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Over 60 of the largest companies in Ireland have publicly committed to set targets based on science by 2024. They are the first signatories of Business in the Community Ireland’s new Low Carbon Pledge. Business in the Community Ireland, the national network for sustainability, created the initial Low Carbon Pledge in 2018 with the aim of being a starting point for their member companies to commit to cutting their carbon footprint, report annually on their progress and develop a credible roadmap towards a net-zero economy. The new Low Carbon Pledge now calls on businesses to set science-based carbon emission reduction targets no later than 2024 (i.e. what science says is necessary to limit global warming to 1.5°C). The 61 signatories are: A&L Goodbody, Abbvie, ABP Foods, Accenture, Actavo, AIB, ALDI, Allianz, An Post, Arup, Aviva, Bank of Ireland, Bidvest Noonan, Boots, Britvic, BT Ireland, Cairn Homes, Cisco, Cook Medical, Dawn Meats, Deloitte, DePuy Synthes, Diageo, Dublin Bus, EirGrid, Enterprise-Rent-a-Car, ESB, Fujitsu, Gas Networks Ireland, Grant Thornton, HEINEKEN Ireland, Hovione Ireland, Irish Rail, Irish Distillers, Irish Water, Janssen, Johnson & Johnson Vision Care, KBC Bank, Keelings, KPMG, Lidl, M&S, Momentum Support, Mercury Engineering, Musgrave, Ornua, Permanent TSB, PM Group, PwC, RTÉ, Sky, Sodexo, SSE, Tesco, Three Ireland, Ulster Bank, Verizon, Veolia, Virgin Media Ireland, Vodafone and William Fry. The 61 signatory companies will commit to: Record their entire carbon footprint, both direct (Scope 1 & 2) and indirect (Scope 3) emissions Reduce emissions that they are directly responsible for (Scope 1 & 2), as well as play their part in reducing emissions across their Supply Chain (Scope 3) Report individually through an annual report or website or other publicly available equivalent source and collectively through an Annual Business in the Community Ireland Low Carbon Report As our understanding improves, signatory companies are asked to commit to regularly Reviewing their carbon reduction targets to align to the latest climate science. Minister for Communications, Climate Action & Environment, Eamon Ryan T.D. welcomed the announcement and commented, “As COP26 approaches, we must accelerate our climate response across our economy and society. I commend Business in the Community Ireland on this collective action especially as it brings together companies from different sectors and at different levels of maturity on their decarbonization journey. A low carbon economy is imperative for our post-pandemic recovery as it will support our long-term competitiveness, job creation and social cohesion.” The key strength of the Pledge lies in the collaborative platform which enables signatory companies to learn from each other’s successes and challenges. By working collectively, the Low Carbon Pledge movement builds capacity, fosters innovation and drives the ambition in delivering the changes needed. Tomás Sercovich, CEO, Business in the Community Ireland (BITCI), said, “With yesterday’s publication of the Climate Action Bill which commits Ireland to be a net-zero carbon State by 2050, the role of business in reaching this target is vital. Investors, regulators, consumers, suppliers and employees expect business to lead the net-zero vision we all aspire. Transparency and accountability are fundamental for the change to happen. The Low Carbon Pledge is a clear demonstration of businesses driving towards decarbonization, creating the business models, innovation and jobs for a low carbon future. As more businesses join this Pledge, we will use our collective voice to drive the new systems thinking we need to overcome this fundamental challenge.”    

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And commit to setting science-based carbon emission reduction targets

Ireland: Over 60 companies sign up to BITCI’s new Low Carbon Pledge

Mar 29, 2021

Today, together with over 50 other businesses in Ireland, we have committed to new climate action goals.  As part of Hovione’s commitment to climate action, we are proud to have signed up to the new Business in the Community Ireland Low Carbon Pledge. And we commit to set our carbon emissions reduction targets based on science by 2024 across our entire business and supply chain. The Low Carbon Pledge is the first dedicated pledge generated by Irish businesses to set industry standards on sustainability and reduce carbon emissions. Originally launched in 2018, the Pledge has now evolved and calls on all Irish businesses to work towards setting science-based emission reduction targets by 2024. This is a landmark day for Hovione Cork as we continue to work towards low carbon operations and commit to new climate action goals.   Find more about Sustainability at Hovione      

