Cecilia Barese, MD, PhD
Medical Director. Medical Strategy at Pacira BioSciences, Inc.- Claim this Profile
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Spanish Native or bilingual proficiency
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English Native or bilingual proficiency
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Italian Native or bilingual proficiency
Topline Score
Bio
Credentials
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Board in Pediatrics
Sociedad Argentina de Pediatria -
International Technologist in Molecular Biology (MB)
American Society for Clinical Pathology (ASCP) -
U.S.M.L.E. (United States Medical Licensing Examination)
ECFMG
Experience
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Pacira BioSciences, Inc.
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United States
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Medical Director. Medical Strategy
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Mar 2023 - Present
In-vivo gene therapy programs In-vivo gene therapy programs
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ACELYRIN, INC.
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United States
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Biotechnology Research
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1 - 100 Employee
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Medical Director. Clinical Development
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Nov 2022 - Jan 2023
Small molecules (Izokibep: IL-17 inhibitor) Small molecules (Izokibep: IL-17 inhibitor)
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AVROBIO
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United States
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Biotechnology Research
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1 - 100 Employee
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Director. Clinical Development. Medical Monitoring
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Apr 2021 - Sep 2022
Medical lead during trial conduct, supported subjects enrollment /follow-up and study milestones. Sponsor medical monitor interacted with independent DMC members and pharmacovigilance CRO. Monitored efficacy, safety and early signal detection of investigational drug AVR-RD-02 (NCT04145037 and NCT04836377). Authored study protocols/amendments, synopsis, regulatory documents, and supported the clin ops activities. Contributions to the briefing document of AVR-RD-03 (Pompe disease).
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Director, Analytics, Translational Research Department
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Jun 2017 - Mar 2021
Oversaw the execution of non-clinical studies for the Pompe disease program from early stage development to pre-IND. Provided medical/scientific oversight to investigators, bench scientists, and the translational laboratory on the assigned program (Pompe disease). Oversaw assay qualification and validation for IND-enabling. Monitored progress of works at CROs and reviewed non-clinical study data/reports. Authored and reviewed technical documents, including SOPs, biomarkers test procedures and… Show more Oversaw the execution of non-clinical studies for the Pompe disease program from early stage development to pre-IND. Provided medical/scientific oversight to investigators, bench scientists, and the translational laboratory on the assigned program (Pompe disease). Oversaw assay qualification and validation for IND-enabling. Monitored progress of works at CROs and reviewed non-clinical study data/reports. Authored and reviewed technical documents, including SOPs, biomarkers test procedures and bioanalytical contributing reports. Subject matter expert on immunogenicity testing of new drug product. Contributor by authoring Pompe disease briefing package when required.
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Children's National Hospital
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United States
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Hospitals and Health Care
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700 & Above Employee
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GLP Cell Therapy Manager
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Jun 2013 - May 2017
In a translational medicine role supported the GMP lab, the translational research lab, study coordinators, and investigators of the FACT-accredited program for "off-the shelf" immunotherapies targeting infections after bone marrow transplantation and post-transplant lymphoproliferative disease (IST P1/2 FDA regulated clinical trial). Scientific contributor to proof-of-concept studies on T-stemness in VST products granted with the California Institute of Regenerative Medicine funding… Show more In a translational medicine role supported the GMP lab, the translational research lab, study coordinators, and investigators of the FACT-accredited program for "off-the shelf" immunotherapies targeting infections after bone marrow transplantation and post-transplant lymphoproliferative disease (IST P1/2 FDA regulated clinical trial). Scientific contributor to proof-of-concept studies on T-stemness in VST products granted with the California Institute of Regenerative Medicine funding. Scientific advisor to junior faculty, fellows, and clinical research associates in the DoE, study conduct, and