Lalit Baregama, PhD

G-***, Safal Parisar-*, South Bopal

Ahmedabad-380058, INDIA

Mobile: +91-909*******

E-mail: acvgse@r.postjobfree.com

Objective: To contribute in the discovery and development of affordable drugs that provides significant advances in the treatment/prevention of human diseases; with maintaining business revenue growth and company’s goal.

Profile:

PhD in Medicinal Chemistry.

Fifteen years of International Business Development and long term partnership projects accomplishments in Pharmaceutical industry (Cadila, Vimta Labs, WuxiAppTec, Ranbaxy-Daiichi, HiKAL and Western Drugs). Managed a 50 personnel cross functional team.

Respective market evaluation and strategic long term business partnership for product development, in-licensing, out-licensing and contract manufacturing. Demand and supply meet as per customer time line.

New Product development and life cycle management: Market evaluation, Product selection, R&D, technology development, piloting, clinical trials and commercialization as per regulatory requirement.

International Business Development and Project Management from inception to commercialization for Pharma projects (R&D, APIs, CRO, CMO-Formulation, bulk production) with US, Europe & APAC customers.

Publication: 28 Patents, 14 Research Papers, 17 Conference Presentations, 18 Abstracts in conferences.

Industrial Experience:

Jan 2015-Present: General Manager-International Business Development (APIs & Formulation-Contract Manufacturing), Cadila Pharmaceuticals Ltd, Ahmedabad, India.

Strategy planning, Global Business Development, licensing and Project Management for Pharmaceutical product development and commercialization. Managing the cross functional divisions like R&D, APIs, formulation development, piloting manufacturing, clinical, legal-regulatory and commercialization for the individual projects to meet the project goal and revenue target within timeline for given market.

Strategic long term partnership development to meet the demand and supply of customers.

Nov 2013-Jan 2015: Head-International Business Development, Vimta Labs Ltd, Hyderabad, India.

International Business Development and Project management for Pharmaceutical services to Pharma, Biotech, veterinary and medical devices customers in US, Europe and Asia region.

Product approval, vendor approval as per regulatory requirement to meet the on time supply of the customers.

Sept 2012-Nov 2013: CEO and President, Syngeny PharmaTech Pvt Ltd, Udaipur, India.

International Business Development (US, Europe and SEA-APAC), Organizational Management, Project management and Supply and Sourcing Management for Product Development and Contract Manufacturing Services (CRAMS-APIs, intermediate and specialty chemicals).

Jan 2011-Aug 2012: President, Western Drugs Ltd, Udaipur, India.

Global Business Development thru long term strategic partnership, Organizational Management, Research Project management and Supply and Sourcing Management for CRAMS/CMO.

May 2008-Jan 2011: Group Leader, Acoris (HiKAL) Research Ltd, Pune, India.

Synthetic Chemistry Project management, International Business client and people management for Product development and manufacturing (custom synthesis, APIs, specialty chemicals and intermediates, FTE/FFS projects). Project timeline, people allocation, budgeting and project tracking to meet the target and time line.

Maintaining the talent pool and contribution to the organizational development to achieve the business target.

Mar 2007-Apr 2008: Principal Scientist (Associate Director)-R&D, Medicinal Chemistry, WuxiAppTec Co. Ltd (WuXiPharmaTech), Shanghai, P. R. China.

Synthetic Organic/Medicinal Chemistry research projects execution for USA customers (Drug Discovery, Custom synthesis, APIs, specialty chemicals and pharma intermediates projects). FTEs and FFS projects.

International client/Business management. Contribution for achieving the organizational goals and revenue.

Mar 2003-Mar 2007: Research Scientist- Medicinal Chemistry, New Drug Discovery Research and Development (NDDR), Ranbaxy Research Laboratories Ltd., Gurgaon, India.

Project Management: Designed and synthesized New Chemical Entities (NCEs) to identify a new clinical candidate as posphodisterase-4 inhibitors (PDE-4) for Asthma & COPD.

