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PHARMACCESS LEADERS FORUM Eurostars Hotel, Berlin, Germany October 16th-18th, 2013 4 EVENTS IN ONE: Hear keynote presentations from the experts: This event will feature presentations from: 20 Payers, HTAs & KOLs & 32 Pharma Industry Market Access Experts DAY 1 & DAY 2, 3RD ANNUAL - INTERNATIONAL PHARMACEUTICAL PAYERS’ & HTA SUMMIT Day 3 / Stream 1 3rd Annual – AMNOG IN ACTION Day 3 / Stream 2 2nd Annual - MARKET ACCESS FOR HIGH VALUE SPECIALTY & BIOLOGIC MEDICINES Day 3 / Stream 3 MARKET ACCESS FOR VACCINES & INFECTIOUS DISEASE MEDICINES Professor Finn Børlum Kristensen MD, PhD, Director, Coordinating Secretariat, EUnetHTA, Chairman of the EUnetHTA executive committee Dr Andy Stainthorpe Associate Director Centre for Health Technology Evaluation National Institute for Health and Clinical Excellence, United Kingdom Dr Martin van der Graaff, Secretary, Reimbursement Committee CVZ (Health Care Insurance Board), Netherlands Antje Behring Officer, Pharmaceutical Department GBA, Germany Roy D. Baynes MD PhD Senior Vice President, Oncology Therapeutics Gilead Sciences Inc., USA

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Page 1: PHARMACCESS LEADERS FORUM - PDCI Market Access Level Berlin PHARMACCESS Conference... · PHARMACCESS LEADERS FORUM Eurostars Hotel, Berlin, ... crisis and rapidly increasing healthcare

PHARMACCESSLEADERS FORUMEurostars Hotel, Berlin, GermanyOctober 16th-18th, 2013

4 EVENTS IN ONE:

Hear keynote presentations from the experts:

This event will feature presentations from:

20 Payers, HTAs & KOLs &

32 Pharma Industry Market Access Experts

Day 1 & Day 2,3rD annual - InTErnaTIOnal PHarMaCEuTICal PayErS’ & HTa SuMMIT

Day 3 / Stream 13rd annual – aMnOG In aCTIOn

Day 3 / Stream 22nd annual - MarKET aCCESS FOr HIGH ValuE SPECIalTy & BIOlOGIC MEDICInES

Day 3 / Stream 3MarKET aCCESS FOr VaCCInES & InFECTIOuS DISEaSE MEDICInES

Professor Finn Børlum Kristensen MD, PhD, Director, Coordinating Secretariat, EunetHTa, Chairman of the EunetHTa executive committee

Dr andy StainthorpeAssociate DirectorCentre for Health Technology Evaluationnational Institute for Health and Clinical Excellence, united Kingdom

Dr Martin van der Graaff, Secretary, Reimbursement CommitteeCVZ (Health Care Insurance Board), netherlands

antje BehringOfficer, Pharmaceutical Department GBa, Germany

roy D. Baynes MD PhDSenior Vice President,Oncology TherapeuticsGilead Sciences Inc., uSa

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EventOver v iew

Day 1 & Day 23rd annual - InTErnaTIOnal PHarMaCEuTICal PayErS’ & HTa SuMMIT: ManaGInG a lIMITED BuDGET FOr EXPEnSIVE MEDICInES WHIlST EnCOuraGInG InnOVaTIOnA benchmarking meeting for health plans & insurers, payers, health technology assessors & health ministry officialsBerlin, Germany, October 16th - 17th 2013

Event Overview“Payers” (health plans, sick funds & insurers, payers, health technology assessors, hospital financial management & health department officials) in almost all circumstances, in both developed and developing countries are under extreme budgetary pressure. Many health systems in the developed world, face ageing populations, economic crisis and rapidly increasing healthcare costs in general, including the sustained cost increases of innovative and novel drugs. This is forcing payers to make difficult choices regarding which medical procedures & medications to fund and reimburse. No longer are “me too” drugs that have achieved regulatory approval simply approved for reimbursement at high prices. Payers need to make tough decisions based on what they define as “value”, unfortunately sometimes at the expense of funding treatments in some “lower priority” disease indications or individual patients. Despite intense political pressure from patients and stakeholders who believe healthcare is an inalienable “right” and should be “free for all,” the reality is that payers have an finite and limited budget, and face a high-degree of risk in decision making. They operate within an environment where a multitude of products are on offer, each making various therapeutic claims of efficacy and safety, often with insufficient data to validate supposed health outcome improvements over existing treatment options. How can payers make the right decision in a high-risk, high uncertainty environment? Various options and decision-making tools exist, some old, some novel. Traditional decision making based on, for example, price referencing, DRGs budgets or generic substitution are still significant. However, recent advances in the sophistication of HTA analysis and modeling, flexible pay for performance models, risk-sharing and value-based pricing schemes have become increasingly important to mitigate payer risk and allocate financial resources to the areas of pressing need. Savings and outcome improvements can also be found through finding efficiency gains at the healthcare delivery level, providing the right incentives for prescribers and improving patient adherence.

Why this meeting?This meeting will provide an ideal opportunity for “payers” and other decision makers from both public and private organisations, to benchmark with peers internationally and provide pharma companies an invaluable insight into the decision making processes and approaches of these vital stakeholders. Attendees will be able to understand and develop best practice approaches to such vital and common challenges, with the ultimate goal of encouraging innovation and improving patient access to novel and powerful medications.

Day 3 / Stream 13rd annual – aMnOG In aCTIOn: EXPErIEnCES WITH THE GErMan PHarMaCEuTICal PrICInG & rEIMBurSEMEnT rEFOrMDemonstrating value and innovation in Europe’s largest & most dynamic marketBerlin, Germany, October 18th 2013

Event OverviewThe German Healthcare system is the EU’s largest and best financed, which until recently has used free-market pricing and as such represents a crucial first step in a pharma company’s EU launch strategy. The large number of sick funds combined with the free pricing policy has resulted in an extremely competitive environment for pharmaceutical and medical device market leaders to operate in until now. The current reform (AMNOG), is affecting pricing and reimbursement procedures and market and patient-access as a whole. Although several manufacturers have completed the application process with relative success, some questions remained unanswered and some challenges are still in debate such as the choice of an appropriate comparative therapy. Reference prices and early benefit assessment internationally, are still linked to the German market prices and this has different consequences for different stakeholders across Europe. Additional uncertainties for the German markets include: When and how should selective contracting take place?: How to define a comparator in the absence of a recognised standard of care for niche drugs? & how should internal market access departments be re-structured in order to better fit the new evidence requirements & stakeholders?

Why this meeting?To answer and discuss these crucial points, Industry and non-industry stakeholders will meet at this event after almost two years of AMNOG experiences. This will be an excellent opportunity to gain a real understanding of AMNOG in action & how they can best work within this system.

Day 3 / Stream 22nd annual - MarKET aCCESS FOr HIGH ValuE SPECIalTy & BIOlOGIC MEDICInESDemonstrating value to achieve market access for expensive drugs in high-growth specialty marketsBerlin, Germany, October18th 2013

Event OverviewThis one-day event will look uniquely at biologics & higher-cost specialty drugs and the market access challenges they face. The issue of generating quality evidence and demonstrating value to global payers, health technology assessors and other key stakeholders is a major challenge for all products, but an acute one for specialty products across many therapeutic areas and specifically oncology. Such drugs may include niche biologics, expensive small molecules, orphan drugs, personalised medicines or biosimilars. This event will look at the overcoming the current challenges which face biologics & specialty medicines developers: Generating strong evidence to demonstrate value; understanding the latest innovative market access techniques & satisfying HTA requirements to build the right dossier. The discussion will focus on the best practices to the major issues which apply to these higher cost specialty medicines including implementing & designing pay-for-performance schemes and working within value-based pricing models to maximise patient access.Why this meeting?All participants who will attend this event will experience real-life examples on how to deliver value to payers, as well as satisfying patient needs in challenging conditions for expensive medications.

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Who Will Benefit:PAYERS, HTAs & POLICY MAKERS: Senior representatives from Payers, health plans & insurers, Public health experts, health technology assessors, hospital financial management, government & health ministry officials, health management and managed care organizations, epidemiology, horizon scanning, scientific advice, pharmacy strategy & budget management.

Industry: Corporate senior management, vice presidents, directors,senior managers in:Market access, health economics, pricing & reimbursement, health outcomes, government & regulatory affairs as well as those focused on designing studies to achieve value-adding endpoints, such as r&D strategy, clinical development and medical affairs.

OTHER STAKEHOLDERS: regulatory agencies, key-opinion leaders, independent health economists, health researchers and academics, physicians, patient groups, consultants & solution providers.

Event Structure:Day 1 Day 2 Day 3 - Stream 1 Day 3 - Stream 2 Day 3 - Stream 3

International Pharmaceutical Payers’ & HTA Summit

Third Annual - AMNOG in Action: Experiences with

the German Pharmaceutical

Pricing & Reimbursement

Reform

Second Annual - Market Access for

High Value Specialty & Biologic Medicines

Market Access for Vaccines & Infectious Disease Medications

EventOver v iew

Event Partners:

Day 3 / Stream 3MarKET aCCESS FOr VaCCInES & InFECTIOuS DISEaSE MEDICInESAchieving market access for treatments of preventable & transmittable conditionsBerlin, Germany, October18th 2013

Event OverviewVaccines & Infectious diseases (HIV, hepatitis, tuberculosis, influenza, anti-biotics, anti-infectives) as a broad area have several market access considerations in common, including issues such as possible central tendering, a variety of market access stakeholders and also the concept of preventative & prophylactic use for societal benefit. Market access in the case of large seasonal product purchases or pre-emptive flu pandemic stocks are difficult to justify in standardized health economic terms and even harder in terms of payment & price-volume agreements. Novel antibiotics face the additional challenge of being “held back” by payers as a means of maintaining clinical effectiveness (reducing resistance to antibiotics over time) which is in conflict with their commercial intent & looming patent expiry. Often these products are utilized in emerging markets and this presents additional challenges of stakeholder engagement and mapping for optimal market access. Value demonstration & economic evaluation is specifically difficult within this paradigm of preventative use and this one day stream will feature experts including the WHO and leading vaccines developers discussing how they deal with market access issues and how they look to address them.

