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Asoke Mukherjee, HFD-***, ODE-*, CDER, FDA, Tel: 301-***-****, ********@*****.***

Address: *** ********* ***, ************, ** 20878

1. Career Objectives:

To develop strategic Biotechnology and small molecular products from research to regulatory approvals in the areas of asthma and autoimmune diseases.

2. PROFESSIONAL APPOINTMENTS

Senior Expert Pharmacologist

Anti-inflammatory, Pulmonary and Anti-allergic Drug

Products

Pharmacologist Division of Pulmonary, Allergy and

Rheumatology Products, HFD-570,

10903 New Hampshire Avenue, Silver Spring, MD 20993

Oct 2005-Present

Division of Anti-inflammatory , Analgesic and Ophthalmic Drug Products, HFD-550 (formerly PDES)

March 1993 - Sept 2005

Pilot Drug Evaluation Staff

Center for Drug Evaluation

and Research

Food and Drug Administration

April 1989 - March 1993

Pharmacologist

Division of Oncology and Radio-Pharmaceuticals, CDER, FDA

April 88 - April 1989

Research Scientist Department of Pharmacology

Smith Kline & French

King of Prussia, PA 19406

1985 - 1987

3. EDUCATION

1982 - 1984

Postdoctoral Fellow

Lung Pharmacology Training Program

Department of Pharmacology

School of Medicine

Yale University

New Haven, CT

1979 - 1982

1973 - 1978

Postdoctoral Researcher

Division of Pharmacology

College of Pharmacy

The Ohio State University, Columbus, OH

Ph.D.- Pharmacology

All-India Institute of Medical Sciences

New Delhi, India

Advisor: P.K. Gujral, M.D., Ph.D. (Harvard)

Thesis: Pharmacological Study of Sodium Curcuminate and some other analogs. Some observations on the mode of their anti-inflammatory action.

1970 - 1972

M.S. - Drug Assay

Department of Pharmacology

All-India Institute of Medical Sciences

New Delhi, India

Advisor: S. D. Seth, M.D.

Thesis: Study on some pharmacological actions of musk, an indigenous drug.

1965-1969 B. S.- Pharmacy

College of Engineering and Technology

Jadavpur University

Calcutta-32, India

Professional Experience EXPERIENCE

Regulatory and Experimental Research:

Provide leadership and consultations in the areas of autoimmune diseases and asthma on translational medicine from bench to clinic in the areas of biologics and small molecules. Expertise on developing anti-inflammatory therapies targeted to various immune pathways and development of experimental models.

Evaluation of pharmacology and toxicology data to support safety for the proposed human investigation, IND and marketing of Pharmaceuticals and biotechnology products, NDA and BLAs.

Review of Scientific data with respect to content, quality, adequacy, human risk and to contribute to recommendations regarding phase IV post marketing commitments and requirements (PMC and PMRs), necessity of developing REMS (risk evaluation and mitigation strategy).

Drugs reviewed within CDER are for the treatment of arthritis, inflammatory lung diseases and asthma, analgesics, anesthetics, neuromuscular blockers, Ophthalmic Drugs and treatment of chemical dependence.

Participated in the NDA day discussions for primary and secondary review of NDAs, Arthritis and Drug Abuse Advisory Committees on various issues related to the drug development.

Development of new guidelines and regulatory policy within the Center and for the International Harmonization of regulatory policies. Provide technical recommendation for the development of new propellants for aerosols.

4. Administrative and Management Courses:

Senior Executive Service Qualifications, Briefing

For Career in Federal Govt. May 2000

Technical writing for reviewers. Nov 1999

EEO Advisory Council Training May 1996

Successful negotiations. Oct. 1993

Team Building Workshop. Oct. 1992

Interpersonal Skills and Leadership. Dec. 1991

Effective Communication Strategies, Feb. 1989

Basic Drug and Biologics Law, Nov. 1988

Introduction to Microcomputers and DOS, June 1988

5. Managerial or supervisory Experience:

A. Planned and Participated in an organizational effort for developing self-directed work force through on-the-job training and participation in the national workshops. I peer reviewed (supervised) 4-6 pharmacologists from 1991-1994 to direct, advise and supervise pharmacologists for IND and NDA evaluation, drafting labels to confirm agency guidelines and policy, with the responsibility for signing approval letters for NDAs. Represented the Carcinogenicity Assessment Committee at the CDER. Participated in the supervisory control and other administrative responsibilities in the Division, e.g., drafting new position descriptions, employee’s performance plans and recruitment activities.

B. Recommended appropriate regulatory research on the rationale development of Ant-inflammatory drugs in the National Symposium.

C. Served as member of FDA/PMA committees on computerized data submissions, International Coalition of Chlorinated Propellant Replacement for Aerosol Products, Immunotoxicology Committee and Subcommittee for Abuse Liability Assessment for Drug Abuse Advisory Committee at FDA and Arthritis Working Groups in the Agency.

