Global Business Development- Pharma/ CRO / CMO
Resume:
Lalit Baregama, PhD
G-***, Safal Parisar-*, South Bopal
Ahmedabad-380058, INDIA
Mobile: +91-909*******
E-mail: **********@*****.***
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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