BioBridge Strategies LLC Strategies for the New Biology...Mindray Nanogen Roche Zyomyx ACD Caprion...

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BioBridge Strategies LLC

Strategies for the New Biology©

February, 2013

www.bbstrategies.com

http://www.bbstrategies.com/

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BioBridge Strategies

BioBridge Strategies is a global consulting firm that identifies

how pharmaceutical, biotech, diagnostic and device companies

can optimally develop and position their unique technologies or

products for maximum clinical and economic impact in the

healthcare marketplace. BioBridge Strategies develops

strategic and operational solutions for young and mature

companies focusing on the “new biology”.

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What are the product opportunities?

What are the most attractive products and segments?

What is the clinical and economic value of each

product?

What are market entry strategies to maximize value?

What are the business options?

How much does it cost to implement?

What are the milestones that will decrease risk and

increase value?

Answers and Recommendations

Optimizing Value

3

Critical Questions ……..

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Introduction to BioBridge Strategies

The BioBridge Strategy Process

Impact Analysis

BioBridge Strategies Examples

Business Modeling

Agenda

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Business Structure

Affiliates

Associates

The Company BioBridge Strategies

Proactive development of business Objective to develop the business Ownership in BioBridge Ability to do independent business

activities

Reactive development of projects Arms length relationship Complementary or overlapping skills

• Market Analysis • Strategic Assessment • New Marker Assessment • Value Assessment • Value Development • Operational Efficiency

• Diagnostics • Pharmaceutics • Biotech • Genomics/Proteomics

Activities Industries

Business Development Infrastructure Analysis Legal entity

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Who are we?

Lou Riceberg, PhD Principal

Ph.D. in biochemistry from Brandeis University

>25 years’ experience in the IVD industry Corning Medical Ciba Corning Chiron Diagnostics

Areas of interest include: Technology Strategy Applications of technologies

across industries Practical business strategies

Harald Rinde, MD, MBA Principal

MD from Royal College of Surgeons in Ireland

MBA, Northwestern University >25 years’ experience in the

pharmaceutical and IVD industries Ciba Geigy/Novartis Chiron Pharma Start-ups

Areas of interest include: Marketing Cross business synergies Business strategy Health economics, value/

impact modelling

San Diego Basel

Anke-Peggy Holtorf, PhD, MBA Business Director Europe

Adjunct Faculty of Univ. of Utah, Pharmacotherapy Outcomes Research

MBA from Univ. of Birmingham PhD in biological sciences,

Philipps University Marburg >20 years experience in R&D

and marketing of products and services in pharmaceutical and chemical industries

Areas of interest include: Health Technology Assessment Product / service synergies Marketing Outcomes research Training

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Who Are Our Clients?

Pharma Diagnostics Startups Technology

■ Abbott ■ Adamas ■ Angelica

Therapeutics ■ Ascent ■ Bayer ■ Chiron ■ Dow Pharma ■ Isis ■ Merck Serono ■ Novartis ■ Roche Pharma ■ Wyeth

■ bioMerieux ■ Bayer Healthcare ■ Biotrin ■ Fujirebio ■ GeneLex ■ Hitachi High

Technologies ■ Luminex ■ Mindray ■ Nanogen ■ Roche ■ Zyomyx

■ ACD ■ Caprion ■ Clarient ■ Clondiag ■ DNAR ■ Iconix ■ ImmuArray ■ Investigen ■ ParAllele ■ Predicant ■ Raindance ■ Silicon

Biosystems ■ SomaLogic ■ Tecan

■ Cellpoint ■ Crescendo ■ Critical

Diagnostics ■ Curetis ■ diaDexus ■ ICP ■ Satoris ■ Singulex ■ SRU Biosystems ■ Targeted Dx &

Therapeutics ■ Synthera ■ Tethys

Other

■ General Electric ■ Intel ■ J&J Research ■ (J&J) Ethicon

Endosurgery ■ Tecan

■ USA ■ Canada ■ France ■ Germany ■ Switzerland ■ Ireland

Non-Profit

Organizations

■ BioRegio Jena/Germany

■ Catalysis Foundation for Health

■ Enterprise Ireland

■ Gates Foundation

■ RAND Corp. ■ UNITAID ■ WHO

■ Belgium ■ Japan ■ China ■ Korea ■ Australia ■ Israel

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Rx

Dx

BioBridge Strategies - History

BioBridge Strategies

Founded in 2003

Harald: Medicine and Pharma with an appreciation of diagnostics

Lou: Diagnostics with an appreciation of medicine and Pharma

The clinical and economic value of diagnostics and pharmaceuticals in clinical medicine

Business analysis and modeling focusing on stakeholder value

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BioBridge Strategies: How We Help Our Clients

Analyze and map current medical practice and key

stakeholders

Identify and evaluate unmet medical needs and necessary

user requirements

Determine the products required to address unmet

medical needs and necessary user requirements

Determine the clinical and economic value of the selected

products, the potential reimbursement level and the user

requirements’ impact on value

Determine the types of organizations and partnerships

required to deliver new products to end users

Estimate the financial requirements for discovering,

developing and delivering new healthcare products

Get sponsors and healthcare leaders excited about the

prospects of addressing unmet global healthcare needs

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Medical Practice

Unmet Needs

Solutions

Value

Delivery

Financial Needs

Presentation

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BioBridge Strategies: Depth of Team Experience

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…and much more

Clinical Studies and

Regulatory Path

Business

Development

Global Sales and

Marketing

Product

Development

Medical Practice and

Epidemiology

Clinical Laboratory

Management

Market and Technology

Assessment

Value/Impact Analysis

and Publication

Reimbursement

Strategies

Investor

Presentations

Strategic and Tactical

Planning

Business and

Financial Modeling

Accomplished executives with practical functional experience and success

on the market . . .

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Impact Analysis


Business Modeling

Agenda

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What We Do… The BioBridge Approach

The Technology

or Product

Diseases/market

segmentation/

clinical intervention

points;

clinical & economic

impact

Business strategy to

maximise the return /

net present value for

the company and

maximise the value of

the company

Unmet

Medical Needs

Technology

Capabilities

Potential

Applications

Clinical and

Economic Value

&

Business Options

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Initial Filtering Diseases by Relevant Criteria

e.g. Relevance to

technology

e.g. Market

size/number of

patients

e.g. Time to market

All Relevant Diseases

Scre

en

1

Screen

2

Scre

en

3

XXX

Diseases XX

Diseases

X-XX

Diseases

Opportunities to

be evaluated in

the Commercial

Attractiveness/

Technical

Likelihood of

Success

Analyses

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Clinical Intervention Points (1)

Potential Applications

1 Prediction (primary prevention), Screening

2 Diagnosis, Staging, Prediction (secondary prevention), Prognosis, Therapy Selection

3 Disease Monitoring, Therapy Monitoring, Selection of New/Second Line Therapy

Years

Dis

ease s

everity

Clinically detectable

disease

Pre-Diagnosis Monitoring

Diagnosis Recurrence

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Intervention Point

Definition Examples

Prediction

(primary, secondary)

Testing for the risk of developing

disease in the future

• BRCA testing in women with

strong family history of breast

or ovarian cancer

• PLAC test predicting future

cardiovascular events

Broad Screening

Testing broad spectrum of

individuals for markers of disease

before clinically apparent disease. Often limited by age groups.

