Companion Diagnostics - A Unique Outcome and Opportunity

Companion Diagnostics - A Unique Outcome and Opportunity

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Description: Companion Diagnostics A Unique Outcome and Opportunity - from Two Awkward Healthcare Industry Parents! What is Companion Diagnostics?:- A companion diagnostic device can be an in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Biopharmaceutical firms expect investment in the field to increase by a third in the next five years.

 
Author: Andrew J Beard PhD (Fellow) | Visits: 512 | Page Views: 755
Domain:  Medicine Category: Therapy 
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Contents:
Presentation at Siemens Academy Day 21st April 2016

“Companion Diagnostics – A Unique Outcome and Opportunity - from Two
Awkward Healthcare Industry Parents!”
Andrew J Beard. PhD.
Head of Siemens Companion Diagnostics & Strategic Biomarkers Group.
© Siemens AG 2016 All rights reserved.

Answers for life.

Todays Out-of the Box Agenda

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 2

Todays Out-of the Box Agenda

What do we know about Companion Diagnostics
and Personalized Medicine?
Good Parenting and Partnering?
What is Siemens doing in this space?

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 3

What is Companion Diagnostics?

Companion Diagnostics
Precision Medicine

Personalized
Medicine for improved
patient outcomes

“A companion diagnostic device can be an in vitro diagnostic device or an imaging tool
that provides information that is essential for the safe and effective use of a
corresponding therapeutic product.”
– U.S. Food and Drug Administration

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 4

Companion Diagnostics (Personalized Medicine) is a Major Trend in
Healthcare Today and in Future

Safer, More Effective Drugs

What is Driving
Personalized
Medicine?

Faster Time to a Cure

Cost-Effective Healthcare

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 5

HIV Co-receptor Tropism Example of a Companion Diagnostic Test

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 6

Evolution of Molecular Characterization of Lung Cancer

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 7

7

48-yr old Female Non-smoker with NSCLC ALK Fusion
Pre-treatment

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 8

After 2 cycles of Therapy

Kwak EL, et al. ESMO/ECCO 2009 (Abstract G6 and oral presentation)

Marketed Therapeutics Reliant on a CDx Generated ~$19B in Therapeutic
Revenues in 2013
Biopharma WW marketed CDx drug revenue segmentation (2013)*
Percent of revenues
100
90
80

~$19B

~$19B

Infectious disease

~$19B

Predictive

Other***
Iressa (AZ)
Erbitux (BMS)

Therapy selection
/ monitoring

Tasigna (Novartis)

70

Sprycel (BMS)

60

Note:

Tarceva (Roche)**

50
40

Gleevec
(Novartis)

** Includes all Tarceva revenues, not just those from
first-line treatment for EGFR+ NSCLC patients
*** Other includes Mekinist, Bosulif, Tafinlar, Vectibix,
Selzentry, Kadcyla, Xalkori, Tykerb/Tyverb,
Perjeta, Zelboraf, and Victrelis

Oncology
Source:

Therapy selection

30
20

* 2013 revenues are actual or analyst estimates;
PHC products include those with labels that require
/ recommend PharmDx tests for candidacy

Company websites and press releases, Annual
reports, EvaluatePharma®, L.E.K. analysis of
therapeutic sales

Herceptin
(Roche)

10
0
Drug
(Company)*
© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 9

Therapeutic
area

Test
purpose
© 2014 L.E.K. Consulting LLC. All rights reserved.

A New Landscape for the Pharmaceutical Industry

42% of all drugs in development are personalized
medicines1

73% of oncology drugs in development are
personalized medicines1

Personalized medicines

Personalized medicines

Biopharmaceutical firms expect investment in the field to increase by a third in
the next five years1
1 Tufts Impact Report: Personalized medicine gains traction but still faces multiple challenges. May/June 2015.
© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 10

Policy Issues In Personalized Medicine

Reimbursement
Health care
Provider
Education and
Adoption

Regulation

Patient
Education

Personalized
Medicine

Privacy / Ethics

R&D Incentives

Intellectual
Property

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 11

Comparative
Effectiveness
Research

Parents and Partnering for a Companion Diagnostic Test!

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 12

Parents and Partnering for a Companion Diagnostic Test!
In US…
• 40-50% if marriages end up with divorce
• Average marriage is 8 years
Common reasons…
“Lack of commitment”
“Lack of equality”
“Un-realistic expectations”

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 13

Parents and Partnering for a Companion Diagnostic Test!
Observations and Behaviours
RX

DX

20x

1x

Therapy
development
high risk!

Test
development low
risk!

