Mr. Ambra is an experienced industry executive and has led various multinational drug and device development programs, many of which resulted in successful regulatory approvals. In 2012, he founded and led a full-service U.S. based CRO, DZS Clinical Services, focused on supporting small and mid-sized drug and device companies. During his time there, he led the organization through significant growth and was instrumental in developing one of the first unified eClinical platforms in the industry. In 2018, DZS was successfully acquired by the WDB Holdings group. Before that, Mr. Ambra spent 20 years in the clinical research industry, having held strategic leadership positions with leading Sponsors and CRO companies. Throughout his career, Mr. Ambra has continued to foster a culture of excellence, a sense of urgency, and a sincere desire to bring new and innovative therapeutics to patients.
Norifumi Ninokata has a Master’s degree in Management Technology from the Tokyo University of Science, Japan. Since joining WDB Holdings in 2005 as a Director of Sales and Global Business Promotion, Mr. Ninokata has been mainly involved in developing business plans and leading personnel work and management of WDB subsidiaries. As the President & CEO of Business Succession Partners Co., Ltd., in 2010, he was responsible for overall business development and expansion of WDB group business.
In addition, as the President & CEO of WDB Medical Data, Inc., since 2016, Mr. Ninokata was responsible for managing the business in the US with other subsidiaries of WDB Holdings and executing WDB group business. Following the successful acquisition of DZS Clinical Services in the US, he was appointed as the President of DZS in September 2018, followed by his appointment as the President of Oy Medfiles Ltd. in May 2020.
Mirja Savolainen, MSc (Biochem)
Director, R&D and Laboratory Services
Mirja Savolainen has led the R&D and analytical services unit at Medfiles Ltd since 2007. Before that she worked for 10 years as a laboratory manager of the microbiological laboratory: her main responsibility was to set up and develop microbiological services. Before Medfiles she held various teaching positions on laboratory techniques in microbiology and cell biology at the University of Kuopio. Mirja Savolainen has also been the responsible director of Medfiles Ltd since 2008; this is a mandatory position stipulated by the Finnish Medicines Act for every company with a GMP licence. She has experience in quality issues as well as occupational safety. She has a long track record in CRO business with a wide range of duties from those of a scientific expert to marketing and business unit management.
Minna Haapalahti, MSc (Biochem)
Director, Regulatory Affairs and Safety
Minna Haapalahti has worked at Medfiles since 2010 leading regulatory services since 2018. She has over 19 years experience of biochemistry and pharmacy. She has operated in several research and product development positions in university, research organisations and in Red Cross’ Blood Service in Finland and Germany. Before coming to Medfiles she was involved in research and development of biomedicines, in quality assurance and quality control of blood products as well as stem-cell research. Minna Haapalahti has experience also from quality control of in vitro -diagnostic tests (IVD) in ISO9000-certified company. She has medicinal legislation education and very extensive knowledge from EU’s marketing authorization processes and designing them. Minna Haapalahti has also long experience from CRO business and from leading the business unit service.
Essi Sarkkinen, PhD (Clinical Nutrition)
Director, Clinical Research
Essi Sarkkinen has worked for Medfiles since 2014, and from October 2019, she has led the Medfiles clinical research services. Prior to that, Essi led the Medfiles Food & Nutrition team. Before Medfiles, Essi has worked with the food and pharmaceutical industry in various positions. All in all, she has over 30 years of experience in research and development as well as in clinical research. Essi’s speciality is food and nutrition research, but she has also worked in clinical research for the pharmaceutical industry from the beginning of the 2000s. In addition, she has over 20 years of experience in food regulatory affairs and various regulatory processes. Essi has a PhD in clinical nutrition and has been qualified with the title of docent at the University of Eastern Finland. Before joining Medfiles, she has worked at length both for the academia as well as for various CRO businesses in a wide range of duties, from scientific research to leadership and management.
Masahiro Yoneda holds an MBA degree in Strategic Management from the Chuo University in Tokyo. He joined WDB in 2000 and since then has been engaged in several business development projects and management duties. He has an experience of 14 years as a Branch Manger in WDB Holdings and has expertise in sales and marketing as well. In addition, Masahiro has experience of working in human resources management with large Japanese pharmaceutical companies in their laboratory services. In March 2017, Masahiro Yoneda was appointed as the Director of Oy Medfiles Ltd.
Scientific Consulting and Advisory Board
Tuija Keinonen, PhD (Pharm)
Tuija Keinonen has been the CEO of Medfiles Ltd between 1999 and 2005 and then the CEO of Medfiles Group since 2005. She has about 30 years of experience in contract research business and its establishment. She has now led Medfiles Ltd and been the member of the board for over 14 years. Before this position Tuija Keinonen was Medfiles’ clinical research director (and 4 years the quality director responsible for establishment of the company’s quality system). Before Medfiles she worked as a deputy pharmacist in charge of a hospital pharmacy (Vaajasalo hospital) and project researcher (pharmaceutical chemistry) at the University of Kuopio. In 2003, Tuija Keinonen defended her doctoral dissertation (Clinical Drug Trials in Finland: Quality and Characteristics) on pharmacology and toxicology at the University of Kuopio.
She has published scientific articles on clinical trials and pharmaceutical chemistry. Furthermore, Tuija Keinonen led for over 3 years a contract manufacturing organization, Medipharmia Finland Ltd, a former subsidiary to Medfiles Group (the former Medikalla Group). She has experience in business acquisitions and business integration. She holds several positions of trust both in the private and public sector as well as board memberships. She was elected as Alumna of the Year 2019 by University of Eastern Finland. She is a frequently invited speaker at courses and seminars. Tuija Keinonen has also been an Estonian honorary consul (appointed by Ministry of Foreign Affairs of Estonia) since 2012.