DESIGN FOR DIFFERENTIATION & VALUE® CURRICULUM

Attract, Retain, and Develop Talent while Enhancing Organizational Capability to Create Imaginative Development Plans to Drive Competitive Advantage and Achieve Success in the Market.


OBJECTIVES:

  • Prepare Commercial, Medical, and Access Leaders for active & successful collaboration with R&D by providing the knowledge, credibility, and confidence to effectively inform development decisions

  • Provide the insights & common language necessary to improve communication & partnership across Commercial, Medical, Access, and R&D.

  • Identify key learnings, insights, and practical applications from both successes & failures derived from real life oncology clinical development examples.

  • Differentiate your organization from its peer set through focused investment in people development and the execution of unique & rigorous training program


MODULES:

Introduction to Design for Differentiation & Value®

Describe Clinical Development Process & the Critical Role of appropriate Risk-Taking & Strong Cross-Functional Partnership in Driving Market Success.
Effectively Employing Endpoints to Drive Value

Effectively incorporate Traditional, Non-traditional, & PROs into your clinical development plans to establish your Brand’s value.
BioStats for Non-Biostatisticians

Learn key concepts of Biostatistics and how to apply them in Clinical Development.
The Opportunities & Challenges of Precision Medicine in Oncology

Introduction to Biomarkers & Key Considerations in their development and commercialization.
Regulatory Considerations & Strategy in Oncology Development

Improve your understanding of the Regulatory landscape & terminology to help inform development strategies.
What Do Payers Want?

Provides a foundational understanding of the primary types of Payers, what types of evidence they are seeking, & how they impact commercial success.
Leveraging the Power of Real-World Data to Drive Value

Provides a foundational understanding of the application & limitations of Real-World Data Generation in the support of your Brand’s Value Story.
What’s the Target: Trial Design for Success in the Market

How to development an actionable Target Product Profiles & a rigorous approach to enhancing trial design to establish value & position your assets for commercial success (vs regulatory approval alone).
Designing Differentiated Product Labeling

Development of a strong labeling strategy to inform clinical development, guide engagement of regulatory bodies, and deliver a differentiated profile that translates data into effective claims.
Assessing the Financial Value of Developmental Options

Overview of Techniques Applied to Assess Financial Value of individual assets and to drive portfolio decisions.
Introduction to Design for Differentiation & Value®

Describe Clinical Development Process & the Critical Role of appropriate Risk-Taking & Strong Cross-Functional Partnership in Driving Market Success.
Effectively Employing Endpoints to Drive Value

Effectively incorporate Traditional, Non-traditional, & PROs into your clinical development plans to establish your Brand’s value.
BioStats for Non-Biostatisticians

Learn key concepts of Biostatistics and how to apply them in Clinical Development.
The Opportunities & Challenges of Precision Medicine in Oncology

Introduction to Biomarkers & Key Considerations in their development and commercialization.
Regulatory Considerations & Strategy in Oncology Development

Improve your understanding of the Regulatory landscape & terminology to help inform development strategies.
What Do Payers Want?

Provides a foundational understanding of the primary types of Payers, what types of evidence they are seeking, & how they impact commercial success.
Leveraging the Power of Real-World Data to Drive Value

Provides a foundational understanding of the application & limitations of Real-World Data Generation in the support of your Brand’s Value Story.
What’s the Target: Trial Design for Success in the Market

How to development an actionable Target Product Profiles & a rigorous approach to enhancing trial design to establish value & position your assets for commercial success (vs regulatory approval alone).
Designing Differentiated Product Labeling

Development of a strong labeling strategy to inform clinical development, guide engagement of regulatory bodies, and deliver a differentiated profile that translates data into effective claims.
Assessing the Financial Value of Developmental Options

Overview of Techniques Applied to Assess Financial Value of individual assets and to drive portfolio decisions.

Introduction to Design for Differentiation & Value®

Describe Clinical Development Process & the Critical Role of appropriate Risk-Taking & Strong Cross-Functional Partnership in Driving Market Success.

Effectively Employing Endpoints to Drive Value

Effectively incorporate Traditional, Non-traditional, & PROs into your clinical development plans to establish your Brand’s value.

BioStats for Non-Biostatisticians

Learn key concepts of Biostatistics and how to apply them in Clinical Development.

The Opportunities & Challenges of Precision Medicine in Oncology

Introduction to Biomarkers & Key Considerations in their development and commercialization.

Regulatory Considerations & Strategy in Oncology Development

Improve your understanding of the Regulatory landscape & terminology to help inform development strategies.

What Do Payers Want?

Provides a foundational understanding of the primary types of Payers, what types of evidence they are seeking, & how they impact commercial success.

Leveraging the Power of Real-World Data to Drive Value

Provides a foundational understanding of the application & limitations of Real-World Data Generation in the support of your Brand’s Value Story.

What’s the Target: Trial Design for Success in the Market

How to development an actionable Target Product Profiles & a rigorous approach to enhancing trial design to establish value & position your assets for commercial success (vs regulatory approval alone).

Designing Differentiated Product Labeling

Development of a strong labeling strategy to inform clinical development, guide engagement of regulatory bodies, and deliver a differentiated profile that translates data into effective claims.

Assessing the Financial Value of Developmental Options

Overview of Techniques Applied to Assess Financial Value of individual assets and to drive portfolio decisions.


CUSTOMIZE YOUR TRAINING

Design for Differentiation and Value is a flexible and interactive curriculum that can be delivered live at your site or virtually.  Its modular format allows for the topics covered to be tailored to organizational and individual development needs.

Interested in Design for Differentiation & Value training for your organization?

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