Why this meeting?This one day stream of our PharmAccess Leaders Forum will tackle the unique challenges faced by companies manufacturing these essential products which bring a high, yet difficult to justify societal benefit. Leading experts in the field will uniquely look at how to communicate and demonstrate value to global payers and health technology assessors for vaccines and infectious disease medicines.

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Payers, HTas & leading academics

annalisa SammarcoHealth EconomistOffice for Pharmaceutical Policy aIFa, Italy

Professor Finn Borlum Kristensen MD, PhD, Director, Coordinating Secretariat, EunetHTa, Chairman of the EunetHTa executive committee

Dr andy StainthorpeAssociate DirectorCentre for Health Technology Evaluationnational Institute for Health and Clinical Excellence, united Kingdom

antje BehringOfficer, Pharmaceutical Department GBa, Germany

Dr Karen FaceyHonorary Senior Research Fellow, Department of Health Economics and HTAuniversity of Glasgow, Scotland

Dr Martin van der GraaffSecretary, Reimbursement CommitteeCVZ (Health Care Insurance Board), netherlands

robert SauermannDepartment of Pharmaceutical AffairsMain association of austrian Social Security Institutions, austria

Vinciane KnappenbergPharmaceutical Expertnational Institute for Health & Disability Insurance (Riziv-Inami), Belgium

antonio Sarria SantameraDirector, Agency for Health Technology AssessmentInstitute of Health Carlos III, Spain

Inaki Gutierrez-IbarluzeaKnowledge Manager Basque Office for Health Technology assessment, Spain, Secretary, HTai

Koonal ShahHealth EconomistOffice of Health Economics, UK

Dr rowan Hillson MBE, MD, HonDSc, FrCPFormer National Clinical Director for DiabetesDepartment of Health, uK

Olivier WongConsultant & Guideline Committee Member Former Voting Member, Commission de la TransparenceHaS, France

Evert Jan van lente, Senior DirectoraOK-Bundesverband (leading German statutory health insurance), Germany

Paul F.M. Krabbe PhDAssociate Professor, Head Health Technology Assessmentuniversity of Groningen, The netherlands

Jakub adamskiChief Expert, Drug Policy and Pharmacy DepartmentMinistry of Health Poland

Jaime Espin, Professorandalusian School of Public Health EaSP, Spain

Dott. Marco Marchetti, Technology Evaluation UnitUniversity Hospital Agostino GemelliCatholic university del Sacro Cuore, rome, Italy

Kees de JoncheereDirector, Department of Essential Medicines and Health ProductsWorld Health Organization, Switzerland

Dr. Mathias FlumeConsulting Pharmacist, Head of Business Unit Prescription ManagementKVWl, Dortmund (association of statutory health insurance physicians, Westfalia-lippe)

Christopher MilneDirector of ResearchTufts Center for The Study of Drug Development, uSa

Speaker sOver v iew

Kathy HughesVice Presidentavalere’s Health Economics and Outcomes research, uSa

Thomas F. Goss, PharmDSenior Vice PresidentBoston Healthcare

Prof. Bernd Brüggenjürgen, MD, MPHManaging DirectorBoston Healthcare

Colin Wight, Chief ExecutiveGalbraithWight

W. neil Palmer, President & Principal ConsultantPDCI Market access Inc.

Gary JohnsonManaging DirectorInpharmation

Olivier EthgenExecutive DirectorSerfan Innovation, Belgium

Dr. Gijs Hubben, CEOBaseCase, Germany

Dr. Mel WalkerVP, Head of Market Access,Otsuka Pharmaceuticals Europe

Sylvie GabrielSenior Vice PresidentGlobal Market Access & PricingIPSEn Pharma, France

roy D. Baynes MD PhDSenior Vice President, Oncology Thera-peuticsGilead Sciences Inc., uSa

Dr. Florian TurkVice PresidentGlobal Market Access & Healthcare SolutionsGlaxoSmithKline

Dr. Ilana WideraDirector Market AccessEuropean Oncology Business unitPfizer, Belgium

Dr. Carl Hubertus SchrederHead of Market AccessStallergenes GmbH – Germany

Markus FrickDirector of Pricing & Reimbursementresearch-Based Pharmaceutical Companies association (VFa), Germany

Dr. Klaus SuwelackGeneral ManagerI3G GmbH, Johnson & Johnson, Germany

Dr. Alexander NatzSecretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs (EuCOPE), Belgium

Oliver Stahl Director Market AccessEli lilly, Germany

Dr. Jochen FleischmannDirector Health Economics & Market AccessJanssen-Cilag GmbH, Germany

Sascha Glanemann MSc, MBaSenior Director Marketing & Market AccessInterMune GmbH, Germany

Kirill DanishevskyHead of Pricing and Reimbursementnovartis Pharma llC, russia

Dr. Günter Harms Market Access & Public Affairs Director, EMEAShire Deutschland GmbH

Philippe GodfroidGlobal Pricing & ReimbursementGSKBIO, Belgium

Eckhardt Petri, PhD, MHBaAssociate DirectorGlobal Medical Affairsnovartis Vaccines and Diagnostics GmbH, Germany

Jan PosthumusHead of Global Market Access and Market ResearchBasilea, Switzerland

rose-Marie BoylanSenior Manager, Market Access for Teva Innovation, Canada

Industry Experts

Expert Solution Providers

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08.00 Registration08.30 Chairperson’s Opening Remarks: Dr. Mel Walker VP, Head of Market Access, Otsuka Pharmaceuticals Europe

aCHIEVInG ECOnOMIC VS. ClInICal OuTCOMES FOr MarKET aCCESS

08.40 achieving a compromise between market access & regulatory requirements in early r&D

❖ Early interaction (phase II trials) between payers and regulatory advisors may be worth it to avoid overoptimistic assumptions.

❖ Smart study design and sensitivity analysis may bridge the gap between expectations and reality.

❖ Keep abreast not only on science but also on payers’ heterogeneity, new trends and economic framework.

❖ Merge different countries (EU US Canada China Brazil) and different backgrounds to mitigate the risk of false assumptions.

Olivier Wong, Consultant & Guideline Committee Member, Former Voting Member, Commission de la Transparence, HaS, France

09.20 Patient-centered research & care: regulatory & payer promises vs. reality

❖ What does the ideal world of patient-centered research & care look like?

❖ How close to this ideal are regulators and HTA organisations/payers in the US, the UK and Germany?

❖ FDA, PCORI & other organisations in the United States: High aspirations.

❖ EMA & NICE in the United Kingdom: Established track record. ❖ EMA & IQWiG in Germany: Up and coming. ❖ Where are we now and how close to the ideal can we get?

Kathy Hughes, Vice Presidentavalere’s Health Economics and Outcomes research, uSa

10.00 using registries to improve clinical practice and health outcomes Dr rowan Hillson MBE, MD, HonDSc, FrCPFormer National Clinical Director for Diabetes, Department of Health, uK

10.40 Networking & Coffee Session

rESulTS OF ManaGED EnTry & rISK-SHarInG aGrEEMEnTS

11.00 AIFA experiences with scientific advice & managed entry agreements to satisfy endpoints and reduce risk

❖ How to monitor outcomes and decide on product value? ❖ The Italian experience with scientific advice. ❖ The role of managed entry agreements to monitor outcomes.

annalisa Sammarco, Health EconomistOffice for Pharmaceutical Policy AIFA, Italy11.40 Sharing the burden in market access flexibilisation

❖ What about QoL as a reimbursement alibi? ❖ What about outcome measures in general? ❖ Gaps in shared vision building illustrated by Dutch “Coverage

with Evidence Development” experience.

Dr Martin van der Graaff, Secretary, Reimbursement CommitteeCVZ (Health Care Insurance Board), netherlands

12.20 utilising HTa to enhance decision-making during a financial crisis

❖ Considering life cycle of technologies. ❖ Promoting rationalisation not rationing. ❖ How to deal with disinvestment or de-prescription? Pilot studies.

Inaki Gutierrez-Ibarluzea, Knowledge Manager HTAi SecretaryBasque Office for Health Technology Assessment, Spain

13.00 Luncheon Break

14.00 Experiences of innovative agreements across Europe: What have we learnt?

❖ Managed entry agreement, the Belgian experience in the European context.

❖ Overcoming the dilemma: Fast patient access vs. lack of evidence and budgetary uncertainty.

❖ Taxonomy of early access schemes. ❖ Overview of various managed entry agreements.

Vinciane Knappenberg, Pharmaceutical ExpertNational Institute for Health & Disability Insurance (Riziv-Inami), Belgium

InnOVaTIVE ValuE MEaSurEMEnT METHODS

14.40 aMnOG is established, what are the next steps?antje Behring, Officer, Pharmaceutical Department GBa, Germany

15.20 Networking & Coffee Session

15.40 ‘unmet need’ as a potential source of economic value in value-based pricing schemes

❖ Definitions and ways of measuring unmet need. ❖ Exploratory empirical study: Do members of the UK general

public support the use of unmet need as a health care priority - setting criterion?

❖ Case study findings.

Koonal Shah, Health EconomistOffice of Health Economics, UK

16.20 a new measurement method that expresses overall Qol in a single value: The best from different frameworks

❖ Explain the limitations of present approaches of measuring QoL.

❖ Show its connection to the best measurement model for subjective phenomena: The Rasch model.

❖ Make clear what this new QoL measurement model adds.

