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Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
SPONSORS AND EXHIBITORS
• Rupert Gale, Respiratory Global Market Access Head, GSK
• Dr. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen
• Sascha Glanemann, Head of Market Access, Teva
• Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon
• Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene
• Ritva Lehtonen, Market Access & External Affairs Director, Hospital Tenders, Sanofi
• Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta
• Toros Sahin, Head of Market Access and Health Economics, Sanofi
• Thomas Temme, Head if Market Access & Public Affairs, Shire
• Richard Marsh, Head of Market Access, Allergan
• Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo
• Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Boehringer Ingelheim
• Anne Marciniak, Senior Director, International HEOR, Allergan, UK
• Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd
• Carla Niven, Senior Principal, IMS Health
• Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise Oncology, Merck.*
• Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
• Dr. Steve Bradshaw, Managing Director, Valid Insight
• Oliver Timmis, CEO, AKU Society
FEATURING KEY INDUSTRY EXPERTS
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
Market Access, Pricing and Reimbursement
2016 Europe
9 – 10th june 2016 HILTON Kensington, London UK
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
Market access is a complex and protracted process that
pharmaceutical and biotech companies go through in order to
ensure their products are made available in as many countries
as possible and most importantly that these products are
reimbursed and made available to patients who needs them.
Due to the development of more and more hi-tech drugs coming
to the market,market access has become very important over the
last 5-10 years resulting in increasing pressure on healthcare
systems and/or governments to cut the costs of their drugs bills.
For example, the National Institute of Clinical Excellence (NICE)
plays a key role in the UK market – deciding whether or not
new treatments are cost effective. In order for companies to
have their products reimbursed at the best price possible by the
NHs they must work harder, gather many data around the health
economic impact and cost effectiveness of their products and
present their data to NICE.
Today market access has become far more challenging due to a
number of factors: the increase of competing drugs in the same
therapeutic area, the need to contain rising costs, dependence of
evidence based medicine and health technology assessment to
influence payer decision. In addition, Biosimilar drugs have given
payers more choice in deciding what products they will cover.
It has been said that the emerging markets are a key driver of the
global pharmaceutical industry’s growth and will be for years to
come. IMS Health has predicted that by 2017 they’ll account for
one-third of industry sales and still be growing at double-digit
rates.
The two-day Market Access, Pricing and Reimbursement 2016
Europe will provide a unique platform for the convergence
of stakeholders in the industry to interact, discuss and
network with top tier government, hospitals, pharmaceuticals,
biopharmaceuticals and non-profit organizations as well as
regional and local manufacturers to discuss and share on the
macroeconomic factors, policies, issues and drivers that will
steer pharmaceutical industry.
Gain Latest Insights On
• Market Access strategies: How can we maximize our
strategies?
• Early Market Access of Health Technologies:
The implications.
• Challenges  Opportunities in pharma pricing,
reimbursement and market access: Changing market
trends and influences
• Emerging Markets: What knowledge, strategies and
resources will be needed to maximize pricing and access
and hurdles faced.
• Pricing  Reimbursement: for Orphan Drugs and Biosimilar
• Patient Access: How can this continue to improve?
• Data Collection  Management: Using Real World Evidence
and Patient Reported Outcomes for pricing and access
• International Collaboration: Where do we agree and differ?
• Looking to the Future: What lies ahead?
Who Will You Meet
Presidents, Heads/Chiefs, Directors, VPs and Man-
agers of:
• Market Access
• Pricing and Reimbursement
• Patient Outcomes
• Health Economics and Outcomes Research
• Payer Relations/ Evidence
• Data Management/ Analysis
• Regulatory Affairs
• Public/ Government Affairs
• Payers, HTA Officials and Physicians
MEDIA PARTNERS
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
KEY INDUSTRY EXPERTS
Rupert Gale, Respiratory Global Market Access Head, GSK
Rupert Gale is currently the Global Head of Market Access and Pricing for the Respiratory Franchise at GSK. He has
over 18 years experience in the pharmaceutical industry, the majority of which has been in the payer field. During
this time Rupert has also worked for Novartis, Bayer, and in consulting. His leadership spans the global, regional
and local levels and has worked on projects from early development, through multiple HTA submissions in support
of reimbursement, to post launch pricing optimisation. His primary interest is the development and implementation of
payer customer centric solutions that make a difference to patients by supporting the uptake of effective medicines.
Prior to joining the pharma industry Rupert worked in business-to-business marketing where he specialised in
strategic customer alliances.
Dr. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen
Mr. Sascha Glanemann, Head of Market Access, Teva
Sascha Glanemann, MSc., MBA, Head of Primary Care and Market Access of the company Teva GmbH since March
2014. Before this he held different leading positions in the pharmaceutical industry (InterMune Deutschland GmbH,
Actelion Pharmaceuticals Deutschland GmbH). Study of Health Economics and several years’ experience preceded.
Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon
Head HEOR, Governmental and Public Affairs, at Alcon, Germany since 2012
Medical Doctor, trained in Psychiatry and Neurology, PhD in Neuropathology, since 1999 different leading positions
in Pharmaceutical Industry, from 2006 to 2011 Head Clinical Research and Pharmacovigilance at BPI, German
PharmaceuticalIndustryAssociation.ExpertinOutcomesResearch,HealthCareResearch,HTAandPharmacoeconomy,
long experience in Public and Governmental Affairs. Since joining Alcon responsibility for pharmaceuticals and
devices, involved in German AMNOG procedures and new regulatory framework for devices. Member in various
scientific associations like dggoe, DNebM,
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
KEY INDUSTRY EXPERTS
Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene
Frank is Global Head, Pricing and Market Access of Immunology  Inflammation, Celgene. Prior to joining Celgene
in 2010, Frank held leading global Pricing and Market Access positions at JJ and Wyeth. Frank specializes in
strategically creating and enhancing value, demonstrating value proposition, and maximizing pricing and market
access potentials of pharmaceutical products and portfolios. Frank has a track record of Building franchise PMA
teams from ground up; Driving corporate executive PMA decisions; Optimizing PMA potentials through innovative
HEOR strategies; and Building creative, effective and comprehensive PR toolkit with successful launches.
Ritva Lehtonen, Market Access  External Affairs Director, Hospital Tenders, Sanofi
Ritva is currently leading the access and pricing team in Finland for Sanofi group that is responsible for market
access strategy and implementation including health economic, pricing and reimbursement as well as hospital tender
strategy and implementation. External affairs and stakeholder management is essential part of the access activity.
She has more than 20-year experience in the pharma industry for several functions including business as a business
unit director, medical as medical director and regulatory as a regulatory manager. She is also working closely with
other European countries especially with Nordic and Baltic countries. She is master in pharmacy by training from
Helsinki University and eMBA from Helsinki University of Technology, Business Economics. She had taken several
continuing education courses in relation to professional tasks like health economic and pricing.
Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta
Toros Sahin, Head of Market Access and Health Economics, Sanofi
TorosahinisMarketAccessHealthEconomicsDirectoratSanofiGroupTurkey,responsibleforpricing,reimbursement
and health economics activities under the umbrella of Sanofi Group (Sanofi, Zentiva, Genzyme). He has received his
undergraduate and graduate (M.sc.) degrees from Boaziçi University, on Molecular Biology  Genetics. He has also
completed a postgraduate program in Health Economics for Healthcare Professionals at the University of York, UK. He
previously worked for Sandoz in business development and pricing  reimbursement fields and is working for Sanofi
since 2008. He is married with one daughter, fluent in English and beginner in German and Japanese.
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
KEY INDUSTRY EXPERTS
Thomas Temme, Head if Market Access  Public Affairs, Shire
Thomas started his career as a business development manager at a biopharmaceutical startup company, working
on 8-digit in- and out-licensing and MA projects as well as the company’s IPO. In his role as project manager in
a strategy consulting firm, he consulted various large German health insurances and medical technology companies
and worked on AMNOG processes with a large number of pharmaceutical companies. In 2014, Thomas joined Shire
to head the market access and public affairs work in Germany, Austria and Switzerland. He holds a master’s degree
in sociology and an MBA.
Richard Marsh, Head of Market Access, Allergan
Richard Marsh is Head of Market Access for the UK and Ireland for Allergan, a position he has held since 2013. Prior to
that he has worked in market access and government affairs roles for two other major pharmaceutical companies as
well as in consultancy. Richard has over 20 years of experience of working with the NHS and in health policy, having
also been for five years the special adviser to the Secretary of State for Health.
Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo
Dr. Pearl Gumbs acquired her MSc in Health Economics and Policy Administration from Maastricht University and MSc
in Health Services Research from Erasmus University, Rotterdam. She later obtained her PhD degree in Pharmaco-
Economics and Pharmaco-Epidemiology from the Utrecht University. Pearl has over 13 years of experience in both
Academia setting and the pharmaceutical industry. She has had the opportunity to lecture and train students on
various Market Access and HEOR disciplines across various European Universities. Her pharmaceutical industry
experience encompasses over 8 years focusing on Health Economic topics which has led her to fulfil various roles at
a Local, Regional and Global setting. Pear is currently working at Daiichi-Sankyo Europe where she is the Regional
Sr Manager, Health Economics and Outcomes Research (HEOR) within the Market Access Department. Pearl Gumbs
is currently living in Munich, Germany and enjoys various outdoor activities.
Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Boehringer Ingelheim
Adam is a Senior Global Payer Strategy Manager working in oncology pipeline at Boehringer Ingelheim. He is
managing global pricing and market access strategies for the oncology portfolio and driving the development
of innovative market access approaches and payment schemes. Since September 2015 he is also heading the
Boehringer Ingelheim Pricing Team working across the whole Boehringer Ingelheim prescription medicines portfolio.
Prior to joining Boehringer Ingelheim Adam worked as a life sciences strategy consultant for IMS Consulting, Truven
Analytics and Simon-Kucher  Partners in Belgium, France, Germany, Poland, Romania and The United States. He
also worked as a research assistant at Jules Gonin Eye Hospital in Lausanne, Switzerland and as a Junior Project
Leader at AnalyCen in Poland and Sweden.
Adam holds a M.Sc. in Molecular Biology and Biotechnology from University of Warsaw, Poland, and a Ph.D. in
Neurosciences from University of Geneva, University of Lausanne and EPFL, Switzerland. He has published several
articles in international peer reviewed journals, and lectured at international conferences on developmental
neuroscience and retinal degeneration.
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
KEY INDUSTRY EXPERTS
Anne Marciniak, Senior Director, International HEOR, Allergan, UK
Anne is currently Senior Director, European HEOR with Allergan. She has 20-year experience in Market Access
and Health Economics in the pharmaceutical industry, including Pfizer, Amgen and recently Daiichi-Sankyo. With
her teams, she lead the Market Access strategy of multiple compounds in the European environment focussing on
meeting the needs of payers at national, regional and local levels. She has hands-on experience in establishing
strategies and leading their cross-functional execution, integrating all elements of product value in particular clinical
and safety profile, health economics and price. She believe that through engagement of all partners involved in the
delivery of health care including payers the best value will be achieved for patients and citizens
ultimately financing care. She is a physician by training with qualification in Health Economics and Epidemiology.
Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise
Oncology, Merck.*
Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd
Dutch nationality. Board Director of PPi Healthcare Consulting Ltd. Degrees in health economics (Universities of
Groningen and Utrecht) and public health (Harvard, USA). PhD in pharmaceutical economics. More than 25 years
of experience in market access issues involving pharmaceuticals and medical devices with work experience in the
pharmaceutical industry, CRO’s and WHO. In addition, investment and healthcare restructuring projects (especially
rehabilitation facilities for handicapped persons) for the public and private sector in Central and Eastern Europe,
Africa, Middle East and Asia. Assignments from the health insurance sector, medical technology and pharmaceutical
industries as well as institutional agencies such as the European Union, the World Bank and the Netherlands’
Government. Expert in market access issues involving pharmaceuticals and medical devices, project development
sourcing, health financing and insurance and public/private mix. Fluent in Dutch, English, German. Conversant in
French and Russian.
Carla Niven, Senior Principal, IMS Health
Current responsibility
• Lead for EU PMA Centre of Excellence
• Member of the IMSCG Oncology thought leadership team
Profile overview
Carla has +15 years of experience in PMA. Her therapeutic areas of expertise include Oncology, Diabetes, Pain
and Cardiovascular. She was Head of Market Access, Pricing and Reimbursement at Takeda Pharma Europe. Prior
to joining Cambridge Pharma Consultancy in 2000, Carla was a Medical Representative for Merck Sharp and Dohme
in the UK.
Education
B.Sc Hons in Biological Sciences with Anatomy Honors from the University of Edinburgh
Diploma in Marketing from the Chartered Institute of Marketing
Areas of expertise
Global Pricing and Market Access strategy development for pre and post launch brands
Expertise in Oncology, Orphan diseases, MS, Pain, Diabetes, CV and Gout
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
KEY INDUSTRY EXPERTS
Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Since 2009, Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs
(www.eucope.org) in Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From
2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI).
Before, he has been a lawyer with Sträter Law Firm in Germany with a special focus on discount agreements
and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition law with the European
Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with
international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice,
Prof. Dr. Dr. Ulrich Everling.
