This document provides information about the 23rd annual Pharmaceutical Pricing and Market Access conference, which will take place on October 11-12, 2017 in London. The conference will feature workshops on drug pricing and the use of real-world evidence in market access on October 10th. Speakers will discuss topics such as collaborating with payers, patient engagement, orphan drugs, biosimilars, international reference pricing, the UK pricing landscape, value-based pricing, integrating real-world data, and reimbursement considerations for cell and gene therapies. Regulatory agencies like the FDA and HTA bodies will also present on developing market access strategies and ensuring the patient perspective.

1. www.pharmaceuticalpricing.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
A: The future of drug pricing
Workshop Leaders:
Ad Rietveld, Director, RJW & partners
John Spoors, Associate Director, RJW & partners
08.30 - 12.30
B: Using Real World Evidence (RWE) to translate expedited regulatory
approval into faster reimbursed patient access
Workshop Leaders:
Janice Haigh, VP Pricing & Market Access, PAREXEL Access Consulting
Oliver Leatham, Vice President, Global Head of Pricing & Market Access, PAREXEL Access Consulting
Richard Macaulay, Principal Consultant, PAREXEL Access Consulting
13.30 - 17.30
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS | TUESDAY 10TH OCTOBER 2017, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
@SMIPHARM
CHAIR FOR 2017:
• Barbara Jaszewski, VP Global Pricing and Market
Access, Lundbeck
FEATURED SPEAKERS:
• Nneka Onwudiwe, PRO/PE Regulatory Review
Officer, FDA
• Patrick Mollon, Director Health-Economics,
Outcomes Research & Epidemiology, Shire
• Fabrizio Zucca, Director Patient Access, Sobi
• Klaas Postema, Sr Director Market Access & Pricing
Generics Europe, Teva
• Mercedes Prior, International Market Access
Director, Grifols
• Anne Marciniak, Senior Director, International
HEOR, Allergan
• Ritva Lehtonen, Market Access & External Affairs
Director, Sanofi
HIGHLIGHTS IN 2017:
• Hear from Swedish Orphan Biovitrum (SOBI)
on how to collaborate with payers to achieve
market access
• Listen to Grifols on whether value based pricing
is affordable
• Learn how HTA and Regulatory Agencies better
meet the needs of patients with Allergan
• Discuss translational market access with
AstraZeneca
• Learn how to integrate real-world data into
pricing with Lundbeck
WORKSHOPS: 10TH
CONFERENCE: 11TH-12TH
OCT
2017HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi Present the 23rd in its series Conference on…
Pharmaceutical Pricing
and Market Access
BOOK BY 31ST MAY AND SAVE £400
BOOK BY 30TH JUNE AND SAVE £200
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First time ever
FDA present
at our annual
Pharmaceutical
Pricing Pricing and
Market Access
conference

2. Pharmaceutical Pricing and Market Access
Day One | Wednesday 11th October 2017 www.pharmaceuticalpricing.co.uk
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Barbara Jaszewski, VP Global Pricing and Market Access,
Lundbeck
REGULATORY UPDATE & MARKET ACCESS STRATEGY
KEYNOTE ADDRESS
9.10 From premarket to postmarket: Developing a strong
market access strategy for medical devices
• Manufacturers should determine the proper
classification of their device early in device
development
• Identify a clinical or economic advantage and
generate the appropriate clinical and health economic
evidence to support a strong value proposition
• Define the target audience(s) within the market access
decision making process. For each target audience,
identify whether they are decision-makers or influencers
Nneka Onwudiwe, PRO/PE Regulatory Review Officer, FDA
9.50 The changing pharma environment
• From disease to patient thinking
• How do we (pharma) keep delivering value to society
• Can you keep measuring value without a holistic view?
Klaas Postema, Sr Director Market Access & Pricing
Generics Europe, Teva
10.30 Morning Coffee
11.00 Collaborating with payers to achieve market access
• Aligning contracting with a value-based healthcare
system
• Implementing real-world data to showcase product
value
• Increase in payer confidence of product efficacy
Fabrizio Zucca, Director Patient Access, Sobi
PATIENT ENGAGEMENT
11.40 What would the optimal process of integrating patient
engagement from development to reimbursement
decisions look like?
