Downloaded 64 times
Uploaded byAjaz Hussain
Will Biosimilars Be A Driver For Innovation
The keynote address discusses whether biosimilars will drive innovation in biopharmaceutical manufacturing, concluding that while competition may foster product innovation, it is not expected to drive process innovation due to significant regulatory barriers. The speaker emphasizes that systemic issues in communication and regulatory acceptance contribute to innovation failure in a highly regulated environment. The biosimilars debate highlights these failures, underscoring the need for effective scientific resolutions within the sector.
More Related Content
Similar to Will Biosimilars Be A Driver For Innovation
Will Biosimilars Be A Driver For Innovation
- 1. 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
- 2. 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.
- 3. 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)
- 4. 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)
- 5. 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)
- 6. 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
- 7. 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
- 8. 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
- 9. The Biosimilar debate touches upon several important reasons for innovation failure in a regulated environment
- 10.
- 11.
- 12. 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
- 13. 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
- 14.
- 15.
- 16.
- 17.
- 18.
- 19.
- 20.
- 21.
- 22.
- 23. 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