real world health intelligence
TRANSCRIPT
As a global research consultancy,we are committed to providing thehighest level of scientific evidenceon the value of medicines andhealth technologies
Analytica Laser studies and services currentlyreach more than 20 countries
Our senior team unites more than 110 specialistsand consultants including 40 PhD/MD/PharmDand 50 MSc/BSc
MAIN OFFICES
NEW YORK
MONTRÉAL
LONDON
PARIS
MADRID
MILAN
KRAKOW
BASEL/LÖRRACH
WELL-POSITIONED TOPROVIDE STRATEGICCONSULTING ANDSCIENTIFIC RESEARCHSERVICES TO HEALTHCAREINNOVATORS AROUNDTHE WORLD
GLOBAL SERVICE LINES
REAL WORLDDATA SOLUTIONS
DECISION ANALYTICS+ MODELING
VALUE + ACCESSCONSULTING
Burden of illness+
Outcomes research+
Quality of life+
Drug utilization+
Resource use+
Continuous benefit/risk+
PAES / PASS+
PGRx+ proprietary datasets
Electronic health data+
US healthcare databases+
Surveys+
+ Predictive modeling
+ Performance software
+ Bridging studies
+ Bayesian statistics
+ MTC / NMA
+ Disease modeling
+ Economic modeling
+ Enriched RCTs
+ Clinical trial analytics
Market access consulting+
Health economics+
Outcomes+ -based agreements
Reimbursement +submissions
Core HTA submissions+
Systematic reviews+
Global value dossiers+
Investment strategy+
MCDA+
REAL WORLDDATA SOLUTIONS
Our real world data group offers solutions for every need, from
niche needs identification, justifying access, differentiating
value, quantifying an opportunity to demonstrating benefit/risk.
Analytica Laser’s proprietary PGRx Real World Datasets are a
unique source of real world data with a variety of applications.
Powered by the strongest epidemiology team in the industry,
we also offer multiple solutions for advanced observational
studies in risk and effectiveness research, as well as custom
outcomes research programs.
Our observational study experts, health economistsand PRO specialists join forces with operationalteams across Europe and North America to designand conduct HEOR studies as well as AdvancedPharmacoepidemiology research. Our work isregularly published in the leading journals:
+ The Lancet
+ Value in Health
+ Amer J Epidemiology
+ Diabetes Care
+ Blood
+ Int J Medicine
+ Pharmacoepidemiology & Drug Safety
+ Heart
+ Arthritis & Rheumatology
OU
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REAL WORLD DATA SOLUTIONS ACROSSTHE EVIDENCE CONTINUUM
Unmet need+Treatment patterns+Burden of illness+Market sizing+
Cost minimization+Cost offsets+Cost effectiveness and +budget impact analysis
+ Drug utilization studies+ Relative effectiveness+ Outcomes performance+ PAES
Benefit/risk assessment+Risk management+Signal detection+PASS+
+ Electronic health records
+ Administrative medical records
+ Chart reviews
+ Ad hoc surveys
+ Observational studies
QUANTIFYOPPORTUNITY
JUSTIFY ACCESS
MEASUREPERFORMANCE
ENSURE SAFETY
ELECTRONIC DATABASES STUDIES
+ UK
+ France
+ Denmark
+ Germany
+ Italy
+ Spain
+ Israel
+ USA
+ Sweden
PGRx REAL WORLD DATASETSMEDICAL INFORMATION + PATIENT VOICE
30+ epidemiologists, statisticians and data managers provide analysis and study design services leveraging electronic healthcare databases available for various key markets.
Available for license, Analytica Laser’s proprietary PGRx Real World Datasets offer aunique opportunity for obtaining extremely high-quality data in real-time, combiningboth medical information extracted from medical records and linkage to patientsquestionnaires. Datasets are currently available for 12 therapeutic areas and morethan 20 disorders.
WHEN THE QUESTION IS…
…the quality of PGRx data makes a real difference
understanding patient needs…
PGRx data showed that the quality of life of patients with acute coronary syndrome varies greatly according torisk factors and forms of the disease1, impacting drastically the burden of illness and the cost-effectivenessassessment of the different interventions.
