viresolve millipore new product commercialization
TRANSCRIPT
VIRESOLVE
Millipore New Product Commercialization
The need
Drugs derived directly from mammalian blood plasma or cell often contained viruses extracted along with these substances Human growth hormone often contained Creutzfeldt-
Jakob virus Genentech’s tPA for heart attack, developed using
recombinant DNA & Monoclonal antibodies derived from mammalian blood also contained viruses
Viral contamination was also a potential result of careless laboratory procedures
Understanding the customers
Highly dissatisfied with current methods of virus removal
Two key customers convinced top management at Millipore to develop solution
Validation, or proof of virus removal is becoming important for customers
Tangential flow membrane technology
Tangential flow membrane technology Fluid slowly pulled through the membrane by suction
Advantages over dead-end ultrafiltraion Offer less clogging Better performance when used to discriminate
between particles of similar size
Disadvantages Not simple for users to operate
Viresolve
Size exclusion membrane Smaller particles, like proteins, pass Larger particles, like viruses, retained
Validation of virus removal Published proof that a specific virus has been removed
to a specific degree in manufacturer’s test facility Correlating integrity test to test each purchased
membrane
Industry
At least half of business tied to pharmaceutical market
Viresolve targeted to tap into fast growing biopharmaceutical market, which were therapeutics produced through genetic engineering
Biopharmaceutical market to grow from $3 billion in 1992 to $30 billion by 2000
History of Viresolve Project
1985
• Experts searches for additional applications of the technology
• Shortlisting of 11 promising applications
1986
• Promising virus removal trials presented• Customer information gathered• Key customer requests development
1987
• Project officially funded and development work begins
• Membrane manufacturing process altered to enable production of membranes with fewere defects in pore size
History of Viresolve Project
1988
• Decision made to focus on membrane development before firming designs to deploy the membrane
1989
• Formal project plan constructed by project leader• Different sections of team to work in parallel
1990
• Working membrane developed• Six tests at customer sites are conducted between 1987
& 1990• Paul Sekhri hired
Business Market Processes
Crafting Market
Strategy
Market Sensing
Managing Market
Offerings
Business Channel
Management
Gaining Customers
Sustaining Customer
Relationships
Understanding value
Creating value
Delivering value
Business Market Processes
Crafting Market
Strategy
Market Sensing
Managing Market
Offerings
Business Channel
Management
Gaining Customers
Sustaining Customer
Relationships
Understanding value
Creating value
Delivering value
Market Sensing
Market Sensing
Defining the market
Monitoring Competition
Assessing Customer Value
Gaining Customer Feedback
Defining the Market : Segmentation
Based on size of Protein Makers of proteins using recombinant DNA technology
Protein Size : small (under 70,000 daltons) Customers : Makers of interferons, growth factors, clotting
stimulating factors, interleukins, hotmones
Makers of proteins using monoclonal antibodies Protein Size : moderate (under 180,000 daltons) Customers : Makers of monoclonal antibodies, Ig fragments
Blood processors Protein Size : As large or larger than largest commonly known
virus (Problem : Size exclusion fails) Bigger part of the market
Viresolve/70
Viresolve/180
Proposed Viresolve 3
Inactivation of virusPhysical Removal of virus
Physical techniques like heat, UV radiation Harm or destroy
proteinChemical
techniques (solvent detergent method by New York Blood Center) Ineffective against
virus with no lipid coating
Dead-end filtration technology Pall’s Nylon 66
Not effective aginst small virus, polio
Asahi’s Planova Less challenging to
install Destructive integrity test
compared to Viresolve’s nondestructive correlating integrity test
Monitoring Competition
Assessing Customer value
Three-part package Membrane using superior tangential flow technology Validation data, which competitors don’t have Verification through correlating integrity test
Customers consulted about whether to sell membrane modules as disposable 10-foot-square module validated upto 5 time reuse as
customers found it too expensive for frequent disposal Other modules sold as single-use membrane
PremiumPricing
Gaining Customer Feedback
Six tests at customer sites conducted
Prelaunch versions of Viresolve called ‘specials’
List of 50/60 customers targeted for specials developed
Gained feedback on the product which was in alpha stages
Sales were also achieved
Crafting Market Strategy
Product Leadership strategy
Market Development
Diversification
Market Penetration
Product Development
CurrentProduct
NewProduct
NewMarket
CurrentMarket
Business Market Processes
Crafting Market
Strategy
Market Sensing
Managing Market
Offerings
Business Channel
Management
Gaining Customers
Sustaining Customer
Relationships
Understanding value
Creating value
Delivering value
Managing Market Offerings
Breakthrough
Platform
Enhancement
Extent of Product Change
Ext
en
t of
Pro
cess
Ch
an
ge
Large
Large
Small
Small
Viresolve
Managing Market Offerings
Product 3 Different sizes
1/3-square-foot (for research work) 1-square-foot 10-square-foot (for production work)
Pricing Premium Pricing 1/3-square-foot module : $500 1-square-foot module : $1200
1-square-foot ultrafiltration membrane : $500 - $600 10-square-foot module : $2000
10-square-foot module : $1000 - $1200
Business Channel Management
Training the sales force
• Launch Manual & Reference Materials for each salespersonPreparing
training materials
• Presentations & teaching sessions
• ‘Wet work’ with actual Viresolve modules
Conducting 2 day seminar • Handling faxes
from salespersons
Responding to followup
questions from field
Business Channel Management
Advertising & promotion through Word-of-mouth Scientific press Conferences Trade press
Attended trade conferences & made presentations
PR firm hired
Helped conduct
press conference
s
Articles written into reputable journals
Customers read and calls up
Business Market Processes
Crafting Market
Strategy
Market Sensing
Managing Market
Offerings
Business Channel
Management
Gaining Customers
Sustaining Customer
Relationships
Understanding value
Creating value
Delivering value
Gaining Customers
Strategy 1 To insert Viresolve in the R&D stages
Reason Familiarity with product & FDA approval process would
facilitate a natural progression to using it in production
Action R&D engineer hired to concentrate on R&D insertion
since organization historicaly focuses on production scale end
Gaining Customers
Strategy 2 To push Viresolve/70 hardest in the initial stages of
launch
Reason Disparity between protein & virus sizes being greatest
for applications that Viresolve/70 was targeted at, chances for dramatic success were best with this product
Such dramatic success would lead to commercial success of later products in the Viresolve line
Sustaining Customer Relationship
Initial contact made
Customer fills a form stating virus
removal needs
Salesperson faxes the form to application engineers
Application engineers informs
within 2 days whether or not the application made
sense
Application engineer,
customer & salesperson meet
to conduct feasibility study
using sample
Within 2 weeks application engineer
completes report and forwards to
customer
Customer decides whether to buy or
not
From this point, salesperson keeps in touch for any further technical
assistance
Other Issues
Absence of US regulations Customers avoiding the usage of virus removal technology US launch of Viresolve more challenging
Absence of 10-Sqft module Production tool Short-term interest in Viresolve Hence top development priority
Several promising extensions of Viresolve Removal of nucleic acids or pyrogens
Uncertainty about the sustainability of the product Not required in case synthesizing of proteins
Thank You