Silvia Mauri

👋 Meet Us! We're excited to tell you that Vincenzo and Alberto will be attending the European Pharmacovigilance Congress organized by Pharma Education Center! 🎉 They are looking forward to connecting with fellow professionals, sharing insights and engaging in conversations about the latest trends in pharmacovigilance. It's going to be a fantastic opportunity to collaborate and learn from each other. If you'll be there, come say hello and join the conversation! #TruliantConsulting #Pharmacovigilance #RiskManagement

40

#Rheumatoid diseases often present with non-specific symptoms early on, making clinical diagnosis challenging. At Samir Medical Supplies in collaboration with DIESSE Diagnostica Senese S.p.A., we offer a wide range of Laboratory tests:   CHORUS ANA-8  CHORUS ANA-SCREEN  CHORUS anti-CCP  CHORUS Cenp-B  CHORUS dsDNA-G  CHORUS dsDNA-M  CHORUS ENA-6 S  CHORUS Jo-1   CHORUS RF-G  CHORUS RF-M  CHORUS Scl-70  CHORUS SM CHORUS SnRNP-C  CHORUS SS-A  CHORUS SS-B  CHORUS U1-70 RNP    These tests not only confirm the presence of #autoimmune activity but can also help differentiate between RA and other #inflammatory or autoimmune conditions. Early diagnosis through these markers enables timely intervention, which is crucial in preventing irreversible joint damage and improving long-term outcomes.   To learn more about CHORUS and its tests, visit our site below and scroll down to Clinical Lab and click on Special Chemistry Test.   https://lnkd.in/dUZVtTeR

39

What does the future of drug manufacturing look like? What can a CDMO do to  manage the quickly changing landscape of pharmaceuticals? In this Endpoints News webinar, Alessandro Maselli, CEO of Catalent Pharma Solutions, talks with editor John Carroll about: -- Stability, trust and growth management that come from working with CDMOs -- What’s changing in the CDMO industry (consolidation, innovations, NDAs) -- The effect of “reshoring” from Asia to the US and/or Europe, thanks to the BIOSECURE Act and other factors At Ritedose, we can help you manage growth and deal with the changing CDMO climate! Watch the webinar recording: https://lnkd.in/e7z6BP6u

13

🔎 Are you curious about AVITHRAPID's WP4 (Dompé farmaceutici SpA) ? 👀 Take a look below! 👇 📑 Work Packages ⚗ #Drugdiscovery is a multidisciplinary effort. AVITHRAPID brings together a team of highly skilled experts in molecular modeling, structural biology, assay development, toxicity profiling, antiviral drug discovery, animal model testing, and clinical trials. 🤳 Several partners have successfully worked on the discovery of novel antiviral substances. In addition, one pharma partner has identified a small molecule drug against #Zika #virus that is ready to enter #clinical #trials. 🔬 The unique portfolio of substances ranges from validated hits to pre-clinical candidates with proven in vivo efficacy. 💻 To further develop and validate this portfolion the AVITHRAPID consortium will work together in 8 Work Packages (WPs) which operate as an integrated pre-clinical drug discovery value chain.

10

💊 Missed last month's webinar on how the pharmaceutical industry can embed nature into sustainability efforts? Catch the replay! Quantis' Pharma Lead Emmanuel Hembert and Angelini Pharma's Stefano Germini share insights on how pharma companies can understand their nature dependencies, mitigate environmental risks and build resilience. 🎥 Watch the webinar here: https://bit.ly/3YWPtZS

