Introduction

• • A. Since October 2015: President (CEO) of a self-founded consulting firm “inDevlligence” acting in Drug Product development strategies and Pharmaceutical Quality management with following proposed services:
    • 1.Innovative Product CMC Development and Regulatory Strategy
    • 2.Target Product Profile (TPP) & Commercial Image Document (CID)
    • 3.Competitive Intelligence & Business Development for advanced Drug Delivery Forms
    • 4.Due Diligence
    • 5.GMP QA organisation optimisation & deployment
    • 6.Training courses
  • B. October 2006 to Oct. 2015: Director Innovation & Development – Head Pharmacist / QP Théramex-Teva (Monaco site)

As one of the administrator of Théramex-Teva directorate, I was acting as the Head Pharmacist (QP or “Responsible Pharmacist”) according to EU/ French pharmaceutical regulations. This function encompassed the supervision of all regulated pharmaceutical activities and full accountability before European, French and Monaco Health authorities.

• • • 2013-2014: Transfer of “Exploitant” responsibilities to Teva France. All Women’s Health regulatoryactivities have been commissioned to a newly created European centre of excellence (Harlow, UK) for the management of EU & RoW dossiers.
    • 2011-2013: Definition with Teva ‘s Global and European QA of the best possible scenarios for themanagement of Quality Assurance and Quality Control of both R&D and commercial products belonging to Women’s Health franchise.
    • Conduct of internal Audits (Merck KGaA & Teva) and CROs (analytical, clinical) / CMOs external audits
    • Management of 4 dual inspections for the renewal of GMP certificate for Development & Commercialproducts conducted by AFSSPS / ANSM (French Health Agency) and DASS (Monaco Inspectorate) in 2008-2011-2014.
    • Mock audits, preparation to Pre-Approval Inspections for FDA and ANVISA (Brazil Health Agency) of
      several of our main industrial subcontractors (French CMOs). All CMOs being duly certified.
    • Member of Merck KGaA project team to create, launch and deploy Merck External Manufacturingorganisation. Virtual technical operations to manage commercial products manufacturing. Batch records review and release processes being still parts of affiliate’s responsibilities for selected markets (RoW).
    • Refinement of pharmaceutical development GMP area for the production of Hormone products. Thisclinical development zone (production up to 1/10 scale validation batches for solids and semi-solids products) was duly granted with an EU-GMP certificate.
    • Reorganisation of Pharmacovigilance activities in 2008 and in 2012: transfer to Merck Serono Global DrugSafety and then to Teva Global Pharmacovigilance. Management of interfaces with Health agencies (PSURs review and validation), commercial and industrial partners in Europe/RoW and internal
      departments.
    • Member of Merck KGaA international task forces for analytical and clinical outsourcing in EU + US.Reflection on the best options to optimise costs – execution /timelines and Quality (BPF & BPC) management.
    • Preparation and management of 2 inspections by DASS/ANSM for renewal of French “Exploitant” status(2008 & 2011).
    • Discussion and proposal for the deployment within Théramex sales and marketing department of TevaFCPA (Foreign Corrupt Practices Act) guidelines (2012).
    • Further to reorganisation, definition and enforcement of a new Quality practices, certification of ThéramexSales force in 2007 and 2010 according to new referential guidelines “Charte de la Visite Médicale”.
  • C. Jan. 2011 to Sept. 2014: Head of Women’s Health CMC:

Management of Pharmaceutical Development of Teva Global Women’s Health project portfolio and supportive development activities for European & RoW commercial products. CMC covers chemical &pharmaceutical developments, technical writing and WH competitive intelligence (CI/BI).

• • D. March 2009- Jan. 2011: Director of Innovation & Development Business Unit -Théramex

This new business unit (70 staffs) encompassed all development activities (clinical & non clinical), Regulatory Affairs, Competitive Intelligence supporting project portfolio and business development.

• • E. October 2006 to March 2009: Director of non clinical R&D activities -Théramex

Division (50 staffs) of Théramex R&D department (Merck Serono business unit specialised in women’s health therapies) covering chemical development, analyticals, formulation-scale-up, toxicology, technical writing & project management support.

• • F.November 2004 to October 2006: Head of Pharmaceutical Development LCM projects – Merck KGaA

Within Merck Global Pharmaceutical Development organisation, I was leading the worldwide development of all LCM projects: Drug Product specifications, formulation design, analytical development, manufacturing of clinical medications, industrial transfer and technical writing of eCTD dossiers. Most of these activities (formulation, manufacturing, QC/release) were “being externalised and subcontracted to CROs/ CMOs.

• • G. October 1998 to November 2004: Head of Pharmaceutical Development Department – Merck Santé sas

Within French subsidiary of Merck KGaA group – Germany R&D Division. Coordination of pharmaceutical development activities of 3 pharmaceutical development centres ( Lyon, Suresnes, Hitchin-UK). Our missions covered design & development of drug products ( NCEs or LCM) with management of formulation, analytical
development and technical writing of CMC parts.

• • H. March 1990 to October 1998: Head of R&D at Tilderm Systems Division – Laboratoire Fournier (France)

Tilderm was a drug delivery research centre mainly focused on the design and development of transdermal systems, iontophoretic devices and needleless injection technologies. 57 scientists & technicians (103 personels in this division including GMP plant). More than 50% of R&D activities were performed on contract basis for pharmaceutical companies. This division was having polymer research group, formulation department, analytical development department, cGMP pilot and industrial facilities for clinical trials medications preparation and QC/release labs.

