Onofrio Mastandrea

Faster access in Italy and prioritisation of innovative drugs that address unmet need—these are the ambitions of AIFA Agenzia Italiana del farmaco following its recent reorganisation. Roberto Nisticò, the Agency’s new President, made these commitments in his first meeting with Marcello Cattani, the President of Farmindustria (tinyurl.com/y5xrudu4).   In a press release, Nisticò said: “We are working to reduce the time of access procedures with a reduction of bureaucracy and with administrative simplification, ensuring that citizens may quickly use truly innovative medicines.” To that end, a technical working group has been established to identify simplification tools that will prioritise the approval of drugs that can improve the quality of care and expand the therapeutic options available. In addition, the Scientific and Economic Committee (CSE) will be relieved of certain (unspecified) procedures that could be carried out automatically. The CSE will hold more frequent meetings in the short term to clear the backlog of applications that has built up “because our goal is to prioritise drugs that fill a therapeutic gap,” according to Nisticò.   A new online platform for access authorisation procedures will be established. Pierluigi Russo, AIFA’s Technical and Scientific Director, says the objective is “to make communication between companies and the Agency more effective and transparent concerning the CSE process, in addition to updating the guideline on the dossiers for requesting the price and reimbursement of medicines.”   Addressing problems associated with antimicrobial resistance will also be high on AIFA’s agenda. There is a need for incentives and rapid approval pathways for novel antibiotics. Nisticò believes “an effective model is the legislation that has allowed to incentivise the research for orphan drugs for rare diseases, which can be duplicated for new antibiotics not resistant to bacterial infections. But this will require legislative action, also at a European level, and we will commit to raising awareness among decision-makers at various levels.”   AIFA has confirmed that it will apply the EU Regulation on Health Technology Assessment and make use of joint clinical assessment reports. They will help to support “a multidimensional evaluation of the drug on the healthcare system, economic aspects and protection of citizens' health.” #Italy #AIFA #HTA #marketaccess #innovation

88

This year, World Mental Health Day and World Sight Day coincide! A powerful reminder of how closely connected these two fields are. 👁 🧠 October 10th, 2024 – a day to reflect on the importance of maintaining both good mental and ocular health, two areas that are very close to my heart. At Angelini Pharma España we’ve been dedicated to ocular health for over 40 years, working to improve the eye health of our patients. More than ever, we recognize the strong link between the eye and the brain. The eye is a gateway to the brain, allowing us to detect neurological conditions like stroke and multiple sclerosis, and highlighting conditions such as glaucoma, where brain and eye health are deeply connected. We are committed to advancing our understanding of this connection to ensure better outcomes for our patients' overall health. 💫 #WorldSightDay #VisionAwareness #ProudAngelini #EyeHealth #AngeliniVoices Sociedad Española de Oftalmología #WorldMentalHealthDay #AngeliniPharma #AngeliniPharmaBrainHealth #BrainHealth #AngeliniPharmaBrainHealthCare #BrainHealthCare

51

📰 Another treatment option is on the horizon in the Pulmonary Hypertension space. News of a new collaboration here: 🌍 The Italian pharma company Chiesi Italia, pens a #strategic partnership to capitalize on Gossamer Bio's pulmonary hypertension (PH) development experience and Chiesi's history of respiratory leadership. 🤝 Plans under this agreement include launching a Phase 3 trial around mid-2025, of seralutinib in PH-ILD in addition to the ongoing Phase 3 trial in PAH: ⏩ "Gossamer CEO Faheem Hasnain said the partnership allows the company to rapidly accelerate R&D investments for its sole asset, including a phase 3 trial launch in PH-ILD, an indication with few available treatments." #Chiesi #GossamerBio #Biotech #StrategicAlliances #RandD #PH #PulmonaryArtertialHypertension #CV #Cardiovascular #Pharma #Healthcare

4

The aging population and rise in chronic diseases necessitate technological innovation in healthcare. This study in Italian used Activity-Based Costing to quantify the costs of managing migraine patients at IRCCS Mondino, Pavia, and estimate the NHS's economic burden. The analysis detailed patient pathways and activities, revealing significant expenses from hospitalizations and medications. The model can be adapted for other diseases to optimize healthcare resource allocation and management. #ActivityBasedCosting #migraine #healthcareresource Follow us CliCon S.r.l. Società Benefit

9

Readiness for the journey….

