Project Manager Development

Asit Datta, Ph.D. MBA

E-mail: abiv68@r.postjobfree.com, Tel: 91-983*******

[A US citizen temporarily residing in India. Not necessarily need any

additional relocation assistance]

SUMMARY

Twenty years of broad-based experience in managing strategic developmental

activities in pharmaceutical and diagnostic sectors, including clinical and

operational management, biotechnological reagent and product development,

technology assessment, and in scientific marketing, in the US and Indian

healthcare industry. Extensive experience in interacting with global

opinion leaders, customers, vendors, and in making presentations in

worldwide symposia. Served thrice on NIH Review Panels on Biodefense.

Invited to serve on Wellcome Trust (UK) Review Panel to provide expert's

opinion on scientific proposals. Demonstrated ability to interact with

diverse cross-functional groups within and outside organization, and with

overseas affiliates. Senior level experience in developing and managing

strategic long-range plans.

EXPERIENCE

Director, Calcutta Business School (Oct 2009 - Present)

Lead the operational and academic activities of a newly-founded residential

post-graduate business school to a world-class Center for Excellence,

oversee the Management Development Center for corporate executives,

implement healthcare management program. Identify and allocate resources.

Strategize developmental plans. Collaborate with industry and academia to

develop integrated management education program. Foster collaborative

activities with overseas institutions. Serve on the Indian Chamber of

Commerce Expert Committee on Education and Training

Senior Director of Strategic Projects, Dr. Reddy's Laboratories (India)

(2007 - 2009)

Manage cross-functional strategic product development, launching, and

licensing activities for differentiated products for global market. Liaise

with opinion leaders, collaborators; coordinate clinical,

pharmacovigilance, and regulatory activities worldwide to execute a

seamless process for clinical trials

ABBOTT LABORATORIES, USA (1991-2006)

Sr. Clinical Project Manager/Operation Manager

. Develop post-marketing clinical strategies for anti-infectives, formulate

long-range plans and project scopes and present to Sr. Executives for

portfolio analysis

. Manage clinical projects, publication plans, interact with CROs,

pharmacovigilance staff, and opinion leaders

. Serve on Clinical Operation sub-committees to strategize continuous

process improvements

. Establish and manage annual project budgets

. Coordinate timely completion of regulatory submissions

Clinical Project Manager

. Develop strategic post-marketing clinical plans for Cardiovascular &

Anesthesia products

. Administer investigator-initiated trials and Registry programs, including

physician and CRO interaction, publication plans, financial management,

and overall project management

. Coordinate post-marketing clinical trials with medical liaisons and

worldwide affiliates

. Critically examine proposals for scientific validity

. Develop procedures and database to disseminate information and track

global clinical trials

EXPERIENCE (Contd.)

Senior Scientist, Technology Assessment

. Evaluate scientific merits of external technologies/ingredients for

pediatric and adult nutritional products and medical foods

. Recommend R&D and Business Development Groups for potential in-licensing

opportunities

Quality Compliance Coordinator

Developed and implemented improved Quality Initiatives for Production and

Process control at Abbott Diagnostic Division in compliance with FDA

guidelines

. Interacted with Quality, Operation, Regulatory, and external consultants

to provide technical feedback

. Devised plans, and implemented document changes to improve material and

process control

. Coordinated remediation processes with manufacturing teams and planners

Lead Scientist/Project Manager, Rapid Diagnostics Determine Malaria

Program

. Sourced, evaluated, and recommended technologies and reagents from

external researchers

. Evaluated third party vendors for scale ups and managed all outsourcing

activities

. Purified antibodies, established specifications, transferred processes to

Process Development and Manufacturing

. Developed design goals for products through customer interviews

. Negotiated and implemented licensing agreements with external researchers

. Coordinated product development activities with various Abbott groups

Projects transferred over to Dainabot (Japan) for further development and

launch

Senior Scientist, Rapid Diagnostics R&D, TestPack Plus H.pylori,

. Examined existing patents, selected specific antigenic proteins, and

devised purification strategy

. Scaled up antigen production to gm quantities

. Organized cross-divisional roundtable on H.pylori Diagnosis and Treatment

. Spearheaded Voice of the Customer and Shadow Programs for the Business

Unit

TestPack Plus H.pylori was launched in May'99.

Senior Scientist, Congenital Disease Diagnostics for AxSYM

. Developed Rubella IgG and IgM assays for AxSYM

. Authored submission packets for 510(k) and for European Regulatory

Agencies

Two products launched in 1995 in the US and ROW.

