Building the Right Commercial Organization for an Emerging Biotech

Build for the Market You Have

For an emerging biotechnology company, building the first commercial organization is one of the largest investments leadership will make before launch.

Hiring too early increases burn.

Hiring too late increases execution risk.

Building the wrong capabilities can do both.

PharmaKonsult helps biotechnology leaders determine what commercial capabilities must exist, when they should be built and how organizational design should reflect the therapy, market and strategic objectives.

Commercial Organization Design Starts With the Market

There is no universal biotechnology commercial organization.

A rare-disease launch involving a concentrated group of specialists requires a different model from a therapy addressing thousands of community physicians.

Organization design should reflect:

• patient population;
• physician concentration;
• Centers of Excellence;
• referral pathways;
• treatment complexity;
• access burden;
• distribution model;
• patient support;
• competitive environment;
• expected launch adoption;
• company capital;
• long-term portfolio strategy.

The commercial organization should follow the opportunity.

The opportunity should not be forced to fit a predetermined organization. Related: First Commercial Launch and U.S. Biotech Commercialization.

The Capabilities Leadership Must Consider

Commercial Leadership

Strategic direction, organizational accountability, board communication, capital allocation and cross-functional leadership.

Medical Affairs

Scientific engagement, evidence communication, external expert relationships and alignment around unmet need and market understanding.

Market Access

Payer strategy, reimbursement, evidence requirements, distribution, specialty pharmacy and patient access.

Marketing

Market development, positioning, segmentation, customer understanding and launch strategy.

Commercial Operations

Data, analytics, targeting, forecasting, systems, incentive design and operational execution.

Field Organization

The appropriate customer-facing model based on physician concentration, patient location and adoption dynamics.

Patient Services

Navigation, reimbursement support, education and assistance addressing barriers between prescription and treatment.

Training

Product, disease, market, access and customer readiness across commercial teams.

Not every capability must be built internally.

That is precisely why organization planning matters. See also Build or Outsource a Biotech Commercial Organization?.

Build, Buy or Outsource?

Leadership should examine each capability through three questions:

• Does this capability create strategic differentiation?
• Must institutional knowledge remain inside the company?
• Is external expertise more efficient during the current stage?

Emerging biotechnology companies can preserve capital by outsourcing appropriate capabilities while retaining internal ownership of strategically important decisions.

The answer may evolve.

What should be outsourced 30 months before launch may need internal leadership 12 months before launch.

Hiring Sequence Matters

Organization design is not simply about the final structure.

It is about sequence.

Critical strategic roles often need to exist before larger execution teams because those leaders determine:

• market assumptions;
• access strategy;
• agency selection;
• organizational design;
• technology requirements;
• launch governance;
• hiring priorities;
• external partnerships.

Bringing execution capacity into the organization before strategic decisions are sufficiently mature can create unnecessary cost and rework.

When Should Commercial Leadership Be Hired?

There is no universal month.

The better question is:

For some companies, this can occur considerably before launch.

Commercial leadership may be required when the company is deciding:

• whether to commercialize independently;
• how much capital commercialization requires;
• what evidence the market will need;
• how indications should be sequenced;
• what capabilities should be internal;
• what commercial organization the opportunity supports.

Timing should follow decision requirements. Related: Launch Readiness Assessment and Biotech Commercial Strategy.

Right-Sizing the Field Organization

Sales-force size should not be copied from another launch.

Field structure should reflect:

• number of target physicians;
• concentration of prescribing;
• call frequency;
• geography;
• account complexity;
• treatment setting;
• referral networks;
• Centers of Excellence;
• patient identification requirements;
• access complexity.

Rare and specialty markets can sometimes require relatively small but highly experienced field organizations supported by strong Medical Affairs, access and patient-services capabilities.

Commercial Organization Cost

The cost of commercialization extends beyond field representatives.

Leadership should incorporate:

• executive leadership;
• personnel;
• benefits;
• recruiting;
• agencies;
• data;
• technology;
• analytics;
• training;
• medical capabilities;
• access infrastructure;
• patient support;
• legal/compliance requirements;
• distribution;
• operational support.

The question should therefore not be:

How much will the sales team cost?

It should be:

Organization and Culture

Structure alone does not create performance.

Companies transitioning from R&D to commercial operations also experience cultural change.

Decision speed, accountability, cross-functional coordination and risk tolerance can change as the organization approaches launch.

Leadership should deliberately establish:

• decision rights;
• accountability;
• governance;
• escalation processes;
• cross-functional expectations;
• performance standards.

Commercialization is an organizational transformation—not simply the addition of a sales department. Related: Commercial Leadership & Culture.

PharmaKonsult's Approach

Commercial organization planning can include evaluation of:

• market requirements;
• capability requirements;
• leadership needs;
• internal versus outsourced functions;
• hiring sequence;
• organizational structure;
• field organization model;
• commercial operating costs;
• cross-functional integration;
• launch governance.

The objective is to help leadership build what the business requires while avoiding premature infrastructure and unnecessary complexity. Related: Commercial Readiness Framework.

When Companies Engage PharmaKonsult

Companies may benefit when:

• approaching Phase III;
• preparing for first launch;
• recruiting first commercial leadership;
• preparing a commercialization budget;
• determining whether to build or partner;
• right-sizing an existing plan;
• evaluating commercial capabilities;
• preparing for board investment decisions.

Closing

PharmaKonsult provides senior commercial perspective to biotechnology leaders building the organization required for U.S. commercialization.

Related Resources

• First Commercial Launch
• Launch Readiness Assessment
• Biotech Commercial Strategy
• Commercial Readiness Framework
• U.S. Biotech Commercialization
• Build or Outsource a Biotech Commercial Organization?

Discuss Your Commercial Organization

PharmaKonsult provides senior commercial perspective to biotechnology leaders building the organization required for U.S. commercialization.