Dear 9 Big Pharma

speakers reveal
their strategies
9 Big Pharma
speakers reveal
their strategies

Colleague...
Researched & Organized by eyeforpharma Researched & Organized by eyeforpharma

and top tips and top tips

World Class Speakers Pharma Pharma

After many months speaking to senior-level
pharma industry executives in Canada, the biggest
challenge we’re facing right now is how to bring
at a Glance Market Access Two Day Conference
November 10–11, 2009 Market Access Two Day Conference
November 10–11, 2009
a drug to market effectively and efficiently in this
challenging environment.
Brian O’Rourke
Vice President, CDR
Canada Radisson Admiral,
Toronto, Ontario Canada Radisson Admiral,
Toronto, Ontario
This is your invitation to attend an innovative summit Normand Laberge
that will address the most pressing issues unique Vice President, Rx&D
Add Value for Stakeholders to SPEAKER FACULTY:
to the Canadian pharma industry.

This meeting will address the key challenges you

Barbara Ouellet
Executive Director, PMPRB Achieve Effective Drug Approval Who Should Attend?
Daaron Dohler Brian O’Rourke
face including payor, patient and KOL engagement, President & General Manager,
relationship building, pricing & reimbursement Takeda Canada, Inc
The event will attract VPs, heads, Vice President
CDR
strategy, CDR plans, pricing & drug safety and
Doug Grant directors and managers of:
internal access management. Barbara Ouellet
Vice President, Bayer Executive Director
// Market Access PMPRB
Hear from experts on the changing governmental Anna Braeken
and provincial landscape and learn how to get the Head General Medicine, Bayer // Pricing & Reimbursement Daaron Dohler
most out of your relationship on a federal level. Lesia Babiak // Health Economics
SAVE Add Value for President and General Manager

We will bring together pharma industry thought-

Director Federal Affairs & Health Policy, CDN $300 Stakeholders to Takeda Canada, Inc
Johnson & Johnson // Federal Policy book before 18th
Achieve Effective Doug Grant
leaders from Bayer, Abbott, BMS, Takeda, J&J September
Krista Scaldwell // CDR Policy
and teamed them up with CDR, PMPRB and
Vice President, BMS Drug Approval Vice President Corporate Affairs
Bayer
Cancer Care Ontario as well as many other key // Provincial Policy
stakeholders to provide you with a platform for Martin Mason Krista Scaldwell
Partner, Gowlings Legal Experts Will Discuss: // Better CDR Engagement
learning, debate and networking. // Regulatory Affairs Vice President Market Access
David Shum // The Impact Of PMPRB // Best Practice Pricing & BMS
You will leave the summit with a case-study driven Director Reimbursement & Health Economics, // Commercial Management On Pharma In 2010 Reimbursement Case Studies
Lesia Babiak
road map for success in Canadian market Roche // Effective Internal Market // Federal & Provincial Director, Federal Policy
access landscape – guaranteed. Scott Gavura Access Management Government Communication Janssen-Ortho
Director Provincial Drug Reimbursement
I look forward to meeting you and your

4 EASY WAYS TO REGISTER

Programs, Cancer Care Ontario
colleagues in Toronto.
Claudia Neuber eyeforpharma always deliver cutting-edge,
Best regards, Senior Pricing Manager, AstraZeneca eyeforpharma events Real Case concise conferences on a global scale, I am proud to
Studies from
Gerogre Wyatt CALL +1 866 996 1235
Managing Director, Wyatt Health
never fail to deliver. FAX +1 800 814 3460 be associated with them and see them as a key player
Jon Gwillim
Ed Schoonveld
Principal, Market Access & Pricing Practice Lead, Ian Talmage, VP Global Marketing, Bayer Healthcare
EMAIL register@eyeforpharma.com
ONLINE www.eyeforpharma.com/MACanada
6 VPs in delivering up-to-date intelligence to the industry.
VP North America ZS Associates Len Starnes, Head Of Digital Marketing & Sales, Bayer Schering
eyeforpharma Neelima Firth
Director, The Aequitas Group
PS. Sign up early and save CDN $300!
Visit www.eyeforpharma.com/MACanada For the latest information visit www.eyeforpharma.com/MACanada
Follow me on LinkedIn Supported by
PM 36O Global Sponsor Gold Sponsor Supporting Sponsor
www.linkedin.com/in/JonathanGwillim
THE FULL SPECTRUM OF PRODUCT MANAGEMENT
// 8 Presentations From VPs
Group Search: Reasons // 18 Senior Level Speakers Join eyefoprharma’s Market Access Canada
// 12+ Hours Worth of Networking LinkedIn group to be kept updated and to open
Market Access for Canadian Pharma
to Attend // The Premier Meeting Place for up your network to the key players in the space.
Search for ‘Market Access Canada’
Pharma & Regulators in Canada in the Group directory.
Dear 9 Big Pharma
speakers reveal
their strategies
9 Big Pharma
speakers reveal
their strategies

Colleague...
Researched & Organized by eyeforpharma Researched & Organized by eyeforpharma

and top tips and top tips

World Class Speakers Pharma Pharma

After many months speaking to senior-level
pharma industry executives in Canada, the biggest
challenge we’re facing right now is how to bring
at a Glance Market Access Two Day Conference
November 10–11, 2009 Market Access Two Day Conference
November 10–11, 2009
a drug to market effectively and efficiently in this
challenging environment.
Brian O’Rourke
Vice President, CDR
Canada Radisson Admiral,
Toronto, Ontario Canada Radisson Admiral,
Toronto, Ontario
This is your invitation to attend an innovative summit Normand Laberge
that will address the most pressing issues unique Vice President, Rx&D
Add Value for Stakeholders to SPEAKER FACULTY:
to the Canadian pharma industry.

