Clinical Manager

KAKUBHAI ROSH VORA, Ph.D.

*** ************ ******

Westfield, NJ 07090

Phone: 908-***-**** (Cell)

Phone: 908-***-**** (Home)

E-mail: *********@*****.***

OBJECTIVE:

To obtain a managerial position in the field of Clinical Research in

product development that presents challenges and requires dedicated hard

work and innovative approaches to solve problems.

SUMMARY & QUALIFICATIONS:

Articulate, innovative, pharmaceutical professional with extensive

experience in development, monitoring and management of multiple clinical

research projects in a variety of therapeutic fields with successful

outcome. Therapeutic areas of expertise include respiratory diseases,

dermatology, acute and chronic pain management, oncology and the various

gastrointestinal and rectal conditions. Obtained 13 Rx product approvals

from FDA in the last 7 years at G&W Lab. Successfully monitored clinical

studies in the development of two new chemical entities NDA's at Chemex

Pharmaceuticals. Have developed protocols for clinical studies and

developed clinical reports. Also acquired extensive experience in

manufacturing and packaging products for human clinical studies. Thorough

understanding and knowledge of GMP's, GLP's and GCP's. Have successfully

interacted with the FDA in various capacities. I possess strong

communication skills and effective inter-personal skills that build

relationships, motivate others and generate enthusiasm. A team player who

thrives in a challenging environment. Highly experienced in CRO development

of clinical trials including all aspects of the clinical studies.

SKILLS:

Proficient in Microsoft Word, Excel, Power-point slides, internet searches,

database management, SOPs, technical reports and organization of technical

meetings.

PROFESSIONAL EXPERIENCE:

G&W Laboratories, South Plainfield, New Jersey

1996 to 2009

In charge of clinical studies and product development: Performed

BA/BE clinical trials of rectal suppositories (promethazine and

mesalamine) and topical dermatological products (corticosteroid and

antifungal drugs). Monitored studies at investigation sites and reviewed

study outcomes with FDA. Was in charge of acquiring, randomizing,

labeling, shipping and accounting of all clinical supplies. Obtained FDA

approval of ANDA's. Selected and supervised CROs in all aspects of

clinical trials. Completed trials within budget on time.

Block Drug Company, Jersey City, New Jersey 1995 to

1996

Manager, Product Development: Developed drug products, prepared clinical

supplies for clinical studies: Hydrocortisone acetate 2.5% rectal foam

and Homeopathic Nytol tablets.

Chemex Pharmaceuticals, Inc., Fort Lee, New Jersey

1987 to 1995

Developed new chemical entity drug Rx products (Actinex and Amlexanox),

prepared and supplied all clinical supplies, monitored clinical studies

and submitted reports to NDA on each product. Both NDA's were approved by

FDA. Chemex was acquired by Block Drug Company.

EDUCATION & LICENSES:

M.S. and Ph.D., Pharmacy, University of Maryland

B.S., Pharmacy, Gujarat University, India and University of Michigan

Licensed as Registered Pharmacist in New Jersey &

Florida

ACHIEVEMENTS:

1. Prescription Products: Approved NDAs/ANDAs

(1) Actinex (10% masoprocol) topical cream - NDA 19940 from Chemex.

Approved 9/4/1992.

(2) Amlexanox (5%) oral paste - a cure for canker sores, minor

aphthous ulcers. NDA 21727 from Chemex. Approved 9/29/2004.

Marketed by Swarz Pharma as Aphthasol.

(3) Hydrocortisone Acetate (2.5%) Aerosol Foam - topical anti-

inflammatory: Filed ANDA from Block Drug Company.

(4) Promethazine 25mg and 12.5mg Suppositories - ANDAs from G&W Labs.

Approved 2/5/2002.

(5) Fluticasone propionate 0.05% Cream: ANDA 77055 from G&W Labs.

Approved 6/30/2006.

(6) Fluticasone propionate 0.005% Ointment: ANDA 77168 from G&W Labs.

Approved 3/3/2006.

(7) Mometasone furoate 0.1% Ointment: ANDA 77401 from G&W Labs.

Approved 6/20/2006.

(8) Mometasone furoate 0.1% Cream: ANDA 77447 from G&W Labs. Approved

5/22/2006.

(9) Mometasone furoate 0.1% Lotion: ANDA 77678 from G&W Labs.

Approved 11/21/2007.

(10) Indomethacin 50 mg Suppositories: ANDA 73314 from G&W Labs.

Revision approved 2008.

(11) Halobetasol propionate 0.05% ointment: ANDA 77721 from G&W Labs.

Approved 9/7/2006.

(12) Halobetasol propionate 0.05% Cream: ANDA 78162 from G&W Labs.

Approved 4/24/2007.

(13) Ciclopirox 8% Topical Solution Nail Lacquer: ANDA 78233 from G&W

Labs. Approved 9/18/07.

(14) Metronidazole 0.75% Cream: ANDA 77549 from G&W Labs. Approved

12/19/2007.

2. Prescription Products: ANDAs Awaiting FDA Approval at G&W Labs:

(1) Metronidazole 0.75% Gel: ANDA filed 02/22/2006.

(2) Calcipotriene 0.005% Scalp Solution: ANDA August 2006.

(3) Ciclopirox olamine 1% Cream: ANDA August 2006.

3. Investigational drug products, which were clinically tested in humans

(Per IND Protocols) for Chemex Pharmaceuticals:

(1) EPC-K1: Antiallergic (Topical formulas)

(2) Masoprocol: Antioxidant, Free radical scavenger (Topical

formulas)

(3) Meso-nordihydroguaiaretyl tetrapivalate: Anti-inflammatory

(Topical formula)

(4) Meso-nordihydroguaiaretyl tetrapropionate: Anti-inflammatory

(Topical formula)

(5) Amlexanox: Antiallergic (Topical and oral formulas)

(6) TCV-309: PAF antagonist (Topical formula)

(7) Spectinomycin: Antibiotic (Topical formula)

(8) Glyceryl-3-phosphate,tri(cyclohexylammonium) salt: Antiallergic

(Topical Formula)

AFFILIATIONS:

American Academy of Dermatology; American Association of

Pharmaceutical Scientists; American Pharmacists Association; Drug

Information Association; Regulatory Affairs Professional Society.

KEY WORDS:

Clinical research, clinical trials, project management, product

development, dermatology, topical, oral solids, semisolids, ANDA, NDA,

clinical protocols, reports, randomization, labeling, clinical

supplies, study monitors, CRA, cancer, oncology, injectable, pharmacy,

pharmacist, drugs, scientist

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