D. Member, EEO advisory Council, CDER, FDA

6. Honors

Certificate of Honor for Community Leadership

On Asian American Network, DHHS, USA

From Senator and Governor of Maryland 2005

CDER, FDA recognition Award 1999

Celebrex and Arava Review Teams

CDER, FDA Team excellence award 1999

FDA, Award of Merit as a Member of 1999

Rheumatology Working Group, FDA

FDA, Group recognition Award, 1994

LAAM review and Approval Team

National Research Award, U.S.A. 1982 - 1984

Health Services Scholarship,

Government of India 1970 - 1972

National Scholarship, Govt. of India 1965 - 1968

7. Professional and Honor Societies

Member, ASPET 1982 - Present

Executive Committee, DDDRA, ASPET 2000 - 2002

Char person, DHHS-APANET 2003 – 2005

Department of Health and Human Services

8. Any Authored Speeches and Articles: Published Research Articles: 20 (see the list attached)

9. Chapters in Books:

Mukherjee, A., Chen, C., Jean, L. and Coutinho, C.B.: Preclinical Pharmacodynamics of Anti-inflammatory Drugs. In The Integration of Pharmacodynamics, Pharmacokinetics and Toxicokinetics in Rational Drug Development. Edited by Yacobi, Shah, Skelly and Benet. Plenum Press, N.Y., 1993, pp. 105.

Mukherjee, A. and Lieberman, R.: Preclinical pharmacokinetics-pharmacodynamics and its application to the clinical development of Tacrolimus (FK-506) in organ transplantation and autoimmunity: A Review on regulatory research. In Principles of Drug Development for Transplantation and Autoimmunity. Edited by Lieberman, R and Mukherjee, A. Chapman and Hall, New York, pp 453-481, 1996.

10. Books Edited:

Principles of Drug Development in Transplantation and Autoimmunity,

Edited by Lieberman, R. and Mukherjee, A., Chapman and Hall, New York, 1996.

PUBLICATIONS: In the field of asthma, inflammation and metabolic diseases

Mukherjee, A., Saha, A.K. and Bhaduri, A.: A colorimetric method for the estimation of amylase activity in diastase preparations. J. Ind. Pharm. Mfg., 8, 337 341 (1970).

Seth, S.D., Mukhopadhyay, A., Tariq, M. and Arora, R.B.: Effect of hydrocortisone and hydrocortisone antivenene combination on plasma fibrinogen level in Russuell's viper envenomation Ind. J. Expt. Biol., 10, 357 359 (1972).

Seth, S.D., Mukhopadhyay, A., Bagchi, N., Prabhakar, M.C., and Arora, R.: Antihistaminic and spasmolytic effects of musk. Jap. J. Pharmacol., 23, 673 679 (1973)

Mukhopadhyay, A., Seth, S.D. and Bagchi, N.: Cardiac and CNS actions of musk. Ind. J. Pharm., 35, 169 170 (1973).

Seth, S.D., Mukhopadhyay, A., Ragunathan, K. and Arora, R.B.:Pharmacodynamics of musk. Monograph published by C.C.R.I.M.H., pp. 1 96, New Delhi, India (1975).

Sober, D.J., Chang, J., Fairchild, E.H., Fowble, J.W., Mukhopadhyay, A., Feller, D.R. and Miller, D.D.: Selective and potent beta adrenergic agents within the tetrahydroisoquinoline class: Effect of methyl substitution at the benzylic carbon of the 1 (3,4,5 trimethoxybenzyl) group of trimetoquinol. J. Med Chem., 24, 970 974 (1981).

Mukhopadhyay, A., Sober, D.J. Slenn, R.T., Amin, H.M., Miller, D.D. and Feller, D.R.: Bronchoselective actions of a new series of trimetoquinol analogs. Europe. J. Pharmacol., 77, 209 219 (1982).

O'Brien, M., Patel, S.T., Mukhopadhyay, A., Newman, H.A.I., Feller, D.R., Kokrady, S.S, Witiak, D.T., Lanese, R.R. and Rice, J.C.: Hypolipidemic effects of clofibrate and selected chroman analogs in fasted rats. I. Chow fed Animals Lipids, 16 903 911 (1981).

Mukhopadhyay, A., Basu, N., Ghatak, N. and Gujral, P.K.: Anti Inflammatory and irritant activities of curcumin analogs in rats. Agents and Actions, 12, 508 515 (1982).

Mukhopadhyay, A., Patel, S.T., O'Brien, M., Kodrady, S.S., Newman, H.A.I., Feller, D.R. and Witiak, D.T.: Hypolipidemic effects of clofibrate and selected analogs in fasted rats. II. High sucrose fed animals. Lipids, 18, 59 67 (1983).

Douglas, J.S., Duncan, P.G and Mukhopadhyay, A.: The antagonism of histamine induced tracheal and bronchial muscle contraction by diphenhydramine: Effect of maturation. Brit. J. Pharmacol., 83. 697 705, 1984.

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