Dr. LE GOFF Philippe Ing. Chemin de la BIOLLEYRE 5 … · Dr. LE GOFF Philippe Ing. Swiss and French Citizenships 13 March 1963 _ BREST (F-29200) Chemin de la BIOLLEYRE 5 CH-1066

Dr. LE GOFF Philippe Ing.

Swiss and French Citizenships 13 March 1963 _ BREST (F-29200)

Chemin de la BIOLLEYRE 5

CH-1066 EPALINGES Tel : +41 79 370 46 27

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Ingénieur EHICS Ecole Européenne des Hautes Etudes des Industries Chimiques de Strasbourg (France _ 1986)

D.E.A. Chimie Organique Université Paris XI (1988)

Ph.D. in Physical Sciences (Chemistry)

Ecole Polytechnique - Palaiseau (France _ 1990)

Marking expertise ▪ Engineering

o Control of manufacturing processes in pharmaceutical and chemical industries o HVAC and air control in cleanrooms

▪ GMP requirements

o Quality Risk Management according to ICH-Q9 o Quality systems according to ICH-Q10

▪ Development of decision-making tools and computer aided physics modeling

o Prediction and quantification of airborne contamination o 3D Reconstruction of digitized objects and/or environments o Wave Energy Field Interaction Modeling o Process modeling and optimization of operational parameters o Dynamic Sustainability Modeling o Advanced Quantitative Structure Activity Relationship o Encrypting systems

Professional experience (current)

Managing director of H&LG Consultants (period: 2000 – 2017) H&LG Consultants is a Swiss private owned Company, founded in September 2000 by Catherine Hugel-LeGoff and myself. H&LG Consultants provides:

▪ Organization of the HealthCare sector (Pharmaceuticals, Cosmetics and Medical devices) with customized services in the domain of technical aspects related to regulatory and normative requirements.

▪ Innovating solutions to assist Organizations that need to control their activities by numerical modeling




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Recent operations I had the opportunity to conduct for H&LG Consultants are:

Pharmaceuticals and Cosmetics: ▪ Global qualification (VMP; DQ-IQ-OQ-PQ) of Production Facilities in Pharmaceutical Industry, with:

o More than 80 HVAC systems for Cleanrooms o More than 40 Laminar Flow or Safety Cabinets o More than 45 Manufacturing equipment units o More than 12 Packaging lines o More than 07 Purified Water (or WFI) Systems

▪ National Regulatory Application Files in Pharmaceutical Industry (17 successfully applied dossiers) ▪ GMP (EU-GMP; FDA; KFDA) compliance audits and Inspection preparation and/or active participation for more than

20 Pharmaceutical Companies in Western Europe and USA ▪ Regulatory and technical assessments of industrial performances of organizations selected as candidates for Due

Diligent ▪ Development and implementation of project managements in compliance with GLP requirements for:

o Pharmacy and Drug preparation for animal trials o Husbandry o Toxicology

▪ Integration and validation of computerized system for: o Technical Surveillance of production areas (5 systems under GMP and GLP requirements)

Medical Devices: ▪ Technical design and development of Medical Devices for indications in:

o Cardiac Surgery o Urology o Embryology o Dentistry

▪ Preparation and Implementation of required documentation for Quality System Certification in Medical Devices Industry

o in 2001; 1 Organization certified ISO 13485 :1996, ISO 9001 :1994 and EN 46001 :1996 o in 2005; 1 Organization certified ISO 13485 :2003 and ISO 9001 :2000 o in 2007; 2 Organizations certified ISO 13485 :2003 and ISO 9001 :2000 o in 2008; 1 Organization certified ISO 13485 :2003 and ISO 9001 :2000 o in 2009; 1 Organization certified ISO 9001 :2008 o in 2014; 1 Organization certified ISO 13485 :2003 and ISO 9001 :2008

▪ Preparation and Application of Product Design Dossiers for EC Certification of Medical Devices (from Class IIa to Class III) according to Eur. Council Directive 93/42/EC and 2007/47/CE

o with compliance to Annex II.3 requirements ▪ Preparation of FDA standardized application files

o HDE; Humanitarian Device Exemption o Pre-IDE; pre-Investigational Device Exemption o 510(k) clearance

Project management for several Clinical Investigations for Medical Devices from Class IIa to Class III

Defense and Civil Protection related activities: ▪ These activities are developed in relation with a US SDVOSB Organization. Achievements have to be kept confidential

and cannot be disclosed in this document.




