Gilles DELLA CORTE, MD
PROFESSIONAL EXPERIENCE
Since April 2016 CEO and Founder of DELLMED CONSULTING (Ornex-France)
Consultancy for Biotech, Start-up and Pharmas for Clinical Development strategy, Due Diligences coordination, Medical Affairs, Outsourcing, Clinical Research Organization
So far: Support to Relief Therapeutics (Start-up Geneva) for Phase I program
Support to Maia Consulting for SAEs narratives writing for a biotech in Basel
Support to Voisin Consulting Life Sciences for SAE narratives for a start-up in Basel, for RMP and PBRER writing for a Pharma in Paris, for CTD module 2.7.4 for a top ten big Pharma
CMO ASIT Biotech (Liege-Belgium) Responsible for medical aspects of an innovative Phase 3 compound for allergic patients desensitization
Medical consultant for LFB (Les Ulis-France) Advice about clinical development issues with blood derivatives. Writing of a study publication for a normal human immunoglobulin in chronic inflammatory demyelinating polyneuropathy. Writing of a 2.7.4 module for a new Recombinant Coagulation Factor VIIa approval in hemophilia
Jan 2013 to March 2016 CLINICAL DEVELOPMENT DIRECTOR in ANERGIS SA (Lausanne)
And since June 2015 VP HEAD OF CLINICAL DEVELOPMENT
Responsible for the clinical development of 3 compounds in the field of allergies (vaccine for desensitization using contiguous overlapping peptides) with the lead compound in Phase II and 2 others at preclinical stage. Budgets, planning, contracts, FDA and EMA Briefing books and advisory meetings, Phase III and Pediatric Investigational Plan preparation, presentations in congresses. Member of the Management Team. Managed the relationship with several international CROs and consultants/Steering Committee.
Feb 2004 to Dec 2012 Several SENIOR MEDICAL DIRECTOR positions in SERONO and then MERCK SERONO (Geneva) following successive reorganizations
Responsible for development of projects from Proof of Concept to Life Cycle Management in different fields (Cardiology, Oncology, Rheumatology and Endocrinology)
2009-2012: Senior Medical Affairs Director
Management of Growth hormone pharmacogenomics studies program and Easypod™ Device (electronic injector pen) development
2008: Medical Advisor Exploratory Medicine
Medical advice on Translational Medicine projects e.g. Protocol advice for QT study for safinamide (Parkinson); due diligence for Tetrahydrobiopterin (BH4) in cardiovascular diseases
2007: Medical Director Global Clinical Development Unit
Medical Responsible of a POC study with IGF18 (cartilage growth factor) in knee osteoarthritis, Medical Review writing for a new indication (cartilage injury)
2004-2006: Medical Sciences Director in Experimental Medicine
Responsible for Translational Medicine projects e.g. Clinical Development Plan for IL18-BP in cardiovascular diseases; oral cladribine in Waldenström disease, efalizumab in Multiple Myeloma
July 2003 to Jan 2004 SCIENTIFIC and BUSINESS DEVELOPMENT DIRECTOR in THERAPHARM (CRO France)
Responsible for developing business and ensuring medical support to Clinical Operations. Acting as scientific support for the Therapharm Phase I site
April 2000 to Jan 2003 COUNTRY DIRECTOR FRANCE and GROUP DIRECTOR PROJECT MANAGEMENT WESTERN EUROPE in OMNICARE CLINICAL RESEARCH France (CRO, then THEOREM and CHILTERN)
General Management of the French affiliate (35 persons) and supervision of Project Teams (CRAs, Project Leaders) for France, Benelux and Spain.
