BEGIN:VCALENDAR VERSION:2.0 PRODID:-//CiviCRM//NONSGML CiviEvent iCal//EN X-WR-TIMEZONE:Europe/London METHOD:PUBLISH BEGIN:VTIMEZONE TZID:Europe/London BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0100 TZNAME:BST DTSTART:20261013T100000 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:CiviCRM_EventID_2007_e86a4f28f24ec85011f2b11344e0bb4c@onenucleus.com SUMMARY:Getting Your CMC Strategy Right – a Cambridge Semi nar X-ALT-DESC;FMTTYPE=text/html:

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. 

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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.

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This semin 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.

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Agenda:
\n 10.00-10.20: R egistration and refreshments
\n 10.20-10.30: Welcome and Introduction 
\n 10.30-11.15: Ses sion 1 – What does a robust CMC Strategy look like in practice (Constanze\, Director of CMC\, Epitop ea)
\n 11.15-12.00: Session 2 – Develop for S cale: Early Drug Product and Fill-Finish Decisions That Shape Clinical Success and Commercialisation (David Cox\, Site Director\, Eramol)
\n 12.0 0-12.15: Comfort Break
\n 12.15-13.00: Sessio n 3 – De-risking you CMC through an investor persp ective (speaker TBC) 
\n 13.00: Networking Lu nch
\n 14.00: Close

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Event is kindly hosted by...
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This seminar is:

\n \n 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 seminar 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 10.00-10.20: Registration and refreshments\n \n 10.20-10.30: Welcome and Introdu ction \n \n 10.30-11.15: Session 1 – What does a r obust CMC Strategy look like in practice (Constanz e\, Director of CMC\, Epitopea)\n \n 11.15-12.00: Session 2 – Develop for Scale: Early Drug Product and Fill-Finish Decisions That Shape Clinical Succ ess and Commercialisation (David Cox\, Site Direct or\, Eramol)\n \n 12.00-12.15: Comfort Break\n \n 12.15-13.00: Session 3 – De-risking you CMC throug h an investor perspective (speaker TBC) \n \n 13.0 0: Networking Lunch\n \n 14.00: Close\n \n \n \n E vent is kindly hosted by...\n \n \n \n \n \n \n \n This seminar is:\n \n \n \n \n Free for One Nucl eus Gold\, Partner and Corporate Sponsor/Patron me mbers\;\n £30 + VAT for One Nucleus Silver Member s\;\n £50 + VAT for Non Members.\n CATEGORIES:Events CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/London:20261013T100000 DTSTART;TZID=Europe/London:20261013T100000 DTEND;TZID=Europe/London:20261013T140000 LOCATION:The Press\n Station Road\n Foxton\n Cambridge\, CB 22 6SA\n United Kingdom\n URL:https://onenucleus.com/civicrm/event/info?reset=1&id=2007 END:VEVENT END:VCALENDAR