Project Manager Quality Assurance

Syed Shahabuddin, PhD

847-***-**** (H) **** W Wren Court, Libertyville, IL 60048

215-***-**** (M) ********@*******.***

Seasoned and accomplished Life Scientist possessing 15+ years experience, with 10+ years in biopharmaceutical industry environment combined with over five years of experience as a primary author writing regulated scientific documents. Demonstrated knowledge and experience in a combination of regulatory and scientific writing including Manuscripts, Abstracts, Posters, Research Reports, Clinical Study Reports/Synopses/Protocols/Investigator brochure, Regulatory Documents for INDs, NDAs, ANDAs, BLAs and annual reports. Managed multiple and diverse projects concurrently and demonstrated ability to develop relationships and generate internal and external collaborations. Excellent leadership skills and strong management experience demonstrated through direct reports and crross functional matrix.

PROFESSIONAL EXPERIENCE

Consultant, PristinePharma, LLC, Libertyville, IL May 10-Present

PristinePharma, LLC is a contract research organization (CRO) and consulting company providing customized drug development services to the global biopharmaceutical industry. The company combines strategic consulting, project management, medical writing, and regulatory support with outsourced CRO services to facilitate drug development.

Responsibilities and Accomplishments:

Provide road map and strategic plan for small molecule and biologic drug development

Identify and manage most appropriate CRO per customer needs and budget

Provide consulting in all phases of the FDA product review and approval process

Prepare study documents, including protocols, reports, and presentations

Senior Manager, Jina Pharmaceuticals, Libertyville, IL 2008-2010

The company used proprietary formulation technology to develop marketed drugs for oncology, infectious diseases and organ transplantion

Responsibilities and Accomplishments:

• Led clinical drug development projects involving oncology, inflammatory, and infectious diseases; responsibilities included:

Preparation of investigator’s brochure, clinical trial Phase I/II protocol, protocol synopsis, and other documents for IND and NDA/505(b)(2)

Preparation of intellectual property documents

• Designed, coordinated, managed and monitored clinical trial studies; served as the single point of contact for all external projects contracted to Indian CROs; Managed project timelines

• Manage multiple and diverse projects concurrently

• Set agendas, conducted project team meetings, including international teleconferences, and prepared meeting minutes

• Coordinated and managed the six clinical trials in India from start to submission

• Worked with senior management and project team leaders to create and execute comprehensive development plans for investigational drugs

• Provided critical activity status updates to senior management

Project Manager, Preclinical, InNexus Biotechnology, Scottsdale, AZ Jun 07-Nov 07 (5 m contract)

The company planed to develop antibody therapeutics against Non-Hodgkin Lymphoma and Breast Cancer by conjugating anti-CD20 and anti-Her2 monoclonal antibodies with a homodimerizing peptide with a premise to produce higher potency antibody drug.

Responsibilities and Accomplishments:

• Oversaw conjugated antibody non GLP preparation, and characterization

• Facilitated and coordinated Ab efficacy study including protocol development in xenograft tumor mouse model; served as the single point of contact for all external projects contracted to CROs

• Worked with several CROs and CMOs for developing IND enabling studies such as:

o selection of most appropriate species

o animal toxicity, PK/PD, and immunoreactivity/immunogenicity

o pharmacodynamic biomarker evaluation

o release and stability testing

o large scale conjugated Ab drug manufacturing

• Developed and reviewed Investigator Brochure for IND

• Initiated IND application

• Managed timelines and project budget

• Managed a cross functional team in matrix environment

• Involved in companies new business development/alliances for their proprietary Dynamic Crosslinking Technology (DXLTM).

Project Manager, R&D, NeoPharm, Waukegan, IL 2005- 2007

The company’s goal was to develop cancer therapeutics including biologic product recombinant CINTREDEKIN BESUDOTOX (IL13-PE38) for Glioblastoma (Phase III) and several liposomal small molecules for a variety of malignancies (pre-IND, Phase I-II).