• PSA for prostate cancer • Colonoscopy

• Mammography • Pap smear

Targeted Screening

Testing selected, higher risk

individuals.

• CT scans for lung cancer for

heavy smokers

Diagnosis Presence of signs / symptoms of

disease. Confirmation of disease or differential diagnosis.

• Any symptomatic disease


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Intervention Point

Definition Examples

Staging Degree or advancement of disease • Stage I – IV of cancer

Prognosis Predict outcome disease.

• Her-2 in breast cancer

• Gleason Score in prostate

cancer

Therapy Selection Selection of appropriate therapy for

disease subtypes

• Antibiotic resistance

• Her-2 (Herceptin)

• EGF receptors (Avastin)

Disease Monitoring Assessment of level of disease

activity or recurrence

• Increase in PSA

• Circulating tumor cells

Therapy Monitoring

Detection/quantitation of markers

that assess disease progression or

efficacy of intervention

• CD4 in HIV

• Circulating tumor Cells


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Commercial and Technical Evaluations of Opportunities (Example Only)

Commercial Attractiveness T

op

Dis

ea

ses

Mortality QoL Incidence Speed of

Onset

Pharma

Intensity

Time to

Meaningful

Sales

Health

Economics

Score

W e i g h t i n g F a c t o r s

Technical Likelihood of Success

Development

Cost

Time to

Commercial

Launch

Time to Proof

Of Concept

Regulatory

Hurdles

Clinical

Proof

Availability

Of Samples

Intellectual

Property

Biomarker

Availability

Product

Specifications

Score

W e i g h t i n g F a c t o r s

To

p

Dis

ea

ses

Technological Likelihood of Success

Co

mm

erc

ial A

ttractiv

en

ess

Low High

Low

High

Criteria tailored to the specific opportunity

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Commercial Attractiveness

Technical Likelihood of

Success

Lo Hi

Lo

Hi Reserve

a few

Out

license

a few

Do a few

Don’t

touch!

Reserve

a few

Do a few

Out

license

a few

Reject

most

DO IT NOW!

Selection of Key Opportunities

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Impact Analysis


Business Modeling

Agenda

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Impact Analysis / Value Analysis / Health Economics

Benefits Cost

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Impact or Value Analysis – Key Questions

• What is the impact on medical decisions?

• What is the impact on clinical outcomes (life years and quality of life)?

• What is the impact on healthcare cost?

• What is the impact on related Pharma/Diagnostics/Devices/Etc.?

• What is the financial impact on the prescribing physicians?

• What is the impact of test performance characteristics (sensitivity/specificity/

positive and negative predictive values)?

• What is the value of various applications or strategic market entry strategies

and how could this impact the clinical development?

• What is the reimbursement potential?

• How can impact analysis / modeling support reimbursement?

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Key costs elements

Direct Non-

Medical Cost Direct Medical Cost Indicrect

Costs

• Home help

• Transportation

• Reduced work

productivity

• Absenteeism

• Unemployment

• Hospitalization

• Primary drug cost

• Physician visits

• Diagnostic procedures

• Disease complications

• Adverse drug events

• Physiotherapy

• Occupational therapy

• Complementary/ alternative

remedies

Examples of Key Cost Components

…. focus on key cost drivers that impact payers that will reimburse the analysed products

Healthcare Cost That May be Impacted

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Benefits Quantified

A quality-adjusted life year (QALY) takes into account both

quantity and the quality of life generated by healthcare

interventions. It is the arithmetic product of life expectancy and a

measure of the quality of the remaining life years

Quality of Life:

Personal perception of health

Pain

Mobility

Ability to function in daily living

Ability to work

Level of emotional well being

Feeling of energy

Social interactions

Health utilities:

1 = Perfect health

0 = Death

Negative = Worse than death

Quantified

Quality Adjusted Life Years (QALYs)

1. Life years

2. Quality of life

3. Calculate QALY: Number years * health utilities

QALY Cost

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Intervention Cost-Effectiveness

(Cost/QALY)

Influenza vaccine Cost saving

Pneumococcal vaccine Cost saving

Beta-blockers after myocardial infarction <$10,000

Mammographic screening $10,000 - $25,000

Colon-cancer screening $10,000 - $25,000

Osteoporosis screening $10,000 - $25,000

Management of antidepressant medication Cost saving - $30,000

Hypertension medication (DBP >105 mm Hg) $10,000 - $60,000

Cholesterol management, as secondary prevention $10,000 - $50,000

Implantable cardioverter–defibrillator $30,000 - $85,000

Dialysis in end-stage renal disease $50,000 - $100,000

Lung-volume–reduction surgery $100,000 - $300,000

Left ventricular assist devices $500,000 - $1.4 million

Cost-Effectiveness is quantified: “Cost per incremental quality adjusted life year (QALY)

Cost effective:

• Cost per QALY: <$50,000 - 60,000

Marginally cost effective/”expensive”:

• Cost per QALY: $50,000 - $100,000

Cost-Effectiveness and Willingness to Pay

Payors in the US generally are willing to pay about $50,000 - $60,000

per QALY (cost-effectiveness threshold)

Not cost effective/”unattractive”:

• Cost per QALY: >$100,000

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Dominant/”cost saving”:

• Cost saving and provide

incremental QALYs

Table adopted from: N engl j med 353;14. October 6, 2005. Peter J. Neumann, Sc.D., Allison B. Rosen, M.D., Sc.D., and Milton C.

Weinstein, Ph.D. Medicare and Cost-Effectiveness Analysis.

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To

tal

Co

st

Higher

Lower

Patient outcomes

Improved Worse

More costly,

better patient

outcomes

“Depends on

cost per QALY”

Less costly,

improved patient

outcomes

“Implement

immediately”

More costly,

worse patient

outcomes

“Forget it”

Less costly, worse

patient outcomes

“Depends on

consequences

and cost savings”

The Cost-Effectiveness Plane

Current practice

dominates

New practice dominates

Review relative costs

and benefits

Review relative costs

and benefits

Pri

ce/R

eim

burs

em

ent

level

Economics of New Medical Technologies

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Health Economics in a Broad Range of Therapeutic Areas

BioBridge Strategies create value/impact, or health economic,

models for many of their clients

Since 2003 BioBridge Strategies has created 156 models, or on

average 17 per year

Six of the models have been published

Therapeutic area Number HE's per TA Cancer 67

Infectious diseases 26

Cardiovascular 17

Alzheimer’s Disease 13

Diabetes 10

Toxicity 6

Nephrology 6

Autoimmune 3

Transplant 3

Gastro 2

Neurology 1

Psychiatry 1

Musculoskeletal diseases 1

Total 156

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Analyses Over a Broad Range of Technologies and Sample Types

Technologies

Immunochemistry

Immunohistochemistry

Mass Chromatography

Nucleic Acid Testing

Sample Types

Blood

CSF

Circulating Tumor Cells

Plasma

Stool

Tissues

Urine

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Value is NOT in a Vacuum

Internal Data

External Data

Model structure

Cost-

effectiveness

analysis

Value to stakeholders:

