Therapeutic Areas: Neuro, IBD, Cancer In charge of three clinical programs. Coordination of all clinical activities including regulatory and operations Writing and review of all the documentation Relationships with CROs (clinic / PK / PD), IP, nurses, study coordinatorsCoordination of GMP manufacture to avoid any product disruption at the Hospital pharmaciesVery High Quality standards

R&D• Implementation of pharma standards in the company• Improvement of product formulation prior to regulatory development• Design and Coordination of in vitro and in vivo data in the chosen cancer indication• Design and Coordination of non-regulatory and regulatory toxicology studies• Coordination of production plant activities required for GMP certification• Obtention of a GMP certificate for the manufacture of matrix implant drug product• Coordination of Regulatory paper work (IMPD, IB, Protocol)• Coordination of the clinical trialMiscellaneous• Obtention of an Orphan Drug Designation (ODD) at EMA for the use of CEB-01 in Soft tissue sarcoma• Meetings at European and Spanish medicine agencies• 1 patent filled

Selection of CROs and academic labs, contracts negociations, and management of all external collaborations for R&D program, including discovery, regulatory toxicology, CMC, clinic. Whole activities representing close to 80 people located in EU, US, Asia. Selection and coordination of consultants activities.Discovery: Driving discovery efforts in the field of autoimmune disease, peptides synthesis, X-ray protein structure, virtual screening/docking, H2L screening cascade design, lead optimization.Toxicology: deeply involved in protocol and data discussions for full package studies up to 13 weeks studies and reprotox.CMC: coordination of programs from non-GMP to GMP batchs, including drug product formulation.Clinic: Coordination of regulatory submissions (IB, IMPD) for phase 1a and phase 1b/2a. Writing of clinical synopsis/protocol for clinical phase 1a, 1b and 2a. Key input in dose escalating schedule, PK interpretation and doses selection.Participation to data package for investors and participation to discussions.

Implementation of the companyR&D in metabolic diseases and inflammationDrug development including discovery, tox preclinic, and clinicCoordination of paper work for a Phase zero, phase 1a, Phase 1b, and support to Phase 2aFDA and european agencies meetingsParticipation to the company setup - Recruitment of -1 and 1 levelsRegular reporting to the Scientific Advisory BoardMore than 10 patent filingsCROs' Contracts negotiations, and management

Pharmacology / Diabetes / Inflammation1 patent30 international scientific publicationsDirector of 2 Ph.D. thesesDiscovery and characterisation of a new anti-diabetic compoundManagement of Research projects

Biosensors for insecticide detection using quartz based detection coupled to enzyme immobilisation technicsA great opportunity to discover Asian culture.