Press Room

Article / Sep 17, 2009

Welcome speech by Guy Villax at the 6th Hovione Seminar

The event that marked the start of the celebrations of Hovione's 50th anniversary.

Welcome speech by Guy Villax, Chief Executive, to the attendees of the 6th Hovione Seminar.

Estoril, 17th September 2009

Ladies and Gentlemen – Good Morning and Welcome,

I am delighted that you all came from far away to be here with us to celebrate the 50th anniversary of Hovione. Thank you. I am so glad to see so many faces – from so many moments – recent relationships and very long standing ones. Only a moment ago Gerold Stamm was telling me my father supplied him with doxycycline in 1979.

In 2007, I was a witness before a sub-committee of Congress and I said that for 40 years I had had a front seat watching the growth and evolution of the pharmaceutical industry. There have been endless changes, but what I feel is most important is to do with people.

For a long time careers would last a shorter time than the lives of companies, today it is the other way around. Most careers last far longer than companies. Among many stories that shaped Hovione, the one about us supplying Agouron with Viracept stands out as a good example. When the original 10 tons per year forecast became a 100 ton per year challenge, Hovione rose to the occasion. We were trusted to do the impossible, we committed to do our best, and together we came though and delivered a $500m sales product in the 1st year. Agouron was so successful it was bought by Warner Lambert, then by Pfizer. But still today many of the people that worked with us then to do the impossible -and made sure the market was never short of product- are now working in many other biotechs across California and they have great memories of what collaborations can achieve. The Agouron story was -to me- the first evidence that the outsourcing model not only worked, reduced risk and cost but that it was also robust and able to meet the toughest challenge. Viracept at some stage mobilised 1000m3 of reactor capacity.

So business is about networks, people that trust each other and work together to achieve great things.

Second listening to customers is not easy. In addition to listening carefully one has to really understand the client’s context. Unless we are familiar with the driving forces that shape decisions within a customer we will never be able to be proactive and truly become aligned with it. The most challenging aspect of the future way of working in the pharmaceutical industry is how to work collaboratively. The “procurement” model will soon be dead because the Parma Industry is now facing for the first time ever strong Darwinian pressures. The need to survive will drive evolution and only the fittest will succeed, the issue here is not being the best among equals – the winner will be of a new shape, working in a new way. But it takes two to tango, so a new shape of supplier to emerge we need a new shape of customer.

Third – again people, people make things happen. At the top big decisions get taken, but the outcome is to do with execution, Getting it done, right first time – every time is a matter for everyone in the company – and it is especially at the operations level, whether in the lab or operating reactors, that actions are taken that result in good yields or not, in deviations or not, in surprises – better good than bad. You can only procedurise so far, you need to count on the human side – to do this you need great people. This does not happen by chance, it is not determined by culture, or nationality, or even by education – it is a matter of leadership, of somehow providing everyone in the company with a sense of belonging, making work meaningful.

Nothing gives our work more sense than when we are told what our products do for patients. Yesterday a customer told me he has a desk full of letters from parents of children that suffer from cystic fibriosis. This is a terrible illness, these kids probably never had a good night’s sleep in their life. Peter was telling me that after 3 weeks on the new drug, they sleep – their life is changed. Hovione is part of that effort, this is why we are here.

There are many people that should be mentioned as key in our first 50 years. Whether as customers giving us business and opportunities to make a difference, or as team members developing the solutions and manufacturing the products. The way we will show our appreciation is by focusing on the work ahead, making sure Hovione continues to do a good job.