This meeting will address the key challenges you

Barbara Ouellet
Executive Director, PMPRB Achieve Effective Drug Approval Who Should Attend?
Daaron Dohler Brian O’Rourke
face including payor, patient and KOL engagement, President & General Manager,
relationship building, pricing & reimbursement Takeda Canada, Inc
The event will attract VPs, heads, Vice President
CDR
strategy, CDR plans, pricing & drug safety and
Doug Grant directors and managers of:
internal access management. Barbara Ouellet
Vice President, Bayer Executive Director
// Market Access PMPRB
Hear from experts on the changing governmental Anna Braeken
and provincial landscape and learn how to get the Head General Medicine, Bayer // Pricing & Reimbursement Daaron Dohler
most out of your relationship on a federal level. Lesia Babiak // Health Economics
SAVE Add Value for President and General Manager

We will bring together pharma industry thought-

Director Federal Affairs & Health Policy, CDN $300 Stakeholders to Takeda Canada, Inc
Johnson & Johnson // Federal Policy book before 18th
Achieve Effective Doug Grant
leaders from Bayer, Abbott, BMS, Takeda, J&J September
Krista Scaldwell // CDR Policy
and teamed them up with CDR, PMPRB and
Vice President, BMS Drug Approval Vice President Corporate Affairs
Bayer
Cancer Care Ontario as well as many other key // Provincial Policy
stakeholders to provide you with a platform for Martin Mason Krista Scaldwell
Partner, Gowlings Legal Experts Will Discuss: // Better CDR Engagement
learning, debate and networking. // Regulatory Affairs Vice President Market Access
David Shum // The Impact Of PMPRB // Best Practice Pricing & BMS
You will leave the summit with a case-study driven Director Reimbursement & Health Economics, // Commercial Management On Pharma In 2010 Reimbursement Case Studies
Lesia Babiak
road map for success in Canadian market Roche // Effective Internal Market // Federal & Provincial Director, Federal Policy
access landscape – guaranteed. Scott Gavura Access Management Government Communication Janssen-Ortho
Director Provincial Drug Reimbursement
I look forward to meeting you and your

