Commercialization Strategy for Product Launch The right formula for commercial success

Map the course for commercial success

The path from product development toward commercialization is challenging for many clinical-stage and small companies who must balance limited resources, competing priorities and a tough regulatory approval process. As these companies hit clinical trial endpoints and progress through phase II and III studies, their leaders come to a strategic business decision: Do they pursue large pharma relationships and out-licensing opportunities or continue down the path of retaining control by pursuing their own commercialization strategies? In making this decision, there are a number of challenges: • Disparate global, federal and state regulations

Optimize commercial strategies Deloitte understands these challenges and our advisors provide executives proactive analysis, strategy and planning. We work with clients to help them:

• Cost and operational challenges of health care reform

• Build an integrated compliance infrastructure

• Pricing pressures from payers and regulators

• Effectively demonstrate a product’s value

• Tight timelines to implement regulatory changes

• Understand complexities of contracts and government pricing

• Lack of internal resources, infrastructure and experience • Effective monitoring and compliance auditing

• Create stakeholder value through better revenue management • Lower costs and gain efficiencies by outsourcing commercial operations • Increase knowledge through staffing and training

Meet regulatory requirements and reduce risk As companies prepare for commercialization, interactions with regulators, payers and health care professionals increase, thereby increasing the expectation of having an established compliance program that upholds regulatory requirements and reduces risk. A solid compliance program acts as the mechanism to keep your commercialization plan on track. Without one, you may be at risk of a compromised launch and vulnerable to civil and criminal penalties, fines and CIAs.

Commercialization strategy for product launch

Our keen focus on compliance and commercial success supports our clients’ efforts to maintain a culture of compliance, improve operational efficiencies, and ultimately, reduce commercial expenses.

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Understanding the evolving regulations is daunting and developing an internal team can interfere with a company’s timing and financial plans. Our managed services approach provides the knowledge and capabilities to keep companies moving in the right direction.

Commercialization strategy for product launch

Traction and speed to keep your launch moving

Many clinical-stage companies have determined that a large pharma relationship is not necessarily required to launch a product in the US market. These companies are seeing an opportunity to retain control over their products by pursuing their own commercialization strategies in the form of a virtual commercial model. Gain efficiencies

Gain business insight

By working with us, companies can focus on their core R&D competencies while our specialists take on the day-to-day challenges of commercial activities. We have over 100 specialists with backgrounds in corporate compliance, compliance audit, government programs, commercial contracting, finance, technology and data analytics who deliver management of commercial operations.

• Timely reports and analytics for accurate financial analysis and insight into commercial performance • Integrated data that provides insight across the organization • Increased awareness of regulatory changes that may impact business processes • Help prevent costly fines, penalties and reputational damage

Our comprehensive commercialization solution leverages industry leading practices, methodologies and our • Reallocate staff to activities that focus on driving business proprietary systems to support critical commercial activities. performance Our solution can be tailored to meet your needs, ease your • Leverage industry leading practices, methodologies and obligations and keep you focused on driving your business our proprietary systems forward.

Case study: optimized commercial strategy for an effective product launch Business challenge

How we helped

Benefits

A clinical-stage company was given a PDUFA date and planned to commercially launch its first product. With the pressure of managing burn rate with limited capital, building a commercial organization was not fiscally feasible. A managed services provider was the selected option.

We delivered a customized approach that provided our compliance and risk advisory services and technology-driven managed services. We developed a compliance program and supported the integration of a compliance infrastructure that included transparency, contract oversight and government pricing.

After its launch, the client has more options than it did a year ago. The company now benefits from our data integration that helps to improve performance and provides business insight. Additionally, the client realized a significant cost savings over internal systems and the FTEs required to manage the systems.

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Commercial excellence at the finish line and beyond

Our advisors specialize in providing clinical-stage and small companies with an understanding of the stakeholders and services needed to launch products. We help you to define, evaluate and implement what is needed in order to achieve an effective launch, and to thrive post-launch in a dynamic health care environment. We can bring together the right vendors, technology and support services that your product needs. Typical launch timeline Drug development milestones

Phase III clinical trials

Stage

-24 months

Submission preparation

NDA Regulatory review submission

NDA approval

-12 months

Ongoing commercial operations

Launch

Post-launch

Risk management, transparency reporting

Compliance Clinical and commercial compliance and risk program design, operational governance advisory services

Compliance operations (CCO, Medical Affairs, advisory board)

Operations and training

Compliance Quality auditing and management monitoring plan

Vendor compliance audits

Risk management and oversight plan, system and process compliance audits

Ongoing corporate and commercial compliance audits

Pricing strategy

Product launch plan

Market potential analysis, pricing analytics

Pricing compendia data

Patient access and channel Trade and strategy, third party logistics distribution (3PL) evaluation

Trade launch plan and state licensing

Managed services operations

Payer mix landscape analysis, setup and training

Government programs assessment

Resource/outsource evaluation

Product lifecycle planning

Execute trade launch plan, 3PL contract assessment

Contract plans and administration

Government calculations, payment processing, managed care management

Contact us to request a detailed timeline that provides a summary of these services as they fit within a typical commercialization path.

Commercialization strategy for product launch

When companies make the decision to build a commercial organization, they need flexible options based on financial execution and timing. We allow them to focus on their therapeutic products and not worry about creating overhead as they prepare for launch.

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The right formula for commercial success

About us

Managed Services Operations

Our services focus on risk mitigation and operational performance. We provide deep industry and compliance knowledge, subject matter specialists, and a technology platform to manage complex commercial operations.

• Optimize channel strategies that drive commercial effectiveness • Create additional stakeholder value through better revenue management • Lower costs through a managed services approach

Compliance and Risk Advisory Services Compliance and Risk

• Build and maintain a compliance infrastructure across business lines • Better management of risk through monitoring and compliance auditing

Operational Excellence Business Insight

• Maintain up-to-date and compliant policies and procedures Managed Services

• Understand interdependencies between compliance, contracts and government pricing

Business Intel Products • Gain insight into commercial activities • Effectively demonstrate the value of product(s) • Understand business performance to help you reduce risk and achieve efficiency

This document contains general information only and Deloitte is not, by means of this document, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This document is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this document. As used in this document, “Deloitte” means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting. Copyright © 2016 Deloitte Development LLC. All rights reserved.