Dr. Sanjay Singh

Currently

Chief Executive Officer and Executive Director Gennova Biopharmaceuticals Ltd, Pune, India

Responsibilities

  • Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health, Govt. of India for development of the India Guidelines on Similar Biologics (Regulatory Requirements for Marketing Authorization).
  • Governing body of the Institute of Life Sciences (ILS) – Bhubaneshwar, an autonomous institute of Department of Biotechnology (DBT), Govt. of India. Member of the advisory board of ILS –Ahmedabad.
  • Working group for Gene Therapy constituted jointly by the Department of Health Research (DHR) and Department of Biotechnology (DBT), Govt. of India.
  • Indo-US Vaccine Action Programme (VAP), Invited Member.
  • Member of the Scientific Advisory Board of the National Center for Cell Sciences (NCCS).
Dr. Sanjay Singh

Career Timeline

2006 – present CEO, Gennova Biopharmaceuticals Ltd., Pune, India.
2003 – 2006 Head, Antigen Research Section at National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA.
2000 – 2003 Senior Staff Scientist at National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA.
1996 – 2000 Research Scientist at International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India

Honors and Awards

  • US Department of Human and Health Services
  • 2005-Special Act or Service Award
  • 2004-Staff Recognition Award, NIAID/NIH

Academic Background

  • Ph.D. in Biochemistry from the Central Drug Research Institute (CDRI), Lucknow, India.

Career Highlights

  • During his tenure at the NIH, Dr. Singh was successful in taking four recombinant vaccine candidates from gene to Phase I human clinical trials.
  • At Gennova, Dr. Singh’s leadership has facilitated the launch of Elaxim™ (TNK-tPA for AMI); Tenectase™ (TNK-tPA for AIS); Vintor™ (Erythropoietin); Emgrast™ (Sargramostim); Exgrast™ (Filgrastim); PEGEX™ (Pegylated filgrastim) and Hamsyl®(Pegaspargase) in the market.
  • Key role in development of transmission blocking vaccine for Malaria under REDMAL – Seventh Framework Program (FP7) for Research and Technological Development of the European Committee for elimination and eventual eradication of Malaria.
  • His scientific acumen lead to the approval of Tenecteplase for Acute Ischemic Stroke (AIS), – First time in the World.
    • This innovation was recognized by the Department of Biotechnology (DBT), Govt. of India for the ‘Biotech product, process development and commercialization award 2019’.
    • Additionally, this ‘Make in India’ product has found its way in the list of drugs for emergency care for stroke management in the guideline –’Prevention and Management of Stroke’, issued by the Ministry of Health and Family Welfare, Govt. of India.

Selected publications

  • NPJ Vaccines. 2018 Sep 28;3:48. doi: 10.1038/s41541-018-0083-3
  • NPJ Vaccines 2017 2:10 ; doi:10.1038/s41541-017-0011-y
  • PLoS Clin Trials, 2007, 2(4):e12.
  • Infection & Immunity, Jul 2005, 73(7):3963-70.
  • Journal of Biological Chemistry, 2001, 276 (20): 171 11.

Selected patents

  • Pharmaceutical Composition of Tenecteplase (TNK-tPA), 2018 (US9943575B2)
  • Pharmaceutical Composition of Tenecteplase (TNK-tPA), , 2010 (PCT/IN2011/000863)
  • A Noval Process for Purification of rHu-GCSF, 2015 (PCT/IN2015/050066)
  • A Novel Purification Process for Isolation and Commercial Production of Recombinant TNK-tPA (PCT/IN2015/050137)