MDTServices

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Mira PAVLOVIC-GANASCIA, MD

 

CURRICULUM VITAE

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CURRENT POSITIONS

 

Medicines Development and Training (MDT) Services – Founder

27, rue Jules Siegfried, 75020 Paris, www.mdt-services.eu

• Training sessions in the field of regulatory science, health technology assessment, methodology of clinical trials and outcomes assessment

• Scientific support of? data generation for relative efficacy and relative effectiveness assessment of drugs and other health technologies

 

Consultant Dermatologist

Service de Dermatologie, Hôpital Tenon, 4, rue de la Chine, 75020 Paris

Cabinet de Dermatologie, 21, rue de la Plaine, 75020 Paris, www.dermatologie.pro

• Out-patient clinic, including emergency dermatology

 

Board Member
1) Patient-Centred Outcomes Department, Université Paris-Diderot, Sorbonne Paris Cité, EA 7334, Recherche Clinique Ville-Hôpital, Méthodologies et Société (REMES), Paris, France

• Participation in Board discussions on patient-centred outcomes in institutional research studies

 

2) NDA HTA Advisory Board, NDA Advisory Services Ltd, Grove House, Guildford Road, Leatherhead, Surrey, KT22 9DF, UK, www.ndareg.com

• Support of pharmaceutical companies in their clinical development programs to meet regulatory and HTA requirements for data generation in Europe

 

 

PREVIOUS POSITIONS

 

HEALTH TECHNOLOGY ASSESSMENT, EUROPEAN COLLABORATION AND INTERNATIONAL AFFAIRS - HTA

 

Deputy Director (2010-2015), La Haute Autorité de Santé (HAS), 2 avenue du Stade de France, 93218 Saint Denis La Plaine Cedex, France

 

Coordination of international actions related to HTA:

• SEED (Shaping Early European Dialogues) Coordination (2014 – 2015): SEED is the project financed by the European Commission to set up early dialogues with developers and HTA bodies as permanent activity in Europe. Chairing and coordination of 11 ED (8 on drugs and 3 on non-drug technologies). Four out of 11 ED are done as parallel EMA-SEED scientific advice;

• EUnetHTA JA2 (2012 - 2015): WP7 lead aiming at improving the quality of initial and additional evidence generation for HTA: elaboration of general methodological and disease-specific guidelines for all health technologies, coordination of early dialogues (multi-HTA and EMA-HTA parallel scientific advice) with health technology developers (all health technologies);

• EUnetHTA JA1 (2010 – 2012): WP7 lead and WP5 co-lead on additional evidence generation and methodology of relative effectiveness assessment of pharmaceuticals. Coordination and elaboration of 9 methodology guidelines (see Annexe 1); definition of the framework for relative effectiveness assessment for reimbursement purposes in Europe;

• Collaboration with EMA as EUnetHTA representative: EPARs review, guidelines review, EMA-HTA scientific advice, databases for drugs and other health technologies (EVIDENT, ENCEPP);

• Participation in other international actions: Green Park Collaborative (disease-specific guidelines elaboration by multinational group of experts), Tapestry initiative (multi-stakeholder platform for scientific advice for companies), ISG on HTA-regulatory interaction, ISPOR reviews.

 

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FRENCH MEDICINES AGENCY (AFSSAPS)

Head of Scientific advice (2001- 2010):

• Management of national scientific advice requests on questions pertaining to the quality, safety and efficacy of medicinal products in development; 100 – 110 scientific advice reports per year.

• Member of Innovation Committee at AFSSAPS. Scientific management and facilitation of access to market innovative medicinal products in France.

Key expert for clinical evaluation - European Commission Twinning project (2007 – 2009):

• Twinning project CARDS 2005 SR 05 SO 01 “Capacity Building of the National Medical Products Agency” with Serbian Medicines and Medical Devices Agency, financed by European Commission. Key expert for clinical evaluation capacity building.

