navigating to commercialization.braymond.11.01...trial advocacy. bla filing pdufa t s advisory board...
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Navigating the Road to Commercialization:Key Steps and Strategy Models to Consider
Brion Raymond, Founder C2C Strategy Consulting
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• Key Activities from Early Days to Approval
• Building an Initial Forecast
• Strategy Models:• Follow the patient• Follow the process
• Moving from Strategy to Tactics
Overview of Today’s Discussion
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Commercial planning starts as early as pre-IND
Pre-IND
Phase II
Phase I
Phase III
Filing PDUFA
Is There a Market?q Define unmet needq Develop and Test TPPq Engage 3-5 KOLsq First in class or best in class?
Market Sizing & Dynamicsq Draft forecast q Market research ‘light’q Broaden KOL advisors
Early Commercial Plansq Product positioningq Commercial
organization designq Cross-functional
resource requirementsq Communication Planq KOL strategy
Launch Strategyq Three C’sq Accessq Messaging and brandingq Quantitative researchq Initiate cross-functional
launch teamq KOL engagementq Disease or MOA education
Tactical Launch Readinessq Label language / risk
mitigationq Marketing and sales buildoutq Pricingq Payers & reimbursementq Distribution Contractingq IT systemsq Financial reportingq Societies and advocatesq KOL Speaker programs
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Setting up your forecast model –Starting with the patient funnel
Disease incidence and prevalence
Diagnosis and treatment rates
Patient eligibility
Market share
Access cut
Compliance & persistence
Bilateralrate
1. Patients Eligible for Your Drug
2. Intent to Treat Population
4. Multipliers to get to Annual Treatments
InjectionsPer Year
3. Patients Treated
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Early Strategy Development –Follow the patient
NaïveNIUPatient
Anterior Intermediate Pan Posterior
Optometrist/Ophthalmologist
GeneralPractitioner
OtherSpecialist Self-Referral
RetinaSpecialist/UveitisSpecialist
Drops
FullWorkup
BilateralUnilateral
LocalSystemic
Cleared Persists
Co-Managew/Rheumatologist StayswithSpecialist
OralCorticosteroidsand/orImmunomodulators
???
Cleared Persists
DropsorInjectedSteroid OralCorticosteroid
Cleared Persists
Taper Biologics
Taper
Anterior?
UveitisSpecialist
Yes
No
Forecast model inputs
Referral patterns
Target customers
New opportunities
Product Positioning
Competitive environment
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Developing Your Non-Promotional Strategy –Follow the process
Fees Product X Your ProductPatients per
Year 2000 12000
Therapy Cost 6X Y
Medical Benefit Reimbursement 6X * 1.06 Y*1.06
Procedures 6 4
Office Visits 12 4
Diagnostics 12 4
Practice costs (Xc) 2*(Xc)
Annual Impact P Q
Outside the Practice
Impact on the Practice
Inside the Practice
* These analyses inform non-promotional tactics and decision-making only
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Transitioning from Strategy to Tactics –Using the consumer buying process as a tactical guide
Awareness Belief Trial Advocacy
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BLA FILING PDUFA
Mar
ket
Anal
ytic
s
Advisory Board Advisory Board
Data Release FDA Approval
BLAFiling
Mar
ket A
cces
s
Mar
ketin
g &
Sale
s
Promotions DevelopmentCongress Materials
Website
Launch Campaign DevelopmentDisease Ed Campaign
Med
ia
Market ResearchPre-launch Baseline Survey
Dose-based Forecast model update
Mar
ket A
cces
s Distribution DesignContracting
OPDP Submission
Hire, train Payer Account Managers Payer Account Team active
Reimbursement support tools
AMCP dossier
Operationalize programs,
End-user price research & analysisPayer Ad Board
Campaign Testing
DATA UNBLINDING
Topline Data Presentation
Forecast model update
Hub/Call Center Design
Advisory Board
Sales Force Organization Design Sales HiringSales
TrainingIC and CRM Design
Apply for Type I CPT Code
Pre-Data Post data to 3 months before PDUFA Peri-launch to Year 1$0.5-$3.5M $4-8M $20-50M
Sales Force Deployed
Commercial activities (and budget) then begin therace to the finish line
Forecast modeling
Market Research
Forecast updates
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THANK YOU
C2CSTRATEGYClinical to Commercial