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DTSTART;TZID=Europe/Brussels:20230418T100000
DTEND;TZID=Europe/Brussels:20230419T190000
DTSTAMP:20230110T151000Z
CREATED:20230110T150742Z
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UID:5629-1681812000-1681930800@www.europabio.org
SUMMARY:CEBioForum 2023
DESCRIPTION:CEBioForum is a brand that has been creating a business environment related to biotechnology for over 20 years\, organizing the most important event of this type in the industry\, dedicated to the development of biotechnology in Poland and Europe \n\n\n\nCEBioForum 2023 will take place on April 18-19 in Warsaw \n\n\n\nBecause we strongly believe that networking is the basis for building lasting business relationships\, CEBioForum 2023 is held only face-to-face\, giving you a chance to make new connections with business partners\, scientists and decision makers from the government\, who contribute to biotech development in Poland and other CEE countries. \n\n\n\nCEBioForum 2023 is more then discussion panels\, networking and the opportunity to present your company. During the conference banquete\, we will honor outstanding people and companies with CEBioForum Awards 2023. \n\n\n\nSo save the date 18-19th of April and be with us in Warsaw at CEBioForum 2023. \n\n\n\n\nMore information
URL:https://www.europabio.org/event/cebioforum-2023/
CATEGORIES:External
ATTACH;FMTTYPE=image/png:https://www.europabio.org/wp-content/uploads/2023/01/Biomanufacturing-Policy-Summit-2023-1.png
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DTSTART;TZID=Europe/Brussels:20230418T150000
DTEND;TZID=Europe/Brussels:20230418T160000
DTSTAMP:20230406T134218Z
CREATED:20230124T170639Z
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UID:5708-1681830000-1681833600@www.europabio.org
SUMMARY:Development of Orphan Biologics: Challenges and Opportunities
DESCRIPTION:Webinar sponsored by Catalent \n\n\n\n\n\n\n\n\n\nThe development of therapies for rare diseases comes with distinct challenges\, including patient recruitment\, setting meaningful clinical endpoints\, manufacturing and supply and finding the regulatory and market pathway to ensure patients can access therapy. \n\n\n\nFor biologic products (growth factors\, monoclonal antibodies\, other complex proteins)\, development and production costs tend to be higher due to the complexity of the drug substance. To manage costs\, the clinical development and manufacturing and Chemistry\, Manufacturing and Controls (CMC) teams need to be aligned to ensure drug product is delivered on time to meet clinical trial needs. \n\n\n\nThese challenges sit within a wider regulatory and legislative framework for orphan medicinal products (OMPs) that defines whether companies can successfully develop a novel product to market and thus the decisions made for selecting therapeutics and target diseases early in development. \n\n\n\nDuring this webinar\, speakers cover aspects of clinical trial design for orphan biologics products\, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.Key Learning Objectives \n\n\n\n\nConsiderations in identifying meaningful clinical endpoints for orphan diseases\n\n\n\nOrphan clinical trial design considerations and strategies to ensure sufficient patient recruitment\n\n\n\nManufacturing and clinical supply strategies to ensure supply of clinical trial materials while collecting data needed to support NDA submission\n\n\n\nRegulatory and legislative frameworks that guide decision making for innovation in rare diseases\n\n\n\n\nAgenda \n\n\n\n15:00: Welcome and introduction – Claire Skentelbery\, Director General EuropaBio \n\n\n\n15:05: Current Development of Orphan Drugs in Europe – Matthias Schoenermark\, Professor\, President and CEO\, SKC Beratungsgesellschaft mbH \n\n\n\nProf. Schönermark opens the session with an overview of the current status of orphan drug development in the EU. He discusses the main challenges for market entry of new orphan drugs into the EU market and highlights key recommendations to drug developers to address these challenges. \n\n\n\n15:20: Orphan Biologics and CGT Development – CMC and Clinical Trial Supply Considerations – Wai Lam Ling\, Ph.D.\, Vice President\, Science and Technology\,  Catalent \n\n\n\nDr. Ling discusses the difference in CMC challenges encountered during an orphan biologics vs CGT programme\, with a focus on product quality as the most significant hurdle to approval. She addresses manufacturing approaches to ensure regulatory compliance and factors behind a successful product\, particularly robust\, reproducible and cost-effective pathways. Finally\, supply chain liabilities are discussed\, with risks to production of biologics and their clinical supply. \n\n\n\n15:45: Successful Strategies and Business Model For Companies Bringing Their Orphan Drug To Market –Thomas Bols\, Head of Government Affairs and Patient Advocacy\, EMEA & APAC\, PTC Therapeutics \n\n\n\nThomas Bols addresses the spectrum of opportunities and barriers for innovation within orphan drug development\, particularly across different regulatory territories\, and the critical role of smaller companies in addressing unmet medical needs. He focuses on the legislative and regulatory pathways that exist in Europe for orphan drugs and the potential impact of the upcoming pharmaceutical and OMP legislation revisions for company innovation and patient benefits. \n\n\n\n16:00: Close \n\n\n\n\nRegister here
