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confidential
BioBridge Strategies LLC
Strategies for the New Biology©
February, 2013
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
9
Medical Practice
Unmet Needs
Solutions
Value
Delivery
Financial Needs
Presentation
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BioBridge Strategies: Depth of Team Experience
10
…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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Introduction to BioBridge Strategies
The BioBridge Strategy Process
Impact Analysis
BioBridge Strategies Examples
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
13
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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
14
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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
Clinical Intervention Points (2)
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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
Clinical Intervention Points (3)
16
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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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Introduction to BioBridge Strategies
The BioBridge Strategy Process
Impact Analysis
BioBridge Strategies Examples
Business Modeling
Agenda
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Impact Analysis / Value Analysis / Health Economics
Benefits Cost
20
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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
22
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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
25
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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
29 Companies
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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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Introduction to BioBridge Strategies
The BioBridge Strategy Process
Impact Analysis
BioBridge Strategies Examples
Business Modeling
Agenda
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BioBridge Strategies: How We Have Helped our Clients
30
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
31
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
32
Historical Approach New Paradigm for Sustainability
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Introduction to BioBridge Strategies
The BioBridge Strategy Process
Impact Analysis
BioBridge Strategies Examples
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
34
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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
35
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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
36
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
37
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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
38
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
39
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
40
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
41
• 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
42
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Introduction to BioBridge Strategies
The BioBridge Strategy Process
Value-Added
BioBridge Strategies Examples
Business Modeling
Agenda
confidential 44
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
Show clinical utility
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
Show clinical utility
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
46
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
confidential
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
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
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.
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).
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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Impact, value or economic analyses for pharmaceuticals
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
confidential
Impact, value or economic analyses for pharmaceuticals
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
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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
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
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).
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
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Personalized medicine
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).
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
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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
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).
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
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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
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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].
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.
65
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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.
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.
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
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Obesity
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.
68
confidential
Pulmonary diseases
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].
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
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Smoking cessation
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].
71
confidential
Gastrointestinal diseases
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.
72
confidential
Other chronic diseases
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.
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