Syed Shahabuddin, Ph. D.

847-***-**** (O) **** W Wren Court,

Libertyville, IL 60048

215-***-**** (M)

abh4u8@r.postjobfree.com

Seasoned and accomplished Pharmaceutical Research and Development

Professional possessing strong oncology and inflammation background with

extensive experience in CMC, pre-clinical and clinical drug development

project management, and CRO management. Excellent interpersonal,

communication, and leadership skills.

EXECUTIVE SUMMARY

> PhD in Immunology

> Over 25 years professional experience including:

o Nearly 8 years pharmaceutical drug development

> 6 years preclinical and clinical studies and regulatory

affairs

> 8 years project management

o Extensive academic research and teaching experience

> Experience and knowledge of biologics and small molecule drug

development

> Strong working knowledge and experience of oncology and inflammation

therapeutic areas

> Excellent ability and proven track record in scientific presentation

and publication

> Demonstrated ability to evaluate and interpret preclinical, clinical

toxicology and pharmacology data

> Knowledge of FDA, other regulatory agency and professional

requirements, regulations and guidance; Prepared regulatory documents

such as clinical trial protocols, Investigator Brochure (IB), and IND,

NDA/505(b)(2), and BLA for FDA, EMEA, MHRA, and DCGI

> Demonstrated ability to coordinate numerous external collaborative and

contract research activities

> Demonstrated strong interpersonal & matrix management leadership

skills with demonstrated abilities to work effectively in a team

environment

> Strong organizational skills and demonstrated ability to multitask

efficiently and prioritize quickly

> Demonstrated strong computer skills and knowledge with the use of PM

tools (Microsoft Project)

> Demonstrated ability to work independently as well as in highly

integrated cross functional teams

> Demonstrated strong oral and written communication skills

Professional Experience

Founder, 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.

Senior Manager, Jina Pharmaceuticals, Libertyville, IL Jun 08-

May 10

The company used proprietary formulation technology to develop marketed

drugs for oncology, infectious diseases and organ transplantion

Responsibilities and Accomplishments:

. Led pre-clinical and clinical drug development projects involving

oncology, inflammatory, and infectious diseases; responsibilities

included:

> Planning and coordination of animal efficacy,

toxicity and PK/PD studies

> 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 pre-clinical and clinical

trial studies; served as the single point of contact for all external

projects contracted to Indian CROs; Managed project timelines

. Coordinated and managed the following DCGI registered trial in India

from start to submission:

Syed Shahabuddin, Ph. D. Page two

1. An open label, single oral dose study to evaluate the

tolerability and pharmacokinetics of Amphotericin-B 25 mg

enteric coated tables in healthy adult human male subjects under

fasting conditions

2. An open label, single oral dose study to evaluate the

tolerability and pharmacokinetics of Amphotericin-B 150 mg (6 x

25 mg) enteric coated tables in healthy adult human male

subjects under fed and fasting conditions

3. An open label, balanced, randomized two-period, two-treatment,

two-sequence, and two-way crossover study to evaluate safety and

pharmacokinetic comparison of intravenous infusion of Paclitaxel

Lipid Suspension and Taxol in patients with metastatic breast

cancer

4. An open label, single dose, randomized, parallel study to

evaluate the tolerability and pharmacokinetic comparison of

intravenous infusion of Tacrolimus Lipid Suspension (Test

Product) and Prograf (Reference product) in healthy adult human

male subjects

5. A phase I, open label, oral, single-dose, escalating,

randomized, parallel study to evaluate safety, tolerability and

pharmacokinetics of Endoxifen and Tamoxifen in healthy adult

human male and female subjects under fasting conditions

6. An open label, balanced, randomized, two-period, two-treatment,

two-sequence, and two-way crossover study to evaluate safety and

pharmacokinetic comparision of intravenous infusion of Docetaxel

Lipid Suspension and TAXOTERE in advanced solid tumor patients.