38

Check out AUX-001 Phase 1a results presented at European Society of Cardiology annual meeting in London by Uwe Tigör, MD, our Chief Medical Officer at Auxilius Pharma. Phase 1a study explored the safety, tolerability, and pharmacokinetics of our compound, which is promising new medication for chronic stable angina. Now that the meeting’s embargo has lifted, we’re thrilled to share these results with you! Check out the attached presentation for more details. If you’d like the full version of the deck, feel free to reach out directly to @Uwe Tigör, MD or to me #cardiology #CSAP #AUX001 #ESC #newmedication #biotech #news

48

🌟 New Governance and HTA Model for Medical Devices in Italy 🌟 I would like to share some thoughts on the new governance and Health Technology Assessment (HTA) model for medical devices in Italy. While this change aims to bring more efficient and transparent management of health technologies, ensuring equitable and timely access to innovative medical devices, there are some concerns that need to be addressed. The new model aims to: ·      Improve the assessment of health technologies through an integrated and multidisciplinary approach. ·      Promote transparency and collaboration among the various institutions involved in the HTA process. ·      Ensure that procurement decisions are based on solid and up-to-date scientific evidence. However, one must wonder whether the Italian bureaucracy will be able to manage this type of activity effectively or if it will be another case of "an elephant giving birth to a mouse." The complexity and rigidity of the current system raise doubts about its ability to adapt to these new requirements. This evolution is essential to address the current and future challenges of the healthcare system, but it remains to be seen if it will truly improve the quality of care and optimize the use of available resources. #HealthcareGovernance #HTA #MedicalDevices #HealthcareInnovation #PublicHealth #HealthTech

5

🤳 𝐂𝐃𝐌𝐎 𝐌𝐚𝐫𝐤𝐞𝐭 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 𝐓𝐡𝐢𝐬 𝐖𝐞𝐞𝐤 🔄 Alfasigma has rebranded its CDMO Business Unit as Morpho, underscoring its growth and leadership in the pharmaceutical industry. Established in 2017, Alfasigma’s CDMO arm has built a strong reputation in third-party pharmaceutical development and manufacturing. The rebrand as Morpho reflects the company's evolution and future ambitions to expand its capabilities in the sector. 🤝 Matica Biotechnology, Inc. and CytoImmune Therapeutics have entered a strategic partnership to advance cell therapy targeting cancer. Matica will produce viral vectors at its Texas GMP facility, while CytoImmune will manufacture the cell therapies in Puerto Rico. The collaboration aims to accelerate clinical trials and the development of new cancer therapies. ⚙️ Evonik is refocusing its Health Care division on high-growth sectors like complex APIs, drug delivery systems, and biosolutions such as lipids for mRNA and gene therapies. As part of this shift, the company will discontinue keto acid production at its Hanau facility by the end of 2025, affecting 260 employees, who will receive support for job transitions. 💉 Kindeva Drug Delivery has completed its first registration batch at its high-volume injectable manufacturing site in Bridgeton, marking a major milestone. The facility, designed to expand injectable production, will install three additional production lines over the next 18 months to meet increasing demand for pharmaceutical products. 📊 Cellipont Bioservices has named Darren Head as CEO, further strengthening its leadership as the company embarks on an expansion phase. The appointment coincides with a minority growth equity investment from HealthQuest Capital, which, alongside continued backing from GPP, will fuel Cellipont’s growth in cell and gene therapy manufacturing. 🌍 MilliporeSigma has opened a €290 million biosafety testing and cell banking facility in Rockville, Maryland. This state-of-the-art 23,000-square-meter complex consolidates operations into one building, enhancing efficiency, collaboration, and automation to meet rising global demand for biosafety and analytical testing services. 🏭 Ardena has acquired Catalent Pharma Solutions's state-of-the-art facility in Somerset, NJ, enhancing its late-stage and small-scale commercial manufacturing capabilities for oral drug products. This acquisition supports Ardena’s goal to offer end-to-end pharmaceutical development solutions across its global network of GMP facilities. 🚀 Thermo Fisher Scientific has launched Accelerator Drug Development, expanding its CDMO and CRO services. This follows significant upgrades to its Middleton, WI, GMP facility and expansions in Cincinnati, OH, and Bend, OR, which will boost manufacturing and testing capabilities for oral solid dose drugs, addressing issues like solubility and bioavailability in pharma and biotech development. Stay tuned for more industry highlights! #CDMO #News

9

🌍 World Pharma Today recently had the opportunity to interview Evotec, a pioneering biotechnology company, during the CPHI Milan event at #FieraMilano, #Italy. I'm thrilled to share insights from this conversation, highlighting Evotec's innovative contributions that are driving the future of biotech. Stay connected for more updates from this exciting event! #CPHIMilan #Evotec #Biotechnology #PharmaInnovation #FieraMilano #WorldPharmaToday

