ABHIJIT S. BAPAT, M.D., Ph.D.

* ****** **, ******* **, 11791

Tel. (H)+91-11-474*-**** (C) +91-880-***-****

e-mail: sy1rb0@r.postjobfree.com

SUMMARY

Physician-Scientist trained in Internal Medicine, with a PhD in Immunology and Microbiology

Ph.D. Thesis: Polarized Differentiation of Macrophages (Advisor: Michael K Hoffmann MD)

Completion of Internal Medicine Internship in the US; ECFMG Certification valid indefinitely

>10 years experience in Discovery, Translational and clinical development background to POC, Phase II

Successfully led preclinical programs at GLP tox stage through Phase I studies after

IND/CTA filings to Phase II programs

6+ years experience in driving molecules from lead optimization to Clinical Development leading through Phase I, into Phase II POC studies (European studies conducted in UK or EU)

Exposure to Phase III studies (interpretation and analysis of data – EU studies)

7 years of academic research experience in cellular and translational Immunology with a focus on auto immune disorders, HIV and cancer

2 years molecular pharmacology experience – enzymology and protein-protein interactions

3 years experience in clinical pharmacology

4 years people management

Functional and project leadership with full budget responsibility

Successful biotech start-up experience in India

Understanding of Emerging Markets with nuances

Translational Medicine experience in Autoimmune disease (includes RA, SLE and IBD), metabolic disorders, COPD and dermatology

Immunology, Inflammation, Metabolic Disorders and Dermatology

Industry

Participated in clinical development of agents for Rheumatoid Arthritis (RA) and Osteoarthritis (OA), (DMARDS and DMOAD's) as well as other inflammatory disorders such as IBD, COPD, and atherosclerosis and metabolic disorders including dyslipidemia

Drove the development programs for DMARD's, DMOAD's and agents being developed for IBD, COPD and dyslipidemias.

Participated in development of reformulations of therapeutic agents for Osteoporosis aimed to offer a better safety and tolerability profile in patients

Led a program from GLP Tox into Phase I Clinical studies to develop an agent for COPD

Medical Director leading CETP-inhibitor Development from GLP Toxicology through successful Phase I clinical development into progression to Phase II studies

Participated in design and execution of studies initiated to identify new putative surrogate biomarkers for RA and OA exploiting proteomic technology.

Participated in extensive preclinical studies with immunomodulatory agents ameliorating RA and SLE in academic setting, and RA, OA, IBD, COPD, atherosclerosis and dyslipidemia in Industry setting.

Performed due-diligence on preclinical pharmacology, immunology, ADME and toxicology data to determine suitability of profile for clinical development.

Performed due diligence on external licensing opportunities with therapeutics agents in development for SLE and SS.

Development of novel drug delivery in dermatology through nanomedicine based technology platform

Academia

Managed a cellular and translational immunology laboratory.

Research interests focussed on inflammation, immunoregulatory pathways and immunomodulation.

Elicited discrete APC differentiation pathways leading to distinct effector T cell or anergic or tolerogenic T cell responses.

Studied immunomodulation via differential engagement of TNF-TNFR family constituents including agonistic engagement of CD137 on T cells.

Demonstrated amelioration of disease in mouse models of RA and SLE through agonistic engagement of CD137.

Studied immunomodulation of NK-T cell activity after agonistic engagement with CD137.

Participated in extensive experimental work on the mechanism of antibody dependent cell mediated cytotoxicity (ADCC) in HIV.

Familar with animal models of disease.

EDUCATION

Microbiology and Immunology, Research Associate 2004 - 2005

Howard Hughes Medical Institute

Albert Einstein College of Medicine, Bronx, New York

Advisors: Steven Porcelli, M.D. and William R. Jacobs Jr., Ph.D.

Molecular Pharmacology, Postdoctoral Fellow 2002 - 2004

Weill Medical College of Cornell University

New York, NY

Advisors: Jochen Buck, M.D., Ph.D. and Lonny Levin, Ph.D.