• Payers

• Patients

• Society

• Key decision makers

Maximized

Business

Value

Social values,

politics

Value Analysis Stakeholders Pricing/

Reimbursement

Strategy

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Impact Analysis


Business Modeling

Agenda

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BioBridge Strategies: How We Have Helped our Clients

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Examples include…

Evaluated the impact of innovative products on healthcare costs through health economic/impact analyses

Created value dossiers and whitepapers to optimize reimbursement positioning for Europe and USA

Established market entry strategies to ensure faster time to market and highest reimbursement potential

Assessed pharmaceutical pipeline for potential companion diagnostics options

Developed product extension strategies for global IVD company

Identified distribution options for US focused products

…and much more

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BioBridge Strategies: What We Bring to the Table

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Business Plan Market Access Product/Market Feasibility Commercialization Value Creation

BioBridge Strategies Contributes to all Stages of Company Growth…

Commercial

Readiness

Timeline and goals

Clinical validation

Regulatory

Market development

Market plan

Value assessment and

communication

Pricing & Market Access

Plan

Contracting Options

Development

Development strategy

In-house studies

Pre-clinical field studies

Thought leader studies

Timeline and goals

Prototype

Value assessment

Pricing, reimbursement

Global

Expansion

Full scale production

Supply chain mngt.

Quality Control

Sales and Marketing

Distribution

Stakeholder

management and

communication

Customer Service

Customer Support

Product line expansion

Partnerships/Alliances

Continuous value

assessment and

communication

Research

Market opportunity

Value assessment

User requirements

Product requirements

Timeline and goals

Expert input

Feasibility

Com

merc

ializ

ation

Pro

duct

Valid

ation

Feasib

ility

Busin

ess C

oncept

Value

Time

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Sustainable Market Access Has Become More Complex

and Requires Continuous Nurturing

Development for

regulatory approval

driven mostly by

technical data

Physicians were the

key decision makers

targeted by marketing

activities

Multiple decision-makers

Unique information needs and tailored

strategies

Demonstration of product value throughout life

cycle, from early modeling to clinical and

economic impact in real world setting

Proactively reach key stakeholders throughout

entire life-cycle

Life cycle management through strategic and

value impact analyses of new indications, new

claims, new markets, innovative pricing, etc.

throughout life cycle and whole value chain

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Historical Approach New Paradigm for Sustainability

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Impact Analysis


Business Modeling

Agenda

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BioBridge Strategies ISPOR Activities

Global Health Care Reimbursement Systems & Decision Processes

Working Group

Roadmap for Germany

Health Technology Assessment of Medical Devices & Diagnostics

Working Group

Roadmap for Germany

Personalized Healthcare workgroup

Leadership team http://www.ispor.org/sigs/PersonalizedMedicineDevelopmentandReimbursementWG.asp

Current And Future Use Of Pharmacoeconomics And Outcomes

Research Data In Decision Making In The USA. http://www.ispor.org/research_pdfs/36/pdffiles/PHP42.pdf

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http://www.ispor.org/sigs/PersonalizedMedicineDevelopmentandReimbursementWG.asp

http://www.ispor.org/research_pdfs/36/pdffiles/PHP42.pdf





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Case Study - Pharmaceutical Company With a Companion Diagnostic

Client

Leading European global pharmaceutical company

Need

The company needed to understand the reimbursement environment for high price /

high value diagnostics in Europe and relevant examples of similar products

Deliverables

BioBridge defined and mapped current reimbursement situation and trends for

appropriate product categories in Germany, UK, France and USA

A detailed example of a companion diagnostic

Detailed evaluation of 19 diagnostic products (75% for cancer indications) including

analysis of the companies, indications/intended use/labeling, pricing,

reimbursement, pricing support, financial assistant schemes and high level impact

evaluation selected diagnostics

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Case Study - Stakeholder Analysis for Personalized Medicine

Client

Top ten Switzerland-based global pharmaceutical company

Need

Identify the key stakeholders for personalized medicine

Develop the benefit rationale and value proposition for each of the

stakeholder groups

Deliverables

Created an extensive repository of slides

with several levels of details and

targeted messages to each external

stakeholder

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Slide Compendium

Slide Compendium

Slide Compendium

Slide Compendium

Slide Compendium

Slide Compendium

Slide Compendium

Slide Compendium

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Case Study – Value Proposition of a Surgical Technology

Client

Leading American device company

Need and deliverables

Extensive literature review, qualitative and quantitative analysis and

summary of key findings

Analysis of existing health technology assessments and treatment

guidelines

Develop a global value proposition and rational for use of their unique

surgery technology for communication with key stakeholders, especially

payors

Develop a manuscript for publication of the clinical benefits and cost-

effectiveness of their technology

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Case Study – Price Justification of a Biologic in Switzerland

Client

Swiss affiliate of a large US Pharma company

Need / Deliverables

Needed to justify the high price of their biologic in Switzerland after three

years on the market

Analyzed extensive Swiss clinical outcomes database

Collected work impact, quality of life and home aid data

Applied cost to the data and demonstrated overall cost savings (see figure)

Outcome

No change to the price

Several conference presentations

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1. Work and Productivity Loss in a Swiss Cohort of Patients with Moderate to Severe RA: Results from Swiss Clinical Quality Management Survey. Adrian Forster, Harald Rinde*, Synoeve

Daneel, Jean Blaise Wasserfallen, Jorge Wernli, Amitabh Singh. Presentation Association of Rheumatology Health Professionals Annual Scientific Meeting, San Antonio, October 2004

2. Etanercept demonstrated significant reduction of burden of illness after 3 years of treatment in Swiss moderate to severe RA cohort. Harald Rinde*, Adrian Forster, Synove Daneel, J-B.

Wasserfallen, Amitabh Singh, Jorge Wernli (publication submitted)

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

$70,000

$80,000

No biologic Biologic

Co

st

per

year

Cost of treatment of rheumatoid artheritis in Switzerland

Lost income

Other help

Help from relatives

Home help

Home nursing

Physician visits

Hospital

Drug cost

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Example Project: Evaluation of Diagnostic Technologies

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Phase 2 Phase 3 Phase 4 Phase 1 Phase 5

Opportunity Identification

Detailed Opportunity Analysis

Medical

Practice &

Potential

Applications

Commercial

Attractiveness

and

Technical

Likelihood of

Success

Quantifying

Value &

Reimburse-

ment (Health

Economics)

Technology

Map,

Potential

Clinical

Benefits

Defining &

Quantifying

the

Business

Final

Report

and

Recom-

mendations

Closure

… case study to follow

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Case Study - Strategic Assessment Diagnostic Technology

Client

European molecular diagnostic technology startup company with seed funding

Need / Deliverables

Identify most attractive diagnostic applications and markets

Determine value proposition (health economics and reimbursement)

Generate business and financial models

Develop investor presentation

Outcome

Secured Series A funding from European investment firm

Currently developing diagnostic products in the selected indications

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Resp

HAI

HAP

Diarr

CAPFever

IVF

Sepsis

SSI

Travel

Cell

UTI

Patient

Personnel

TB

3

8

13

18

23

28

11.5 13.5 15.5 17.5 19.5 21.5 23.5 25.5 27.5 29.5

Co

mm

erc

ial A

ttra

cti

ve

ne

ss

Technical Likelihood of Success

$0

$50

$100

$150

$200

$250

$300

$350

$400

$450

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Mil

lio

ns

Reference Lab

Direct Sales

Dx Licensee Only

Internal Serv Lab

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Example of a Clinical Segmentation Analysis: Pneumonia

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• CHEST 2005; 128:3854–3862). Marin H. Kollef, MD, FCCP; Andrew Shorr, MD, MPH, FCCP; Ying P. Tabak, PhD; Vikas Gupta, PharmD, BCPS; Larry Z.