• Meaningful patient engagement: what are best
practices and what can be measured?
• What is the patient’s role in informing the decision
process for approval and reimbursement of new
medicines?
• The future of patient engagement: Opportunities and
pitfalls
Finn Ziegler, Director, Global Patient Access, LEO Pharma
12.20 Networking Lunch
13.20 How can HTA and Regulatory Agencies better meet the
needs of patients by ensuring the patient perspective is
held paramount
• Ensuring the patient remains in the best interest of
everybody
• How can HTA and regulatory bodies work together to
achieve this
• HTA benefits to date
Anne Marciniak, Senior Director, International HEOR,
Allergan Ltd
GROWING MARKETS: ORPHAN DRUGS & BIOSIMILARS
14.00 Rare diseases and orphan drugs: A market access
outlook
• A lucrative market but how to gain access?
• Evolving funding environment
• The role of RWE
Patrick Mollon, Director Health-Economics, Outcomes
Research & Epidemiology, Shire
14.40 Afternoon Tea
15.10 HTA landscape: The perspective of a smaller rare disease
company
• Heterogeneous HTA requirements vs. small company
resources
• HTA requirements vs. rare disease reality
• Positive HTA rare disease trends and what a small
company would desire
Fabian Schmidt, Head of Market Access and External
Affairs, Orphan Europe
15.50 How to ensure optimal market access for biosimilars
• The economics of biosimilars
• How should we price biosimilars?
• What can be done by payers to ensure long term
savings?
Anthony Nash, Consultant and Advisor to Pharmaceutical
Industry, Former Head of Global Market Access, Mylan
16.30 Chairman’s Closing Remarks and Close of Day One
Register online at www.pharmaceuticalpricing.co.uk
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3. Pharmaceutical Pricing and Market Access
www.pharmaceuticalpricing.co.uk Day Two | Thursday 12th October 2017
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Barbara Jaszewski, VP Global Pricing and Market Access,
Lundbeck
OPENING ADDRESS
9.10 Translational market access
• Application of market access prism throughout
x-functional development
• Market access input in commercial strategy: can one
live without the other?
• Evidence & confidence: the 21st century biopharma
market access expert hybrid
Susana Murteira, Global Head New Indications,
AstraZeneca
9.50 International Reference Pricing (IRP)
• Country specific reference pricing update – special
review of Southeast Europe
• The deterioration of the value of the local currencies
and the impact of this
• How seriously are we taking this?
Sasa Perovic, Head of Pharmacoeconomics and Pricing
Department, Hemofarm AD
10.30 Morning Coffee
GLOBAL CASE STUDIES
11.00 How to utilise strategic partnerships for market access
purpose in a Finnish setting?
• Challenges in strategic partnerships
• Focus to external and internal elements in Finland
• Creating alliances with data providers and healthcare
stakeholders
• Enhancing strategic capabilities for all partners through
a “win-win” dialogue
Ritva Lehtonen, Market Access & External Affairs Director,
Sanofi
11.40 Italian Drug Agency - AIFA- New algorithm for market
access of innovative drugs
• The main changes: different levels of innovations and
related benefits
• Pros and cons in valuing a new drug
• Accessing the new annual 1bn€ special funds and
direct inclusion in all Regional formularies
• How to manage the new method to gain the best
benefits in P&R processes
Fabrizio Gianfrate, Professor of Health Economics,
University of Ferrara
12.20 Networking Lunch
13.20 The UK pricing and reimbursement landscape
• Accelerated Access Review (AAR) – an update
• Current pricing strategies and market access
arrangements
• The future of UK pricing
John Spoors, Associate Director, RJW & partners
14.00 Value based pricing - is it affordable?
• Cost of the product vs value to the patient
• What effect would value based pricing have on market
access?
• Is there potential for this strategy?