1Value in Health, 2015
ensuring safety…
PGRx data were used in multiple risk management plans. It generalised the methodology used in the famous“fen-phen” study (IPPHS2) conducted by Lucien Abenhaim, which had uncovered the risk of these drugs and thusprevented an epidemic of fatal disease in Europe and the US.
2New England J Medicine
expediting access…
With price negotiations at an impasse, PGRx was accepted by payers as offering the necessary confidence inproduct value for a conditional pricing arrangement in the prevention of stroke by new anticoagulants. A similarmethod was used for confirming the role of statins in the prevention cardiovascular disorders3.
3Int J Cardiology, 2014
Our scientific advice enjoys the attention of regulators, payers and HTAbodies around the world. We are excited that our expertise has beenrequested by various recent public-private initiatives
+ Improving methods for post-launch safety monitoring and real-time benefit risk assessment
+ Member, Work Programme 2: Pharmacoepidemiology study designs framework
+ Leader, Work Programme 6: Methods validation in multiple data sources
+ Innovating RWE methods to inform clinical R&D decision-making, relative effectiveness evaluation
+ Leader, Work Package 2: Leverage RCTs and Phase IIIb studies to decrease efficacy-to-effectiveness gap
+ Organizing multi-centre, independent, post-authorization studies to strengthen the monitoring of authorized medicines in Europe
+ Regular participant in ENCePPPlenary Sessions and Scientific Conventions
+ Principal investigator of 1 ENCePP-registered collaborative study
+ Protocol reviewer of 1 ENCePP-registered collaborative study
DECISION ANALYTICS+ MODELING
Leveraging best-in-class capabilities in modeling, simulation,
mathematics and Bayesian statistics, Analytica Laser employs
advanced analytics frameworks and proprietary software to study
real world outcomes for drug value assessment.
Through the suite of proven methodologies, our team of experts
can leverage information available at any stage of development
and market access process. This informs strategic decisions for
drug evaluation and evidence generation.
Gaps in real world evidence have emergedas a critical challenge across the productlifecycle. Being able to explore a series ofhighly complex scenarios in a timelymanner is more vital than ever
From early stage development to launch,reimbursement, and outcomes performance– we help you navigate the most difficulttrade-off decisions
We can draw on a global team of statisticians,epidemiologists and analysts with expertise inadvanced predictive modeling and simulation
ANALYTICS AND MODELING SERVICES ACROSS THE PRODUCT LIFECYCLE
Analytica Laser has contributed to advance the methodological development in MTC and Bayesian meta-analysisand in large IMI/EU funded research projects on benefit/risk characterization and communication.
PHASEII
PHASEIII
REGISTRATION ACCESS EXPANSION
R&D
Drug positioning+
Optimal design and +planning
Pipeline prioritization+
PRE-MARKETING
+ Launch strategy
+ Pragmatic trial design
+ Payer-relevant evidence and value development
POST MARKETING
Risk sharing strategy+
Performance plan models+
Predicting comparative effectiveness+
Real world cost effectiveness models+
The interaction of risk factors with drugefficacy is not what varies from onepopulation to another – it is the distributionof these factors that does. This is why drugeffectiveness may be different fromcountry to country, or from one healthcaresystem to another
PROF. LUCIEN ABENHAIM
Pioneer of PharmacoepidemiologyFormer Executive Board Member, World Health Organization
OUR PROVEN FRAMEWORK FOR “BRIDGING TO EFFECTIVENESS”
Coverage+Medical Practices+Screening Policies+
Patterns of use, dose, +treatment durationPast history of exposure+Co+ -prescriptionsAdherence+
+ Age, gender, behaviors+ Co-morbidities+ Disease stage/severity+ Other baseline risk factors
and genetics relevant to disease/drug
HEALTH CARE SYSTEM
EFFICACY
EFFECTIVENESS
The team specializes in bridging efficacy to effectiveness in terms of modeling:
+ Clinical trial to real-life populations+ Proxy outcome to actual outcome
+ Country to country+ One comparator to another
DRUG USE PATIENT POPULATION
REALWORLDIMPACT
PATIENTS
EXPOSURE
SYSTEMS
USERS CHARACTERISTICS
Patients demographics, prognosis factors, +treatment pattern history
USE
+ Prescription patterns, decision rules to switch or adjust dose
+ Patients adherence and patterns of use HEALTHCARE SYSTEM FACTORS
Coverage+Medical practices policies+
The industry’s first dynamic andversatile tool dedicated to buildingpredictive models for effectiveness
We’re using our proprietary
technology HOPE to translate
clinical trial findings and population
health knowledge into expected
real world impact. Based on a
Bayesian dynamic modeling engine,
it allows for consideration of
dynamic exposure and influence
of risk factors in its predictions.