Paul F.M. Krabbe PhDAssociate Professor, Head Health Technology Assessmentuniversity of Groningen, The netherlands

17.00 areas of payer emphasis worthy of discussion from a clinical trialist’s personal point of view

❖ Personalised medicine as the antithesis of generalisability. ❖ Clinical meaningfulness: In the eye of the beholder. ❖ Comparative effectiveness: Rules of the road. ❖ Budget impact and perverse analyses & incremental cost

effectiveness. ❖ Observational data, confounding and hierarchy of evidence. ❖ Third-party guides to validity despite regulatory approval.

roy D. Baynes MD PhDSenior Vice President, Oncology TherapeuticsGilead Sciences Inc., uSa

17.40 Panel Discussion: Overcoming differences in clinical vs outcomes endpoints

❖ Should regulatory & payer-determined outcomes be aligned? How? Is this realistic?

❖ Overview of harmonisation efforts. ❖ Improving the effectiveness of scientific advice programmes inc.

joint-advice. ❖ How should pharma companies develop evidence for a myriad

of stakeholders with differing requirements in real-life?

Professor Finn Børlum Kristensen MD, PhD, EunetHTa & EunetHTa executive committeeInaki Gutierrez-Ibarluzea, Basque Office for Health Technology Assessment, SpainHans Van der Meersch, national Institute for Health & Disability Insurance (Riziv-Inami), Belgiumantonio Sarria Santamera,Institute of Health Carlos III, Spain

Simon Holt, VP, Global Head HEOR, Novartis Pharma AG, Switzerland

18.10 Chairperson’s Closing Remarks 18.20 End of Day One

19:30 - Exclusive Complimentary networking Dinner for all event participants

THIRD ANNUAL INTERNATIONAL PHARMACEUTICAL PAYERS’ & HTA SUMMIT

DAY 116th October, 2013

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08.30 Registration & Coffee

09.00 Chairperson’s Opening Remarks: Colin Wight, Chief Executive, GalbraithWight

HTa IMPOrTanCE DurInG TIMES OF auSTErITy

09.10 Major policy developments that have impact on real world evidence developmentDr andy StainthorpeAssociate Director, Centre for Health Technology Evaluationnational Institute for Health and Clinical Excellence, united Kingdom

09.50 Working together for efficient HTA in Scotland ❖ The consortium approach to HTA. ❖ Industry engagement. ❖ Patient involvement. ❖ Future challenges.

Dr Karen FaceyHonorary Senior Research Fellow, Department of Health Economics and HTA, university of Glasgow10.30 Networking & Coffee Session

10:50 More accurate HTa & economic modelling to enhance decision making

❖ Patient registries and observational research to understand unmet need in specific patient populations and assess product “value”.

❖ Examples from specialty care & chronic diseases.

antonio Sarria SantameraDirector, Agency for Health Technology AssessmentInstitute of Health Carlos III, Spain

11.30 Market access at regional level: Communicating value to payers and healthcare providers

❖ Client Case study: A global strategy for regional value communication.

❖ How to present clinical data and economic data: Visual and interactive value stories are key to staying within the comfort zone of both KAMs and customers.

❖ Centrally manage your mobile app development in-house: Empower affiliates to localize their own apps, stop re-inventing the wheel in every country and avoid slow and costly outsourcing.

❖ Can CLM be applied to market access and key account management? What are actionable KPIs?

Dr. Gijs Hubben, CEOBaseCase, Germany

HTa HarMOnISaTIOn In EurOPE

12.10 European initiatives in HTa to harmonise evidence requirements

❖ The current European outcomes environment. ❖ Early scientific advice to technology sponsors. ❖ Additional data collection. ❖ Guidelines on assessing outcomes. ❖ Aligning HTA and regulatory needs.

Professor Finn Børlum Kristensen MD, PhD, Director, Coordinating Secretariat, EunetHTa, Chairman of the EunetHTa executive committee

13.00 Luncheon Break

DruG rEIMBurSEMEnT In CEE

14.00 recent developments in pricing and reimbursement in Poland

❖ Background of recent reforms. ❖ Overview of the reimbursement procedure. ❖ Pricing and reimbursement decisions. ❖ Cost-containment measures. ❖ Managed entry agreements.

Jakub adamski, Chief Expert, Drug Policy and Pharmacy Department,Ministry of Health Poland

DEMOnSTraTInG ValuE WITH QualITy EVIDEnCE

14.40 The abject failure of pharma forecasts to capture market access

❖ Why silos and vague qualitative market access research are to blame.

❖ Where market access should fit in a forecast. ❖ How to estimate the impact of market access on a forecast.

Gary Johnson, Managing Director, Inpharmation

15.20 Networking & Coffee Session

15.40 Facing key challenges in evidence generation & value demonstration

❖ Study End points. ❖ Study comparators. ❖ Real life data compared to study data. ❖ International reference pricing.

Dr. Ilana Widera, Director Market Access, European Oncology Business unit, Pfizer, Belgium

16.20 Three vital areas for improving market access for industry & payers

❖ Removing ‘unforced errors’ from market access planning & implementation.

❖ Focusing beyond national pricing & reimbursement. ❖ Having the right discussion at the right time on funding &

affordability.

Colin Wight, Chief Executive, GalbraithWight

17.00 Panel Discussion: Best practices in demonstrating value to payers & HTa’s in times of austerity

❖ Flexible & innovative pricing & reimbursement models. ❖ Generating superior pre & post marketing evidence. ❖ Achieving market access in complex emerging markets.

Dr. Ilana Widera, Pfizer, BelgiumJakub adamski, Ministry of Health Poland 17.40 Chairperson’s Closing Remarks

17.50 End of Day Two

DAY 2 17th October, 2013

THIRD ANNUAL INTERNATIONAL PHARMACEUTICAL PAYERS’ & HTA SUMMIT

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18th October, 2013DAY 3 - Stream 1

THIRD ANNUAL

AMNOG IN ACTION: EXPERIENCES WITH THE GERMAN PHARMACEUTICAL PRICING & REIMBURSEMENT REFORM

08.00 Registration & Coffee 08.30 Chairperson’s Opening Remarks:

aMnOG: WHaT WaS aCHIEVED? WHaT IS EXPECTED?

08:40 2.5 years of AMNOG: Which patterns have been identified?

❖ AMNOG overview to this stage. ❖ Describe how is the system is behaving so far? ❖ Which processes can companies expect in early assessment

stages?

Markus Frick, Director of Pricing & Reimbursementresearch-Based Pharmaceutical Companies association (VFa), Germany

09.20 Being prepared for the aMnOG Dossier – Too early to evaluate until it is suddenly too late?

❖ Getting prepared for the early benefit assessment early enough. ❖ Understanding the GBA requirements from a clinical data

perspective. ❖ Integrating the data requirements into the international

development strategy. ❖ Addressing the need for German health services research data.

Prof. Bernd Brüggenjürgen, MD, MPH, Managing DirectorBoston Healthcare

PayEr / InDuSTry COnTraCTInG

10.00 Innovative contracting models beyond pharmaceuticals between industry and health insurance – Industry view

❖ Care management as new business model for the industry. ❖ Disease management for better outcome and reduced costs. ❖ Case study integrated care for schizophrenia patients. ❖ New role of the industry?

Dr. Klaus Suwelack, General ManagerI3G GmbH, Johnson & Johnson, Germany

10.30 Innovative contracting models beyond pharmaceuticals between industry and health insurance – Health insurance view

❖ Need for care management in chronic illnesses. ❖ Decision criteria for partnering models. ❖ Case study integrated care for schizophrenia patients.

Evert Jan van lente, Senior DirectoraOK-Bundesverband (leading German statutory health insurance)

11.00 Networking & Coffee Session

11.20 Payer / Industry contracting: lessons learned and future initiatives

Evert Jan van lente, aOK-Bundesverband (leading German statutory health insurance)

Dr. Klaus Suwelack, I3G GmbH, Johnson & Johnson, Germany

11.40 Comparing experiences from different aMnOG assessment processes: Similarities and differences

❖ Practical experiences from assessment procedures in several indications.

❖ Recommendations for future processes.

Dr. Jochen Fleischmann, Director Health Economics & Market AccessJanssen-Cilag GmbH, Germany

12.20 aMnOG - What happens after the assessment process is over?Dr. Mathias FlumeConsulting Pharmacist, Head of Business Unit Prescription ManagementKVWl, Dortmund (association of statutory health insurance physicians, Westfalia-lippe)

13.00 Luncheon Break

aMnOG’S EFFECT On EurOPEan MarKETS

14.00 Early benefit assessments and their impact on International reference pricing

❖ The choice of the appropriate comparative therapy. ❖ Outcomes of the early benefit assessment. ❖ Relation between benefit assessment and the formation of

reference price groups. ❖ Early benefit assessment of orphan drugs. ❖ Products which are already on the market. ❖ Impact on International Reference Pricing.

Dr. Alexander Natz, Secretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs (EuCOPE), Belgium

14.40 The impact of the prices negotiated in aMnOG to other countries

❖ Germany still is a price anchor in many other markets and this does have implications on price flexibility.

❖ In that respect, it is crucial to watch where the AMNOG prices are positioned in the European price band.

❖ How that might impact other markets? ❖ How that might impact market access in Germany?

Oliver Stahl, Director Market Access, Eli lilly, Germany

15.20 Networking & Coffee Session

OrPHan DruGS aSSESSMEnTS unDEr aMnOG

15.40 Market access for orphan drugs under aMnOG

❖ New Government – What is to be expected for orphans. ❖ Value Dossier – Comparator or not? ❖ Pricing negotiations: Strategy and tactics. ❖ Practical insights and lessons learned.