11

Sanofi always knew I was going to have a baby... Here is the Timeline: -Feb 1st, 2023: Informed Sanofi about the expected birth of Matteo. -Feb 13th, 2023: Dismissed without cause, effective from May 31st, 2023. -May 5th, 2023: Matteo was born. -May 31st, 2023: Effective date of my dismissal. Sanofi was duly notified in accordance with its own parental leave policy (which they claim is gender-neutral and allows for 6 months), which requires the company to be informed at least 3 months before the probable birth date. On February 1st, 2023, I informed the company that I was expecting the birth of Matteo, who came into the world on May 5th, 2023. Despite this, in an action that clearly reveals the discrimination faced (again) by me and my family, I was dismissed without cause on February 13th, 2023, effective as of May 31st, 2023 (indeed after Matteo was already born). This was not an isolated case of #discrimination, but rather part of a continuous pattern of disrespect towards me, my husband, and our son Matteo. What happened to my #family should not happen to anyone else. Source: https://lnkd.in/eRw-YBAf, https://lnkd.in/er7gAepM, https://lnkd.in/er7gAepM, https://lnkd.in/e2hj94i3 #PorMatteo

25

What does it mean to be MSL in Angelini Pharma❓ Thogether with our strong partner #MoreLaboratoriodiOrganizzazione and some of our most advanced MSLs we will reshape the MSL role in Angelini Pharma in the upcoming weeks, to be ready for the future. 💪 I am grateful to lead this wonderful project. 🌱🚀🩷🙌 In the dynamic landscape of pharmaceuticals, the role of Medical Science Liaisons (MSLs) is evolving every day to meet the ever-changing demands of healthcare. In Angelini we know that our MSLs are pivotal in bridging scientific knowledge and clinical practice, ensuring that healthcare professionals have access to the latest research and insights. This evolution is driven by our commitment to enhancing patient care through innovation and collaboration. By leveraging cutting-edge technologies and fostering strong relationships with key opinion leaders, our MSLs are not just adapting to change but leading it, embodying our mission to make a meaningful impact on global health. #MSL #MSLS #medicalscienceliaison

171

16 commenti

Many people in my network, incl. those from the industry, keep asking me “what exactly is your new company doing”? If anything – it’s a call to action for us Alfasigma to build stronger employer branding, especially outside of Italy. One step at a time, here is my “Alfasigma 101”! ▶ We are privately-owned Italian multinational pharma group with a focus on innovative medicines and consumer healthcare. Starting in 1948 in Bologna, Alfasigma grew to become Top 5 pharma player in Italy with our products being sold in more than 100 markets. Our key focus is Gastro, Vascular and Rheumatology with a portfolio of Innovative Rx and consumer healthcare products. Being private allows to focus on doing what’s right while avoiding the pressure of “pleasing” financial markets. The last 2 years were truly transformational as Alfasigma embarked on a journey to build even stronger portfolio and become a truly global player. ▶ We strengthened consumer portfolio with Sofar S.p.A. acquisition in Italy, also actively leveraging it across C&EE and Emerging Markets. A strong presence in US was established with acquisition of Intercept Pharmaceuticals. Acquisition of JAK-i business from Galapagos gave us an opportunity to enter Rheumatology and expand presence in Western Europe. The two bio-tech acqusitions also gave us an R&D pipeline which will fuel further growth. We are also actively looking to expand our geo footprint further – from Latin America to Asia. ▶We doubling business in 3 years, looking to repeat it again, not only through "what" we do, but also "how". Being an ambitious mid-size player, we can’t win through “mass” – rather by being faster, more agile, more entrepreneurial. Its best told by two of our values – “Learn to Dare” and “Think Big, Act Small”, which really tell about a new DNA of Alfasigma. None of that is a rocket science – yet this is where Big Pharma often fails and where we are thriving. ▶ We are not (yet) as big as J&J or don’t have (yet) that much spotlight as NovoNordisk – but we are at a time and place when company reinvents itself and builds a new future. A great place to be if you are excited by growth and ambitions and don’t mind to roll your sleeves! We are growing and every day there is a new opportunity – especially at Alfasigma Growth Markets which spreads from LATAM to C&EE, MEA and Asia. If you feel that your hands are tied with endless ppt slides and your ideas take forever to happen – check out Alfasigma, even if you have not heard about us before. There could be more than meets the eye! We are looking for new colleagues but also open for different partnership opportunities. “Bookmark” Alfasigma in your mind – there is a lot come!

