Clinical Global Development

Our Research & Development team represents a fundamental asset for the business. It comprises integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemistry and manufacturing controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, project management and leadership, and R&D portfolio management.  Moreover, R&D functions also support products already on the market through pharmacovigilance and regulatory activities.

Headquartered in the purpose-built and fully integrated new Research and Development Centre in Parma, the team also has important activities in Paris, Chippenham (UK), Rockville (US) and now in Lidingo (Sweden) and Hillerod (Denmark): the latter two sites comprise the new colleagues from Zymenex. The goals of this experienced cross-functional team are highly focused on the delivery of the pipeline on a global basis and increased productivity to support the growth goals.

Most of Chiesi’s medicinal products originate from in-house research whilst others involve cooperation and partnerships with other pharmaceutical companies; in fact, 75% of our turnover comes from the products developed by our R&D division.

For several years, an increasing proportion of the company’s revenues have been invested in Research & Development; in fact, out of 1000 European companies, the Chiesi Group is the top Italian company for R&D investment and ranks 7^th among the major national groups in every industry.  ^[1]

Another important result which underlines the major commitment of the Chiesi Group to Research & Development: in Europe we are among the companies filing the highest number of patents, ranking in 5^th place in Italy. [2]

During the past 6 years our Group, due in part to the investment in R&D, has achieved sustainable growth: a 75% increase in income, the launch of a new product on average every two years, the opening of seven new subsidiaries and the creation of over 750 new jobs.

[1]     European Commission, Joint Research Centre, EU Industrial R&D Scoreboard 2014

[2]     European Patent Office, 2014 Report.

Pharmaceutical Affairs

The "Pharmaceutical Affairs, Pharmacovigilance and Medical Information" Pole is composed of several units:

• The Regulatory Affairs unit manages the registration and updating of marketing authorization (MA) records of products registered in France. It verifies product advertising, packaging, and in general, the application of the texts relating to the French Public Health Code.
• The Quality Assurance unit implements a quality management system. It manages pharmaceutical statutes on the sites of Bois-Colombes (headquarters) and la Chaussée St-Victor (industrial site). It ensures compliance of internal and external (subcontracting) practices with the current regulations.
• The DMOS unit ensures compliance with the DMOS law called "anti-gift law" which governs the relationships between health professionals and companies. It is responsible for submitting applications to official bodies and provides training to collaborators.
• The Pharmacovigilance unit monitors and prevents the risk of adverse events.
• The Medical Information unit disseminates scientific and medical information relevant to the proper use of the company medicinal products.

Public Affairs, Market Access and Communication

Focused around two major axes, this Directorate is responsible for:

on the one hand, interacting with the agencies and State departments responsible for health policies and negotiation in the context of market access procedures;

and on the other hand, external and internal communication.

Operational Departments

The operational departments are intended to strengthen our presence with Health stakeholders, and our expertise in our therapeutic areas, including in Pulmonology.

The promotional activities are carried out through:

• A "Specialty Care" Business Unit which brings together the sales, Marketing, Medical teams dedicated to the promotion of our specialty products in neonatology and kidney and liver transplantation;
• A "Retail" Business Unit which brings together the promotional (including networks of Medical Sales Representatives for general practitioners and specialists) and Marketing teams, dedicated to the promotion of our products intended for private practices, first in the respiratory field but also in malnutrition.

Business Knowledge and Customer Strategy

The Business Knowledge and Customer Strategy Directorate aims to handle knowledge of our environment, our customers and our markets, as well as the efficiency of our organization to define the strategy for our company to optimize its performance on the French pharmaceutical market.

The "Business Knowledge" Pole brings together the activities of Sales Force Effectiveness (SFE), market studies, and Business Development. Its role is to provide the most appropriate marketing strategy for each customer and for each product in their competitive landscape.

The "Customer Strategy" Pole brings together the activities of Customer Relationship Management / Close Loop Marketing (CRM/CLM) and analysis of all operations around a customer. Its role is to suggest recommendations on the means to be implemented to optimize communication with its customers.

 Production

The factory, built in 1992 is located at la CHAUSSEE ST-VICTOR (41).

It has seen two major developments:

• 2007: Increase in storage capacity (1,200 m²) and internalization of the distribution activity,
• 2014: Extension of the industrial site (3,900 m²) and installation of a production line for €22 million of investment, (for a total built surface of 8,200 m²)

The factory is specialized in the manufacture of medicinal products in powder form and the packaging of aerosol and dry forms and has a production capacity of 20 million units.

It has become the main factory of the group for manufacturing and packaging a device for powder inhalation for the treatment of respiratory diseases.

It supplies the French (30%) and international (70%) markets, in particular the German, English, Belgian, Italian and Spanish subsidiaries of the CHIESI Group.

Medical Affairs

The Medical Affairs Directorate led the medical strategy of the subsidiary taking into account the global strategic issues and in compliance with the ethics and regulation. This directorate interfaces with many partners: internally, the Global and especially the R&D, the key operational functions of the subsidiary, marketing, sales, strategy management, regulatory affairs and, externally, opinion leaders, learned societies or Health Authorities.

It is organised into 3 poles:

• the scientific affairs which provide their expertise to internal customers, including in the field through the "regional medical responsible" function and are guarantor of the quality of scientific messages in the laboratory communication.
• the training of Medical Sales Representatives networks which establishes training plans in accordance with the Charter of the Medical Examination and business training needs. It allows our Medical Sales Representatives to master the environment of diseases related to the laboratory activity and to ensure knowledge of our medicinal products to enhance them and develop their proper use.
• the monitoring and market access that manages the economic lifecycle of marketed or future products (prices, reimbursements, relationships with Trustee Authorities) and the analysis of the economic, political, scientific, regulatory, and competitive environment which should help Chiesi to adapt better and faster to change.

Alliances and Partnerships

Our growth and development strategy is based on the search for local or global opportunities on behalf of our head office, and this is done through:

• Co-development agreements
• Licensing agreements (in-licensing or out-licensing)
• Acquisitions of products (medicinal products, diagnoses or medical devices)
• Acquisitions of companies
• Product co-promotion agreements (co-branding, co-marketing, product swap, cross co-promotion ...)
• Alliances and partnerships during the marketing phase (co-promotion, co-branding, co-marketing, product swap, cross co-promotion ...)

Chiesi France is based on a merger-acquisition history (Logeais Laboratories ...). Today, we are constantly looking for new partners in all types of therapeutic areas and especially in Specialty Care, whether it is for medicinal products, diagnoses or medical devices.

Do not hesitate to contact us to propose an alliance or a partnership.