Yonni Shem-Tov’s Post

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

It's a jam-packed event for Qinecsa Solutions at World Drug Safety Congress Europe. Stop by booth #55 to find out how they are #advancingdrugsafety to the next level!

Very nice piece summarising a talk on key elements to consider when building efficient regulatory documents

Use MVA partner meetings to raise awareness of your technology, competencies and expertise among potential partners and customers in the Medicon Valley cluster! We are fully booked in Q2 – see some of the upcoming MVA partner meetings co-organized with dedicated MVA member companies below – but we are open for business from mid September and onwards. In other words, don´t wait too long if you plan to use the MVA partner event concept to raise awareness of your special competencies and expertise and reach out to potential partners and customers in the region. We already have the first Q3 meeting in the pipeline and Q3 and Q4 are typically quite busy! Upcoming partner meetings: 4th of June: Addressing the complexity of immunogenicity testing with BioAgilytix https://lnkd.in/gJKnZit9 7th of June: The strategic considerations to successfully navigate the regulatory complexities of targeted medicines with Cencora PharmaLex https://lnkd.in/dcWhGX4j 11th of June: How to Ensure Compliance with EU GMP Annex 1 – a practical perspective with Cencora PharmaLex https://lnkd.in/dnguxS_E 12th of June: Rationalizing the Preclinical-Clinical Hurdle – How to Overcome the Toxicology Exposure Challenge with Quotient Sciences https://lnkd.in/dvuS2k57 19th of June: A Strategic CDMO Approach in Drug Development and Commercialization with FAREVA https://lnkd.in/dcERAm26 Learn more about the three different partner event concepts, the attractive pricing and risk sharing model and how to learn more on the links below MVA Good Morning Meetings: https://lnkd.in/dEn96V3c MVA Boost Seminars: https://lnkd.in/eMATzSDi MVA Full Day conferences: https://lnkd.in/d4m9nYeD Any questions, reach out to Director, Member Engagement and Communication, David Munis Zepernick, dz@mva.org https://lnkd.in/dwericeY

Register now for the 2024 Avoca Quality Consortium Summit, an industry-wide virtual event on May 14-15! Andy Lee, senior vice president, Head of Global Clinical Trial Operations, Merck, will kick off the Summit with opening remarks, highlighting that quality consists of getting it right the first time. Andy leads and manages all operations related to the conduct of Merck’s clinical trials, with particular focus on global in-patient studies that are designed and executed to meet cost, speed, and quality standards. Don’t miss his expert insights on maximizing time in order to modernize clinical trials. Learn more and register: https://lnkd.in/gHPTG5m2  ______________  As a benefit of membership, Avoca Quality Consortium (AQC) member companies will receive four complimentary passes and a discounted rate for additional attendees. Not a member of the AQC? Click here to learn more: https://lnkd.in/dfAyNRr Hosted by Avoca, A WCG Company. #WCG #AQCSummit #ClinicalTrials #Quality #Summit 

Very proud of our Director of Compliance - Jason Chung - on his role as the assistant lead for HDA's Asian American and Pacific Islander Employee Network (APEN) ERG! We love to see our employees take active roles to make healthcare a more inclusive, diverse industry. Here's a quick preview, but be sure to read the full interview with Jason and Vidhya below! HDA: What do you hope to accomplish through the industry-wide ERG? What does success look like?  Chung: I hope to be able to facilitate the building of a program where people from diverse cultures, backgrounds and professions can connect and grow through that diversity. Success [looks like] increased active participation and more importantly the quality of the feedback from active members. The current immediate initiative is to grow active participation in APEN. Read the full article here: https://lnkd.in/esWxyptT

ALL THINGS ATMP ✅ Recently, ATMP Sweden hosted 12 speakers over 3 days, in a well-executed online conference; the ATMP World Tour 2024 🌍🌎🌏 It covered a wide range of ATMP-related topics, presented by international experts. The recordings from the event are available until the end of this month and you should go check it out, if any of the points below resonate with you: ⭐ It is important to be an ATMP advocate and make a positive impact ⭐ Regulatory systems should be evidence-based and keep up with the speed of innovation ⭐ Access to visible role models in CGT is needed ⭐ Accelerated regulatory approvals are necessary, especially in the rare disease space ⭐ Commercialization of ATMPs is relevant; and keeping ATMPs non-commercial is also important It is evident that the field of ATMP is complex and requires collaboration between a multitude of disciplines to succeed and bring the beneficial therapeutic effects all the way to the patients. Let's keep up the stamina together🚀 #ATMP #cgct #recommendation #collaboration

DIA Europe 2024 is coming up and Trials@Home will be there! On Wednesday, 13 March 2024, 15:10 – 16:20 CET, Dimitrios Athanasiou MBA, our World Duchenne Organisation project partner, will be a panelist on “Clinical Trials with Decentralised Elements” (S0202, Track: Clinical Trials Development & Operations) Session Description: This session will discuss the evolving global landscape for decentralised clinical trials, to (1) impact of recent and ongoing DCT initiatives and activities by various stakeholders (2) evaluate where we are in fulfilling the promise of DCTs for each stakeholder (3) debate what still needs to be done to advance the use of decentralised elements. More info here: https://lnkd.in/gJ-XEptC

Gulf sovereign wealth funds are continuing to consolidate assets, grouping them into platforms to become regional and global champions. ADQ has consolidated its life science assets into a new platform, Arcera, which seeks to align with #AbuDhabi Economic Vision 2030. The value of the new #pharma company exceeds US$2 billion, based on Global SWF data, and is likely to grow rapidly ahead of an IPO - potentially next year. Global SWF takes a look at Arcera's building blocks and what lessons it may take from ADQ's consolidated healthcare platform, PureHealth, which listed in December: https://lnkd.in/ePvU4xiB

@Matt Wetzel @Julie Tibbets An excellent overview of where we're at and where we could be heading as the complex legal, regulatory and compliance requirements are ever changing for the life sciences, medtech, and diagnostic industries.