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TANYA SCHARTON-KERSTEN, PhD, RAC

President and Founder

Tanya Kersten is a scientist and Global Regulatory Affairs Professional (20+ years and RAC). She has a PhD in Immunology; experience with bacterial, metabolic, neurologic and viral disease prevention and treatment. Focused on innovative biologics, gene therapies, and vaccines. Motivated by developing AND implementing global regulatory strategies for novel and emerging platform technologies. Engaged, get things done, risk-based decision maker and ‘doer’ for complex CMC projects.

 

LinkedIn

Curriculum Vitae (CV)

Publications

 

FOCUS

  • CMC expert for innovative biological, device and drug technologies
  • FDA and worldwide health authority meetings and negotiations

 

EXPERTISE

  • 20+ years of experience in regulatory filings for gene therapy, bacterial and viral vectored vaccines, DNA and RNA constructs, proteins, and nanoparticles
  • IND/CTA, BLA-MAA, and post marketing submissions and approvals
  • Request for designations, pre-preIND/INTERACT, preIND, EOP2 and preBLA meetings (US) and equivalent in US.
  • Authoring and review of gap analyses, risk assessments, white-papers, RTQ (responses to questions) for investors, funding agencies and health authorities
 

CREDENTIALS

  • B.A. Immunology and Microbiology from University of California at Berkeley.
  • PhD Immunology from the University of Pennsylvania
  • Postdoctoral fellowship at the National Institute of Allergy and Infectious Diseases, National Institutes of Health
  • Regulatory Affairs Professional Society member and global certified professional

Alumni Associations

Professional Memberships