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Professional experience (past) Professional activity started in year 1988, as I joined the chemical branch of SNPE (Société Nationale des Poudres et Explosifs) that supplied Industry with active ingredients and intermediates. I served SNPE as Development Chemist until I was proposed in 1990 to become R&D Manager in a joined team with Japanese chemists to develop a new highly active monomer. This project, shared between Europe and Japan, has been successfully completed by early 1993. From 1993 to 1997, I founded in a Chemical Subsidiary of SNPE an ‘’Optimization Laboratory’’ in order to service process development to Pharmaceutical Industry. Several strategic projects were successfully achieved within the context of this laboratory. This professional stay in SNPE (from 1988 to 1997) provides with specific experience in fields of:

▪ Engineering and process with highly active or toxic compounds: o Organo-phosphorus species o Phosgene and derivatives o Oxalyl chloride and Carbon monoxide o Acyl isocyanates o …

▪ Management of restricted information in a Defense Organization ▪ Management of strategic projects in a Defense Organization

In 1997, decision was taken to found my first own company to provide HealthCare Industry with technical and regulatory support. Named H&LG Ingénierie, this company has been established in France (F-67000 Strasbourg) and then moved to Switzerland to become H&LG Consultants. I also served as Chief Technology Officer of HyGie-Tech (period: 2009 – 2015) HyGie-Tech is a Swiss private owned Company, founded in February 2009, to exploit the CFD software HG_Flow integrating the code aerTLN co-developed by C. Hugel_LeGoff and Ph. LeGoff. HG_Flow is an expert roCFD software computing 3D modeling of aeraulic flows and quantification of airborne contaminants. HG_Flow is declined in 3 distinct modules addressed to the fields:

▪ of healthcare industries by the prevention of the risks of cross contamination ▪ of defense and civil protection where risk of intoxication is potentially high ▪ of industries requiring a precise control of air motion.

The function of Scientific Director of HyGie-Tech covers the missions of:

▪ Management of the CFD software HG_Flow o Testing and integration of the improvements o Development and maintenance of HG_Flow related softwares (Solver; Grid generator; Viewer) o Security of data o Development of communications tools related to the software HG_Flow

▪ Scientific expertise towards customers of HyGie-Tech o Determination of the critical conditions o Analysis of operational configurations o Research of preferred configurations

▪ Validation of the results provided by HG_Flow




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Main oral and written contribution (2007 2017)

Patents and scientific articles 1. Title: An in vivo culture system for human embryos using an encapsulation technology : a pilot study, Authors: C. Blockeel, P. Mock, G. Verheyen, N. Bouche, Ph. Le Goff, Y. Heyman, C. Wrenzycki, K. Höffmann, H. Niemann, P. Haentjens, M.-J. de Los Santos, M. Fernandez-Sanchez, M. Velasco, P. Aebischer, P. Devroey and C. Simón. Publication: Human Reproduction, 2009, 24(4), pp 790 – 796 2. Title: Approche thérapeutique globale dans le traitement des maladies neurodégénératives Authors: Ph. Le Goff et al. Applicant: Cerebel SA Publication: PCT/IB2007000131 3. Title: Système Intra-utérin récupérable Authors: Ph. Le Goff et al. Applicant: Anecova SA Publication: PCT/IB2007002913 4. Title: Procédure de moulage de poly(1,4-dioxanone) Authors: Ph. Le Goff et al. Applicant: Bioring SA Publication: PCT/FR2008051199 5. Title: Système pérenne de localisation 3D d’un individu en progression à l’intérieur d’un bâtiment Authors: Ph. Le Goff, C. Le Goff et al. Applicant: HyGie-Tech SA Publication: PCT/IB2011000812 6. Title: Biodegradable Implant for the subconjunctival controlled release of an active molecule Authors: Ph. Le Goff et al. Applicant: Cerebel-Invest Publication: WO 2012/114186 7. Title: Procédé et système informatisé de modélisation des flux aérauliques notamment pour l’évaluation quantitative du risque de contamination aéroportée Authors: Ph. Le Goff et C. Le Goff Applicant: HyGie-Tech SA Publication: PCT/IB2013000654 8. Title: Méthode de traitement d’un nuage de points Authors: Ph. Le Goff et C. Le Goff Applicant: HyGie-Tech SA Publication: PCT/EP2014/051346 9. Title: Méthode d’évaluation et de gestion des risques et vulnérabilités systémiques et sectoriels encourus par une organisation Authors: Ph. Le Goff et C. Le Goff Applicant: H&LG Consultants SàRL Publication: 00654/13 Publication: PCT/IB2014/059415




