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Cancer Immunotherapy: Building on Initial Successes to Improve Clinical Outcomes

  • ID:RM003414
  • Published: May-2017
  • Pages:218
  • IPR
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Cancer Immunotherapy: Building on Initial Successes to Improve Clinical Outcomes

This new report builds on our 2014 Insight Pharma Report, Cancer Immunotherapy: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies. In that report, we focused on the major classes of cancer immunotherapy drugs that were then emerging from academic and corporate research: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies. This new report includes an updated discussion of approved and clinical stage agents in immuno-oncology, including recently-approved agents. It also addresses the means by which researchers and companies are attempting to build on prior achievements in immuno-oncology to improve outcomes for more patients. Some researchers and compaShow More

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Acknowledgements v


Introduction


CHAPTER 1:
An Overview of the IVD Industry and Market
Figure 1.1: The Importance of IVD in healthcare
What does “healthcare” mean?
Healthcare trends and why they matter
Figure 1.2: Macro Healthcare Trends
The world’s population is getting older
Figure 1.3: Growth in the Aging Population
Emerging economies are continuing to grow
Figure 1.4: Improved Access to Healthcare in Emerging Economies
The word is facing an epidemic of chronic diseases
Figure 1.5: Growth of Chronic Disorders
The Affordable Care Act is redefining the business of healthcare
Figure 1.6: Healthcare Reform Overview
Healthcare delivery is becoming increasingly decentralized
Figure 1.7: Decentralization of Healthcare
Figure 1.8: The Rise of Retail Health Clinics
Integration is making personalized healthcare a reality
Figure 1.9: Personalization of Care - Targeted Therapies
Global healthcare spending is out of control
Figure 1.10: Unsustainable Growth of Healthcare Spend
Summary


SECTION TWO: THE IVD INDUSTRY TODAY
Figure 1.11: IVD Definition
What do we mean by IVD?
Figure 1.12: IVD Market Segmentation
Figure 1.13: IVD Market
Who are IVD’s clients?
Applications of IVD
Figure 1.14: Key Trends/Drivers Within IVD
Figure 1.15: Recent Activity in the IVD Market


SECTION 3: LOOKING FORWARD
Integrated delivery networks and consolidation will be the rule, rather than the exception
Figure 1.16: Growth of Integrated Delivery Networks (IDNs)
Figure 1.17: Consolidation of Healthcare
Characteristics of Integrated Health Delivery Networks
Figure 1.18: Growth of ACOs
Figure 1.19: ACO Objectives
Remote patient care and monitoring will become indispensable components of healthcare
Figure 1.20: Personalization of Care - Remote Patient Monitoring
Figure 1.21: Personalization of Care - Remote Patient Monitoring
Health information technology will grow ever more integrated
Figure 1.22: Personalization of Care - Healthcare Data Analytics
Have you heard about “Patients Like Me”?
Data-driven and evidence-based medicine will become the new reality
Figure 1.23: Personalization of Care - Healthcare Data Analytics
Figure 1.24: Improved Outcomes and Cost Effective Care



CHAPTER 1 REFERENCES


CHAPTER 2:

Product Concept Development and Validation

SECTION 1: Understanding the current clinical paradigm
Overview of the patient care cycle/clinical paradigm
What is the Patient Care Cycle?
Figure 2.1: Mapping the Patient Journey to Key Diagnostic Steps
Figure 2.2: Clinical Care Pathway Analysis - Getting Started
Using the care cycle to map patient flow
Figure 2.3: Analyzing the Workflow
Figure 2.4: Clinical Care Pathway Overview
Figure 2.5: Prostate Cancer Diagnostic Workflow
Identifying relevant stakeholders
Mapping parallel diagnostics workflows

SECTION 2: Identifying unmet needs and opportunities
Identifying underlying clinical needs
Figure 2.6: Identifying Unmet Needs and Opportunities
Figure 2.7: Identifying Unmet Needs - Breast Cancer Example
Figure 2.8: Opportunity Identification and Characterization
Value proposition development
Figure 2.9: Assessing Buyer Values and Requirements
Figure 2.10: Mapping Buyer Values to Opportunities
Example analysis: Philips
Figure 2.11: Case Example - Philips Stroke Care


SECTION 3: Characterizing and prioritizing opportunities for selection

Defining the addressable patient population
Figure 2.12: Market Sizing
Figure 2.13: Opportunity Prioritization
Figure 2.14: Competitive Landscape Assessment
3.2 Understanding the diagnostic requirements
Defining clinical utility for the opportunity
Figure 2.15: Evaluation Framework for Diagnostic Tests

CHAPTER 2 REFERENCES


CHAPTER 3:

Diagnostic Development
What is an IVD?
IVD Classification
Marketing Diagnostic Tests
ASRs
IVDs
LDTs
Figure 3.1: Comparison of Diagnostic IVD and LDT Development Pathways
Clinical Laboratory Improvement Amendment (CLIA)

Overview of Laboratory Developed Tests (LDTs)

Types of IVD technologies
Technology and platform considerations
Design process and control—a brief overview
Figure 3.2: Design Control Process Overview
Why Design Controls?
Stage-gate Product Development
Figure 3.3: Product Development Management
Figure 3.4: Stage Gate Process for Diagnostic Development
Figure 3.5: Needs Identification and Assessment
Figure 3.6: Deliverables and Decisions by Stage-Gate Phase
Figure 3.6: Deliverables and Decisions by Stage-Gate Phase
Project management
Development process
Design & development planning
Design input
Design output
Design review
Design verification and validation
Design transfer
Design changes
Design history file
Precision Medicine
Beyond the U.S.
LDT guidance


