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The evolution of the pharmaceutical sector between digital transformation and new regulatory processes

October 05 2021

The evolution of the pharmaceutical sector between digital transformation and new regulatory processes
We thank HBR Italia for the report about the two "CEO Round tables" which took place during the kick off of the “Executive Programme in International Pharma and Healthcare Administration” with the participation of: Pierluigi Antonelli, CEO Angelini, Silvio Belletti, Partner BCG, Elcin Barker Ergun, CEO Menarini Group, Ugo Di Francesco, CEO Chiesi, Deborah Dunsire, CEO Lundbeck, Eriona Gjinukaj, COO Dompé, Jens Grueger, Director and Partner BCG & President ISPOR, Jordi Llinares Garcia[1], Work Stream Head at European Medicines Agency, Gianfranco Nazzi, CEO Almirall, Guido Rasi, Professor of Microbiology, Tor Vergata University, chair by Luca Magni, Professor of Practice Luiss Business School. The full version of the article is now available in English. The new "CEO Round table" will be held with the start of the second edition of the programme on October 19, 2021. The Impact of the pandemic on the pharmaceutical sector and the relationship between innovation and regulation: two of the hottest topics on the table of the CEOs of the pharmaceutical sector were discussed in the two panels organized by the Luiss Business School to present the first edition of the Executive Program in International Pharma and Healthcare Administration. The debates, introduced by Silvio Belletti and Jens Grueger, Partner of the Boston Consulting Group, were attended by main exponents of the Italian and world industry, and moderated by Luca Magni, Professor of Practice Luiss Business School. During the first of the two panels, attended by Pierluigi Antonelli, CEO of Angelini, Ugo di Francesco, CEO of Chiesi and Deborah Dunsire, CEO of Lundbeck, as well as Guido Rasi, professor of microbiology and former director of AIFA and EMA, we discussed how the pandemic has impacted the operational dynamics of the pharmaceutical sector, focusing on three main themes, introduced by Silvio Belletti (BCG): the interaction between companies and doctors, the regulatory dynamics and clinical development, smart working. Company-doctor interaction: towards a new-generation Customer Engagement The pandemic first blocked and then reduced for several months the visits of scientific informants to doctors, forcing companies to reinvent the way to interact with prescribers, leveraging virtual instruments. If it is true that, as a BCG survey shows, more than 50% of doctors expects or hopes that the relationship between virtual and face-to-face interactions will remain the one seen during the pandemic, it is also true, as Deborah Dunsire pointed out, that "personal promotion and face-to-face interactions remain crucial, especially when it comes to promoting a new drug being launched". For this, Pierluigi Antonelli hoped for "the transition to a hybrid model", also stressing that it is "crucial that the development of digital skills is not limited to the sales force but involves the whole organization". Ugo Di Francesco is also on the same wavelength, highlighting how "the adoption of a digital-oriented business model has reached different levels of maturity depending on the geographical areas", much more advanced in China and the United States, than in Europe. Dunsire and Di Francesco also underlined how it is essential that pharmaceutical companies exploit the digital opportunity to promote contents that are as tailor-made and personalized as possible, in order to maximize the doctor's customer experience and to express the commercial resolve in greater returns for companies. Regulatory dynamics: new scenarios, but Europe risks being left behind Just as the pandemic has impacted the interactions between business and physician, the world of clinical development has also seen significant changes along at least two main directions. In the first place, with COVID the so-called virtual trials have doubled, that is to say those clinical studies where the recruitment of patients and/or the evaluation of the results take place remotely. Also, the pandemic and the vaccine rush have shown the possibility of significantly shortening the development and approval times of drugs (typically above 5 years). It will now be essential to understand whether these accelerated development and approval timelines (which depend on various factors, including greater involvement of regulators in the development phases, parallelization of the same and the use of surrogate endpoints) can become the rule and not remain an exception due to the exceptional circumstances of COVID-19. In this regard, Professor Rasi underlined how it is "more difficult for this to happen in Europe than in the United States". The reason, however, would not be due to a more "conservative" approach by EMA compared to the FDA, but rather to the "difficulty in bringing together 27 member States in which a culture typically averse to risk prevails". Smart working: towards a hybrid model Finally, the round table focused on the issue of remote working, a particularly hot topic in this moment of transition from a due smart working to desired smart working. As Antonelli pointed out, "even before COVID, hypotheses for the introduction of remote work were being studied" and, from this point of view, "the pandemic represented a sort of forced test that highlighted the strengths but also the limits of this model ". While it is true that the logistical advantages are out of the question (provided that employees are equipped with adequate tools), it is also true that collaboration and innovation risk to be, if not compromised, at least limited. Consequently, as shared by Dunsire and Francesco, the need to "define hybrid models that allow you to benefit from the advantages of working from home without this translating into abandonment of the offices", which must remain the beating heart of the company's life, or the “backbone”, as Antonelli defined it. Keeping up is essential Rather than creating the need for a