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Other Publications 1. Title: Inside PIC/S : Implementing Quality Risk Management. Representatives to the PIC/S provide an example of methodology for implementing ICH Q9 Authors: L. Viornery et Ph. Le Goff Publication: Pharmaceutical Technology, 2009, 33(12), (2 pages) 2. Title: Quality Risk Management. Implementation of ICH Q9 in the pharmaceutical field _ an example of methodology from PIC/S. Authors: L. Viornery et Ph. Le Goff Publication: PIC/S _ PS/INF 1/2010 (30 pages) 3. Title: Qualité et Traitement d’Air dans les Entreprises du Médicament Author: Ph. Le Goff Publication: Counter Terror Business 2011 (4), p 107 4. Title: Biological and Chemical Defence Author: Ph. Le Goff Publication: HyGie-Tech, Octobre 2010, (78 pages) 5. Title: Bonnes Pratiques d’utilisation des réactifs, solvants et solutions titrées : méthodologie de la gestion des dates de péremption. I. De l’analyse de risque à l’établissement de règles d’exploitation au laboratoire Authors: E. Bauthier-Loiseau et Ph. Le Goff Publication: STP Pharma Pratiques, 2012, 22(2), pp 59 - 65 6. Title: Validation de logiciels scientifiques. Cas des logiciels de CFD (« Computational Fluid Dynamics ») Author: Ph. Le Goff Publication: STP Pharma Pratiques, 2012, 22(2), pp 67 - 73 7. Title: ICH Q8, Q9 et Q10. Intégration des approches scientifiques dans la gestion de la qualité Author: Ph. Le Goff Publication: BCMI 2013 – Guide de l’Ultra-Propreté, 7ème Ed., pp 86 – 89. 8. Title: The use of Scientific Calculation and Informatics Modelling in Managing Risk of Exposure by Air Contamination in the Pharmaceutical Sector Author: Ph. Le Goff Publication: STP Pharma Pratiques, 2015, 25(6), pp 439 - 446 Conferences 1. Title: Manufacturing of risky molecules in non dedicated facilities Authors : Ph. Le Goff et M. Sanchez (Afssaps / DIE) Date: 23.XI.2007 Event: PIC/S and ISPE Workshop on Systems Approach to Quality Risk Management, Singapore.




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2. Title: Quality Risk Management. An enhanced and mutually shared methodology to comply with Q9 and Q10 Authors : Ph. Le Goff ; F. Bruneaux (Afssaps) et L. Viornery (Afssaps) Date: 18.IX.2008 Event: PIC/S. Expert Circle Quality Risk Management, Malte. 3. Title: Eu-GMP Annexe 1 : vers des solutions quantifiées, prédictibles et efficaces Author: Ph. Le Goff Date: 29.IV :2009 Event: 8ème forum A3P Suisse, Neuchâtel. 4. Title: Méthodologie de la Gestion du Risque Qualité, une proposition du PIC/S Authors: Ph. Le Goff et J. Morenas (PIC/S Chairman) Date: 24.XI.2009 Event: 9ème forum A3P Suisse, Neuchâtel. 5. Title: Quality Risk Management. Implementation of ICH-Q9 guideline in pharmaceutical field. An example of methodology from PIC/S Authors: Ph. Le Goff et L. Viornery (Afssaps) Date: 20.V.2011 Event: 4ème European GMP Conference, Heidelberg. 6. Title: Application dans le domaine des biotechnologies de l’exemple PIC/S de méthodologie de Gestion du Risque Qualité Author: Ph. Le Goff Date: 18.X.2011 Event: 24ème Congrès international A3P, Biarritz. 7. Title: HG_Flow software: a high performance, risk oriented, Computational Fluid Dynamics Modeling System for Chemical and Biological Defense Author: Ph. Le Goff Date: 14.XI.2011 Event: NDIA Physics-based modeling in Design & Development for US Defense Conference, Denver (CO). 8. Title: HG_Flow : roCFD to mitigate risk of airborne contamination Author: Ph. Le Goff Date: 25.IV.2012 Event: Counter Terror Expo 2012, Londres. 9. Title: Risk Oriented CFD. Modeling the risk of Airborne Contamination Author: Ph. Le Goff Date: 7.XI.2012 Event: NDIA Physics-based modeling in Design & Development for US Defense Conference, Denver (CO). 10. Title: Modélisation et Calcul Scientifique. Apports et Limites Author: Ph. Le Goff Date: 17.I.2013 Event: HCFDC Session Nationale « Résilience et Sécurité Sociétales » 2012, Paris. 11. Title: Vom Scan zum Plan/Computer Simulation Raumklima für Project u. Anlagaoptimierungen Author: Ph. Le Goff Date: 25.VI.2013 Event: Schweizerischer Fachverband Flächenheizung und -Kühlung, Sommertreff 2013 Zürich.




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12. Title: HVAC propagated Airborne Contamination _ Contribution to Exposure Risk Evaluation Author: Ph. Le Goff Date: 23.X.2014 Event: PIC/S Seminar: “Dedicated facilities or not“ _ Paris 13. Title: Apports du calcul scientifique et de la modélisation par système informatisé à la gestion du risque d’exposition par aéro-contamination dans le secteur pharmaceutique. Author: Ph. Le Goff Date: 04.VI.2015 Event: SFSTP 47ème Congrès International - Technologies Innovantes : Leurs Apports dans les Procédés Industriels 14. Title: Gestion du Risque Qualité _ Application au cas des Excipients de l’exemple de méthodologie PIC/S Author: Ph. Le Goff Date: 23.IX.2015 Event: SFSTP ; Excipients LD du 19.03.2015 15. Title: Risk Modeling by scientific computing. Application in the updated context of EU-GMP Author: Ph. Le Goff Date: 29.IX.2015 Event: Forum A3P Suisse

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Dr. LE GOFF Philippe Ing. Chemin de la BIOLLEYRE 5 … · Dr. LE GOFF Philippe Ing. Swiss and French Citizenships 13 March 1963 _ BREST (F-29200) Chemin de la BIOLLEYRE 5 CH-1066