4 EASY WAYS TO REGISTER

Programs, Cancer Care Ontario
colleagues in Toronto.
Claudia Neuber eyeforpharma always deliver cutting-edge,
Best regards, Senior Pricing Manager, AstraZeneca eyeforpharma events Real Case concise conferences on a global scale, I am proud to
Studies from
Gerogre Wyatt CALL +1 866 996 1235
Managing Director, Wyatt Health
never fail to deliver. FAX +1 800 814 3460 be associated with them and see them as a key player
Jon Gwillim
Ed Schoonveld
Principal, Market Access & Pricing Practice Lead, Ian Talmage, VP Global Marketing, Bayer Healthcare
EMAIL register@eyeforpharma.com
ONLINE www.eyeforpharma.com/MACanada
6 VPs in delivering up-to-date intelligence to the industry.
VP North America ZS Associates Len Starnes, Head Of Digital Marketing & Sales, Bayer Schering
eyeforpharma Neelima Firth
Director, The Aequitas Group
PS. Sign up early and save CDN $300!
Visit www.eyeforpharma.com/MACanada For the latest information visit www.eyeforpharma.com/MACanada
Follow me on LinkedIn Supported by
PM 36O Global Sponsor Gold Sponsor Supporting Sponsor
www.linkedin.com/in/JonathanGwillim
THE FULL SPECTRUM OF PRODUCT MANAGEMENT
// 8 Presentations From VPs
Group Search: Reasons // 18 Senior Level Speakers Join eyefoprharma’s Market Access Canada
// 12+ Hours Worth of Networking LinkedIn group to be kept updated and to open
Market Access for Canadian Pharma
to Attend // The Premier Meeting Place for up your network to the key players in the space.
Search for ‘Market Access Canada’
Pharma & Regulators in Canada in the Group directory.
Day 1 / Conference Agenda
November 10, 2009
 ession A: Federal
S  ession C: Public Drug
Government Access
Dynamics
Where do we stand?
The Canadian Healthcare
market in a global context
// H ear a descriptive and comparative
analysis of the Canadian market from
an IP, Pricing and reimbursement
aspect and how this impacts on your
geographic strategy.
// Establish where the future funding
and control lies, with the PMPRB
or Provincial authorities?
// Develop best-practice in listing
negotiations and understand how
transparency and value can lead
to greater success in pricing.
Normand Laberge Vice-President,
Rx&D
Explore novel approaches
in a new marketplace
// Learn how a flexible global culture
can be applied and implemented
for local success.
// Hear an expert view of how a new start
up in Canada can maximize success
in a rapidly changing environment.
// Best practice examples of how
to adapt in today’s marketplace.
Daaron Dohler President, Takeda Inc
Government Relations Strategies:
critical success factors for resolving
regulatory, reimbursement and
health policy challenges
// H ow to work effectively with your
biggest customers: governments.
// Stakeholder and government
advocacy to support your regulatory,
reimbursement and policy objectives.
// Examples of how to implement an
effective product life-cycle strategy in
the evolving regulatory environment.
Bill Dempster Director,
Health & Pharma, Global Public Affairs
WORKSHOP Lesia Babiak Vice-Chair, Federal Policy,
 reparing for a negotiated
P Johnson & Johnson
agreement: ensuring
a profitable outcome
Adam Siskind
Associate Principal. ZS Associates
CALL +1 866 996 1235
4 EASY WAYS FAX +1 800 814 3460
EMAIL register@eyeforpharma.com
TO REGISTER ONLINE www.eyeforpharma.com/MACanada
 ession B: Provincial
S Strategies you need to implement
Government Approval
& Relationships
A Policy Update from the Common
Drug Review (CDR)
// A n update on the CDR process,
timelines and activity you need to
know for effective drug approval.
// New initiatives introduced by the CDR.
// Understand how you can solidify your
submission to the CDR.
// Future trends in the reimbursement
environment you need to be aware of.
Brian O’Rourke Vice President, Common
Drug Review (CDR)
CDR: What you need to know to
succeed in the Canadian Healthcare
Technology environment.
// S ubmissions to the CDR: What they
need to see to give you the ‘Yes’.
// How you can effectively manage
your mainstream and biologics
submissions to develop a consistent
and credible plan which will enhance
long-term relationships with the CDR.
// How you can overcome the challenges
and meet the gold standard.
to get the best probability of national
coverage for your drug
// E stablish where the future funding
and control will lie: PMPRB or
Provincial authority and what this will
mean for the price of your drug.
// Discover strategies which dictate the
provincial thinking when discussing
your reimbursement.
// Develop best-practice methods in listing
negotiations and how value can lead
to success in pricing.
Doug Grant, Vice President,
Corporate Affairs, Bayer
New ways in creating value through
the measurement of real world
drug safety and effectiveness
(RWDSE)
// P ayers have always said that they
will pay for drugs that are effective
in the real world, but how do you prove
effectiveness in the real world?
// What perspectives and elements
do you need to consider when
measuring real world drug safety
and effectiveness?
// Learn a practical approach to
measuring effectiveness that will
validate desired outcomes and give
payers the confidence they need
to reimburse your drug.
George Wyatt Managing Director,
Wyatt Health.
PA N E L D I S C U SS I O N
Strategies to succeed
in a competitive market for
public reimbursement
Day 2 / Conference Agenda
November 11, 2009
S  ession D: Market Access
Plan Approval &
Government Relationships
Use systemic treatment data
to improve outcomes for patients
// A n update on the New Drug Funding
Program, with highlights of treatment
patterns and program forecasts.
// A description of CCO’s data analysis
and reporting framework for systemic
treatment data.
// Why you should incorporate this
framework to help you align best
practice with public reimbursement.
Scott Gavura Director, Provincial Drug
Reimbursement Programs
The Provincial Challenge: Examine
real challenges and opportunities
when getting your drug approved in
the provinces and learn the crucial
do’s and don’ts when in negotiations
// T he methods you need to know
when presenting drug safety, cost-
effectiveness and pricing agreements
between each province and what the
major barriers are that you will face.
// Discover what priority the provinces
give for approval and what added value
you need to show to win them over.
// Establish a clear plan that ensures
you continue to improve on dialogue
and relationships to develop a win-win
situation in the provinces.
Krista Scaldwell VP Market Access,
Bristol Myers Squibb
How you should plan and
implement negotiated agreements
for drugs in today’s market
// A nalyze the current negotiated
agreement environment and
impacts on stakeholders.
// Are negotiated agreements
a fad or trend?
// Looking forward: is the future for