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Business Action on climate

The Low Carbon Pledge

Mar 24, 2021

  Dear representatives of the Commission, Dear Ministers, Ladies and Gentlemen, Good-Morning It is a privilege for me to address you.   Dear Pedro thank you for giving me this opportunity.   I have been fortunate to have a front row seat watching the Pharmaceutical Industry since I was born, that was 60 years ago. Hovione was founded by my father, a Hungarian refugee, in the basement of our home in Lisbon. Often as children we could not go into the garden because a bromination was going on a l’air libre for safety reasons! My first job in the family business, aged 24, was selling active ingredients made in Portugal to Indian firms in Bombay, Madras, Delhi and Goa.   I will start by telling you about the successes of our industry and end with our failures as these are the ones we need to collectively tackle.   10 years after the HIV virus was discovered in Paris and Washington, American companies invented the protease inhibitors that would treat this horrible disease. But who made these complex molecules industrially possible then were exclusively European companies.   In the last decade several cures for Hepatitis C were discovered. Over 4 million patients have been cured and ¾ of those with pills made with a Hovione process with product that came out of our plants in Portugal and Ireland.   It is also important to acknowledge the complexity of the manufacturing processes and the extreme specialization that each step requires. Remdesivir, one of 3 approved therapies for Covid-19 needs factories in two continents just to make the active ingredient, but it won’t work without an enabling excipient called Captisol® that Hovione makes exclusively. To face the pandemic’s tremendous demand we are now making per month what we usually made per year.   Europe has 600+ plants that have the science, the technology, the know-how and the capacity to be the workhorse of innovative medicines for global supply. For most of us it has been some time that we have stopped focusing on serving the generics industry of our home market, Europe. Hovione has not supplied one kilo of a generic API to Germany for 15 years because one cent of difference means the Indian product is preferred. Had we not exported to the USA and served innovators and generics there we would be bankrupt, or weak and unable to invest in R&D and new technology.   The beauty of the pharma ecosystem is that the very high prices of patented products pay for the R&D and the risk, but as soon as the patents expire the best science can be had for a few cents per pill. Innovative drugs, under patent, and the large multinationals are today a minority volume player – over 80% of prescriptions are filled by generics.   Today the EU is not in control of its generic medicines – we face frequent shortages and a geostrategic fundamental dependence for APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.    We have ended up in this untenable situation due to 1) the unbridled market forces of globalization and 2) 30 years of EU regulations that failed to consider that pharma is an intensely globalized and highly competitive industry.   Europe was once the cradle of pharmaceuticals. In the 50s any American that wanted to study chemistry had to learn to speak German as all good text books were written in German. We have faced a 30 year decline – today in the top 10 largest generic firms in the world only 1 is European.     As an industry we survived by moving away from intermediates and generic APIs – including the essential ones – and focusing on high value innovative products. The world is competitive and if the climate in Europe in unfavorable to certain segments, factories move – it is that simple.   Nobody saw the unfolding of this radical structural transformation. Nobody heard Industry’s calls for levelling the playing field.     In 2004 the EU API industry founded EFCG, the European Fine Chemicals Group, a member of CEFIC, to level the playing field, this need remains.    In my first trip to Brussels to flag the growing risk to patients and the lack of level playing field, in 2005, I was met with bemusement, étonnement and some sarcasm. In 2007 I testified at a hearing of a sub-committee of the US congress in connection with the risks to patient from imported APIs. I went public and frequently said and wrote that EU Regulators inspected on proximity not risk. The contaminated heparin tragedy that killed over 150 patients occurred in 2008. By 2011 our advocacy work resulted in the Falsified Medicines Directive, too little, too late.    Today price pressure has driven the European Generics supply chain to, in 74% of cases, buy from low-cost countries. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental damage and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – the EU industry cannot compete with such low standard, low cost operations.    In summary in the last 30 years a large part of the EU API and intermediates industry disappeared to the benefit of its competitors. Certain key technologies (eg fermentation, nitration, halogenation) almost disappeared from Europe. This represents a damaging loss of critical mass, as these technologies act as platforms that allow the production of many different APIs.  Fermentation is key to making many antibiotics. Without fermentation Europe is now totally vulnerable and dependent on supplies from Asia/China.   To reduce this dependence and to ensure the resilience of the medicines supply chains on the long term, the only solution is to rely on the robust, reliable, competitive and sustainable manufacturing capabilities we still have in Europe.   So what are Industry’s proposals in this regard?   First, we must support the existing European manufacturers of APIs and intermediates in the on-shoring of technologies that will guarantee the supply of the essential medicines. Dual sourcing of the essential medicines must be a cornerstone of our policies.   Second, level the playing field with other world regions to ensure that import and purchase requires not only verified compliance with GMPs, but also demands process safety, respect for the environment and an absolutely reliable supply chain. Linking the purchase of critical supplies to the sole criteria of price cannot be a sustainable supply strategy.   Third, we need a long-term EU industrial policy that can accelerate sustainable Research, Development and industrialization of innovative and green technologies, as well as manufacturing capacities within the EU territory.   Fourth, regulatory centralization, transparency and flexibility. EMA must be given more clout. We need a central record of EU shortages.  EMA must know the complete supply chain mapping of each medicine, so it can act. EMA should turn into a compliance matter the good example of the Swedish regulator that considers environmental aspects when granting permits and approving products and APIs.   We are optimistic that this straightforward strategy will be successful to eliminate not only existing drug shortages but more importantly avoid future risks of shortages.     Europe can rely on its the 600+ existing manufacturing sites, on its strong innovation capacity, its highly-trained workforce to reverse the trend and build back a robust pharmaceutical industry in Europe.   Industry is involved in the Commission’s EU Pharma Strategy Structured Dialogue. We are looking forward to working with the Commission to implement, as quickly as possible, the appropriate structural, pragmatic and efficient measures to support our industry.    However as we embark to build the future and drive a Renaissance of the European API and generic industry it is imperative that we first look into the past and understand what got us into this situation of dependence and weakness.    The US and Japan have already launched countermeasures, we must work with our allies and not independently.   An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field.   European citizens deserve medicines that are Affordable, Accessible and most importantly Available.    Dear Commission representatives, you can count on me and on our industry associations to fill in the blanks, spend time analyzing the situation and design a solution for the future.   Thank you for your attention.   Guy Villax CEO, Hovione Lisbon, 22nd March 2021 PDF version       Find more about this virtual event at 2021portugal.eu    

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EU Presidency: COMPET - Internal Market and Industry

Guy Villax speech to the Informal Meeting of Ministers Responsible for Competitiveness

Mar 22, 2021

Cork, Ireland, 17 March 2021 – Hovione announced at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase the successful completion of its Phase 2 clinical trial in 270 patients with Dry Eye caused by Meibomian Gland Dysfunction (MGD). The well controlled and representative study was conducted across 26 clinical sites in the United States and tested 2 different strengths of minocycline against vehicle in a 1:1:1 randomization. This is the first dry eye therapy targeting MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic and the first and only ophthalmic formulation of minocycline in clinical development, contingently named Meizuvo®. The study observed superior clinical outcome in the 70% of patients with positive inflammatory biomarker at baseline, who achieved statistically significant (p=0.02) improvement of 25 points in the Visual Analogue Scale (VAS) discomfort after 2 weeks of treatment, dropping further to 35 points by the end of treatment (an improvement greater than 50%). The sign endpoint inferior Cornea Fluorescein Staining, which is a measure of corneal damage in dry eye, had a statistically significant improvement against vehicle in both active arms at day 57 (p=0.009). The product was safe and well tolerated with less than 3% of subjects reporting blurring vision or eye irritation. Carla Vozone, Vice President of the innovative proprietary portfolio at Hovione commented: “The correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking”. Ms. Vozone explained that investigational Meizuvo® not only has the potential of adding a much needed treatment specific for assay recognized inflammation, but could also reduce the risk of failure in the pivotal studies by inclusion of the patient sub-set most responsive to the drug. OIS panelists, who shared their Clinical Perspectives, consensually identified chronic inflammation as the underlying cause of Dry Eye Disease highlighting the relevance of diagnostics to recognize such inflammation. George Magrath, M.D., CEO of Lexitas Pharma Services stated “We were thrilled with the opportunity to work on this exciting project.  Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative. The results in the overall population were encouraging in both signs and symptoms.  The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.”   About Minocycline Ophthalmic Meizuvo® (contingent brand name), is the first minocycline repurposed for ophthalmic administration, targeting a novel indication for inflamed MGD. It is a preservative-free formulation enabled by Hovione’s proprietary minocycline base which is stabilized as a microparticle in a novel vehicle. The highly tolerable formulation maximizes bioavailability, efficacy and reduces systemic effects. Tetracyclines have been known to treat MGD through anti-inflammatory activity and inhibition of matrix metalloproteinases (MMPs). Minocycline is of particular interest due to its lipophilic nature and resultant affinity to the meibomian gland. Previous research also suggests lipase inhibition effect, which decreases meibomian gland lipid degradation and consequently avoids the release of fatty acids, a synergistic mechanism of downregulating the inflammatory process. As such, minocycline has the potential to address several of the mechanisms that lead to the chronic nature of MGD.   About Inflamed Meibomian Gland Dysfunction MGD is a highly prevalent, chronic condition in the eyelid glands which alters the lipid composition of the tears and triggers evaporation-induced tear hyperosmolarity. Evaporative Dry Eye, which affects 27 million people in the USA, constitutes approximately 80% of all Dry Eye Disease and is largely caused by MGD. The pathophysiological changes of the meibomian gland and tear film instability trigger an inflammatory cascade which results in increased matrix metalloproteinase (MMP-9). Left untreated, the MMP-9 activity in the tear will disrupt the corneal epithelial barrier and induce damage of the ocular surface causing ocular irritation and visual morbidity in dry eye patients. Hovione’s presentation made by Courtney Smith, Director of Business Development & Licensing is accessible here     About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.    