Trained and managed a team of chemists with their best work performance and career advancement.

Academic and professional accomplishments:

Market evaluation, product selection, strategic planning, target identification, implementation and execution of individual project from inception to commercialization (drug development, ANDA and P I-IV) for long term business partnership with US, Europe and APAC customers; in-lined with company goals and set revenue targets for specific therapeutic segment and region.

Strategic multi-years collaboration for licensing and new market entry projects: Analysis (regulatory, market, competitors, pricing), planning (SWOT and know-how), engagement (business model, partners and customers) and operation (business set up and hand over to marketing team).

Accomplishment of projects for IND, NDA, APIs, ANDA, first to file and Para I- IV submission by providing and managing the Preclinical to clinical trial (BA/BE, Phase I-IV) services.

Accomplishment of scale up projects (Lab development, custom synthesis, Formulation development, piloting, and clinical trials) to support late stage clinical development and commercialization. Well versed with all regulatory audits (GxP, FDAs, MHRA, EDQM, WHO, aaalac, MoH, etc).

Invited Speaker: Strategic Outsourcing Partnership in CRAMS, InformEx Conference-2013, Anaheim, USA.

Invited speaker & Panelist: Contract Manufacturing World Asia- BioPharma Asia Convention-2012, Singapore.

Panelist: InformEx International Conference: Life Cycle Management of the Drugs-2012, New Orleans, USA.

Participation in CPhI International Conferences “Contract Partnership Executive Summit (C-Level)-2011” on invitation at Frankfurt, Germany.

Panelists and invited speaker in many International conferences and summit which are dedicated to global business strategies for Pharmaceutical-Drug Discovery and Development and CRAMS.

Travel award for presentation at IUPAC 38th Congress, World Chemistry Congress, Federation of Asian Chemical Societies 9th Congress and Asian Federation of Medicinal Chemistry Congress, 2001, Australia.

National Award: Maharana Raj Singh Award-2002 (Maharana Mewar Foundation, India) for research.

Swarn Jayanti Samman by HRD Minister Govt of India for special contribution to M.L. Sukhadia University in last fifty years (Golden Jubilee) in technology innovation and development in Pharma/Chemical Sciences.

Educational Qualification:

Ph.D. (Sept 1999-July 2002): Medicinal Chemistry. M. L. Sukhadia University, Udaipur, INDIA.

M.Sc. (1997-1999): Organic Chemistry. M. L. Sukhadia University, Udaipur, INDIA.

Project Management Professional (PMP) certification: PMI, USA (PMBOK-completed).

Research Publication

(A) Patents: 28

Sr. No.

Title

Patent

Application Number

Publication

Date

1

PYRAZOLO(3,4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

ZA200906418

26.05.2010

2

PYRAZOLO (3, 4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

MX2009009793

18.12.2009

3

PYRAZOLO [3, 4-B]PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

EP08737619

02.12.2009

4

PYRAZOLO (3, 4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

EP08737621

02.12.2009

5

PYRAZOLO (3, 4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

KR20090120505

24.11.2009

6

PYRAZOLO (3, 4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

SG200906026-0

29.10.2009

7

INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

EP 07826506

12.08.2009

8

INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

KR20090069309

30.06.2009

9

INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

MX2009003100

21.05.2009

10

CONDENSED ISOXALINE DERIVATIVES AS INHIBITORS OF PHOSPHODIESTERASE TYPE - IV

US2009048247 (A1)

19.02.2009

11

Phosphodiesterase Inhibitors

US2008280926 (A1)

18.12.2008

12

Substituted Indazoles as Inhibitors of PDE 4

US2008312285 (A1)

18.12.2008

13

PYRAZOLO (3, 4-B) PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

WO2008111010 (A1)

18.09.2008

14

PYRAZOLO [3, 4-B] PYRIDINE DERIVATIVES AS PHOSPHODIESTERASE INHIBITORS

WO2008111009 (A1)