Senior Scientist, Infectious Disease Diagnostics, Recombinant Assay

Development

. Purified and refolded recombinant Rubella antigens. Demonstrated

increased reactivity. To the best of knowledge, first refolding works at

Abbott.

. Demonstrated Recombinant Rubella assay feasibility with microparticles

and beads

. Purified and scaled up recombinant Lyme antigens. Demonstrated

Recombinant Lyme assay feasibility on IMx. Purified antigens transferred

to Shield Diagnostics (UK)

Product launched by Shield Diagnostics in 1999.

EXPERIENCE (Contd.)

Additional accomplishments at Abbott

. Launched COUPE Registry, designed to investigate perioperative usage of

Corlopam(

. Actively participated in Diagnostic Division Technical Advisory Board for

three years

. Led a team to teach a course on Enzyme Kinetics

University of Wisconsin Biotechnology Center, Madison, WI

Biochemistry Group Leader, Biopulping Consortium, 1990-1991

Responsible for leading the group investigating fungal enzymes used in

biodegradation of wood

. Isolated lignin degrading enzymes from both solid-state and liquid

culture fungal colonies

. Examined the efficacy of the enzymes in industrial wood delignification

Institute for Enzyme Research, Madison, WI

Research Associate, 1987 - 1990

Studied structure and enzymology of Pyruvate Dehydrogenase Complex

Brookhaven National Laboratory, Stony Brook, NY

Guest Asstt Scientist, 1989 - 1991

Food Research Institute, Madison, WI

Research Associate, 1984 - 1986

Studied structure function relationships of Botulinum neurotoxin.

EDUCATION

Capital University, Columbus, OH 2003 - 2005

MBA (with Distinction)

Oklahoma State University, Stillwater, OK 1982 - 1984

Ph.D. in Biochemistry

Tufts University, Boston, MA 1981-1981

Graduate Research Assistant

Chittaranjan Natl Cancer Res Center, Calcutta, India

1978-1980

Research fellow

Calcutta University, Calcutta, India 1976-1978

M.Sc. in Physics (Specialization in Biophysics)

PROFESSIONAL RECOGNITION

. Served as a Reviewer on NIH - NIAID Panels on Biodefense and SARS

. Invited to serve on Wellcome Trust Review Panel

. Invited speaker at Austrian Society for Biotechnology, Vienna; at

International Center for Genetic Engineering and Biotechnology, Trieste,

Italy, and at Conference of Association of Physicians of India

. Invited to attend Gordon Research Conferences on Fungal Metabolism

(1990), and Malaria (1998)

PROFESSIONAL RECOGNITION (contd)

. Certificate of appreciation, USDA

. National Scholar, Govt of India, 1971-1978

. Rank holder in B.Sc and M.Sc Examinations in India

. Numerous endowment awards for academic excellence, India

. Recipient of award to attend the 10th International Biophysics Congress

(1990)

. Member of Sigma Xi, and Phi Lambda Upsilon

BIBLIOGRAPHY

"Can a polypill safely halve cardiovascular risk? An international

randomised placebo-controlled trial of a four-component combination pill

("polypill") in people at raised risk of cardiovascular disease" (Accepted

for publication in British Med Journal)