Dr. Steve Bradshaw, Managing Director, Valid Insight
Steve Bradshaw has had over 16 years in healthcare both as a clinician and as an expert advisor to the pharma industry.
His expertise is in developing value-based market access strategies and solutions, including the implementation
and use of real-world studies. In the rare and orphan disease space he has experience with multiple products and
conditions ranging from Fabry disease through to retinitis pigmentosa.
Dr Bradshaw writes and speaks regularly on the challenges facing the global healthcare environment; he has
presented widely and has over 30 publications. His career features being Editor at Nature Clinical Reviews, an
ophthalmic surgeon in the NHS, and various positions to senior executive level in market access and HEOR consulting
firms. He is a peer reviewer for several industry and medical journals and currently holds a position on the Pharma
IQ Advisory Board.
Oliver Timmis, CEO, AKU Society
Oliver Timmis is the Head of Projects for the AKU Society, an entrepreneurial patient organisation supporting those
diagnosed with a rare disease, alkaptonuria (AKU). Oliver leads on funding applications for new projects, allowing for
the creation of a National AKU Centre for UK patients, and international phase III clinical trials called DevelopAKUre.
He graduated with a BA(hons) in Natural Science (Physiology, Development and Neuroscience) from Cambridge
University. Oliver volunteers at Eurordis (Rare Diseases Europe) on their DITA (Drug Information, Transparency and
Access) taskforce, sits on the Patient Advisory Council at the RD Connect registries project, and is a member of
the Patient-centered Special Interest Group at ISPOR. He also volunteers for Findacure, the Fundamental Diseases
Partnership.
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
DAY 1 | 9th June 2016 | LONDON
08.00 Registration
09.00 Chairperson’s Opening Remarks
MARKET ACCESS  STRATEGIES
09.10 Early parallel scientific advice EMA/HTAs for successful market access in Europe.
Presentation
• The process
• Experience and key learnings
• Impact on clinical development process
• Impact on national HTA
Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon.
09.50 Holistic Value Creation and Pricing  Market Access Strategy
Presentation
• Market access strategy vs. regulatory strategy
• Value creation process in LCM
• Collaboration with HEOR
Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene.
10.30 Morning Break  Networking
11.10 The HTA arms race
Presentation
• Are evidence requirements becoming wider or deeper?
• Value vs. uncertainty
• How does this align with real world data gathering and early access?
Dr. Gwilym Thompson, Health Economics Lead, Janssen Pharmaceuticals.
11.50 Outcomes of the first 5 years of AMNOG and its international implications
Presentation
• Orphan Drugs under AMNOG
• International Reference Pricing
• Price Transparency
Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).
12.30 Presentation Spotlight Presentation
13.10 Networking Lunch
CHALLENGES  OPPORTUNITIES
14.10 Challenges in pharma pricing and market access’
Presentation
• Challenges in access environment including equitable access
• What are the needs of our stakeholders, budget holders and influencers?
• Challenges to a long term sight for access strategy
• What are the issues in localization of the value stories?
• Finland have suffered economic regression for some years and we are facing several cost containment challenges and saving
plans by the government that is very similar to other European countries and the presentation will reflect this.
Ritva Lehtonen, Market Access  External Affairs Director, Hospital Tenders, Sanofi.
MARKET ACCESS  STRATEGIES
CHALLENGES  OPPORTUNITIES
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
14.50 How to overcome the challenges?
Presentation
• Ways in which market access can be made successful
• Local and global knowledge – Keeping up to date on pricing and market access.
• Understanding the local payer and decision-maker needs as these relate to pricing, reimbursement and market access.
• Identify and remove all barriers to prescribing, ensuring a rapid uptake of a new product at an optimum price.
Dr. Steve Bradshaw, Managing Director, Valid Insight.
15.30 The effect of global trends on payer decision-making and market access
Panel Discussion
• Current market trends and influences.
• The impact of market changes on drug development and marketing needs.
• What is the current and future market value?
• What is the pricing and reimbursement structure for orphan drugs in US and Europe?
Panelist:
Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise Oncology, Merck Group.
16.10 Tea Break  Networking
MARKET ACCESS EXCELLENCE FOR EMERGING MARKETS
16.50 What knowledge, strategies and resources will be required in order to maximize your company’s pricing and access in
the emerging markets?
Presentation
• Understanding which types of markets offer the greatest potential returns and what those markets want from you.
• Gain insight on the ever-shifting payer landscape and be better prepared to innovate in market access.
• Hurdles faced in Emerging markets.
• Which emerging markets are considered as most relevant today and in the future?
• Resources needed to maximize pricing and access in the emerging markets.
17.30 Market Access in Turkey: Risks and opportunities in the post Healthcare Transformation Era
Presentation
• Overview of Turkish Market Access  Healthcare Environment
• Basics of the Turkish Pricing  Reimbursement System
• Changing dynamics of the reimbursement system: Alternative models
• Government’s mid-long term vision on pharmaceutical industry
Toros Sahin, Head of Market Access and Health Economics, Sanofi.
18.10 Chairperson’s Closing Remark  End of Day 1
MARKET ACCESS EXCELLENCE FOR EMERGING MARKETS
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
DAY 2 | 10th June 2016 | LONDON
08.00 Registration
09.00 Chairperson’s Opening Remarks
PRICING, REIMBURSEMENT  PATIENT ACCESS
09.10 The evolving Oncology PMA landscape
Presentation
• Pricing and market access trends for novel oncology products
• Evolving payer evidence requirements (including impact of Immuno-oncologics)
• Implications for novel oncology products
Carla Niven, Senior Principal, IMS Health.
09.50 Very Early Market Access of Health Technologies: What Are the Implications?
Presentation
• Concept of “early market access of health technologies”
• Significance of “early market access” versus “market access”
• Methods of “early market access”
• Case studies
• Approach of PPi Healthcare Consulting Ltd
Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd.
10.30 Market access and pricing for Biosimilars
Presentation
• Factors affecting market access of Biosimilars – Registration, similarity, comparability studies, substitution, pricing
and reimbursement.
• Developing a consistent payer and pricing strategy.
• What impact will Biosimilars have on healthcare costs?
11.10 Morning Break  Networking
11.50 Three German dossiers: European Orphan Drug access diversity in the DACH nutshell
Presentation
• The effects of European rare diseases policy in the last 15 years
• Similarities and dissimilarities of today’s access procedures for Orphans
• Some success factors for orphan drug manufacturers accessing diverse European market
• Country specific and joint themes and outlooks in Orphan drug politics  regulation
Thomas Temme, Head if Market Access  Public Affairs, Shire.
12.30 Presentation Spotlight Presentation
13.10 Networking Lunch
DATA COLLECTION  MANAGEMENT
14.10 Observational Data (OD) for Market Access purposes: Mind the Gap
Presentation
• The gap between research and market access
• How to craft your data collection strategy?