DEAL OR NO DEAL?DECISION ANALYTICS FOR OUTCOMES-BASED CONTRACTING
Across all health systems, payers and reimbursement authorities are urging the adoption ofperformance-based contracting. What if you’d be able to identify the sources and quantify theimpact of uncertainty around outcomes-based agreements?
Our proprietary HOPE technology enables us to:
Test highly complex scenarios to optimize your plan design and inform payer negotiations and contracting+
Understand what outcome, comparator and time horizon to select+
Define the best methods to measure performance and opt for the most appropriate payment models+
YOUR REAL WORLDSETTING
CLINICAL TRIALEFFICACY
RELEVANTDRIVERS OF
EFFECTIVENESS
HOPEMODEL ANDSIMULATION
We are committed to removing theuncertainties between clinical trialefficacy and real world effectiveness sothat you can succeed with outcomespredictions and payer engagements
DEC
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NA
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+ M
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ELIN
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Our global team draws on morethan a decade of experienceleveraging the industry’s mostadvanced modeling frameworks forperformance-based agreements
VALUE + ACCESSCONSULTING
Analytica Laser’s diverse teams provide a full range of strategic
market access services in an integrated model.
Our life sciences and medical device partners rely on our
strategic capabilities in real world evidence, advanced
simulation and unique payer insights.
We have completed hundreds of global value dossiers, helped
to secure approval and maintained coverage and
reimbursement through high-quality evidence of value and
impactful reimbursement submissions across all major markets.
Our market access consultants follow a structuredV+A analysis to measure what matters for yourproduct lifecycle management
Payer Research
Quantitative Pricing Research
HTA Strategy
Lifecycle DecisionAnalytics
Health Economics
Real World DataGeneration & Analysis
MARKETACCESS
OUR COMPREHENSIVE APPROACH
In-depth and structured review of available evidence
Build your product value dossier based on what matters to decision-makers
Align with payers’ evidentiary needs and uncover evidence gaps
Optimize evidence generation
Measure quantitatively and qualitatively real world benefit/risk
Measure real world value through MCDA studies that integrate evidence and regional insights
Positioning and marketing strategy
Bring the patient voice –speak the language of regulators, HTA organizations and payers
Develop real-world data on values and preferences
Gain insight on HCPs and patient values and preferences (MCDA driven panels)
Collect rich insights and data on regulator, HTAs and payers (MCDA driven ad-boards)
EVIDENCEINTELLIGENCE
PRODUCTINTELLIGENCE
CONTEXTINTELLIGENCE
COVERING BOTH SCIENTIFICAND REAL WORLD PERSPECTIVES
Value Message Development
Strategic Planning for Optimal Access
Potential Value Analysis
Scientific Engagement
Pricing and Payer Research
Economic models for HTA
submission and Regulatory
support
Profile testing, positioning and real-life models
Multi-criteria Decision Analysis
(MCDA)
Consistency & Continuity:
comprehensive lifecycle support
Communications (manuscripts, presentations,
workshops, trainings, mock
negotiation)
Core HTA Submission (GVD/Value
Dossier)
Reimbursement Submissions
throughout the world
ENABLING BREAKTHROUGHINNOVATION FORTOMORROW’S CURES
Analytica Laser partners with early stage Biotechto strategically optimize their market value in thecontext of financing or partnering deals.
