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Dr. Prajakt Barde

Asst. Medical Director
Serum Institute of India Ltd
D-3, Amar Nagari

Brief Biography:

  • M.D. (Clinical Pharmacology & Therapeutics), from Seth GS Medical College and KEM Hospital, Mumbai.
  • Working as Assistant Medical Director with leading global Vaccine/Biotech manufacturer (Serum Institute of India Ltd, Pune) with a footprint in over 150 countries worldwide.
  • Over 5.0+ years of experience in the field of Vaccines and Biotechnology involving strategy planning, strategic alliances, licensing, negotiations & contracts, clinical development, medical writing & pharmacovigilance, NRA licensure, WHO pre-qualification, international registration, and product commercialization.
  • Overall 8.0+ years of work experience in clinical development with several publications in peer reviewed indexed journals.
  • A successful track-record of conceptualizing and executing several projects.
  • Achievement: Successfully completed end-to-end clinical development of two H1N1 vaccines (Live Attenuated Influenza Vaccine and Inactivated Influenza Vaccine) and finally NRA licensure and successful introduction of H1N1 vaccine in record time of 12 months. (A pandemic influenza vaccine in India: From strain to sale within 12 months. Vaccine. 2011 Jul 1;29 Suppl 1:A16-21)

Academic positions:

  • 09.04.2007 to till date: Working as Assistant Medical Director with Serum Institute of India Ltd, Pune (SIIL).

  • Spearheading overall end-to-end clinical development and medical & regulatory affairs activities for novel vaccines/biotech products; spanning pre-clinical/toxicology, clinical (Phases I-IV), NRA licensure, WHO Pre-Qualification, international registrations, and product commercialization.
  • Planning and designing of studies, writing protocols and clinical trial reports.
  • Drive strategic multi-level co-development partnerships for novel vaccines.
  • Heading overall project management, medical & regulatory affairs for large multi-centric clinical trials.
  • Build and operationally manage a medical team and coordinate other associated functions of clinical research. 
  • Primary responsible for providing timely and accurate scientific inputs in response to queries from NRA, medical and marketing team.
  • Ensure timely preparation of safety summaries; periodic safety update reports (PSUR); product summary file (PSF); common technical document (CTD); summary product characteristics (SPC)
  • Currently working on novel vaccines/biotech product; Meningococci A conjugate vaccine, Rabies monoclonal antibodies, Seasonal influenza vaccine, Dry Powder Measles vaccine and Vero cell rabies vaccine. 

Research interests:

Vaccine research: Following publications in international peer reviewed journals.

  1. Satwekar AM, Telang SS, Ghorpade NA, Barde PJ, Patwardhan MR, Kulkarni PS. Diphtheria and Tetanus Antibody Persistence in Indian Pre-school Children and Response to a Booster dose of DT Vaccine. World Journal of Vaccines, 2011, 1, 5-9.
  2. Dhere R, Yeolekar L, Kulkarni P, Menon R, Vaidya V, Ganguly M, Tyagi P, Barde PJ, Jadhav S. A pandemic influenza vaccine in India: From strain to sale within 12 months. Vaccine. 2011 Jul 1;29 Suppl 1:A16-21.
  3. Hirve S, Bavdekar A, Juvekar S, Agarwal D, Barde PJ, Mangrule S, Patwardhan M, Pandit A, Kulkarni PS. A comparative study to evaluate the safety and immunogenicity of two lots of Haemophilus influenzae type-B conjugate vaccine manufactured at different scales. Vaccine. 2011 Jun 7. [Epub ahead of print]
  4. Kulkarni PS, Sapru A, Bavdekar A, Naik SS, Patwardhan M, Barde PJ, Pandit AN. Immunogenicity of Two Diphtheria-Tetanus-Whole Cell Pertussis-Hepatitis B Vaccines in Infants: A Comparative Trial. Human Vaccine. 2011. (Accepted for publication)
  5. Kulkarni PS, Barde PJ, Meesala R, Winston SE, Sievers RE, Cape SP, Griffin DE, Lin WH, Godin S. Finishing the Unfinished: II. Initiation of Phase I Clinical Trial of Inhalable Dry Powder Measles Vaccine. 6th Annual Grand Challenges in Global Health Project. Presented at the 6th Annual GCGH meeting; 25-27 October 2010, Seattle, WA.

 In following papers Author acknowledged my statistics contribution.

  1. Gawande S, Vaidya M, Tadke R, Kirpekar V, Bhave S. Progressive Muscle Relaxation in Hyperemesis Gravidarum. Journal of South Asian Federation of Obstetrics and Gynaecology, January-April 2011;3(1):28-32.
  2. Ashok, G, Rajendran P. Jayam S, Karthika R, Kanthesh BM,  Vikram Reddy E, and Kulkarni PS. Assessment of immune response and safety of two recombinant hepatitis B vaccines in healthy infants in India. African Journal of Biotechnology 2011; 10 (59): 12707-10.
  3. Siddiqui R, Gawande S. Shende T, Tadke R. SSRI-induced Coagulopathy: is it reality? Therapeutic Advances in Psychopharmacology 2011; 1(5) [Epub ahead of print]

What I think of the idea behind WebmedCentral:

Its a good idea.