VTU Group’s Post

The conversation on the future of #pharma is continuing at #LAC24 with a focus on #UPC and unitary UPC. European Commission - Gedeon Richter Pharma GmbH - Polpharma

🌟 Honored to Present at GMDS Conference! 🌟 Yesterday, I had the pleasure of presenting the latest results from the EGDE group at the GMDS conference in Dresden during the ATF workshop organized by Ralf Bender, Friedhelm Leverkus, and Anika Großhenning. A key topic we discussed: In Germany, the G-BA cited reasons other than a "dramatic effect" in 84% of cases, and IQWiG in 60%, for accepting single-arm studies with/without external control arms. Some of these reasons included a very small target population or the absence of therapeutic alternatives. Interestingly, in about 1/3 of the cases, no evidence was presented to G-BA and IQWiG at all. This could be due to reasons not being well understood by pharmaceutical companies or the high demands for adjustments required for indirect comparisons. We posed an important question: Should we consider better clarifying the requirements or even lowering them? After all, lower evidence is still better than no evidence at all. 📊💡 #GMDS2024 #HealthData #Pharma #EvidenceBasedMedicine #ClinicalTrials #RegulatoryScience #HealthcareInnovation

Work with us on your samples to explore how powerful the application of this technology through our ED-1 system can be, for your solid-state challenges

The much-anticipated Draghi report on Europe’s competitiveness emphasises the significant contribution of the pharmaceutical industry to the EU’s economy. Faced with major obstacles in R&D funding, drug approval times and market fragmentation, Europe should: - Sustain and expand R&D investment, particularly in innovation hubs for advanced therapies. - Simplify regulatory procedures to accelerate drug approval timelines. - Harness the potential of digital health data through the European Health Data Space (EHDS) and AI to enhance innovation efficiency and through the whole medicine lifecycle. #EuropeanUnion #Healthcare #Pharma

This week I attended an insightful presentation from Ema Paulino and Dr Pranab Kalita at the 2024 International Pharmaceutical Federation (FIP) congress. A great discussion on the role of RWE in addition to RCT to support patient outcomes. It is important to think about the role of RWE and Big Data collection. How it can support pharmacists deliver the best health outcomes plus track and measure patient quality of life impacts. #Haleon #Pharmacists #FIP2024

The Role of the ELDICO ED-1 in the future of Pharma and CRO Innovation: The pharmaceutical industry and Contract Research Organizations (CROs) are constantly pushing boundaries to accelerate drug development, improve efficiency, and deliver life-saving medicines. At the heart of this innovation lies the ELDICO ED-1. Over the coming weeks, we will be showing you why, sharing material from the Pharma world and the CROs who have already chosen the ELDICO ED-1. We will be highlighting the growing role of ELDICO with leading CROs such as Triclinic Labs, Inc. and Holodiag - Now part of Icrom who have recently purchased an ELDICO ED-1 to stay ahead in a competitive industry. We will share real-world applications from polymorph analysis to impurity identification as seen from our partners Ardena and TeraCrystal. This series will not only celebrate various achievements but also explore the profound implications of the ELDICO ED-1 for the future of pharma and CROs. Stay tuned! To request some initial information and already take a closer look, click here https://hubs.li/Q034h2h00 #MicroED #3DED #PharmaInnovation #CROs #DrugDiscovery #LifeSciences #Innovation #pharma #polymorph #crystallisation #solidstateanalysis #drugdevelopment #eldico

This an interesting read. Of particular relevance to me - skills shortages continue to be a concern for the industry, and so it's more important than ever that organisations consider not just their talent acquisitions strategies, but also talent retention and succession planning

#Flavonoids & #Polyphenols #Biomarkets to establish #mode_of_action and efficacy of feed additives in animal nutrition. #Flavonoids is a real strategy and complementary to find alternatives to AGP and as ZnO replacement. To make things easier to technical teams, these anti-inflammatory agents should be proved as first step IN VITRO and later to show its benefits IN VIVO. The use of inflammatory markets are key for this selection. Problems due to inflammatory process 1.- Lower feed intake 2.- Catabolism muscle 3.- Diseases 4.- Increasing pathogens (Ej.Clostridium) 5.- Affected INTESTINAL PERMEABILITY. 6.- Increasing MALABSORTION process. #Biomarkers Less invasive: Plasma and acute phase proteins. NON-invasive: Faecal, urine, saliva.   Biomarkers in human - Intestinal fatty acid binding protein (IFABP) (Cell damaged, inflammation) - Claudin 3 (permeability, link inflammation) - Pancreatitis Associated Protein (PAP,reg3) (Inflammation) - MPO (Mieloperoxidase) - Acute Pase proteins (haptoglobin) #PigIntestinal Enterocyte - Intestinal fatty acid binding protein (IFABP) (Cell damaged, inflammation) - Claudin 3 (permeability, link inflammation) - Pancreatitis Associated Protein (PAP,Reg3) (Inflammation) #Blood Acute Phase proteins (haptoglobin) Inflammatory cells markers MPO (Mieloperoxidase) Enterotoxigenix E.coli test post infection Human Elisa cross reacts For acute enterocyte damage #Plasma, Urine and faeces PAP Pancreatitis associated protein (also Reg 3) mRNA level (Elisa Test) #CONCLUSIONS FOR ANIMAL NUTRITION 1.- Intestinal health can be determined by using faecal markers IN VIVO and cell system IN VITRO. 2.- Inflammatory markets such as PAP and MPO similar results different species. 3.- Faecal MPO is the cheapest and simple 4.- Other parameters as villus/ crypt ratio, microbiota provide extra information, 5- IN VITRO markets are essential to establish comparative feed additives activity. (check with your experts the key ones). #Biomarkers, #Flavonoids, #Polyphenols, #Bioflavex, #HTBA

I am excited and thrilled to speak on this important topic comparing the various bioavailability enhancing technologies with case studies. Overlooking Softgel as a dosage form whether it is for DCS II or IV and considering it as a last resort instead of making it a first choice is proving costly both in terms of time and money especially with new treatment modalities like Protein degraders and other poorly bioavailable molecules. Please join us to see how we BUST various MYTHS with data/ facts on the MOST versatile dosage form ever, (that is Softgel)and see it for yourself to convince..

The PreIND Meeting is your first and best chance to get off on the right foot with #FDA. Check out our guide for making the most of this important milestone. https://lnkd.in/ggrBPDcR #preind #ectd #regulatoryaffairs #regulatoryoperations #pharma #lifesciences #biotech #meetingmanagement