プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Gaurav G.に依頼

United Kingdom

Senior Research Scientist/consultant with 16+ years proven experience in vaccines/ virology in Biotech industry/academia

プロフィール概要

I have proven and grown quickly in different roles from lab scientist to technical lead, trouble-shooter, project manager, the group leader (in a team of 35 scientists), Head of R&D and has acquired extensive experience in the field of Vaccine and biologicals over 16 years. I have 39 publications and 6 patents in the field of Vaccines, Biologicals and Virology. Currently, I am working in the adeno-vectored COVID19 vaccine development group and transmission blocking Malaria vaccine (TBV) group at Jenner Institute, University of Oxford as Senior Research Scientist since Jan 2018 for product development, technology transfer and GMP production of clinical vaccines for human safety and efficacy studies. It is a senior role in supporting and supervising all aspects of the transmission-blocking malaria research program led by Professor Sumi Biswas. I lead and establish projects at Jenner Institute efficiently to achieve lower cost, higher yields (mg to gm. /litres) and with acceptable GMP standards. Now GMP batches are under stability studies and ready for clinical trials of these novel candidate vaccines-Pfs25 (already initiated), Pvs25. All work will evaluate in human clinical trials TBV candidates for safety and efficacy using adult healthy volunteers in the UK including field trials on African children. Besides, I also developed 3 other innovative, Virus like particles (VLPs) as universal vaccine carriers. These are made up of fusion proteins forming VLPs of either Hepatitis B Spycatcher or Hepatitis E P239 or HPV 16 L1 monomeric protein fused with targeted TBV antigen(s) and proven to be efficacious in preclinical animal models. They are now ready with pilot-scale processes to produce in GMP for clinical trials depending upon funding support. They will be evaluated in clinical trials for the prevention of Malaria and other infectious diseases. I have presented my approaches for making potent Malaria and other vaccines using VLPs in 'Protein Australia 2019' which was very much appreciated by the scientific community. I am drafting my papers, patents and then looking for funding opportunities to take them forward for clinical trials. This novel VLPs based platform technologies worked as a carrier to deliver antigens that are non-immunogenic to give a stronger immune response in preclinical studies so far. Therefore, it accelerates the selection of new vaccine candidates for TBV and can be then applied to other emerging pathogens vaccines like Ebola & COVID-19 where stronger immune retort is essential with lower production cost. It can solve global unmet medical needs to produce such vaccines at affordable costs with the highest quality standards based on my expertise in the field for recombinant host systems mammalian cells, Yeast and E coli. I am also advising for GMP process development in different projects of Malaria vaccines lead by Prof Simon Draper and Director Prof Adrian hill. Apart from this, I guided 2 master students in the thesis under the Erasmus program. Moreover, I am teaching schools under the University of Oxford multiple school projects as a volunteer. I have been awarded grade 8.2 from 7.2 based on my contribution in the last couple of years at Jenner in Sept 2019. I am also working as a consultant to Etna Biotech, Italy for novel vaccines (HPV 9 valent) and biologicals (Dengue & single chain camelid Mabs) product development since July 2019. I am also supporting start-up Vaxbio limited for COVID-19 vaccine development. Before joining at Jenner Institute, I did my Ph.D. in Virology and established the first HPV vaccine from India until the phase 2 clinical trial. I worked parallelly in a team led by eminent Vaccinologist, Dr. Reinhard Glueck, Cadila Healthcare Limited, India from 2009-2017 for 22 multiple vaccine projects. Lead as a subject matter expert and redeveloped modern technologies for better quality and affordable vaccines from the early stage to the final market authorization stage (Measles, Rubella, and Varicella) and commercial launches (Influenza) successfully. My expertise and team efforts resulted in launching the first tetravalent influenza vaccine (Vaxiflu 4) from India and second worldwide. I brought forward several novel vaccines (for Chikungunya, Japanese Encephalitis, Ebola, Congohemorrhagic fever, Malaria, Leishmania, Hypercholesteremia, universal influenza) and new adjuvants by establishing their methods, seeds and doing early preclinical proof of concept studies. I contributed to securing the following funding awards *[7 million Euros from the EU (https://www.mulevaclin.eu/home)] *[60 million Indian rupees (https://www.birac.nic.in/projects_supported.php?scheme=1&iscomplete=5)] *[4,647,149 euros from the EU (http://www.euvaccine.eu/portfolio/project-index/edufluvac)] *[2.5 million Euros from the Italian government (https://www.playourope.eu/en/node/116)] Evident by international patents, peer-reviewed publications and many national as well as international conference presentations (refer CV). I could demonstrate multilevel of talents to handle and achieve results for very novel and challenging product development with many international collaborations with IDRI, USA; NIH, USA; WHO centre for Leishmaniasis, Spain; NIBSC, UK and established such novel vaccines with preclinical data (Leishmania, Influenza). Our efforts were well recognized by international news as follows *[https://www.idri.org/idri-zydus-agreement-leish-vx/] *[http://www.wtec.org/vaccine2/RpdVaccMfg-Asia-final07.12.11.pdf] I have contributed to viral vaccine monographs as an official expert for United States Pharmacopeia and WHO guidelines for Rabies and HPV vaccines.I worked in Panacea biotech limited (2005-2009) and Biomed private limited (2004-2005) for vaccine development in human & poultry viral vaccines and as an animal house in charge. I have managed cross-functional teams of QC, QA and regulatory in these tasks which makes me flexible and universal for vaccine development in any kind of atmosphere. I wish to highlight my lab management experience under GMP for Biosafety level II/III for human vaccine development for 22 various above-mentioned projects of viral vaccines from 2009-2017. The labs were compliant as per GMP requirements for injectables vaccines under EU GMP/ WHO guidelines. I faced many audits for various products from national, International agencies to comply for GMP requirements during various stages of product development (Preclinical, Clinical and commercialisation) and passed successfully with minor compliance points. I have also contributed for design of facilities from beginning, commissioning, installation and final qualification under GMP biosafety level II/III as a subject matter expert. I was also an approved GMP manufacturing personnel from National FDA of India and also recently successfully developed 2 malaria vaccine candidates ready for clinical trial under EU GMP guidelines and released by MHRA one of them in my current job at Jenner Institute. I am open for suitable projects. Kind regards Gaurav

専門分野

• ★ Vaccine Development
• ☆ Virology
• ☆ Biotechnology & Bioengineering
• ☆ Veterinary Medicine
• ☆ Hepatitis
• ☆ Ebola
• ☆ Chikungunya
• ☆ Eastern Equine Encephalitis Virus
• ☆ Dengue

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

Product Development Formulation

職務経験

Consultant

Vaxbio limited

12月 2019 - 現在

Senior research scientist

Jenner Institute, University of Oxford

1月 2018 - 現在

学歴

PhD virology

Amity institute of virology and immunology

12月 2011 - 11月 2017

Master of veterinary Sciences in Microbiology and Immunology

College of veterinary sciences

1月 2002 - 1月 2004

Doctor of veterinary Medicine

Bombay Veterinary college, Mumbai

7月 1996 - 10月 2001

認定資格

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