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

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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

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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