H O W T O A C C E L E R AT E O U T C O M E S

O F B I O M A R K E R I N F O R M AT I O N A N A L Y S I S

A D A M C A R R O L L , P H D C S O , A M P L I O N I N C .

A D A M @ A M P L I O N . C O M F E B R U A R Y 1 7 , 2 0 1 5

Information overload is a persistent problem for professionals interested in molecular biomarkers and is exacerbated by ‘single-use information culture’ within organizations.

Do you want to discover how your organization can solve these challenges?

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

At Amplion, we see biomarkers as the key to delivering on the promise of personalized medicine. From drug research and discovery and companion diagnostic development to patient care, we understand that biomarkers will drive personalized care.

Researchers can now have an unprecedented view of the clinical biomarker landscape with every biomarker in an FDA-approved test or drug label, thousands of biomarkers in clinical trials.

And with the recent inclusion of Laboratory Developed Tests (LDTs,) 30% more of the newest and most innovative clinical biomarkers are now normalized and readily accessible through the intuitive interface of BiomarkerBase™.

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

How Do You Stay Up To DateWith Biomarker Trends?

Subscribe to the Biomarker Trends Blog to keep up with the issues related to developing and commercializing biomarker-based IVD tests.

Click here and subscribe.

W H AT D O Y O U W R I T E O N A N E P I T U B E ?

http

://ww

w.fl

ickr.com/p

hotos/jep

oirrier/349580669/

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

W H AT N A M E D O Y O U G I V E A F I L E ?

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

U S E R E X P E R I E N C E

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

T W O K E Y C H A L L E N G E S :

1. PRESERVING INFORMATION-Institutional Knowledge -“Single-Use” Information Culture

2. FINDING INFORMATION-High volume & velocity -Information, not data

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

N O V E L B I O M A R K E R P U B L I C AT I O N S

Pu

blic

atio

ns

0

1000

2000

3000

4000

Publication Year

2003 200420052006200720082009 2010 2011 2012 2013 2014

Researchers announce new candidate biomarkers daily.

Many of these will not prove to be useful in a clinical setting.

Biomarkers already in the clinic provide essential, actionable opportunities for use in test and drug development.

Clinical Biomarkers Are Essential

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

F I N D I N G C L I N I C A L B I O M A R K E R S I S H A R DInformation exists in numerous, unconnected databases.

Each of these databases is challenging to search in a comprehensive way.

Result?

There is significant potential for missed opportunities.

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Use Case 1:

Search Term Studies Returned

Ca 125 251

Ca-125 251

Mucin-16 187

Mucin 16 187

Muc16 3

Which trials measure CA-125?

Synonyms are not normalized

Results must be parsed

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Biomarkers can be described in: • Conditions • Interventions • Arms • Outcome Measures

• Measure • Description

• Brief Description • Detailed Description • Eligibility > Criteria

Use Case 2: Find ALL clinical trials that measure levels of epidermal growth factor receptor.

Search interface limits which fields

are searched

Only way to search completely is to parse

XML documents

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Test Names: • OVA1™ Test • ROMA™ • VIDAS® CA 125 II Assay™ • Others...

Can’t search test databases

by Intended Use.

Can’t search more than one Product Code.

OVA1 & ROMA: same Product Code, different FDA Databases.

Can’t search by the molecular

target measured.

Use Case 3: Find tests available for supporting diagnosis of ovarian cancer.

Product Code: • [ ONX] • [ ONX] • [ LTK]

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Create a comprehensive summary using tests, drugs,

clinical trials, and publications.

Use Case 4:

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

T H E S O L U T I O N I S B I O M A R K E R B A S E

http://www.biomarkerbase.com

A manually curated knowledge base that aggregates and organizes clinical biomarker information from publicly available sources.

A solution to the challenges of accessing and using those sources.

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Begin Commercialization

H O W D O W E B U I L D O U R B I O M A R K E R P L A N ?

Gather Biomarker Information

Organize Information

Analyze Information Act

FDA Test Databases

Drugs@FDA

ClinicalTrials.gov Manual AnalysisPowerPoint

Access

Excel

PubMed

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Begin Commercialization

Gather Biomarker Information

Organize Information

Analyze Information Act

K N O W L E D G E B A S E

Manual AnalysisPowerPoint

Access

Excel

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

K N O W L E D G E M A N A G E M E N T

Gather Biomarker Information

Organize Information

Analyze Information

Begin CommercializationAct

Manual Analysis

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Gather Biomarker Information

Organize Information

Analyze Information

Begin CommercializationAct

K N O W L E D G E M A N A G E M E N T

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

About Amplion

Remember the last scene from Raiders of the Lost Ark where the Ark of the Covenant becomes lost in a sea of identical wooden crates inside a gigantic warehouse?

At Amplion, we liken the Ark of the Covenant to how hugely valuable — but largely inaccessible — biomarker data is currently housed. Sure, it’s there — but good luck finding it. 

We want to change that, which is why we created Amplion’s flagship product, BiomarkerBase™ that’s already reinventing translational research for a number of the largest drug and diagnostics companies worldwide.  

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E

Based in Bend, Oregon, Amplion is accelerating personalized medicine by making it easier for drug and diagnostic development professionals to both access and analyze information about clinical biomarkers. 

Want To Stay Up To Datewith Biomarker Trends?

Subscribe to the Biomarker Trends Blog to keep up with the issues related to developing and commercializing biomarker-based IVD tests.

Click here and subscribe.

Ready to Escape the Single-Use Information Culture?

Turbo Charge Your Biomarker Planning with BiomarkerBase™

Schedule your demo here.

Manage, analyze and share both public and proprietary information that drives your biomarker planning

Stop losing organizational biomarker knowledge when someone walks out the door

Assess the risks and benefits of applying a particular biomarker to your project

Collaborate with colleagues on appropriate biomarker planning for all clinical applications

Automatically generate your biomarker plans and other reports

T H A N K Y O U

A D A M C A R R O L L , P H D C S O , A M P L I O N I N C .

A D A M @ A M P L I O N . C O M F E B R U A R Y 1 7 , 2 0 1 5

S TAY U P T O D AT E W I T H B I O M A R K E R T R E N D S H E R E