Internal Medicine, Postgraduate Training (PGY-1) 2001 - 2002

Westchester Medical Center

New York Medical College

Doctor of Philosophy (Ph.D.) 1997-2001

New York Medical College

Valhalla, NY

Laboratory of Michael K Hoffmann M.D.

Resident Physician - Medical Oncology & Bone Marrow Transplantation 1995-1996

All India Institute of Medical Sciences

New Delhi, India

Clinical Intern 1994-1995

All India Institute of Medical Sciences

New Delhi, India

Bachelor of Medicine and Bachelor of Surgery (M.B. B.S) 1989-1993

All India Institute of Medical Sciences

New Delhi, India

WORK EXPERIENCE

VYOME BIOSCIENCES 2010 - ongoing

New Delhi, India

Director - Clinical Affairs, Operations and Biology R&D

Reporting to the Board of Directors

Key Responsibilities

Lead and operationalise a nano-biotechnology start-up with a therapeutic focus on dermatology and immunology

Build proprietary nanomedicine technology platform to convert existing drugs, in conjunction with combinatorial and polymer chemistry towards building a pipeline of dermatological therapeutics with enhanced efficacy and attenuated toxicity and extension to oral and/or parenteral formulations

Build novel proangiogenic and re-epithelializing promoting biological from IP in-licenced from Harvard University as wound healing agents for Diabetic Foot Ulcer disease

Provide leadership in design, implementation and execution of R & D programs

Establish and run Biology R&D laboratory

Provide strategic input into the clinical development of pipeline R&D programs

Prepare Product Development Plans (C-CDP and L-CDP) for therapeutic dermatological agents

Resource planning and management (FTE’s and budget) of R&D programs

Participation in investor interactions

Participation in formulation of IP strategy in conjunction with scientists and attorneys

Interact and negotiate with government agencies towards raising non-dilutive grant funding

Interact with third party vendors

Develop and maintain network with K.O.L’s in dermatology, polymer sciences and nano-technology

Establish and liaise with Scientific Advisory Board

Establish and liaise with Clinical Advisory Board to develop TPP

DR. REDDY’S LABORATORIES

Hyderabad, India

Associate Director, Clinical Development, Proprietary Products R&D 2009-2010

Reporting to VP, Drug Development

Associate Director, Clinical Development, Discovery Research 2008-2009

Reporting to President, R&D and Commercial

Principal Scientist, Clinical Development, Discovery Research 2006-2008

Reporting to President, R&D and Commercial

Key Responsibilities (European studies)

Medical Director responsible for Clinical Development and Regulatory Affairs

Physician-in-charge with medical responsibility for 2 programs from lead optimization to IND/CTA filing, approval and first in human and other subsequent European studies (filed/approved – 2008-2009)

Provide medical inputs, management and leadership of the early clinical development organization across multiple therapeutic areas, pain/inflammation, autoimmune disorders, respiratory disorders, anti-infectives and cardiovascular medicine with a focus on mechanism of action, clinical unmet needs and Target Product Profiles

Represented Clinical Development at research reviews and target selection towards structuring R&D portfolio

Conception and Design of Clinical Development Plans

Development of Investigator Brochure, Protocols, CRFs, data evaluation, pharmacovigilance and study reports for all programs allocated (pre-clinical and clinical)

Phase I safety and tolerability studies (European studies)

Strategy and design of Phase II POC (European studies)

Analysis and interpretation of Phase III data (European studies)

Manage clinical outsourcing of studies including evaluation and audit of CRO’s and participation in joint project teams

Medical responsibility, site initiation, medical monitoring, SDV and site close-out of clinical studies

Maintain network with K.O.L’s in relevant therapeutic areas

Establishment and execution of processes in evolving differentiated formulation development strategy with 505(b)2 enabling sNDA applications.

