Eisai Co., Ltd.’s Post

Since its inception in 1995, the DUPHAT_UAE conferences have evolved into globally acclaimed pharmaceutical events. Professionals, academicians, and experts have played a pivotal role in elevating DUPHAT's stature and recognition on the international stage. Esteemed organizations such as ASHP, EUFEPS, ESCP, SHPA LTD, ISPE, ESOP, International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT), ACPE inc, and others have consistently #supported and #patronized the #conference , fostering greater #collaboration and #cooperation. The continuous backing of the Dubai Health Authority has been instrumental in DUPHAT's ascent, solidifying its position as the premier #pharmaceutical #conference in the region. Click the link to watch the highlights: https://lnkd.in/dw6cU4xg #health #care #wellness #fitnessmotivation #fitnessfirst #medicine #hospitals #healthcare #pharmaceutical #technology #packaging #modern #government #events #movement #change #artificialintelligence #robotics #science #vaccination #pfizer #healthcare #patientcare #optimization

Article: Survey of Human Oxidoreductases and Cytochrome P450 Enzymes Involved in the Metabolism of Chemicals, DOI: 10.1021/tx500444e We analyzed literature resources and calculated the fractions of the oxidoreductase enzymes FMO (microsomal flavin-containing monooxygenase), AKR (aldo-keto reductase), MAO (monoamine oxidase), and cytochrome P450 that participate in metabolic reactions. The calculations show that the fractions of P450s involved in the metabolism of all chemicals (general chemicals, natural and physiological compounds, and drugs) are rather consistent with the findings that > 90% of enzymatic reactions are catalyzed by P450s. Regarding drug metabolism, three-fourths of the human P450 reactions can be accounted for by a set of five P450s: 1A2, 2C9, 2C19, 2D6, and 3A4, and the largest fraction of the P450 reactions is catalyzed by P450 3A enzymes. P450 3A4 participation in the metabolic reactions of drugs varied from 13% for general chemicals to 27% for drugs. This work is an effort to add to previously published papers: Rendic, S., and Guengerich, F. P. (2012). Contributions of human enzymes in carcinogen metabolism. Chem. Res. Toxicol. 25, 1316 1383. Rendic, S. (2002) Summary of information on human CYP enzymes: Human P450 metabolism data. Drug Metab. Rev. 34, 83 448. Rendic, S., and Di Carlo, F. J. (1997). Human cytochrome P450 enzymes: a status report summarizing their reactions, substrates, inducers, and inhibitors. Drug Metab. Rev. 29, 413–580.

The present text contains the following updates: A discussion of ethanol metabolism by ADH and P450 enzymes is updated, & additional literature is cited (pp. 37–38). The text presents the updated data for the text/book Metabolism of Drugs and Selected Xenobiotics and publications Update Information on Drug Metabolism Systems-2009, Part I (PMID: 20307256) and Update Information on Drug Metabolism Systems-2009, Part II Summary of Information on the Effects of Diseases and Environmental Factors on Human Cytochrome P450 (CYP) Enzymes and Transporters ( PMID: 20302566). Newly added tables, e.g., Tables 3.4.1-2. and 3.4.1-3 and discussions (Chapter 10.3–3). Additional attention is put to the metabolism of PHYSIOLOGICAL COMPOUNDS (e.g., function, substrates, inhibitors, inducers) covering the 22 (of the total of 57) human P450s. The tables are related to the publication: Human cytochrome P450 enzymes 5-51 as targets of drugs and natural and environmental compounds: mechanisms, induction, and inhibition—toxic effects and benefits. Rendic SP, Peter Guengerich F. Drug Metab Rev. 2018 Aug;50(3):256-342. doi: 10.1080/03602532.2018.1483401. PMID: 30717606

The Chacruna Institute concluded today our trilogy of articles of contribution to the current conversation. Check this piece by Ali McGhee, PhD https://lnkd.in/gxbmkGjg