18.09.2008

15

SUBSTITUTED INDAZOLES AS INHIBITORS OF PDE 4

EP2006795373

11.06.2008

16

INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

WO2008035315 (A2)

27.03.2008

17

3-INDAZOLYL-ISOXAZOLINE DERIVATIVES AS INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

EP2006744776

27.02.2008

18

Inhibitors of phosphodiesterase type-IV

US2008009535 (A1)

10.01.2008

19

CONDENSED ISOXALINE DERIVATIVES AS INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

EP2006710372

26.12.2007

20

Phosphodiesterase Inhibitors

US2007259874 (A1)

08.11.2007

21

Isoxazolines and their use as inhibitors of phosphodiesterase type-IV

EP07105020

03.10.2007

22

SUBSTITUTED INDAZOLES AS INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

WO2007029077 (A1)

15.03.2007

23

3 - INDAZOLYL - ISOXAZOLINE DERIVATIVES AS INHIBITORS OF PHOSPHODIESTERASE TYPE - I

WO2006129158 (A2)

07.12.2006

24

PURINE COMPOUNDS WHICH CAN BE USED AS PHOSPHODIESTERASE (PDE) TYPE IV INHIBITORS

EP2004806371

06.09.2006

25

PHOSPHODIESTERASE INHIBITORS

EP2004798996

30.08.2006

26

CONDENSED ISOXALINE DERIVATIVES AS INHIBITORS OF PHOSPHODIESTERASE TYPE-IV

WO2006085212 (A2)

17.08.2006

27

PURINE COMPOUNDS WHICH CAN BE USED AS PHOSPHODIESTERASE (PDE) TYPE IV INHIBITORS

WO2005058898 (A2)

30.06.2005

28

PHOSPHODIESTERASE INHIBITORS

WO2005051931 (A2)

09.06.2005

(B) Research Paper Publications: 14

Sr. No.

Title

Name of Journal

Year/Volume/

Page No.

1

Synthesis of Alkoxyphthalimide derivatives of p-bis-(2-hydroxy-4-aryl-6-iminothiazolidino[4,5-b]pyrimidin-N6-yl)biphenyls

Journal of Indian Chemical Society

2005, 82, 337-341.

2

Synthesis of 3H, 9H, 10H, 10aH-10-aryl-2-aryliminothiazolidino[4,5-b][1,5]benzodiazepinesand their alkoxyphthalimide derivatives

Indian Journal of Chemistry,

2005, 44B, 1243-1247.

3

Evaluation of Antimicrobial activity of Some Novel Alpha Substituted Hydroxylamine Derivatives,

Indian Journal of Pharmacology,

2004, 36 (5), 315.

4

Synthesis and antimicrobial activity of new polyfunctionally substituted pyridines and their fused derivatives

Indian Journal of Chemistry,

2004, 43B, 1314-1320.

5

Synthesis and biological evaluation of 7-N-(n-alkoxyphthalimido)-2-hydroxy-4-aryl-6-arylminothiazolidino [2,3-b] pyrimidines and related compounds

Indian Journal of Chemistry,

2004, 43B, 1306-1313.

6

Novel Synthesis of substituted oxygen substituted hydroxylamine derivatives of Heterocyclic compounds,

International Journal of Chemical Science,

2003, 1(1), 25-30.