Responsibilities and Accomplishments:

• Led process development and manufacturing of cancer therapeutics including recombinant protein CINTREDEKIN BESUDOTOX (IL13-PE38) conjugated protein (in Phase III) and several liposome encapsulated cancer drugs (Phase I-II)

• Worked with senior management and project team leaders to create and execute comprehensive development plans for investigational drugs

• Developed and reviewed SOPs

• Coordinated and monitored numerous external collaborative and contract research activities; served as the single point of contact for all external projects contracted to CROs and CMOs

• Set agendas, conducted project team meetings, and prepared meeting minutes

• Exercised leadership, matrix management role, monitoring progress, and reporting to management on project deliverables

• Developed Gantt charts to monitor project activities

• Managed a cross functional team in matrix environment

• Developed project budgets and manage project expenses against approved budget

• Developed and reviewed progress report for regulatory documentation

• Worked in conjunction with Quality Assurance Unit to identify and implement process improvement for study execution and documentation

• Member BLA task force, steering committee, and Project Management team

• Prepared regulatory documents such as CTD and BLA for FDA (USA), EMEA (EU), MHRA (UK),

• Followed and implemented ICH, EMEA, FDA, GLP, GMP and GCP guidelines

• Participated in company’s propriety technology licensing meetings

Assistant Professor of Med, Temple Univ Sch of Med, Philadelphia, PA 2003-2005

The aim of the project was to study chemokine receptor (CXCR3) in human airway epithelial cells (HAEC) to evaluate its role in airway inflammatory diseases such as asthma and COPD.

Responsibilities and Accomplishments:

• Investigated CXCR3 mRNA and cell surface expression, CXCR3 ligands (ITAC, IP10, Mig) induced cell migration and signal transduction in a primary and a transformed HAEC

• Conducted several projects in collaboration with investigators within Temple University (e.g., effects of cigarette smoke extract on chemokine and MMP release by HAEC).

• Trained and managed postdoctoral fellows and technologists

Senior Scientist, EpiGenesis Pharmaceuticals, Princeton, NJ 2001-2002

Company’s goal was to develop antisense oligonucleotide drugs targeting chemokines and chemokine receptors for asthma, allergic rhinits, and COPD.

Responsibilities and Accomplishments:

• Designed and screened 900 oligos targeting chemokines (Eotaxin, RANTES, and MCP-4) and chemokine receptors (CCR1 and CCR3)

• Discovered numerous positive candidates; advanced 2-5 candidates to in vivo testing in ovalbumin induced asthma mouse model

• Moved 2 candidate anti-eotaxin and anti-CCR3 drugs in asthma mouse model for validation; studied specific pro-inflammatory cytokines, chemokines, and chemokine receptor expression as pharmacodynamic biomarkers to evaluate the efficacy of candidate antisense

• Recommended novel therapeutic targets as a member of EpiGenesis core committee

• Managed and mentored two direct reports and a team in cross functional environment

Assistant Professor and Senior Scientist, Department of Pathology, College of Medicine, and Armed

Forces Hopital, Riyadh, Saudi Arabia 1991- 1997

• Studied the role of numerous cytokines and adhesion molecules as potential pharmacodynamic biomarkers in asthma and cancer patients

• Managed and mentored eight direct reports

Consultant, Department of Pathology, Asir Hospital, Abha, Saudi Arabia 1987-1989

• Evaluated several established markers, e.g, AFP, -HCG, CEA, CA-125, and CA-19.9 for the diagnosis and prognosis of a variety of malignancies in on chemotherapy

• Managed and mentored two direct reports

Reader, Department of Life Sciences, University of Bombay, India 1984-1987

• Evaluated angiogenesis factor as tumor markers in solid human malignancies

• Managed and mentored five direct reports

EDUCATION

Ph.D. (Immunology) University of Manchester, UK

Postdoctoral Fellowship Southern Illinois University School of Medicine, Springfield, IL

Postdoctoral Fellowship Johns Hopkins University School of Medicine, Baltimore, MD

INVITED SPEAKER

Biosimilars and Follow-On Biologics Americas, Feb 28-March 2 2011, Boston, MA

Topic: Unwanted immunogenicity of biosimilars

University of Arizona, Tuscon, Sep 2007

Topic: Biotech and enterpreneurship

Center for Substance Abuse Research (Annual Retreat), Temple Univ, Philadelphia, PA March 2005

Topic: Chemokine receptors in airway diseases at their role in airway inflammation

PROFESSIONAL AFFILIATIONS

American Academy of Asthma, Allergy, and Immunology (AAAAI)

American Society of Pharmaceutical Scientists (AAPS)

American Association of Immunologists (AAI)

Clinical Immunology Society (CIS)

Drug Information Association (DIA)

PUBLICATIONS AND PATENTS: More than 30 publications in peer reviewed journals

Selected Publications

1. Shahabuddin S, Rao AR, and Mustafa AS. 1980. Effects of Arecoline on the immune response in mice. Ind J Exptl Biol 18:1493-1994.

2. Shahabuddin S and Kumar S. 1983. Quantitation of angiogenesis factor in bovine retina and tumour extracts by means of radioimmunoassay. Br J Ophthal 67:286-291.

