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Michela brings with her almost 20 years of experience in market access of innovative new therapies and orphan drugs from different perspectives, both local and international.
She began her career in consulting, where she spent about 7 years working in different settings and for both public and private healthcare clients. During this experience she completed successful projects involving both regional and national stakeholders and where she also worked on the development of international access strategies working with HQs of multinational companies.
She then moved to AstraZeneca Italy in 2010, where she had the opportunity to work in the access team, in roles of increasing responsibility, gaining proven experience in the development of pricing and access strategies for innovative drugs. He worked closely with the territory and had the opportunity to develop important partnership projects with payers and institutions.
Prior to joining Napo Therapeutics, Michela served as Head of Market Access Rare Diseases Europe & Emerging Markets at Chiesi Global Rare Diseases, where she was responsible for developing access and reimbursement strategies for the rare disease drug portfolio, working closely with local market access teams or partners to ensure implementation.
Michela holds a Bachelor’s degree in Management Engineering from the University of Bologna and a Master’s degree in International Health Care Management, Economics and Policy from SDA Bocconi in Milan.
Over the last 15+ years he worked for top-tier pharmaceutical companies developing extensive local and international commercial experience in different therapeutic areas with a particular focus in rare haematologic neoplasms, oncology, and neuroscience. Prior to joining Napo Therapeutics, between 2019 and 2022 Massimiliano served as Franchise Head Multiple Myeloma Europe & Canada at Takeda Pharmaceutical International leading the regional team based in Zurich for the development and commercialization of the multiple myeloma franchise. In his previous role at Takeda, between 2016 and 2019 he successfully led the cross-functional efforts to bring an oral orphan drug for multiple myeloma to the Italian market. Between 2007 and 2016 Massimiliano worked for Eli Lilly where he held roles of increasing responsibility in various functional areas such as financial planning, business development and alliance management, commercial strategy, marketing, and sales. Massimiliano holds a master’s degree in Economics of Institutions and Financial Markets and an Executive MBA with focus on Entrepreneurship from LUISS Business School. Most recently he complemented his executive education completing the Leading Strategic Growth program at Columbia University.
Before joining Napo Therapeutics, Stefano served from 2015 to mid-September 2022 as Chief Financial Officer and M&A Director at Consulcesi Group, a leading international healthcare service group, based in Lugano (Switzerland) and oversighting EU subsidiaries.
He started his professional career in 1998 as an auditor for KPMG, based in Milan (Italy) and secondment in Southampton (UK), focusing on assurance, transaction services, process engineering and IFRS conversion projects.
In 2006 he spent one year as a Finance Manager for Bioxell SpA, a biotech company listed on the main segment of the Zurich stock exchange, and from 2007 to 2012 served as Director of Finance and Chief Operating Officer for Savills Investment Management, a real estate investment manager headquartered in London (UK) and offices in Luxembourg and Milan (Italy), dealing with investments, finance, operating activities and transactions involving EU regulated entities and cross-border institutional funds.
From 2013 to 2014 Stefano also worked as Chief Financial Officer for an Italian pharmaceutical retail company and successfully led the company’s listing process (IPO) on both the Alternative Investment Market of the Milan stock exchange and the Marché Libre (Euronext) segment of the Paris stock exchange.
Stefano holds a bachelor’s degree in Business Economics and a master’s degree in Corporate Finance. He also was a member of the Board of Directors of several European companies.
The company is seeking an experienced Head of Market Access, Pricing and HEOR, owner of pre-market access strategic plan in key selected markets for Europe, commercial pricing strategy and accountable for international market access policies.
He/she will assess the markets’ existing health care environment and create stakeholder value propositions.
The role reports to the Chief Medical Officer and works closely with CRO, clinical development functions and medical affairs. The overall scope of the role is to plan, execute, maintain oversight and report on clinical trials, from planning, vendor selection and site feasibility, through study close out. Ensure all trial outputs from protocol development to final clinical study report (including archiving of the Trial Master File) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines.