Press Release
Showing promise in Dry Eye Disease associated with Inflamed Meibomian Gland Dysfunction

Hovione completes its Phase 2 clinical trial of the first minocycline ophthalmic

Mar 17, 2021

This March is B Corp month – a whole month dedicated to celebrating businesses who are doing things differently and driving change and raising awareness in a globally coordinated social media effort to celebrate B Corps. In 2017, we became a Certified B Corp. Being the first Chemical/ Pharmaceutical Company integrating an innovative community of companies that use the power of business to solve social and environmental problems. Being a B Corporation means that to ensure our long‑term viability we will contribute positively to economic, environmental, and social sustainability. As a Certified B CorporationTM we want to contribute to redefine success in business, meeting the highest standards of social and environmental performance, setting our Team Members for success and personal satisfaction, and aspiring to use the power of markets to solve social and environmental problems. Collectively, B Corps lead a growing global movement of people using business as a force for goodTM. We are proud to be a B Corporation.                 Learn more about Hovione being a B Corporation      

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We are proud to be a B Corporation.

It's B Corp Month

Mar 10, 2021

This year’s theme for International Women’s Day is #ChooseToChallenge to celebrate the achievements of women around the world. Today Hovione women also #ChooseToChallenge. From Portugal to the USA, Ireland, Macau and India, we celebrate our team’s achievements. Thank you to Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso and Tânia Dias for raising their hands high.  From challenge comes change. Read their statements here.   O tema deste ano do Dia Internacional da Mulher é #ChooseToChallenge - Escolher Desafiar - para celebrar as conquistas das mulheres em todo o mundo. As mulheres Hovione também aderiram à campanha #ChooseToChallenge. De Portugal aos EUA, Irlanda, Macau e Índia, celebramos as conquistas da nossa equipa.   Obrigada Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso e Tânia Dias por levantarem as vossas mãos. Do desafio vem a mudança. Leia os seus testemunhos aqui.     My name is Kristen and I’m a HR Business Partner at Hovione USA. My journey at Hovione has been one of my proudest professional achievements. I started June of 2017 in the capacity of a split role, supporting HR initiatives while maintaining office management. I have since been promoted twice and currently hold the role of HR Business Partner. Hovione provides the necessary tools and opportunities for TM’s to have a fulfilling and challenging career. O meu nome é Kristen e sou HR Business Partner na Hovione EUA. O meu trajeto na Hovione é uma das conquistas profissionais de que mais me orgulho. Comecei em junho de 2017 a apoiar iniciativas de RH enquanto mantinha a gestão do escritório. Desde então, fui promovida duas vezes e atualmente exerço a função de HR Business Partner. A Hovione fornece as ferramentas e oportunidades necessárias para que as Colaboradoras tenham uma carreira gratificante e desafiadora. Kristen Parisi - HR Business Partner Hovione USA     My name is Madhu and I’m a Director at Hovione India office. I believe in a world where everyone – regardless of their age, gender, religion, disability, sexual orientation, or ethnicity - is provided with equal opportunities and I share this belief with Hovione. To all my colleagues around the world I raise my hand: by working at Hovione we have committed ourselves to save lives and improve the quality of life of millions of patients. There is no limit to what we can do together. Be proud. Be happy! O meu nome é Madhu e sou diretora do escritório da Hovione Índia. Acredito num mundo onde todos - independentemente da sua idade, sexo, religião, incapacidade, orientação sexual ou etnia - tenham oportunidades iguais e partilho esta convicção com a Hovione. A todas as minhas colegas em todo o mundo, levanto a minha mão: ao trabalhar na Hovione, comprometemo-nos a salvar vidas e a melhorar a qualidade de vida de milhões de pacientes. Não há limite para o que podemos fazer em conjunto. Tenham orgulho. Sejam felizes! Madhu Gautam - Director of Hovione India Hovione India     My name is Camie Lou and I’m the Administrative Manager at Hovione Macau. I am proud to be part of a workplace where everyone is welcomed and so many women have the opportunity to achieve their full potential. I am challenged every day to perform my best and to all my colleagues around the world, I raise my hand: celebrate daily your personal and professional achievements. Let’s celebrate this day together! O meu nome é Camie e sou Administrative Manager na Hovione Macau. Tenho orgulho de fazer parte de uma empresa onde todos são bem-vindos e onde muitas mulheres têm a oportunidade de atingir todo o seu potencial. Sou desafiada todos os dias a dar o meu melhor e para todas as minhas colegas em qualquer parte do mundo levanto a mão: comemorem diariamente as vossas conquistas pessoais e profissionais. Vamos comemorar este dia juntas! Camie Lou - Administrative Manager Hovione Macau     At Hovione Eireann, we are very proud of our diverse and inclusive culture and love to find ways to celebrate it. One aspect of our diversity is our gender balance across our teams and at all levels of the organization and therefore we have again decided to plan an event to celebrate the annual ‘International Women's Day’ on Monday March 8th. We will host a virtual art class, during which we will design a card to send to a woman who inspires us. In keeping with this year’s theme, #choosetochallenge, we are challenging ourselves to try something new and creative, keeping in mind the importance of ensuring everyone on our teams has a voice. This year our event is in aid of Cuanlee, a women's refuge in Cork city which has seen a big increase in calls for help this year due to the lockdowns over the past 12 months. We hope our contribution towards them helps in some way with the challenges they face every day. Na Hovione Irlanda, temos muito orgulho da nossa cultura diversificada e inclusiva e adoramos encontrar formas de a celebrar. Um aspeto da nossa diversidade é o equilíbrio de género nas nossas equipas e em todos os níveis da organização e, por isso, decidimos novamente planear um evento para celebrar o ‘Dia Internacional da Mulher’ na segunda-feira, 8 de março. Faremos uma aula de arte virtual, durante a qual desenharemos um cartão para enviar a uma mulher que nos inspire. De acordo com o tema deste ano, #choosetochallenge, estamos a desafiar-nos para tentar algo novo e criativo, tendo em mente a importância de garantir que todos nas nossas equipas têm uma voz. Este ano, o nosso evento irá apoiar a Cuanlee, um refúgio feminino na cidade de Cork, que teve um grande aumento no número de pedidos de ajuda devido aos confinamentos dos últimos 12 meses. Esperamos que a nossa contribuição as possa ajudar a enfrentar os desafios de todos os dias. Mary Hennessy - Director of Human Resources Ireland Louise Dennehy - HR Business Partner, Linda Cullinane - Supply Chain Director, Sarah Downing - QA Director, Sarah Scott - Product Quality Manager Hovione Ireland     My name is Tânia and I’m an Events Coordinator at Hovione Portugal. In my professional career, I have always achieved my goals, always keeping an attitude based of humility, integrity, and an open mind! Joining Hovione was one of those goals, and it has brought me new experiences, both professionally and personally. O meu nome é Tânia e sou Events Coordinator na Hovione Portugal. No meu percurso profissional, tenho lutado sempre para concretizar as metas a que me proponho, seguindo sempre a minha visão pessoal de humildade, integridade e otimismo! A entrada na Hovione foi uma dessas metas, que me tem trazido novas experiências quer a nível profissional como pessoal. Tânia Dias - Events Coordinator Hovione Portugal     My name is Mafalda and I am a proud scientist at Hovione R&D Portugal. My journey here began six years ago, as an analytical chemist, and evolved to management positions, all within R&D. I am passionate about science, business and people! I truly believe that we can all achieve our goals and pursue our passions, if we truly work for it, independent of gender, race, sexual orientation or religion. The sky is, indeed, the limit! O meu nome é Mafalda e sou uma orgulhosa cientista na Hovione Portugal. A minha viagem começou aqui há seis anos, como analytical chemist, e evoluiu para cargos de gestão, tudo dentro da área de R&D. Sou apaixonada pela ciência, negócios e pessoas! Acredito verdadeiramente que todos podemos alcançar os nossos objetivos e seguir as nossas paixões, se realmente trabalharmos para isso, independentemente do género, raça, orientação sexual ou religião. O céu é, de facto, o limite! Mafalda Paiva - Group Leader, R&D Analytical Development Hovione Portugal     My name is Marilena and I’m an Operational Excellence Engineer at Hovione Portugal. I always thought that to practice cross fit you had to be very strong and a bit crazy. Guess what, I am one of the crazy ones, and all I needed was to step out of my comfort zone, to practice a lot and never give up. O meu nome é Marilena e sou Operational Excellence Engineer na Hovione Portugal. Sempre achei que para praticar cross fit era necessário ser uma pessoa muito forte e louca. Adivinhem, eu sou uma das loucas, e tudo o que eu precisava era sair da minha zona de conforto, praticar muito e nunca desistir. Marilena Ornelas - Operational Excellence Engineer Hovione Portugal     My name is Beatriz and I’m a scientist at Hovione Portugal. From a small town to the capital, from engineering to pharmaceutical development, I feel a sense of accomplishment knowing my everyday small tasks help to save lives. I was lucky to be born in a place where I had all the opportunities available for me, however this is still not the case for so many women all around the world. I will continue to speak up for them.  O meu nome é Beatriz e sou cientista na Hovione Portugal. De uma pequena cidade à capital, da engenharia ao desenvolvimento farmacêutico, sinto-me realizada por saber que as minhas pequenas tarefas diárias ajudam a salvar vidas. Tive a sorte de nascer com todas as oportunidades à minha espera, mas esse ainda não é o caso de muitas mulheres em todo o mundo. Por elas, continuarei a falar. Beatriz Noriega Fernandes - Scientist, R&D DPD Inhalation Hovione Portugal     My name is Sónia and I work at RDP Analytical Sciences at Hovione Portugal. I feel glad to be able to enjoy a fulfilled life by combining the things that I love most: family, science and helping others. O meu nome é Sónia e trabalho na área de RDP Analytical Sciences na Hovione Portugal. Estou feliz por ter uma vida plena ao combinar as coisas que mais amo: família, ciência e ajudar os outros. Sónia Cardoso - RDP Analytical Sciences Hovione Portugal     My name is Marianna and I'm a Scientist at Hovione Portugal. Study hard. Play the cello. Move abroad. Run a half marathon. Explore different cultures. Work hard. Do a headstand. Innovate. Have fun. Change lives. Love. Choose to challenge. The sky is the limit. Women are versatile, support and acknowledge them! O meu nome é Marianna e sou cientista na Hovione Portugal. Estuda muito. Toca violoncelo. Muda de país. Corre uma meia maratona. Explora diferentes culturas. Trabalha no duro. Pratica headstand. Inova. Diverte-te. Muda vidas. Ama. Escolhe desafiar. O céu é o limite. As mulheres são versáteis, vamos apoiá-las e reconhecê-las! Marianna Katz - Scientist – R&D Products Hovione Portugal              

