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Will Biosimilars Be A Driver For Innovation

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Information about Will Biosimilars Be A Driver For Innovation

Published on September 24, 2010

Author: a2zpharmsci

Source: slideshare.net

Description

The Biosimilar debate touches upon several important reasons for innovation failure in a regulated environment – successful, scientific, resolution will be important for the entire sector.
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Will Biosimilars be an Important Driver  for Innovation and Continual  Improvement in Biopharmaceutical  Manufacturing? Ajaz S. Hussain, Ph.D. A Keynote Address: Business of Biosimilars September 20‐22, 2010, Hyatt Regency,  Boston, MA www.biosimilarsevent.com

Disclaimer • The opinions expressed in this presentation are those  of the speaker and do not necessarily reflect the views  and/or policies of his current or former employers.

Innovation • “The act of introducing something new” (the  American Heritage Dictionary) • “A new idea, method or device” (Webster  online) • “Change that creates a new dimension of  performance” (Peter Drucker) • “The ability to deliver new value to a customer” (Jose Campos)

Product & Process Innovation* (outside the pharmaceutical sector) Rate of Innovation Rate of Product Innovation Rate of Process Innovation #1 Dominant Design Rate of Process Innovation #2 performance maximization sales maximization cost minimization uncoordinated segmental systemic Time *A modified representation of the Utterback‐Abernathy´s model of industrial  product and process innovation. The Int. J. Mgmt Sci., Vol. 3, No. 6, 639–656 (1975)

Innovation Modes, Innovation Failure, Typical  Sectors, and Policy Response Mode of  Innovation  Typical  Policy  Innovation Failure Sector Instruments • Application  •Knowledge   •Biotech.,  • High‐tech  of high‐ originates  material  bridging  science  outside  science,… institutions  technology commercial  to facilitate  sector – this  diffusion of  is not well  advances communi‐ cated to  Regulatory potential  Competing Regulatory Acceptance Interests Guidelines users Research Policy. 29: 437 (2000) 

Sources of Innovation Failure  • Ineffective trans‐disciplinary communication – Systems approach vs. reductionists approach – Competing commercial interests – Role of clinical studies to address uncertainties in  quality? – Clinical – Quality Divide – Inspection – Review Divide – Other

Process Design Through Analytical &  Process Integration: ‘Biosimilar Delta’ Driver for process innovation If timely acceptance by regulators Product Innovation Innovation 2nd Generation ry Product o ve sc Launch Di Process Innovation Development (industry wide or Biosim) 1st Generation Product Biosimilar Product Launch Biosim Delta 1st Generation Product Regulatory  Process ‘Originator Delta’ sales maximization cost minimization segmental systemic Time

My Point of View • Will Biosimilars be an Important Driver for Innovation and  Continual Improvement in Biopharmaceutical Manufacturing? • No – Competition, by shifting demand, can be a driver for product  innovation. However, competition can not be expected to be an  important driver for process innovation – High, non‐scientific, barriers to entry (product approval & designation)  will ensure that process innovation remains only an option that some in  industry will exercise – Recent financial crisis may have reemphasized the need for process  innovation and/or  may altered the course of process innovation  but…….our society is not yet prepared to address important reasons for  innovation failure in a regulated environment  • But, the Biosimilar debate touches upon several important reasons  for innovation failure in a regulated environment

The Biosimilar debate touches upon  several important reasons for  innovation failure in a regulated  environment

At FDA, in 2004, A Focus on Innovation  and Continual Improvement www.fda.gov/ohrms/dockets/ac/04/.../2004‐4080b1_01_manufSciWP.pdf

A Systems Perspective on Regulatory  Compliance & Types of Improvement www.fda.gov/ohrms/dockets/ac/04/.../2004‐4080b1_01_manufSciWP.pdf

Types of Improvement CAPA Continual Improvement Innovation Product is out of  Product is within  Revolutionary, to be a  “specification” (OOS)  “specifications” leader or there are  Acceptance criteria ‐ ROI, Top‐down procedural deviations variable/continuous  Project based ʺCrisisʺ ‐ immediate  data Specialist/Technical  action needed Evolutionary,  experts involved Required by  incremental, daily  Superior ability to  regulators activity justify specifications Carried out by plant  and convince  and quality staff regulators ʺDrive out fearʺ that inhibits continuous learning and improvement ‐“Specifications” www.fda.gov/ohrms/dockets/ac/04/.../2004‐4080b1_01_manufSciWP.pdf

Specification ‐ Uncertainty Quality –to- Clinical gap is a significant challenge! Regulatory specifications established after “clinical trials” CMC Review – CGMP Inspection Disconnect Specification – Capability: Disconnect http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005‐4137S1_06_Hussain.ppt#371,11,Quality – Clinical Gap: Uncertainty

Biosimilar Development: A Focus on  ‘Design Specifications’ http://www.sandoz.com/assets/content/en/product_range/biosimilar_presenation/Pioneering_Global_Development_of_Biosimilars_BIO_2008_FNa_FINAL.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is  from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

Ajaz S. Hussain. This slide is from a presentation at the 5th EGA Symposium on  Biosimilars, London (2007). Full presentation is available on the internet. www.bogin.nl/files/A_Hussain.pdf

My Point of View • Will Biosimilars be an Important Driver for Innovation and Continual  Improvement in Biopharmaceutical Manufacturing? • No – Competition, by shifting demand, can be a driver for product innovation.  However, competition can not be expected to be an important driver for process  innovation – High, non‐scientific, barriers to entry (product approval & designation) will  ensure that process innovation remains only an option that some in industry will  exercise – Recent financial crisis may have reemphasized the need for process innovation  and/or  may altered the course of process innovation but…….our society is not  yet prepared to address important reasons for innovation failure in a regulated  environment  • The Biosimilar debate touches upon several important reasons for innovation failure in a regulated environment – successful,  scientific, resolution will be important for the entire  sector

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