Liu, MD, PhD; and R. S. Johannes, MD, MS. Epidemiology and Outcomes of Health-care–Associated Pneumonia*

• Agency for Healthcare Research and Quality (AHRQ), Research in Action Issue 7, 2002; CID 2007:44:S27-72

• Am J Respir Crit Care Med 2005:171, pp 388-416

• AHRQ Healthcare Cost and Utilization Project

• National Healthcare Quality Report 2005;Expert Interviews, American Lung Association

VAP: Ventilator associated pneumonia

HAP: Hospital acquired pneumonia

CAP: Community associated pneumonia

VAP

HAP

CAP (hospitalized)

CAP (non-hospitalized)$0

$20,000

$40,000

$60,000

$80,000

$100,000

$120,000

$140,000

$160,000

$180,000

0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0%

Co

st o

f dis

eas

e

Mortality rate

Pneumonia Value Map

Bubble size: Patient numbers 150,000

300,000

900,000 3.1 mill

Objective Develop a sequence of market launch and

expansion to maximize the value of the project

To establish highest value and a high price/reimbursement, initial market should be VAP

or HAP

Once the price has been established expand into, hospitalized CAP and later general

CAP

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Value of Risk Stratification and Preventive Treatment of Pre-Diabetes

Client

US based diagnostic company with a novel biomarker technology

Need / Deliverables

Needed to quantify and publish the clinical and economic value of identifying

patients at risk of developing type 2 diabetes mellitus

Price and reimbursement established

Abstracts and oral presentations at ADA and ISPOR

Publication accepted to Journal of Medical Economics

Sean Sullivan, Louis Garrison, Harald Rinde Janice Kolberg Edward Moler. Long-Term Cost-Effectiveness of a Diabetes Risk Score

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Value-Added


Business Modeling

Agenda

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Opportunity Assessment

Disease

Perspectives

Functional

Expenses

Other

Sources of

Income

Business

Approach

Reimbursement

Degree of

Clinical Impact

Special interest

Groups

Served

Market

Pharma

Aspects

Headcount

Facilities

COGS

Royalties

Adoption Rate Income Expenses

+

+

+

+

+

+

+

+

+

$$$$

$$$$

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Define Various Business Options

Model 1: Partnership No internal discovery

Show clinical utility

License out as a prototype to a Dx

manufacturer

No internal service lab

No internal kit manufacturing

Model 2: CLIA Lab Do internal discovery


Set up an internal service lab to:

Create awareness

Establish ASP

Obtain reimbursement

Transfer to a major commercial

reference lab

Stop internal lab service

Model 3: Integrated Dx Company Do internal discovery


Set up an internal reference lab to:

Create awareness

Establish ASP

Obtain reimbursement

Transfer to a major commercial

reference lab

Stop internal lab service

Become a Dx kit manufacturer and

sell kits

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P&L Calculations for Each Business Option

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2010 2011 2012 2013 2014 2015

Revenue $0 $0 $0 $3,658,621 $11,686,254 $28,957,613 Revenue Growth NA NA NA NA 69% 60%

COGS $0 $375,950 $885,852 $1,275,328 $2,280,171 $3,703,308 COGS % of Revenue Infinity Infinity Infinity 34.9% 19.5% 12.8%

Gross Profit $0 ($375,950) ($885,852) $2,383,293 $9,406,082 $25,254,305 Infinity Infinity Infinity 65.1% 80.5% 87.2%

Operating Expenses R&D $790,938 $2,146,226 $3,762,894 $4,564,745 $4,971,950 $5,546,418

R&D % Revenue Infinity Infinity Infinity 124.8% 42.5% 19.2% Commercial Operations $0 $772,500 $3,925,922 $8,390,298 $12,118,769 $13,592,086

Comm Ops % Revenue Infinity Infinity Infinity 229.3% 103.7% 46.9% Administration $370,000 $700,770 $1,573,926 $2,313,361 $3,363,350 $3,785,594

Administration % Revenue Infinity Infinity Infinity 63.2% 28.8% 13.1% Total Operating Expenses $1,160,938 $3,619,496 $9,262,741 $15,268,405 $20,454,069 $22,924,098

Op Exp % Revenue Infinity Infinity Infinity 417.3% 175.0% 79.2% Capital Expense $850,000 $150,000 $550,000 $1,570,000 $1,150,000 $150,000 Investment in Working Capital ($95,420) ($202,073) ($463,828) $413,704 $1,560,543 $4,074,019 EBITDA ($1,160,938) ($3,619,496) ($9,262,741) ($11,609,784) ($8,767,815) $6,033,515

Op Prof % Revenue Infinity Infinity Infinity -317.3% -75.0% 20.8%

Headcount 7.0 24.0 51.0 81.5 113.0 130.0

Operating Cash Flow ($1,915,518) ($3,567,423) ($9,348,912) ($13,593,489) ($11,478,359) $1,809,496 Cumulative Cash Flow ($1,915,518) ($5,482,941) ($14,831,853) ($28,425,342) ($39,903,701) ($38,094,205)

NPV of Pretax Operating Cash

Flow $14,963,516 25% Discount Rate NPV of Terminal Value $101,821,598 5.0 Times Terminal Value TOTAL NPV $116,785,114

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How Can We Help You?

47

Clinical Studies and

Regulatory Path

Business

Development

Global Sales and

Marketing

Product

Development

Medical Practice and

Epidemiology

Clinical Laboratory

Management

Market and Technology

Assessment

Value/Impact Analysis

and Publication

Reimbursement

Strategies

Investor

Presentations

Strategic and Tactical

Planning

Business and

Financial Modeling

Let’s Discuss Further

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Contacts

Louis Riceberg, PhD

Principal, BioBridge Strategies, LLC

7835 Hemingway Ave

San Diego, CA 92120

USA

Phone: +1 619 287-6898

Fax: +1 619 287-6899

Mobile: +1 781 929-4786

E-mail: [email protected]

Skype: louriceberg

Harald Rinde MD, MBA

Principal, BioBridge Strategies, LLC

Oberwilerstrasse 70

CH-4102 Binningen

Switzerland

Phone: +41 61 423-8717

Fax: +41 61 423-8718

Mobile: +41 79 210-9979

Phone USA: +1 858 866-9354

Mobile USA: +1 619 606-6803

E-mail: [email protected]

Skype: haraldrinde2803

48

www.bbstrategies.com

mailto:[email protected]



http://www.bbstrategies.com/

confidential 49

BioBridge Strategies Publications:

By Topic

confidential

Impact, value or economic analyses for diagnostics

E Faulkner, L Annemans, L Garrison, M Helfand, AP Holtorf, J Hornberger, D Hughes, et al. “Challenges in the

Development and Reimbursement of Personalized Medicine—Payer and Manufacturer Perspectives and Implications for

Health Economics and Outcomes Research: A Report of the ISPOR Personalized Medicine Special Interest Group.” Value

Health 15, 1162–1171 (2012).