• • I.April 1988 to March 1990 : Head of Transdermals R& D department (3 groups) – Laboratoire Fournier

Transdermal systems design, slow release micro-beads formulation (fatty matrix technology). Creation of these two new laboratories from scratch ( lab. installation, scientists/ technician recruitment, GMP pilot lab. definition and qualification ). Design and development of Estradiol patch (Esclim )

• • J.March 1986 to April 1988 : Modified release forms group leader – Galenical department, Laboratoire Fournier.

Formulation of slow release tablets, bioavailability optimization for poorly absorbed drug. Design of a enhanced formulation of Fournier block buster : Fenofibrate ( Lipanthyl 200 M, co- micronized drug with surfactant ).

• 2007-2011: Co-development of an innovative contraceptive pill with Organon- Merck & Co (“Natural” 17β Estradiol / progestin-Nomesgestrol acetate pill). Submission to EMA in July 2009 according Centralised Procedure granted CHMP/EC in July 2011 and FDA registration in progress.
• 2010: Member of the top management team which conducted the Merger & Acquisition process of Théramex France and Italy by TEVA (Elaboration of information memo, preparation and participation to 6 management presentations, Due Diligence deputy for company’s portfolio and product development queries).
• 2006: Co-development of a new form of Metformin for elderly patients with the Japanese company Dainippon Sumitomo. This innovative drug product is a taste masked, instantaneous water soluble powder that will greatly improve compliance for type II diabetes patient (approved in EU in Q2/08).
• 2005-2006: NDA approval of the first cyanide poisoning antidote in the USA (Cyanokit).
• 2005: International development for both EU and FDA submissions of a cyanide poisoning antidote (Cyanokit). Submission ot FDA in June 2006.
• 2004: FDA registration of Acamprosate (Maintenance of alcohol abstinence therapy) in partnership with Forest Labs.
• 2002 : Team leader of French group for the definition of a new global (European) organisation for pharmaceutical development line function with Merck Ethicals.
• 1999 : Set up of a new global CMC organisation to manage HR, Development Standards, and Pharma. Dev. Tasks related to NCEs projects.1996 : Phase I Clinical trials with the first version of our Iontophoretic system for major chronic pain treatment.
• 1994 : First market approval for our estradiol transdermal patch (Oesclim). Launched in feb.95 in France, its market share is now comparable to those of Ciba’s Estraderm (leader for TTS) in 1997.
• 1988 – 1991 : Definition, construction supervision and qualification of an entirely new GMP facility for transdermal manufacturing.
• 1987 – 1988 : Design and pharmaceutical development of several formulations based on monodispersed sustained release micro-beads ( MicroGalenicTechnology ).
• 1986 : Design of a new formulation for Fournier’s best seller Lipanthyl/Fenofibrate featuring a very high bioavailability profile # Lipanthyl 200 mg micronised (sold in Europe, Asia, registered in North America and in Japan ).

• 6/1982 : French Pharmacist Grade (: Pharmaceutical Technology & Engineering ) – Dijon, University of Burgundy – Faculty of Pharmacy. Tron-Loisel Award (Best Pharmaceutical Scholarship Prize).
• 12/1983 : Pharm. Doctorate Thesis – Dijon, University of Burgundy – Faculty of pharmacy ” Fundamental dissolution/diffusion studies on inert matrix systems based on semi-synthetic cellulosic polymers “.
• 11/82 – 12/84 : Post Doctorate Research Program : DESTI – MRT (French Ministry of Research & Technology ) / Laboratoires Fournier – CNRS (dual sponsorship) :
  • – 1983 : Pharmaceutical Technology Department – University of Pharmacy (Dijon)
  • – 1984 : School of Chemical Engineering – Polymer Sciences Department /Prof. NA. Peppas, Purdue University – West Lafayette – (Indiana-USA)

• Statistics in Biology
• Statistics in Experimental Design
• Pharmacokinetics – vitro/vivo correlations
• Thermal Analysis
• Peptids Delivery Systems
• Analytical development
• Pulsatile Drug Delivery / Chronobiology
• Value Analysis, Failure Mode & Risk Analysis
• Financial forecasts related to R&D projects
• R&D management – Team Building
• Project Management – Program Scheduling
• Improving R&D through Strategic Decisions
• Financial issues in the Pharmaceutical Industry
• Preparing for a FDA pre-approval inspection
• Multi-cultural project management (French-USA-German-Japan)
• New EU regulations for manufacturing clinical trial medications
• CMC Benchmarking – Optimising R&D organisation
• Crystallisation processes and scale-up
• LCM projects strategy
• Senior management courses
• Strategy & Innovation
• Social management
• Crisis management / Media trainingPharmacovigilance (French & European regulations)
• French regulations covering publicity-promotional activities of pharmaceutical products
• French & European Pharmaceutical Responsibilities “Exploitant & Fabricant”
• Merck Serono BioPharma Mini-MBA Programme (London Business School, 2009)
• French Regulations related to 29 Dec.2011 Health Laws
• US and European Anti-corruption laws