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Microsoft powerpoint - noymer-massmedic-2011.ppt

Drug-Device Combination Products
Peter D. Noymer, Ph.D.
Vice President, Product R&D

MassMEDIC / March 3, 2011
Background – current experience
Background – “personal pipeline”
AERx® - diabetes
AERx® - other
Intraject® - migraine
Staccato® - agitation
Staccato® - other CNS
– 2 companies (Aradigm, Alexza), approximately 12 years– One product approved (SumavelTM DoseproTM – Zogenix – approved July 2009)– One NDA in the review process (Staccato® Loxapine)– 8-10 other development candidates • There are an additional ~20 novel drug-device combination products being developed just for inhalation at other companies Some of the challenges …
Business
Engineers
Chemists
Small companies
Large companies
Device regulations
Drug regulations
Business & Biology
• Fundamental for almost any medical product – Businesses work to control risk, optimize outcomes & financial returns – Human biology / physiology is inherently unpredictable – Portfolio approach – multiple product development efforts, “spread the bets” – Staged approach – funding tied to advances in progress and risk reduction Engineers & Chemists
– But combination product must work as a whole system
• Organizational structure & development procedures can – Scientists & engineers “under the same roof” vs. different management lines – Product development procedures/practices designed to keep activities in synch Small & Large Companies
– New/disruptive technologies often from startup companies – Economic realities drive trend toward partnerships / JV’s / M&A to reach • Partnerships are just like personal relationships – Different “personalities” that need to mesh – Corporate agendas that can get in the way • Effective partnership management is a good approach – Many companies employ “alliance management” staff – Regular care & feeding of any relationship can help avert issues Drug & Device Regulations
– Ultimately same foundational principles – Guidelines are evolving on how to blend specific elements • Application review process becomes more complex – Multidisciplinary reviews become the norm – CDER, CDRH and any other divisions that have a key stake – Sponsor needs to ensure all audiences are considered Getting there from here …
Drug-Device Combination Products
Peter D. Noymer, Ph.D.
Vice President, Product R&D

MassMEDIC / March 3, 2011

Source: http://www.massmedic.com/wp-content/uploads/2011/03/ddcp311.pdf

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The Knowledge Engineering Review , Vol. 23:1, 101–115. c 2007, Cambridge University PressDOI: 10.1017/S0269888907001270 Printed in the United KingdomA context-sensitive framework for lexical ontologiesTONY VEALE and YANFEN HAO School of Computer Science and Informatics, University College DublinE-mail: tony.veale@ucd.ie, yanfen.hao@ucd.ie Human categorization is neither a binary nor a contex

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CORRECTION EXERCICE n°5 EXERCICE 5 La prescription médicale ce jour est : - Soluté glucosé à 5 %, 2 litres / 24 h avec : - 2 g de KCl / L - 4 g de NaCl /L Vous disposez d’ampoules de 10 mL à 10 % de KCl, d’ampoules de 20 mL à 20 % de NaCl. Le premier litre de G5 % avec les électrolytes (KCl et NaCl) à été posé à 0 h. Augmentin® 1 g x 2/24 h dans 50 ml de soluté ph

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