clinical research data analysis. Show less In a translational medicine role supported the GMP lab, the translational research lab, study coordinators, and investigators of the FACT-accredited program for "off-the shelf" immunotherapies targeting infections after bone marrow transplantation and post-transplant lymphoproliferative disease (IST P1/2 FDA regulated clinical trial). Scientific contributor to proof-of-concept studies on T-stemness in VST products granted with the California Institute of Regenerative Medicine funding… Show more In a translational medicine role supported the GMP lab, the translational research lab, study coordinators, and investigators of the FACT-accredited program for "off-the shelf" immunotherapies targeting infections after bone marrow transplantation and post-transplant lymphoproliferative disease (IST P1/2 FDA regulated clinical trial). Scientific contributor to proof-of-concept studies on T-stemness in VST products granted with the California Institute of Regenerative Medicine funding. Scientific advisor to junior faculty, fellows, and clinical research associates in the DoE, study conduct, and clinical research data analysis. Show less
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National Heart, Lung, and Blood Institute
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United States
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Research Services
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300 - 400 Employee
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Research Fellow
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Aug 2008 - Jun 2013
Conducted translational reseach focused on improving the safety and efficacy of hematopoietic stem and progenitor cell (HSPC) gene therapies utilizing integrating viral vectors, via a “suicide gene” strategy. Expanded the application of suicide gene technologies to induced pluripotent stem cells to improve the safety of regenerative medicine therapies. Managed complex large animal study protocols, and a collaboration between the government research laboratory, international academic… Show more Conducted translational reseach focused on improving the safety and efficacy of hematopoietic stem and progenitor cell (HSPC) gene therapies utilizing integrating viral vectors, via a “suicide gene” strategy. Expanded the application of suicide gene technologies to induced pluripotent stem cells to improve the safety of regenerative medicine therapies. Managed complex large animal study protocols, and a collaboration between the government research laboratory, international academic laboratories (Baylor College, TX), and biotech companies (MolMed, Milan, Italy and Bellicum, TX) Mentored and instructed multiple students and new laboratory members and contributed to the conduct of several research projects Mentor: Cynthia E. Dunbar, M.D. Show less Conducted translational reseach focused on improving the safety and efficacy of hematopoietic stem and progenitor cell (HSPC) gene therapies utilizing integrating viral vectors, via a “suicide gene” strategy. Expanded the application of suicide gene technologies to induced pluripotent stem cells to improve the safety of regenerative medicine therapies. Managed complex large animal study protocols, and a collaboration between the government research laboratory, international academic… Show more Conducted translational reseach focused on improving the safety and efficacy of hematopoietic stem and progenitor cell (HSPC) gene therapies utilizing integrating viral vectors, via a “suicide gene” strategy. Expanded the application of suicide gene technologies to induced pluripotent stem cells to improve the safety of regenerative medicine therapies. Managed complex large animal study protocols, and a collaboration between the government research laboratory, international academic laboratories (Baylor College, TX), and biotech companies (MolMed, Milan, Italy and Bellicum, TX) Mentored and instructed multiple students and new laboratory members and contributed to the conduct of several research projects Mentor: Cynthia E. Dunbar, M.D. Show less
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University of Buenos Aires
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Argentina
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Higher Education
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700 & Above Employee
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Assistant Professor. Human Genetics and Molecular Biology, School of Pharmacy and Biochemistry
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2006 - 2008