3. Kumar S, West D, Shahabuddin S, Arnold F, Haboubi N, and Reed H. 1983. Angiogenesis factor from human myocardial infarct. Lancet II: 364-368.

4. Shahabuddin S, Arnold F, Costelo CB, and Kumar S. 1984. Tumour angiogenesis factor in urological cancers. Br J Urology 56:490-494.

5. Shahabuddin S, Kumar S, West D, and Arnold F. 1985. A study of angiogenesis factors from five different sources using a radioimmunoassay. Int J Cancer 35:87-91.

6. Shahabuddin S. 1991. Expression and release of IL-2 receptor and production of IL-2 by activated T Lymphocytes subsets. J Clin and Lab Immunol 36:27-32.

7. Shahabuddin S. 1993. Expression of IL-2 receptor subunit p55 (CD25) on normal human lymphocytes. J Clin Immunol Immunopathol 69 (2): 175-179.

8. Shahabuddin S. 1995. Quantitative differences in CD8+ T lymphocytes, CD4/CD8 ratio, NK cells and HLA-DR+ activated T Cells of racially different male populations. J Clin Immunol Immunopathol 75 (2): 168-170.

9. Shahabuddin S, Al-Ayed I, El-Rab Gad MO, and Qureshi MI. 1998 Lymphocyte subset reference ranges in healthy Saudi Arabian children. J Ped Allergy Immunol. 9: 44-48.

10. Beck LA, Stellato C, Shahabuddin S, Nickel R, and Schleimer RP. 2000. The role of chemokines in allergic diseases of the airways. In: Progress in inflammation research. MJ Parnham; ed., Birkhauser Verlag AG: publisher. pp. 109-118.

11. Shahabuddin S, Ponath P, and Schleimer RP. 2000. Migration of eosinophils across endothelial cell monolayers: Interactions among IL-5, endothelial activating cytokines and C-C chemokines. J Immunol. 164(7): 3847-3854

12. Lee SC, Brumet ME, Shahabuddin S, Woodworth TG, Georas SN, Leiferman KM, Gilman SC,

Glaudue RP, Schleimer RP, and Beck LA. 2000. Cutaneous injection of macrophage inflammatory

protein-1a into human subjects induces significant recruitment of neutrophils and monocytes.

J Immunol. 164(6): 3392-3401

13. Stellato C, Brummet M, Plitt J, Shahabuddin S, Baroody F, Liu M, Ponath P, and Beck L. 2001.

Expression of the CC Chemokine Receptor CCR3 in Human Airway Epithelial Cells. J Immunol. 166: 1457-1461.

14. Kelsen SG, Aksoy MO, Yang Y, Shahabuddin S, Litvin J, Safadi F, and Rogers TJ. 2004. The Chemokine receptor, CXCR3, and its slice variants are expressed in human airway epithelial cells. Am J Physiol Lung Cell Mol Physiol. 287(3): L584-91

15. Aksoy MO, Yang Y, Ji R, Reddy PJ, Shahabuddin S, Litvin J, Rogers, TJ, and Kelsen SG. 2005. CXCR3 Surface Expression in Human Airway Epithelial Cells: Cell Cycle Dependence and Effect on Cell Proliferation. Am J Physiol Lung Cell Mol Physiol. Dec 16

16. Shahabuddin S, Ji R, Wang P, Brailoiu E, Dun N, Yang Y, Aksoy MO, and Kelsen SG. 2006. CXCR3 Chemokine Receptor-Induced Chemotaxis in Human Airway Epithelial Cells:Role of p38 MAPK and PI3K Signaling Pathways. Am J Physiol Cell Physiol. Feb 8

17. Shoukath M Ali; Ahmad A; Shahabuddin S; Ahmad MU. 2010. Endoxifen is a new potent inhibitor of PKC: A potential therapeutic agent for bipolar disorder. Bioorganic & Medicinal Chemistry Letters. 20(8):2665-7

18. Ahmad A, Shahabuddin S, Sheikh S, Kale P, Manjunath K, Rane, RC and Ahmad I. 2010. Endoxifen a New Cornerstone for Breast Cancer Therapy: Demonstration of Safety, Tolerability and Systemic Bioavailability in Healthy Human Subjects. Clinical Pharmacology & Therapeutics. 88(6):814-817

Selected Abstracts

1. Shahabuddin S. 1992. Expression of IL-2 receptor p55 subunit of unstimulated peripheral blood mononuclear cells of normal blood donors. J Leuk Biol Suppl 3. Abs. 3;3.

2. Shahabuddin S. 1993. Activated T Lymphocytes subsets express and release variable quantities of IL-2 receptor and IL-2. J Immunol 150 (8/II), 130A.