negotiated agreements sustainable?
David Shum Director Reimbursement,
Health Economics Roche
PA N E L D I S C U SS I O N Please charge my credit card:
Private payers in the Canadian
Market. What are the future
challenges and opportunities.
Visit www.eyeforpharma.com/macanada for more information
S  ession E: Pricing
with Commercial Divisions
Strategies you need to know
in the product launch phase
// W hen should you start and who
should you speak to? How to ensure
your marketing is aligning the
messages agreed upon in Market
Access negotiations.
// One goal - one strategy - one message:
Best practice in setting up your launch
team to effectively optimize market
access knowledge.
// Learn the importance of how feedback
from the field force can produce an
effective internal cycle of information
to further improve approval processes.
Anna Braeken Head of General
Medicine, Bayer
What should marketers know
about payers, market access
and risk sharing?
// O verview of global payer environment
and latest trends.
// How should market access impact
the marketing process and clinical
research?
// How do you craft a value story
that is compelling to payers?
// What exactly is risk sharing and
who is actually sharing?
Ed Schoonveld Principal, Market Access
& Pricing Practice Lead, ZS Associates
Expanded access using Named
Patient Programs: Named Patient
Programs to speed pre-launch
market access
// L
 earn the role of Named Patient
Programs and expanded access
programs, what they are and
why they exist.
// Understand the Special Access
Program of Health Canada from
a pharma perspective including
legal, regulatory and compliance
requirements.
// Review best in class recommendations
and internal resource requirements to
effectively manage and execute named
patient programs.
Neelima Firth Director,
The Aequitas Group
Three Simple Steps to Register Now!
Or visit www.eyeforpharma.com/macanada to register instantly
S
& Reimbursement
- Key Strategies For FOR PHARMA & EARLY BIRD PRICE STANDARD
BIOTECH COMPANIES (Save CDN $300 - Register by September 18th, 2009) PRICE
Effective P&R Negotiations
The Changing PMPRB landscape Gold Pass
and the impact of the new Excessive 2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1699 CDN $1999
Pricing Guidelines
Access to pre-event and post event networking.
// W hat are the main changes to the
PMPRB’s 1994 Excessive Pricing
Guidelines?
Silver Pass
// What are the implications of the
2 Day Conference Pass,
Workshops, Roundtables, Lunch,
CDN $1499 CDN $1799
new Guidelines?
Access to pre-event and post event networking.
// What can be expected in the future
and what measures should be taken.
FOR SOLUTION PROVIDERS EARLY BIRD PRICE STANDARD
Barbara Ouellett Executive Director,
& CONSULTANTS (Save CDN $300 - Register by September 18th, 2009) PRICE
Patented Medicine Prices Review Board
Measuring the long-term impact
Gold Pass
of pricing regulations
2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1799 CDN $2099
// D iscover how to manage PMPRB
Access to pre-event and post event networking.
scrutiny whilst developing competitive
prices in the market. Silver Pass
// Identify what market forces are
2 Day Conference Pass, CDN $1599 CDN $1899
proving major barriers in sustaining Workshops, Roundtables, Lunch,
long-term pricing i.e Generics, Public Access to pre-event and post event networking.
Opinion, how you can manage these
to lower the impact on your drug.
// Understand what the new excessive
NGOs And Regulatory Bodies Pass
price guidelines released this summer 2 Day Conference Pass, Full event recording, CDN $699
will mean for your products. Access to all workshops, Access to all roundtables,
Lunch, Access to pre-event and post event networking.
Martin Mason Partner, Gowlings Legal
Canadian pharmaceutical pricing
– where do we go from here?
Full event recording CDN $400
// N ew PMPRB Guidelines – examine
the day to day impact on Canadian
pricing practice. Mr/Mrs/Ms/Dr: First name: Last name:
// How does Canada fare in the global
Company: Position/Title:
context of competitive pricing?
// Looking ahead – is there a formula Telephone: Fax:
for success?
Email:
Claudia Neuber Senior Pricing Manager,
AstraZeneca Address: Postcode: Country:
PA N E L D I S C U SS I O N I enclose a check/draft for: Credit card number:
Reality in 2010 and beyond (Payable to First Conferences Ltd)
Expiry date: Security number:
// U nderstand the emerging role of the
Please invoice my company:
pharmacists as KOLs in the Market Name on card:
Access environments. Purchase Order Number:
// How can innovatives move away from
‘me-too’ drugs to show incremental
value from the current formulary drug. Amex Visa Mastercard Signature:
// Establish new ways in creating clear
and transparent safety of your drug.
FAX THIS FORM BACK TO +1 800 814 3460
Senior Level Pharma Speakers TBC
TERMS & CONDITIONS Places are transferable without any charge. Cancellations before October 9, 2009 incur an administrative charge of 25%. If you cancel your registration
after October 9, 2009 we will be obliged to charge the full fee. Please note – you must notify eyeforpharma in writing of a cancellation, or we will be obliged to charge the full fee.
The organisers reserve the right to make changes to the programme without notice. All prices displayed are exclusive of VAT unless otherwise stated but, VAT will be charged,
where applicable, at the prevailing rate on the invoice date and the relevant details will appear on the invoice. NB: FULL PAYMENT MUST BE RECEIVED BEFORE THE EVENT
Day 1 / Conference Agenda
November 10, 2009
 ession A: Federal
S  ession C: Public Drug
Government Access
Dynamics
Where do we stand?
The Canadian Healthcare
market in a global context
// H ear a descriptive and comparative
analysis of the Canadian market from
an IP, Pricing and reimbursement
aspect and how this impacts on your
geographic strategy.
// Establish where the future funding
and control lies, with the PMPRB
or Provincial authorities?
// Develop best-practice in listing
negotiations and understand how
transparency and value can lead
to greater success in pricing.
Normand Laberge Vice-President,
Rx&D
Explore novel approaches
in a new marketplace
// Learn how a flexible global culture
can be applied and implemented
for local success.
// Hear an expert view of how a new start
up in Canada can maximize success
in a rapidly changing environment.
// Best practice examples of how
to adapt in today’s marketplace.
Daaron Dohler President, Takeda Inc
Government Relations Strategies:
critical success factors for resolving
regulatory, reimbursement and
health policy challenges
// H ow to work effectively with your
biggest customers: governments.
// Stakeholder and government
advocacy to support your regulatory,
reimbursement and policy objectives.