Co-ordinator – Orphan Disease Task Group

External and internal review of all data/due diligence on programs towards management of in-licensing/out-licensing opportunities

Active participation in monthly R&D reviews and quarterly reviews with the CEO/Management Council

Member of the Joint Development Committee for a co-development program

Member of the extended Business Development Council of the Company

Close collaboration with commercial and business development teams in providing medical and strategic input in characterizing NPV, developing Target Product Profile’s and performing due diligence on multiple early stage compounds to aid in project prioritization and portfolio optimization and planning

Key Achievements

4 IND/CTA with NCEs, filed and approved in Europe

CETP- inhibitor: Medical Director for three clinical studies; all studies started and completed in 9 months to progression to Phase II

Submitted 3 abstracts for oral/ poster presentations based on clinical data from above studies

Managed all studies within time and budget

Developed clinical strategy for Phase II, POC study in target population

Identified CRO and selected sites and investigators

Negotiated budgets

Developing differentiated products strategy through 505(b)2 route- from idea generation to pre-clinical to clinical POC

Clinical evaluation and Commercial assessment of potential in-licence and out-licence programs

Medical input to all pre-clinical programs

On management team for portfolio reviews

Instrumental in re-organizing effective clinical and portfolio management

ACADEMIC RESEARCH

Immunology Research:

7 years of research experience in cellular and translational Immunology with a focus on auto-immune disorders, cancer and infectious disease

Studied immunoregulatory pathways with agonists of CD137 as applied to translational/experimental medicine with a particular focus on the auto-immune disorders, Rheumatoid Arthritis and Systemic Lupus Erythematosus.

Managed a cellular and translational immunology laboratory; conversant with cellular and molecular biology techniques as well as animal models of disease

Studied antigen-presenting cell (APC) biology and their orchestration of the immune system. Delineated distinct differentiation pathways through which differential T cell effector mechanisms including activator as well as anergic and tolerogenic responses are elicited.

Studied differential immunoregulation of NK-T cells after agonistic engagement of CD137.

Drove extensive experimental work on the mechanism of antibody dependent cell mediated cytotoxicity (ADCC) in HIV.

Ph.D. Thesis: Polarized Differentiation of Macrophages

Advisor: Michael K. Hoffmann, M.D, Professor, New York Medical College and formerly

Head, Department of Cellular Immune Reactions and Member, Memorial Sloan Kettering

Cancer Center, New York, NY.

Molecular Pharmacology Research:

2 years of research experience studying enzymology and protein-protein interactions of the enzyme soluble-Adenylyl Cyclase (sAC)

Familiar with biochemical and molecular biology techniques and assays in enzymology

Conversant with enzyme kinetic analysis

Didactic Postgraduate Coursework:

Successfully completed the following major courses as part of Ph.D. training:

Basic Immunology

Advanced Immunology

Medical Microbiology

Virology

Molecular Biology

Biostatistics

Advanced Biostatistics

Epidemiology

MEDICAL TRAINING & RESEARCH

Medical Training:

Westchester Medical Center, Valhalla, NY:

Postgraduate training in Internal Medicine (PGY-1) at the University Hospital of New York Medical College (2001-2002)

All India Institute of Medical Sciences, New Delhi, India:

Post graduate training in medical oncology and bone marrow transplantation at the super-specialty cancer hospital of the Institute (1995-1996)

All India Institute of Medical Sciences, New Delhi, India:

Clinical Internship (1994-1995)

Clinical Research:

Participated in the conduct of Phase II studies in oncology

TEACHING EXPERIENCE

Teaching Assistant

Department of Microbiology and Immunology

New York Medical College:

Teaching second year medical students in the areas of Medical Microbiology (1998-1999)

AWARDS

Chairman’s Excellence Award: Best Innovation Team, Dr. Reddy’s Laboratories, 2010