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Choose To Challenge

2021 International Women's Day - Read statements

Mar 08, 2021

Guy Villax spoke for the EU API industry at the EU Pharma Strategy Structured Dialogue that the EU Commission launched today. He said: EFCG members make Active Pharmaceutical Ingredients, the core of medicines. The EU has not been in control over its generic medicines for some time – we face frequent shortages and a geostrategic fundamental dependence on APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.   We have ended up in this untenable situation due to i) unbridled market forces and globalization and ii) 30 years of EU regulations that did not consider that pharma is an intensely globalized and highly competitive industry.  Europe was once the cradle of pharmaceuticals. Today price pressure has driven the generics supply chain to prefer to buy 74% of APIs and precursors from low cost countries with limited regulation. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – EU industry cannot compete with such low cost operations.   EFCG was founded to level the playing field, this need remains. An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field. The US and Japan have already launched countermeasures, we must work with our allies and not independently. European citizens deserve medicines that are Affordable, Accessible and most importantly Available. EFCG knows the issues well and is ready to help, count on us in this partnership. Pierre Luzeau will next list the needed solutions.     The meeting gathered representatives of pharma industry (generics and innovators), patients, hospital pharmacists as well as addressed Minister Marta Temido, MEPs Dolors Montserrat and Nathalie Colin–Oesterlé, Commissaires Kyriakides and Breton, Vice President Schinas.    About the Structured dialogue on Security of Medicines Supply   About EFCG    

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Today, at the EU Pharma Strategy Structured Dialogue