Mercedes Prior, International Market Access, Grifols
14.40 Afternoon Tea
15.10 Biosimilars – will they have a “chilling” effect on drug
prices?
• Prices – will originators stand their ground or give in to
biosimilars?
• Can new drugs in same therapeutic class maintain high
prices in face of lower priced biosimilars?
• From biosimilar approval to biogenerics in practice?
Steinar Madsen, Medical Director, Norwegian Medicines
Agency
BIG DATA & GENE THERAPIES
15.50 Integrating real-world data into pricing
• Partnerships with health economics teams to gather
data
• Comparative analysis of new products against legacy
therapies
• Development of measures to highlight quality of life
• Long-term approaches to positioning real-world data
Barbara Jaszewski, VP Global Pricing and Market Access,
Lundbeck Denmark
16.30 Reimbursement considerations for cell and gene therapies
• Cell and Gene therapies: what is challenging from a
reimbursement perspective
• Lessons learned so far for securing commercial viability
• Dealing with data uncertainty
Panos Kafalas, Head of Health Economics and Market
Access, Cell and Gene Therapy Catapult
17.10 Chairman’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
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4. HALF DAY PRE-CONFERENCE WORKSHOP A
Tuesday 10th October 2017
Holiday Inn Kensington Forum, London, UK
08.30 - 12.30
The future of drug pricing
Workshop Leader:
Ad Rietveld, Director, RJW & partners
John Spoors, Associate Director, RJW & partners
Workshop overview:
Pharmaceutical innovation is forcing payers and companies
to rethink their pricing objectives and methodologies for setting
and deciding on price. More and more ultra-orphan drugs are
entering the market, often at very high price levels creating
difficulties for healthcare systems to cope with the associated
costs of these products. At the same time, personalised
medicine is developing with the first gene therapies having been
introduced or in late stages of clinical development. Companies
are confronted with the issue of how to price these treatments to
recoup their investment costs while payers need to think about
the affordability of these new treatments. A basic rethink of
pricing and funding models is required.
Why should you attend?
To understand the likely future pricing environment for specialty
pharmaceuticals and how to optimally prepare for expected
changes in this environment
Programme
08.30 Registration and Coffee
09.00 The current pharmaceutical pricing landscape
10.00 Product innovation and its impact on traditional
pricing and funding methodologies
10.30 The future pharmaceutical pricing landscape
11.00 Morning Coffee
11.30 Potential future pricing models for high cost
specialty products
12.00 Other product support that is likely to play a role
in future payer decision-making on price and
funding
12.30 Close of Workshop
About the Workshop Leaders:
Ad Rietveld:
Ad has spent most of his professional career in the
pricing and reimbursement of pharmaceuticals
with positions as a government payer, in
consulting and in industry. He is widely seen as one of the
foremost experts working in pricing and reimbursement.
During his years in consultancy at RJW & partners since
2008 and previously at Cambridge Pharma Consultancy
(now part of IMS Health) from 2000. Prior to working in
consultancy, Ad was Deputy Director of Pharmaceutical
Affairs at the Dutch Ministry of Health, responsible for the
development and implementation of pharmaceutical cost
containment policies. Ad has a degree in medicine and an
MBA from the Rotterdam School of Management.
John Spoors:
John joined RJW & partners as a Consultant in
2012 and promoted to Senior Consultant in 2014.
He has 7 years’ experience in the pharmaceutical
sector. He started his career at Merck, Sharp and Dohme,
After 2 years at MSD, John joined Helen Johnson Consulting
Limited, where he worked for 3 years on HTA and policy
projects. At RJW and partners, John provides expertise
on UK HTA and policy issues and received the “Best New
Investigator” award for his podium presentation on UK
Patient Access Schemes at ISPOR in Berlin in 2012. John
has a BA in politics and economics from the University of
Manchester and is currently studying for a BSc in natural
sciences at the Open University.