Dec 1998 to May 1999 Clinical Research Director PHOENIX INTERNATIONAL France (CRO, then MDS Pharma Services recently acquired by INC Research)
Management of Project Leaders and CRAs (4-6 persons), logistics of Clinical Trials. Sponsors relationship for “Requests for Proposal”
Sep 1997 to June 1998 Medical Director in LARIME (Phase I Centre in La Rochelle, France)
Investigator for Healthy Volunteers, interface with the sponsors, Clinical Reports for Pharmacokinetic and Bioequivalence Phase I studies
Jan 1995 to Aug 1997 Head of the Cardiovascular Department in SOLVAY PHARMA France / Hanover (Now ABBOTT)
Medical Advisor for Clinical Development Plans for cardiology compounds in Hanover.
Set up of Phase I program for Tedisamil (treatment for arrhythmia currently marketed as Pulzium® in atrial fibrillation)
Management of Project Leaders and CRAs in France for phase I to IV clinical trials (5-7 persons). Launch of a new central hypertensive drug (moxonidine) including Price discussion with French Health Authorities (currently marketed as Physiotens® by Abbott)
July 1992 to Dec 1994 International Project Leader in IRIS (SERVIER LABORATORIES R&D Headquarter, France)
Full project leadership for Phase I program for ivabradine (If channels inhibitor with bradycardic effect currently marketed as Procolaran® in angina pectoris and heart failure) and medical responsible for a study with a long-acting formulation of trimetazidine (anti-ischemic drug in coronary disease)
Nov 1990 to June 1992 Product Specialist in PHARMUKA (RHONE-POULENC-RORER Affiliate, France, now SANOFI-AVENTIS)
Full project leadership for Phase III for Low Molecular Weight heparin (enoxaparine) used as curative treatment of venous thrombosis in France, Therapeutic Interest Overview writing for AFSSAPS (now ANSM). Marketing interface for launch preparation (KOL management, REPs training)
Set up of Phase III for beta-blocker use in heart failure (celiprolol)
1981-1990 Hospital Medical Practice in Villejuif (France) Dakar (Senegal) and Marseilles (France),
Cardiology (9 semesters), Cardiac Surgery (1 semester), Nephrology (1 semester), Internal Medicine (1 semester), Internal and Tropical Medicine (3 semesters) Cancerology (1 semester)
INITIAL EDUCATION
1994 Cardiovascular Pharmacology Degree (PARIS V University)
1992 General Pharmacology Degree (PARIS XI University)
Clinical Trials Methodology Degree (DIU, AIX-MARSEILLES 2 University)
1990 Medical Statistics Certificate (CESAM, PARIS VI University)
1987 Specialization in Cardiology
Medical Doctorate
1982 Tropical Medicine University Diploma
1980 Examination as Resident (Intern) for Public Hospitals
1973-1981 Medical Studies (Paris XI Faculty of Medicine)
MAIN TRAININGS
2016 Mindfulness Based Stress Reduction (MBSR Geneva)
2016 WordPress (Groupe Si2A)
2014 Personal training English (CREATIVE LANGUAGE CENTER)
2012 Crucial confrontations (VITALSMARTS)
2012 Change management
2011 Clinical Overview Writing (DIA)
2011 Presentation courses (B.POIRIER)
2006, 2007, 2009 Interactive Communication courses (DIOREM)
2006 Individual Coaching
2005 Project Leadership courses (GLOBALPARTNERS)
2004 Team building (GLOBALPARTNERS)
2004 Creating new drugs (GLOBALPARTNERS)
2002 Proficiency assessment (MPSL)
2000 Training GPMP (Global Project Management Process)
1998 Training about Firm Creating (CEPAC) 3 months full-time
1996 Training on Advanced GCP (Oxford Workshops)
1991 Communication Training for executives (CEGOS)
1991 Work time Organization Training (BOSSARD)
AWARDS
1988 Appointment as “Assistant Chef de Clinique” (Consultant) by Marseilles Faculty of Medicine
1987 Gold Medal Resident from Medicine Faculty of Marseilles
1986 Laureate Searle Foundation for Hypertension Research
PERSONAL INFORMATION French citizen
English: fluent professional
Hobbies: fitness, yoga/mindfulness meditation, motorbike, cinema, theatre, concert, reading
Computer: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, MS Project),WordPress