URL:https://www.europabio.org/event/development-of-orphan-biologics-challenges-and-opportunities/
LOCATION:Catalent
CATEGORIES:EuropaBio,External,Healthcare Biotech
ATTACH;FMTTYPE=image/png:https://www.europabio.org/wp-content/uploads/2023/01/Biomanufacturing-Policy-Summit-2023-5.png
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DTSTART;TZID=Europe/Brussels:20230424T100000
DTEND;TZID=Europe/Brussels:20230425T190000
DTSTAMP:20230111T144717Z
CREATED:20230111T144716Z
LAST-MODIFIED:20230111T144717Z
UID:5648-1682330400-1682449200@www.europabio.org
SUMMARY:Swiss Biotech Day 2023
DESCRIPTION:The Swiss Biotech Day has become one of the leading biotechnology conferences in Europe and a fixed date in the community’s calendar. In 2022\, the conference demonstrated the impressive growth of the Swiss biotech industry and presented an exciting program with ideal networking opportunities for over 1\,100 participants across the globe. \n\n\n\nIn 2023\, the Swiss Biotech Day will again offer high-level experts from the life science industry the space to network\, discuss and discover trends in R&D\, manufacturing\, data management\, artificial intelligence and innovative financing over one and a half days. In addition\, international biotech delegations can take part in the “Global Village” to strengthen their ties with Switzerland as a biotech hub and promote cross-border investments\, public-private partnerships\, research and development collaborations and exchange of talent.  \n\n\n\nWe hope to see you in Basel on April 24-25\, 2023 in person again. \n\n\n\nWhat to expect: \n\n\n\n\nMeet 1.000+ senior experts from the life science industry\n\n\n\n70+ exhibitors and global village with international delegations from all over the world\n\n\n\nSwiss Biotech Success Stories Awards\n\n\n\nInnovative biotech start-ups and medium-sized biotech companies\n\n\n\nThematically focused panel discussions\n\n\n\nSwiss Biotech Report 2023\n\n\n\nPre-scheduled one-to-one partnering meetings\n\n\n\nGeneral Assembly of the Swiss Biotech Association\n\n\n\n\n\nMore information
URL:https://www.europabio.org/event/swiss-biotech-day-2023/
LOCATION:Congress Center Basel\, Messeplatz 21\, Basel\, 4058\, Switzerland
CATEGORIES:External,Industrial Biotech
ATTACH;FMTTYPE=image/png:https://www.europabio.org/wp-content/uploads/2023/01/Biomanufacturing-Policy-Summit-2023-2.png
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DTSTART;TZID=Europe/Brussels:20230427T140000
DTEND;TZID=Europe/Brussels:20230427T151500
DTSTAMP:20230412T135959Z
CREATED:20230322T114230Z
LAST-MODIFIED:20230412T135959Z
UID:6092-1682604000-1682608500@www.europabio.org
SUMMARY:EuropaBio Biomanufacturing Policy Summit 2023: Where next for Europe?
DESCRIPTION:Summit outcomes and next steps \n\n\n\n\n\nOn 15th March\, EuropaBio hosted its first Biomanufacturing Policy Summit in Brussels\, with the aim of setting the vision for Europe’s global innovation\, competitiveness\, and sustainability on biomanufacturing\, while raising awareness among policy-makers. The Summit established a starting point\, a first step for a long journey that needs to be traveled by all stakeholders in Europe – SMEs\, large companies\, expert services\, and EU institutions – and which has already started in other parts of the world. \n\n\n\n80 attendees from industry\, national associations\, and stakeholders across the public and private spectrum presented\, debated\, and proposed.  In a fast-moving industrial transition\, calls for visionary policies\, enabling regulation\, and urgent action were some of the key takeaways from the summit. You can see the March 15th Summit agenda here. \n\n\n\nWould you like to find out more? \n\n\n\nJoin us on April 27 between 14:00 – 15:15 CET for a summit presentation and follow-up and add your voice to the discussion. This webinar will wrap up the main outcomes of the summit and lay the groundwork for future discussions. \n\n\n\nBiomanufacturing is key to the digital and green transitions and to securing a competitive and resilient future for Europe. Stay tuned for Europe’s future in biomanufacturing! \n\n\n\nAGENDA\n\n\n\n14:00: Welcome and introduction – Claire Skentelbery\, Director General\, EuropaBio \n\n\n\n14:10: Biomanufacturing Policy Summit report presentation – Virginia Claudio\, Sr Adviser & Programme Manager\, EuropaBio \n\n\n\nThe report presentation summarises the summit outcomes and builds policy recommendations for the development of the Biomanufacturing landscape in Europe. \n\n\n\n14:20: Report perspectives & reflections from healthcare and biotech industries\, and national associations – Sarah Moundir\, EU Public Affairs Senior Manager\, Novartis | Gwenael Servant\, Board Executive\, Abolis | Inga Matijosyte\, Vice President\, LithuaniaBIO \n\n\n\nA diverse group of stakeholders representing the wide spectrum of Biomanufacturing shares their views over the report outcomes\, as well as the priorities for their companies and organisations. \n\n\n\n14:50: Discussion and Q&A with the audience \n\n\n\nA discussion based on questions from the audience with a focus on the next steps for policy making on Biomanufacturing. \n\n\n\n15:10: Close – Closing remarks. \n\n\n\n\n\n\nRegister Here
URL:https://www.europabio.org/event/europabio-biomanufacturing-policy-summit-2023-where-next-for-europe/
CATEGORIES:Biomanufacturing Platform,EuropaBio
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