Quality and Clinical Director

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1 Curriculum Vitae PERSONAL INFORMATION Minna Leppänen WORK EXPERIENCE April 2014 Present Quality and Clinical Director Scaffdex Ltd, (Finland) Responsibility in quality, regulatory and clinical issues concerning bioabsorbable medical devices and tissue engineering products: - Development of regulatory strategies - Planning and management of regulatory submissions - Management of the Company's ISO certified quality system - Management and coordination of internal end external quality assurance - Post-market surveillance and safety issues - Responsibility of risk management of clinical products and R&D projects - Responsibility of clinical development January 2011 Present Veterinarian (part-time) University of Tampere, (Finland) Director of the Laboratory Animal Unit in the School of Medicine General management and responsibility of the Unit Tasks of the designated veterinarian of the Unit Vice-member of the national competent authority for animal use August 2011 November 2013 Senior researcher (part-time) University of Tampere, (Finland) Senior researcher in a development project for a novel tissue engineering project in the School of Medicine. Main responsibilities - Planning, realization and reporting of long-term non-clinical safety studies - Development of regulatory strategy - Planning of risk evaluation and risk management based of EMA's risk based approach guideline (EMA/CAT/CPWP/686637/2011) -Planning of the first clinical Proof of Concept-study The work in this project has started as consultant in 2011 and continues as consultant from January 2014 onwards. September 2008 December 2009 Lecturer (temporary) Unversity of Tampere, (Finland) Temporary lecturer in the Institute of Biomedical Technology courses of Biobusiness and Biotechnological Product Development March 2009 April 2014 Clinical Specialist Scaffdex Ltd, (Finland) Clinical specialist within field of bioabsorbable medical devices and tissue engineering products 1/12/14 European Union, Page 1 / 5

2 R&D tasks, especially non-clinical and clinical development Regulatory issues Post-market surveillance and safety Quality issues Non-clinical and clinical risk management February 2006 March 2009 Managing Director EvoStem Finland Oy, (Finland) General management of the company. January 2002 Present Consultant ML Consulting Tmi, (Finland) Part-time consultation services within veterinary medicine and medicine drug and medical device development non-clinical and clinical research risk management and quality issues regulatory issues August 2003 January 2006 Clinical Specialist Linvatec Biomaterials Ltd, (Finland) Clinical development of medical devices Post-market surveillance Risk management Regulatory affairs February 2000 July 2003 R&D manager Orion Corporation Plc/ Orion Pharma Ltd, (Finland) Responsibilty for veterinary rug development projects Project management Clinical study leader Adverse event evaluations and PSURs Marketing support Post-market surveillance May 1990 January 2000 Veterinarian Keski-Uudenmaan Eläinlääkäriasema Oy, (Finland) Companion animal veterinary practice Management duties as company owner and CEO. April 1987 April 1990 Veterinarian and municipal food hygiene officer 1/12/14 European Union, Page 2 / 5

3 Various, (Finland) Farm and companion animal practice in various communities, municipal food hygiene and environmental health officer EDUCATION AND TRAINING September 1982 May 1988 Licentiate of Veterinary Medicine (DVM) College of Veterinary Medicine, Helsinki, (Finland) Qualification and legislative studies for a veterinarian January 1989 May 1990 Food hygiene officer qualification studies and examination College of Veterinary Medicine and Finnish Ministry for Agriculture and Forestry, Helsinki, (Finland) Official state examination for qualification of municipal and state health and food hygiene officer. January 1995 May 1999 Specialist competence in companion animal medicine and surgery University of Helsinki, Faculty of Veterinary Medicine, (Finland) March 1996 April 2000 PhD University of Helsinki, Faculty of Veterinary Medicine, (Finland) Ph.D studies and thesis within the field of veterinary epiedemiology January 2006 December 2007 MBA Hanken, School of Economics, Helsinki, (Finland) General management and business degree January 2011 March 2011 Accredited Competence for Planning and Management of Animal Experiments University of Helsinki, (Finland) C-category competence course for scientists in laboratory animal science by the European Union, the Council of Europe and Federation of European Laboratory Animal Science Associations curriculum. January 1988 Present Several trainings Several national and international Several courses and trainings in different countries e.g. in veterinary medicine, epidemiology, drug development, medical device development, regulatory affairs, languages, statistics ADDITIONAL INFORMATION Expertise Veterinary medicine, tissue engineering, bioabsorbable medical devices, clinical development, regulatory issues, quality, risk management, commercialization, strategy planning, project management, GCP, ISO, laboratory animal science. Publications PhD Thesis Utilizing health programmes for controlling canine genetic diseases in Finland 2000 MBA Thesis "How to build the brand from the beginning to the success Case EvoStem Finland Ltd" Peer-reviewed articles: 1) Leppänen M., Saloniemi H. Screening and controlling canine 1/12/14 European Union, Page 3 / 5