14

Join Valeria Grigoriev, MBA, our Senior Regulatory Affairs Specialist, along with presenter’s from Phortas and the Head of Scientific Advice from the #EMA.   RAPS Europe Euro Convergence   Tues May 7, 13:45 – 14:45 CEST Location: A 05 + A 06   Meeting EMA and FDA: Formal and informal pathways, in search of alignment   Why attend? • Enhance regulatory engagement: Understand how scientific advice and informal meetings can improve communication and collaboration with regulatory agencies, enabling participants to establish effective lines of communication throughout drug development. Evaluate whether alignment with EMA and FDA is an actually achievable Parallel SA (PSA) meeting goal. • Optimize development strategies: Establish suitable type of topics and questions to be raised during informal versus scientific advice meetings, as well as get the best practices for concluding an exhaustive briefing package. Learn how to tailor drug development plans based on insights gained from regulatory interactions, allowing participants to make informed decisions, mitigate risks, and expedite the development process. • Improve compliance and quality assurance: Discover best practices for maintaining compliance and ensuring high-quality standards throughout drug development by applying lessons learned from successful Scientific Advice and informal interactions with the #FDA and EMA.   A full description of the session follows:   As regulatory affairs professionals we are familiar with the official meetings offered by the regulatory authorities EMA and FDA and, their importance for adequate drug development. An example of optional meetings offered during various time points in the product life cycle to support the resolution of scientific and regulatory issues is Scientific Advice (SA). These meetings in the US are typically referred to, for example as Type, A, B or C meetings. SA is not legally binding on authorities regarding any future marketing authorization application for the medicine concerned. In this way, no pre-evaluation of the results of the studies or conclusions on benefit-risk assessments can be granted. And still, the increase in the number of scientific advice requests remains constant. Interestingly, few regulatory professionals are familiar with all types of interactions offered by both EMA and FDA. Rarely used authority interactions, namely EMA SME briefing meetings and FDA INTERACT or pre-breakthrough meetings, hold significant benefits for drug development. In this session, we will discuss the advantages and disadvantages of SA and informal meetings as well as best practices for the preparation of such meetings. A reflection from a 5-year Parallel (PSA) program review will be presented on whether alignment with EMA and FDA in a PSA meeting is an achievable goal. Besides identifying the best candidates and the most suitable development phase to apply, the most noteworthy findings will be emphasized. #regulatory #pharmaceuticals 

15

2 commenti

📢 Exciting News in Biopharma & Supply Chain Management! Biotest AG and Kedrion Biopharma - USA have signed a ground-breaking agreement for the U.S. commercialisation of their new immunoglobulin product, following FDA's recent BLA approval on June 13, 2024. As a procurement and supply chain recruiter, this partnership marks a significant milestone. The seven-year agreement, once finalised, is expected to drive approximately $1 billion in sales, marking Biotest’s largest commercial deal and setting a new standard in biopharmaceutical supply chain operations. Key Highlights: 🌐 Strategic Impact: This agreement underscores the crucial role of strategic partnerships in biopharma. Kedrion’s expertise and extensive U.S. distribution network will be pivotal in ensuring the success of Biotest’s product. 🚚 Supply Chain Excellence: The collaboration highlights effective supply chain management, crucial for rapid market entry. Kedrion’s ability to navigate U.S. market complexities promises a seamless journey from manufacturing to patient delivery. 🌟 Innovation & Quality: Biotest’s immunoglobulin, manufactured at their advanced “Biotest Next Level” facility, sets new benchmarks in production innovation. Its FDA approval, based on stringent safety and efficacy evaluations, emphasises a commitment to maintaining supply chain quality. 💼 Market Dynamics: Planned for Q1 2025, the U.S. launch addresses rising demand for immunoglobulin therapies. Financial terms underscore Kedrion’s role in accelerating market penetration, ensuring swift patient access and creating a robust, efficient supply chain. This collaboration is set to elevate demand for supply chain professionals adept at regulatory navigation and logistics management, vital for ensuring quality and efficiency in therapy rollout. Excited about the positive impact on patients and the biopharma supply chain landscape! #Biotest #Kedrion #SupplyChain #Procurement #Biopharma #Innovation #FDAApproval #Immunoglobulin #MarketLaunch #Distribution

8

1 commento

➡ To all process equipment suppliers in Life Science: #autoclave #asepticfilling #washer #isolator #watersystems #wfi #puresteamgenerator #cleanroom #bioreactors #fermenter and more 🔧 Elevate Your Project Optimisation and Efficiency with PQE Group's Expert Services!🔧 We are your go-to partner for comprehensive support and solutions, tailored to meet your specific needs. Our extensive range of services includes: ✅ Commissioning and Qualification Support   - Expertise in FAT/SAT-IOQ protocols writing and execution ✅ Data Integrity & CSV   - Ensuring your data is accurate and compliant ✅ Resources Full-time Involvement for Internal Validation Department   - Dedicated professionals ready to integrate with your team ✅ Calibration Services   - Utilizing our own instruments park to maintain precision ✅ QMS Improvement Support   - Enhancing your Quality Management System for better compliance and efficiency ✅ GxP Training   - Comprehensive training to ensure your team is well-versed in Good Practice standards ➡ Why Choose PQE Group? ✔️ Worldwide Technical Structure Capabilities   - Leveraging our global presence to support your needs ✔️ Local Services with Global Governance   - Ensuring consistent and high-quality service wherever you are ✔️ Framework/Master Service Agreement   - Simplifying collaboration with flexible agreements ✔️ Cost-Effective Solutions   - Delivering value without compromising on quality ✔️ Deep Expertise in Regulated Environments, Pharma Standards   - Specialized knowledge to navigate stringent regulations ✔️ Strong Knowledge of Process Manufacturing Equipment   - Deep understanding of your equipment and processes ✔️ Focused Expertise in Commissioning & Qualification   - Ensuring your systems are operational and compliant ✔️ Use of In-House Measurement Instruments   - Reliable and precise measurements with our equipment ✔️ Turn Key or Time & Material Delivery   - Flexible delivery models to suit your project needs ✔️ Multi-Cultural and Language Approach   - Bridging communication gaps with our diverse team Let PQE Group partner with you to elevate the performance, compliance, and reliability of your equipment. Share your project infos and the challenge you will face and we will tailormade a solution to support you! Reach out to me at [email protected] and discover how we can add value to your operations! #ProcessEquipment #CommissioningSupport #DataIntegrity #CalibrationServices #QMSImprovement #GxPTraining #ValidationServices #GlobalExpertise #CostEffective #PharmaStandards

