Rona LeBlanc-Rivera, Ph.D.


Principle Consultant , Regulatory Affairs


[email protected]
Rona LeBlanc-Rivera, Ph.D. joins RCA as a Pharmaceutical Director of Regulatory Affairs with over 23 years of experience spanning the FDA and the pharmaceutical industry. She is responsible for developing regulatory strategies and establishing policies according to business and client needs, both domestically and internationally. Rona also provides direction and oversight to projects, advise clients on regulatory strategies, and submissions to the FDA.
 
Prior to joining RCA; Rona served as a FDA reviewer in chemistry, manufacturing and controls (CMC) for biologics and generic drug applications (IND, BLA, ANDA, DMF) for 9 years, 9 years as a regulatory affairs professional in the pharmaceutical industry, and over 5 years as a pharmaceutical industry consultant for drug product applications (pre-approval and post-approval), including support as primary liaison with FDA. Her experience includes evaluating data, planning, execution, writing, critical review and maintenance of all sections of submissions (Abbreviated New Drug Applications, Drug Master Files, Investigational New Drug Applications, New Drug Applications).
 
She has held the title; Microbiology/Sterility Assurance subject matter expert (aseptic processing, terminal sterilization), provided CMC and regulatory strategy for products in development as well as commercial lifecycle management, covering ANDA, IND, NDA and DMF submissions to the FDA during her career.
 
Rona received her Ph.D. in Cellular and Molecular Biology from The University of Michigan in Ann Arbor, MI, was a Postdoctoral Research Fellow at NIAID/NIH in Bethesda, MD, and received her Bachelor of Science in Microbiology from Cornell University in Ithaca, NY.
 

Major Publications:

  • Gamma interferon impedes the establishment of herpes simplex virus type 1 latent infection but has no impact on its maintenance or reactivation in mice. Lekstrom-Himes JA, LeBlanc RA, Pesnicak L, Godleski M, Straus SE. Journal of Virology. 2000 Jul;74(14):6680-6683.
  • Lack of lnterleukin-6 (IL-6) Enhances Susceptibility to Infection but Does Not Alter Latency or Reactivation of Herpes Simplex Virus Type 1 in IL-6 Knockout Mice. LeBlanc RA, Pesnicak L, Cabral E, Godleski M, Straus SE. Journal of Virology. 1999 Oct;73(10):8145-8151.
  • The comparative effects of famciclovir and valacyclovir on herpes simplex virus type 1 infection, latency, and reactivation in mice. LeBlanc RA, Pesnicak L, Godleski M, Straus Journal of Infectious Diseases. 1999 Sep;180(3):594-9.
  • Treatment ofHSV-1 infection with immunoglobulin or acyclovir: comparison of their effects on viral spread, latency, and reactivation. LeBlanc RA, Pesnicak L, Godleski M, Straus SE. Virology. 1999 Sep 15;262(1):230-6.
  • Defective entry of herpes simplex virus types 1 and 2 into porcine cells and lack of infection in infant pigs indicate species tropism. Subramanian G, LeBlanc RA, Wardley RC, Fuller AO. Journal of General Virology. 1995 Sep;76 (Pt 9):2375-2379.

 

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