Rinde, H., C.J. Zech, E. Jonas, K. Bergmann, and A.P. Holtorf. “PMD33 The Impact of Three Different Imaging Strategies

on Surgery Planning for Patients With Colorectal Cancer Liver Metastases.” Value in Health 15, no. 7 (November 2012):

A350–A351.

Holtorf, A.P., K. Bergmann, M.J. Kim, S. Phongkitkarun, A. Sobhonslidsuk, H. Rinde, and J.M. Lee. “PMD28 Comparing the

Cost and Diagnostic Efficiency of Gadoxetic Acid-Enhanced MRI Versus Extracellular Contrast Media-Enhanced MRI and

Multidetector Computed Tomography in Patients With Suspected Hepatocellular Carcinoma in Thailand and Korea.” Value in

Health 15, no. 7 (November 2012): A349–A350.

Holtorf, A.P., K. Bergmann, M.J. Kim, S. Phongkitkarun, A. Sobhonslidsuk, H. Rinde, and J.M. Lee. “Comparing the Cost

and Diagnostic Efficiency of Gadoxetic Acid-Enhanced MRI Tomography in Patients With Suspected Hepatocellular

Carcinoma in Thailand and Korea.” Value in Health 15, no. 7 (November 2012): A349–A350; PMD28.

doi:10.1016/j.jval.2012.08.877.

Harald Rinde, MD, MBA, Anne Rubin, MBA. Cost-effectiveness of the cardiovascular marker ST2 in providing risk

stratification after acute heart failure. [ISPOR 14th Annual European Congress, Madrid] Nov 2011.

Sean D. Sullivan, PhD, Louis P. Garrison, PhD, Harald Rinde, PhD, Janice Kolberg, PhD, Edward Mohler PhD. “Cost-

Effectiveness of Risk Stratification for Preventing Type 2 Diabetes Using A Multi-Marker Diabetes Risk Score”. [Journal of

Medical Economics Vol. 14, No. 5, 2011, 609–616] Jul 2011.

Stephen Williams, Rachel Ostroff, Mark Messenbaugh, Harald Rinde, Lou Riceberg, York Miller, Harvey Pass. How Good

is Good Enough? An Evaluation of Minimum Performance Standards for Acceptance of New Diagnostic Tests in Lung

Cancer. [American Thoracic Society International Conference, Denver] May 2011.

Faulkner, Eric C, AP Holtorf, M Longacre, and Lieven Annemans. 2011. Value-Based Reimbursement For Personalized

Medicine: Where Do We Stand? ‘Value in Health‘. Madrid, Spain, November.

Edward J. Moler, PhD , Louis P. Garrison, Jr, PhD, Harald Rinde, MD, MBA, Janice Kolberg, PhD , Sean D. Sullivan, PhD.

“The Value of Personalized, Predictive Risk-assessment Tools for the Prevention of Chronic Diseases”. JSM 2010 (Joint

Statistical Meeting, Ontario, Jul-2010.

50

http://www.ispor.org/congresses/spain1111/issuepanels.asp




confidential

Impact, value or economic analyses for diagnostics

Sean D. Sullivan, Richard Polluck, Louis P. Garrison, Harald Rinde, Janice Kolberg. “Long-Term Cost-Effectiveness of a

Diabetes Risk Score”. [American Diabetes Associations 69th Scientific Sessions in New Orleans. Scientific Sessions

Abstract Book, the June 2009 supplement to the journal Diabetes] Jun-2009

Sean D. Sullivan, Louis P. Garrison, Harald Rinde, Janice Kolberg, Edward Moler and Mickey Urdea. “Long-Term Cost

Effectiveness of a Diabetes Risk Score in Clinical Practice”. [ISPOR Thirteenth Annual International, New Orleans. Value in

Health, International Society for Pharmacoeconomics and Outcomes Research, Volume 11 Issue 3, Pages A322 -353

May/June 2008].

A.-P. Holtorf (2006) BioValley Seminar Series “Creating Value with Diagnostics”

51

confidential

Impact, value or economic analyses for pharmaceuticals

Holtorf, AP. (2013) “PATIENT REPORTED OUTCOMES.” In Pharmacoeconomics. Principles and Practice. Chapter 5.

Torino, Italy: SEEd srl, First edition. ISBN: 978-88-9741-938-9.


Development and Reimbursement of Personalized Medicine—Payer and Manufacturer Perspectives and Implications for

Health Economics and Outcomes Research: A Report of the ISPOR Personalized Medicine Special Interest Group.” Value

Health 15, 1162–1171 (2012).

Anke-Peggy Holtorf, Diana Brixner, Brandon Bellows, and Abdulkadir Keskinaslan. “Current and Future Use of HEOR Data

in Decisionmaking in the US and Emerging Markets.” American Health & Drug Benefits, 5/7, 428–438; (2012).

Biskupiak JE, Dunn JD, Holtorf A-P. Implementing CER: What Will It Take? J Manag Care Pharm. 2012;18(5 Supp A):S19–

29.

Holtorf, A.P., H. Rinde, and N. Maniadakis. “PHP142 Drug Shortages Around the World and the Underlying Reasons.”

Value in Health 15, no. 7 (November 2012): A314.

Faulkner, Eric C, AP Holtorf, M Longacre, and Lieven Annemans. 2011. Value-Based Reimbursement For Personalized

Medicine: Where Do We Stand? ‘Value in Health‘. Madrid, Spain, November.

Holtorf, A P, Gary Oderda, Andres Pichon-Riviere, and Abdulkadir Keskinaslan. 2011. The Role Of Health Economic And

Outcomes Research (Heor) Evidence In Formulary And Reimbursement Decisions In Latin America Versus The United

States. In Value in Health. Vol. 7. Mexico City, September.

Holtorf, A-P, A Keskinaslan, JE Biskupiak, and DI Brixner. 2010. Current and Future Use of Pharmacoeconomic and

Outcomes Research Data in Decision Making in the USA. Poster presented at the ISPOR 13th Annaual European Meeting,

November, Prague.

A.P.Holtorf, D. Brixner, J. Biskupiak. Current and future use of health economic and outcomes research data in decision

making. Workshop. ESMDM Meeting, Hall, Austria, 31.May-2.June 2010

Brixner DI, Holtorf A, Neumann PJ, Malone DC, & Watkins JB (2009) Standardizing quality assessment of observational

studies for decision making in health care. J Manag Care Pharm 15:275-83.

Szeinbach, Sheryl L, Noreen Sullivan, Enrique Seoane-Vazquez, Amit Chhabra, Eric Faulkner, Anke-Peggy Holtorf, Dimitri

Polygenis, Mayvis Rebeira, Jose Manuel Rodriguez, and Karl Matuszewski. “Identifying Key Decision Pathways in Health

Technology Assessment Around the World.” Orlando, 2009.