• How to disseminate the OD internally and externally?
• How to close the gap between research and market access?
Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo
PRICING, REIMBURSEMENT  PATIENT ACCESS
DATA COLLECTION  MANAGEMENT
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
14.50 Accelerated Access: Delusion or Deliverable?
Presentation
• Market access in the UK depends on the actions and decisions of hundreds of different payer organisations and influencers as
much as on the decisions of bodies such as NICE or the SMC
• Now is a particularly challenging time for these bodies as they face mounting demands and budgets that are held back by
the straitjacket of austerity
• Despite initiatives such as the UK Government’s Accelerated Access Review, this environment is becoming more rather than less
demanding – how should pharma respond?
Richard Marsh, Head of Market Access, Allergan.
15:30 DevelopAKUre: Case study of a patient-centric clinical trial
• DevelopAKUre, clinical trials for the rare disease, alkaptonuria
• The role of the patient group in clinical trials
• How to maximise patient input into the planning and design of clinical trials
• How to maximise patient retention and patient recruitment during clinical trials
• Ensure good dissemination of results to patients
Oliver Timmis, CEO, AKU Society.
16:10 Tea Break  Networking
COLLABORATIONS  LOOKING TO THE FUTURE
16.50 Future of pharma pricing, reimbursement and market access: What lies ahead?
Panel Discussion
• Is the industry ready and equipped to meet the challenges presented?
• How can the industry respond positively to rising concerns around cost, clinical data and involvement in the research process?
• How can stakeholders collaborate in order to progress whilst continuing to provide safe and efficacy products?
Panelist:
Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Borhringer Ingelheim.
Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta.
17.30 Are we ready for the Healthcare Future?
Presentation
• Connected Health is reality, Big data is already there, 3D Printing happen
• Genomics is getting faster. Healthcare is getting customized, getting individualized.
• Are our standardized HTA, pricing  reimbursement instruments prepared for this challenges.
Sascha Glanemann, Head of Market Access, Teva.
18.10 Developments in pricing and reimbursement in leading pharma markets
Presentation
• Overall analysis of pricing and reimbursement in leading pharmaceutical markets.
• How will the pricing and reimbursement landscape change from now to 2025?
• Implications of pharma pricing and reimbursement legislation and related developments in the principal European
pharm market.
• Current  Future trends in the pricing and reimbursement sector.
18.40 Chairperson’s Closing Remark  End of Conference
COLLABORATIONS  LOOKING TO THE FUTURE
Market Access, Pricing and Reimbursement 2016 Europe
• 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK •
• Telephone: +44 (0) 207 193 3485 • Email: info@paradigmglobalevents.com • Website: www.paradigmglobalevents.com •
11
Biosimilars Global Congress 2014 Europe
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17th
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September 2014 | London, UK
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booking via credit card. We reserve the right to decline any booking for the event. If payment
is not made at the time of the booking an event, then an invoice will be issued and must be
paid in full within 14 days from the date of the booking stated on the invoice and immediately
prior to the event. A credit card guarantee may be requested if the full payment has not been
received in full before the event and payment will be taken before entry to the event. We are
unable to allow a delegate to attend an event or have access to the Document Portal unless
payment has been received in full by us prior to commencement of the event. Paradigm
Global Events reserves the right to charge interest on unpaid invoices.
Cancellation
The event organized by Paradigm Global Events Ltd, a limited liability company formed under
English company law and registered in the UK. Cancellations received in writing more than 45
days before the conference date, will be eligible for 50% of the due less a £75 administration
fee. If you are unable to send substitution then Cancellations must be made in writing.
Cancellations made less than 45 days before the event date will not be entitled to a refund.
Substitutions / Name Changes
If you are unable to attend you may nominate, in writing, another delegate to take your place
any time prior to the start of the events. Two or more delegates may not share a place at an
event. Please make separate bookings for each delegate.
Alterations
Paradigm Global Events Ltd reserves the right to make alterations to the event / executive
briefing content, timing, speakers or program and venues beyond our control. The event may
be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global
Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a
result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any
transport disruption or individual transport delays and in such circumstances the normal
cancellation restrictions apply.
Data Protection
The information that we collect and store relating to you is primarily used to enable us to
provide our services to you, to respond to your inquiries about our offerings, and to offer you
other products, programs or services that we believe may be of interest to you. We
sometimes use such information to communicate with you. If you choose to submit content for
event publication or event program, we may publish your name and other information you
have provided to us. If you are a previous or existing customer, we may contact you with
information about products and services similar to those, which were the subject of a previous
sale to you. Furthermore, we may use your data, or permit selected third parties to use your
data, so that you can be provided with information about unrelated products and services
which we consider may be of interest to you. We or they may contact you about these
products and services by any methods that you consented at the time your information was
collected. As set out above, we are committed to safeguarding your personal information.
Whenever you provide such information, we are legally obliged to use your information in line
with all laws concerning the protection of personal information, including the Data Protection
Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection
laws”
Fee:
The event fee includes lunch, refreshments and conference documents provided on the day.
This fee does not include travel, hotel accommodation, transfers or insurance.
Payment of Invoice
Our aim is to establish and maintain a long-term business relationship with all our clients and
customers, however failure to pay in accordance with clause causes us significant problems
and expense in chasing late payers. For late payers we will take action to enforce full
payment of the invoice, and without prejudice any other rights, to terminate the contract with
you in respect of any future supplies and to compensation for debt recovery cost under “The
Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by
“The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may
not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees
(minimum £40) will be payable to offset our costs in this matter. We may set and vary credit
limits from time to time and may not accept any further orders if such credit limits are
exceeded. If you have a problem with any product or service please contact us immediately
and we will try and resolve the issue. You should however pay the invoice in full by the due
date to prevent further action!
Delegate Details
Terms and Conditions of Booking
Formation and Incorporation:
There is a 50% liability on all bookings once made, whether by fax, email or by post. Receipt
of this booking form, inclusive or exclusive of payment constitutes formal agreement to attend
and acceptance of the terms and conditions stated and are sold on a firm sales basis.
Payment Terms
Paradigm Global Events Ltd requires full payment of the amount to be made at the time of
booking via credit card. We reserve the right to decline any booking for the event. If payment
is not made at the time of the booking an event, then an invoice will be issued and must be
paid in full within 14 days from the date of the booking stated on the invoice and immediately
prior to the event. A credit card guarantee may be requested if the full payment has not been
received in full before the event and payment will be taken before entry to the event. We are
unable to allow a delegate to attend an event or have access to the Document Portal unless
payment has been received in full by us prior to commencement of the event. Paradigm
Global Events reserves the right to charge interest on unpaid invoices.
