Eric Laïlle Email & Phone Number

Overland Park, Ks, Us

United States

I contribute to strategic planning, design and execution of the clinical development strategy of one of Cellectis allogenic CAR-T cells program.

Overland Park, Kansas, United States

I contributed to the development of Onureg (CC 486; oral azacitidine) which was approved by the FDA on 01 September 2020 (and several other agencies in 2021) for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.I was a clinical scientist on the phase 3 AG-221-AML-004 study, which compared the efficacy and safety of AG-221 (CC-90007) versus conventional care regimens in older subjects with late-stage acute myeloid leukemia (AML) harboring an isocitrate dehydrogenase 2 (IDH-2) mutation.

Overland Park, Kansas

I was the lead clinical scientist for the Phase 3 AZA-MDS-003 study, which evaluated CC-486 treatment in subjects with red blood cell transfusion-dependent anemia and thrombocytopenia due to IPSS lower-risk myelodysplastic syndromes (MDS). CC-486 was associated with a significantly higher rate of RBC transfusion independence versus placebo and with improvements in hemoglobin and platelet counts over time. The most common adverse events were GI and hematologic events. Although overall death rate was similar between treatment arms, more early deaths occurred in the CC-486 arm, most related to infections in patients with significant pretreatment neutropenia. Further evaluation of CC-486 in patients with MDS is needed, including rational identification of patients most likely to benefit from the drug.I was the lead clinical scientist for the Phase 1 CC-486-CAGEN-001 study (Bioequivalence and Food Effect); the results of this trial indicated that the 1 x 300 mg tablet formulation (planned for commercialization) was bioequivalent to the 2 x 150 mg tablets used in the Phase 3 CC-486 registration study and that CC-486 can be taken with or without food. I contributed to the development of Istodax (Romidepsin) which was approved in Japan in July 2017 for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. I was also the lead clinical scientist for the FDA Post Marketing Requirement (PMR) study; this was a Phase 1 hepatic impaired study. Based on the results of the study the Istodax label was updated and approved by the FDA in November 2018 and in Japan in 2019.

Within several oncology programs, I am responsible for the clinical pharmacology and pharmacokinetics. I am involved in study design, protocol writing, data analysis, and report writing. Other responsibilities include writing and reviewing sections of regulatory documents, IND annual report, investigator brochure, etc. I also prepare and review publications and posters/presentations for scientific meeting as well as Celgene’s internal presentations.

Dess De Pharmacocinétique Approfondie Appliquée Au Développement Des Médicaments, Pharmacokinetics

Diplôme d’Etude Supérieures Spécialisées (DESS) de Pharmacocinétique Approfondie Appliquée au Développement des Médicaments [Higher.

Diplome Universitaire De Pharmacocinétique, Pharmacokinetics

Pharmacokinetic College Degree

Maîtrise De Biochimie, Biochemistry

M.S. Biochemistry