Article: Roles of selected non-P450 human oxidoreductase enzymes in protective and toxic effects of chemicals: Review and compilation of reactions The paper gives an overview of the metabolic reactions of drugs, natural products, physiological compounds, and other (general) chemicals catalyzed by Flavin monooxygenase (FMO), monoamine oxidase (MAO), NAD(P)H quinone oxidoreductase (NQO), and molybdenum hydroxylase enzymes (aldehyde oxidase (AOX) and xanthine oxidoreductase (XOR)), including roles as substrates, inducers, and inhibitors of the enzymes. The metabolism and bioactivation of selected examples of each group (i.e., drugs, “general chemicals,” natural products, and physiological compounds) are discussed. We identified a higher fraction of bioactivation (toxication) reactions for FMO enzymes than other enzymes, predominately involving drugs and general chemicals. With MAO enzymes, physiological compounds predominate as substrates, and some products lead to unwanted side effects or illness. AOX and XOR enzymes are molybdenum hydroxylases that catalyze the oxidation of various heteroaromatic rings and aldehydes and the reduction of several different functional groups. While neither of these two enzymes contributes substantially to the metabolism of currently marketed drugs, AOX has become a frequently encountered route of metabolism among drug discovery programs in the past 10– 15 years. XOR has even less of a role in the metabolism of clinical drugs and preclinical drug candidates than AOX, likely due to narrower substrate specificity. The literature indicates that several compounds that are substrates of non-P450 oxidoreductases are also substrates of one or more P450s or other enzymes, and they might also interact with drug transporters. It is shown that multiple metabolic properties of a compound/drug have to be considered when drug-drug metabolic interactions or toxicity caused by a compound is evaluated.

What should the EU clinical trial ecosystem in 2030 look like? How do we get there and ensure it is competitive and attractive? How do we ensure CTR implementation reaches its maximum potential and we get the benefits it was designed to deliver? How do we maximise cross-stakeholder collaboration to achieve our common goals? All of these are topics that we could cover at the next DIA Europe 2025 in Basel. If you have ideas for other topics that would lead to thought-provoking discussions on current and future topics for clinical trials, start writting and submit your abstract today! The deadline for abstracts’ submission to DIA Europe 2025 is fast approaching - don't miss this chance to showcase your work at one of the most dynamic conferences in the pharmaceutical arena. 📅 Deadline: 14th May 2024   As one of the DIA Europe 2025 Topic Leads for the Clinical Trials Innovation track, together with Monique Al, I'm eagerly looking forward to reviewing all the abstracts and building engaging sessions that reflect the cutting-edge research and innovation in our field. Your contribution could shape the discussions and insights shared at the conference.   Abstracts can be submitted here: https://lnkd.in/eQ5YjwUZ Let's make DIA Europe 2025 unforgettable together! #DIAEurope2025 #AbstractSubmission #Innovation #Research #Healthcare 

Olon's events schedule for 2024 is on our website! Whether you need high-potency #API, Generic/Biosimilar API, or de novo process development & robust #CMC support, come meet with us to discuss high-quality & highly sustainable ways to meet your #GMP project goals. Hope to see you soon! #CDMO #ProcessDevelopment #ProcessOptimzation #ProcessValidation #Bioprocess #pharmaceuticalmanufacturing #HPAPI #ADC #NCE #QbD #analyticalchemistry #analyticaldevelopment #drugdevelopment #DMF #organicchemistry #sustainability #ESG #esgcompliance #greenchemistry #IND #BLA #RegulatorySubmissions #antibodydrugconjugates #biologics #biosimilars #biosimilar #Generics #GenericDrugs #clinicaldevelopment

Boston Scientific wins Farapluse approval in China

✨ China Big Favour Policies for Foreign Investment in the Healthcare Sector ✨ 👍1. The Special Administrative Measures (Negative List) for Access of Foreign Investments (2024 Edition) was issued on Sep. 8. After this revision, the restrictions on foreign investment access in China's manufacturing sector have been removed. 👍2. Starting September 5, Hainan implemented a "Zero Tariff Policy for Drugs and Medical Devices in the Hainan Free Trade Port". Drugs and medical devices that are exempted from import tariffs and import value-added tax in this notice include: 1. Imported drugs and medical devices that have been approved for registration in China; 2. Drugs (excluding vaccines) and medical devices that have not yet been approved for registration in China according to relevant regulations of the State Council, but are approved by the Hainan Provincial People's Government to be imported and used in the pilot zone. 👍3. China’s Ministry of Commerce, the National Health Commission, and the National Medical Products Administration issued a notice announcing the expansion of pilot programs for foreign investment in the healthcare sector, marking a significant relaxation of China’s long-standing restrictions on foreign investment in the healthcare industry. Foreign-invested enterprises will be allowed to engage in the development and application of human stem cell and gene diagnostic and treatment technologies in Beijing Free Trade Zone, Shanghai Free Trade Zone, Guangdong Free Trade Zone, and Hainan Free Trade Port. It also permits the establishment of wholly foreign-owned hospitals (excluding traditional Chinese medicine, and the acquisition of public hospitals is also excluded) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and Hainan Island. MediCore has extensive regulatory consulting experience in medical device sector and has assisted thousands products to register and successfully obtain the appropriate registration certificates. If you are interested in China's medical deivice market, don't let regulations stop you! Get in touch with MediCore today! 🔜 https://lnkd.in/g9-VmJT2 📧 han@medicore.com.cn