Guy Villax spoke for the EU API industry

Feb 26, 2021

    好利安藥廠火警疏散演習 Fire and evacuation simulator at the pharmaceutical factory “Hovione”   Firefighters fought the fire by the storage tank. The Fire Brigade (CB) held on the morning of February 24th this year, a fire and evacuation simulator with dangerous chemical substances in the pharmaceutical factory “Hovione” together with Hovione FarmaCiencia SA, with the intention of intensifying the measures contingency and the coordination and communication mechanism between both parties in case of incidents. The exercise simulated that a worker discovered that the leak occurred at the connection point of the methanol solution storage tank, thus causing a fire. The employee immediately sounded the fire alarm, the pharmaceutical factory's emergency and contingency team immediately proceeded to the internal contingency action, called the CB to ask for assistance and adopted security measures to evacuate the employees to the evacuation and meeting place. During the evacuation period, there was 1 worker who was injured. After becoming aware of the occurrence of a fire at the pharmaceutical factory “Hovione”, the CB immediately dispatched 9 emergency vehicles and 38 firefighters to the site to fight the fire, carry out the evacuation and search according to the defined plan, as well as provide nursing care for the injured and simulate transport to the hospital. The simulation lasted almost 1 hour. CB and the pharmaceutical factory “Hovione” sent around 160 people to participate in the simulation, whose main purpose is to test the responsiveness and the communication mechanism between the relevant parties in case of incidents. The respective process went well, after the simulation, both parties held a review meeting, whose objectives and expected results were achieved. [Translated from the original]       好利安藥廠火警疏散演習 為加強與好利安藥廠在發生事故時的應變措施及協調溝通機制，消防局於本年2月24日上午，與好利安製藥科學股份有限公司在氹仔好利安藥廠聯合舉行化學危險品火警及疏散演習。 演習模擬工作人員發現一個含有甲醇溶液的儲存缸接駁口出現洩漏並發生火警，工作人員隨即按動火警警報，藥廠緊急應變隊伍即時啟動內部應變計劃，同時致電消防局求助，以及採取安全措施疏散員工到逃生集合點，於疏散期間有一名員工不慎受傷。消防局接報好利安藥廠發生火警後，立即派遣9架緊急車輛及38名隊員趕赴現場，按照既定計劃進行滅火及疏散搜救行動，並對傷者進行即時護理及模擬送院，演習過程歷時約1小時。 消防局和好利安藥廠合共派出近160名人員參與是次演習，主要目的是測試發生事故時雙方的應變能力及溝通機制，演習過程順利，事後雙方進行檢討會議，並達到預期目的及效果。     Simulacro de incêndio e evacuação na fábrica farmacêutica “Hovione” Os bombeiros combateram o fogo junto do tanque de armazenamento. O Corpo de Bombeiros (CB) realizou na manhã do dia 24 de Fevereiro do corrente ano, um simulacro de incêndio e evacuação com substâncias químicas perigosas na fábrica farmacêutica “Hovione” em conjunto com a Hovione FarmaCiencia SA, com o intuito de intensificar as medidas de contingência e o mecanismo de coordenação e comunicação entre ambas as partes em caso de incidentes. O exercício simulou que havia trabalhador que descobriu que ocorreu a fuga no ponto de ligação do tanque de armazenamento da solução de metanol, acontecendo assim um incêndio. O empregado tocou imediatamente o alarme de incêndio, a equipa de emergência e contingência da fábrica farmacêutica procedeu logo à acção de contingência interna, ligou ao CB para pedir auxílio e adoptou as medidas de segurança para evacuar os funcionários para o local de evacuação e encontro. Durante o período de evacuação, havia 1 trabalhador que ficou ferido. Depois de ter tido conhecimento da ocorrência de incêndio na fábrica farmacêutica “Hovione”, o CB enviou de imediato 9 veículos de emergência e 38 bombeiros ao local para combater o fogo, executar a acção de evacuação e busca conforme o plano definido, bem como prestar os cuidados de enfermagem junto do ferido e simular o transporte para o hospital. O simulacro durou quase 1 hora. O CB e a fábrica farmacêutica “Hovione” enviaram cerca de 160 pessoas para participar no simulacro, cuja finalidade principal é testar a capacidade de resposta e o mecanismo de comunicação entre as partes pertinentes em caso de incidentes. O respectivo processo correu bem, depois do simulacro, ambas as partes procederam a uma reunião de revisão, cujos objectivos e resultados esperados foram alcançados.   Read the article at News.Gov.MO        

Press Clipping
News.Gov.MO, February 25, 2021

Fire and evacuation drill at the pharmaceutical plant “Hovione”

Feb 25, 2021

  3 FEBRUARY 2021 - Belem Cultural Centre - CCB, LISBON - (online event)   The Case for Sustainable Accounting Standards When the planet faces big issues, scientists are the first to flag them, the first to understand them, the first to design solutions – sadly science is seldom at the table when business decisions are taken. When the issues are simple, such as the ozone hole above Antarctica, scientists can get decision-makers to understand and act and we have Science to thank for the Montreal protocol: 20 years elapsed from discovery to inverting the trend – this speed is possible when the problem is simple: a single chemical reaction -ozone and chlorine- and a single culprit – man-made CFC gases. Climate change is very complex, there are multiple causes, the magnitude of change needed is massive and therefore cannot be solved without a transversal approach. Scientists are not able to influence decision-making because they do not speak the language of business. Companies, CEOs, asset managers, shareholders, funds march to the tune of profitability, their language is that of financial performance – today’s accounting standards ignore externalities and measure business profit not accounting for the good and the bad impacts of business on society and on the environment. Sustainable accounting standards that measure profitability adjusted for social and environmental impact is the necessary new common language if we are to ensure scientists, business and other stakeholders understand each-other. If we do not measure, we cannot manage. CFOs don’t know what is a mole of a newton, as much as most people in this room might not know what is EBITDA or an impairment. We must measure unambiguously the true and complete value of business. This measure of value added corrected for sustainability can connect to a measure of sustainable GDP of a city or of a country, which in turn can connect with the value of the world's ecosystem services and natural capital. Tracking this performance over time will allow to assess the trajectory of the health of our planet. Sustainable accounting standards will drive business to hire new skills. Finance and controlling areas will recruit scientists, engineers, anthropologists, sociologists... Over time the Chief Financial Officer will see its role evolving to that of a Chief Value Officer. If business adopts sustainable accounting standards, executives and shareholders will know the complete extent of their impact and the liabilities they face from exposure to climate change. No one can then plead ignorance. Taxation can take into account social benefits and environmental costs thereby driving desired behaviors. No amount of Science Based targets and Mission Oriented R&D projects can ever come close to the impact on Climate Change that Business harnessed by the right accounting standards can deliver by doing its day-to-day work in a manner that considers the people and the planet. Sustainable accounting standards will allow the market forces to drive decisions in the right direction. Putting a man on the moon by the decade’s end, may be more inspiring than making every company in the EU to comply with Sustainable Accounting Standards. This may come across as a small step for the EU Commission to take, but it would be a giant leap for the planet. How could Horizon Europe spur the innovations necessary not only to embrace sustainable accounting practices, but also make it possible for economic, business and investment actors to evolve the underlying logic of market capitalism to value natural, social and human capital on par with financial? Could the EU lead the world in this evolution during next 10 years?”   Guy Villax Lisbon, 3rd February 2021 PDF version       Find more about this virtual event at 2021portugal.eu  

News
EU Presidency: Informal Meeting of Ministers Responsible for Research

The Case for Sustainable Accounting Standards

Feb 03, 2021

  Lisbon, Portugal, 12th January 2021 – Hovione, the leader in Pharmaceutical Spray Drying, today announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions. This platform is the most advanced and most accurate tool to identify optimal and commercially viable Amorphous Solid Dispersions formulation by Spray Drying (ASDs). During drug development, it is crucial to quickly find the optimal formulation assuring fast progress to clinical supplies and minimal formulation changes till commercialization.   ASD-HIPROS, the Hovione Intelligent PROprietary Screening methodology, is able to rapidly screen for the best combination of polymers, drug loads, surfactants and solvents by using an advanced computational tool followed by producing scale-independent representative samples of the most promising formulations, which are evaluated for performance and stability.   “ASD-HIPROS is a multiple-step screening service that was perfected in the last 15 years and is able to provide an accurate assessment of Spray Dried Dispersion, in less than 2 months and requiring as little as 5-g of API.” commented Dr. Filipe Gaspar, Hovione’s Chief Technology Officer. “Our accumulated experience and expertise in Spray Drying were used for the development of this platform. It offers a rational formulation definition using a combination of in silico computational modelling and high throughput formulation testing, maximizing the chances of identifying a winning formulation based on outputs obtained from Spray Drying prototypes”.   “We offer a seamless experience, for our customers, and a secure path for their drugs to clinical supplies and commercialization, thanks to our unmatched experience, know-how and manufacturing capacity.” stated Dr. Jean-Luc Herbeaux, Hovione’s Chief Operating Officer.     About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.     Contact Isabel Pina | Director External Communications ipina@hovione.com |Tel.: 0035121 982 9362    