Thank you
Guy Villax
Chief Executive
Hovione

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International Pharmaceutical Industry journal speaks with Márcio Temtem, VP Strategic Business Management at Hovione, about how the company’s deep-rooted expertise in complex chemistry differentiates it within the CDMO landscape, enables seamless integration from drug substance to drug product, and supports partners in accelerating the development of high-potency APIs, advanced formulations, and next-generation therapeutic modalities. How does your complex chemistry expertise differentiate you from other CDMOs and how does it translate into helping partners accelerate the development of increasingly sophisticated APIs and formulations? Hovione has been associated with complex chemistry since its genesis. The company started by developing very tough chemistry on corticosteroids and antibiotics, which was an expertise that in the 90s we transferred into the contract manufacturing business.  Since then, Hovione has been exploring chemistry and its complexity in contract manufacturing through several angles. One is the ability to have assets across the globe and at different scales that allow the company to address various client needs. Another example of being able to tackle the complexity is having assets that can address molecules with different levels of potency. High potency is something that we offer in many of our facilities. Over the years, we have also tackled chemistries that are difficult to manage, like hydrogenations and cryogenic reactions. All these are part of a menu that we offer into the services. Hovione is always attentive to the client’s needs. The next step after chemistry, which typically tends to be particle engineering, either by means of crystallisation, controlled crystallisation, jet milling, or one of the technologies that we master most, spray drying. We keep attentive to these needs and we keep upgrading our toolbox with new hardware and new software. On the hardware side, we recently announced a partnership with Microinnova to embed continuous flow into our offering. On the software side, we have added micellar chemistry, a water-based approach to chemically synthesise active ingredients, addressing sustainability within the broader pharmaceutical industry. How does your manufacturing approach ensure seamless integration from drug substance to drug product both technically and operationally? Hovione has sites located in Europe, Asia, and North America, designed to offer clients a seamless, integrated approach across our network, not only in terms of processes, but also in terms of technologies. These facilities serve clients globally, although naturally some clients favour the local site. In terms of integration, Hovione offers the synthesis of the active ingredient, the manufacturing of intermediates such as amorphous solid dispersions, and the final drug product all in one site. Many companies claim to offer integrated services, but they do this across multiple sites. Hovione does the integration at one site, which reduces hand-offs, streamlines operations and ensures technical alignment. How do technologies such as spray drying and particle engineering, when combined with your chemistry expertise, enhance formulation performance and streamline scale-up timelines? Spray drying has become one of the most versatile technologies in our industry. It addresses challenges that both chemists and formulators face. Chemists are often concerned with problems such as yield, purity or ways of obtaining the right solid-state characteristics of the API, such as polymorphic form. Spray drying can provide a means of isolating materials that are very difficult to isolate by other methods. Examples of compounds that benefit from this include peptides and sugars. On the formulation side, spray drying addresses one of the biggest challenges in the industry: the poor solubility and consequently bioavailability of most of the new drugs. Seventy to ninety per cent of the new drugs in development are poorly soluble. Over the past 20 years, Hovione has developed a platform for making amorphous solid dispersions by spray drying. This platform allows new formulations to be developed with minimum quantities of API and in a short number of few weeks. The technology provides a seamless scale-up from grams to tons, gives clients line-of-sight to commercial production, and saves valuable API at early stages of development. It also allows integration between drug substance and drug product, linking synthesis, intermediate manufacture, and final product in a single site, which is unique in the industry. As molecules and processes become more complex, so too do supply chains. How does Hovione ensure consistency, quality, and regulatory confidence across global operations? Hovione maintains consistency, quality and regulatory confidence through a combination of global assets, standardised platforms and processes, and cross-functional expertise. Our sites are designed to serve global clients while maintaining local responsiveness. We offer high-potency capabilities and advanced particle engineering to address complex molecular challenges. By standardising technologies and processes across sites, Hovione ensures predictable outcomes and adherence to global regulatory requirements. This integrated approach supports reliable supply chains even as molecules and processes grow more complex. With the rise of HPAPIs, novel excipients, and emerging therapeutic modalities, how is Hovione evolving its chemistry and process capabilities to support the next generation of pharmaceutical innovation? We see a trend towards more complex molecules and increasing demand for high-potency compounds. Hovione continues to invest globally, expanding capabilities in high-potency APIs, novel excipients, emerging modalities, and emerging delivery routes such as inhalation or nasal delivery. Chemistry is used as a tool to enable these delivery routes, including synthesis, crystallisation to achieve the right polymorphic form, shape, and size, and optimisation of interactions with excipients. All this is interconnected with our platforms, and amorphous solid dispersions by spray drying, designed to improve bioavailability, the one with the most market credits. Our capabilities bridge drug substance and drug product development and allow us to serve commercial products of different volumes, from small batches to larger scales, all while handling high potency and complex chemistries.   Read the full article at International-Pharma.com  

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