reporting procedures to track time progress

• Designed all Case Report Forms (CRF) for all clinical trials

• Reviewed, analyzed clinical data, and provided study updates for clinical team

• Generated and presented annual clinical reports, and summaries for Senior Management and Clinical Investigators

INTRINSIC THERAPEUTICS INC., Woburn, MA 2003-2004

Develops safe and effective therapies for soft- tissue injuries of the spine.

Clinical Data Analyst Consultant

• Managed and monitored five Clinical Sites and ensured that clinical trials are conducted, recorded, and reported in accordance with the clinical protocol requirements, SOPs, and ICH GCP

• Designed all Case Report Forms (CRF) for all clinical trials

• Standardized and managed data collection, data edit checks, SAE tracking, and data cleanup to ensure proper documentation and filing of clinical study

• Established and trained clinical team for the use of a Web-based Electronic Database Capture (EDC) system

• Established patients’ data binders

• Created innovative ways to identify and gather missing CRF’s or incomplete data from the investigational sites

• Reviewed, analyzed clinical data, and provided study updates for clinical team

• Generated and presented annual clinical reports, and summaries for Senior Management and Clinical Investigators

ADERANS RESEARCH INSTITUTE INC., Philadelphia, PA 2002-2003

Develops safe and effective tissue products for hair restoration. The tissue products are based upon molecular and cellular mechanisms of hair follicle growth and multiplication.

Director of Cell Biology

• Designed, initiated, and directed the research efforts on factors that are responsible for hair follicle growth and multiplication.

• Took tissue products from initial research through proof of concept and into human clinical trials.

• Developed systems and instruments for commercialization.

ANTIGENICS INC., Woburn, MA 2000-2002

Develops high efficacy, low toxicity treatments for a wide range of diseases including cancers, infectious, autoimmune and degenerative disorders.

Senior Research Manager of Technology Development

• Took products from initial research through proof of concept and into human clinical trials.

• Wrote Investigational New Drug Applications (IND’s) and coordinated preclinical data with FDA for IND submission and regulatory filling.

• Designed, initiated, and directed the CD91 Small Molecule Drug Discovery Program “CD91 is the heat shock proteins (HSP’s) receptor”. Screened combinatorial chemistry libraries to discover small molecules that would block the interaction between the HSP’s and their receptor, CD91. The goal of this program was to develop drugs for the treatment of autoimmune diseases such as diabetes, multiple sclerosis, lupus, and rheumatoid arthritis.

• Established and managed more than ten independent external academic scientific collaborations. The purpose of these collaborations was to establish the efficacy of HSP’s as vaccines in different mouse models of human diseases including cancer (Lymphoma, and Fibrosarcoma), infectious diseases (HIV, HSV1, 2, RSV, West Nile Virus, Salmonella, Yersinia, Listeria, and Malaria), and autoimmune diseases (Experimental Allergic Encephalomyelitis, Diabetes, and Lupus).

• Discovered and solved the problem of HSP’s quality control related to their biological activities.

• Reviewed scientific research proposals and budgets for contract agreements.

• Initiated and organized a scientific seminar series at Antigenics.

• Established new service contracts with pharmaceutical and biotech companies.

• Evaluated more than twenty potential in-licensing technology opportunities for Antigenics.

UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE, Seattle, WA 1992-2000

Department of Molecular Biotechnology, Laboratory of Dr. Leroy E. Hood

Senior Research Fellow

• Developed T cell receptor transgenic mice as animal models for the complex autoimmune disease, rheumatoid arthritis to address several fundamental questions including, induction of a rheumatoid arthritis-like disease; the mechanisms of tolerance induction in vivo and in vitro; and T cell activation and migration from the blood to the joints. These transgenic animals are unique animal models and may provide novel insights into the cause and treatment of human rheumatoid arthritis.

• Developed a rapid detection method of antigen-specific T cell hybridomas.

• Developed new methods to clone and sequence any rearranged TCRV , V or IgVH, V . genes.

• Established synovial endothelial cell lines and developing an in vitro system to study the molecular interaction between autoreactive T cells and synovial endothelial cells.

• Managed, trained, and supervised more than fifteen individuals with different scientific backgrounds including MD/Ph.D. fellows, Ph.D. graduate students, research associates and undergraduate students.

