Pipeline Commercialization
Our pipeline commercialization practice maximizes
product opportunity value by optimizing the myriad clinical
development, labeling, pricing, and product positioning options
into a focused commercialization plan targeted at a value-driven
product profile.
Representative context of our pipeline commercialization
engagements includes:
- Product research-to-commercialization
conversion, often following technology proof-of-principle
- Lead product commercial planning, often
requiring indication/market selection from among many potential
product profiles
- Commercialization of products from
partnering, strategic alliances, licensing, and restructurings
activities
Representative scope of our pipeline commercialization
engagements can include:
- Multiphase analysis and planning, from:
description of the universe of addressable indication/market
segment product profiles; through feasibility, development,
market, and commercial analysis of key product profiles;
to lead product profile selection and planning
- Key clinical and preclinical development
plan milestone identification, technology risk assessment,
budgeting, and timeline estimation
- Technology environment forecasting
and analysis, from pharmacologic gene targets, molecular
pathways, and disease mechanisms to engineering electronic
design, mechanics, and polymers, as needed
- Clinical environment forecasting and
analysis employing evidence-based methodologies, literature
reviews, and primary research
- Product unmet medical need, practicability,
and acceptance evaluation with in-depth roundtables and
interviews among front-line and thought-leading clinicians
from all key practice settings
- Multi-scenario product performance
benchmarking and forecasting of key product features, advantages,
benefits, efficacy endpoints, and outcomes
- Clinical and epidemiologic analysis
and stratification of target patient populations, procedure
volumes, and/or product placement sites
- Product pricing, reimbursement, and
purchasing evaluation with in-depth roundtables and interviews
among: formulary and materials managers; P&T, capital
equipment, GPO, and coding committee members; and HCFA,
state-sponsored, and private insurance carriers.
- Product price estimation and forecasting,
from comparable and conjoint analysis through integrated
pharmacoeconomic modeling of cost-utility, cost-of-illness,
payor-stratified reimbursement, and value-based pricing.
- Multi-scenario efficacy and price-linked
potential market models
- U.S. and worldwide market penetration
and revenue models, benchmarked by product group and vertical
industry sector
- FDA approval pathway identification,
approvability assessment, and timeline estimation
- Commercial and market risk evaluation
with in-depth, confidential interviews among senior industry
executives from all key vertical industry sectors
- Manufacturing scale-up and GMP/QSR/standards
compliance assessment, budgeting, and timeline estimation
- Patents, licenses, and other intangibles
assessment and planning
- Pro forma program financial modeling,
including forecasts of enterprise earnings, earnings dilution,
and cash flow
- State-of-the-art modeling of shareholder
value employing discounted cash flow (including program
IRR), real options (including compound and switching options),
and comparable (including milestone-based) methodologies
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