12

The lesson by Alessio Bove, our Pilot Plant Manager at the Italian Dipharma Francis site in Mereto di Tomba (UD), has become a fixed appointment in the University of Pavia’s Master in Drug Design and Development. For several years now, our colleague Alessio Bove has been invited annually to share his expertise. Last week, at the 2024 edition of the Master, Alessio presented “API Production: #technologytransfer and #troubleshooting management”. How does #Dipharma ensure its processes are robust and reproducible? How does the company assess the safety of new processes? Can #Dipharma consistently meet customer deadlines? Alessio addressed these questions in his presentation and detailed how technology transfer is a pivotal phase in #drugdevelopment, greatly influencing the success of both product development and subsequent commercial manufacturing. He explained Dipharma's approach to mastering this complex step by: 1.     Gaining comprehensive insights into potentially critical process parameters during the familiarization and optimization stages of process development. 2.     Conducting systematic HazOp studies with multidisciplinary teams of experts to identify and mitigate hazards, ensuring the best solutions for process safety management. 3.     Implementing a thorough risk management strategy during the preliminary stages of industrial scale-up planning. Alessio Bove also highlighted #Dipharma’s commitment to meeting deadlines through a transparent and realistic timeline estimation process. This is grounded in our extensive #experience and aligned with customer expectations. Our approach involves keeping clients thoroughly informed throughout the process, ensuring clear and consistent communication about project progress. This transparency builds trust and assures clients of our dedication to delivering on time. Our unwavering commitment to robust and reproducible processes, comprehensive safety evaluations, and adherence to production timelines reinforces our pledge to provide the highest #quality products and services to our clients. To know more how we can support you, taking care of your needs: https://lnkd.in/ermD5P2 Dipharma Francis S.r.l; Dipharma Inc.; Università di Pavia; #research; #master; #apis; #CDMO; #cuttingedgetechnology #management #development #safety

77

1 commento

🌟 𝐀𝐭 𝐎𝐋𝐃 𝐏𝐇𝐀𝐑𝐌𝐀 𝐰𝐞 𝐚𝐫𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐞𝐱𝐜𝐢𝐭𝐞𝐝 𝐰𝐡𝐞𝐧 𝐨𝐟𝐟-𝐥𝐚𝐛𝐞𝐥 𝐮𝐬𝐞𝐬 𝐨𝐟 𝐀𝐏𝐈𝐬 𝐚𝐥𝐫𝐞𝐚𝐝𝐲 𝐤𝐧𝐨𝐰𝐧 𝐢𝐧 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐞 𝐚𝐫𝐞 𝐢𝐝𝐞𝐧𝐭𝐢𝐟𝐢𝐞𝐝!💡💡 A recent study https://lnkd.in/dYXZcCNr has highlighted the potential of repurposing the #asthma medication #budesonide for treating #pancreaticcancer. This innovative approach could open new avenues for effective #cancertherapies, utilizing existing drugs with well-known safety profiles. It's a promising step towards improving outcomes for pancreatic cancer patients, a disease known for its aggressive nature and limited treatment options. 👏Kudos to the researchers for their groundbreaking work! Let's continue to support and advocate for such innovative solutions in the fight against cancer. 🤓𝑊𝑎𝑛𝑡 𝑡𝑜 𝑘𝑜𝑛𝑜𝑤 𝑚𝑜𝑟𝑒 𝑜𝑛 𝐵𝑢𝑑𝑒𝑠𝑜𝑛𝑖𝑑𝑒? Contact us at 📧 [email protected] 🖥️ https://lnkd.in/encYiXcZ #cancerresearch #pharmaceuticalinnovation #healthcare #budesonide #pancreaticcancer #medicaladvancements #drugrepurposing #offlabel