change, therefore, the pandemic has brought out needs that in a certain sense were already latent, imposing the need for companies in the sector to know how to reinvent themselves quickly and accelerating the introduction of new operating models, with a strong push on the digital element. The ability of companies to be able to seize this challenge in the required timeframes and in the best ways will be fundamental to obtain an advantage over competitors and, on the one hand, to capture market growth in the post "rebound" phase COVID and, on the other hand, be prepared for long-term challenges. The second roundtable hosted Elcin Barker Ergun, CEO of Menarini, Eriona Gjinukaj, COO of Dompé, Gianfranco Nazzi, CEO of Almirall and Jordi Llinares, Head of the Research and Innovation Department of EMA, spoke. The introduction by Belletti and Grueger focused on how innovation in the pharmaceutical sector has been the protagonist of the last decade. Just think, for example, that the drugs for rare diseases approved every year in the United States ranged between 50 to more than 300, or that the market for "novel modalities" (such as, for example, gene therapies), which currently has revenues of approximately $ 3 billion, should increase its value tenfold in less than 5 years. Despite a wave of innovation, which has made it possible to obtain results that were unthinkable until a few years ago from a clinical point of view, there are still several obstacles that complicate the approval processes or market access for new drugs. USA and Europe: the numbers and the reasons for the gap As shown by a study by the Boston Consulting Group, of the 220 drugs approved by the FDA in the United States between 2015 and 2019, only 97 were also approved in Europe and only in 22% of the cases this happened with shorter deadlines than in the United States. For Eriona Gjinukaj "especially small and medium-sized companies in Europe encounter difficulties in obtaining approval from the regulatory body". This requires a "greater flexibility in the evaluation of data relating to medicines that are administered to patients who often, without a cure, they would risk losing their lives”. Jordi Llinares was also on the same wavelength, underlining that in Europe there would be "a cultural reluctance to collaborate between regulatory bodies, pharmaceutical companies and key opinion leaders in the clinical development phase, attributable above all to fears of possible conflicts of interest for the latter”, which would result in an inevitable slowdown in the approval times for drugs. It is also interesting to note, as highlighted by Elcin Barker, that the gap between Europe and the USA is not only registered in terms of drug approval times, but also in the access times to individual national markets. In fact, if it is true that in some European countries, such as Germany, "it is preferred to allow patients immediate access to the drug, solving the issues related to price and reimbursement at a later time", there are other national realities where instead the opposite happens, and “a long negotiation on prices heavily slows down the entry on the market of even highly innovative drugs”. In this sense, Gianfranco Nazzi stressed "the need to work together to find a solution that has a financial basis and that allows the problem to be solved". Outcome-based models and the role of digital: a long but inevitable road The discussion then moved on to how satisfy the need for payers to keep costs under control and, at the same time, guarantee the highest level of quality of care, with outcome-based reward models, which provide a reimbursement linked to the success of the therapy. In this sense, Eriona Gjinukaj reiterated how for some time the industry has been trying to propose outcome-based models, which however "clash with the complexity of large-scale management even in countries - such as Italy - which have been the front line since several years". To this end, according to Grueger it is fundamental "to work on a common model among all European countries", which potentially leverages - as Llinares hypothesized - on a "federation of European databases that uses data of type real world” to facilitate the adoption of outcome-based payment systems. Emerging Countries: political instability undermines efforts towards advanced regulatory systems The final parenthesis on emerging countries is also very interesting: if for Europe the fundamental issue is to close the gap with the United States in terms of flexibility of regulatory processes and marketing access, in emerging countries " several drugs are not even available and the regulatory agencies are poorly structured and not very transparent”, underlined Gianfranco Nazzi. According to Jordi Llinares, "there have been efforts at a global level to create a sort of" African EMA "and the EMA itself has entered into bilateral agreements with various developing countries to strengthen the skills of local regulatory bodies". Political instability, however, weighs like a boulder on the attempts to carry out these projects and to bring emerging countries in step with the more economically developed ones. Renew regulatory processes to capture innovation A situation in which, as Silvio Belletti pointed out, innovation grows at a much higher rate than GDP, witnesses the difficulty in being able to capture the value of innovation itself. To reverse the trend, it therefore becomes essential to renew the regulatory processes, simplifying them and aligning them, as far as possible, with US best practice. Shorter approval and access times, collaboration between companies, key opinion leaders and regulatory bodies even during clinical trials, outcome-based models that reward products with the greatest impact on patients' health: the challenges are not lacking, it's up to Europe collect them and direct them towards creating a success story. [1] With great sadness we join the grief of family, friends and colleagues for the sudden and unexpected passing away of Jordi Llinares Garcia. 10/5/2021
Amsterdam Fashion Academy pharma
Be a change leader: the post-Covid challenge of the Luiss Business School