Sascha Glanemann MSc, MBa, Senior Director Marketing & Market AccessInterMune GmbH, Germany

16.20 Panel discussion: understanding patterns in aMnOG to better forecast future drug assessments

Dr. Alexander Natz, Secretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs (EuCOPE), Belgium

Dr. Jochen Fleischmann, Director Health Economics & Market AccessJanssen-Cilag GmbH, Germany

antje Wallstab, MDraDirector Regulatory Affairs Central EuropeGilead Sciences, Germany

17.00 Chairperson’s Closing Remarks

17.10 End of Day Three

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18th October, 2013DAY 3 - Stream 2

SECOND ANNUAL

MARKET ACCESS FOR HIGH VALUESPECIALTY & BIOLOGIC MEDICINES

08.00 Registration & Coffee08.30 Chairperson’s Opening Remarks: W. neil Palmer, President & Principal Consultant, PDCI Market access Inc.

aCHIEVInG MarKET aCCESS FOr SPECIalTy MEDICInE THrOuGH SuPErIOr ValuE DEMOnSTraTIOn

08:40 Business-to-business value creation as a key success principle for market access in specialty selling Dr. Florian Turk, Vice President, Global Market Access & Healthcare SolutionsGlaxoSmithKline 09.20 Pharmaceutical companies try to substantiate their products with the best “added value”

❖ But do we know what patients really appreciate in their drug therapy?

❖ Patients have to take a more holistic treatment decision rather than looking at a single parameter.

❖ Conjoint analyses help to understand patients’ mind set better. ❖ Examples from immunology & oncology serve as learning cases.

Dr. Carl Hubertus Schreder, Head of Market AccessStallergenes GmbH – Germany09.50 Canadian market access for specialty & biologic medications

❖ Overview of Canadian health care system and pharmaceutical funding.

❖ Public and private drug plan coverage of specialty medications and biologics (and bio-similars).

❖ Price regulation / PMPRB price guidelines: Overview and implications of recent changes.

❖ HTA: CADTH/CDR, pCODR, INESSS – updates and overview of new listing (risk sharing) agreement process.

❖ Implications of international pricing/reimbursement policy reforms (AMNOG, VBP) on Canada.

❖ Outlook.

W. neil Palmer, President & Principal Consultant, PDCI Market access Inc.

10.30 Networking & Coffee Session

10.50 Anticipating how differences in country-specific evidence requirements can affect market access & reimbursement decisions for oncology drugsThomas F. Goss, PharmD, Senior Vice President, Boston HealthcareProf. Bernd Brüggenjürgen, MD, MPH, Managing Director, Boston Healthcare

unDErSTanDInG ValuE In THE EyES OF PayErS FOr CanCEr THEraPEuTICS

11.30 The use of external reference pricing of medicines in Europe and its influence in pricing and access to oncology medicines

❖ The practice of external reference pricing in Europe. Benefits and limitations.

❖ Evidence about the use of ERP in oncology medicines. Case study.

❖ Implications in market access: Delays and price setting.

Jaime Espin, Professor, andalusian School of Public Health (EaSP), Spain12.10 The austrian payers’ view on outpatient oncology treatments:

❖ Conditions for reimbursement of anticancer drugs in Austria. ❖ Which evidence and endpoints are requested? ❖ The impact of Quality of Life on decision making and pricing. ❖ What is the benefit of innovation on gaining access for a product? ❖ What is the role of HTA now and in the future? ❖ The current reimbursement situation - products and costs. -

Development of costs and other trends. ❖ Critical aspects of personalizing medicine and orphanising drugs

in oncology.

robert Sauermann, assoc Prof, MD, Department of Pharmaceutical Affairs,Main association of austrian Social Security Institutions, austria

12.50 Luncheon Break

14.00 The Gap of Evidence in Oncology: How to produce evidence that can support decision making process in health care system

❖ Evidence produced is not always useful for decision makers at different level of health care system.

❖ Analysis of reason because the evidence gap is existing. ❖ Future scenario for a sustainable relationship among industry and

regulator in order to improve sustainability of health care systems. ❖ Impact of future scenario on industries and regulators.

Dott. Marco Marchetti, Technology Evaluation unit, university Hospital agostinoGemelli, Catholic university del Sacro Cuore, rome, Italy

nICHE PrODuCTS PErSPECTIVES

14.40 Market access from a high-value biologics perspective

Sylvie Gabriel, Senior Vice President Global Market Access & PricingIPSEn Pharma, France

15.20 Networking & Coffee Session

SPECIalTy rEIMBurSEMEnT In EMErGInG MarKETS

15.40 Why are orphan drugs different? achieving sustainable access for orphan drugs

❖ Orphan drug regulation and market access incentives in Europe. ❖ Specific R&D and market access challenges for orphan drugs. ❖ The challenge of demonstrating the value of orphan medicines. ❖ Stakeholder engagement to address rare disease and orphan

drug challenges; Examples. ❖ National plans for rare diseases in EU member countries.

Dr. Günter Harms, Market Access & Public Affairs Director, EMEAShire Deutschland GmbH

16.20 Market access for high-value specialty & biologic medicines in russia: lessons learned

❖ The patchy structure of the Russian reimbursed market ❖ Market overview: High value specialty & biologic medicines in

Russia. ❖ Healthcare reform strategy: What was approved by the Russian

government? ❖ The role and structure of HTA today and in the future.

Kirill Danishevsky, Head of Pricing and Reimb.novartis Pharma llC, russia

17.00 Chairperson’s Closing Remarks

17.10 End of Day Three

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18th October, 2013DAY 3 - Stream 3

MARKET ACCESS FOR VACCINES &INFECTIOUS DISEASE MEDICATIONS

08.00 Registration & Coffee08.30 Chairperson’s Opening Remarks

VaCCInES anD InFECTIOuS DISEaSES MEDICInES:WHErE arE WE nOW? WHErE arE WE GOInG?

08:40 Meeting the need for infectious diseases medicines: Can the market sustain development?

❖ How does the R&D pipeline for infectious diseases match up to the unmet medical needs in mature, emerging, and next wave markets?

❖ Have R&D incentive programs created viable markets for infectious disease prophylaxis in the US and other mature markets?

❖ What influence do patient, public health and political stakeholders have on payer decision-making in the mature markets?

Christopher MilneDirector of ResearchTufts Center for The Study of Drug Development, uSa

ValuE DEMOnSTraTIOn & PrICInG COnSIDEraTIOnS

09.20 HTa assessments for niche medicines and possible impacts of international reference pricing in times of austerity measures

❖ Market access for niche and innovative product types. ❖ HTA initiatives to value niche medicines (i.e. cost effectiveness,

relative effectiveness). ❖ Achieving market access for innovative medications during times

of austerity and limited budgets.

Alexander NatzSecretary GeneralEuropean Confederation of Pharmaceutical Entrepreneurs, Belgium

10.00 WHO’s initiatives to improve access to vaccines and infectious diseases medicines

Kees de JoncheereDirector, Department of Essential Medicines and Health ProductsWorld Health Organization, Switzerland

10.40 Networking & Coffee Session

STraTEGIC MarKET aCCESS FOr VaCCInES anD InFECTIOuS DISEaSES MEDICInES

11.00 Accessibility of vaccines in Asia-Pacific markets: “The Expand” project

❖ Current initiatives on accessibility for vaccines. ❖ “Expand” in the Philippines: Context of case study. ❖ Starting situation, key programme components. ❖ Approach to pricing within the APAC region. ❖ Engagement of medical professionals. ❖ Results.

Philippe GodfroidGlobal Pricing & ReimbursementGSK Biologicals, Belgium

SPEaKEr TESTIMOnIal

“I went to speak for NextLevel and didn’t really know if it would be a good use of time. After, I felt truly honored to have been asked. Seniors from payer, Government, and Healthcare joined industry as delegates. Really senior people. Very impressive.”

Vice President, Global Market Access, novartis

11.40 Multi-criteria decision analysis (MCDa) in the case of vaccines/infectious diseases drugs

❖ MCDA encompasses a rather broad set of approaches and methods to guide decision-making while accounting for multiple criteria.

❖ In the case of immunization program, public health decision makers operate within finite short-term budget and may have different preferences on what constitutes the population health value of the program.

❖ How MCDA can be operated to assess a portfolio of vaccines? ❖ How MCDA can be combined with healthcare budget

optimization techniques to prioritize among a portfolio of vaccines?

Olivier Ethgen, Executive DirectorSerfan Innovation, Belgium

12.20 Special considerations relating to vaccines and immunization

❖ Should vaccines be assessed differently from pharmaceutical products?

❖ Is “herd/indirect protection” a valid endpoint? ❖ GRADE in vaccines assessment. ❖ US CBER, UK NICE, Australia TGA: Regulatory aspects. ❖ Vaccines health economics.

Eckhardt Petri, PhD, MHBa, Associate Director, Global Medical Affairsnovartis Vaccines and Diagnostics GmbH, Germany

13.00 Luncheon Break

14.00 HIV: Ethics, economics and the social value of a drug choice

❖ Building the social value case for the need for premium priced medications.

❖ Shifting cost to consequence: Ethics, economics & disability prevention.

❖ Building the political will & shifting policy.

rose-Marie Boylan, Senior Manager, Market Access for Teva Innovation, Canada

14.40 The business case for infectious diseases medicines from a market access perspective

Jan Posthumus, Head of Global Market Access and Market ResearchBasilea, Switzerland

15.20 Networking & Coffee Session

15.40 Panel Discussion: Designing a market access strategy for preventative & infectious medicines

❖ Similarities and differences between vaccines and infectious diseases and other therapeutic areas.

❖ What can the industry do differently to gain market access? ❖ Which stakeholders offer greater influence to manufacturers of

these products?