7

Pricing and Evaluation Reforms Mark the Launch of Italy’s New Scientific-Economic Pharmaceutical Commission The Italian Medicines Agency (AIFA) has established the Scientific-Economic Pharmaceutical Commission (CSE) to improve drug pricing and evaluation. The CSE will replace previous committees, streamlining decision-making and increasing transparency. The commission will include representatives from various government sectors and feature flexible protocols, allowing remote participation. Patient associations and scientific societies will be consulted, and conflicts of interest will be declared annually. The CSE will have the power to act quickly in urgent situations. Overall, the new framework aims to improve access to innovative treatments and rationalize drug pricing and reimbursement in Italy. For more details please click the link! https://lnkd.in/dyZUtsqx #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

4

Top 5 Focus Areas of EU GMP Annex 1

56

2 commenti

The CEO of NCNbio srl MariaLuisa Nolli was yesterday in Rome for the 3rd EU-Innovation Network multi-stakeholder Meeting "Translating Innovation into access for ATMPs" organized by European Medicines Agency, AIFA Agenzia Italiana del farmaco and Heads of Medicines Agencies and chaired by Falk Ehmann (EMA) and Paolo Foggi (AIFA, SAWP). It has been a valuable open forum to discuss the present framework and identify further actions that could facilitate patient access to safe and effective #advancedtherapies. The conclusions have been wrapped up in the Round Table "The most pressing needs – proposal for the next concrete actions", which underlined the need for properly funding those treatments, in the words of Gonzalo Calvo Rojas - Hospital Clínic de Barcelona. As a matter of fact, at the moment CAR-T therapies appear not to be sustainable for all the patients (Andrea Biondi - Università degli Studi di Milano-Bicocca). In order to extend the access to care, suggests Alessandro Aiuti - Università Vita-Salute San Raffaele, we should prevent disinvestment by companies, for example reducing the costs of regulatory compliance and ensuring the appropriate #intellectualproperty protection (Riccardo Ena - Assobiotec). All the stakeholders, highlights Pia Rivetti di Val Cervo, PhD - AIFA, must cooperate with a view to have a smoother process and a faster access to the treatments. #atmp

28

Antibiotic Use in 2024: how is Italy scoring? 🔎 The recent #OsMed2023 Report by AIFA reveals concerning data regarding antibiotic use in Italy, emphasizing the urgency of proactive and regionally-coordinated efforts to combat antibiotic resistance. Despite slight reductions in usage, Italy still ranks among the EU countries with the highest antibiotic consumption rates—both in human and veterinary medicine. According to the 2024 National Report on antibiotic use (based on 2022 data), Italy, alongside Greece, maintains a top spot in Europe for the prevalence of antibiotic-resistant bacteria. Regional disparities are striking, with the South seeing significantly higher rates of antibiotic prescriptions (44.8%) compared to the North (30.9%), underscoring the need for nationwide guidelines on prescription appropriateness. 📉 Although antibiotic use has declined somewhat post-pandemic, recent data shows a worrying +6.4% rise in consumption. Nearly 4 in 10 Italians received an antibiotic prescription in the past year—a statistic that calls for immediate reflection and action. Italy’s experience is a critical reminder: antibiotic resistance is a threat that demands our sustained focus. Collaborative efforts to drive education, targeted policies, and more stringent prescription practices are essential if we are to reduce these rates and lead Europe toward a more responsible and sustainable approach to antibiotic use. https://lnkd.in/dNvf8MRC #AntibioticResistance #Healthcare

9

We are thrilled to announce our collaboration with LB Research srl - Clinical Trials Management at the highly anticipated Simposio AFI in 2024! With our innovative solutions and the expertise of LB Research, we are confident that we will make a significant impact. Take advantage of learning more about our groundbreaking solutions at booth #1. We are excited to meet you there and explore how we can help you achieve your goals. Let's make the most of this incredible event together! https://lnkd.in/dsc6hDY3 #clinicalresearch #healthcaredata #healthcareit #healthcaresoftware #data #healthcare #pharmaceuticals #digitalhealthcare #pharmaceuticaltechnology #clinicalresearch #clinicaltrials #digitalhealth #healthtechnology #healthtech #clinicalresearch #clinical #cro #clinicaldata #clinicaltrialmanagement #clinicalstudies #clinicaldataplatforms #remotehealthcare #remotehealth #clinicaloperations #clinicaldevelopment #clinicaloperations #clinicaldata #remotemonitoring #datamanagementplatform #datamanagement #pharma #lifescience #rwe #rwd #epro #sops #etmf #edc #sdv #edc #cra #rtsm #sae #uat #gcp #qa #ecoa #iwrs #esource #econsent