3. Shahabuddin S, Zwaan FE, Jeha MT, and Sargent A. 1994. Myeloid surface antigen expression in acute lymphoblastic leukemia. J Immunol 152, 3212.

4. Shahabuddin S and Qasim M. 1996. Soluble interlukin-2 receptor levels patients with treated and untreated malignancies. FASEB J 10 (5), 1294.

5. Qasim M and Shahabuddin S. 1996. Soluble ICAM-1, Selectins and CD44 in human malignancies.

FASEB J 10(5), 2695.

6. Shahabuddin S, Ponath P, Plitt J, Bickel C, and Schleimer RP. 1999. Eosinophil transendothelial migration in vitro: Synergism between endothelial activators and chemokines.

J Allergy Clin Immunol 103, S184.

7. Shahabuddin S, Plitt J, Barnett MS, Brawner M, and Schleimer RP. 1999. Evidence for mRNA expression of chemokine receptors CCR4 and CXCR4 in endothelial cells. FASEB J 13(5), A657.

8. Shahabuddin S, Plitt J, Stellato C, Beck LA, Barnett MS, Brawner M, and Schleimer RP. 2000. Expression of CC-chemokine receptors in the human bronchial epithelial cell line BEAS-2B. J Allergy Clin Immunol.105: A1108

9. Tang L, Wild JS, Aguilar D, Shahabuddin S, Cong H, Liu, J, Hwang O, Nyce JW, and Van Scott, MR. 2003. Antisense-mediated inhibition of eotaxin expression: a therapeutic strategy for inhibiton of eosinophilic inflammation in asthma. Keystone Symposium Drug Target Validation: Gene Suppression. A305.

10. Shahabuddin S, Aksoy MO, Yang Y, Au A, Ji, R, and Kelsen SG. 2004. The Chemokine Receptor CXCR3, induces Airway Epithelial cell Migration and Affects alpha5 beta1 integrin. Am. J. Res and Crit care Med. 169 (7) A 565

11. Aksoy MO, Yang Y, Shahabuddin S, Ji R, Rogers TJ, and Kelsen SG. 2004. Surface expression of the chemokine receptor, CXCR3, in human airway epithelial cells is Cell-Cycle dependent. Am. J. Res and Crit Care Med. 169 (7) A 564

12. Shahabuddin S, Wang P, Ji R, Yang Y, Aksoy MO, Kelsen SG. 2005. Signal Transduction Pathways Involved in CXCR3-Mediated Chemotaxis of Normal Human Bronchial Epithelial Cells (NHBEC). Proc Am Thoracic Soc 2:A104.

13. Wang P, Shahabuddin S, Ji R, Yang Y, Aksoy MO, Bardi G, Kelsen SG. 2005. Regulation of CXCR3 Expression and Function in Human Airway Epithelial Cells (HAEC). Proc Am Thoracic Soc 2:A104.

14. Gaddapara T, Aksoy MO, Shahabuddin S, Ji R, Yang Y, Kelsen SG. 2005. The Acute Effects of Cigarette Smoke Extract on the Release of CXC Chemokines and Matrix Metalloproteinases (MMP) by Human Airway Epithelial Cells. Proc Am Thoracic Soc 2:A104.

15. Ji R, C. Lee, Yang Y, Aksoy MO, Wang P, Shahabuddin S, Kelsen SG. 2005. Inhibition of CXCR3 Expression in Non-Small Lung Cancer by RNA Interference. Proc Am Thoracic Soc 2:A104.

16. Ahmad A, Shahabuddin S, Sheikh S, Kale P, M. K, R. C. Rane RC, Ahmad I. 2010. First-in-human study evaluating safety and pharmacokinetics of endoxifen, a potent estrogen-receptor antagonist for breast cancer. J Clin Oncol 28:15s, (suppl; abstr 3087)

Presentations

Annual Conference of Indian Immunology Society, Hyderabad, India. 1985

Shahabuddin S and Kumar S. Demonstration of antigenic similarity among angiogenic factors from various sources.

Annual Conference of Indian immunology Society, New Delhi, India. 1986

Shahabuddin S. Detection and quantitation of an angiognenesis factor by radioimmunoassay.

Annual meeting American Society for Microbiology, Dallas, TX. 1991

Shahabuddin S, Tewari RP, and Khardori N. Role of Surface Molecules in Adherence of Histoplasma capsulatum to human Umbilical Vein Endothelial cells.

2nd International Congress on Cytokines: Basic principles and Clinical Applications.

Florence, Italy. 1992

Shahabuddin S. Effects of Cytokines on proliferative Response of Human CD4+ T Lymphocyte subsets.