Responsible for orphan drugs (2000- 2001):

• Participation in scientific evaluation of orphan drug designation requests at AFSSAPS and EMA.

Clinical assessor in dermatology (1998 – 2001):

• Evaluation of marketing authorization submissions (national and EMEA procedures). Rapporteur for several centralized EMEA procedures.

• Participation in elaboration of good practice recommendations: recommendations for use of topically applied products (corticosteroids, antibiotics, de-pigmenting agents), recommendation for treatment of acne, psoriasis, VZV and HSV infection.

• National scientific advice on clinical development of drugs in the field of dermatology.

 

EUROPEAN MEDICINES AGENCY (EMA)

SAWP Scientific advice working party

Vice-Chair (2007 – 2010), member (1998-2007)

• Scientific, clinical, methodology, and regulatory peer-review of all advice provided by the SAWP before validation by the CHMP.

• Consistency check with CHMP opinions for marketing authorisations and EWP guidelines, peer-review of all advice given from 2007 to 2010.

• Scientific, methodology and regulatory input on advice in fields of competence (dermatology, immunology, oncology, ophthalmology, endocrinology, quality of life, anti-thrombotics, biosimilar products).

• Coordinator for more than 400 scientific advice reports.

 

Similar Biological Medicinal Products Working Party (BMWP)

EWP representative (2005 – 2010).

• Participation in the elaboration of guidelines on preclinical and clinical development of new recombinant proteins similar to recombinant proteins already authorized in EU.

 

Efficacy working party (EWP)

French representative (2001 – 2010).

• Rapporteur and co-rapporteur for several disease-specific and general guidelines on clinical development of medicinal products. Elaboration of several guidelines in different fields of medicine including advanced therapies guidelines.

 

 

PHARMACEUTICAL INDUSTRY

 

International clinical trials leader, Laboratoires Servier, Courbevoie, France (1996 – 1998).

• Management of 12 phase II and phase III multi-center international clinical trials in East and Central Europe (fields: dermatology, oncology, cardiology, diabetes, osteoporosis, hormone replacement therapy). Declaration of adverse effects (pharmacovigilance) (East and Central Europe).

 

 

PREVIOUS HOSPITAL AND UNIVERSITY POSITIONS

 

Consultant dermatologist :

Hôpital Saint-Antoine, Paris.

Department of Dermatology, Hôpital Ambroise Paré, Boulogne (92).

Department of Dermatology, Intensive Care Unit, Hôpital Henri Mondor, Créteil.

 

Coordinator of clinical trials sponsored by Agence Nationale de Recherches sur le SIDA (ANRS), Department of Dermatology, Hôpital Ambroise Paré, Boulogne (92).

 

Foreign assistant in dermatology, Faculté Saint Antoine, Université Paris VI. Work on specialty thesis: "Role of magnetic resonance imaging (MRI) in adults presenting with acute severe infectious cellulitis".

 

Foreign resident full time, Department of Internal Medicine, Hôpital Tenon, Paris.

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EDUCATION/DIPLOMES

 

Diploma « DIUE Lasers médicaux » (2012).

 

Specialist Degree in France « Conseil National de l'Ordre des Médecins »,  (2001)

 

National Classifying Exam for Specialists in Dermatology and Sexually Transmitted Diseases (Classified 2001).

 

Medical Doctor Degree (General Medicine) Attestation du Ministère de l'Education Nationale, de l'enseignement supérieur et de la recherche  (1995).

 

Inter-University Diploma « Dermatologie d'urgence » - emergency care in dermatology (1994 - 1995), Faculté Pitié-Salpétrière, Université Paris VI. Department of Dermatology, Intensive Care Unit, Hôpital Henri Mondor, Créteil.

 

Inter-University Diploma « Formation des investigateurs aux essais cliniques des médicaments» - clinical trials (1993 - 1994), Faculté Lariboisière, Université Paris VII.