Cancellation
The event organized by Paradigm Global Events Ltd, a limited liability company formed under
English company law and registered in the UK. Cancellations received in writing more than 45
days before the conference date, will be eligible for 50% of the due less a £75 administration
fee. If you are unable to send substitution then Cancellations must be made in writing.
Cancellations made less than 45 days before the event date will not be entitled to a refund.
Substitutions / Name Changes
If you are unable to attend you may nominate, in writing, another delegate to take your place
any time prior to the start of the events. Two or more delegates may not share a place at an
event. Please make separate bookings for each delegate.
Alterations
Paradigm Global Events Ltd reserves the right to make alterations to the event / executive
briefing content, timing, speakers or program and venues beyond our control. The event may
be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global
Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a
result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any
transport disruption or individual transport delays and in such circumstances the normal
cancellation restrictions apply.
Data Protection
The information that we collect and store relating to you is primarily used to enable us to
provide our services to you, to respond to your inquiries about our offerings, and to offer you
other products, programs or services that we believe may be of interest to you. We
sometimes use such information to communicate with you. If you choose to submit content for
event publication or event program, we may publish your name and other information you
have provided to us. If you are a previous or existing customer, we may contact you with
information about products and services similar to those, which were the subject of a previous
sale to you. Furthermore, we may use your data, or permit selected third parties to use your
data, so that you can be provided with information about unrelated products and services
which we consider may be of interest to you. We or they may contact you about these
products and services by any methods that you consented at the time your information was
collected. As set out above, we are committed to safeguarding your personal information.
Whenever you provide such information, we are legally obliged to use your information in line
with all laws concerning the protection of personal information, including the Data Protection
Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection
laws”
Fee:
The event fee includes lunch, refreshments and conference documents provided on the day.
This fee does not include travel, hotel accommodation, transfers or insurance.
Payment of Invoice
Our aim is to establish and maintain a long-term business relationship with all our clients and
customers, however failure to pay in accordance with clause causes us significant problems
and expense in chasing late payers. For late payers we will take action to enforce full
payment of the invoice, and without prejudice any other rights, to terminate the contract with
you in respect of any future supplies and to compensation for debt recovery cost under “The
Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by
“The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may
not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees
(minimum £40) will be payable to offset our costs in this matter. We may set and vary credit
limits from time to time and may not accept any further orders if such credit limits are
exceeded. If you have a problem with any product or service please contact us immediately
and we will try and resolve the issue. You should however pay the invoice in full by the due
date to prevent further action!
Delegate Details
Card Billing Address:
Direct Tel: Direct Mobile:
Email address:
Card Holder’s Signature:
By Electronic Bank Transfer: Please transfer the full funds to Paradigm Global
Events Ltd bank account.
Methods of Payment: All payment must be made in Sterling.

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Market Access

  • 1. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • SPONSORS AND EXHIBITORS • Rupert Gale, Respiratory Global Market Access Head, GSK • Dr. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen • Sascha Glanemann, Head of Market Access, Teva • Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon • Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene • Ritva Lehtonen, Market Access & External Affairs Director, Hospital Tenders, Sanofi • Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta • Toros Sahin, Head of Market Access and Health Economics, Sanofi • Thomas Temme, Head if Market Access & Public Affairs, Shire • Richard Marsh, Head of Market Access, Allergan • Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo • Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Boehringer Ingelheim • Anne Marciniak, Senior Director, International HEOR, Allergan, UK • Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd • Carla Niven, Senior Principal, IMS Health • Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise Oncology, Merck.* • Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) • Dr. Steve Bradshaw, Managing Director, Valid Insight • Oliver Timmis, CEO, AKU Society FEATURING KEY INDUSTRY EXPERTS Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • Market Access, Pricing and Reimbursement 2016 Europe 9 – 10th june 2016 HILTON Kensington, London UK
  • 2. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • Market access is a complex and protracted process that pharmaceutical and biotech companies go through in order to ensure their products are made available in as many countries as possible and most importantly that these products are reimbursed and made available to patients who needs them. Due to the development of more and more hi-tech drugs coming to the market,market access has become very important over the last 5-10 years resulting in increasing pressure on healthcare systems and/or governments to cut the costs of their drugs bills. For example, the National Institute of Clinical Excellence (NICE) plays a key role in the UK market – deciding whether or not new treatments are cost effective. In order for companies to have their products reimbursed at the best price possible by the NHs they must work harder, gather many data around the health economic impact and cost effectiveness of their products and present their data to NICE. Today market access has become far more challenging due to a number of factors: the increase of competing drugs in the same therapeutic area, the need to contain rising costs, dependence of evidence based medicine and health technology assessment to influence payer decision. In addition, Biosimilar drugs have given payers more choice in deciding what products they will cover. It has been said that the emerging markets are a key driver of the global pharmaceutical industry’s growth and will be for years to come. IMS Health has predicted that by 2017 they’ll account for one-third of industry sales and still be growing at double-digit rates. The two-day Market Access, Pricing and Reimbursement 2016 Europe will provide a unique platform for the convergence of stakeholders in the industry to interact, discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals and non-profit organizations as well as regional and local manufacturers to discuss and share on the macroeconomic factors, policies, issues and drivers that will steer pharmaceutical industry. Gain Latest Insights On • Market Access strategies: How can we maximize our strategies? • Early Market Access of Health Technologies: The implications. • Challenges Opportunities in pharma pricing, reimbursement and market access: Changing market trends and influences • Emerging Markets: What knowledge, strategies and resources will be needed to maximize pricing and access and hurdles faced. • Pricing Reimbursement: for Orphan Drugs and Biosimilar • Patient Access: How can this continue to improve? • Data Collection Management: Using Real World Evidence and Patient Reported Outcomes for pricing and access • International Collaboration: Where do we agree and differ? • Looking to the Future: What lies ahead? Who Will You Meet Presidents, Heads/Chiefs, Directors, VPs and Man- agers of: • Market Access • Pricing and Reimbursement • Patient Outcomes • Health Economics and Outcomes Research • Payer Relations/ Evidence • Data Management/ Analysis • Regulatory Affairs • Public/ Government Affairs • Payers, HTA Officials and Physicians MEDIA PARTNERS
