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
Glossary ORIF – Open reduction internal fixation THJR/THR – Total hip joint replacement TKJR/TKR – Total knee joint replacement TAQ’s – Toe’s, Ankle’s, Quad’s exercises Quads Lag – Able to extend knee but falls into a degree in flexion on SLR or IRQ Quads Lack – Pt unable to fully extend knee and remains in this degree of flexion during Useful reading! David J. Da
ellaOne® – ett effektivt akut p-piller ELLAONE® är ett så kallat akut-p-piller som kan förhindra att graviditet uppstår efter oskyddat samlag. ELLAONE® innehåller ulipristalacetate 30mg, en aktiv syntetisk progesteronreceptormodulerare. Den huvudsakliga verkningsmekanismen antas vara hämning eller fördröjning av ägglossningen. ELLAONE®-behandlingen påbörjas så snart som
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