Einstein Scholar Award – Nomination, 2004

Merit Certificate and Scholarship, National Mathematical Olympiad, India, 1986

Silver Medal, National Talent Search Contest, New Delhi, India, 1986

CERTIFICATIONS

Medical Council of India, New Delhi, 1995 (valid indefinitely)

Educational Commission for Foreign Medical Graduates (ECFMG), Philadelphia, 1996 (valid indefinitely)

Successful completion of the United States Medical Licensing Examination (USMLE) – Steps 1 &2 and medical internship in the U.S

PUBLICATIONS & PRESENTATIONS

Journal Articles

MHC Class 1 molecules on CD4 cells regulate receptor mediated activation signals. Wang, Z.Q., Bapat, A.S., Trejo, V., Orlikowsky, T., Mittler, R.S. and Hoffmann, M.K. Cellular Immunology, 193(1): 108-114, 1999.

Polyspecific self-reactive antibodies in HIV-infected individuals facilitate T cell deletion and inhibit costimulatory accessory cell function. Wang, Z.Q., Horowitz, H.W., Orlikowsky, T., Hahn, B., Trejo, V., Bapat, A.S., Mittler, R.S., Rayanade, R.J., Yang, S.Y. and Hoffmann, M.K. Journal of Infectious Diseases, 180(4): 1072-1079, 1999.

Interleukin 10 induces macrophage apoptosis and expression of CD16 (FcγRIII) whose engagement blocks the cell death program and facilitates differentiation. Wang, Z.Q., Bapat, A.S., Rayanade, R.J., Dagtas, A.S. and Hoffmann, M.K. Immunology, 102(3): 331-337, 2001.

CD137 costimulatory T cell receptor engagement reverses acute disease in lupus-prone NZB x NZW F1 mice. Foell, J., Strahotin, S., O’Neil, S.P., Mc Causland, M.M., Suwyn, C., Haber, M., Chander, P.N., Bapat, A.S., Xiao-Jie, Y., Chiorazzi, N., Hoffmann, M.K. and Mittler, R.S. Journal of Clinical Investigation, 111(10): 1505-1518, 2003.

Anti-CD137 antibodies in the treatment of autoimmune disease and cancer. Mittler, R.S., Foell, J., McCausland, M., Strahotin, S., Niu, L., Bapat, A. and Hewes, L.B. Immunologic Research, 29(1-3):197-208, 2004.

Engagement of the CD137 (4-1BB) costimulatory molecule inhibits and reverses the autoimmune process in collagen-induced arthritis and establishes lasting disease resistance. Foell, J.L., Diez-Mendiondo, B.I., Diez, O.H., Holzer, U., Ruck, P., Bapat, A.S., Hoffmann, M.K., Mittler, R.S. and Dannecker, G.E. Immunology, 113: 89-98, 2004.

Pharmacodynamics and pharmacokinetics of DRL-17822, a potent CETP inhibitor, in healthy subjects. Hasham, S, Mangapathiraju, T., Vittal, S., Bapat, A., Rao, M., Sai, S., Shanavas, A., Allenby, K and Kumar, R. Clinical Pharmacology and Therapeutics (submitted) 2010.

Safety and tolerability of single and multiple ascending doses of DRL-17822, a potent CETP inhibitor, in healthy male subjects. Bapat, A., Rao, M., Allenby, K and Kumar, R (in preparation)

Macrophages differentiate into helper subsets analogous to helper T cell subsets and have the potential to direct helper T cell differentiation. Bapat, A.S., Wang, Z.Q., Dagtas, A.S., Rayanade, R., Horowitz, H.W., Mittler, R.S., Seligman, S.J. and Hoffmann, M.K. (in preparation).

Assessment of immunoregulatory drug activities in human macrophage cultures. Bapat, A.S., Wang, Z.Q., Marshall, W.E., Chen,S. and Hoffmann, M.K. (in preparation).

Plasmin renders cancer cells drug resistant through the liberation of insulin like growth factor. Chun, M., Bapat, A.S., Hammerling, U. and Hoffmann, M.K. (in preparation).

