will biosimilars be a driver for innovation
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.TRANSCRIPT
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)
Dominant Design
Rate of Innovation
Time
Rate of Product Innovation
Rate of Process Innovation #1
Rate of Process Innovation #2
systemicsegmentaluncoordinated
*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)
cost minimizationsales maximizationperformance maximization
Innovation Modes, Innovation Failure, Typical Sectors, and Policy Response
Mode of InnovationInnovation
FailureTypical
SectorPolicy
Instruments
•
Application of high‐
science technology
•Knowledge originates
outside commercial
sector – this is not well
communi‐ cated to
potential users
•Biotech., material science,…
• High‐tech bridging
institutions to facilitate diffusion of advances
Research Policy. 29: 437 (2000)
RegulatoryGuidelines
RegulatoryAcceptance
CompetingInterests
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’
Innovation
Timesystemicsegmentalcost minimizationsales maximization
1st
GenerationProductLaunch
2nd
GenerationProductLaunch
Product Innovation
Process Innovation(industry wide or Biosim)
1st
Generation ProductRegulatory Process
Biosimilar ProductDevelopment
Discovery
‘Originator Delta’
Biosim Delta
Driver for process innovationIf timely acceptance by regulators
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
Product is out of “specification” (OOS) or there are procedural deviationsʺCrisisʺ ‐ immediate action neededRequired by regulators
Product is within “specifications”Acceptance criteria ‐variable/continuous dataEvolutionary, incremental, daily activityCarried out by plant and quality staff
Revolutionary, to be a leaderROI, Top‐downProject basedSpecialist/Technical experts involvedSuperior ability to justify specificationsand convince regulators
CAPA Continual Improvement Innovation
ʺDrive out fearʺ that inhibits continuous learning and improvement ‐“Specifications”
www.fda.gov/ohrms/dockets/ac/04/.../2004‐4080b1_01_manufSciWP.pdf
Specification ‐
Uncertainty
http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005‐4137S1_06_Hussain.ppt#371,11,Quality –
Clinical Gap: Uncertainty
Quality –to- Clinical gap is a significantchallenge!
Regulatory specifications established after “clinical trials”
Specification – Capability: Disconnect
CMC Review –CGMP InspectionDisconnect
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