// Examples of how to implement an
effective product life-cycle strategy in
the evolving regulatory environment.
Bill Dempster Director,
Health & Pharma, Global Public Affairs
WORKSHOP Lesia Babiak Vice-Chair, Federal Policy,
 reparing for a negotiated
P Johnson & Johnson
agreement: ensuring
a profitable outcome
Adam Siskind
Associate Principal. ZS Associates
CALL +1 866 996 1235
4 EASY WAYS FAX +1 800 814 3460
EMAIL register@eyeforpharma.com
TO REGISTER ONLINE www.eyeforpharma.com/MACanada
 ession B: Provincial
S Strategies you need to implement
Government Approval
& Relationships
A Policy Update from the Common
Drug Review (CDR)
// A n update on the CDR process,
timelines and activity you need to
know for effective drug approval.
// New initiatives introduced by the CDR.
// Understand how you can solidify your
submission to the CDR.
// Future trends in the reimbursement
environment you need to be aware of.
Brian O’Rourke Vice President, Common
Drug Review (CDR)
CDR: What you need to know to
succeed in the Canadian Healthcare
Technology environment.
// S ubmissions to the CDR: What they
need to see to give you the ‘Yes’.
// How you can effectively manage
your mainstream and biologics
submissions to develop a consistent
and credible plan which will enhance
long-term relationships with the CDR.
// How you can overcome the challenges
and meet the gold standard.
to get the best probability of national
coverage for your drug
// E stablish where the future funding
and control will lie: PMPRB or
Provincial authority and what this will
mean for the price of your drug.
// Discover strategies which dictate the
provincial thinking when discussing
your reimbursement.
// Develop best-practice methods in listing
negotiations and how value can lead
to success in pricing.
Doug Grant, Vice President,
Corporate Affairs, Bayer
New ways in creating value through
the measurement of real world
drug safety and effectiveness
(RWDSE)
// P ayers have always said that they
will pay for drugs that are effective
in the real world, but how do you prove
effectiveness in the real world?
// What perspectives and elements
do you need to consider when
measuring real world drug safety
and effectiveness?
// Learn a practical approach to
measuring effectiveness that will
validate desired outcomes and give
payers the confidence they need
to reimburse your drug.
George Wyatt Managing Director,
Wyatt Health.
PA N E L D I S C U SS I O N
Strategies to succeed
in a competitive market for
public reimbursement
Day 2 / Conference Agenda
November 11, 2009
S  ession D: Market Access
Plan Approval &
Government Relationships
Use systemic treatment data
to improve outcomes for patients
// A n update on the New Drug Funding
Program, with highlights of treatment
patterns and program forecasts.
// A description of CCO’s data analysis
and reporting framework for systemic
treatment data.
// Why you should incorporate this
framework to help you align best
practice with public reimbursement.
Scott Gavura Director, Provincial Drug
Reimbursement Programs
The Provincial Challenge: Examine
real challenges and opportunities
when getting your drug approved in
the provinces and learn the crucial
do’s and don’ts when in negotiations
// T he methods you need to know
when presenting drug safety, cost-
effectiveness and pricing agreements
between each province and what the
major barriers are that you will face.
// Discover what priority the provinces
give for approval and what added value
you need to show to win them over.
// Establish a clear plan that ensures
you continue to improve on dialogue
and relationships to develop a win-win
situation in the provinces.
Krista Scaldwell VP Market Access,
Bristol Myers Squibb
How you should plan and
implement negotiated agreements
for drugs in today’s market
// A nalyze the current negotiated
agreement environment and
impacts on stakeholders.
// Are negotiated agreements
a fad or trend?
// Looking forward: is the future for
negotiated agreements sustainable?
David Shum Director Reimbursement,
Health Economics Roche
PA N E L D I S C U SS I O N Please charge my credit card:
Private payers in the Canadian
Market. What are the future
challenges and opportunities.
Visit www.eyeforpharma.com/macanada for more information
S  ession E: Pricing
with Commercial Divisions
Strategies you need to know
in the product launch phase
// W hen should you start and who
should you speak to? How to ensure
your marketing is aligning the
messages agreed upon in Market
Access negotiations.
// One goal - one strategy - one message:
Best practice in setting up your launch
team to effectively optimize market
access knowledge.
// Learn the importance of how feedback
from the field force can produce an
effective internal cycle of information
to further improve approval processes.
Anna Braeken Head of General
Medicine, Bayer
What should marketers know
about payers, market access
and risk sharing?
// O verview of global payer environment
and latest trends.
// How should market access impact
the marketing process and clinical
research?
// How do you craft a value story
that is compelling to payers?
// What exactly is risk sharing and
who is actually sharing?
Ed Schoonveld Principal, Market Access
& Pricing Practice Lead, ZS Associates
Expanded access using Named
Patient Programs: Named Patient
Programs to speed pre-launch
market access
// L
 earn the role of Named Patient
Programs and expanded access
programs, what they are and
why they exist.
// Understand the Special Access
Program of Health Canada from
a pharma perspective including
legal, regulatory and compliance
requirements.
// Review best in class recommendations
and internal resource requirements to
effectively manage and execute named
patient programs.
Neelima Firth Director,
The Aequitas Group
Three Simple Steps to Register Now!
Or visit www.eyeforpharma.com/macanada to register instantly
S
& Reimbursement
- Key Strategies For FOR PHARMA & EARLY BIRD PRICE STANDARD
BIOTECH COMPANIES (Save CDN $300 - Register by September 18th, 2009) PRICE
Effective P&R Negotiations
The Changing PMPRB landscape Gold Pass
and the impact of the new Excessive 2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1699 CDN $1999
Pricing Guidelines
Access to pre-event and post event networking.
// W hat are the main changes to the
PMPRB’s 1994 Excessive Pricing
Guidelines?
Silver Pass
// What are the implications of the
2 Day Conference Pass,
Workshops, Roundtables, Lunch,
CDN $1499 CDN $1799
new Guidelines?
Access to pre-event and post event networking.
// What can be expected in the future
and what measures should be taken.
FOR SOLUTION PROVIDERS EARLY BIRD PRICE STANDARD
Barbara Ouellet Executive Director,
& CONSULTANTS (Save CDN $300 - Register by September 18th, 2009) PRICE
Patented Medicine Prices Review Board