 

Attestation de formation spécialisée en Dermatologie, Training in dermatology, (1993 – 1994): Faculté René Descartes, Université Paris V. Department of Dermatology, Hôpital Ambroise Paré, Boulogne.

 

Diplôme du Collège de Médecine des Hôpitaux de Paris, (1990 - 1991): Training in dermatology and internal medicine, Department of Internal Medicine, Dermatology unit, Hôpital TENON, Paris.

 

Degree Specialist in Dermatology and sexually transmitted diseases. (1994)

 

Master Degree in Endocrinology. (1989)

Research field: non-insulin-dependent diabetes mellitus.

 

Doctor of Medicine, Faculty of Medicine, Belgrade University (1986)

 

 

MEMBERSHIPS

 

Société Française de Dermatologie

European Academy of Dermato-venerology

International Society for Pharmaco-economic and Outcomes Research (ISPOR)

 

LANGUAGES SPOKEN

 

French, English, Serbian.

 

 

 

 

 

GUIDELINES

 

EMA guidelines
 

1. Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus. CPMP/EWP/1080/00 REV. 1

 

2. Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk. CPMP/EWP/707/98 REV.1 CORR

 

3. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. CHMP/EWP/2454/02 CORR

 

4. Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women. Ref. EMEA/CHMP/021/97 REV. 1

 

5. Guideline on clinical investigation of medicinal products for the treatment of migraine. Ref. CPMP/EWP/788/01 REV. 1

 

6. Concept paper on the need for a guideline on the clinical investigation of medicinal products intended for treatment of systemic and cutaneous lupus erythematosus. Ref. EMEA/CHMP/EWP/604040/2009

 

7. Guideline on clinical evaluation of diagnostic agents. REF. CPMP/EWP/1119/98/REV. 1

 

8. APPENDIX 1 to the Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98 REV. 1) on imaging agents. Ref. EMEA/CHMP/EWP/321180/2008

 

9. Reflection paper on the Regulatory guidance for the use of health-related quality of life (hrql) measures in the evaluation of medicinal products. Ref. EMEA/CHMP/EWP/139391/2004

 

10. Points to consider on adjustment for baseline covariates. CPMP/EWP/2863/99

 

11. Guideline on clinical development of fixed combination medicinal products. Ref. CHMP/EWP/240/95 REV. 1

 

12. Note for guidance on photo safety testing. CPMP/SWP/398/01

 

13. Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome. CPMP/EWP/785/97

 

 

EUNETHTA guidelines

 

1. Endpoints used for REA of pharmaceuticals : clinical endpoints

 

1. Endpoints used for REA of pharmaceuticals : composite endpoints

 

1. Endpoints used for REA of pharmaceuticals : surrogate endpoints

 

1. Endpoints used for REA of pharmaceuticals : Health-related quality of life

 

1. Endpoints used for REA of pharmaceuticals : Safety

 

1. Comparators and comparisons: Direct and Indirect comparisons

 

1. Comparators and comparisons: Choice of comparator

 

1. Level of evidence: Internal validity

 

1. Level of evidence: External validity (applicability)

 

 

CLINCAL RESEARCH STUDIES

 

2. Essai ANRS 027 : Traitement par l'acide tout-trans rétinoique de la Maladie de Kaposi associée au SIDA.

 

3. Essai ANRS 042 : Traitement local des lésions cutanées de Maladie de Kaposi associée au SIDA: comparaison randomisée de la cryothérapie conventionnelle et de la cryochirurgie utilisant le protoxyde d'azote

 

4. Essai ANRS 045 : Comparaison de deux schémas de doses de chimiothérapie associée au Lénograstim (rHu G-CSF) au cours du sarcome de Kaposi pulmonaire ou cutané étendu lié au SIDA.

 

5. Essai ANRS 060 : Etude de l'évolution de la Maladie de Kaposi cutanée de patients infectés par le VIH sous traitement Foscarnet ou Ganciclovir pour une rétinite à cytomégalovirus.