369

22 commenti

" 👨‍⚕️ The CUP of Milan Mystery 👨‍⚕️ " Logline: A group of pharmacists attending CPHI Milan to secure business contracts stumble upon a groundbreaking idea, but their journey takes a suspenseful turn when they realize they are not the only ones after this innovation. Short Story: 👉 A group of ambitious pharmacists, led by Dr. Emilly, arrived in Milan for the prestigious CPHI conference. Their mission was clear: secure new contracts and build relationships to propel their business forward. The bustling conference was a hub of innovation, with professionals from around the globe sharing cutting-edge ideas. 👉 As they navigated the crowded halls, Emilly and her team collected valuable information and networked with potential partners. One evening, while reviewing their notes at a quaint Milanese café, they stumbled upon a revolutionary concept that could transform their business. Excitement buzzed among them as they realized the potential of this new idea. 👉 However, their enthusiasm was short-lived. Emilly noticed a mysterious figure, always lurking in the background, seemingly eavesdropping on their conversations. The team dismissed it as paranoia, but the feeling of being watched persisted. 👉 The next day, during a crucial meeting with a potential client, their presentation was interrupted by a power outage. In the ensuing chaos, Emilly’s laptop, containing all their research and the new idea, was stolen. Panic set in as they realized the gravity of the situation. 👉 Determined not to let their hard work go to waste, the pharmacists embarked on a thrilling chase through the streets of Milan. Clues led them to an abandoned warehouse on the outskirts of the city. Inside, they discovered a rival pharmaceutical company, led by the enigmatic Dr. Rossi, who had been trailing them all along. 👉 A tense confrontation ensued, with Emilly and Victor negotiating the future of the groundbreaking idea. In a surprising twist, they reached a compromise: a partnership that would benefit both companies and revolutionize the industry. 👉 As the conference concluded, Emilly and her team returned home, not just with new contracts, but with a powerful alliance and a renewed sense of purpose. The suspenseful journey had taught them the value of trust, collaboration, and the relentless pursuit of innovation. #PharmacyAdventure #InnovationJourney #MilanChase #PharmaPartnership #TrustAndCollaboration #IndustryRevolution #SuspensefulJourney #GroundbreakingIdeas

6

Ho appena finito il corso “Measure What Matters: Succeeding with Objectives and Key Results (OKRs)” di Measure What Matters, John Doerr e Ryan Panchadsaram! Dai uno sguardo: https://lnkd.in/db3vZZp3

8

1 commento

I'm thrilled to share highlights from our recent meeting held in the beautiful landscape of Italy. This gathering brought together our Europe country leaders to discuss our strategy on a global level, future mindset, leadership principles, and the imperative need to continue with our innovation efforts.   Our 2 day meeting session was filled with interesting discussions. We delved deep into our global strategy, exploring how we can harmonize our efforts across different regions to create a more cohesive and impactful approach. Emphasizing a future mindset, we explored emerging trends that are set to redefine our industry and shape our strategic direction. We examined the principles that underpin effective leadership in today’s dynamic environment, focusing on how we can lead with purpose, resilience, and adaptability. It was inspiring to see the commitment to not only drive business success but also to foster a culture of innovation and continuous improvement.   This experience was not only productive but also incredibly interesting and inspiring. Together, we can lead with purpose and drive transformative change.   #tevapharm #tevapharmaceuticals #tevaotc #internationalmeeting #Leadership #Innovation #GlobalStrategy #FutureMindset #GMSummit  

208

4 commenti

Sharing a great post on key takeaways from #CPhIMilan and the evolving CDMO and pharmaceutical market from our Daniele Giavini

3

1 commento

if you are interested learning how Ariceum Therapeutics exploits intranuclear targets to develop new anti-cancer drugs, meet my colleagues to learn more about #ATT001 #oncology #radiopharmaceuticals

5

Wow, what a fantastic event to have been a part of! I guided 400 women leaders across pharma through day 1 of the #hbaels ; together we learned: - There is still much work to do to reach gender parity, using the gender pay gap as an example we oscillate between 11-14% and 2023 was 12.8% - Diverse leadership make better decisions. Alicia C. Staley grounded us in WHY gender equality is so important by sharing her journey as a patient - Christina Busmalis showed us the fantastic opportunity AI represents to speed up drug development, but there is a female data gap which creates inherent biases - Yasmin Baba highlighted this data gap and showed us how femtech can be a part of the answer but... - ...it needs a $7 trillion investment, currently 2% of VC investment is in femtech - To increase the funding we need to make the businesses that could be a solution a success so lean in! - Alex Brock led a fantastic panel of industry leaders sharing their perspectives on AI in healthcare and femtech and how they are embracing them #hbaels #medicalcommunications #syneoshealth

29

3 commenti

Still starving 😬 about #AI and what’s going on in the industry? 🤖 Looking for #diverse AI perspective?🧏‍♀️ Hence, don’t think twice and join me at #AIHubFrankfurt on October, 23 and contribute to the panel discussion about “Ethics and Gender Parity in AI”👭🚀 🔜 Looking forward to see you next week… #AIWeekFrankfurt #AIHubFrankfurt #Innovation #AIWeek #AIW24 #womenintech #LifeForward

62