The Hovione Technology Transfer Center (TTC) in New Jersey has passed successfully a pre-approval inspection by FDA. The inspection was carried out from 9 to 12 October by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER). No form 483 was issued. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is expected in Q1 2008, with a launch foreseen later that year. This is an exciting milestone for our New Jersey Technology Transfer Center. This successful FDA compliance inspection gives a green light to an NDA compound - we look forward to further expanding small scale commercial manufacturing opportunities at our New Jersey site”, said Mr. Dave Hoffman, President of the US Operations.

On 11 October 2007, the TTC celebrated their VPP status with OSHA with the presentation of a flag and plaque by OSHA. The presentation was made by Gary Roskoski, Director – Marlton Area Office and Martin Davis, Compliance Assistance Specialist to the responsible team. East Windsor Mayor, Janice Mironov, congratulated the TTC for a job well done.

Other dignitaries were in attendance: Portuguese Consul of New Jersey (Consulate General and Advisor), Portuguese Chamber of Commerce, Millennium BCP Bank, East Windsor Council Members, and numerous magazine and news publication representatives.

Last 1st November, Mr. Guy Villax, CEO of Hovione, gave a testimony, on behalf of EFCG (European Fine Chemicals Group) in Washington DC to a Hearing of the United States House of Representatives Sub-Committee on Oversight and Investigations of the Committee on Energy and Commerce, entitled "FDA Foreign Drug Inspection Program: A System at Risk".

During the speech Mr. Villax (the only non-US witness invited to give testimony) highlighted the increasing difficulties being faced by the EU (and US) Health Authorities in coping with the effects of globalisation to ensure a GMP-complaint supply of active pharmaceutical ingredients (APIs) destined for the use in the EU medicines market.

A copy of the full Testimony is available on the EFCG website.

Lisbon saw the gathering of 220 European entrepreneurs, on the 28th and 29th October, at the European Group of Family Enterprises Conference, organized by the Portuguese Association of Family Enterprises. APEF, chaired by Peter Villax – Member of Hovione’s Board of Directors, promotes Family Enterprises, endeavoring to protect their interests by improving society awareness and organising training sessions for its members.
The Conference included an important address by the President of the European Commission, José Manuel Durão Barroso, who referred to the family enterprises as the motor of the European economy, pointing out their sustainable development qualities and their pursuit of long term objectives, the best way, as he put it, to bring to safe harbour the Lisbon Strategy.
The event was also marked by a round table of European entrepreneurs, among whom were Denis Solvay and Thierry Peugeot, members of European families who have been contributing to the European economy since the 19th century.
The success of the Conference was unanimously recognised by all participants and marked a turning point in the way family enterprises are perceived by the political authorities and how they should deal with the visibility of their actions.

Hovione welcomed in Lisbon, on the 11th and 12th September last, one of the four annual meetings held by EPAG (European Pharmaceutical Aerosol Group), a standards association of European companies dedicated to the development and production of pharmaceutical formulations for medicine inhalation. At this meeting, various matters were discussed concerning inhalation, namely in terms of regulations, an area in which EPAG enjoys a strong cooperation with the regulating entities. This was also a unique opportunity for the market’s competing companies to share experiences crucial to the development of this activity in which Hovione has become leader over the last years.

Hovione was invited to participate in the 2007 PDA/FDA Joint Regulatory Conference, held last September, in Washington DC, USA. This is the largest event of its kind in the world, attended this year by around 800 participants accounting with over 100 presentations.
Evolution of the Global Regulatory Environment: A Practical Approach to Change provided the theme for three days of debate. Luísa Paulo, GMP Compliance Director at Hovione was speaker at the session “Change Management - Industry Perspective”. Hovione is often invited to contribute to conferences, round tables and group meetings of the industry, participating actively in the creation of policies and quality standards. At this conference, Hovione discussed matters related to quality and GMP with other colleagues of the largest American companies. An important testimony among the world’s large regulating powers.

The area of Innovation and Product Development (I&PD) was created with the main purpose of identifying and assessing new business opportunities concerning both the development of new products and the implementation of new technologies in the Company. Its mission is to manage the innovation process in a structured and methodical way in order to create knowledge and boost the development of innovative projects. Also within the functions of this new area are: i) the building of an interface between external entities such as Universities and Research Centres and the Hovione Scientific Advisory Board, to attract more know-how, technology and experience to Hovione; ii) the market analysis in terms of requirements, technological trends and state-of-the-art, and iii) to create connections between the Research and Sales areas promoting new ideas and innovative projects.

In order to reinforce a permanent relationship with the Universities, Hovione has created the role of “Ambassador”. The idea is to promote a close relationship between Universities and the business world, establishing communication links among parties to provide a better understanding of one another.