Main contributor to molecular analyses of single nucleotide polymorphisms (SNP) for genes involved in innate immunity in patients with serious immunodeficiency diseases.Specific studies: MPO, MBL2, NA1/NA2 forms of FcgammaRIIIB in X-CGD patients with the severe disease phenotype. Oversaw the immunodeficiency clinic in the Dr. R. Gutierrez Children’s Hospital and in collaboration with the Dermatology Section led the first interferon gamma phase I clinical trial for the treatment of severe… Show more Main contributor to molecular analyses of single nucleotide polymorphisms (SNP) for genes involved in innate immunity in patients with serious immunodeficiency diseases.Specific studies: MPO, MBL2, NA1/NA2 forms of FcgammaRIIIB in X-CGD patients with the severe disease phenotype. Oversaw the immunodeficiency clinic in the Dr. R. Gutierrez Children’s Hospital and in collaboration with the Dermatology Section led the first interferon gamma phase I clinical trial for the treatment of severe atopic dermatitis in children sponsored by Boehringer Ingelheim pharma Show less Main contributor to molecular analyses of single nucleotide polymorphisms (SNP) for genes involved in innate immunity in patients with serious immunodeficiency diseases.Specific studies: MPO, MBL2, NA1/NA2 forms of FcgammaRIIIB in X-CGD patients with the severe disease phenotype. Oversaw the immunodeficiency clinic in the Dr. R. Gutierrez Children’s Hospital and in collaboration with the Dermatology Section led the first interferon gamma phase I clinical trial for the treatment of severe… Show more Main contributor to molecular analyses of single nucleotide polymorphisms (SNP) for genes involved in innate immunity in patients with serious immunodeficiency diseases.Specific studies: MPO, MBL2, NA1/NA2 forms of FcgammaRIIIB in X-CGD patients with the severe disease phenotype. Oversaw the immunodeficiency clinic in the Dr. R. Gutierrez Children’s Hospital and in collaboration with the Dermatology Section led the first interferon gamma phase I clinical trial for the treatment of severe atopic dermatitis in children sponsored by Boehringer Ingelheim pharma Show less
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Indiana University–Purdue University Indianapolis
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United States
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Higher Education
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700 & Above Employee
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Visiting Scientist and Clinical Fellow in the Immunodeficiency Clinic, Riley Children's Hospital
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Mar 2003 - Sep 2006
Described the mechanism by which mouse gene-modified bone marrow cells have increase competitive engraftment after low-intensity TBI and G-CSF administration. Conducted serial transplantation using an X-CGD knockout mouse model and functional and biochemical assessment of gene-corrected cells to monitor the reconstitution of the NADPH-oxidase in defective X-CGD phagocytes after gene transfer. Evaluated the effectiveness of low-intensity marrow conditioning to achieve clinically relevant… Show more Described the mechanism by which mouse gene-modified bone marrow cells have increase competitive engraftment after low-intensity TBI and G-CSF administration. Conducted serial transplantation using an X-CGD knockout mouse model and functional and biochemical assessment of gene-corrected cells to monitor the reconstitution of the NADPH-oxidase in defective X-CGD phagocytes after gene transfer. Evaluated the effectiveness of low-intensity marrow conditioning to achieve clinically relevant levels of engraftment of gene-modified cells in absence of survival or growth advantage for marrow cells expressing the corrected phenotype. Observing pediatrician in the immunodeficiencies clinic at Riley Hospital for Children under the supervision of Dr. Robert Nelson. Mentor: Mary C. Dinauer, MD, PhD. Washington University. dinauer_m@kids.wustl.edu Show less Described the mechanism by which mouse gene-modified bone marrow cells have increase competitive engraftment after low-intensity TBI and G-CSF administration. Conducted serial transplantation using an X-CGD knockout mouse model and functional and biochemical assessment of gene-corrected cells to monitor the reconstitution of the NADPH-oxidase in defective X-CGD phagocytes after gene transfer. Evaluated the effectiveness of low-intensity marrow conditioning to achieve clinically relevant… Show more Described the mechanism by which mouse gene-modified bone marrow cells have increase competitive engraftment after low-intensity TBI and G-CSF administration. Conducted serial transplantation using an X-CGD knockout mouse model and functional and biochemical assessment of gene-corrected cells to monitor the reconstitution of the NADPH-oxidase in defective X-CGD phagocytes after gene transfer. Evaluated the effectiveness of low-intensity marrow conditioning to achieve clinically relevant levels of engraftment of gene-modified cells in absence of survival or growth advantage for marrow cells expressing the corrected phenotype. Observing pediatrician in the immunodeficiencies clinic at Riley Hospital for Children under the supervision of Dr. Robert Nelson. Mentor: Mary C. Dinauer, MD, PhD. Washington University. dinauer_m@kids.wustl.edu Show less
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Education
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University of Buenos Aires
Doctor of Philosophy - PhD, School of Pharmacy and Biochemistry, Molecular Biology. University of Buenos Aires, Summa Cum Laude -
2005 -
Indiana University–Purdue University Indianapolis
Department of Pediatrics, Division of Hematology/Oncology Riley Children's Hospital, Clinical experience in the outpatient clinic/inpatient service under supervision. Accredited program -
1999 -
University of California, Los Angeles. Mattel Children's Hospital
Department of Pediatrics Allergy and Immunology, Attended outpatient and inpatient service under supervision during 8 consecutive months. -
Universidad Nacional de Rosario
Doctor of Medicine - MD, Medicine
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