+ Full asset valuation
+ Target patient population selection
+ Clinical trial design
+ Competitive landscape
+ Pricing studies
+ Preparation and participation to investor and partnering meetings
We’re leveraging a unique team of senior industry executives and entrepreneurs, former HTA decision-makers, scientists, and seasoned strategy consultants to offer innovative expert advice.
EXECUTIVE LEADERSHIP
Lucien AbenhaimPhD, MD, MSc
CHAIRMAN
London, UK
Fmr+ . Executive Board Member of the World Health Organization
Honorary Prof. of Epidemiology, London +School of Hygiene & Tropical Medicine
Roman CascianoMSc
EVP & GM,VALUE + ACCESS
New York, USA
+ Founder of Analytica International
+ 20 years’ experience in value assessment, HEOR and market access strategy
Billy AmzalPhD, X-Eng, MSc, MPA
EVP, DECISION ANALYTICS
London, UK & Paris, France15+ + years’ experience in clinical program design, modeling and analytics
Established and led model+ -based development at Novartis
Lamiae GrimaldiPhD, PharmD, MSc, MPH
EVP, EPIDEMIOLOGY ANDREAL WORLD DATA SOLUTIONS
Paris, France+ 15+ years’ experience in clinical
pharmacology & pharmacoepidemiology
+ Co-founder of PGRx System
EXPERT MANAGEMENT TEAM
Sumeet BakshiMBBS, MMS, MBA
London, UK
VP, Real World Evidence Solutions+
17+ + years’ experience, fmr. Pfizer and J&J
Patrizia BertoPharmD, MBA
Milan, Italy
+ Sr. Global Consultant and Managing VP, Italy
+ 30 years’ in biopharma with 20 years’ of HECON/ MA consulting
Matthew BroughamMSc, DipHeathEcon
Montréal, Canada
Sr. Global Consultant +
Fmr+ . VP, CADTH (Canada) and Fmr. CEO, PHARMAC (NZ)
20+ + years’ HTA/HEOR experience
Emmanuel CoeytauxPhD, X-Eng
New York, USA
Managing VP, Strategy Consulting+
15+ + years’ experience, fmr. R&D Strategy Director at Sanofi and BCG Principal
Jessica JalbertPhD
New York, USA+ Director of Pharmacoepidemiology
+ Assistant Prof. of Healthcare Policy and Research, Weill Cornell Medical College
Jenifer EhrethPhD
Paris, France Sr. Global Consultant +
15+ + years’ experience in biopharma and devices
+ University Prof. in Health Economics
Hélène KarcherPhD, X-Eng
Basel, Switzerland
+ VP, Global Head of RW Modeling
+ Fmr. MIT academic and drug developer (Novartis US/Europe)
Artak KhachatryanPhD, MD
London, UK
+ Sr. Director, Pharmacoepidemiology
+ 10+ years’ experience as lead epidemiologist in various international studies
Hanane KhouryPhD
Montréal, Canada
Assoc. Director, MCDA expert and Lead +investigator for the EVIDEM collaboration
10+ + years’ experience in MCDA and reimbursement dossier development
Marta MartinezPharmD, MBA
Madrid, Spain
+ Director, Outcomes Research
+ 10+ years’ experience in CROs and industry
Dima SamahaPharmD, MAS
London, UKSr. Director, Value & Access+
Fmr+ . Advisor on Innovation and External Affairs at INESSS, Québec
Ulrich NeumannMSc, MA, FRSA
New York, USA
Sr. Director, Commercial Development+
Business Consultant, Outcomes+ -based Contracting
+ 15 years’ experience in marketing
Lee SternMSc
New York, USA
+ VP, Business Development
+ 15+ years’ experience in HEOR
Jacek WalczakMD, Spec
Krakow, Poland
VP, Central and Eastern Europe+
15+ + years’ experience global market access and systematic reviews
Elvira MullerPhD, MPH
Lörrach, Germany
Managing VP, Germany+
15+ + years‘ experience in HTA and global market access
WHY ANALYTICA LASER?
SCIENTIFICRIGOR
+POPULATION
HEALTH INSIGHTS
ANALYTICALEXCELLENCE
+DECISIONALRELEVANCE
REAL WORLDKNOWLEDGE
+STRATEGIC
INTELLIGENCE