Scientific consultant to PHARMACIA BIOTECH INC., Milwaukee, WI (1995-1997)

• Market analysis, information presented to R&D facility.

• Field test of new technical information software.

Scientific consultant to IRVINE SCIENTIFIC INC., Irvine, CA (1995)

• Training of Field sales force in Irvine, CA

CALIFORNIA INSTITUTE OF TECHNOLOGY, Pasadena, CA 1989-1992

Division of Biology, Laboratory of Dr. Leroy E. Hood

Research Fellow

• Established the collagen-induced arthritis as an autoimmune disease mouse model system in the laboratory.

• Developed and established different strategies to specifically delete the pathogenic T cells in two autoimmune mouse model systems: collagen-induced arthritis (CIA) and experimental allergic encephalomyelitis (EAE).

PUBLICATIONS

1. El-Kholy, A., Facklam, R., Osman, G. E. and Rotta, J. 1978. Serological identification of group A streptococci from throat scraping before culture. J. Clin. Microbiol. 8, 725.

2. Ellner, J. J., Kamel, R., Olds, G. R., Osman, G. E., El-Kholy, A. and Mahmoud, A. A. F. 1980. Suppressor splenic T-lymphocytes in human Hepatosplenic Schistosomiasis mansoni. J. Immunol. 125, 308.

3. Ellner, J. J., Olds, G. R., Osman, G. E., El-Kholy, A. and Mahmoud, A. A. F. 1981. Dichotomies in the reactivity to worm antigen in human Schistosomiasis mansoni. J. Immunol. 126, 309.

4. Tweardy, D. J., Osman, G. S., El-Kholy, A., and Ellner, J. J. 1983. Abnormalities of immunosuppression in patients with hepatosplenic Schistosomiasis mansoni. Trans. Assoc. Am. Physicians 96, 392.

5. Ellner, J. J., Tweardy, D. J., Osman, G. E. et al. 1985. Increased blastogenic responses to worm antigen and loss of adherent suppressor cell activity after treatment for human infection with Schistosoma mansoni. J. Infect. Dis. 151, 320.

6. Tweardy, D. J., Osman, G. S., El-Kholy, A., and Ellner, J. J. 1987. Failure of immunosuppressive mechanisms in human Schistosoma mansoni infection with hepatosplenomegaly. J. Clin. Microbiol. 25, 768.

7. Brodeur, P., Osman, G. E., Mackle, J. and Lalor, T. 1988. Organization of the mouse IgH-V gene locus. Dispersion, interspersion, and the evolution of VH gene family clusters. J. Exp. Med. 168, 2261.

8. Osman, G. E., Wortis, H. H., and Brodeur, P. H. 1988. Strain variation in the frequency of Abelson murine leukemia virus-transformed fetal liver pre-B cells bearing complete immunoglobulin heavy chain rearrangements. J. Exp. Med. 168, 2023.

9. Osman, G. E. 1989. The effect of the X-linked immunodeficiency (xid) mutation on the fetal VH-repertoire. Ph.D. Thesis, Immunology Program, Tufts University School of Medicine, Boston, Massachusetts.

10. Hood, L., Kumar, V., Osman, G., Beall S., Gomez, C., Funkhouser, W., Kono, D., Zaller, D., Urban, J. 1989. Autoimmune disease and T cell immunologic recognition. Cold Spring Harb. Symp. Quant. Biol., 54 (2), 859.

11. Zaller, D. M., Osman, G., Kanagawa, O. and Hood, L. 1990. Prevention and treatment of murine experimental allergic encephalomyelitis with T cell receptor V -specific antibodies. J. Exp. Med. 171, 1943.

12. Osman, G. E., Brodeur, P. H., Rosenberg, N. E. and Wortis, H. H. 1992. The immunoglobulin VH repertoire of fetal liver derived pre-B cells is influenced by the expression of a gene linked to X-linked immune deficiency. J. Immunol. 148, 1928.

13. Osman, G. E., Feild, M., Cheng, K. C. and Hood, L. 1991. Characterization of the T-cell repertoire and the arthritogenic epitope(s) in collagen-induced arthritis. J. Cell. Biochem. 15A, 314.

14. Osman, G., Toda, M., Kanagawa, O., and Hood, L. 1993. Characterization of the T- cell receptor repertoire causing collagen arthritis in mice. J. Exp. Med. 177, 387.