Christopher Milne, Tufts Center for The Study of Drug Development, uSa

Jan Posthumus, Basilea, Switzerland

rose-Marie Boylan, Teva Innovation, Canada

Eckhardt Petri, PhD, MHBa, novartis Vaccines and Diagnostics GmbH, Germany

16.20 Chairperson’s Closing Remarks

16.30 End of Day Three

Page 10: PHARMACCESS LEADERS FORUM - PDCI Market Access Level Berlin PHARMACCESS Conference... · PHARMACCESS LEADERS FORUM Eurostars Hotel, Berlin, ... crisis and rapidly increasing healthcare

Vienna, Austria May 6th- 8th 2013Day 1: Achieving Regulatory & Payer-Determined EndpointsDay 2 & 3 Streams: Stream 1: Oncology Health Outcomes & Market Access Measuring & demonstrating enhanced value for oncology medicationsStream 2: Achieving Quality of Life Endpoints Quantifying & determining value for patient-centric health outcomes

SPRING

EventPar tner s & Networ k ing

Are you interested in presenting your company products and services to this senior-level audience? If so please contact: [email protected] Our team will be happy to tailor a package to suit your needs and get you the optimal level of exposure!

NetworkingThe Pharmaccess leaders Forum will provide all delegates the chance to meet one another through our many networking opportunities. With pre-event, mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants. This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.

Event Partners:

Media Partners

Page 11: PHARMACCESS LEADERS FORUM - PDCI Market Access Level Berlin PHARMACCESS Conference... · PHARMACCESS LEADERS FORUM Eurostars Hotel, Berlin, ... crisis and rapidly increasing healthcare

Past attendees PharmaAccess (Autumn), Berlin, November 2012

Company Job Title Country

Hays Account Manager Germany

Hays Account Manager Germany

Stallergenes GmbH, Germany Head of Market Access Germany

D A K – Unternehmen Leben, Germany

Head, The Department Care Management, Product Management Division

Germany

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Secretary General Belgium

Shire, Germany Medical Director, Clinical Development & Medical Affairs

Germany

InterMune Germany GmbH Senior Director Marketing & Market Access

Germany

Johnson & Johnson Medical GmbH Director Access & Reimbursement, Specialist doctor for Anaesthesiology

Germany

VFA Germany

Novartis Pharma AG, Switzerland Head of Market Access, IHC Switzerland

Novartis Pharma AG, Switzerland Global Head Health Economics & Outcomes Research, Critical Care Business Franchise

Switzerland

Merck Serono S.A, Germany Vice President, Global Development & Medical / Health Services Research

Germany

Otsuka Pharmaceuticals VP, Head of Market Access UK

Shire Germany GmbH Market Access & Public Affairs Director Germany

Amgen, Austria Director, Health Economics Central & Eastern Europe

Austria

Ethicon Endosurgery, Germany European Manager Health Outcomes Germany

RC CEE & Ph, Russia Head of Department / Department for international cooperation and strategic development

Russia

AXA Global Life, France Director/Head of Employee Benefits & Health

France

Covidien AG, Switzerland Vice President Healthcare Economics & Reimbursement EMEA

Switzerland

Novartis Pharma AG, Switzerland Director Global Advocacy Switzerland

Merck, Sharp & Dohme, Turkey Market Access Manager Turkey

Sanigest Health Solutions, Costa Rica

President Costa Rica

Agency of Quality and Accreditation in Health Care and Social Welfare, Croatia

Clinical pharmacologist and toxicologist / Assistant Director / Department for Development, Research and Health Technology Assessment

Croatia

Pharmaceutical Department GBA Officer Germany

EU net HTA Director, Coordinating Secretariat Denmark

National Institute for Health & Clinical Excellence (N.I.C.E.) UK

Associate Director UK

Haute Autorite de Sante Deputy Director of the HTA Division France

National Institute for Health & Disability Insurance (INAMI-RIZIV)

Secretary General Belgium

NHS Futures Forum CEO UK

German Agency for HTA (DAHTA) & Medicine Innovation

Head of German Agency for HTA (DAHTA) & Medicine Innovation

Germany

University of Glasgow Honorary Senior Research Fellow UK

UK Thalassaemia Society & Eurordis

Senior Advisor UK

Grunenthal Senior Market Access Manager Germany

Bayer Pharma AG Head of Global Market Access Germany

Ministry of Health and Haute Autorite de Sante (HAS-Sante)

Senior Advisor France

IMS Health Editor UK

FarmavitaR+ Business Development & Market Access

Astellas Pharma Kft. Product Manager Hungary

Hays Marketing / Corporate Communications Germany

Pfizer Access Project Manager Turkey

Pfizer Corporate Health Project Manager Turkey

Novartis Pharma GmbH, Germany Head Health Care Management & National Health Policy Manager

Germany

Novo Nordisk Pharma GmbH Senior Manager Market Access Planning & Effectiveness

Germany

UCB Pharma Head of Value and Reimbursement Germany

Human Capital Advisory Group Director UK

Baxter New Market Development Director China

Fresenius Kabi Director Business Development Germany

Company Job Title Country

PDCI Market Access Inc. President & Principal Consultant USA

Kantar Health Vice President, Global Market Access USA

Kantar Health Head of EU Market Access USA

Kantar Health Senior Director – Oncology Market Access EU

USA

BaseCase CEO Germany

Boehringer Ingelheim Marketing Sp. Z.o.o.

Corporate Affairs Director Poland

Quintiles Commercial Key Account Director Germany

SERFAN Innovation s.p.r.l. Executive Director Belgium

Inpharmation Managing Director UK

Novartis Global Market Access Director NS Switzerland

Novo Nordisk Senior Manager Healthcare & Market Access

Germany

Novartis Global Market Access Director Switzerland

Archimedes Pharma General Manager Germany

Tillotts Pharma Manager BD&L Switzerland

GILEAD Sciences GmbH Director Regulatory Affairs Germany

Novartis Director HE&OR Switzerland

Numerus Ltd Business Development Manager Germany

Novo Nordist Director, Market Access Canada

Adelphi Access Ltd UK

Ministry of Social Affairs in Estonia Head of the Medicine Department Estonia

Bristol Myer Squibb VP Market Access Europe France

Gfk Bridgehead Germany

Plasma Protein Therapeutics Association

Senior Manager Germany Belgium

Plasma Protein Therapeutics As-sociation

National Affairs Manager Belgium

CSL Behring Director Public Affairs Europe Germany

Therabel Pharma Managing Director Belgium

Berlin-Chemie AG Director, Regulatory Affairs Germany

Smart&Bi Health care Consultant Belgium

IRIS Director Coordination Emerging Coun-tries

France

UCB Pharma Sr Health Outcomes Mgr Immunology Belgium

Novartis Pharma Head of Critical Care Market Access Switzerland

PAREXEL International Senior Director Business Development Germany

Novartis Head of Oncology National Acces + Ext. Affairs

UK

Boehringer Ingelheim Marketing Department Head Germany

Celgene International Executive Director Switzerland

Abacus International Director HTA UK

State Institute for Drug Control Head of Reimbursement Unit Czech Republic

Celgene Senior Director USA

Lundbeck Market Access Manager France

PARI Pharma GmbH Director, Marketing & Sales Germany

Popewoodhead Commercial Development Manager UK

Popewoodhead Managing Director UK

Popewoodhead Senior Consultant UK

Allergan Pricing Reimbursement & Access manager

Belgium

Bristol Myer Squibb Associate Director, Global Market Ac-cess ONCO

USA

Real Endpoints Senior Writer & Analyst UK

Vifor Pharma Global Director HE & Access Switzerland

Grunenthal Medical Director Germany Germany

Celgene Country Manager Turkey

Celgene Associate Director, Regulatory & Market Access

Turkey

Boston Healthcare Vice President Asia USA

Boston Healthcare Executive Director USA

Novartis Pharma Head Novartis Pharma Services Supply Chain

Switzerland

Celgene Market Access Manager Switzerland

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Vienna, Austria May 6th- 8th 2013Day 1: Achieving Regulatory & Payer-Determined EndpointsDay 2 & 3 Streams: Stream 1: Oncology Health Outcomes & Market Access Measuring & demonstrating enhanced value for oncology medicationsStream 2: Achieving Quality of Life Endpoints Quantifying & determining value for patient-centric health outcomes

SPRING

SpeakerBiogr aph ies

Dr Martin van der Graaff, Secretary, Reimbursement Committee, CVZ (Health Care Insurance Board), netherlands

Martin van der Graaff (1955) studied Pharmacy and received his Ph.D. at Leiden University. He spent 11 years in R&D at Organon

and Solvay Pharma, covering subjects such as lyophilization, injection formulation, human pharmacokinetics and bioequivalence, preclinical development studies, and toxicology. He then moved on to the association of the innovative pharmaceutical industry, Nefarma. For 12 years he was, in different positions, responsible for subjects ranging from regulatory and registration issues, biotechnology, environmental issues, to orphan drugs and sustainable development. In 2008 he changed track from the private to the public sector and joined the Dutch Healthcare Insurance Board (CVZ), and is currently Secretary of the Scientific Advisory Board of CVZ. The constant factor in his professional life has always been the drive to supply patients with the best possible medicines, and, where feasible and sustainable, even better ones.

robert Sauermann, assoc Prof, MD, Department of Pharmaceutical AffairsMain association of austrian Social Security Institutions, austria

Robert Sauermann, Resident of Vienna, Austria. Date of birth 1974. Study of Medicine at the Medical University of Vienna, doctoral thesis at the Infectious Diseases laboratory. Specialist in Internal Medicine and Clinical Pharmacology. Scientific focus on pharmacokinetics and antibiotics. Current positions:Department of Pharmaceutical Affairs of the Main Association of Austrian Social Security Institutions for medical evaluation of drugs in the reimbursement processAssociate professor at the Department of Clinical Pharmacology, Section of Pharmacokinetics at the Medical University of Vienna.