"Recent Trends in Malaria Diagnosis", a chapter in Medicine Update (Vol 9,

1999), published by the Association of Physicians of India

"Purification and Characterization of a Novel Protease from the Solid

Substrate Cultures of Phanerochaete chrysosporium", Datta A, J Biol Chem

(1992), 267, 728-736

"Identification of a Spefic Manganese Peroxidase among Liglinolytic Enzymes

Secreted by Phanerochaete chrysosporium during Wood Decay", Datta A,

Bettermann A, and Kirk TK, Appl Environ Microbiol (1991), 57, 1453-1460

"Characterization of the Inhibition of Escherichia coli Pyruvate

Dehydrogenase Complex by Pyruvate", Datta A, Biochem Biophys Res Commun

(1991), 176, 517-521

"Mapping the Lipoyl Groups of the Pyruvate Dehydrogenase Complex by use of

Undecagold Clusters and Scanning Transmission Electron Microscopy", Yang

YS, Datta A, Hainfeld JF, Furuya FR, Wall JS, and Frey PA, Biochemistry

(1994), 33, 9428-9437

"2-Acetylthiamin Pyrophosphate (Acetyl-TPP) pH-Rate Profile for Hydrolysis

of Acetyl-TPP and Isolation of Acetyl-TPP as a Transient Species in

Pyruvate Dehydrogenase Catalyzed Reactions", Gruys KJ, Datta A, and Frey

PA, Biochemistry (1989), 28, 9071-9080

"Botulinum Neurotoxin Types A, B, & E: pH Induced Difference Spectra",

Datta A, and DasGupta BR, Molec and Cell Biochem (1988), 81, 187-194

"Circular Dichroic and Fluorescence Spectroscopic Study of the Conformation

of Botulinum Neurotoxin Types A and E", Datta A, and DasGupta BR, Molec and

Cell Biochem (1988), 79, 153-159

"Botulinum Neurotoxin Type B (Strain 657): Partial Sequence and Similarity

with Tetanus Toxin", DasGupta BR, and Datta A, Biochimie (1988), 70, 811-

817

"Substrate Channeling of Oxalacetate in Solid-State Complex of Malate

Dehydrogenase and Citrate Synthase", Dattaa A, Merz JM, and Spivey HO, J

Biol Chem (1985), 260, 150**-*****

PRESENTATION

"Polyethylene Glycol Induced Heteroassociation of Malate Dehydrogenase and

Citrate Synthase", Merz JM, Webster TA, Appleman JR, Manley ED, Yu HA,

Datta A, Ackerson BJ, and Spivey HO, Arch Biochem Biophys (1987), 258, 132-

142

"Mitomycin C-Irradiation Combination Therapy - an In Vivo Study on Mouse",

Datta A, Mukherjee S, Sinha SS, and Bhattacharya KL, Indian J Cancer

Chemotherapy (1980), 2, 39-44

PRESENTATION (contd)

Invited Speaker at the Annual Conference of Association of Physicians of

India 1999. "Recent Trends in Malaria Diagnosis"

Abbott Technology Exchange 1999. "Evaluation and Optimization of Pan-

Malarial Monoclonal Antibody for Determine( Malaria Assay"

Abbott Technology Exchange 1996. "Preparation, Characterization, and

Selection of Immunospecific Helicobacter pylori Antigens"

Abbott Technology Exchange 1996. "Incidence of IgG specific for H. pylori

in Lake County Volunteers"

7th European Congress of Clinical Microbiology and Infectious Disease

1995,and 95th General Meeting of American Society of Microbiologists 1995.

"Development of the Abbott Rubella IgG and IgM Assays"

ADD Technology Exchange 1994. "Development of AxSYM Rubella G and M

Assays"

Abbott Corporate Technology Exchange 1993. "Expression and Purification of

Borrelia burgdorferi Recombinant Proteins"

Abbott Corporate Technology Exchange 1993. "Utility of Recombinant

Proteins for the Specific Serological Detection of Lyme Disease"

6th European Congress of Clinical Microbiology and Infectious Disease 1993.

"Development of Recombinant Proteins for the Specific Serological

Detection of Lyme Disease"

ADD Technology Exchange 1992. "Expression, Purification, and Renaturation

of Recombinant Rubella Proteins-Potential Use in Diagnostic Assays"

ADD Technology Exchange 1992. "Cloning, Expression, and Purification of

Four Diagnostically Significant Borrelia burgdorferi Recombinant Proteins"

ADD Technology Exchange 1992. "Serological Response in Patients with Lyme

Disease to Borrelia burgdorferi Recombinant Proteins"

10th International Biophysics Congress 1990. "3D Organization of Lipoyl

Moieties in the Pyruvate Dehydrogenase Complex Using Undecagold Clusters

and Scanning Transmission Electron Microscopy"

Annual Meeting of the Federation of American Societies for Experimental

Biology (FASEB) 1988. "Pyruvate Dehydrogenase Complex- Characterization of

Acetyl-Thiamine Pyrophosphate as a Steady State Species"

Annual Meeting of the FASEB 1987. "(1) "Botulinum Neurotoxin Type B

(Strain 657): Partial Sequence and Similarity with Tetanus Toxin"; (2)

"Botulinum Neurotoxin Types A, B, and E: pH Induced Difference Spectra"

Annual Meeting of the FASEB 1986. "Botulinum Neurotoxin Type E:

Activation and Conformation"

Annual Meeting of the FASEB 1985. "Generality of the Protein Associating

Effect of Polyethylene Glycol"

Annual Meeting of the FASEB 1984. "Substrate channeling of Oxalacetate in

Solid-State Complex of Malate Dehydrogenase and Citrate Synthase"

26th West Central State Biochemistry Conference 1983. "Properties of the

Solid-State Enzyme Complex of Malate Dehydrogenase and Citrate Synthase"

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