Press Release
The Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation

Hovione Launches ASD-HIPROS

Jan 12, 2021

As the European Commission prepares a new pharmaceutical strategy, manufacturers seek financial support and technology investment by Rick Mullin NOVEMBER 27, 2020 | APPEARED IN VOLUME 98, ISSUE 46   When the COVID-19 pandemic exposed weaknesses in the pharmaceutical supply chain in the US—in particular its dependence on products outsourced to Asia—the government responded forcefully. The Trump administration led with an initial grant of $354 million, with a possible $458 million to follow, for a newly formed company, Phlow, dedicated to manufacturing critical active pharmaceutical ingredients (APIs) domestically. Next came a letter of intent for a $765 million loan to Eastman Kodak to convert a specialty chemical plant at the company’s headquarters in Rochester, New York, into an API manufacturing complex dedicated to “reshoring” pharmaceutical chemicals from China and India. Now it’s Europe’s turn. The European Commission (EC) has been studying the global supply chain, setting itself a year-end deadline for delivering a drug and health-care strategy. Proposed road maps solicited by the EC from manufacturers of APIs and finished drugs illustrate differences between the US approach and Europe’s possible path to self-sufficiency in pharmaceutical manufacturing. In a meeting in April with the European Union conference of presidents, the EU’s health and food safety commissioner, Stella Kyriakides, raised the matter of supply chain vulnerabilities exposed by the COVID-19 pandemic. Kyriakides cited “structural weaknesses in the EU’s medicines supply chain and a high dependence on non-EU countries for active pharmaceutical ingredients” and recommended that supply chain issues be addressed in an EU strategy. The EC solicited public comment on the proposed strategy in June. Judging from the recommendations put forward by European associations representing drug and pharmaceutical chemical firms, the commission’s approach will differ significantly from the tack taken by the outgoing Trump administration. Rather than spending millions of euros launching made-in-Europe ventures, the EC will likely leverage a sizable established manufacturing base. Likewise, industry guidance for Europe’s plan places greater emphasis on making its supply chain more secure rather than less global, while maintaining and expanding the region’s manufacturing footprint. Adrian van den Hoven, general director of Medicines for Europe, an association of generic-drug and API makers, stresses that reshoring cannot be viewed as simply resuming the manufacture of products that have been outsourced to China and India. “It’s a question of making it sustainable to invest and continue to invest in Europe,” van den Hoven says. “We still have a pretty robust industrial footprint in Europe, with a lot of capabilities.” But growth has flattened in recent years, he adds, as manufacturers in countries like India have taken market share.     Medicines for Europe’s proposals to the EC include a change to generic-drug pricing, which individual countries currently set at the lowest possible levels to reduce the cost of subsidized health care. The association proposes a scheme that would allow prices to be negotiated from the bottom up based on a supplier’s cost of goods, regulatory costs, and other considerations. For hospital and retail purchases, van der Hoven says Medicines for Europe favors “multi-winner tenders,” in which buyers are required to purchase from several suppliers as opposed to awarding contracts to the lowest bidder, a practice that has fueled consolidation among drug suppliers. The group also advocates government support for technology development. Van den Hoven points to Europe’s almost $900 billion COVID-19 recovery package, “The commission has made it clear that some of the funding will be available for technology investment by our sector,” he says. Medicines for Europe also advocates global coordination of drug supply as opposed to rampant reshoring. “It is important that we maintain critical technologies in Europe,” van den Hoven says. “That said, we don’t believe we can or should produce everything in Europe.” That view is seconded by Luis Gomes, senior vice president of operations at the Portuguese API firm Hovione. He’s also chairman of the Pharmaceutical Activities Committee of the European Fine Chemicals Group (EFCG), an industry association. “I think the commission has an understanding that it needs to strengthen the production of pharma products in Europe in order to reduce the dependence and vulnerability of the supply chain,” Gomes says. “I think regulators need a kind of road map to pursue what I would call meaningful pharmaceutical production reshoring in Europe. That starts with priorities.” The EC must arrive at a list of critical APIs that need to be manufactured in Europe, Gomes says. Those no longer made in Europe can be reintroduced, thus increasing the domestic manufacturing base. “And it’s not only APIs one cares about,” he says. “You are also dependent on supply of intermediates and building blocks. You need to look at the supply chain from an end-to-end perspective.” Pharmaceutical chemistry presents a significant hurdle given that many of the reactions involved have disappeared from Europe in the wake of the region’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation and other environmental tightening over the past 2 decades. For example, REACH required expensive environmental controls on reactions such as nitration, fluorination, and bromination, which are critical to making certain drug ingredients. “I think REACH created an incentive for production of these chemicals to move to other places, especially Asia, but that doesn’t mean they cannot be manufactured again in Europe,” Gomes says. Like Medicines for Europe, EFCG sees a need for the government to invest in green technology. Financial support will also be needed to establish European production of critical drugs and drug ingredients now made exclusively overseas. Maggie Saykali, director of resins and fine chemicals at the European Chemical Industry Council (Cefic), says in an email that her trade association also has been in discussions with the EC regarding vulnerabilities in the pharmaceutical supply chain. Cefic is preparing a report with recommendations at the commission’s request. “One of the pillars of our roadmap is selective reshoring of the critical technologies needed for the molecules for which long-term supplies must be guaranteed,” Saykali writes. “In order to be sustainable in the long run, this selective reshoring needs support for process innovation, expansion of existing EU production facilities and enforcement of a level playing field for the highest-quality safety, environmental, and social standards.” Sources agree that continuous manufacturing technology will play a role in developing efficient and green manufacturing. They also agree that the Research Center of Pharmaceutical Engineering’s Center for Continuous Flow Synthesis and Processing (CC Flow) initiative at Graz University is the center of continuous technology development in Europe. C. Oliver Kappe, scientific director of CC Flow, says that his lab is not communicating directly with the EC on the development of a reshoring strategy but that several of its partners are contract manufacturers and members of associations such as EFCG. Kappe says the lab plans to set up a facility near Graz, Austria, that will pilot the manufacture of both APIs and finished drugs in a fully continuous fashion. Continuous manufacturing could help avert crises such as drug shortages during pandemics in Europe, Kappe argues. He notes that CC Flow has worked on a process for manufacturing remdesivir, a COVID-19 treatment developed by Gilead Sciences. It also has collaborated with a similar center in the US, the Medicines for All Institute at Virginia Commonwealth University. Medicines for All is a partner in Phlow, the company launched by the Trump administration to repatriate generic drugs. While Europe has taken a few pages from the US response to the COVID-19 pandemic—the EU recently announced it would create a biomedical research agency comparable to the Biomedical Advanced Research and Development Authority, the US government agency that launched Phlow—the European path will inevitably differ. Observers note that Brussels is coordinating 27 independent countries’ efforts, ensuring a more protracted process than experienced in Washington. One EU country has floated a Phlow-like venture with a view toward securing domestic supply of acetaminophen. The government of France is sponsoring a partnership with the French drug firms Sanofi and Upsa and the French API maker Seqens to establish domestic supply of the analgesic, which currently comes mostly from China. Seqens manufactures bulk acetaminophen there. Upsa and Sanofi manufacture most of the finished drug used in France, but they source API from China. The plan, still at a preliminary stage, would have Seqens add capacity for the API in France. Van den Hoven at Medicines for Europe likes the hospital and health-care-facility purchasing strategy adopted by Phlow and its partner Civica Rx, a nonprofit launched in 2018 to help manage generic-drug prices and prevent shortages for member institutions. But he questions the US government’s decision to spend up to $800 million establishing a new company to foster domestic manufacturing of APIs. “It’s an incredible amount of money,” he says. “In Europe, we can do it for a lot less.” He points to Sandoz’s deal with the Austrian government to invest more than $175 million at its site in Kundl, Austria, Europe’s last large antibiotics plant. “This is really small change for a production site that supplies half of Europe with penicillin,” van den Hoven says. On Nov. 25 the EC issued its Pharmaceutical Strategy for Europe, which outlines a raft of initiatives the commission will put forward for approval by the European governing bodies. The strategy, which is not finalized, addresses many of the manufacturing issues raised by industry associations, including pricing policies and investment in green technology. But it lacks details on regulatory changes impacting the use of continuous process manufacturing, and it does not suggest the creation of a list of critical APIs. Van den Hoven says the commission is still fielding input from industry pending a finalized plan. Europe’s drug manufacturers are awaiting further direction from the EC just as the world braces for a surge in COVID-19 infections that may reignite supply chain anxiety. Van den Hoven notes, however, that the first wave of the pandemic was marked by a cooperative response globally. For instance, Europe expedited the export of drugs used in intensive care units to the US despite crisis-level demand for the same drugs at home, he says. “The political climate is a little tense right now,” van den Hoven says. “But at some point people are going to have to go back to cooperation again.”   Read the full article on C&EN website  