  • 3. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • KEY INDUSTRY EXPERTS Rupert Gale, Respiratory Global Market Access Head, GSK Rupert Gale is currently the Global Head of Market Access and Pricing for the Respiratory Franchise at GSK. He has over 18 years experience in the pharmaceutical industry, the majority of which has been in the payer field. During this time Rupert has also worked for Novartis, Bayer, and in consulting. His leadership spans the global, regional and local levels and has worked on projects from early development, through multiple HTA submissions in support of reimbursement, to post launch pricing optimisation. His primary interest is the development and implementation of payer customer centric solutions that make a difference to patients by supporting the uptake of effective medicines. Prior to joining the pharma industry Rupert worked in business-to-business marketing where he specialised in strategic customer alliances. Dr. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen Mr. Sascha Glanemann, Head of Market Access, Teva Sascha Glanemann, MSc., MBA, Head of Primary Care and Market Access of the company Teva GmbH since March 2014. Before this he held different leading positions in the pharmaceutical industry (InterMune Deutschland GmbH, Actelion Pharmaceuticals Deutschland GmbH). Study of Health Economics and several years’ experience preceded. Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon Head HEOR, Governmental and Public Affairs, at Alcon, Germany since 2012 Medical Doctor, trained in Psychiatry and Neurology, PhD in Neuropathology, since 1999 different leading positions in Pharmaceutical Industry, from 2006 to 2011 Head Clinical Research and Pharmacovigilance at BPI, German PharmaceuticalIndustryAssociation.ExpertinOutcomesResearch,HealthCareResearch,HTAandPharmacoeconomy, long experience in Public and Governmental Affairs. Since joining Alcon responsibility for pharmaceuticals and devices, involved in German AMNOG procedures and new regulatory framework for devices. Member in various scientific associations like dggoe, DNebM,
  • 4. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • KEY INDUSTRY EXPERTS Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene Frank is Global Head, Pricing and Market Access of Immunology Inflammation, Celgene. Prior to joining Celgene in 2010, Frank held leading global Pricing and Market Access positions at JJ and Wyeth. Frank specializes in strategically creating and enhancing value, demonstrating value proposition, and maximizing pricing and market access potentials of pharmaceutical products and portfolios. Frank has a track record of Building franchise PMA teams from ground up; Driving corporate executive PMA decisions; Optimizing PMA potentials through innovative HEOR strategies; and Building creative, effective and comprehensive PR toolkit with successful launches. Ritva Lehtonen, Market Access External Affairs Director, Hospital Tenders, Sanofi Ritva is currently leading the access and pricing team in Finland for Sanofi group that is responsible for market access strategy and implementation including health economic, pricing and reimbursement as well as hospital tender strategy and implementation. External affairs and stakeholder management is essential part of the access activity. She has more than 20-year experience in the pharma industry for several functions including business as a business unit director, medical as medical director and regulatory as a regulatory manager. She is also working closely with other European countries especially with Nordic and Baltic countries. She is master in pharmacy by training from Helsinki University and eMBA from Helsinki University of Technology, Business Economics. She had taken several continuing education courses in relation to professional tasks like health economic and pricing. Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta Toros Sahin, Head of Market Access and Health Economics, Sanofi TorosahinisMarketAccessHealthEconomicsDirectoratSanofiGroupTurkey,responsibleforpricing,reimbursement and health economics activities under the umbrella of Sanofi Group (Sanofi, Zentiva, Genzyme). He has received his undergraduate and graduate (M.sc.) degrees from Boaziçi University, on Molecular Biology Genetics. He has also completed a postgraduate program in Health Economics for Healthcare Professionals at the University of York, UK. He previously worked for Sandoz in business development and pricing reimbursement fields and is working for Sanofi since 2008. He is married with one daughter, fluent in English and beginner in German and Japanese.
  • 5. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • KEY INDUSTRY EXPERTS Thomas Temme, Head if Market Access Public Affairs, Shire Thomas started his career as a business development manager at a biopharmaceutical startup company, working on 8-digit in- and out-licensing and MA projects as well as the company’s IPO. In his role as project manager in a strategy consulting firm, he consulted various large German health insurances and medical technology companies and worked on AMNOG processes with a large number of pharmaceutical companies. In 2014, Thomas joined Shire to head the market access and public affairs work in Germany, Austria and Switzerland. He holds a master’s degree in sociology and an MBA. Richard Marsh, Head of Market Access, Allergan Richard Marsh is Head of Market Access for the UK and Ireland for Allergan, a position he has held since 2013. Prior to that he has worked in market access and government affairs roles for two other major pharmaceutical companies as well as in consultancy. Richard has over 20 years of experience of working with the NHS and in health policy, having also been for five years the special adviser to the Secretary of State for Health. Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo Dr. Pearl Gumbs acquired her MSc in Health Economics and Policy Administration from Maastricht University and MSc in Health Services Research from Erasmus University, Rotterdam. She later obtained her PhD degree in Pharmaco- Economics and Pharmaco-Epidemiology from the Utrecht University. Pearl has over 13 years of experience in both Academia setting and the pharmaceutical industry. She has had the opportunity to lecture and train students on various Market Access and HEOR disciplines across various European Universities. Her pharmaceutical industry experience encompasses over 8 years focusing on Health Economic topics which has led her to fulfil various roles at a Local, Regional and Global setting. Pear is currently working at Daiichi-Sankyo Europe where she is the Regional Sr Manager, Health Economics and Outcomes Research (HEOR) within the Market Access Department. Pearl Gumbs is currently living in Munich, Germany and enjoys various outdoor activities. Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Boehringer Ingelheim Adam is a Senior Global Payer Strategy Manager working in oncology pipeline at Boehringer Ingelheim. He is managing global pricing and market access strategies for the oncology portfolio and driving the development of innovative market access approaches and payment schemes. Since September 2015 he is also heading the Boehringer Ingelheim Pricing Team working across the whole Boehringer Ingelheim prescription medicines portfolio. Prior to joining Boehringer Ingelheim Adam worked as a life sciences strategy consultant for IMS Consulting, Truven Analytics and Simon-Kucher Partners in Belgium, France, Germany, Poland, Romania and The United States. He also worked as a research assistant at Jules Gonin Eye Hospital in Lausanne, Switzerland and as a Junior Project Leader at AnalyCen in Poland and Sweden. Adam holds a M.Sc. in Molecular Biology and Biotechnology from University of Warsaw, Poland, and a Ph.D. in Neurosciences from University of Geneva, University of Lausanne and EPFL, Switzerland. He has published several articles in international peer reviewed journals, and lectured at international conferences on developmental neuroscience and retinal degeneration.
