More than 15 years of experience in regulatory and quality area of pharmaceutical, medical device and in vitro diagnostics medical device industries. Senior management experience in the regulatory compliance in the EU and in the global market authorizations in the Americas and Asia-Pacific, leading the MDSAP certification and dealing with the main Regulatory Authorities. Expertise in the quality assurance system and in the regulatory aspects of design controls, risk management, complaint and post-market surveillance. Strong skills in regulatory strategy acquired with the participation to international projects of product development and supporting manufacturing transfer. Focused on the key quality and regulatory affairs initiatives to drive continuous improvement and to be a bridge builder between the regulatory requirements and practical implementation in companies.
More than 15 year experience in the Medical Device Industry with leadership roles in the Operations area. Knowledge of Global organizations with relevant reporting requirements and multi-year participation to the Senior Management Board with definition of strategic and operative goal for the local organization as well as Roll-out of Corporate and Business Unit strategies. Deep understanding of the med-tech environment acquired with international projects of product development, manufacturing scale-up, supply chain optimization, ERP implementation and company integration including the due diligence process. Important exposure and experience over Lean Manufacturing practices and KPI setup Degree in Industrial Engineering and Global Executive MBA, SDA Bocconi
Accountant since 1995, after having been associated in important Brescia firms, about ten years ago I founded the firm of which I am a senior partner and in which, right from the start, alongside the technical-fiscal competence, a business consultancy orientation to render services to its customers more oriented towards global support. My activities of management analysis, financial planning, improvement of the company’s organizational issues are appreciated by clients who recognize the Firm as an important partner with whom to share their growth. This recognition often leads me to assume operational roles, as well as in Boards of Statutory Auditors, also in various Boards of Directors. As a professional I am also a Statutory Auditor and Technical Advisor to the Judge.
With 30 years of experience in Orthopaedics and medical devices in the role of Medical Science Director, has built a clear understanding of clinical needs and market opportunities through the development of global strategic medical programs and the involvement of a world-wide Key Opinion Leaders network. One of her main focuses is the promotion of clinical evidence on the benefits of medical devices and dissemination of best clinical practices.
After serving as an Assistant Professor of Biomedical Engineering at Tulane University in New Orleans, Alastair joined Johnson & Johnson in 1981, becoming VP Worldwide Business Development for Johnson & Johnson Orthopaedics where he was responsible for the acquisition of DePuy by J&J. Since 2000, he has founded and been CEO of numerous companies in orthopaedics which were successfully sold. He is currently a Board Member of First Wave Technologies, Applied UV (NASDAQ) and Chairman of the Board of Ensemble Orthopaedics. He holds a PhD from the University of Surrey (UK) and an MBA from Columbia University in New York.
Claudio Giuliano has been active in the venture capital industry since 2000. Claudio co-founded in 2007 Innogest Capital, a venture capital firm with about € 200 Mln under management, and a partner in the Healthcare and Cardiovascular practice at Innogest. Claudio serves as chairman of the VC Committee of the Italian VC and PE association (AIFI) and is part of several private and public bodies involved in start-up and entrepreneurship development. Prior to Innogest, Claudio was anAssociate Director at The Carlyle Group (London), a strategy consultant at Bain &C o (Italy) and a Supply Chain Manager at Hewlett-Packard (California and France). Claudio holds a Summa cum Laude Master of Science in Electronic Engineering from Politecnico di Torino (Italy), a Summa cum Laude Diplôme d'études approfondies in Microelectronics from l’Institute Nationale Polytecnique in Grenoble (France) and an MBA from INSEAD (Dean’s List), in Fontainebleau (France).
Francesco has served as Executive Vice President and Member of the Executive Committee of Biogen Idec (NASDAQ: BIIB). Previously he was Group Vice President and President of Schering-Plow Europe and Canada, executive positions at Pfizer and CEO at Pharmacia and Dompè Biotec. Currently he sits on the boards of Neopharmed Gentili, Italfarmaco, Diadem and Greenbone. He is a Board Member of the Helsinn Group in Switzerland, a member of the Board and the Investment Committee of the 3B Future Fund (venture capital fund focused on oncology) in Luxembourg.
Diogo holds a degree in Marketing & Finance and has titles in Global Strategy & Negotiation and others. During the 16+ years Diogo spent at Johnson & Johnson, he became President EMEA for DePuy. Subsequently, he joined Smith & Nephew as Group President Europe & Canada. Since 2016, he has been elected to various Non Executive Director positions and is a Managing Partner for Prosperon Ventures.
From 2005, Francesca has been a Managing Director of META Ventures (MV), the financial company of META Group managing public-private co-investment risk capital funds in Italy, Poland and Slovenia. She has a deep experience knowledge on key features and regulation of EU financial instruments, having worked for the European Commission and other important international donors (EIB).
Roberto is c of 3BFuture fund. Prior to this, Roberto was Head of Corporate Business Development at Helsinn. Roberto has held several Senior Director positions in various pharmaceutical companies including Pfizer, Indena, Pharmacia & Upjohn, Nerviano Medical Sciences and Boehringer Mannheim. Roberto is on the board of several portfolio companies in Europe and the US. He holds a PharmD degree. Roberto currently serves on the board of Fore Biotherapeutics, GreenBone Ortho S.p.A., iOnctura and OncoResponse Inc.