Article
C&EN, 20 May 2019

Europe’s drug supply chain gets ready for a makeover

Nov 27, 2020

Experts Share Their Opinions on How the Custom Manufacturing and Research Industry can Tackle the Impact of the Covid-19 Pandemic and a Demanding Economic Climate   20.10.2020 - The coronavirus crisis caused by the Covid-19 pandemic has uncovered problems that have been smoldering beneath the surface of the pharmaceutical industry — including CMOs/CDMOs and CROs — and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious. The ongoing pandemic is putting pharmaceutical R&D strategies to the test and also challenging manufacturing planning and supply chain management. Particularly in this industry segment, the supply chain is global, complex and interconnected. Each link must be strong enough to ensure that the road from lab to final drug product is as smooth as possible, even under the most difficult circumstances. In addition to the pandemic, the growing threat of a no-deal-Brexit amid old and new trade conflicts and increasing protectionism, is putting even more stress on companies operating in the pharma sector. In cooperation with Wombat Capital*, a cross-border investment bank, CHEManager asked executives and experts of CMOs, CDMOs and CROs operating in the pharmaceutical sector to share their opinion on current challenges for their industry and how these challenges may influence changes in their market and opportunities.   Expert Interview: Jean-Luc Herbeaux       16.10.2020 - So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious. The ongoing pandemic is putting pharmaceutical R&D strategies to the test and also challenging manufacturing planning and supply chain management. Particularly in this industry segment, the supply chain is global, complex and interconnected. Each link must be strong enough to ensure that the road from lab to final drug product is as smooth as possible, even under the most difficult circumstances. In addition to the pandemic, the growing threat of a no-deal-Brexit amid old and new trade conflicts and increasing protectionism, is putting even more stress on companies operating in the pharma sector. In cooperation with Wombat Capital, a cross-border investment bank, CHEManager asked executives and experts of CMOs, CDMOs and CROs operating in the pharmaceutical sector to share their opinion on current challenges for their industry and how these challenges may influence changes in their market.   What in your opinion and from your perspective are the main impacts of the coronavirus pandemic on the drug supply chains? Jean-Luc Herbeaux: While Covid-19 placed some strain on global supply chains and logistics, the pharma industry overall showed surprising resilience considering the severity of the situation. The pandemic highlighted the strong reliance and dependence of drug and medical product supply on China and India and the limitations of such a supply model. It caused governments to look at pharmaceutical manufacturing in a more strategic manner, including potential repatriation, to guarantee access to life-saving medicines to cater to the most extreme demands. A new type of “nationalism” promoting preferential (or even exclusive) access to therapies and vaccines has emerged in the meantime and it has the potential to greatly disrupt the established global manufacturing and supply models.   Many Western CDMOs have already shifted operations back to the USA and Europe as intensive business activity in China has driven up labor costs. In addition, national policies, trade-related developments such as Brexit and the US-China dispute and impacts of pandemics are likely to require repatriation of at least part of the supply chain in many countries. Could CMOs/CDMOs be beneficiaries of restructured supply chains? J.-L. Herbeaux: CMOs/CDMOs have a chance to benefit from the repatriation trend, which already started some years back. The first wave of relocation, which started some 4 or 5 years ago, stemmed from quality and regulatory considerations. This repatriation was very beneficial to CDMOs with assets and quality systems in good standing as they were able to gain access to business which had escaped them up to that point. The new wave seems to be driven by countries and their citizens coming to terms with the fact that most of their medical supplies are from foreign countries and entities. The recent Covid-19 crisis has revealed the limits associated with reliance on third party country supplies and the ongoing Covid-19 vaccine and therapy “nationalism” further exacerbated the sentiment that repatriation of pharma assets is now a strategic priority. We ought to recognize that the Covid-19 pandemic is extreme in terms of impact and medical supply needs. It has overwhelmed the global supply chains in unprecedented ways and no economically sound supply strategy could have prepared us for an event of such global proportion. In these special times, there is a risk of overheating and of wrong capital investment decisions. Investments need to make sense not only for the short term (i.e. in Covid-19 times) but also for the long haul (once the world returns to a more normal reality). In this overheated environment, experienced western CDMO´s with flexible assets and operating models and with meaningful engineering capabilities are probably the best bet for this industry. They know how to ramp up and run assets in an effective and nimble manner and make best use of these assets now and in the future thanks to their ability to accommodate an ever-changing portfolio.   What do you think the impact of the repatriation of the drug supply chain will have on the M&A activity in the CMO/CDMO industry? Do you think that this would create an impact on valuations? J.-L. Herbeaux: The pharma industry is very likely to weather the Covid-19 crisis better than other sectors and accordingly, one can expect valuation to go up at a time when investors may be looking for safe heavens. The demand-supply balance for M&A candidates in the USA will also drive multiples. One can foresee that the high availability of cash and short-term hype may result in some misguided investment decisions in parties and/or assets, which do not represent mid to long-term value. In the pharma CDMO space, assets are important but not sufficient. The right-to-win stems from established competencies in quality, regulatory and manufacturing service excellence and these attributes take time to develop.   Has the inability to hold face-to-face meetings with prospective clients and conduct client visits to sites affected your new business development since the outbreak of the coronavirus pandemic? J.-L. Herbeaux: New business development has become more difficult as travel restrictions have curtailed opportunities for face-to-face interactions. Physical closeness is known to help individuals (or groups of individuals) form interpersonal relations and develop trust. Proximity and face-to-face communication are therefore particularly important for first-time interactions. We see this clearly in our commercial activities: it is a lot easier to maintain or even further established relationships than to develop new ones. Add to this the need for pharma companies to audit new partners and you will understand why existing partnerships are preferred to new ones at this moment.   The CMO/CDMO industry has managed to support efforts to develop vaccines and therapeutics for Covid-19 despite already being at a high level of utilization. What made that possible? J.-L. Herbeaux: From what is published, there is significant cash being deployed to ramp up vaccine production and capacity repurposing or reactivation is also on the agenda. Some of this cash came from governments and public organizations to secure supply. As for Hovione, we are involved in several steep capacity ramp-up exercises and these have been made possible by very strong partnerships with our clients and suppliers. Everyone understands that these are extraordinary times, and all agree that only shared commitments can result in success. The rest is fueled by a sheer desire to save lives. We push our organizations, systems, and processes to new levels of speed and productivity relying on decades of experience, expertise and best-in-class practices. Under these extreme conditions, CAPEX, resources, and associated capacities are deployed faster and products become available in record time. This is what leading and agile CMOs do for a living: deal with the cross-functional and cross-discipline complexity associated with production ramp-up and compress timelines.   For the biopharma CMO/CDMO industry, the pandemic crisis has created great opportunities. What is your opinion on whether and to what degree the CDMO industry will enjoy long-term benefits from its role in tackling the current crisis? J.-L. Herbeaux: One may assume that the public opinion of the pharma industry will have improved during the last months and that any company, including CDMOs, which contributed to solving or alleviating the Covid-19 humanitarian crisis, would have a chance to boost its image externally but also with its own staff. There is little which can compete with being a contributor to tackling a global health crisis and saving lives. Leading CDMOs have certainly showed that they can be trusted and that supply chains supported by CDMOS/CMOs are robust. Moreover, their demonstrated ability to step up and make capacity available on short notice, absorbing much of the complexity associated with reaching new levels of supply, has positioned CDMOs at the core of the industry’s journey to provide therapies and vaccines to billions of individuals. The co-dependence between CDMOs and Pharma companies is stronger than ever, and this should increase the propensity of pharma to outsource.   One of Hovione’s facilities is located in Macau, China. How was the site in particular and your business in China in general affected by the outbreak of the coronavirus pandemic? J.-L. Herbeaux: Macau is a good example of Hovione’s success in controlling the risks associated with Covid-19. Extensive measures were quickly put in place to protect the team members and to ensure the continuity of our manufacturing operations. Many of the raw materials for Macau come from mainland Chinese suppliers and the site was also able to secure its supply chain. The site was even able to adapt to repair specialized equipment with its own staff as technical visits from suppliers were not possible. Our other sites, which have also been running without interruption or disruption, learned from the Macau response and organization. Best practices were quickly rolled out globally under the leadership of a global task force. All our sites are now operating safely according to this new reality. One of our most important decisions has been to offer free testing to our employees with an elevated risk profile, e.g. as they return from holiday.   The race is on to develop treatments and vaccines against Covid-19, and so is the need to assure supply of these potential drugs and vaccines. Pharma companies are leveraging their internal manufacturing networks but also partnering with CMOs/CDMOs. What supply and manufacturing strategies/alliances are in play? J.-L. Herbeaux: The Covid-19 pandemic has engendered an all-out search for treatment options. Many hundreds of compounds for prophylactic and therapeutic use have been tested in the race against this deadly disease. No drug candidate or route of administration has been neglected and innovative formulation concepts are given due consideration under the assumption that regulatory authorities will likely grant accelerated approval to treatment options which show positive clinical outcomes. The patient population is considerable, and the urgency is absolute. The manufacturing capacities for the few treatments that have demonstrated some efficacy (or promise of efficacy) to date are being ramped up to scales and with speeds which transcend anything the industry had seen so far. Pharma companies have sought the help of their partners to ramp up raw material supply and custom manufacturing services to help them deal with this colossal challenge. In times of pressing requirements, strong partnerships are key and unsurprisingly pharma companies have tended to reach out to their existing partners – especially those who demonstrated the ability to meet complicated supply challenges involving new asset deployment and commissioning. We, at Hovione, are part of this select group of CDMOs working closely with partners on both new formulation concepts and steep upscaling of industrial production capacities.   “Emerging”, “virtual” and other small (bio)pharmaceutical companies are driving the discovery and development of new drugs but are mostly dependent on the availability of financing – which could become more restricted due to the economic downturn cause by the economic and epidemiologic disruptions to the global economy. As emerging biopharma companies are important customers of CMOs/CDMOs, how is this going to affect your business? J.-L. Herbeaux: As a leading CDMO known for helping pharmaceutical companies of all sizes bring new and off-patent drugs to market, Hovione is of course dependent on the health of the biotech industry and its pipeline. So far, our business has remained extremely vibrant as our customers do not appear to be short of cash and pipeline projects are progressing as per plan. The last 3 years have been good in terms of biotech financing (the biotech sector in NASDAQ is at an all-time high). So, one may contend that biotech companies’ strong cash positions will allow them to weather the storm as long as the crisis does not perdure and investments do not stop abruptly. After a few months of increasing disruptions in clinical trials due to Covid-19, data now suggest that clinical trial disruptions have started to recede. Most trial disruptions appear to be due to suspension of enrollment – not financials.   Read the full article at CheManager      