Holtorf A, McAdam-Marx C, Schaaf D, Eng B, & Oderda G (2009) Systematic review on quality control for drug

management programs: Is quality reported in the literature? BMC Health Services Research 9:38.

.

52

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http://www.ahdbonline.com/feature/current-and-future-use-heor-data-healthcare-decision-making-united-states-and-emerging-marke






http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=15305.










http://www.ncbi.nlm.nih.gov/pubmed/19326959

http://www.ncbi.nlm.nih.gov/pubmed/19326959

http://www.ispor.org/research_study_digest/details.asp.


http://www.biomedcentral.com/1472-6963/9/38

http://www.biomedcentral.com/1472-6963/9/38

confidential


Diana Brixner RPh, PhD, Daniel Malone PhD, RPh, Anke-Peggy Holtorf PhD, MBA. Use of Real World Data Workshop:

Quality assurance of evidence from real world data (RWD) for reimbursement decisions. ISPOR International Congress,

Paris 2009.

A.-P. Holtorf (2008) Health Technology Assessment and Decision making in the USA. Invited lecture. 14th International

Pharmaceutical Technology Symposium (IPTS). Antalya, Turkey

C McAdam-Marx, DT Schaaf, AP Holtorf, Benjamin Eng, GM. Oderda. Systematic Analysis of Outcomes Evaluations

Applied to Drug Management Programs. Am J Manag Care. 2008;14(11 Spec No.):SP36-SP45.

Holtorf A, Watkins JB, Mullins CD, Brixner D. Incorporating Observational Data into the Formulary Decision-Making

Process—Summary of a Roundtable Discussion. J Manag Care Pharm. 2008;14(3):302-8.

Nickman NA, Haak SW, Harald E, Holtorf A, Joshi A, Kim J, et al. Cost Minimization Analysis of Different Growth Hormone

Devices Based on Time-And-Motion Simulations. In: Value in Health. 2008. Poster at ISPOR 13th Annual International

Meeting, May 3-7, Toronto

A-P. Holtorf; J. LaFleur; D. Servatius; B. Jeffries; D. Brixner, (2007) Prescription Drug Use by Women and Men in Utah

Medicaid. UTAH’S HEALTH: An Annual Review, Volume 12: Supplement: Women’s Health in Utah, pp 97-99, Eds.: National

Center of Excellence In Women’s Health Demonstration Project Region VIII.

Nickman N, Haak SW, Holtorf AP, Joshi AV, Brixner D (2007) Time-And-Motion Evaluation of Different Growth Hormone

Formulations. Poster presentation at ISPOR 10th Annual European Congress in Dublin; Sunday, 21 October 2007.

A-P. Holtorf, J. LaFleur, D. Servatius, B. Jeffries, C. McBeth, D. Brixner, (2007) Statin Treatment of Diabetic Patients in Utah

Medicaid. UTAH’S HEALTH: An Annual Review, Volume 12: Supplement: Women’s Health in Utah, pp 57-71, Eds.: National

Center of Excellence In Women’s Health Demonstration Project Region VIII.

A-P. Holtorf, PhD, MBA; J. LaFleur, PharmD, MSPH; D. Servatius; B. Jeffries, PharmD Candidate; D. Brixner, RPh, PhD,

(2007) Prescription Drug Use in Utah Medicaid. Utah Health Services Research Conference: “Utah Health Services

Research Meets Public Health Informatics”, University of Utah, Salt Lake City (Poster).

A-P. Holtorf, J. LaFleur, D. Servatius, B. Jeffries, C. McBeth, D. Brixner, (2007) Statin Treatment of Diabetic Patients in Utah

Medicaid. Utah Health Services Research Conference: “Utah Health Services Research Meets Public Health Informatics”,

University of Utah, Salt Lake City (Poster).

53

http://uuhsc.utah.edu/coe/womenshealth





confidential


Wasserfallen, Jean-Blaise; Synove, Daneel; Rinde, Harald; Forster, Adrian. “Changes of Working Ability and Handicap in a

Swiss Cohort of Rheumatoid Arthritis Patients Treated with Etanercept in Daily Practice” [3rd Annual Meeting of Health

Technology Assessment International (HTAi), an international society for the promotion of health technology assessment

2006. Published in: International Journal of Technology Assessment in Health Care (IJTAHC)] Jul-2006.

Wasserfallen, Jean-Blaise; Synove, Daneel; Rinde, Harald; Forster, Adrian. “Efficacy of Etanercept in Daily Clinical Practice

in Swiss Cohort of Rheumatoid Arthritis Patients” [3rd Annual Meeting of Health Technology Assessment International

(HTAi), an international society for the promotion of health technology assessment] Jul-2006.

John G. Thomas, Isaiah Litton, Harald Rinde. “Chapter 2: Economic Impact of Biofilms on Treatment Cost” Chapter

2: Editors: John L. Pace, Mark E. Rupp, Roger G. Finch. [Biofilms, Infection and Antimicrobial Therapy. Taylor &

Frances. ISBN: 9780824726430] 2006.

Harald Rinde, Adrian Forster, Synove Daneel, J-B. Wasserfallen, Amitabh Singh, Jorge Wernli. “Etanercept Demonstrated

Significant Reduction of Burden of Illness After 3 Years of Treatment in Swiss Moderate to Severe RA Cohort”. [Association

of Rheumatology Health Professionals Annual Scientific Meeting, San Antonio] Oct-2004.

A Singh, H Rinde, A Forster, S Daneel, J-B Wasserfallen, J Wernli. “Work and Productivity Loss in a Swiss Cohort of

Patients with Moderate to Severe RA: Results from Swiss Clinical Quality Management Study”. [American College of

Rheumatology / Association of Rheumatology Health Proffessionals (ACR/ARHP) Annual Scientific Meeting] 2004.

Karl Klingler, Jurg Barandun, Thomas Scherer, Beat Walder, Harald Rinde and Jorge Wernli. “A Double-Bind Randomized,

Placebo-Controlled Trial for Smoking Reduction Involving Nicotine Replacement Therapy (NRT)”. [75th anniversary of the

Congress of Swiss Pneumologists in St. Gallen, Switzerland. 12th World Conference on Tobacco or Health in Helsinki

August 3-8, 2003].

A.-P. Holtorf, D. Brixner (1996) Separating Fact from Fantasy, Jan. 22-24, 1996, Tucson, Arizona – Panel Discussion.

54

http://books.google.es/books?id=JXebWnvL89MC&pg=PP13&lpg=PP13&dq=harald+rinde+biofilms&source=bl&ots=aFuQOphezo&sig=ekpIqo72jzgNkGRmEsJjPP-TEhU&hl=en&sa=X&ei=dnv2UPq3NcW2hAfsiICwDw&sqi=2&redir_esc=y



confidential

Impact, value or economic analyses for medical devices

AP Holtorf, H. Rinde, F. Rupprecht, H. Alder and D. Brixner (2012). The Economic Impact of Bariatric Surgery,

Advanced Bariatric and Metabolic Surgery, Chih-Kun Huang (Ed.), ISBN: 978-953-307-926-4, InTech.