Measuring the long-term impact
Gold Pass
of pricing regulations
2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1799 CDN $2099
// D iscover how to manage PMPRB
Access to pre-event and post event networking.
scrutiny whilst developing competitive
prices in the market. Silver Pass
// Identify what market forces are
2 Day Conference Pass, CDN $1599 CDN $1899
proving major barriers in sustaining Workshops, Roundtables, Lunch,
long-term pricing i.e Generics, Public Access to pre-event and post event networking.
Opinion, how you can manage these
to lower the impact on your drug.
// Understand what the new excessive
NGOs And Regulatory Bodies Pass
price guidelines released this summer 2 Day Conference Pass, Full event recording, CDN $699
will mean for your products. Access to all workshops, Access to all roundtables,
Lunch, Access to pre-event and post event networking.
Martin Mason Partner, Gowlings Legal
Canadian pharmaceutical pricing
– where do we go from here?
Full event recording CDN $400
// N ew PMPRB Guidelines – examine
the day to day impact on Canadian
pricing practice. Mr/Mrs/Ms/Dr: First name: Last name:
// How does Canada fare in the global
Company: Position/Title:
context of competitive pricing?
// Looking ahead – is there a formula Telephone: Fax:
for success?
Email:
Claudia Neuber Senior Pricing Manager,
AstraZeneca Address: Postcode: Country:
PA N E L D I S C U SS I O N I enclose a check/draft for: Credit card number:
Reality in 2010 and beyond (Payable to First Conferences Ltd)
Expiry date: Security number:
// U nderstand the emerging role of the
Please invoice my company:
pharmacists as KOLs in the Market Name on card:
Access environments. Purchase Order Number:
// How can innovatives move away from
‘me-too’ drugs to show incremental
value from the current formulary drug. Amex Visa Mastercard Signature:
// Establish new ways in creating clear
and transparent safety of your drug.
FAX THIS FORM BACK TO +1 800 814 3460
Senior Level Pharma Speakers TBC
TERMS & CONDITIONS Places are transferable without any charge. Cancellations before October 9, 2009 incur an administrative charge of 25%. If you cancel your registration
after October 9, 2009 we will be obliged to charge the full fee. Please note – you must notify eyeforpharma in writing of a cancellation, or we will be obliged to charge the full fee.
The organisers reserve the right to make changes to the programme without notice. All prices displayed are exclusive of VAT unless otherwise stated but, VAT will be charged,
where applicable, at the prevailing rate on the invoice date and the relevant details will appear on the invoice. NB: FULL PAYMENT MUST BE RECEIVED BEFORE THE EVENT
Day 1 / Conference Agenda
November 10, 2009
 ession A: Federal
S  ession C: Public Drug
Government Access
Dynamics
Where do we stand?
The Canadian Healthcare
market in a global context
// H ear a descriptive and comparative
analysis of the Canadian market from
an IP, Pricing and reimbursement
aspect and how this impacts on your
geographic strategy.
// Establish where the future funding
and control lies, with the PMPRB
or Provincial authorities?
// Develop best-practice in listing
negotiations and understand how
transparency and value can lead
to greater success in pricing.
Normand Laberge Vice-President,
Rx&D
Explore novel approaches
in a new marketplace
// Learn how a flexible global culture
can be applied and implemented
for local success.
// Hear an expert view of how a new start
up in Canada can maximize success
in a rapidly changing environment.
// Best practice examples of how
to adapt in today’s marketplace.
Daaron Dohler President, Takeda Inc
Government Relations Strategies:
critical success factors for resolving
regulatory, reimbursement and
health policy challenges
// H ow to work effectively with your
biggest customers: governments.
// Stakeholder and government
advocacy to support your regulatory,
reimbursement and policy objectives.
// Examples of how to implement an
effective product life-cycle strategy in
the evolving regulatory environment.
Bill Dempster Director,
Health & Pharma, Global Public Affairs
WORKSHOP Lesia Babiak Vice-Chair, Federal Policy,
 reparing for a negotiated
P Johnson & Johnson
agreement: ensuring
a profitable outcome
Adam Siskind
Associate Principal. ZS Associates
CALL +1 866 996 1235
4 EASY WAYS FAX +1 800 814 3460
EMAIL register@eyeforpharma.com
TO REGISTER ONLINE www.eyeforpharma.com/MACanada
 ession B: Provincial
S Strategies you need to implement
Government Approval
& Relationships
A Policy Update from the Common
Drug Review (CDR)
// A n update on the CDR process,
timelines and activity you need to
know for effective drug approval.
// New initiatives introduced by the CDR.
// Understand how you can solidify your
submission to the CDR.
// Future trends in the reimbursement
environment you need to be aware of.
Brian O’Rourke Vice President, Common
Drug Review (CDR)
CDR: What you need to know to
succeed in the Canadian Healthcare
Technology environment.
// S ubmissions to the CDR: What they
need to see to give you the ‘Yes’.
// How you can effectively manage
your mainstream and biologics
submissions to develop a consistent
and credible plan which will enhance
long-term relationships with the CDR.
// How you can overcome the challenges
and meet the gold standard.
to get the best probability of national
coverage for your drug
// E stablish where the future funding
and control will lie: PMPRB or
Provincial authority and what this will
mean for the price of your drug.
// Discover strategies which dictate the
provincial thinking when discussing
your reimbursement.
// Develop best-practice methods in listing
negotiations and how value can lead
to success in pricing.
Doug Grant, Vice President,
Corporate Affairs, Bayer
New ways in creating value through
the measurement of real world
drug safety and effectiveness
(RWDSE)
// P ayers have always said that they
will pay for drugs that are effective
in the real world, but how do you prove
effectiveness in the real world?
// What perspectives and elements
do you need to consider when
measuring real world drug safety
and effectiveness?
// Learn a practical approach to
measuring effectiveness that will
validate desired outcomes and give
payers the confidence they need
to reimburse your drug.
George Wyatt Managing Director,
Wyatt Health.
PA N E L D I S C U SS I O N
Strategies to succeed
in a competitive market for
public reimbursement
Day 2 / Conference Agenda
November 11, 2009
S  ession D: Market Access
Plan Approval &
Government Relationships
Use systemic treatment data
to improve outcomes for patients
// A n update on the New Drug Funding
Program, with highlights of treatment
patterns and program forecasts.
// A description of CCO’s data analysis