. 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

. Followed and implement ICH, EMEA, FDA, GLP, GMP and GCP

guidelines

Consultant, Drug Development, Ovation Pharmaceuticals, Deerfield, IL Mar

08-May 08 (2 m contract)

The company was committed to having a significant impact on patients' lives

through its focus on central nervous system (CNS), and hematology/oncology

therapeutics.

Responsibilities and Accomplishments:

. Operational execution of clinical studies (Phases I-III), including

project timelines, and resources.

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:

. Developed 250 task preclinical project Gantt chart from Ab production

to IND submission

. Oversaw conjugated antibody non GLP preparation, characterization,

specific binding, and cell based potency assays

. 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, immunoreactivity, and PK/PD

o Release and stability testing

o Large scale conjugated Ab drug manufacturing

. Developed and reviewed Investigator Brochure for IND

. Managed timelines and project budget

. Provided critical activity status updates to senior management

. Involved in companies new business development/alliances for their

proprietary Dynamic Crosslinking Technology (DXLTM)

Syed Shahabuddin, Ph. D. Page three

Project Manager, R&D, NeoPharm, Waukegan, IL Aug 05-

Jun 07(~2 y)

The company's goal was to develop cancer therapeutics including recombinant

protein CINTREDEKIN BESUDOTOX (IL13-PE38) for Glioblastoma (Phase III) and

several liposome encapsulated approved cancer therapeutics for a variety of

malignancies (pre-IND, Phase I-II).

As a project manager in R&D/PDM, my responsibility was to manage and

coordinate process development and manufacturing activities of all NeoPharm

therapeutic portfolios following cGMP guidelines.

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 (pre-IND, 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

. Exercised leadership, matrix management role through conducting team

meetings, monitoring progress, and reporting to management on project

deliverables

. Developed Gantt charts to monitor project activities

. Managed cross-functional project timelines

. 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

. 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

Jan 03-Jun 05 (21/2 y)

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

. In addition, collaborated several projects with investigators within

Temple University (e.g., effects of cigarette smoke extract on

chemokine and MMP release by HAEC).

. Trained postdoctoral fellows and technologists

Senior Scientist, EpiGenesis Pharmaceuticals, Princeton, NJ

Feb 01-Aug 02 (~2 y)

Company 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) using

realtime PCR, ELISA and flow cytometry

. Discovered numerous positive candidates, however chose 2-5 candidates

for in vivo testing in mouse ovalbumin asthma model

. Moved 2 candidate anti-eotaxin and anti-CCR3 drugs in asthma model for

validation

. Recommended novel therapeutic targets as a member of EpiGenesis core

committee

. Supervised two technologists

Syed Shahabuddin, Ph. D. Page four

Assistant Professor and Senior Scientist, Department of Pathology,

College of Medicine, and Armed

Forces Hospital, Riyadh, Saudi Arabia 1991- 97 (6 y)

Consultant, Department of Pathology, Asir Hospital, Abha, Saudi Arabia

1987-89 (2 y)

Reader, Department of Life Sciences, University of Bombay, India

1984-87 (31/2 y)

EDUCATION

Ph.D. University of Manchester, UK (1983)

Postdoctoral Fellowship Southern Illinois University School of

Medicine, Springfield, IL (1989-91)

Postdoctoral Fellowship Johns Hopkins University School of Medicine,

Baltimore, MD (1997-01)

Professional Affiliations

American Academy of Asthma, Allergy, and Immunology

(AAAAI)

American Society of Pharmaceutical Scientists (AAPS)

American Association of Immunologists (AAI)

American Society for Microbiology (ASM)

Clinical Immunology Society, (CIS)

Drug Information Association (DIA)

Publications and patents

More than 30 publications in peer reviewed journals and 3

patents

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

Syed Shahabuddin, Ph. D. Page five

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. 2006. CXCR3 Surface Expression in Human Airway

Epithelial Cells: Cell Cycle Dependence and Effect on Cell

Proliferation. Am J Physiol Lung Cell Mol Physiol. 290(5): L909-18

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. 291(1): C34-9.

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 (accepted)

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