Personalized Medicine – The Future of Diagnostics | Diaceutics

Personalized Medicine – The Future of Diagnostics


This case study provides an introduction to personalized medicine and its increasing relevance to the diagnostics industry, explaining core concepts, trends, awareness growth and major drivers of change. It will help you understand:
  • Personalized medicine awareness growth over the last decade
  • Personalized medicine's increasing relevance to many physicians' daily routine, predominantly those in oncology
  • Growth potential for personalized medicine across therapeutic areas
Download this case study to learn more.

1: Case Summary

This case will help you understand:

Personalized medicine awareness growth over the last decade.

Personalized medicine's increasing relevance to many physicians' daily routine, predominantly those in oncology.

Growth potential for personalized medicine across therapeutic areas.
Key messages:

Personalized medicine has featured increasingly in the press and in publications over the last decade, but there is still a lot of ambiguity about what constitutes personalized medicine.

Oncology is still at the forefront of personalized medicine implications. Oncologists see the impact of genomic-based medicine on their daily routine and oncology is the most developed area of biomarker research.

There are already many drugs on the market with a diagnostic association on their label. Personalized medicine space will increase and significantly impact the pharmaceutical model.
Key actions:

Understand the evolution and relevance of personalized medicine in clinical decision-making.

Know the growth potential and opportunities in personalized medicine.

2: Personalized Medicine Awareness Growth in the Public Eye

Number of Citations in Google

So What?
Personalized medicine is newsworthy and is becoming a more familiar term in the public eye.

3: Personalized Medicine Awareness Growth in Emerging Players

So What?
Personalized medicine markets are being established in north America and developing elsewhere.

4: Personalized Medicine Awareness Growth in the Scientific Community

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So What?
Reference to personalized medicine in scientific publications has increased steadily.

5: Personalized Medicine Awareness Growth in Stakeholders

Familiarity with the concept of Personalized Healthcare

Stakeholders: regulators, policy makers, payers, patient organisations
Physicians: oncologists, pathologists, virologists, laboratory heads

*PHC Perception Study conducted by Ebiquity. Results based on interviews with 966 key PHC stakeholders in Brazil, China. Germany. Switzerland. UK. US from Sep 2013 to March 2014


So What?

Today the majority of oncologists primarily responsible for test prescribing are familiar with personalized medicine.

Payer and stakeholder awareness still needs to improve so that personalized medicine's full potential can be realized.

6: Oncology is the Most Important Focus for Personalized Medicine…

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So What?

Oncology remains the leading therapy area for personalized medicine, with 2013 seeing an increase in cancer-associated biomarkers in FDA-approved tests (thanks to the approval of Prosignia, Nanostring with 45 novel biomarkers).

7: ...But Our Pipeline Analysis Revealed an Increasing Number of CNS and Immunology Biomarker-Driven Therapies

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8: The Personalized Medicine Landscape Today is Increasingly Crowded

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So What?

Today, nearly three-quarters of all Phase 3 pipeline from 12 leading pharma companies can be considered as personalized medicine, which is up from just over a half in 2011.

9: Personalized Medicine Coalition View

Drug nameBiomarkerIndicationLaunch
Bosutinib (Bosulif®)BCR-ABL1Leukemia: The molecular response measured by BCR-ABL1 RT-qPCR assists in identifying suboptimal responses and can help inform the decision to switch to alternative therapies that may be more efficacious (or to pursue more stringent monitoring). Furthermore, the tyrosine kinase inhibitor–mediated molecular response provides valuable risk stratification and prognostic information on long-term outcomes.2012
Pertuzumab (Perjeta®)HER2 / neu receptorBreast cancer: Indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.2012
Trametinib (Mekinist®); Dabrafenib (Tafinlar®)BRAFMelanoma: Indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.2013
Ponatinib (Iclusig®)BCR-ABL1Leukemia: The molecular response measured by BCR-ABL1 RT-qPCR assists in identifying suboptimal responses and can help inform the decision to switch to alternative therapies that may be more efficacious (or to pursue more stringent monitoring). Ponatinib is a kinase inhibitor, which inhibits the in vitro tyrosine kinase activity of ABL and T315I mutant ABL.2013

10: FDA View – Table of Pharmacogenomic Biomarkers in Drug Labelling (1)

DrugTherapeutic Area*BiomarkerReferenced SubgroupLabelling Sections
AfatinibOncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R) positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies
BosutinibOncologyBCR/ABL1Philadelphia chromosome positiveIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Studies
Ado-Trastuzumab EmtansineOncologyERBB2HER2 protein overexpression or gene amplification positiveIndications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
VemurafenibOncologyBRAFBRAF V600E mutation positiveIndications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counselling Information

11: FDA View – Table of Pharmacogenomic Biomarkers in Drug Labelling (2)

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12: Key Messages

Key messages:

Personalized medicine has featured increasingly in the press and in publications over the last decade, but there is still a lot of ambiguity about what constitutes personalized medicine.

Oncology is still at the forefront of personalized medicine implications. Oncologists see the impact of genomic-based medicine on their daily routine and oncology is the most developed area of biomarker research.

There are already many drugs on the market with a diagnostic association on their label. Personalized medicine space will increase and significantly impact the pharmaceutical model.
Key actions:

Understand the evolution and relevance of personalized medicine in clinical decision-making.

Know the growth potential and opportunities in personalized medicine.

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