7

Some heterocyclyl substituted derivatives of imdo and oximealkanoids

Oriental Journal of Chemistry

2003, 19 (3), 605-610

8

Synthesis of 3-alkoxy-(p-substituted aryl) biguanidino-4-methyl-2, 3-dihydro (1H)-1, 5-benzodiazepine-2 ones and related compounds

Heterocyclic Communication

2002, 8(6), 607-612

9

Synthesis and antimicrobial studies of 3-alkoxy-5-(p-substituted aryl) biguanidinopentane 2,4-diones and related compounds

Research Journal of Chemistry and Environment

2002, 6 (2), 59-62

10

Synthesis of some benzotriazole derivatives as antibacterial and antifungal agents

Indian Journal of Heterocyclic Chemistry

2002, 11, 203-206

11

Synthesis of some arylalkoxyphthalimides

Journal of Indian Chemical Society

2002, 79, 193-194

12

Synthesis and studies of O-substituted derivatives of benzophenoneoxime

Asian Journal of Chemistry

2001, 13(3), 923-927

13

Synthesis of pharmacologically important 2 4-morpholinyl) alkyloxy]-1H-isoindole 1,3(2H)-diones

Asian Journal of Chemistry

2001, 13 (3), 919-922

14

Synthesis of some isoindole-1,3-(2H)-dione, amino-oxy and biguanidino-oxy derivatives of carbazole

Asian Journal of Chemistry

2001, 13 (2), 569-572

Abstract Publication in International and National Conferences: 18

Membership (1999-2014): American Chemical Society, IUPAC-AFM, ISCA, ICS, ICC, ISCB.

(C) Paper Presentation in National/International Seminars & Conferences: 17

S.

No.

Theme of Event

Title

Organizer

Year

1

Pharmaceutical

Chemspec Asia 2013 Conference, Bangkok,

Thailand (Invited Speaker)

Quartz Chemicals & Specialty Chemicals

2013

2

Pharmaceutical

International Conference at InformEx USA 2013,

Anaheim, USA (invited Speaker)

InformEx World Conference

2013

3

Pharmaceutical and Biotechnology

Contract Manufacturing World Asia- Bio Pharma

Asia Convention, Singapore

(Invited Speaker and Panelist)

Terrapinn, Singapore

2012

4

Pharmaceutical and Biotechnology

Contract Manufacturing Summit, London, UK.

(Invited Key Speaker)

World Conferences by Apple Consulting

2012

5

Pharmaceutical

International Conference on Life Cycle

Management of the Drug (Panelist), New Orleans, USA

InformEx World Conference,

2012

6

Pharmaceutical, Biotechnology and Agrochemical

Contract Partnership Executive Summit (C-Level)

Frankfurt, Germany

(Invited Guest in Worlds ‘C’ Level Summit)

CPhI World Conference

2011

7

Pharmaceutical & Agrochemical Hetrocycles

International Conference on Heterocyclic

Chemistry, Jaipur, India.

University of Rajasthan-Jaipur

2001

8

Research and Development in Chemical Science

Federation of Asian Chemical Societies

9th Congress, Brisbane, Australia.

Federation of Asian Chemical Societies

2001

9

Research and Development in Chemical Science

IUPAC, Asian Federation of Medicinal

Chemistry Congress, Brisbane, Australia.

Asian Federation of Medicinal

Chemistry

2001

10

Research and Development in Chemical Science

IUPAC 38th Congress, World Chemistry Congress

Brisbane, Australia.

World Chemistry Congress Committee

2001

11

Research and Development in Chemical Science

Indian Science Congress, New Delhi, India.

Indian Science Congress Association

2001

12

Development in Chemical Science

Thirty eight Annual Convention of Chemists,

Jodhpur, India.

Indian Chemical Society

2001

13

Research and Development in Chemical Science

National Seminar on Patent Awareness,

Surat, India.

Sardar Vallabhbhai National Institute of Technology

2000

14

Research and Development in Chemical Science

Seminar on Recent Trends in Chemical Sciences,

Udaipur, India.

ML SU, Udaipur

2000

15

Research and Development

Indian Chemical Society, Hardwar, India.

Indian Chemical Society

2000

16

Research and Development in Chemical Science

Indian Society of Chemist and Biologists,

CDRI, Lucknow, India.

Indian Society of Chemist and

Biologists

2000

17

Research and Development

Indian Council of Chemists, Jalgaon, India.

Indian Council of Chemists

1999

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