 

6. A randomised, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Lamisil (terbinafine) 1% topical solution compared to vehicle OD for one week in subjects with Tinea corporis/cruris

 

7. EPITOX-VIH : Etude multicentrique et prospective de cohorte des patients évaluant les facteurs de risque de développement de toxidermies chez les patients infectés par le VIH et traités par les sulfamides à doses curatives.

 

8. Etude de l'efficacité et de la tolérance d'un médicament topique et de son excipient dans le traitement du sarcome de Kaposi périphérique chez les patients porteurs du virus HIV (Laboratoires LEO).

 

9. Essai ANRS 066 : Evaluation de l'efficacité du docetaxel dans le traitement du Sarcome de Kaposi chez les patients infectés par le VIH

 

 

PUBLICATIONS

 

1. P. Saiag, C. Le Breton, M. Pavlovic, N. Fouchard, G. Delzant, J-M. Bigot. Magnetic resonance imaging (MRI) in adults presenting with severe acute infectious cellulitis. Arch Dermatol 1994;130: 1150-8.

 

2. M. Pavlovic, P. Saiag, E. Marinho, F. Blanc, J-P. Lotz, D. Machover. Regression of sclerodermatous skin lesions induced by Octreotide in a patient with carcinoid syndrome. Arch Dermatol 1995;131:1207-8.

 

3. J. Faivre-Meharzi, M. Pavlovic, V. Fauveau, J-C Nicolas, A. Chenon, P. Saiag. All-trans retinoic acid does not stimulate HIV replication in vivo. J Invest Dermatol 1995;104:686.

 

4. P. Saiag, M. Pavlovic, C. Chastang, D. Emilie and Kaposi's sarcoma clinical trials group of ANRS. Treatment of AIDS-related Kaposi's sarcoma with all-trans-retinoic acid. Results of a phase II trial. AIDS 1998;12(16):2167-76.

 

5. P. Saiag, I. Bourlault-Villada, M. Pavlovic, C. Roudier-Pujol. Efficacy of imiquimod on external anogenital warts in HIV-infected patients previously treated by highly active antiretroviral therapy. Letter. AIDS 2002 16(10) :1438-40.

 

6. Téot L, Cherry G, Denis C, Dervaux B, Duncan G, Gottrup F, Harding K, Kerihuel JC, Lautenberg A, Mani R, Meaume S, Messina R, Morris S, Orsted H, Pavlovic M, Peter R, Ricci E, Sibbald G, Sussmann G, Trueman P; World Union of Wound Healing Societies. Reimbursement of dressings: a WUWHS statement. Int Wound J. 2006 Dec;3(4):296-301.

 

7. M. Pavlovic, E Girardin, L Kapetanovic, K. Ho, J-H Trouvin. Similar biological medicinal products containing recombinant human growth hormone: European regulation. Horm Res 2008;69:14-21.

 

8. M. Pavlovic. Health Related Quality Of Life And Its Impact On Drug Development and Reimbursement. Value in Health, in press.

 

9. M. Pavlovic, P. Saiag, F Blanc, E. Marinho, C Cywiner-Golenzer. Amylose cutanée généralisée leuco-mélanodermique: forme familiale. Ann Dermatol Vénéréol. 1992;119(11): 829-32.

 

10. P. Saiag, M. Pavlovic, C. Le Breton, G Delzant, J-M. Bigot. Valeur de l'imagerie par résonance magnétique nucléaire (IRM) dans les cellulites inféctieuses sévères: étude prospective. La Revue de Médecine Interne. 1992;13S:337.

 

11. E Marinho, F Blanc, M. Pavlovic, P. Saiag, J Roland. Orf à type de botryomycome. Revue Européénne de Dermatologie. 1992;4:367-9.