and reporting framework for systemic
treatment data.
// Why you should incorporate this
framework to help you align best
practice with public reimbursement.
Scott Gavura Director, Provincial Drug
Reimbursement Programs
The Provincial Challenge: Examine
real challenges and opportunities
when getting your drug approved in
the provinces and learn the crucial
do’s and don’ts when in negotiations
// T he methods you need to know
when presenting drug safety, cost-
effectiveness and pricing agreements
between each province and what the
major barriers are that you will face.
// Discover what priority the provinces
give for approval and what added value
you need to show to win them over.
// Establish a clear plan that ensures
you continue to improve on dialogue
and relationships to develop a win-win
situation in the provinces.
Krista Scaldwell VP Market Access,
Bristol Myers Squibb
How you should plan and
implement negotiated agreements
for drugs in today’s market
// A nalyze the current negotiated
agreement environment and
impacts on stakeholders.
// Are negotiated agreements
a fad or trend?
// Looking forward: is the future for
negotiated agreements sustainable?
David Shum Director Reimbursement,
Health Economics Roche
PA N E L D I S C U SS I O N Please charge my credit card:
Private payers in the Canadian
Market. What are the future
challenges and opportunities.
Visit www.eyeforpharma.com/macanada for more information
S  ession E: Pricing
with Commercial Divisions
Strategies you need to know
in the product launch phase
// W hen should you start and who
should you speak to? How to ensure
your marketing is aligning the
messages agreed upon in Market
Access negotiations.
// One goal - one strategy - one message:
Best practice in setting up your launch
team to effectively optimize market
access knowledge.
// Learn the importance of how feedback
from the field force can produce an
effective internal cycle of information
to further improve approval processes.
Anna Braeken Head of General
Medicine, Bayer
What should marketers know
about payers, market access
and risk sharing?
// O verview of global payer environment
and latest trends.
// How should market access impact
the marketing process and clinical
research?
// How do you craft a value story
that is compelling to payers?
// What exactly is risk sharing and
who is actually sharing?
Ed Schoonveld Principal, Market Access
& Pricing Practice Lead, ZS Associates
Expanded access using Named
Patient Programs: Named Patient
Programs to speed pre-launch
market access
// L
 earn the role of Named Patient
Programs and expanded access
programs, what they are and
why they exist.
// Understand the Special Access
Program of Health Canada from
a pharma perspective including
legal, regulatory and compliance
requirements.
// Review best in class recommendations
and internal resource requirements to
effectively manage and execute named
patient programs.
Neelima Firth Director,
The Aequitas Group
Three Simple Steps to Register Now!
Or visit www.eyeforpharma.com/macanada to register instantly
S
& Reimbursement
- Key Strategies For FOR PHARMA & EARLY BIRD PRICE STANDARD
BIOTECH COMPANIES (Save CDN $300 - Register by September 18th, 2009) PRICE
Effective P&R Negotiations
The Changing PMPRB landscape Gold Pass
and the impact of the new Excessive 2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1699 CDN $1999
Pricing Guidelines
Access to pre-event and post event networking.
// W hat are the main changes to the
PMPRB’s 1994 Excessive Pricing
Guidelines?
Silver Pass
// What are the implications of the
2 Day Conference Pass,
Workshops, Roundtables, Lunch,
CDN $1499 CDN $1799
new Guidelines?
Access to pre-event and post event networking.
// What can be expected in the future
and what measures should be taken.
FOR SOLUTION PROVIDERS EARLY BIRD PRICE STANDARD
Barbara Ouellett Executive Director,
& CONSULTANTS (Save CDN $300 - Register by September 18th, 2009) PRICE
Patented Medicine Prices Review Board
Measuring the long-term impact
Gold Pass
of pricing regulations
2 Day Conference Pass, Full event recording,
Workshops, Roundtables, Lunch,
CDN $1799 CDN $2099
// D iscover how to manage PMPRB
Access to pre-event and post event networking.
scrutiny whilst developing competitive
prices in the market. Silver Pass
// Identify what market forces are
2 Day Conference Pass, CDN $1599 CDN $1899
proving major barriers in sustaining Workshops, Roundtables, Lunch,
long-term pricing i.e Generics, Public Access to pre-event and post event networking.
Opinion, how you can manage these
to lower the impact on your drug.
// Understand what the new excessive
NGOs And Regulatory Bodies Pass
price guidelines released this summer 2 Day Conference Pass, Full event recording, CDN $699
will mean for your products. Access to all workshops, Access to all roundtables,
Lunch, Access to pre-event and post event networking.
Martin Mason Partner, Gowlings Legal
Canadian pharmaceutical pricing
– where do we go from here?
Full event recording CDN $400
// N ew PMPRB Guidelines – examine
the day to day impact on Canadian
pricing practice. Mr/Mrs/Ms/Dr: First name: Last name:
// How does Canada fare in the global
Company: Position/Title:
context of competitive pricing?
// Looking ahead – is there a formula Telephone: Fax:
for success?
Email:
Claudia Neuber Senior Pricing Manager,
AstraZeneca Address: Postcode: Country:
PA N E L D I S C U SS I O N I enclose a check/draft for: Credit card number:
Reality in 2010 and beyond (Payable to First Conferences Ltd)
Expiry date: Security number:
// U nderstand the emerging role of the
Please invoice my company:
pharmacists as KOLs in the Market Name on card:
Access environments. Purchase Order Number:
// How can innovatives move away from
‘me-too’ drugs to show incremental
value from the current formulary drug. Amex Visa Mastercard Signature:
// Establish new ways in creating clear
and transparent safety of your drug.
FAX THIS FORM BACK TO +1 800 814 3460
Senior Level Pharma Speakers TBC
TERMS & CONDITIONS Places are transferable without any charge. Cancellations before October 9, 2009 incur an administrative charge of 25%. If you cancel your registration
after October 9, 2009 we will be obliged to charge the full fee. Please note – you must notify eyeforpharma in writing of a cancellation, or we will be obliged to charge the full fee.
The organisers reserve the right to make changes to the programme without notice. All prices displayed are exclusive of VAT unless otherwise stated but, VAT will be charged,
where applicable, at the prevailing rate on the invoice date and the relevant details will appear on the invoice. NB: FULL PAYMENT MUST BE RECEIVED BEFORE THE EVENT
Dear 9 Big Pharma
speakers reveal
their strategies
9 Big Pharma
speakers reveal
their strategies