About the Organisation:
RJW & partners Ltd is a consulting
company that specialises in
providing pricing and market
access advice to pharmaceutical
companies. RJW & partners Ltd operates on a global scale
with projects in US, Europe, Asia-Pacific region and Latin
America. Projects can include pricing and landscape
analysis, development of core value dossiers, advisory
board facilitation and affiliate payer negotiation training.

5. HALF DAY PRE-CONFERENCE WORKSHOP B
Tuesday 10th October 2017
Holiday Inn Kensington Forum, London, UK
13.30 - 17.30
Using Real World Evidence (RWE) to translate
expedited regulatory approval into faster
reimbursed patient access
Workshop Leaders:
Janice Haigh, VP Pricing & Market Access,
PAREXEL Access Consulting
Oliver Leatham, Vice President, Global Head of Pricing &
Market Access, PAREXEL Access Consulting
Richard Macaulay, Principal Consultant,
PAREXEL Access Consulting
Workshop overview:
This workshop would include an overview of the current
situation by PAREXEL followed by presentations from
representatives of two HTA payer bodies e.g. NICE and
IQWiG/G-BA to provide their perspectives on how RWE
can be best utilized to meet this emerging market access
challenge.
Programme
13.30 Registration & Coffee
14.00 Regulators are reducing evidentiary demands for
marketing authorization through a range of new
expedited approval pathways
14.45 There are a range of innovative therapies coming
to market that will likely be approved through
such pathways (CAR-T cell therapies, immuno-
oncology agents, and gene therapies) based
on very early clinical data packages, with the
potential for transformational patient benefits but
where substantial uncertainty remains
15.30 Afternoon Tea
16.00 Payers, whom are increasingly demanding more
robust evidence to justify price premiums, will find
it very challenging to appropriately price and
reimburse such therapies
16.30 How companies navigate this emerging
evidentiary gap between regulators and payers
to obtain faster reimbursement will be increasingly
key to ensuring market success
17.00 RWE offers an opportunity to fill these evidentiary
gaps by examining how these medicines are used
and perform in the real world. However, there have
been challenges in how such data is collected,
analyzed and utilized in payer decision-making.
17.30 Close of workshop
About the Workshop Leaders:
Janice joined PAREXEL Access Consulting in
2017 as VP Pricing & Market Access. From 2012
to 2016 she was Practice Leader for Market
Access in Europe at Quintiles Consulting. From
2006 to 2011, Janice was Senior Director Pricing
and Market Access for Astellas Pharma Europe and was
responsible for development and implementation of pricing
andmarketaccessstrategyfornewandin-marketproducts.
Richard is Principal Consultant with over five years’
experience at PAREXEL with expertise in a range of pricing
andmarketaccessstrategy.Richardisarecognizedthought
leader with a particular interest in how oncology drugs can
receive regulatory approval and payer reimbursement in
Europe and the US based on clinical trial packages lacking
phase III data. Richard has completed a PhD from University
College London in how CTLA-4 and PD-1 mediate age-
related immune declines, and is a graduate of Cambridge
University where he received a BA (Hons) in Medicine.
Oliver is an experienced international market
access consultant, as well as a former head of
market access for Astellas UK and previously
director of Clark Medical Market Research..
AcrossEurope,Oliverspecialisesinmarketaccess
strategy and understands what is needed to effectively
implement national policy and strategy at regional and
local levels. Oliver has built ABN (Advanced Budgetary
Notification)deliveryteams,aswellasfullyintegratedmarket
access departments: incorporating HEOR, government
affairs and in-field market access managers.
About the Organisation:
Headquartered near Boston,
Massachusetts, PAREXEL operates
in 85 locations in 51 countries
around the world. We provide
the most comprehensive drug development capabilities
of any CRO worldwide. Our global regulatory expertise,
Phase I-IV clinical research services, integrated eClinical
technologies, and advanced commercialization services
all work together to move you through the development
journey more smoothly and cost-effectively from beginning
to end.

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PHARMACEUTICAL PRICING AND MARKET ACCESS
Conference: 11th -12th October 2017, Holiday Inn Kensington Forum, London, UK Workshops: 10th October 2017, London
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