Navigating to Commercialization.BRaymond.11.01...Trial Advocacy. BLA FILING PDUFA t s Advisory Board...

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