15. Mao, C., Osman, G. E, Adams, S., and Datta, S. 1994. T cell receptor -chain repertoire of pathogenic autoantibody-inducing T cells in lupus mice. J. Immunol. 152, 1462.

16. Dattamajumdar, A., Jacobson, D., Hood, L., and Osman, G. 1996. Rapid cloning of any rearranged mouse immunoglobulin variable genes. Immunogenetics. 43, 141.

17. Dattamajumdar, A., Li, S-W., Jacobson, D., Hood, L., Ladiges, W., and Osman, G. 1996. Characterization of the mouse Tcr -V22 gene subfamily. Immunogenetics. 44, 432.

18. Osman, G., Jacobson, D., Li, S., Hood, L., Liggit, D., and Ladiges, W. 1996. T-cell receptor transgenic mouse models to study immunological tolerance in arthritis (meeting abstract). FASEB J. 10(6) 1800.

19. Osman, G., Jacobson, D., Li, S-W., Hood, L., Liggitt, H. D., and Ladiges, W. 1997. SWR: an inbred mouse strain suitable for generating transgenic mice. Lab.An.Sci. 47, 167.

20. Varma, C. K., Li, S-W., Hood, L. E., Ladiges, W., and Osman, G. E. 1997. A rapid detection of bovine type II collagen-specific T-cell hybridomas. Hybridoma. 16, 287.

21. Osman, G. E., Cheunsuk, S., Allen, S. E., Chi, E., Liggitt, H. D., Ladiges, W., and Hood, L.E. 1998. Expression of a type II collagen-specific T cell receptor transgene accelerates the onset of arthritis in mice. International Immunology. 10,1613.

22. Cheunsuk, S., Gerken, E., Osman, G., Hood, L., and Ladiges, W. 1999. Predictive parameters of joint disease in DBA/1 transgenic mice. J. Gerontol.: Biological Sciences. 54A, B271-B275.

23. Osman, G. E., Hannibal, M., C., Anderson, J., Lasky, S. R., Cheunsuk, S., Liggitt, H. D., Ladiges, C. W., and Hood, L.E. 1999. T cell receptor V deletion and V polymorphism are responsible for the resistance of SWR mouse to arthritis induction. Immunogenetics. 49, 764.

24. Osman, G. E., Hannibal, M., C., Anderson, J., Lasky, S. R., Ladiges, W., and Hood, L.E., 1999. FVB (H-2q) mouse exhibits a deletion of T cell receptor V genes and resistance to arthritis induction. Immunogenetics. 49, 851.

25. Osman, G. E. and Ladiges, W. 2000. Screening Techniques. Chapter 7 in Basic Methods in Antibody Production and Characterization. Editors; Howard G. C., and Bethel, D.R. CRC Press, Inc.

26. Ladiges, W. and Osman, G. E. 2000. Molecular Characterization of Immunoglobulin genes. Chapter 12 in Basic Methods in Antibody Production and Characterization. Editors; Howard G. C., and Bethel, D. R. CRC Press, Inc.

27. E. Kamaric, O. Yeh, A. Velagic, G. Osman, J. Einhorn, M. Vilendecic, G. Lambrecht: "Disc Collapse Following Discectomy Using a Novel Approach to Measure Intervertebral Disc Height". Global Symposium on Motion Preservation Technology, Spine Arthroplasty Society, 5th Annual Meeting, Proceedings p. 84, New York, USA, May 4-7, 2005.

28. E. Kamaric, O. Yeh, A. Velagic, G. Osman, J. Einhorn, M. Vilendecic, G. Lambrecht: "Restoration of Disc Competency by Increasing Disc Height Using an Annular Closure Device". Global Symposium on Motion Preservation Technology, Spine Arthroplasty Society, 5th Annual Meeting, Podium Presentation, Proceedings p. 35, New York, USA, May 4-7, 2005.

29. E. Kamaric, O. Yeh A. Velagic, J. Einhorn, G. Osman, M. Vilendecic MD, G. Lambrecht: " Restoration of Disc Competency by Increasing Disc Height Using an Annular Closure Device ". 20th Annual Meeting, Poster presentation #143, Philadelphia, PA, USA, September 27th – October 1st 2005.

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