Timeline
expectations

Long
development
programs
(typically 10yrs)

Short
development
programs
(typically 1000 patients
Efficacy-seeking

Phase III
• Proven analytical performance
• Clinically validated decision
points
• Prospective clinical validation

Siemens Clinical Laboratory
A Center of Clinical Excellence and Innovation
Siemens Clinical Laboratory (SCL), Berkeley, CA.
A CAP accredited CLIA clinical laboratory in a global diagnostics company since 1994
CLIA Testing Services
Customer & Product Support
Dx / Pharma Development Support
Clinical Trials
Education / Professional
Technical Expertise
RNA & DNA Qualitative and Quantitative Analyses
RNA Expression Analysis
RNA/DNA sequencing
Immunoassays
HPLC and MS
RNA & DNA Qualitative and Quantitative Analyses
Genotyping

Disease Focus
Infectious disease
Oncology
Cardiovascular
© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 16

CDx&SB Group Channels Pharma Interests/Investment into Siemens
Healthcare

CD&SB acts as the conduit between
pharmaceutical companies and Siemens

Pharmaceutical
Company Partners

Siemens Healthcare
Companion Diagnostics Group
(inc. Siemens
Clinical Laboratory Operation)

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 17

Example: Siemens Zika Reference Laboratory Services Concept


Leverage the CLIA lab capabilities to offer Zika test LDTs ** to support pharmaceutical
vaccine development and Siemens product health group
2016
Molecular Test

Serology Tests





Zika antibody (IgM) LDT **
• Detect acute zika virus infection
• Using Siemens Novagnost zika
IgM kit*** components



Zika antibody (IgG) LDT **
• Detect previous exposure to
zika virus infection
• Using Siemens Novagnost zika
IgG kit** components

Zika kPCR test LDT **



• Research use only
** Under development
*** CE-IVD; Not currently available for sale in the U.S.

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 18

Detect presence of zika virus
Using Siemens RUO zika kit*
test components & protocol

CD&SB Business Model

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 19

Publicly Disclosed Companion
Diagnostics Partnerships

Pfizer
Master Services Agreement
(MSA) for Companion
Diagnostics collaboration

Janssen
Pharmaceuticals
Companion Diagnostics immunoassay test for novel
heart-failure drug

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 20

ViiV Healthcare
Companion Diagnostics next-generation
sequencing (NGS) tropism test for HIV-1
treatment

Tocagen Inc.
Novel clinical-trial tests for cancer-selective
gene therapy for patients with brain cancer

CD&SB group Supports Ongoing Clinical-Trials Testing Across a Range of
the World’s Most Threatening Diseases
Current treatment for the most common—and the most deadly—form of primary brain cancer
(glioblastoma, GBM) is limited:

One-third
of GBM patients remain alive 1 year after diagnosis.1

10 months
median survival after diagnosis for all patients.2

16 months
Median survival with current maximal therapy:3 Surgery, radiation, and alkylating. Clinical trials
recommended upon recurrence.

Tocagen Inc. of San Diego, California, has developed a cancer-selective retroviral replicating gene therapy (Toca
511™) to combat brain cancers including GBM—and they needed a collaboration partner to support their clinical-trials
testing and commercialization.
Siemens Clinical Laboratory – Supporting Tocagen clinical trials with viral load, DNA, therapy and antibody tests
© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 21

1. Central Brain Tumor Registry of the United States
2. Data from patients with glioblastoma (GBM). Yabroff KR, et al. Neuro-oncology. 2012;142:351-359.
3. NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. Version 1.2013.

Toca 511 & Toca FC Selectively Turns Tumor into 5-FU Factory

Dual Actions: 5-FU Kills Tumor and Activates Immune System Against Cancer
CD

Tumor

normal brain

Toca 511

CD protein

CD

Toca FC 5-FU

Toca FC 5-FU

necrosis

lymphocytes

Brain and tumor samples from Tocagen clinical trial patients
Modified from M.K. Aghi, MD, SNO-SCIDOT, Nov. 18th, 2015.
© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.

22

Page 22

CD = cytosine deaminase

Partial Response in Subject with GBM
PR at 6 months; continuing at 21 months

Patients tested and monitored with Siemens
Clinical Laboratory clinical trials tests:
• Viral load (RNA)
• Viral DNA
• Viral antibody
• Therapy concentrations (5FC)

Lesion 2
complete
disappearance

Modified from M.A. Vogelbaum, MD, AANS, May 2, 2015 rights reserved.
© Siemens Healthcare Diagnostics Inc. 2016 All
Page 23

FC cycle is every 6 weeks

Summary
• Companion diagnostic tests are here to
stay.
• It is anticipated most future new biomarker
tests will be companion diagnostic tests
• Bringing these new tests to laboratories
requires good partnering and parenting!
• Siemens is actively participating by
leveraging the Siemens Clinical
Laboratory group for CDx development
with strategic pharmaceutical partnerships

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 24

Companion Diagnostics Today

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 25

BACK-UP

© Siemens Healthcare Diagnostics Inc. 2016 All rights reserved.
Page 26