•Parte del Grupo Fundador Organizador de COLAVAC: Comité Latino Americano de Vaccinología para Animales de Compañía.
•Expert Witness en Casos Legales de Arbitraje como Experta en el Desarrollo de Vacunas para Animales.
ANIMAL HEALTH INDUSTRY CONSULTANT
CONFERENCISTA PARA AMERICA LATINA EN VACCINOLOGIA Y
ENFERMEDADES INFECCIOSAS DE CANINOS Y FELINOS.
EXPERiencia:
•22 años en Industria Privada como Líder de Proyecto, Desarrollando y Registrando Vacunas para Felinos y Caninos bajo los requerimientos de la USDA y de la Farmacopea Europea. Vacunas Desarrolladas para Rhône Mérieux, Merial (ahora Boehringer Animal Health) bajo mi grupo con el año de registro:
- Coronavirus Canino a virus vivo modificado y sin adjuvante,Monovalente o con vacuna de Parvovirus en 1994.
- Línea Recombitek®: Vacuna de Moquillo Canino Recombinante Vectorizada sin adjuvante para perros y hurones. Varias Presentaciones C3, C4, C6 y C8 para Perros desde 1997. Monovalente para Hurones en 2001 y Monovalente para Perros en 2013.
- Vacuna de Leucemia Felina Recombinante Vectorizada sin Adjuvante Transdermal en 2004.
- Bacterina de Leptospira canina 4 Lepto® sin adjuvante contra L. canicola, L. grippotyphosa, L. icterohaemorragiae y L. pomona. Con 15 meses de duración de inmunidad para L. grippotyphosa en 2010.
- Vacuna de Rabia 3 años para Gatos Purevax® Recombinante Vectorizada sin Adjuvante en 2013
EXPERIENCE IN NEW PRODUCT DEVELOPMENT:
•Project Leader accountable for designing and delivering all technical aspects of vaccine development through Interdepartmental and multinational teams moving vaccine projects from:
Proof of Concept → Research Phase.
Research → Development → Clinical Trials and Regulatory Phases/Stages
Transfer to Manufacturing. Quality Control and Supply Chain for batch release,
License & Commercial Product Launch
Marketing Support in USA and Latin America.
•By my direct involvement and leadership, the following USDA Vaccine Product Licenses for Rhône Mérieux / Merial, (now Boehringer Ingelheim Animal Health) were obtained:
•Canine Coronavirus MLV, monovalent and several product combination presentations: 1994
Canine Distemper, Canarypox vectored Vaccine: Several product presentations: (C4, C4/CV, C6 and C6/CV Recombitek® Line): 1997. First genetically engineered vaccine licensed for pets in the world.
Canine Distemper, Canarypox vectored Monovalent Vaccine for use in Ferrets; Purevax® Ferret Distemper Vaccine: 2001
Purevax® Feline Leukemia, Canarypox Vectored Vaccine - Transdermal route: 2004
Recombitek 4 Lepto®. A LCIGP (4-way) inactivated non adjuvanted canine leptospira bacterin with unique 15.5-month duration of immunity against L. Grippotyphosa and Prevention claim.2010
Purevax® Feline Rabies 3 year, Canarypox Vectored Vaccine: 2013
EMPLOYMENT:
Lecturer at International Veterinary Conferences and Animal Health Consultant:
Current position since 2013.
Rhône Mérieux, Inc 1991 to 1997, which became Merial in 1997. Athens. GA, 30601. USA*
Aug 1991 – Dec 2000: Senior R&D Scientist AND Technicians Team Coordinator.
Jan 2001 - Feb 2006: Associate Director - Technical Leader Biological R&D.
March 2006- Dec 2012: Director - Project Leader Canine Biologicals R&D USA.
The University of Georgia- Athens GA USA: June 1989- July 1991: Graduate Assistant & Research Coordinator: Characterization of the VG/GA, Newcastle Disease Strain Vaccine Strain was commercialized as vaccine for Poultry by Merial Avian Unit, Gainesville, GA. USA as AVINEWÆ.
*MAJOR RESPONSIBILITIES IN ANIMAL HEALTH INDUSTRY POSITIONS (1991 – 2012):
Accountable for designing and delivering all technical aspects of vaccine development from POC (proof of concept) through USDA licensure and commercial launch leading Project Teams.
The Project Teams were composed of a Marketing Leader and Manufacturing, Regulatory, Research, Analytical, Clinical, Process, Quality Assurance and Supply Chain Team members.
Responsible for life cycle management of each Project.
Prepared realistic Project Budget and Resources needs.
Assessed all technical project risks, developed and validated risk mitigation and backup plans.
Presented and communicated regularly Project updates, with Risks, Mitigation and backup plans along with updated Timelines to the Vice-presidents and “Governing bodies” so everyone was crystal clear about each Project status.
Proactively acknowledged the time to advance the project to the next stage and was very clear when a Project needed to be terminated.
Worked with Functional Heads to assign the appropriate functional team member to the projects I was leading. Team members were essential to the Project success, so I was sure each team member understood the project objectives and their own contributions in the larger context of franchise and company goals. Basically, I was a Mentor to them, since team members did not report administratively directly to me, but to their own Function.