55

http://www.intechopen.com/articles/show/title/the-economic-impact-of-bariatric-surgery


confidential

Impact, value or economic analyses in low to medium income countries

Anke-Peggy Holtorf, Diana Brixner, Brandon Bellows, and Abdulkadir Keskinaslan. “Current and Future Use of

HEOR Data in Decisionmaking in the US and Emerging Markets.” American Health & Drug Benefits, 5/7, 428–438;

(2012).

Holtorf, A P, Gary Oderda, Andres Pichon-Riviere, and Abdulkadir Keskinaslan. 2011. The Role Of Health

Economic And Outcomes Research (Heor) Evidence In Formulary And Reimbursement Decisions In Latin

America Versus The United States. In Value in Health. Vol. 7. Mexico City, September.

Szeinbach, Sheryl L, Noreen Sullivan, Enrique Seoane-Vazquez, Amit Chhabra, Eric Faulkner, Anke-Peggy

Holtorf, Dimitri Polygenis, Mayvis Rebeira, Jose Manuel Rodriguez, and Karl Matuszewski. “Identifying Key

Decision Pathways in Health Technology Assessment Around the World.” Orlando, 2009.

56









confidential

Strategy development for pharmaceutical companies


Development and Reimbursement of Personalized Medicine—Payer and Manufacturer Perspectives and

Implications for Health Economics and Outcomes Research: A Report of the ISPOR Personalized Medicine

Special Interest Group.” Value Health 15, 1162–1171 (2012).

C McAdam-Marx, DT Schaaf, AP Holtorf, Benjamin Eng, GM. Oderda. Systematic Analysis of Outcomes

Evaluations Applied to Drug Management Programs. Am J Manag Care. 2008;14(11 Spec No.):SP36-SP45.

A.-P. Holtorf (1999) A common direction – Collaborations and contributions towards quality in healthcare, Invited

lecture at the XII Malente Symposium, Dräger Foundation, Lübeck: Health Care Systems at Crossroads:

Balancing Individual Needs with Financial Limitations.

Harald Rinde. “Chapter 8: Disease Management in Pharmaceutical Companies” Editor: J. Couch Epilogue:

James, Bill First, Foreword: Philip Caper [The Health Care Professional’s Guide to Disease Management: Patient-

Centered Care for the 21st Century. Aspen Publications, USA] First edition: 1997; Second edition: 1998

57

http://books.google.es/books?id=rQBlTVjpjdAC&pg=PA223&lpg=PA223&dq=harald+rinde+disease+management&source=bl&ots=ZF4InoyP6S&sig=dPOMlvBpmsK_VLJbcAGAqPRAzqc&hl=en&sa=X&ei=I3v2ULCuDImAhQfn3oGQAg&sqi=2&redir_esc=y



confidential

Personalized medicine





Faulkner, Eric C, AP Holtorf, M Longacre, and Lieven Annemans. 2011. Value-Based Reimbursement For

Personalized Medicine: Where Do We Stand? ‘Value in Health‘. Madrid, Spain, November.

Edward J. Moler, PhD , Louis P. Garrison, Jr, PhD, Harald Rinde, MD, MBA, Janice Kolberg, PhD , Sean D.

Sullivan, PhD. “The Value of Personalized, Predictive Risk-assessment Tools for the Prevention of Chronic

Diseases”. JSM 2010 (Joint Statistical Meeting, Ontario, Jul-2010.

58





confidential

European healthcare systems

Holtorf A-P (2001) A Common Direction: Collaborations and Contributions towards quality in Health Care; Edition

Drägerstiftung, Vol. 17 (Gesundheitssystems am Scheideweg: Zwischen Wettbewerb und Solidarität) 138-144





A.-P. Holtorf (1999) A common direction – Collaborations and contributions towards quality in healthcare, Invited

lecture at the XII Malente Symposium, Dräger Foundation, Lübeck: Health Care Systems at Crossroads:

Balancing Individual Needs with Financial Limitations.

A.-P. Holtorf (1996) Moderation of the Symposium ‘Disease management im vernetzten Gesundheitswesen’

(Disease Management in the Integrated Health Care System) including lecture ‘ Integriertes

Gesundheitsmanagement; Herausforderung für die Pharmaindustrie’ (Integrated Healthcare Management;

Challenge for the Pharmaceutical Industry); 14. October 1996 in Munich – as day 1 of the meeting ‘Disease

Management und Online-Medien für das Pharma Produkt Management’ (Disease Management and online media

for the pharmaceutical product management).

A.-P. Holtorf (1996) Integriertes Gesundheitsmanagement und Information: Einfluss auf die pharmazeutische

Industrie (Disease Management and Information: Impact on the Pharmaceutical Industry), Invited lecture, IMS

Pharma Gesprächsrunde, Frankfurt a.M./Germany, 7/8.Nov.1996.

59

confidential

Disease management

Harald Rinde, MD, MBA, Anne Rubin, MBA. Cost-effectiveness of the cardiovascular marker ST2 in providing

risk stratification after acute heart failure. [ISPOR 14th Annual European Congress, Madrid] Nov 2011.

Harald Rinde. “Chapter 8: Disease Management in Pharmaceutical Companies” Editor: J. Couch Epilogue:

James, Bill First, Foreword: Philip Caper [The Health Care Professional’s Guide to Disease Management: Patient-

Centered Care for the 21st Century. Aspen Publications, USA] First edition: 1997; Second edition: 1998

A.-P. Holtorf (1997) Disease Management – Sourcing and managing the underlying information. Invited lecture at

the FT World pharmaceutical conference, London, 24/25. Mar. 97. The paper was published in the Journal

‘Managed Care Europe’ in April 1997.

A.-P. Holtorf (1996) Moderation of the Symposium ‘Disease management im vernetzten Gesundheitswesen’

(Disease Management in the Integrated Health Care System) including lecture ‘ Integriertes

Gesundheitsmanagement; Herausforderung für die Pharmaindustrie’ (Integrated Healthcare Management;

Challenge for the Pharmaceutical Industry); 14. October 1996 in Munich – as day 1 of the meeting ‘Disease

Management und Online-Medien für das Pharma Produkt Management’ (Disease Management and online media

for the pharmaceutical product management).

A.-P. Holtorf (1996) Integriertes Gesundheitsmanagement und Information: Einfluss auf die pharmazeutische

Industrie (Disease Management and Information: Impact on the Pharmaceutical Industry), Invited lecture, IMS

Pharma Gesprächsrunde, Frankfurt a.M./Germany, 7/8.Nov.1996.

60




confidential

Drug shortages

Holtorf, A.P., H. Rinde, and N. Maniadakis. “PHP142 Drug Shortages Around the World and the Underlying

Reasons.” Value in Health 15, no. 7 (November 2012): A314.

61

confidential

Health data management and health information technology

Brendan J. Murray, PhD and Harald Rinde, MD, MBA. “Development of a Flexible Mobile System for the Remote

Management of Chronic Diseases”. [Schweizerische Gesellschaft fur Medizinische Informatik / Swiss Society for

Medical Informatics (SMI 53)] 2004

A.-P. Holtorf (1997) Disease Management – Sourcing and managing the underlying information. Invited lecture at

the FT World pharmaceutical conference, London, 24/25. Mar. 97. The paper was published in the Journal

‘Managed Care Europe’ in April 1997.