Abstracts

Antitumor activity of 1-nitro-9-hydroxyethylamino acridine (C-857). Bapat, A.S., Garikapaty, V.P.S., Yedavelli, S.P.K., Konopa, J., Banerjee, D., Miller, D., Tiwari, R.K. Proceedings of the American Association of Cancer Research 39: 4002, 1998.

Differential action of Resveratrol, a component of red wine, on human cancer cells. Garikapaty, V.P.S., Bapat, A.S., Yedavelli, S.P.K., Hamby, C., Backer, J., Tiwari, R.K. Proceedings of the American Association of Cancer Research 39:1548, 1998.

Safety and tolerability of single ascending doses of DRL-17822, a potent CETP inhibitor, in healthy male subjects. Bapat, A., Rao, M., Vittal, S., Mangapathiraju, T. Hasham, S., Sai, S., Shanavas, A., Sadashivam, V., Allenby, K and Kumar, R. American Diabetes Association – 70th Scientific Session, 2010.

Single dose pharmacodynamics and pharmacokinetics of DRL-17822, a potent CETP inhibitor, in healthy subjects. Hasham, S., Mangapathiraju, T., Vittal, S., Bapat, A., Rao, M., Sai, S., Shanavas, A., Allenby, K., Kumar, R. 78th European Atherosclerosis Society Congress, 2010.

Pharmacodynamics and pharmacokinteics of DRL-17822, a potent CETP inhibitor, in healthy subjects. Hasham, S., Mangapathiraju, T., Vittal, S., Bapat, A., Rao, M., Sai, S., Shanavas, A., Allenby, K., Kumar, R. American Diabetes Association – 70th Scientific Session, 2010

Safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple doses of DRL-17822, a potent cholesterol ester transfer protein inhibitor in healthy male subjects. Dasari, M.R., Bapat, A., Vittal, S., Mangapathiraju, T. Hasham, S., Sai, S., Shanavas, A., Sadashivam, V., Allenby, K and Kumar, R. American Health Association, 2010.

Presentations

Medical Grand Round, Bhopal Memorial Research Hospital, “Polarized Macrophage Differentiation” Bhopal, India, 2006.

Medical Grand Round, Care Hospital System, “Polarized Macrophage Differentiation” Hyderabad,India 2006.

CME, “Translational Immunology”, Indian Academy of Paediatrics, Goa, India, 2007

National Immunology Symposium, University Grants Commission, India - Translational Immunology - Invited Speaker, 2007.

Medical Grand Ground, GSL Medical College, “Translational Immunology – ushering a new dawn in the clinic” Rajamundry, India 2010.

National Clinical Research Training Course, Department of Biotechnology, Government of India & All India Institute of Medical Sciences, New Delhi – Invited Speaker - 2011

PATENTS: Polarized macrophage differentiation as an immune function test: Bapat, A.S. and Hoffmann, M.K. (applied)

Conjugate-based antifungal and antibacterial prodrugs: Bapat, A.S., Mahesh, G., Gokhale, R.S., Shah, S.S., Sengupta, S., Prasad, S., Ghosh, S and Chawrai, S.R (India Filing: 1770/DEL/2011; June 22, 2011)

Conjugate-based antifungal and antibacterial prodrugs: Bapat, A.S., Mahesh, G., Gokhale, R.S., Shah, S.S., Sengupta, S., Prasad, S., Ghosh, S and Chawrai, S.R (U.S Filing: U.S. Serial No. 61/514,305; August 2, 2011)

Topical oil composition for the treatment of fungal infections: Bapat, A.S., Prasad, S., Jain, N., Arora, N., Mahesh, G and Mishra, M. (India Filing: 3746/DEL/2011; December 20, 2011)

PERSONAL DATA

Work Permit US Permanent Residence (Green Card)

Citizenship Indian

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