  • 6. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • KEY INDUSTRY EXPERTS Anne Marciniak, Senior Director, International HEOR, Allergan, UK Anne is currently Senior Director, European HEOR with Allergan. She has 20-year experience in Market Access and Health Economics in the pharmaceutical industry, including Pfizer, Amgen and recently Daiichi-Sankyo. With her teams, she lead the Market Access strategy of multiple compounds in the European environment focussing on meeting the needs of payers at national, regional and local levels. She has hands-on experience in establishing strategies and leading their cross-functional execution, integrating all elements of product value in particular clinical and safety profile, health economics and price. She believe that through engagement of all partners involved in the delivery of health care including payers the best value will be achieved for patients and citizens ultimately financing care. She is a physician by training with qualification in Health Economics and Epidemiology. Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise Oncology, Merck.* Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd Dutch nationality. Board Director of PPi Healthcare Consulting Ltd. Degrees in health economics (Universities of Groningen and Utrecht) and public health (Harvard, USA). PhD in pharmaceutical economics. More than 25 years of experience in market access issues involving pharmaceuticals and medical devices with work experience in the pharmaceutical industry, CRO’s and WHO. In addition, investment and healthcare restructuring projects (especially rehabilitation facilities for handicapped persons) for the public and private sector in Central and Eastern Europe, Africa, Middle East and Asia. Assignments from the health insurance sector, medical technology and pharmaceutical industries as well as institutional agencies such as the European Union, the World Bank and the Netherlands’ Government. Expert in market access issues involving pharmaceuticals and medical devices, project development sourcing, health financing and insurance and public/private mix. Fluent in Dutch, English, German. Conversant in French and Russian. Carla Niven, Senior Principal, IMS Health Current responsibility • Lead for EU PMA Centre of Excellence • Member of the IMSCG Oncology thought leadership team Profile overview Carla has +15 years of experience in PMA. Her therapeutic areas of expertise include Oncology, Diabetes, Pain and Cardiovascular. She was Head of Market Access, Pricing and Reimbursement at Takeda Pharma Europe. Prior to joining Cambridge Pharma Consultancy in 2000, Carla was a Medical Representative for Merck Sharp and Dohme in the UK. Education B.Sc Hons in Biological Sciences with Anatomy Honors from the University of Edinburgh Diploma in Marketing from the Chartered Institute of Marketing Areas of expertise Global Pricing and Market Access strategy development for pre and post launch brands Expertise in Oncology, Orphan diseases, MS, Pain, Diabetes, CV and Gout
  • 7. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • KEY INDUSTRY EXPERTS Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) Since 2009, Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling. Dr. Steve Bradshaw, Managing Director, Valid Insight Steve Bradshaw has had over 16 years in healthcare both as a clinician and as an expert advisor to the pharma industry. His expertise is in developing value-based market access strategies and solutions, including the implementation and use of real-world studies. In the rare and orphan disease space he has experience with multiple products and conditions ranging from Fabry disease through to retinitis pigmentosa. Dr Bradshaw writes and speaks regularly on the challenges facing the global healthcare environment; he has presented widely and has over 30 publications. His career features being Editor at Nature Clinical Reviews, an ophthalmic surgeon in the NHS, and various positions to senior executive level in market access and HEOR consulting firms. He is a peer reviewer for several industry and medical journals and currently holds a position on the Pharma IQ Advisory Board. Oliver Timmis, CEO, AKU Society Oliver Timmis is the Head of Projects for the AKU Society, an entrepreneurial patient organisation supporting those diagnosed with a rare disease, alkaptonuria (AKU). Oliver leads on funding applications for new projects, allowing for the creation of a National AKU Centre for UK patients, and international phase III clinical trials called DevelopAKUre. He graduated with a BA(hons) in Natural Science (Physiology, Development and Neuroscience) from Cambridge University. Oliver volunteers at Eurordis (Rare Diseases Europe) on their DITA (Drug Information, Transparency and Access) taskforce, sits on the Patient Advisory Council at the RD Connect registries project, and is a member of the Patient-centered Special Interest Group at ISPOR. He also volunteers for Findacure, the Fundamental Diseases Partnership.
  • 8. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • DAY 1 | 9th June 2016 | LONDON 08.00 Registration 09.00 Chairperson’s Opening Remarks MARKET ACCESS STRATEGIES 09.10 Early parallel scientific advice EMA/HTAs for successful market access in Europe. Presentation • The process • Experience and key learnings • Impact on clinical development process • Impact on national HTA Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon. 09.50 Holistic Value Creation and Pricing Market Access Strategy Presentation • Market access strategy vs. regulatory strategy • Value creation process in LCM • Collaboration with HEOR Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene. 10.30 Morning Break Networking 11.10 The HTA arms race Presentation • Are evidence requirements becoming wider or deeper? • Value vs. uncertainty • How does this align with real world data gathering and early access? Dr. Gwilym Thompson, Health Economics Lead, Janssen Pharmaceuticals. 11.50 Outcomes of the first 5 years of AMNOG and its international implications Presentation • Orphan Drugs under AMNOG • International Reference Pricing • Price Transparency Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). 12.30 Presentation Spotlight Presentation 13.10 Networking Lunch CHALLENGES OPPORTUNITIES 14.10 Challenges in pharma pricing and market access’ Presentation • Challenges in access environment including equitable access • What are the needs of our stakeholders, budget holders and influencers? • Challenges to a long term sight for access strategy • What are the issues in localization of the value stories? • Finland have suffered economic regression for some years and we are facing several cost containment challenges and saving plans by the government that is very similar to other European countries and the presentation will reflect this. Ritva Lehtonen, Market Access External Affairs Director, Hospital Tenders, Sanofi. MARKET ACCESS STRATEGIES CHALLENGES OPPORTUNITIES
  • 9. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • 14.50 How to overcome the challenges? Presentation • Ways in which market access can be made successful • Local and global knowledge – Keeping up to date on pricing and market access. • Understanding the local payer and decision-maker needs as these relate to pricing, reimbursement and market access. • Identify and remove all barriers to prescribing, ensuring a rapid uptake of a new product at an optimum price. Dr. Steve Bradshaw, Managing Director, Valid Insight. 15.30 The effect of global trends on payer decision-making and market access Panel Discussion • Current market trends and influences. • The impact of market changes on drug development and marketing needs. • What is the current and future market value? • What is the pricing and reimbursement structure for orphan drugs in US and Europe? Panelist: Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma, Global Business Franchise Oncology, Merck Group. 16.10 Tea Break Networking MARKET ACCESS EXCELLENCE FOR EMERGING MARKETS 16.50 What knowledge, strategies and resources will be required in order to maximize your company’s pricing and access in the emerging markets? Presentation • Understanding which types of markets offer the greatest potential returns and what those markets want from you. • Gain insight on the ever-shifting payer landscape and be better prepared to innovate in market access. • Hurdles faced in Emerging markets. • Which emerging markets are considered as most relevant today and in the future? • Resources needed to maximize pricing and access in the emerging markets. 17.30 Market Access in Turkey: Risks and opportunities in the post Healthcare Transformation Era Presentation • Overview of Turkish Market Access Healthcare Environment • Basics of the Turkish Pricing Reimbursement System • Changing dynamics of the reimbursement system: Alternative models • Government’s mid-long term vision on pharmaceutical industry Toros Sahin, Head of Market Access and Health Economics, Sanofi. 18.10 Chairperson’s Closing Remark End of Day 1 MARKET ACCESS EXCELLENCE FOR EMERGING MARKETS