A.-P. Holtorf (1996) Nutzung von Intra- und Internet für neue Marketingkonzepte (Utilisation of Intranet and

Internet for Novel Marketing Concepts) Invited Lecture at the Symposium ‘Internet’ in Munich/Germany, Heinrich

Kongress Management, 18/19 June 1996.

62

confidential 63

BioBridge Strategies Publications:

By Therapeutic Area

confidential

Oncology

Rinde, H., C.J. Zech, E. Jonas, K. Bergmann, and A.P. Holtorf. “PMD33 The Impact of Three Different Imaging

Strategies on Surgery Planning for Patients With Colorectal Cancer Liver Metastases.” Value in Health 15, no. 7

(November 2012): A350–A351.

Holtorf, A.P., K. Bergmann, M.J. Kim, S. Phongkitkarun, A. Sobhonslidsuk, H. Rinde, and J.M. Lee. “PMD28

Comparing the Cost and Diagnostic Efficiency of Gadoxetic Acid-Enhanced MRI Versus Extracellular Contrast

Media-Enhanced MRI and Multidetector Computed Tomography in Patients With Suspected Hepatocellular

Carcinoma in Thailand and Korea.” Value in Health 15, no. 7 (November 2012): A349–A350.

Holtorf, A.P., K. Bergmann, M.J. Kim, S. Phongkitkarun, A. Sobhonslidsuk, H. Rinde, and J.M. Lee. “Comparing

the Cost and Diagnostic Efficiency of Gadoxetic Acid-Enhanced MRI Tomography in Patients With Suspected

Hepatocellular Carcinoma in Thailand and Korea.” Value in Health 15, no. 7 (November 2012): A349–A350;

PMD28. doi:10.1016/j.jval.2012.08.877.

Stephen Williams, Rachel Ostroff, Mark Messenbaugh, Harald Rinde, Lou Riceberg, York Miller, Harvey Pass.

How Good is Good Enough? An Evaluation of Minimum Performance Standards for Acceptance of New

Diagnostic Tests in Lung Cancer. [American Thoracic Society International Conference, Denver] May 2011.

64

confidential

Cardiovascular diseases

Harald Rinde, MD, MBA, Anne Rubin, MBA. Cost-effectiveness of the cardiovascular marker ST2 in providing

risk stratification after acute heart failure. [ISPOR 14th Annual European Congress, Madrid] Nov 2011.

A-P. Holtorf, J. LaFleur, D. Servatius, B. Jeffries, C. McBeth, D. Brixner, (2007) Statin Treatment of Diabetic

Patients in Utah Medicaid. Utah Health Services Research Conference: “Utah Health Services Research Meets

Public Health Informatics”, University of Utah, Salt Lake City (Poster).

Karl Klingler, Jurg Barandun, Thomas Scherer, Beat Walder, Harald Rinde and Jorge Wernli. “A Double-Bind

Randomized, Placebo-Controlled Trial for Smoking Reduction Involving Nicotine Replacement Therapy (NRT)”.

[75th anniversary of the Congress of Swiss Pneumologists in St. Gallen, Switzerland. 12th World Conference on

Tobacco or Health in Helsinki August 3-8, 2003].



65



confidential

Diabetes

Sean D. Sullivan, PhD, Louis P. Garrison, PhD, Harald Rinde, PhD, Janice Kolberg, PhD, Edward Mohler PhD.

“Cost-Effectiveness of Risk Stratification for Preventing Type 2 Diabetes Using A Multi-Marker Diabetes Risk

Score”. [Journal of Medical Economics Vol. 14, No. 5, 2011, 609–616] Jul 2011.




Sean D. Sullivan, Richard Polluck, Louis P. Garrison, Harald Rinde, Janice Kolberg. “Long-Term Cost-

Effectiveness of a Diabetes Risk Score”. [American Diabetes Associations 69th Scientific Sessions in New

Orleans. Scientific Sessions Abstract Book, the June 2009 supplement to the journal Diabetes] Jun-2009

Sean D. Sullivan, Louis P. Garrison, Harald Rinde, Janice Kolberg, Edward Moler and Mickey Urdea. “Long-Term

Cost Effectiveness of a Diabetes Risk Score in Clinical Practice”. [ISPOR Thirteenth Annual International, New

Orleans. Value in Health, International Society for Pharmacoeconomics and Outcomes Research, Volume 11

Issue 3, Pages A322 -353 May/June 2008].

A-P. Holtorf, J. LaFleur, D. Servatius, B. Jeffries, C. McBeth, D. Brixner, (2007) Statin Treatment of Diabetic

Patients in Utah Medicaid. UTAH’S HEALTH: An Annual Review, Volume 12: Supplement: Women’s Health in

Utah, pp 57-71, Eds.: National Center of Excellence In Women’s Health Demonstration Project Region VIII.

66



confidential

Autoimmune diseases

Wasserfallen, Jean-Blaise; Synove, Daneel; Rinde, Harald; Forster, Adrian. “Changes of Working Ability and

Handicap in a Swiss Cohort of Rheumatoid Arthritis Patients Treated with Etanercept in Daily Practice” [3rd

Annual Meeting of Health Technology Assessment International (HTAi), an international society for the promotion

of health technology assessment 2006. Published in: International Journal of Technology Assessment in Health

Care (IJTAHC)] Jul-2006.

Wasserfallen, Jean-Blaise; Synove, Daneel; Rinde, Harald; Forster, Adrian. “Efficacy of Etanercept in Daily

Clinical Practice in Swiss Cohort of Rheumatoid Arthritis Patients” [3rd Annual Meeting of Health Technology

Assessment International (HTAi), an international society for the promotion of health technology assessment] Jul-

2006.

Harald Rinde, Adrian Forster, Synove Daneel, J-B. Wasserfallen, Amitabh Singh, Jorge Wernli. “Etanercept

Demonstrated Significant Reduction of Burden of Illness After 3 Years of Treatment in Swiss Moderate to Severe

RA Cohort”. [Association of Rheumatology Health Professionals Annual Scientific Meeting, San Antonio] Oct-

2004.

A Singh, H Rinde, A Forster, S Daneel, J-B Wasserfallen, J Wernli. “Work and Productivity Loss in a Swiss Cohort

of Patients with Moderate to Severe RA: Results from Swiss Clinical Quality Management Study”. [American

College of Rheumatology / Association of Rheumatology Health Proffessionals (ACR/ARHP) Annual Scientific

Meeting] 2004.

67

confidential

Obesity



68



confidential

Pulmonary diseases





69

confidential

Infectious diseases

John G. Thomas, Isaiah Litton, Harald Rinde. “Chapter 2: Economic Impact of Biofilms on Treatment Cost”

Chapter 2: Editors: John L. Pace, Mark E. Rupp, Roger G. Finch. [Biofilms, Infection and Antimicrobial Therapy.

Taylor & Frances. ISBN: 9780824726430] 2006.

70




confidential

Smoking cessation





71

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Gastrointestinal diseases



72



confidential

Other chronic diseases




Brendan J. Murray, PhD and Harald Rinde, MD, MBA. “Development of a Flexible Mobile System for the Remote

Management of Chronic Diseases”. [Schweizerische Gesellschaft fur Medizinische Informatik / Swiss Society for

Medical Informatics (SMI 53)] 2004

73

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