Academic Qualifications

Curriculum Vitae

Name : Dr. DEEPAK ANANT HEGDE

Address Flat No 51, H-1 Building, A Wing （In India） Shreerang Unit No.24 Co-Op. Housing Society Thane (West ) - 400 601, Maharashtra., India  : + 91 22 2533 3751 E-mail : [email protected] :

Personal

Date of Birth : 6th November 1969

Marital Status : Married

Current position & job profile * As Vice President of Pharmaceutical Services at WuXi PharmaTech ( The largest CRO in China ), Shanghai , China from July 2007 * Currently heading a group of 15 scientists in preformulation and formulation

development

Major achievements and contributions to business: At USV Ltd * Development and registration of nine niche bioequivalent products for ANDA filings, including two combination products. Completion of batches and associated documentation for S-ANDA for a US based generic company. * Development and registration of a low dose bioequivalent product (with 7 strengths) for e-CTD filing, in Europe. * Development of non infringing generic formulation for a high dose drug for compilation of dossier for registration in EU. Provisional Indian Patent application filed for this product by USV Ltd. * Development and commercial launch of biosimilar (peptide injectable) formulation for Indian market. Development of two lyophilized formulation of peptide product upto pre-clinical stage. * Development of one patent non-infringing liquid injectible formulation of biosimilar (peptide injectible) formulation for European market upto pre-clinical stage. Provisional Indian Patent application filed by USV Ltd. for the liquid formulation. * Design and establishment of pilot plant at USV (Daman) which was approved by the US-FDA. At Ipca Labs Ltd. * Development of three formulations for ANDA filing

of 4 At Sandoz Pvt. Ltd. * Development of patent non infringing generic formulation for an Anti-fungal drug for compilation of dossier for registration in EU. Patent application filed for this product by Sandoz (Previously Biochemie), Vienna. * Development of a patent bypass generic formulation of an Anti-lipedemic drug for compilation of dossier for registration in US and EU. Patent application filed for this product by Sandoz (Previously Biochemie), Vienna. * Development of capsule generic formulation for an Anti-fungal drug for which registration completed in EU & RoW countries. Successful technology transfer to Novartis Bangladesh. Products commercially launched in Bangladesh. * Development of Anti-TB products (two, three and four drug combinations) for which registration completed in RSA, EU and RoW countries. Successful technology transfer to Rolab, a subsidiary of Novartis Group of companies in South Africa and to Novartis Bangladesh. Products commercially launched in Europe, RSA, Pakistan, Bangladesh and India. * Identified and initiated the licensing in process for two products developed by Indian pharmaceutical companies for licensing in by the Sandoz group for introduction as generic products into Europe. * Identified and completed licensing in of several new products developed by Indian companies for introduction as new products in India by Sandoz business unit.

ACADEMIC QUALIFICATIONS MASTER OF FINANCIAL MANAGEMENT ( M.F.M ) : July 1997 - May 2000 K.J. Somaiya institute of Management Studies and Research, Vidyavihar, Mumbai 400 077. DOCTOR OF PHILOSOPHY (Ph.D.) : May 1993 - January 1996 The Bombay College of Pharmacy, Kalina , Santacruz (E), Mumbai 400 098. Research Advisor : Dr. H.P. Tipnis Title of Thesis : Studies in Nicardipine Abstract of Thesis : Nicardipine, a dihydropyridine calcium channel antagonist, belongs to a newer class of calcium channel antagonists. The doctoral thesis covered the following.  Development of an analytical method for analysis of the Nicardipine from formulations and plasma.  Development of a sustained release formulation of Nicardipine.  Determination of effect of diet (high lipid, high carbohydrate and high protein) on the bioavailability of Nicardipine.  Bioequivalence studies on some internationally marketed formulations of Nicardipine. Preparation of inclusion complexes of Nicardipine with  cyclodextrin with a view to increase the solubility of Nicardipine and characterisation of the complexes using DSC, SEM, NMR, IR, and dissolution studies.

of 4 MASTER OF PHARMACY ( M.PHARM ) : August 1991 - February 1993 Department of Pharmaceutics, Institute of Technology, BHU, Varanasi 221 005.

BACHELOR OF PHARMACEUTICAL SCIENCES (B. PHARM. SCI.) August 1987- May 1991 The Bombay College of Pharmacy, Kalina , Santacruz (E), Mumbai 400 098. Work Experience  As GM – Drug Delivery Research Lab at USV Ltd. from Oct 2004 to July 2007.

 As Deputy General Manager – Pharma Research at IPCA Labs Ltd. from Feb to Oct 2004

 As Project Manager – Business Development & Licensing , at Novartis Enterprises Pvt. Ltd. from April 2002 to Jan 2004.

 As Project Leader – Formulation development, in leading a team of twelve persons at Healthcare Development Centre, Novartis Enterprises Pvt. Ltd. from April 2000 to April 2002.  As Executive – Formulation development, at Healthcare Development Centre, Novartis Enterprises Pvt. Ltd. From September 1998 to March 2000.

 As Executive-R&D at Rhone Poulenc (I) Ltd. from Jan 1996 to Sept 1998.

Fellowships

 Junior Research Fellowship (Aug 1991- May 1993) and Senior Research Fellowship (May 1993-Dec 1995) in Engineering and Technology from the University Grants Commission, Ministry of Education, New Delhi . Awards

 Novartis Award for Excellence for “Function of the Year”, in Dec 2002.

 Novartis Award for Excellence for “Most Innovative Idea”, leading to a patent, in Dec 1999.

 A. M. Kamath Memorial Award for outstanding performance in Ph.D. programme (1996), in M.Pharm programme (1993) and in Final Year B.Pharm examination (1991).

Professional Affiliations

 Registered Pharmacist (Life member) under Maharashtra State Pharmacy Council. , India

 Life member of Indian Pharmaceutical Association.

of 4 Academic affiliations Examiner for University of Mumbai and SNDT University for Pharmaceutics M. Pharm Sci & Ph.D. thesis evaluation.  Patents  Holder of 2 PCT patents and 5 Indian provisional patent (applications)

Major Training Programmes Attended

 Attended a six-day residential ‘Project Management Workshop’ conducted by Indian Institute of Management (IIM)- Ahmedabad between 4th Sept to 9th Sept 2000.

 Attended the 32nd Controlled Release Society Symposium and exposition held at Miami, Florida, USA in June 2005.

 Attended a two day comprehensive course on Pharmaceutical Freeze Drying organised by Biopharma Technology Ltd., U.K  Research Experience  Development of solid oral dosage forms (generic formulations), IR & MR tablets and capsules for the regulated markets for the regulated markets including US, Europe and South Africa. Also well versed with answering of deficiency letters raised by registration authorities during the course of registration.  Development of solid oral dosage forms (generic formulations), tablets and capsules and the associated documentation for less regulated markets including RoW countries.

 Development of bio-similar injectable formulations for the semi-regulated and regulated markets. Available on request Updated August 2007