Article
CheManager, 20 October 2020

The Coronavirus Crisis: Challenges and Opportunities for CMOs, CDMOs and CROs

Oct 20, 2020

Over the coming months, Hovione will be hiring for positions in quality control, quality analysis, warehouse operations and production operations. Hovione, a contract pharmaceutical manufacturing and particle engineering company, has announced 48 new jobs for its base in Cork. The expansion follows a partnership agreement between Hovione and biopharma company Ligand to ramp up production of Captisol, a product that can improve the solubility and stability of drugs. Captisol is used in the Covid-19 treatment Veklury, which is produced by US pharma company Gilead. New hires will be based at Hovione’s site in Ringaskiddy, Co Cork, which has been in operation for more than 10 years. It was acquired from Pfizer in 2009 and currently employs around 200 people. According to the company’s talent acquisition specialist, Michelle Ahern, the vacancies will span quality control, quality assurance, process engineering, project management, engineering, warehouse operations and production operations. Recruitment for the roles is underway and the team plan to fill them by the end of 2020. Founded in Portugal in 1959 by Diane and Ivan Villax, Hovione helps to bring new and off-patent drugs to market. The pharma manufacturing company has 1,600 staff members around the world, with facilities in the US, Ireland, China, Portugal, India, Japan, Switzerland and Hong Kong. Jean-Luc Herbeaux, COO of Hovione, said that increased demand for Veklury has meant that Hovione will soon be producing in a month the amount of Captisol it normally produces in a year. “This sudden spike in demand has required unique mobilisation efforts across the Hovione network to secure additional raw-material supply, execute major capital-expenditure projects at our sites, maximise operational efficiency, hire additional talent and identify external partners to expand our overall capacity,” he said. Ligand’s president and COO, Matt Foehr, added that Captisol is a “critical component for a number of life-saving medicines”. Hovione Cork’s general manager, Paul Downing, said that the opportunities are for people “who want to join a fast-paced, dynamic, empowering, diverse, inclusive and exciting organisation”. To learn more about working at Hovione, visit the company’s careers portal here.   Read the article at siliconrepublic.com    

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Silicon Republic, October 2, 2020

Pharma manufacturer Hovione announces 48 new jobs for Cork

Oct 02, 2020

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