Precision Medicine with Companion Diagnostics (CDx) is Continually Changing. Is Your Team Ready to Hit the Target?

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Precision Medicine with Companion
Diagnostics (CDx) is Continually Changing
AN INFORMED SALES FORCE
Is Your Team Ready to Hit the Target?

2. © Informa Training Partners, Inc. | 508.668.0288 | www.informatp.com
Precision medicine with CDx promises to:
 Identify patients with a disease or mutation
 Personalize treatment decisions
 Discover/develop novel, targeted therapies
 Optimize patient outcomes
Precision Medicine Initiative (PMI)
 Launched in 2015 by former President Obama
 A new model of patient-powered research
 To accelerate drug discovery
 To develop tools and therapies to deliver precisely what
is best for the patient
The Promise of Precision Medicine

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Definition*
CDx is a medical device, often in vitro, that provides
information essential for safe and effective use of a drug or
biological product
Application*
 Identify those patients most likely to benefit from treatment
 Identify patients at increased risk of adverse events
 Monitor treatment response and adjust dose/regimen
 Identify populations with adequate safety and efficacy data
* Per the US Food and Drug Administration
What Is CDx and Why Is It Used?

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 IHC assay
(HercepTest™)
improved
 FDA approved
Herceptin and
HercepTest
(Sept 1998)
 First CDx developed,
IHC assay for HER2
 Herceptin® for
metastatic breast
cancer
 Novaldex® data
show breast cancer
response/positive ER
status correlation
ER, estrogen receptor
IHC, immunohistochemistry
HER2, human epidermal growth factor receptor 2
1980s 1990s1976
How It All Began—Early History of CDx

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 Immunohistochemistry (IHC)
 Flow cytometry
 Cytogenetic test
 Fluorescence in situ hybridization (FISH)
 Molecular diagnostic tests
 Polymerase chain reaction (PCR), including
reverse transcriptase (RT) PCR
 Microarray
 DNA sequencing
What Are Some CDx Test Types?

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Oncology was the first use and is the largest segment
 Drugs now target specific biomarker rather than tumor type
 Some biomarkers present in more than one cancer type
Biomarker Cancer Type
 HER2  Breast
 Gastric
 BRCA  Breast
 Ovarian
 Anaplastic lymphoma kinase (ALK)  Non-small cell lung cancer (NSCLC)
 BRAF V600E and V600K  Melanoma
 Epidermal growth factor receptor (EGFR)  NSCLC
 KRAS oncogene mutations  Colorectal cancer
 PD-L1  NSCLC
Where Is CDx Used Most Often?

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CDx is expanding into other therapeutic areas
Not Just for Cancer Anymore
Oncology
 Non-transfusion dependent thalassemia
 Cystic fibrosis
 HIV
 Severe growth failure
 Alzheimer’s disease
 Rheumatoid arthritis
 Other autoimmune
 Kidney insufficiency after transplant
 Hepatitis C
 Coronary artery disease
Non-oncology
FDA approved uses
Potential Uses
Clinical Trials

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NGS has potential to detect conditions early and
identify markers to customize treatment
 Becoming more rapid, less expensive
 Not yet routine
 Many labs offer NGS for patients with family history
(eg, cardiomyopathies, certain cancers)
 FoundationFocus™ CDxBRCA*
 Based on NGS
 Approved to detect BRCA 1/2 alterations in ovarian tumor
tissue
 Two FDA guidelines for NGS-based tests to ensure
safety and effectiveness
*A Foundation Medicine CDx
Next-Generation Sequencing (NGS)
—the Future

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Regulations differ by country or region
 Japan: inclusion of biomarker-negative patients in early phase trials
strongly encouraged
 US: including such patients may slow drug development
CDx use is required in label of the agent and the
CDx.*
 If CDx development lags behind the agent, it will take
longer for the agent to be brought to market
* US Food and Drug Administration
FDA approval
CDx Development
Drug Development
Regulatory Hurdles

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CDx can save payers money by reducing overall
healthcare costs; however, getting reimbursement for
these costly tests can be a challenge
 Payers require extensive evidence — sometimes even more
evidence than FDA needs for CDx approval
 Also, reimbursement criteria can vary from payer to payer,
and even from patient to patient
Evidence supporting accuracy and reliability
necessary
 Positive health outcomes and economic value data plays a
major role in reimbursement decisions
Reimbursement in the US

11. © Informa Training Partners, Inc. | 508.668.0288 | www.informatp.com
Informa’s CDx training prepares your team to:
 Lead meaningful discussions with HCPs on the science of CDx
 Recognize the impact of CDx on drug approval times and the
challenges with CDx development
 Understand the clinician perspective on reimbursement
difficulties and navigate the ever-changing CDx payer landscape
 Appreciate the effects of targeted therapies on patients
With CDx, new and effective treatment options
personalized for patients can hit the target and change
lives
Why Train on CDx?
Can your sales team hit their targets?

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Hit the target with Informa’s CDx training.
To learn more please contact
Linda Toscano, Director, Business Development
ltoscano@informatp.com