The responsibilities for this role include the following:
A well-recognized expert in global regulatory affairs, Ms. Amatulli previously served as a Global Regulatory Affairs Director at Dompé, an Italian bio-pharmaceutical company that markets 50 million medication packages in roughly 40 countries around the world. Ms. Amatulli also spent more than six years in regulatory affairs with the Janssen Pharmaceutical Companies of Johnson & Johnson. Her recent track record includes approval of the first biotech drug (eye drops) for the treatment of a rare disease of the eye in the US, China, EU and four other countries; discussion with FDA, EMA and ANVISA about the development plan of 2 investigational products for COVID-19 treatment; the preparation and submission of three Investigational New Drug Applications (INDs) for different therapeutic areas (diabetes, oncology and ophtha); the development of a Global Early Access Program (Managed Access Program and Named-Patient Program); and the set-up of local affiliates in EU-5 countries (France, Germany, Italy, Spain and the United Kingdom), the US, and China from a regulatory standpoint. Ms. Amatulli holds a BS degree in Pharmaceutical Biotechnology from the Università Degli Studi Di Milano, and a master’s degree in Molecular Biology from the Università Degli Studi Milano-Bicocca.
An established leader with Europe’s pharmaceutical industry experience for 20+ years, he possesses a great deal of experience in the field of orphan-drugs. Mr. Mineo previously served Recordati Rare Diseases (former Orphan Europe) as Managing Director and General Manager EMEA, leading the Europe and Middle East Commercial Operations. He was responsible for Sales & Marketing, R&D product development, Medical Affairs, Market Access, Regulatory, Manufacturing and Logistics, as well as the enabling functions to support the business, including Compliance and Quality. During his tenure, he led the commercial launch of Signifor® (orphan drug indicated for the treatment of Cushing disease and Acromegaly) and Isturisa® (orphan drug indicated for the treatment of Cushing Syndrome) in the key EU markets. Further, he pursued the EU marketing authorization approval and the commercial launch of Cystadrops®, an eye drops solution indicated for the treatment of corneal cystine crystal deposits. He holds a master’s degree in Business Administration and has spent over 20 years working in the pharmaceutical industry, particularly in the areas of Commercial and Finance. Mr. Mineo joined Sigma-Tau in 1998, where he served in various roles of growing responsibility in Finance and Administration in the group’s holding company. In 2008, he became Head of Business Operations for the Italian market and Chief Corporate Strategic Planning. At that time, he was also CEO of Lynapharm SA, a French joint venture company focused on hospital CNS products. Prior to joining Recordati Rare Diseases in 2015, he was instrumental in establishing the new Sigma Tau Rare Diseases entity in order to acquire Enzon Pharmaceuticals’ rare diseases portfolio, leading the commercial launch of Oncaspar® (a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with Acute Lymphoblastic Lymphoma) and Adagen® (an enzyme replacement therapy for the treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase). He was also Head of Global International Business overseeing local offices in Spain, France, Benelux, Germany, UK, Switzerland, India, China and the US, as well as an extensive worldwide network of licensees/distributors.
Aphysician with 30+ years of experience in Europe’s pharmaceutical industry and in clinical practice, Dr. Particco possesses in-depth experience in the field of rare diseases, having been involved in the clinical development and launch of Pfizer’s pulmonary hypertension indication for sildenafil and the clinical development of Kedrion Biopharma’s ligneous conjunctivitis indication for plasminogen, with direct experience with patients and experts treating these rare pathologies.
From 2016 to 2021, Dr. Particco served as Vice President, Head of Medical Affairs for Europe for Shionogi Europe, the subsidiary of a leading Japanese pharmaceutical company with global sales of €2.5 billion. Prior to this role, Dr. Particco was Shionogi Europe’s Country Medical Director for Italy, and in 2013 he served as the Country Medical Director for Italy for UCB Italy, a leading European biopharmaceutical company with global sales of €4.6 billion. He also previously served as Director of Global Pharmacovigilance, Medical & Clinical Affairs at Italian firm Kedrion Biopharma, and as the Country Medical Director for Italy for Warner Chilcott, the Italian affiliate of a US pharmaceutical company that is now part of Abbvie. Dr. Particco was with Pfizer/Wyeth from 1999-2010, in the role of Senior Medical Advisor for Biotechnology from 2007-2010, and previously as both a Medical Advisor and a Training Specialist at Pfizer. From 1990-1999, Dr. Particco worked as an obstetrician-gynecologist in Rome, both in private practice and in public health. He received his degree in Medicine and Surgery and his degree in the Specialization in Gynecology and Obstetrics from the Sapienza University of Rome.