Paul F.M. Krabbe PhDAssociate Professor, Head Health Technology Assessmentuniversity of Groningen, The netherlands

Paul Krabbe studied psychology at the University of Utrecht. He completed his PhD dissertation in 1998 at Erasmus University Rotterdam (Dept. of Public Health). At the moment he is positioned

at the Department Epidemiology of the University Medical Center Groningen. He is an expert in (subjective) health-outcome measurement methodology, in particular ‘health-related quality of life’. He has advised and planned many clinical studies and built up substantial experience with evaluation research in the field of health care. In 2004, as a visiting research fellow at the Harvard Initiative for Global Health (chaired by Christopher Murray), he investigated the application of scaling models as an alternative to the standard valuation techniques used to quantify health states. Apart from his methodological research related to health-state quantification, he has coordinated and advised on several medical studies and contributed to the development of the Dutch pharmacoeconomic guidelines to be used in decision-making on reimbursement. As member of the international EuroQol Group, he takes part in scientific research and development on measurement issues. Recently, he coordinated a large experimental study on discrete choice models.

Mattias neyt, MSc, PhD, Economic Analysis Expert,Belgian Health Care Knowledge Centre (KCE)

Mattias Neyt (1978) is an economist (2000, Ghent University) and obtained a Ph.D. in 2006 from Ghent University with a dissertation entitled ‘Economic evaluation of medical innovations’. Since the end of 2005, he has been working as an expert at the Belgian Health Care Knowledge Centre (KCE) where he has co-authored several Health Technology Assessment (HTA) and Health Services Research (HSR) projects. Since 2007, he teaches in EHSAL’s postgraduate health economics program. Together with two colleagues he founded ME-TA in 2010 to offer their expertise to foreign non-profit organizations and to provide training and education in the field of HTA.

Gary Johnson, Managing DirectorInpharmation, uK

Gary Johnson is Managing Director of Inpharmation Ltd. He has consulted for all the top 10 pharma companies and many others too. He is author of the book Principles of Pharmaceutical Pricing: An Evidence Based Approach and a finalist for the MCA Business Book of the Year Award. He has a number of prestigious ‘best paper’ awards

at international conferences. Prior to founding Inpharmation, Gary held senior positions in major pharma companies. He has degrees in Medical Science from Nottingham and Management from London. He is a Sloan Fellow of London Business School and a Fellow of the Royal Society of Medicine.

Kathleen E. Hughes, Vice President, avalere’s Health Economics and Outcomes research, uSa

Kathy Hughes is a Vice President in Avalere’s Health Economics and Outcomes Research practice. She enables clients to gain the best possible market access by demonstrating the value of their products

through quantitative evidence and analytics. Kathy has more than 30 years of experience in providing consulting services to healthcare businesses, managing providers, and leading a managed care organization. This background enables her to scrutinize complex issues in market access thoroughly; craft strategies and tactics that address them most effectively; and plan for and perform the analytics necessary support them. Before joining Avalere, Kathy was co-leader of the Market Access consulting practice at Covance, a

leading pharmaceutical contract research organization. Prior to that, she was the Chief Operating Officer for all ambulatory care, physician practice, and managed care businesses at Holy Cross Health Corp., an integrated delivery system in Maryland. Earlier in her career, she was the Vice President for Corporate and Strategic Planning for Blue Shield of California. Kathy also spent five years as a Senior Manager with Ernst & Young’s Healthcare Management consulting practice in California. Kathy received a M.B.A. from the University of Chicago and a B.A. from Brandeis University. She holds a Certificate of Completion from the Mid-Atlantic Health Leadership Institute at The Johns Hopkins Bloomberg School of Public Health and is a Senior Fellow at the Thomas Jefferson University School of Population Health.

Jaime Espin, Professorandalusian School of Public Health (EaSP), Spain

Jaime Espín has a PhD in Economics (University of Granada), a Bachelor Degree in Law (University of Granada) and a Master in Health Economics (Andalusian School of Public Health). He has been

Visiting Graduate Fellow in the Department of Economics in the University of California (UCSB), Visiting Professor in Duke University (Fuqua Business School) and Visiting Researcher in The University of Chicago. He has also attended to specialized training activities in the University of Harvard and Oxford. He is Professor in the Andalusian School of Public Health, where teaches and coordinates projects related to health economics, economic evaluations and pharmaceutical policies. Prof. Espín is an expert in European pharmaceutical policies and has been external advisor for the European Commission during the High Level Pharmaceutical Forum (Working Group on Pricing). He is currently member of the Experts Committee on Pharmaceutical Policies of the Pan American Health Organization (PAHO/WHO) and member of the Pricing Policy Group of the WHO/HAI Project on Medicines Prices and Availability. He is co-author of the European Commission publication “Differences and Commonalities in pricing and reimbursement systems in Europe” and co-editor of the Pan America Health Organization (WHO/PAHO) publications “The access to high cost medicines in the Americas” and “Guideline for implementing generic strategies in Latin America and the Caribbean as a mechanism to improve access to medicines”.

Colin Wight, Chief ExecutiveGalbraithWight

Colin Wight, Chief Executive, founded GalbraithWight Ltd in January 1997. Dedicated 100% to healthcare GalbraithWight focuses on Market Access, new product planning, launch excellence, brand planning and marketing excellence. GalbraithWight is a team of expert practitioners with extensive international senior level operational

experience who design and deliver solutions for the global healthcare business. Starting originally with Glaxo in R&D, Colin has over thirty years healthcare industry experience, including twelve years with Merck & Co Inc, as Marketing Director for Rhone-Poulenc Rorer (now Sanofi-Aventis), and Sales Director/ Sales and Marketing Director for Bristol-Myers Squibb. Colin has been a member of global strategic marketing teams for cardiovascular and respiratory brands, and global salesforce effectiveness. He has worked alongside leading management consultants including McKinsey and Boston Consulting, and has worked with the positioning experts and well-known authors Al Ries and Jack Trout. Colin has been responsible for some of the most successful launches, including Taxol and Zocor. Colin regularly Chairs international meetings on Market Access, Pricing & Reimbursement. He has authored ‘Scrip’s Guide to Successful Pharmaceutical Marketing’; a detailed insight into pharmaceutical marketing in the 21st Century, and papers and articles on market access. Colin inspires the GalbraithWight team to utilise its class leading understanding and practice of Market Access in all its consultancy projects knowing that Market Access is the single most import determinate of commercial success, globally.

Kirill DanishevskyHead of Pricing and Reimbursementnovartis Pharma llC, russia

Kirill Danishevskiy, M.D., MPH, Ph.D. has extensive experience working for non-for-profit, as well as private and governmental sectors. His professional record includes four years as chief of unit of the Open Society Institute (Soros foundation), five years as research fellow at

the London School of Hygiene and Tropical Medicine, multiple consultancies in Central Asia and other former Soviet republics at UN and World Bank. In 2006 was elected for a 4 years presidency of the Society of Evidence-based medicine (www.osdm.org). He is also a founder of Russian Anti-Tobacco Advocacy Coalition (www.ataca.ru). His publication record includes over 50 papers in international and Russian journals ones, chapters in 7 UN books, two books as editor in chief, over 50 thematic reports and white papers. Currently he heads Pricing and Reimbursement unit of Novartis Pharma, Russia and holds adjunct professorship with Higher School of Economics.

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Vienna, Austria May 6th- 8th 2013Day 1: Achieving Regulatory & Payer-Determined EndpointsDay 2 & 3 Streams: Stream 1: Oncology Health Outcomes & Market Access Measuring & demonstrating enhanced value for oncology medicationsStream 2: Achieving Quality of Life Endpoints Quantifying & determining value for patient-centric health outcomes

SPRING

SpeakerBiogr aph ies

Dr. Iñaki Gutiérrez-Ibarluzea, Knowledge Manager, Osteba, The Basque Office of HTA

Iñaki Gutiérrez-Ibarluzea BSc, MSc, PhD is the Knowledge Manager and Coordinator of the early awareness and alert system of Osteba, the Basque Office for HTA. He is member of the HTAi ISG on

information resources, the HTAi ISG group on Membership and dissemination and chairs the HTAi- ISG on disinvestment of technologies of low-added value. He has been collaborating in different European Union funded projects such as: InnoHTA, EunetHTA, PHGEN I and II and Health ClusterNet playing different roles. He is also coordinating different projects at the Spanish level such as: GENTecS or Information resources group. He is currently the chairman of EuroScan, the International Network for the identification and assessment of new and emerging health technologies. He is also professor at the Nursing School of the Basque Health Service Osakidetza and collaborates with the University of the Basque Country and the University Oberta of Catalonia in different academic activities. He was actively involved in the e-text on HTA promoted by the ISG on information resources and in the development of the HTAi vortal on information resources. At the Spanish level he coordinates the Spanish Group of Agencies for the Identification and assessment of new and emerging technologies and is member of the groups for the assessment of obsolete technologies and the development of post-introduction systems for the assessment of health technologies leaded by the Galician Agency (Avalia-T).

Dr Karen Facey, Honorary Senior Research Fellow, university of Glasgow, Past Chair, HTAi Interest Group of Patient/Citizen Involvement, uK

Karen Facey has been chair of the HTAi Interest Group on Patient/Citizen Involvement in HTA for seven years. She is an independent evidence based health policy consultant, Non Executive Director of a

health provider in Scotland and member of the Scottish Health Technologies Group. She originally worked as a statistician in the pharmaceutical industry and the UK medicines regulatory agency. In the last 12 years she has developed a broader interest in evidence based decision making in health care. In 2000, she established the first national health technology assessment (HTA) Agency in Scotland, which setup the Scottish Medicines Consortium. Karen has developed a passion to see better engagement of patients in drug development and the HTA process. She was guest editor on a special themed edition of the International Journal of Technology Assessment in Health Care about patient issues and was Chair of the HTAi Policy Forum from 2007-2010.

