Nitisha Pyndiah CV – CMC Consultant
Nitisha Pyndiah, PhD
Over six years of experience in biomedical research, biotechnology, FDA and EMA regulatory affairs.
HartmannWillner April 2016-PRESENT
Provide professional advice to clients including regulatory affairs technical and strategic support for the development of biological, biotechnological, and biosimilar products throughout the product lifecycle. Critically review Chemistry, Manufacturing and Controls (CMC); conduct scientific and regulatory gap analyses of Investigational New Drug (IND) Applications; prepare Quality Overall Summaries (QOS), General Investigational Plans, and other sections of FDA submissions in CTD format; prepare FDA meeting documents; review and submit expedited safety adverse event reports.
Regulatory affairs consultant intern
Maxia Strategies LLC, Basel, Switzerland Feb 2016 – Apr 2016
Developed and implemented a regulatory support and compliance system for start-up biopharmaceutical companies. Drafted an Orphan Drug Designation (ODD) application and gained experience in pediatric regulations for the EMA and FDA. Conducted research and provided recommendations about appropriate animal species to be used in a preclinical toxicology study according to gene expression and phylogenetic analysis.
Graduate research assistant
Institute of Microbiology, CHUV, Lausanne, Switzerland Apr 2012 – Sep 2015
Conducted laboratory research in the fields of Virology, Immunology and Molecular Biology including lentiviral vectors to discover innate immunity proteins able to block Human Immunodeficiency Virus (HIV) replication. Such proteins called restriction factors hold great promise for human gene therapy and new HIV therapeutics. Numerous publications in peer-reviewed journals and presentations/awards at national and international meetings.
Institute of Microbiology, CHUV, Lausanne, Switzerland Sep 2011 – Mar 2012
Conducted cohort clinical studies in the fields of Virology and Transplantation to find the association between Mannan Binding Lectins (MBL) levels and the incidence of Cytomegalovirus (CMV) infection in a cohort of transplant patients, thus potentially leading to recombinant MBL treatments reducing the incidence of CMV. Also carried out in vitro experiments to evaluate the impact of recombinant MBL on CMV replication. Required organization and quality control of sample collection in different national centers.
Healthcare Scientist Centre for Infections
Health Protection Agency, London, UK Jan 2009 – Jan 2010
Conducted laboratory studies in the fields of Virology and Vaccines to provide insight into the prevalence of Human Papillomavirus (HPV) in young women in England and to monitor the effect of HPV widespread immunization. Routinely generated and analysed data for National HPV surveillance studies (Department of Health, UK) and vaccine studies for GSK. Drafted Standard Operating Procedures (SOPs); performed quality control to allow the production of accurate data and performed quality assurance assays for World Health Organization (WHO); Data entry and management on Laboratory Information Management System (LIMS); worked under Good Laboratory Practises (GLP) and supervised a team of junior technical officers.
- 2015 – 2016 Regulatory affairs certificate: Pharmaceuticals RAPS Online University
- 2012 – 2015 PhD in Microbiology, University of Lausanne (UNIL), Lausanne, Switzerland, Title: Identification of novel HIV-1 restriction factors
- 2010 – 2011 MSc Medical Molecular Biology (Award Obtained: Distinction), University of Westminster (UoW), London, United Kingdom
- 2004 – 2008 BSc Biochemistry and Molecular Biology, Louis Pasteur University (ULP), Strasbourg, France
- 2002 – 2004 Baccalaureate specialized in Science: Biology, Physics, Chemistry and Mathematics, Lycée Labourdonnais, Mauritius
- Golshayan D, Wójtowicz A, Bibert S, Pyndiah N, Manuel O, Binet I, Buhler LH, Huynh-Do U, Mueller T, Steiger J, Pascual M, Meylan P, Bochud PY, (2016). Polymorphisms in the lectin pathway of complement activation influence the incidence of acute rejection and graft outcome after kidney transplantation. Kidney Int.
- Pyndiah, N., McLaren, P.J., Gawanbacht, A., Krapp, C., Hotter, D., Kluge, S.F., Goetz, N., Heilmann, J., Mack, K., Sauter, D., Thompson, D., Perreaud, J., Rausell, A., Munoz, M., Ciuffi, A., Kirchhoff, F., Telenti, A., (2015). Identification of potential HIV restriction factors by combining evolutionary genomic signatures with functional analyses. Retrovirology
- Pyndiah, N., Telenti, A., Rausell, A., (2015). Evolutionary genomics and HIV restriction factors. Current opinion in HIV and AIDS.
- Apostolidou, S., Hadwin, R., Burnell, M., Jones, A., Baff, D., Pyndiah, N., Mould, T., Jacobs, I.J., Beddows, S., Kocjan, G., Widschwendter, M., (2009). DNA methylation analysis in liquid-based cytology for cervical cancer screening. International Journal of Cancer.
KEY ORAL PRESENTATIONS
Feb 23-26 2015 Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, USA Award: Young investigator studentship; abstract selected for poster presentation and themed discussion
Feb 6, 2013 Swiss Virology meeting, Thun, Switzerland
Sep 6, 2012 Swiss Molecular Microbiology meeting 2012, Villars-sur-ollon, Switzerland
Sep 5, 2012 Session Chair at the Annual Retreat of the CUSO Doctoral Program in Microbial Sciences, Villar sur- ollon, Switzerland
Jun 22, 2012 Joint annual meeting SSI, SSHH, SSM, SSTMP, St Gallen, Switzerland
Regulatory Affairs Professional Society (RAPS), DIA (Drug Information Association), AAPS (American Association of Pharmaceutical Scientists (AAPS), Parenteral Drug Association (PDA).