 

12. M. Pavlovic, F. Blanc, T. Clerici, M. Bernier, E. Marinho, O. Cvijetic, M. Milojevic, P. Saiag. Naevus epidermique dyskeratosique et acantholytique. Ann Dermatol Vénéréol 1994;121 (Suppl 1):86.

 

13. P. Saiag, M. Pavlovic. Maladie de Kaposi. La Revue du Praticien, 1995;317:33-41.

 

14. P. Saiag, M. Pavlovic, D. Emilie, C. Chastang au nom du Groupe Kaposi de l'AC5 de l'ANRS. Traitement par l'acide-tout-trans-rétinoique de la Maladie de Kaposi associée au SIDA. Essai multicentrique de phase II non randomisé. Ann Dermatol Vénéréol 1995;122 (Suppl 1):63.

 

15. J Faivre-Meharzi, M. Pavlovic, V Fauveau, JC Nicolas, A Chenon, P. Saiag et le Groupe Kaposi de l'AC5 de l'ANRS. Effet des retinoides (acide tout-trans-rétinoique) sur la réplication du virus de l'immunodéficience humaine. Ann Dermatol Vénéréol 1995;122 (Suppl 1):126.

 

16. M. Fortier-Beaulieu, M. Pavlovic, P. Saiag. Traitement de la Maladie de Kaposi associée au SIDA par cryochirurgie utilisant le protoxyde d'azote. Ann Dermatol Vénéréol 1995;122 (Suppl 1):143.

 

17. C Roudier-Pujol, M. Pavlovic, P. Saiag. Cellulites néoplasiques : à propos de 5 cas de Carcinoma Erysipelatoides. Ann Dermatol Vénéréol 1995;122 (Suppl 1):145.

 

18. P. Saiag, M. Pavlovic, N. Fouchard, C. Le Breton, O. Chosidow, F. Granier. Formes frontières entre formes "médicales" et "chirurgicales" de dermo-hypodermite bacterienne: trois cas. Nouv Dermatol 1996;15:189.

 

19. H. Assier-Bonnet, M. Pavlovic, F Blanc, M. Bernier, P. Saiag. Syndrome d'hypersensibilité chez un enfant. Ann Dermatol Vénéréol 1996;123(Suppl 1):S121.

 

20. P. Saiag, M. Pavlovic, N. Fouchard, C. Le Breton, O Chosidow, F Granier. Formes frontières entre formes "médicales" et "chirurgicales" de dermo-hypodermite bactérienne : trois cas. Nouv Dermatol 1996;15:189.

 

21. Agence Française de Sécurité Sanitaire des Produits de Santé. Traitement de l'acné par voie générale : argumentaire. Ann Dermatol Vénéréol 1999;126:224-31.

 

22. Agence Française de Sécurité Sanitaire des Produits de Santé. Traitement de l'acné par voie générale : recommandations. Ann Dermatol Vénéréol 1999;126:233-4.

 

23. C. Longvert, M. Pavlovic, M.L. Bafounta, E. Baumelou, I. Bourgault-Villada, P. Saïag. Périonyxis spécifique au cours d'une leucémie lymphoïde chronique B. Ann Dermatol Vénéréol. 2001;128:3S127.

 

24. M. Pavlovic, C. Le Breton, F Granier, N. Fouchard, P. Saiag. Dermo-hypodermites bactériennes : formes frontières entre formes médicales et chirurgicales : trois cas. Ann Dermatol Vénéréol 2002 ;129(11) :1286-90.

 

25. M. Fisekidis, T. Grynkorn-Meas, M. Pavlovic, P Duriez, S Aractingi, P Bouchard. Ichtyose acquise localisée à un carcinoma hépatocelllaire. Ann Dermatol Venereol 2003 ;130 :4S88.