  • 10. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • DAY 2 | 10th June 2016 | LONDON 08.00 Registration 09.00 Chairperson’s Opening Remarks PRICING, REIMBURSEMENT PATIENT ACCESS 09.10 The evolving Oncology PMA landscape Presentation • Pricing and market access trends for novel oncology products • Evolving payer evidence requirements (including impact of Immuno-oncologics) • Implications for novel oncology products Carla Niven, Senior Principal, IMS Health. 09.50 Very Early Market Access of Health Technologies: What Are the Implications? Presentation • Concept of “early market access of health technologies” • Significance of “early market access” versus “market access” • Methods of “early market access” • Case studies • Approach of PPi Healthcare Consulting Ltd Dr. Frans van Andel, Board Director, PPi Healthcare Consulting Ltd. 10.30 Market access and pricing for Biosimilars Presentation • Factors affecting market access of Biosimilars – Registration, similarity, comparability studies, substitution, pricing and reimbursement. • Developing a consistent payer and pricing strategy. • What impact will Biosimilars have on healthcare costs? 11.10 Morning Break Networking 11.50 Three German dossiers: European Orphan Drug access diversity in the DACH nutshell Presentation • The effects of European rare diseases policy in the last 15 years • Similarities and dissimilarities of today’s access procedures for Orphans • Some success factors for orphan drug manufacturers accessing diverse European market • Country specific and joint themes and outlooks in Orphan drug politics regulation Thomas Temme, Head if Market Access Public Affairs, Shire. 12.30 Presentation Spotlight Presentation 13.10 Networking Lunch DATA COLLECTION MANAGEMENT 14.10 Observational Data (OD) for Market Access purposes: Mind the Gap Presentation • The gap between research and market access • How to craft your data collection strategy? • How to disseminate the OD internally and externally? • How to close the gap between research and market access? Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo PRICING, REIMBURSEMENT PATIENT ACCESS DATA COLLECTION MANAGEMENT
  • 11. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • 14.50 Accelerated Access: Delusion or Deliverable? Presentation • Market access in the UK depends on the actions and decisions of hundreds of different payer organisations and influencers as much as on the decisions of bodies such as NICE or the SMC • Now is a particularly challenging time for these bodies as they face mounting demands and budgets that are held back by the straitjacket of austerity • Despite initiatives such as the UK Government’s Accelerated Access Review, this environment is becoming more rather than less demanding – how should pharma respond? Richard Marsh, Head of Market Access, Allergan. 15:30 DevelopAKUre: Case study of a patient-centric clinical trial • DevelopAKUre, clinical trials for the rare disease, alkaptonuria • The role of the patient group in clinical trials • How to maximise patient input into the planning and design of clinical trials • How to maximise patient retention and patient recruitment during clinical trials • Ensure good dissemination of results to patients Oliver Timmis, CEO, AKU Society. 16:10 Tea Break Networking COLLABORATIONS LOOKING TO THE FUTURE 16.50 Future of pharma pricing, reimbursement and market access: What lies ahead? Panel Discussion • Is the industry ready and equipped to meet the challenges presented? • How can the industry respond positively to rising concerns around cost, clinical data and involvement in the research process? • How can stakeholders collaborate in order to progress whilst continuing to provide safe and efficacy products? Panelist: Dr. Adam Kundzewicz, Senior Global Payer Strategy Manager, Head of Pricing UK, Borhringer Ingelheim. Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta. 17.30 Are we ready for the Healthcare Future? Presentation • Connected Health is reality, Big data is already there, 3D Printing happen • Genomics is getting faster. Healthcare is getting customized, getting individualized. • Are our standardized HTA, pricing reimbursement instruments prepared for this challenges. Sascha Glanemann, Head of Market Access, Teva. 18.10 Developments in pricing and reimbursement in leading pharma markets Presentation • Overall analysis of pricing and reimbursement in leading pharmaceutical markets. • How will the pricing and reimbursement landscape change from now to 2025? • Implications of pharma pricing and reimbursement legislation and related developments in the principal European pharm market. • Current Future trends in the pricing and reimbursement sector. 18.40 Chairperson’s Closing Remark End of Conference COLLABORATIONS LOOKING TO THE FUTURE
  • 12. Market Access, Pricing and Reimbursement 2016 Europe • 9 – 10th JUNE 2016 • Hilton Kensington Hotel, London UK • • Telephone: +44 (0) 207 193 3485 • Email: [email protected] • Website: www.paradigmglobalevents.com • 11 Biosimilars Global Congress 2014 Europe Registration form 17th - 19th September 2014 | London, UK Discount Code: _______________ Standard Price Per Delegate: Conference: £1299 + Vat Conference Workshop: £1599 + Vat Distribution of promotional literature : £700 +Vat Distribution of your company’s promotional literature to all the attendees Date of Booking: Title: Forename: Surname: Company: Job Title: Department / Division: Main Switchboard Number: Address: Post /Zip Code: Direct Line: Direct Fax: Mobile: Direct Email Address: Signature: I confirm that I have read and agree to the terms and conditions of the booking. 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If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information was collected. As set out above, we are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws” Fee: The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance. Payment of Invoice Our aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce full payment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees (minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the due date to prevent further action! 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We are unable to allow a delegate to attend an event or have access to the Document Portal unless payment has been received in full by us prior to commencement of the event. Paradigm Global Events reserves the right to charge interest on unpaid invoices. Cancellation The event organized by Paradigm Global Events Ltd, a limited liability company formed under English company law and registered in the UK. Cancellations received in writing more than 45 days before the conference date, will be eligible for 50% of the due less a £75 administration fee. If you are unable to send substitution then Cancellations must be made in writing. Cancellations made less than 45 days before the event date will not be entitled to a refund. Substitutions / Name Changes If you are unable to attend you may nominate, in writing, another delegate to take your place any time prior to the start of the events. Two or more delegates may not share a place at an event. Please make separate bookings for each delegate. Alterations Paradigm Global Events Ltd reserves the right to make alterations to the event / executive briefing content, timing, speakers or program and venues beyond our control. The event may be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any transport disruption or individual transport delays and in such circumstances the normal cancellation restrictions apply. Data Protection The information that we collect and store relating to you is primarily used to enable us to provide our services to you, to respond to your inquiries about our offerings, and to offer you other products, programs or services that we believe may be of interest to you. We sometimes use such information to communicate with you. If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information was collected. As set out above, we are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws” Fee: The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance. Payment of Invoice Our aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce full payment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees (minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the due date to prevent further action! 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