9

2 commenti

MedinCell X CARBOGEN AMCIS: A Partnership in Open Communication In the pharmaceutical industry, where the constraints and stakes are enormous, collaboration and open communication are essential for success. Damien STEFANELLI, Senior Process Development Leader at MedinCell, a pharmaceutical company specialized in long-acting injectables, highlights two key moments that exemplify the synergy between our companies. 🗣️ "One of the challenge we had was that our product was very viscous. MedinCell and CARBOGEN AMCIS were able to work together to overcome the technical issue and adapt the process by using high precision rotary piston pumps.” Discover the full story! Watch the complete video on our website to see how this partnership is driving innovation and achieving success. 🚀 🔗 https://lnkd.in/emG8Rfbe #CDMO #drugproduct

61

📢 We are proud to announce the launch of our new #InnovationPlan, aimed at strengthening our position in the #biopharmaceutical analytical services sector. With a strong focus on enhancing our capabilities and offering cutting-edge services, this initiative will enable us to contribute to providing higher-quality and safer #drugs 💊 💡 At the core of this plan, is innovation in technology, services, and organizational processes. By adopting new technologies, such as data encryption for improved traceability and transparency, we are setting new standards in manufacturing and drug #QualityControl. Funded by the Axencia Galega de Innovación, this 18-month project is a major step forward in our mission to support #DrugDevelopment processes globally. But our commitment goes beyond the company. We're proud to be boosting biotechnological #innovation in #Lugo, contributing to the region's growing #biotech ecosystem. Stay tuned for more updates on this exciting journey! 🚀 More info 👇 https://lnkd.in/d4SqWd_T #InnovaPeme

10

Billion-Dollar US-Distribution Agreement with Kedrion   We are happy to announce that we have established the framework for a long-term agreement with Kedrion Biopharma for the full commercialization and distribution of our new immunoglobulin in the United States, following the Biologic License Application (BLA) approval by the U.S. Food and Drug Administration (FDA) on June 13, 2024.   The framework in the form of a term sheet calls for Kedrion to purchase minimum quantities of our immunoglobulin product during the seven-year term beginning when the definitive agreement is finalized, representing approximately $1 billion in sales for Biotest.   "With our immunoglobulin product, we are very excited to enter this important market for our industry and are committed to developing and delivering more therapies to patients in the U.S. in the coming years. We have taken the first step towards this agreement with Kedrion for in-market commercialization, which represents our largest commercial agreement since the formation of Biotest," said our CEO Peter Janssen. "Based on Kedrion's proven experience and extensive coverage in this important immunoglobulin market, I am confident that our immunoglobulin product will be a commercial success in the U.S. and provide an additional meaningful treatment option to patients."   We are expected to start supplying our product to Kedrion in the fourth quarter of 2024. It is the first drug approved in the U.S. to be manufactured using an innovative process in our state-of-the-art manufacturing facility "Biotest Next Level". It has been evaluated for safety, efficacy and tolerability in two pivotal studies. Market launch is planned for the first quarter of 2025.   Biotest and the Grifols Group have collaborated with Kedrion in the U.S. market for several years. This agreement when finalized will be the largest commercial agreement signed by Biotest in its 78-year history. The financial terms reflect a rapid market introduction thanks to Kedrion's commercial and distribution expertise in the U.S. market and the growing demand for immunoglobulin therapies.   #Biotest #FromNatureForLife #Healthcare #Immunoglobulin #Kedrion #DistributionAgreement

575

31 commenti

Antibiotice, 𝘄𝗼𝗿𝗹𝗱𝘄𝗶𝗱𝗲 𝗹𝗲𝗮𝗱𝗶𝗻𝗴 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿 𝗼𝗳 𝗡𝘆𝘀𝘁𝗮𝘁𝗶𝗻 𝗔𝗣𝗜𝘀. For Nystatin (active substance) we have obtained the following certifications over time: 🔸 EU GMP 🔸 US FDA 🔸 Certification of Suitability According to European Pharmacopoeia 🔸 numerous approvals from clients and audit specialized companies (Rephine, SGS, Blue Inspection Body) from different parts of the world Since 2017, 𝗡𝘆𝘀𝘁𝗮𝘁𝗶𝗻 𝗔𝗻𝘁𝗶𝗯𝗶𝗼𝘁𝗶𝗰𝗲 has become the US Pharmacopoeia reference standard. Currently, the Nystatin produced by Antibiotice is sold in more than 60 countries worldwide. Let’s talk about it @ CPHI 𝗠𝗶𝗹𝗮𝗻, on 8-10 October. #TheFutureTogether #CPHI #pharmaindustry #CPHIMilan

84

1 commento