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DTSTART:20261105T140000
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BEGIN:VEVENT
UID:CiviCRM_EventID_2015_e86a4f28f24ec85011f2b11344e0bb4c@onenucleus.com
SUMMARY:Webinar - Getting Your CMC Strategy Right
X-ALT-DESC;FMTTYPE=text/html:<!DOCTYPE HTML PUBLIC
  "-//W3C//DTD HTML 3.2//EN"><html><body><p>As biot
 ech venture investment continues to trend towards 
 larger but fewer rounds\, there can be an expectat
 ion that the companies have well developed executi
 on plans for moving from discovery to clinic. With
  CMC being critically important to ensuring regula
 tory compliance\, biotechs are having to develop t
 hese plans ahead of financing. </p>\n \n <p>Many o
 f the decisions that shape a successful CMC strate
 gy need to be made much earlier than initially exp
 ected. Decisions around drug product formulation\,
  analytical testing methods\, scalability and manu
 facturing\, can have significant implications for 
 timelines\, costs\, regulatory strategy and ultima
 tely commercial production.</p>\n \n <p>This webin
 ar will explore how biotech companies can get CMC 
 right from the start and build a strategy that sup
 ports development further down the line.</p>\n \n 
 <p><strong>Agenda:</strong><br />\n 14.00-14.05: W
 elcome and Introduction from One Nucleus<br />\n 1
 4.05-14.20: What does a robust CMC Strategy look l
 ike in practice (Constanze Ochmann-Harding\, Direc
 tor of CMC\, Epitopea)<br />\n 14.20-14.35: Develo
 p for Scale: Early Drug Product and Fill-Finish De
 cisions That Shape Clinical Success and Commercial
 isation (David Cox\, Site Director\, Eramol)<br />
 \n 14.35-14.50: De-risking you CMC through an inve
 stor perspective (Claire Patterson\, Thalassa Clar
 a) <br />\n 14.50 – 15.00: Q&A<br />\n 15.00: Clos
 e<br />\n <br />\n <strong>This webinar is:</stron
 g></p>\n \n <ul>\n 	<li><strong>Free</strong> for 
 employees of One Nucleus member organisations\;</l
 i>\n 	<li>£75 + VAT for Non Members.</li>\n </ul><
 /body></html>
DESCRIPTION:As biotech venture investment continues to trend t
 owards larger but fewer rounds\, there can be an e
 xpectation that the companies have well developed 
 execution plans for moving from discovery to clini
 c. With CMC being critically important to ensuring
  regulatory compliance\, biotechs are having to de
 velop these plans ahead of financing. \n \n \n \n 
 Many of the decisions that shape a successful CMC 
 strategy need to be made much earlier than initial
 ly expected. Decisions around drug product formula
 tion\, analytical testing methods\, scalability an
 d manufacturing\, can have significant implication
 s for timelines\, costs\, regulatory strategy and 
 ultimately commercial production.\n \n \n \n This 
 webinar will explore how biotech companies can get
  CMC right from the start and build a strategy tha
 t supports development further down the line.\n \n
  \n \n Agenda:\n \n 14.00-14.05: Welcome and Intro
 duction from One Nucleus\n \n 14.05-14.20: What do
 es a robust CMC Strategy look like in practice (Co
 nstanze Ochmann-Harding\, Director of CMC\, Epitop
 ea)\n \n 14.20-14.35: Develop for Scale: Early Dru
 g Product and Fill-Finish Decisions That Shape Cli
 nical Success and Commercialisation (David Cox\, S
 ite Director\, Eramol)\n \n 14.35-14.50: De-riskin
 g you CMC through an investor perspective (Claire 
 Patterson\, Thalassa Clara) \n \n 14.50 – 15.00: Q
 &A\n \n 15.00: Close\n \n \n \n This webinar is:\n
  \n \n \n \n 	Free for employees of One Nucleus me
 mber organisations\;\n 	£75 + VAT for Non Members.
 \n 
CATEGORIES:Events
CALSCALE:GREGORIAN
DTSTAMP;TZID=Europe/London:20261105T140000
DTSTART;TZID=Europe/London:20261105T140000
DTEND;TZID=Europe/London:20261105T150000
LOCATION:ONLINE - webinar details will be sent to all deleg
 ates closer to the date of the event\n Cambridge\,
  \n United Kingdom\n 
URL:https://onenucleus.com/civicrm/event/info?reset=1&id=2015
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