Dr. Mel Walker, VP, Head of Market Access, Otsuka Pharmaceuticals Europe

Mel’s previous role was specifically created to help GSK develop a deeper understanding of payer needs, through improved engagement with this diverse stakeholder group. In this capacity, he has taken a particular interest in understanding how the needs of HTA bodies can be aligned with those of other key stakeholders to support

appropriate reimbursement and market access strategies and optimal clinical development plans. Recently, he co-led the effort to apply for joint scientific advice from the Swedish HTA and Regulatory authorities through a novel pilot initiative that he believes will become a future standard. Previously at GSK, he headed the European Oncology Health Outcomes team and he continues to devote half of his time to working with Oncology R&D to drive increased emphasis on payer strategies. Mel’s work involves developing an understanding of how payers value medicines and using this information along with a knowledge of reimbursement processes to support patient access to medicines by ensuring that clinical development plans result in products that are “reimbursable” as well as “approvable”. Following a degree in Pharmacy and a doctorate in health outcomes at the Centre for Socioeconomic Research in Cardiff, Mel spent 5 years at Roche Products in the UK where he had health outcomes responsibility for their marketed portfolio. During this time, he co-developed 12 reimbursement submissions for NICE including dossiers for several leading oncology products. Mel has co-authored over 30 research papers and abstracts, as well as 2 book chapters, in the field of health outcomes research and worked in several therapeutic areas including oncology, haematology, osteoporosis, rheumatoid arthritis, nephrology, transplantation, obesity, HIV and Alzheimer’s disease. He has also presented and chaired a international conferences in the areas of market access, the interface between HTAs and regulators, conditional reimbursement and risk sharing.

Professor Finn Børlum Kristensen MD, PhD, Director, Coordinating Secretariat, EunetHTaChairman of the EunetHTa executive committee

Chairman of the Executive Committee, European Network for Health Technology Assessment, EUnetHTA, and Director of it’s Coordinating Secretariat, National Board of Health, Denmark. Adjunct professor in health services research and health technology assessment at

University of Southern Denmark from 1999. Formerly Director of Danish Centre for Health Technology Assessment (DACEHTA), National Board of Health, Denmark 1997 - 2009. University graduate in medicine. PhD in Epidemiology. Specialty in General Practice and in Public Health. International projects in health services research, epidemiology, health technology assessment, and clinical practice guidelines since the 1980’s. Chairman International Network of Agencies for Health Technology Assessment (INAHTA) 2003 -06. Project Leader of EUnetHTA, 2006-08 (www.eunethta.net). Editor of Health Technology Assessment Handbook (English, translated), 2007 and chief editor of three peer reviewed publication series from DACEHTA 1998 - 2009. Member, UK NHS HTA Programme Advisory Group since 2005. Chair, Scientific Council, Ludwig Bolzmann Institute of HTA, Austria since 2007.

Dr. andy StainthorpeAssociate Director Centre for Health Technology Evaluationnational Institute for Health and Clinical Excellence, united Kingdom

Dr Stainthorpe is Head of the Patient Access Scheme Liaison Unit in the Centre for HealthTechnology Appraisal of NICE. The Unit provides advice to the Department of Health (DH) on the feasibility of patient access scheme proposed by industry. This role involves working closely with the NHS, DH, and industry to assess schemes for compatibility with the PPRS and NHS practices. Prior to taking up the role with NICE in 2009, Dr Stainthorpe worked extensively in health research – focussing on health economics and research ethics in national and international projects. He led the setting-up the UK’s Research Integrity Office in 2006, serving as the first Director to 2008. Education include doctorate and further studies in health economics, research ethics and law. He has published research in a range of fields but principally in research integrity, genetics, urology, spinal injuries and telemedicine.

roy D. Baynes MD PhDSenior Vice President, Oncology TherapeuticsGilead Sciences Inc.

Roy Baynes is Senior Vice President Oncology and Inflammation Therapeutics at Gilead Sciences Inc., Foster City, California USA. He was previously Vice President Global Clinical Development, and Therapeutic Area (TA) Head for Hematology / Oncology, at Amgen

Inc. He graduated as a Medical Doctor and obtained a Master of Medicine and Doctor of Philosophy from the University of the Witwatersrand, Johannesburg, South Africa. He has had a long and distinguished career in the haematology-oncology-and stem cell transplantation fields, including drug development, basic research, clinical practice, clinical research, teaching and administration.

Dott. Marco MarchettiTechnology Evaluation Unit University Hospital Agostino GemelliCatholic university del Sacro Cuore, rome, Italy

Marco Marchetti has graduated in medicine at Università Cattolica del Sacro Cuore ( Rome ) and postgraduate in Hygiene and Public Health and Legal Medicine. He is currently the Director of the Health

Technology Assessment (HTA) Unit of the Policlinico Universitario “Agostino Gemelli” at Università Cattolica del Sacro Cuore. He is also the European Director of the International Master Program in HTA and Management since 2001 (http://www.ulyssesprogram.net/ ). He is the Director of Scientific-Technical Office of Institutional review board (IRB) - Ethical review board of the Università Cattolica del Sacro Cuore. He has been experts and referees for Health Technology research proposal in the year 2003 and 2008 by The NHS Health Technology Assessment Programme. - National Coordinating Office for Health Technology Assessment. He was in charge to organize the HTA international 2nd annual meeting “ Bringing HTA into practice”, 20-22 June 2005. He chair of Special Interest Subgroups of HTA international – Htai www.htai.org - “hospital based HTA”. His expertise area are on the following fields: hospital management, quality assurance, risk management, HTA, drug epidemiology, evidence based medicine. He published more than 150 paper on national and international on the subjects he interested in.

Dr. Ilana Widera Director Market Access European Oncology Business unitPfizer, BelgiumDr Ilana widera is director Market access in the European Business Unit Oncology at Pfizer. She joined Pfizer in 2006 after working 10 years in the Belgian sick funds, and being an active member of the Belgian medicines reimbursement committee. Before that Ilana has worked 10 years as a surgeon in the university hospital Erasme in

Brussels. Her main driver is to ensure the best access to innovative drugs for patients. She took the lead in important projects enabling access in Oncology.

antje BehringOfficer, Pharmaceutical Department GBa, Germany

Dr. Antje Behring graduated with a PharmD and PhD in pharmaceutical science from the University of Munich, Germany. After working as consulting pharmacist for a German health insurance company, she joined Germany’s Federal Joint Committee (Gemeinsamer

Bundesausschuss) Pharmaceuticals Department. Since 2011 she has been involved in the procedure for additional benefit assessments for new pharmaceutical products and is responsible for handling incoming dossiers and requests for advice concerning the additional benefit assessment.

Dr. Gijs HubbenCEOBaseCase, Germany

Gijs Hubben is a health economist and one of the founders of BaseCase. He has published extensively in peer-reviewed journals, including on the cost-effectiveness of infectious disease interventions, and screening strategies for hospital acquired infections. With a background in pharmacy, health economics and emerging technologies, Gijs’s understanding of the intersection of these disciplines lies behind the unique service offered by BaseCase: a cloud-based platform to create customer engagement apps, that ensures clinical and economic data are communicated effectively to payers and healthcare providers. Gijs has acted as advisor to the pharmaceutical, medical device and diagnostics industry on communicating clinical and economic value for the past 10 years.

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Vienna, Austria May 6th- 8th 2013Day 1: Achieving Regulatory & Payer-Determined EndpointsDay 2 & 3 Streams: Stream 1: Oncology Health Outcomes & Market Access Measuring & demonstrating enhanced value for oncology medicationsStream 2: Achieving Quality of Life Endpoints Quantifying & determining value for patient-centric health outcomes

SPRING

SpeakerBiogr aph ies

Prof. Bernd Brüggenjürgen, MD, MPH, Managing DirectorBoston Healthcare

Dr. Bernd Brüggenjürgen is Vice President and Managing Director of Boston Healthcare Associates International in Berlin, and supports the company’s work in health economics and outcomes research and

market access in these markets. He is Professor at the Steinbeis University Berlin at the endowed SDK chair for health economics. As a visiting scientist he is responsible for the health system research activities at the Institute for Social Medicine, Epidemiology and Health Economics at the Charité – University Medicine, Berlin. Dr. Brüggenjürgen joined Boston Healthcare following the acquisition of Alpha Care, where he was managing partner, in 2011. Prior to consulting, Bernd worked as head of Health Economics and Disease Management at GlaxoWellcome in Hamburg. For over ten years he has had an active role in the board of the German Association of Health Sciences and Public Health and is now heading the working “economic evaluation” of the German Health Economic Society.

Thomas F. Goss, PharmD, Senior Vice PresidentBoston Healthcare

Dr. Goss has more than 20 years of experience managing and directing health care research, including the impact of public and private payer policy on patient access, health-related quality-of-life, patient preference, patient satisfaction, and health economic evaluations. He also directs disease management program evaluations using patient

outcomes data. He has published extensively in these areas and has more than 40 peer-reviewed publications and over 75 peer-reviewed abstracts and invited publications. Prior to joining Boston Healthcare, Dr. Goss was Vice President and Director of Consulting Services at Covance Market Access Services where he had a 15-year career with increasing levels of responsibility in the areas of client management and executive management. Dr. Goss received a PharmD from the State University of New York at Buffalo, and a BS from the Albany College of Pharmacy. He completed graduate course work in Epidemiology, and a postdoctoral fellowship in Pharmacoepidemiology and Outcomes Research at the State University of New York at Buffalo. Dr. Goss is a member of the American College of Clinical Pharmacy Outcomes and Economics Practice Research Network, and the International Society of Pharmacoeconomics and Outcomes Research.

