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X-WR-CALDESC:Events for Pharma Journalist
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DTSTART:20160101T000000
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20171115
DTEND;VALUE=DATE:20171117
DTSTAMP:20260515T123028
CREATED:20170628T035014Z
LAST-MODIFIED:20170628T035419Z
UID:2414-1510704000-1510876799@www.pharmajournalist.com
SUMMARY:4th annual Biosimilars North America
DESCRIPTION:Building on the success of previous events\, SMi has announced the return of its 4th annual Biosimilars North America Conference\, taking place on November 15 and 16\, 2017 in Iselin\, New Jersey. \nThe market for biosimilars in North America continues to grow and has become highly lucrative. As such\, pharmaceutical companies continue to find ways to differentiate their products in such an emerging market. Thus\, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development\, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements. \nThis year\, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines\, the US market access landscape\, and biosimilars of orphan drugs. \nKey highlights this year will include \n\na presentation from Sandoz on the FDA issuing the long-awaited biosimilar interchangeability guidance;\na session on complex biosimilars and new technologies from MedImmune;\nstrategies to combat legal\, policy and commercial obstacles to development and launch;\ninsights on latest development strategies and market access from Fujifilm Diosynth Biotechnologies;\ncase studies on drug product and formulation development considerations; and\nImplications of the landmark ruling of the Amgen v Sandoz case\n\nKey speakers include \n\nRichard DiCicco\, Chairman\, Harvest Moon Pharmaceuticals Inc\nCindy Cao\, Executive Director & Head of US Regulatory Affairs fo Biopharmaceuticals\, Sandoz\nT. Shantha Raju\, Senior Director\, MedImmune\nChrys Kokino\, Head Global Biologics Commercial\, Mylan\nSteinar Madsen\, Medical Director\, Norwegian Medicines Agency\nBruce Leicher\, Senior Vice President and General Counsel\, Momenta Pharmaceuticals\, Inc\nHiten Gutka\, Principal Scientist Formulation Development – Biosimilar Development\, Oncobiologics Inc\nPatrick Robertson\, Director\, Program Design\, FUJIFIlM Diosynth Biotechnologies\n\nThe full roster of speakers and their topics can be found on www.biosimilars-northamerica.com/pharmajournalist \nRegistration is now live on the event website and there For more information visit: www.biosimilars-northamerica.com/pharmajournalist
URL:https://www.pharmajournalist.com/event/4th-annual-biosimilars-north-america/
LOCATION:Renaissance Woodbridge Hotel\, Iselin\, New Jersey\, USA
ORGANIZER;CN="SMi Group Ltd":MAILTO:events@smi-online.co.uk
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20171116
DTEND;VALUE=DATE:20171118
DTSTAMP:20260515T123028
CREATED:20171018T002540Z
LAST-MODIFIED:20190521T093633Z
UID:3476-1510790400-1510963199@www.pharmajournalist.com
SUMMARY:Lyophilization USA
DESCRIPTION:Following its successful second year\, SMi Group announces the return of its 3rd annual Lyophilization USA Conference to New Jersey\, this November 2017. \n \nAs biopharmaceuticals continue to dominate the market\, the need for greater shelf life and protein stability\, has increased. For many biological products lyophilization is a necessity and the technology is constantly advancing. \nOne of the main challenges in pharmaceutical lyophilization\, continues to be the scale- up and the implementation of QbD protocols for the optimization of cycles. Several companies are researching and developing ways to facilitate commercial bulk lyophilization of vaccines\, protein and cells while also reducing costs. \nLyophilization USA will gather leading experts from top pharma companies to discuss the latest cutting edge developments in freeze drying\, as well as solutions to on-going industry challenges. \nKey Topics Addressed: \n– The impact of controlled nucleation on product quality and the technology being used for controlled ice         nucleation.\n– Examining the development and scale up of a freeze-drying cycle for biotherapeutics.\n– Highlighting the approaches to effective holistic packaging and innovative design. \nFeatured Speakers: \n– Lokesh Kumar\, Associated Scientist\, Genentech\n– Charlie Tang\, Associate Director\, Formulation Development\, Regeneron Pharmaceuticals\n– Guido Schmitz\, Global Head of Packaging & Technology Innovation\, Bayer Consumer Care\n– Perceval Sondag\, Principal Statistician\, Arlenda\n– Eric Munson\, Professor\, Pharmaceutical Sciences\, University of Kentucky\n– Kelly Forney Stevens\, Drug Product Development\, GSK Vaccines\n– Melissa Lash\, Scientist\, Large Molecule Drug Development\, Johnson & Johnson \nView the preliminary agenda here: www.lyophilization-usa.com/pj
URL:https://www.pharmajournalist.com/event/lyophilization-usa/
LOCATION:Iselin\, New Jersey
ORGANIZER;CN="SMi Group Ltd":MAILTO:events@smi-online.co.uk
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