Dr. Vikas Sadvilkar

PROFILE


A Pharmaceuticals Industry professional with over two decades of work experience in HPAPIs, APIs, FDFs and intermediates with emphasis on product development and commercialization; sourcing and toll manufacturing; especially for:

antineoplastics, antivirals, antimalarials, antihypertensives, cardiacs, steroids, hormone replacement therapy (HRT). Diverse expertise in businesses like Formulations, APIs and Intermediates.

APIs business programs were accomplished for:

Gemcitabine via patented route for Eli Lily

Capecitabine for Novartis /Dolder AG

Irinotecan and Topotecan for DSM

Caspofungin for Pfizer

Docetaxel and Paclitaxel via patented route for Pfizer

Imatinib, Gefitinib, Erlotinib and Dasatinib for DSM

FDFs business programs were accomplished for:

Anabolic Steroidal gels & drug incorporated lozenges & gums for Xavier Laboratories, Canada/U.A.E.

Qualified SafeBridge­­­® examinations for HP environments.

Leading researcher for a few patents.

PROFESSIONAL ASSOCIATIONS


Presently working with a Ltd Company as a Sr. VP Pharmaceuticals Division, Mumbai, from Aug 2017 till date.  Reporting to the M.D.

Major activities include:

API and CRM sourcing from Asian & European accredited manufacturers for local distribution.

Contract manufacturing of certain API intermediates for local API manufacturers.

Involved in manufacturing site audits for quality, systems and facility approvals.

Supervising the business of herbal aroma oils and pharma extracts produced in the state of J&K, for local distribution.

Exclusive marketing collaboration initiated with Caregen, S. Korea for growth factor based products for anti-ageing & anti-wrinkles for the Indian market. 

Was associated with Arch Pharmalabs Ltd., as Sr. V.P. – Oncology Business Division(Dec 2006 till Jul 2017); earlier as Technical Director, while on the board of Directors; in both terms, reporting to the CMD; Mr. Ajit Kamath.

Major activities included:

Business process modelling, designing strategies for product selection, assessing highly qualified & trained professionals for the high potency business, designing non-infringing ROS for patented products, devising the risks, issues and impact analysis as a new entrant in a competitive arena and business management of certain bulk drugs & formulations, including High Potency APIs (HPAPIs) and FDFs.

Techno-commercial Support to Marketing and Business Development activities.

Identifying and developing niche vendors from East Asia for sourcing KSMs.

Identifying and developing qualified manufacturing facilities within India and East Asia for critical high potency intermediates.

Devised a business process model to meet USFDA/SafeBridge API manufacturing standards; thereby ensuring growth and horizontal integration

Instrumental in increasing annual turnover from Rs. 150 Crores to Rs. 375 Crores during 2006-2013 with an average profit of 15-16%.

Handling 350 staff members from all the 3 sites.

Resigned due to company finance issues of the banking consortium

Previously associated with Benzochem Lifesciences P. Ltd., as Technical Director (July 2003 till November 2006); reporting to the CMD; Mr. K. V. Vishwanathan.

Major activities included:

Design, development and implementation of a mid-sized business model, protocol development and strategies for business growth for the Tarapur facilities for high potency APIs and FDFs manufacture, as well as  the generic APIs and FDFs facility.

Protocol Improvement & Support to the team for filing of patents, DMFs, dossiers in the EU, the UK, and other CIS countries.

Handling the business systems governance laid by the Executive Board, organizational building and scenario planning with regard to ICH.

Developing contract manufacturing sites for supply of advanced stage intermediates within India

Designing a strategy for preferential technology transfer to a few companies in the EU and the UK utilizing non-infringing routes.

Instrumental in increasing annual turnover from Rs. 15 Crores to Rs. 150 Crores from 2003 till 2006 for the API and FDF business.

Managing the target operating models.

Company acquired by Arch Pharmalabs Ltd.