 

26. Bouchet JL, Brunet P, Canaud B, Chanliau J, Combe C, Deray G, Houillier P, Kourilsky O, Ledneva E, Niaudet P, Ortiz JP, Pavlovic M, Ryckelynck JP, Singlas E, Verhelst D; Société de néphrologie, Société francophone de dialyse, Société de néphrologie pédiatrique; Société francophone de dialyse; Société de néphrologie pédiatrique. Nephrol Ther. 2009 Feb;5(1):61-6. Epub 2008 Dec 11. Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique.

 

27. M. Pavlovic, CM Samama. Comment donne-t-on une AMM pour un anticoagulant ? Mini-revue.

STV, 2009 ;21(4) :1-8.

 

28. Berdaï D, Hotton JM, Lechat P; participates of Round Table n° 1 Giens XXV. Therapie. 2010 Jul-Aug;65(4):329-34. Epub 2010 Sep 21. Comparators (medicinal and non medicinal) for marketing authorization, for public health, for payers and at the European level.

 

29. Berdaï D et al. How to improve the clinical development paradigm and its division into phases I,II and III

Therapie 2011;66(4):331-4, 327-30.

 

30. S. Stamenkovic, O. Chassany , M. Pavlovic. Impact des données de qualité de vie (QoL) sur l’évaluation des medicaments en France. Ann Dermatol Venereol, 2011 ;138 :A193-4.

 

31. F Hulstaert, M. Neyt, I Vinck, S Stordeur, M. Huic, S Sauerland, M. Kuijpers, P Abrishami, H Vondeling, B Flamion, S Garattini, M. Pavlovic, H von Brabandt. Pre-market clinical evaluations of innovative high-risk medical devices in Europe. International Journal of Technology Assessment in Health Care, 2012 ;28:3, 278–284.

 

32. M. Pavlovic, A Alakeel, C Frances. Tick removal with liquid nitrogen. JAMA Dermatol 2013;149(5) :633.

 

33. M. Berntgen, A Gourvil, M. Pavlovic, W Goettsch, HG Eischler, FB Kristensen. Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health 2014 (17), Issue 5, 634-641.

 

34. M. Pavlovic, C. Teljeur, B. Wieseler, M. Klemp, I. Cleemput and M. Neyt on behalf of EUnetHTA. Endpoints for relative effectiveness assessment (REA) of pharmaceuticals. International Journal of Technology Assessment in Health Care 2014(11):30(5):508-13

 

35. S. Kleijnen et al. European collaboration on relative effectiveness assessments: what is needed to be successful? Health Policy, 2015(2):119(5):569-76

 

36. S Kleijnen et al. Improving the contribution of regulatory assessment reports to health technology assessments – A collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health 2014(07):17(5):634-41

 

37. JL Harousseau, M. Pavlovic, H. Mouas, F. Meyer. Shaping European Early Dialogues: The SEED Project. Value in Health 2015 (18), Issue 7, page A562

 

38. M. Pavlovica, J. Garnierb, I. Durand-Zaleskic,* et les participants à la table ronde N°3 de Giens XXXI : Survie sans progression, survie globale et qualité de vie : quel intérêt au plan médico-économique en oncologie ? Thérapie 2016 (71), 59-67

 

39. M. Pavlovic. Challenges for Relative Effectiveness Assessment and Early Access of Cancer Immunotherapies in Europe. Frontiers in Medicine, November 2016. http://dx.doi.org/10.3389/fmed.2016.00056

 

 

BOOKS

 

Biologie – l’ère numérique. CNRS éditions, 2009

 

Les Biosimilaires. Springer, 2011.

 

Cryotherapy. Springer, 2014

 

 

ABSTRACTS 

 

60 abstracts

 

 

THESES

 

Post-graduate thesis: « Role of HDL and LDL cholesterol in the development of atherosclerosis in patients with non-insulin dependent diabetes mellitus » Belgrade University

Specialty thesis: "Role of magnetic resonance imaging (MRI) in adults presenting with severe acute infectious cellulitis ". Published in Arch Dermatol 1994; 130:1150-8.