Twenty-ninth national meeting of Society for Leukocyte Biology. Charleston, SC 1992

Shahabuddin S. Expression of IL-2 receptor p55 subunit on unstimulated peripheral blood mononuclear cells of normal blood donors.

Annual meeting of American Association of Immunologists. Denver, CO. 1993

Shahabuddin S. Activated T Lymphocyte subset express and release variable quantities of IL-2 receptor and IL-2.

International Cancer Congress. New Delhi, India. 1994

Shahabuddin S, Zwan FE, Jeha MT, and Sargent A. Expression of myeloid surface antigens in on of myeloid surface antigens in acute lymphoblastic leukemia. XVI

9th Annual Conference on Clinical Immunology, Anaheim, CA. 1994

Shahabuddin S, Zwaan FE, Jeha MT, and Sargent A. Myeloid surface antigen expression in acute lymphoblastic leukemia.

12th European immunology meeting, Barcelona, Spain. 1994

Shahabuddin S, Zwaan FE, Jeha MT, and Sargent A. Aberrant Immunophenotypes in acute lymphoblastic leukemia.

Annual meeting of American Association of Immunologists, New Orleans, LA 1996

Shahabuddin S and Qasim M. Soluble interleukin-2 receptor levels in patients with treated and untreated malignancies.

Annual meeting of American Association of Immunologists. New Orleans, LA 1996

Qasim M and Shahabuddin S. Soluble ICAM-1, Selectins and CD44 in human malignancies.

Annual meeting of AAAAI, Orlando, FL. 1999

Shahabuddin S, Ponath P, Plitt J, Bickel C, and Schleimer RP. Eosinophil transendothelial migration in vitro: Synergism between endothelial activators and chemokines.

Experimental Biology meeting, Washington, DC. 1999

Shahabuddin S, Plitt J, Barnett MS, Brawner M, and Schliemer RP. Evidence for mRNA expression of chemokine receptors CCR4 and CXCR4 in endothelial cells.

Annual meeting of AAAAI, San Diego, CA. 2000

Shahabuddin S, Plitt J, Stellato, C, Beck L, Barnett MS, Brawner M, and Schleimer RP. Expression of CC-chemokine receptors in human bronchial epithelial cell line BEAS-2B.

ATS International Conference, Orlando, FL 2004

Shahabuddin S, Aksoy MO, Yang Y, Ji R, and Kelsen SG. The Chemokine Receptor, CXCR3,

Induces Human Airway Epithelial Cell Migration and Affects 5 1 Integrin Expression.

Aksoy MO, Yang Y, Shahabuddin S, Ji, R, Rogers, TJ Kelsen SG. Surface expression of the

Chemokine receptor, CXCR3, in human airway epithelial cells is Cell-Cycle dependent.

ATS International Conference, San Diego, CA. 2005

Shahabuddin S, Wang P, Ji R, Yang Y, Aksoy MO, and Kelsen SG. 2005. Signal Transduction Pathways Involved in CXCR3-Mediated Chemotaxis of Normal Human Bronchial Epithelial Cells (NHBEC).

Wang P, Shahabuddin S, Ji R, Yang Y, Aksoy MO, Bardi G, and Kelsen SG. 2005. Regulation of

CXCR3 Expression and Function in Human Airway Epithelial Cells (HAEC).

Gaddapara T, Aksoy MO, Shahabuddin S, Ji R, Yang Y, and Kelsen SG. 2005. The Acute Effects of

Cigarette Smoke Extract on the Release of CXC Chemokines and Matrix Metalloproteinases (MMP)

by Human Airway Epithelial Cells.

Ji R, Lee C, Yang Y, Aksoy MO, Wang P, Shahabuddin S, and Kelsen SG. 2005. Inhibition of

CXCR3 Expression in Non-Small Lung Cancer by RNA Interference.

American Society for Clinical Pharmacology & Therapeutics 111th Annual Meeting, Atlanta, GA. 2010

Ahmad A, Shahabuddin S, Sheikh S, Kale P, Rane R, Ahmad I. 2010. First-In-Human Study of endoxifen: Oral escalating single dose of endoxifen, a potent estrogen-receptor antagonist for breast cancer is safe, tolerable and systemically bioavailable in healthy human subjects.

ASCO Annual Meeting, Chicago, IL 2010

Ahmad A, Shahabuddin S, Sheikh S, Kale P, Rane R, Ahmad I. 2010. First-in-human study evaluating safety and pharmacokinetics of endoxifen, a potent estrogen-receptor antagonist for breast cancer.

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