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
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
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
Drug-Device Combination Products
Background – current experience
Background – “personal pipeline”
Some of the challenges …
Business & Biology
Engineers & Chemists
Small & Large Companies
Drug & Device Regulations
Getting there from here …
Drug-Device Combination Products