W. neil Palmer, President & Principal ConsultantPDCI Market access Inc.

Neil Palmer is President and Principal Consultant of PDCI Market Access Inc (PDCI), a pricing and reimbursement consultancy founded in 1996. In addition to PDCI, Neil has worked with RTI Health Solutions, the Patented Medicine Prices Review Board (PMPRB), the Health Division of Statistics Canada and the research group of the

Kellogg Centre for Advanced Studies in Primary Care in Montreal. He has more than 20 years of experience in pharmaceutical pricing and reimbursement and is a frequent speaker at pharmaceutical conferences in North America and Europe. PDCI Market Access (PDCI) is a leading pharmaceutical pricing and reimbursement (P&R) consultancy based in Ottawa and Toronto. Established in 1996, the firm features a senior team of multi-lingual market access professionals with extensive experience assisting clients navigate the complex P&R challenges facing Canadian pharmaceutical manufacturers. PDCI develops successful P&R strategies and prepares comprehensive submissions to CDR, pCODR, INESSS, public & private payers and the PMPRB. The firm’s senior consultants facilitate meetings with HTA and government agencies, payers, negotiate product listing agreements (PLAs) and resolve pricing compliance issues with the PMPRB. PDCI maintains databases of international pharmaceutical prices and provincial drug claims and costs.

antonio Sarria SantameraDirector, Agency for Health Technology AssessmentInstitute of Health Carlos III, Spain

Dr. Antonio Sarria-Santamera, MD PhD has been the Director of AETS, the Spanish Agency for Health Technology Assessment (AETS) at the Institute of Health Carlos III, the National Institute of Public Health Research, since 2006. After completing his medical specialization in La Paz Hospital in Madrid he worked in different capacities in this centre as well as within the Spanish Ministry of Health. He holds a Master in Public Health and a PhD in Health Services Research. Antonio has also been a Post-Doctoral Fellow at the Center for the Evaluative Clinical Sciences at Dartmouth Medical School from 1993 to 1996. During 2004 he was a Visiting Scholar in the Duke Clinical Health Policy Research Centre. His main areas of research are the development of methods to evaluate the effectiveness of health interventions, with a special interest in applying real world evidence and chronic conditions.

Koonal ShahHealth EconomistOffice of Health Economics, UK

Koonal joined the Office of Health Economics in 2007. His current research interests include health state valuation methodology and the use of social value judgements in health care decision making. He has a BA in Economics and Philosophy from the University of Nottingham,

and an MSc (with distinction) in Health Economics from the University of York. Prior to his appointment at Office of Health Economics, Koonal worked as a Business Analyst for Capital One.

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' - 83 Simple Ways to Register for this event!

CALL:+421 232 662 621

Participant registration Options

GrOuP DISCOunTS

NOTE: For group discounts to apply all delegates must register on the same day.

PaymentsPayment is due within 5 days of registering. a receipt will be issued within 5 days of receipt of payment. CancellationIf you have any questions or issues please contact [email protected] must be in writing and must be received by nextlevel in writing more than 10 business days prior to the event. upon receipt of cancellation notice, nextlevel Pharma will issue a delegate credit voucher for the full amount of the payment to be used towards registration fees at any future nextlevel Pharma event held within 18 months from date of issuance (“expiration date”). all credit vouchers expire automatically expire on the Expiration Date and shall thereupon become void. If cancellation is received more than 30 calendar days before the event then the client is entitled to a 50% refund and the balance in the form of a delegate credit voucher. Participants are advised that credits for cancellations not received more than 5 days before the event will not receive credit vouchers, including cancellations due to weather and other causes beyond the registrant’s control. Substitutions are welcome and are free of charge. If for any reason nextlevel Pharma decides to cancel this conference, nextlevel Pharma accepts no responsibility for covering airfare, travel, hotel or other costs incurred by registrants, including delegates sponsors speakers and guests.Special needs: any participants with special dietary requirements or who require access aids should notify nextlevel Pharma more than 2 weeks prior to the event.

Registration includes:

Includes event documentation (Folder + USB flash drive).

Complimentary invite to our very popular networking dinner for all event participants.

Full delegate list with email addresses of all participants.

Event lunches & networking breaks.

A word from the event’s producer: “Thanks very much to the speakers for their commitment to this event and to guiding me with the agenda development. Based on my discussions with the speakers and panelists I’m looking forward to a highly productive event with many strong, implementable take-home messages for our delegates. I look forward to meeting you in Berlin.”

Best regards,David Blum,nextlevel Pharma

VISIT:www.nextlevelpharma.com

Dates & Venue:16th-18th October, 2013 Eurostars Hotel, Berlin, Germany

Hotel Booking Information will be sent to participants upon registration.Get connected immediately

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SEnD SaVE

2 participants 20% each3-4 participants 30% each5 + participants 40% each

*VAT Exemption: All registrations who do not supply a VAT or tax identification number when registering, will be charged 20% VAT on the delegate registration amount as per local tax laws.

Academics & Non-Profits ____________________ € 950*Consultants & Solution Providers (2day/3day) ____ €2190/€2499*

(For clarification please feel free to email [email protected])

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rEGISTraTIOn DETaIlS - HOW TO rEGISTEr:

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PHARMACCESSL E A D E R S F O R U MEurostars Hotel, Berlin, Germany October 16th-18th, 2013

Dear Valued Customer,nextlevel Pharma are experts in providing the ideal platform for your strategic benchmarking and networking opportunities. I am very confident that by attending this meeting, you will improve your understanding of “best practice” and enhance your strategic decision-making in this vital area.luke rogers, CEO, nextlevel Pharma

OPTIOn 1: Please complete this form and fax back to: FaX: +421 233 010 331OPTIOn 2: Scan and email to [email protected] 3: register online at www.nextlevelpharma.com (click here)

Please select your topic-focused stream for Day 3:3rd annual – aMnOG In aCTIOn: EXPErIEnCES WITH THE GErMan PHarMaCEuTICal PrICInG & rEIMBurSEMEnT rEFOrM2nd annual - MarKET aCCESS FOr HIGH ValuE SPECIalTy & BIOlOGIC MEDICInESMarKET aCCESS FOr VaCCInES & InFECTIOuS DISEaSE MEDICaTIOnS

6. Whilst all reasonable care and effort has been made, nextlevel Pharma reserves the right to alter the programme content without notice. If, for any reason nextlevel Pharma decides to cancel, postpone or merge this conference with another confer-ence, nextlevel Pharma is not responsible for covering hotel, airfare, or other expenses incurred by clients. The conference fee can be credited to a future conference.7. Intellectual Property & Copyright. all nextlevel Pharma materials in relation to this event are exclusively reserved and any unauthorised duplication, publication or distribution is strictly prohibited.8. This agreement shall be governed in accordance with the law of the Slovak republic and the parties submit to the exclusive jurisdiction of the Slovak Courts. However only nextlevel Pharma is entitled to waive this right and submit to the jurisdiction of the courts in which the client’s office is located.9. Client information is kept by nextlevel Pharma and used by nextlevel Pharma to keep clients informed of other related nextlevel Pharma products which may be of interest. If the client does not wish to be contacted further, please tick this box ( ).10. nextlevel Pharma is thankful of client feedback at our events. In some situations, quotes & testimonials made by clients, may be used by nextlevel Pharma in future marketing literature. If you do not wish to be quoted, please tick this box ( ).11. *VAT Exemption: All registrations who do not supply a VAT or tax identification number when registering, will be charged 20% VaT on the delegate registration amount as per local tax laws.12. *next level s.r.o. is not responsible for any social or political unrest, war or “acts of god” (i.e. severe weather, natural disasters) which may prevent an event from occurring. In such cases, a letter of credit can be issued to clients, however refunds are not possible.

1. registration fees include programme materials, food and refreshments.2. Once a completed registration form has been received, full payment is required within 5 working days from receipt of invoice. a receipt will be issued following payment.3. The client recognises that nextlevel Pharma organises high quality events, with strictly limited numbers of attendees and incurs expenses as a result. nextlevel Pharma relies on all it’s clients to honour the agreement and make the required payment in order to guarantee the conference’s success.4. Cancellation & Substitutions: upon receipt of payment, substitutions of delegates can be made at any time before the meeting at no further cost. Once a completed registration form has been received any cancellations will result in a 50% cancellation fee. Cancellations received only 1 month before the conference date cannot be refunded whatsoever. In the result of a cancellation, nextlevel Pharma is willing to provide a delegate credit at full value to the client at any time within 7 days of the event taking place, upon receiving full payment and written notice of non-attendance. any cancellations within 7 days of the event, or delegates who do not attend to the event (no-show), will receive a delegate credit for 50% of their registration fee to be used for future nextlevel events. non-attendance or non-payment does not make this contract void. Payment is always required once the registration form has been received. Payment must be received before the start of the event.5. * For group discounts to apply all delegates must register on the same day.

NEXT LEVEL PHARMA Conference Agreement Terms & Conditions of Booking:

DELEGATE PACKAGES: (Please Select your Delegate Package)

Pharma & Biotech Companies

3 Day COnFErEnCE: 2 Day COnFErEnCE: 1 Delegate €2499* Each €2190* Each2 Delegates - 20% DISCOunT €1999* Each €1752* Each3-4 Delegates - 30% DISCOunT €1749* Each €1533* Each5+ Delegates - 40% DISCOunT €1499* Each €1314* Each

Other Organisations 3 Day COnFErEnCE: 2 Day COnFErEnCE: academic rate €950* Each €950* EachPayers & HTa Organisations €499* Each €499* EachConsultants & Solution Providers €2499* Each €2190* Each

Registration includes:Includes event documentation (Folder + USB flash drive).

Complimentary invite to our very popular networking dinner for all event participants.

Full delegate list with email addresses of all participants.

Event lunches & networking breaks.

Can’T aTTEnD?Event video recordings & documentation (only) _____ €799Event documentation (only) __________________ €399

*VAT Exemption: All registrations who do not supply a VAT or tax identification number when registering, will be charged 20% VAT on the delegate registration

amount as per local tax laws.