Associated with Elder Pharmaceuticals Ltd., Nerul, Navi Mumbai, as Research Head (Jun 2001 till Jun 2003); Reporting to the Sr. VP R&D.

Major activities included:

Research and development of certain generic molecules with scale-up at the Patalganga site for commercial manufacture.

Resigned for better prospects.

Associated with Exponential Chemicals Pvt. Ltd., as Technical Director (February 1995 till May 2001)

Major activities included:

Concept, design and setting-up of a cGMP facility for intermediates and APIs Standardized the production of intermediates of Antimalarials, Bronchodilators, etc.

Resigned for better options near Mumbai


EDUCATION


Earned Ph.D. in Chemistry from the Univ. Dept. Of Chemical Technology (UDCT) in 1994, under the guidance of Dr. S. D. Samant.

Earned M.Sc. in Organic Chemistry from the Univ. Of Mumbai in 1991.

Earned B.Sc. in Chemistry from the Parle College in 1989.
 

INTERNATIONAL PUBLICATIONS & CERTIFICATIONS


‘Claisen-Schmidt Reaction in a Hydrotropic Medium’, J. Chem. Technol & Biotechnol., U.K., 1995, 62, 405-410.

‘Aqueous Solutions of Hydrotropes as Effective reaction Media for the Synthesis of 4-Aryl-1,4-dihydropyridines’,  J. Chem. Technol & Biotechnol., U.K., 1995, 63, 33-36.

The SafeBridge Consultants, USA, organized: basic and advanced courses in the handling and management of high potency compounds with emphasis on toxicity studies, was successfully accomplished in Dublin, Ireland, 2010. Represented through Arch Pharmalabs Ltd.
 

PATENTS


Process for the preparation of Gemcitabine and its intermediates using novel protecting groups and ion exchange resins

Appln no.: 1387/MUM/2007 A

Publn date: 08/05/2009

A novel process for the preparation of Docetaxel

(WO/2009/040829)

A TRANSDERMAL GEL/CREAM COMPOSITION CONTAINING TESTOSTERONE DERIVATIVES FOR TRANSDERMAL DELIVERY SYSTEM

Application: 19/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24

A NOVEL HYDRO-ALCOHOLIC GEL/CREAM COMPOSITION OF NANDROLONE DERIVATIVES FOR SAFE DRUG DELIVERY

Application: 20/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24

A NOVEL HYDRO-ALCOHOLIC GEL/CREAM COMPOSITION PERTAINING ANDROSTEN-17-0L-3-ONE DERIVATIVES FOR SAFE DRUG DELIVERY SYSTEM

Application: 21/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24

A NOVEL HYDRO-ALCOHOLIC GEL/CREAM COMPOSITION OF TRENBOLONE ACETATE AND OXYMETHOLONE DERIVATIVES FOR SAFE DRUG DELIVERY

Application: 22/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24

A NOVEL HYDRO-ALCOHOLIC GEL/CREAM COMPOSITION OF METHANDIEONE AND BOLDENONE DERIVATIVES FOR SAFE DRUG DELIVERY

Application: 23/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24

A NOVEL CHEWING-GUM, LOZENGES INCORPORATED PHARMACEUTICAL COMPOSITION FOR TREATMENT OF ERECTILE DYSFUNCTIONS

Application: 24/MUM/2005, Filing date: 2005-01-07, Publication date: 2006-02-24
 

MEMBERSHIPS & RECOGNITIONS


Appointed as a Special Executive Officer (SEO) by the Govt. Of Maharashtra, India, from 07/04/01 till 07/04/05.

Univ. Of Mumbai Referee for the evaluation of Thesis and Viva-Voce examinations for the M.Sc.  and Ph.D. candidates as recommended by the Vice-Chancellor of Mumbai University.

On technical advisory board of Shri Vinayak Co-op. Bank Ltd., Ahmedabad, Gujarat.

Chief mentor to Mehta & Mehta Associates, Mumbai, for technical due diligence of healthcare & pharmaceutical industry ventures.