CHAPTER 3 REFERENCES


CHAPTER 4:


Regulatory Considerations and Pathways
Regulatory Overview
Figure 4.1: Regulation of Diagnostics - Key Regulatory Authorities (US)
US FDA overview
Risk-based Classification of Devices
Figure 4.2: FDA IVD Regulation Overview - The Three Classes
Devices used in clinical trials
Clinical Laboratory Improvement Amendment of 1988 (CLIA)
Figure 4.3: CLIA - Oversight
Figure 4.4: Oversight Example - California
FDA and CMS Comparisons
European IVD Directive
FDA Approval Pathways
510(k) Clearance
Figure 4.5: 510(k) Approval Process
Pre-market approval (PMA)
Figure 4.6: PMA Approval - Overview Pathways and Timeline
Humanitarian Device Exemption (HDE)
Lab-developed tests (LDTs)
Analyte specific reagents (ASRs)
Companion diagnostics (CDx)
Complementary diagnostics
FDA draft guidelines

Laboratory developed tests (LDTs)
Figure 4.7: LDT Approval - Proposed Level of Oversight
Figure 4.8: LDT Proposed Timeline for Regulatory Oversight
Companion Diagnostics (CDx)
Co-development of CDx with Therapeutic Products

NGS-based IVDs and Diagnosis of Germline Disease
Public Genetic Databases for Clinical Validity for NGS-based IVDs
Emerging issues over IVD regulations and genomic testing

Overview—genetic testing and regulations
The Genetic Information Nondiscrimination Act of 2008
History of GINA
Protections by GINA and other Laws
Limitations of GINA
Ethical, legal, and social issues related to the use of genetic information
Genetic testing inThe AUthorldren
Genetic tests and medical records
Direct to consumer (DTC) testing
Summary


CHAPTER 4 REFERENCES

CHAPTER 5:

Market access planning
U.S. Health Insurance and Reimbursement Overview
Figure 5.1: U.S. Health Insurance Structure
Figure 5.2: Health insurance coverage by type. (Source: healthinsurance.org)
Early health insurance plans
The Rise of Medicare and Medicaid
ACA/Healthcare reform
Figure 5.3: Relationship Between Payment Reform, Provider Organization Models, and Feasibility
Reimbursement overview
Figure 5.4: Flow of funds in the U.S. healthcare system.
Payer coverage decision influences
Figure 5.5: Coverage Decision Influences
The Role of Evidence
HTA Process
Figure 5.6: Health Technology Assessment Organizations by Frequency of Use by Payers and Intended Audience.
Evidence Generation for Diagnostics
Figure 5.7: Study Design Hierarchy of Evidence
Real-World Data
Coding: Molecular Pathology codes
Figure 5.8: Generic Code Types for Molecular Diagnostics
Figure 5.9: Changes in Coding of Molecular Diagnostics
Figure 5.10: Molecular Diagnostic CPT Codes45
Reimbursement Process
Payment
Figure 5.11: PAMA’s Effect on Laboratory Testing Payment Frameworks45
Figure 5.12: The MolDX Framework for Evaluating Molecular Diagnostic Tests45
Contracting for Payment
Figure 5.13: Payer Contracting Process
Functional roles and capabilities
Outlook and What’s to Come
Outlook for Molecular Diagnostics
Evidence and reimbursement in CDx
Summary


CHAPTER 5 REFERENCES

CHAPTER 6:

Commercialization planning and operations
Market planning and operations
Brand planning
Customer segmentation
Brand positioning and brand marketing
Key opinion leaders: Identification and strategy
Forecasting
Marketing channel mix
Figure 6.1: Marketing Strategies for the IVD Industry
Sales planning and operations
Sales force structure and size
Account planning and detailing
Compensation design
Medical affairs
Figure 6.2: Medical Affairs Key Roles and Responsibilities
Overview of medical affairs and medical science liaison (MSL) roles
Scientific writing
Commercialization support: Thought leader management and sales/marketing support
Customer service/support
Setting up an effective client services/support strategy and unit
Summary


CHAPTER 6 REFERENCES


CHAPTER 7:

Wrapping Up and Looking Ahead
A look backward
Healthcare trends
The clinical paradigm and product conception
Diagnostic development
Regulatory frameworks
Market access and reimbursement
Commercialization planning
New technologies
Big data and analytics
What comes next?


CHAPTER 7 REFERENCES


List Of Tables

Tables
Table 1.1: Title
Table 2.2: Biomarkers for Use in Clinical Studies of Checkpoint Inhibitors
Table 3.1: Select Immune Agonists for Cancer Immunotherapy
Table 4-1: Select Bispecific Antibody Agents for Cancer Immunotherapy
Table 5-2: Select Cancer Vaccines Approved and in Clinical Development
Table 6-1: Select cellular immunotherapies in commercial development


List of Figures

Figures
Figure 2.1: T Cell Costimulation by CD28 and Checkpoint Control by CTLA-4
Figure 4.1: Bispecific antibodies in immuno-oncology
Figure 6.1: Bispecific antibodies in immuno-oncology

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