Navigating the Road to Commercialization:Key Steps and Strategy Models to Consider
Brion Raymond, Founder C2C Strategy Consulting
• 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
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
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
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
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
Transitioning from Strategy to Tactics –Using the consumer buying process as a tactical guide
Awareness Belief Trial Advocacy
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
THANK YOU
C2CSTRATEGYClinical to Commercial