September 07 2021

Be a change leader: the post-Covid challenge of the Luiss Business School
This is the main goal addressed by Matteo Caroli, Associate Dean for internationalization, during the Graduation Day with the students of the international Masters: «It's your time to inspire». «You can achieve everything in life if you don't give up»: is the message of the student Jolda Tomani, during the Valedictorian Speech. «It's time to become change-agents». With this advice Matteo Caroli, Associate Dean for internationalization of the Luiss Business School, hailed the Graduation Day of the students of the nine international masters, edition 2018/2019. In the post-Covid world, while we're facing the effects of the pandemic on our economy and society, being a change leader, a person who can inspire personal and professional communities, will be a key factor for the years to come. «It's time to become change-agents in the evolution of your organizations and time to adapt yourself to the frequent changes and transformations», said professor Caroli, who recollected all the stages of the long path walked by the students. They improved their skills and acquired new ones, expanded their network and, by the end, they had «the opportunity to grow». Graduation Day is the final step in this educational path, but it is also «the starting point» for their personal and professional future development. This complex, dynamic and challenging environment requires change agents who can also be leaders of this New Normal time. Thus, Luiss Business School believes that «education is much more than what you learn; it is about how you think and how you act. Our daily commitment is to develop passionate and inspiring leaders who believe growth and entrepreneurship are essential to achieve great results». «Being here showed me that you can achieve everything in life if you don't give up – said Jold Tomani, student of Risk management and insurance, during the Valedictorian Speech. – After finishing my bachelor’s degree in Albania in Business Administration, I decided that I had to find an opportunity to attend the master abroad or not to do the master at all: being accepted with a full scholarship taught me that if you want something, you have to try and don't give up». Living abroad, without friends who speak your language and share the same culture, makes students grow in many ways and let them change their mindset. Thanks to all the experiences shared by professors and successful leaders, students can learn how to translate vision into reality. «The most important thing that I've gained from the master is the development of the soft skills – continued Tomani, who dedicated the degree to her father – I do believe that it is very important to strengthen the hard skills and doing the best in what you do. But if you don't have the soft skills to cooperate and communicate effectively with others, even the best product won't be sold. And the best product is ourselves». The Luiss Business School Alumni become ambassadors in all professional communities, in Italy and abroad. This is powered by the “Connect” community, an exclusive network platform where the Luiss Business School Alumni have the chance to keep on talking with their peers and colleagues, matching with new professional opportunities. Starting from the Graduation Day every is welcome to “Connect”, where all the photos of the ceremony are now available. Register now! 9/7/2021
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Flex MBA: The new programme powered by Insendi



Part-time MBA – Open Day
The Open Day is the event dedicated to the Luiss Business School Part-time MBA, a redesigned MBA, built around the concepts of Hyper-Personalisation, Business Impact and Innovation and dedicated to professionals willing to acquire new managerial and leadership skills, without interrupting their professional paths. The Director, the Academic Coordinator, a Coach, a Career Advisor and Luiss Business School Staff will present alle the news of the next edition of the Part-time MBA starting in Rome on April 7, 2022. Participants have indeed the unique opportunity to interface with them in Q&A sessions and find answers to all their doubts if this programme is the best fit for them. WHEN: 20 November 2021, starting from 10 a.m. WHERE: Luiss Business School, Villa Blanc Campus, Via Nomentana 216, 00162 Rome. Register AGENDA e SPEAKERS: 10.00 – 10.20 | Programme Presentation: Alessandra Perri, Scientific Director Part Time MBA Rome10.20 – 10.40 | Activities Presentation: Maria Isabella Leone, MBA Academic Coordinator11.00 – 11.45 | Masterclass: Edoardo Palmisani, MD & Partner, The Boston Consulting Group12.00 – 12.30 | Career Advisory Presentation12.30 – 13.00 | Coaching Presentation The event is free of charge and will take place from 10 a.m. to 1 p.m. In compliance with Covid safety regulations, the Green Pass Certificate is mandatory to participate. Registration is required. For the protection of all Open Day participants, please note that masks must be worn throughout the event. At the entrance to the venue, staff will take your temperature and hand sanitisation points will be available. Register



Amsterdam Hub – Open Day and Campus Visit
The Open Day and Campus Visit is an opportunity to find out everything about Luiss Business School’s new Amsterdam Hub and the first-level master’s programmes inInternational Management and Fashion & Luxury Business starting in Autumn 2021 in Amsterdam. WHEN: October 18 from 2.30 pm to 6.30 pm CEST WHERE: Amsterdam Hub of Luiss Business School, Nieuwe Herengracht 103 WHAT TO EXPECT? You will be among the first persons to discover Luiss Business School’s new Hub in Amsterdam.  On October 18, for the first time, the Hub will open its doors to welcome prospective students for tours led by Luiss Business School Staff. You will taste the inspiring atmosphere of walking around our campus and be a future student.You will join one-to-one information sessions with masters’ coordinators. During the meetings you will find answers to all your questions about the master’s programme offered by Luiss Business School and, if you are not sure about which one is right for you, you will be guided in your search for the master’s programme that best matches your career aspirations and aptitudes. Take the first step towards your career! Come and visit us, choose a time slot for your info session and take a stroll on the east side of the canal belt of Amsterdam to meet Luiss team and have a look at the new charming and historical hub. REGISTER The master’s programmes presented: Master in International ManagementMaster in Fashion, Luxury and Tourism Management – Major in Fashion & Luxury Business
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Una serie di eventi gratuiti di formazione digitale e di presentazione dell'offerta formativa in live streaming
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