With this initiative the company hopes to continue its policy of recruiting Graduates, Masters and PhDs while cooperating with universities that may create synergies with Hovione’s activities, thus becoming a reference in the academic world.

The Project Management team supports the area of contract manufacture where Hovione provides research and development services.

Hovione has carried out a survey where clients indicated how much they value project management. Our clients recognized our technical ability and the strengths of our project management; they also shared some constructive feedback that we see as opportunities for improvement. Actively listening to its customers, Hovione took the decision to invest in additional resources to support project management and to develop and implement improved ways of working and appropriate tools. Within this discipline, the focus will be on four key dimensions:

● Structured approach - The Project Management team successfully delivers the project objectives (e.g. results, processes, products)
   through a structured approach that includes four key steps: Initiation, Planning, Execution and Closure;
● Team Dynamics - The Project Manager builds and leads the project team, ensures objectives and roles are clear and coordinates
   the activities;
● Communication - The Project Manager ensures proactive and transparent communication internally and with the client.
● Continuous improvement - The Project Manager measures the activity performance against the plan and facilitates learning
   through experience;

At Hovione, excelling in the area of RD Project Management and enhancing the client perception of it requires building on our current strengths and also improving in the above four key areas. We believe this should contribute to differentiate from competitors and be preferred by the clients. Therefore the Project Management team is committed to be the dedicated architect and facilitator of each project but it is clear that all project team members’ contribution and the ownership for each project are critical to make it happen!
Our overall goal is to generate client satisfaction by taking advantage of the excellent range of technical skills and strengths within Hovione in a very effective and efficient way!

Last 21st September Hovione hold another Management Meeting, which assembled around 60 members of its Management. Work started with the presentation of the group’s financial results and business progress indicators, followed by the presentation of the Crystal project, which involved the segmentation of Hovione’s target market to determine strategies for each segment. Also on the agenda was the presentation of the Company’s internal organizational guidelines, to be adopted in the next fiscal year, which opened the discussion on the management models used at Hovione. The final version will be delivered in the 1st quarter of 2008. Another important debate was held on the theme “Raising the Bar”, a project that is leading us towards a strengthening of our leadership skills and to constantly improve our personal performance levels.

Hovione’s plants in Loures and Macau are undergoing a process of certification of its safety systems, according to OSHAS18001, Occupational Health & Safety Management System.
An audit took place at the Loures plant in November – 1st phase – to check the system and find opportunities for improvement. We anticipate the 2nd phase of the certification audit to take place during the first quarter of 2008.
Macau has the preparations underway and the Safety Committee has also started identification of dangers and assessment of risks, in order to carry out the 1st phase of the audit during February 2008. We need everyone’s support so we can ensure better safety and environment.

When I accepted on the job of General Manager of Hovione Macau I was aware that there would be three great challenges ahead: professional, personal and in terms of family. And it is about these that I would like to speak after having spent my first six months in Macau.
Professionally it has been an excellent experience. The adjustment to the new company went smoothly and I was greatly welcomed. Firstly, because Luis Gomes prepared a program of intensive and detailed training on all the major aspects of the company, which allowed me to very quickly join in the daily operations. Secondly, because I found the same company culture, the same professionalism and dedication from everyone that I had been used to in my 13 years at Hovione, and that made me feel right at home. And lastly, because I was ready to learn, be creative and work as part of the team.
Personally this has been a very dynamic period with much learning and constant questioning. My present post requires availability and permanent answers, and there is no room for routine to settle in, something I greatly enjoy.
On the other hand living in Asia, in touch with a culture as rich and as old as the European one, but at the same time so different, is for me, a truly enriching experience.
This adjustment has only been possible thanks to the unconditional support of my family. These six months have not been easy as I have been away from my daughter and wife and in the meantime another daughter was born. Now we are all finally together here in Macau and we face together the challenge of adjusting to a new country, a demanding climate, rich food, new places, new people and almost always a new language. But it is also an opportunity to get to know new cultures and new ways of life and, in short, to have a wider perspective on the global world.
I therefore hope to be able to continue contributing towards the growth and success of our company in Macau and above all always to be able to say “It was worth it”!

During the last week of September and the first of October the New Jersey SAP team traveled to Portugal to start another crucial step in the project. It was time for the New Jersey key users to meet with their Portuguese fellow users and learn as much as possible about the work processes they will be involved with and the use of SAP. It was time for intensive training and learning ; it was also a great opportunity to know more about the company and to interact with people with whom they will be working much closer to from now on.

Editors: Isabel Pina, Raquel Pereira • With the collaboration of: António Almeida, Cristina Barradas, Jorge Pastilha, José Saraiva, Luísa Paulo, Nuno Silva, Paulo Carvalho, Peter Villax.