4 inherited ocular diseases in Finland: epidemiological, economical and health promotional aspect. Veterinary Ophthalmology 1998, 1: ) Leppänen M, Paloheimo A, Saloniemi H. Attitudes of Finnish veterinarians about programs to control canine genetic diseases Prev Vet Med Feb 15;38(4): ) Leppänen M, Saloniemi H. Controlling canine hip dysplasia in Finland. Prev Vet Med Oct 31;42(2): ) Leppänen M, Paloheimo A, Saloniemi H. Attitudes of Finnish dog-breeders about programs to control canine genetic diseases. Prev Vet Med Feb 1;43(3): ) Leppanen M, Maki K, Juga J, Saloniemi H. Estimation of heritability for hip dysplasia in German Shepherd dogs in Finland. Journal of Animal Breeding and Genetics. 2000;117: ) Leppänen M, Paloheimo A, Saloniemi H. Attitudes of Finnish dog-owners about programs to control canine genetic diseases. Prev Vet Med Feb 1;43(3): ) Leppänen M, Mäki K, Juga J, Saloniemi H. Factors affecting hip dysplasia in German shepherd dogs in Finland: efficacy of the current improvement programme. J Small Anim Pract Jan;41(1): ) Leppänen M, Mårtenson J, Mäki K. Results of ophthalmologic screening examinations of German Pinschers in Finland--a retrospective study. Vet Ophthalmol Sep;4(3): ) Leppänen MK, McKusick BC, Granholm MM, Westerholm FC, Tulamo R, Short CE: Clinical efficacy and safety of dexmedetomidine and buprenorphine, butorphanol or diazepam for canine hip radiography. J Small Anim Pract Nov;47(11): ) Vettenranta M, Leppänen M. Kantasolut hevosen jänne- ja ligamenttivammojen hoidossa : kirjallisuuskatsaus Stem cell in treatment of tendon and ligament injuries in horse: a literature review. Suomen Eläinlääkärilehti 115(2009):10 Additionally several congress abstracts and posters, confidential study protocols, reports, expert evaluations and reports. Projects Project leader in a development project for a novel canine cardiac medicine ( ). Participation in clinical development of a small animal sedative agent ( ). Project leader in clinical development of a novel bioabsorbable medical device for human use ( ) and compilation of clinical documentation and risk management documentation for regulatory authorization ( ). Participation in several other medical device development projects. Project leader in development project for an equine stem cell product Responsibility of non-clinical and clinical safety and efficacy program for a novel tissue engineering product and regulatory strategy ( ). Supervisor in seven Master's thesis: - three in veterinary epidemiology (University of Helsinki, Faculty of Veterinary Medicine, Finland) - two in stem cell therapies in veterinary medicine (one in University of Helsinki, Faculty in Veterinary Medicine, Finland and one in Estonian Univversity of Life Sciences, Faculty of veterinary Medicine, Estonia) - one in biotechnology concerning stem cell processing and in vitro evaluation (University of Jyväskylä,The Department of Biological and Environmental Science) - one in industrial management concerning commercialization of biotechnology products for veterinary medicine (Tampere University of Technology, Department of Industrial Engineering, Tampere, Finland) Memberships Vice-member of the national competent authority for animal use in Finland (2011-present). Participation in the World Congress of Osteoarthritis in Barcelona, Spain in 2012 Participation in the PDA Europe Workshop on Advanced Therapy Medicinal Products in Helsinki, Finland in 2011 Participation in the International Cartilage Repair Society Congress in Sitges, Spain, 2011 Participation in the World Regenerative Medicine Congress, Leipzig, Germany in 2009 and 2011; two oral presentations in 2009 covering equine stem cell treatments. Participation in the World Stem Cell Congress in La Jolla, CA, USA in /12/14 European Union, Page 4 / 5

5 Other Relevant Information 1/12/14 European Union, Page 5 / 5

The International Joint Master Programme. Veterinary Public Health (MVPH) Chiang Mai University,Thailand. Freie Universität Berlin, Germany

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