Colleague...
Researched & Organized by eyeforpharma Researched & Organized by eyeforpharma

and top tips and top tips

World Class Speakers Pharma Pharma

After many months speaking to senior-level
pharma industry executives in Canada, the biggest
challenge we’re facing right now is how to bring
at a Glance Market Access Two Day Conference
November 10–11, 2009 Market Access Two Day Conference
November 10–11, 2009
a drug to market effectively and efficiently in this
challenging environment.
Brian O’Rourke
Vice President, CDR
Canada Radisson Admiral,
Toronto, Ontario Canada Radisson Admiral,
Toronto, Ontario
This is your invitation to attend an innovative summit Normand Laberge
that will address the most pressing issues unique Vice President, Rx&D
Add Value for Stakeholders to SPEAKER FACULTY:
to the Canadian pharma industry.

This meeting will address the key challenges you

Barbra Ouellet
Executive Director, PMPRB Achieve Effective Drug Approval Who Should Attend?
Daaron Dohler Brian O’Rourke
face including payor, patient and KOL engagement, President & General Manager,
relationship building, pricing & reimbursement Takeda Canada, Inc
The event will attract VPs, heads, Vice President
CDR
strategy, CDR plans, pricing & drug safety and
Doug Grant directors and managers of:
internal access management. Barbara Ouellet
Vice President, Bayer Vice President
// Market Access PMPRB
Hear from experts on the changing governmental Anna Braeken
and provincial landscape and learn how to get the Head General Medicine, Bayer // Pricing & Reimbursement Daaron Dohler
most out of your relationship on a federal level. Lesia Babiak // Health Economics
SAVE Add Value for President and General Manager

We will bring together pharma industry thought-

Director Federal Affairs & Health Policy, CDN $300 Stakeholders to Takeda Canada, Inc
Johnson & Johnson // Federal Policy book before 18th
Achieve Effective Doug Grant
leaders from Bayer, Abbott, BMS, Takeda, J&J September
Krista Scaldwell // CDR Policy
and teamed them up with CDR, PMPRB and
Vice President, BMS Drug Approval Vice President Corporate Affairs
Bayer
Cancer Care Ontario as well as many other key // Provincial Policy
stakeholders to provide you with a platform for Martin Mason Krista Scaldwell
Partner, Gowlings Legal Experts Will Discuss: // Better CDR Engagement
learning, debate and networking. // Regulatory Affairs Vice President Market Access
David Shum // The Impact Of PMPRB // Best Practice Pricing & BMS
You will leave the summit with a case-study driven Director Reimbursement & Health Economics, // Commercial Management On Pharma In 2010 Reimbursement Case Studies
Lesia Babiak
road map for success in Canadian market Roche // Effective Internal Market // Federal & Provincial Director, Federal Policy
access landscape – guaranteed. Scott Gavura Access Management Government Communication Janssen-Ortho
Director Provincial Drug Reimbursement
I look forward to meeting you and your

4 EASY WAYS TO REGISTER

Programs, Cancer Care Ontario
colleagues in Toronto.
Claudia Neuber eyeforpharma always deliver cutting-edge,
Best regards, Senior Pricing Manager, AstraZeneca eyeforpharma events Real Case concise conferences on a global scale, I am proud to
Studies from
Gerogre Wyatt CALL +1 866 996 1235
Managing Director, Wyatt Health
never fail to deliver. FAX +1 800 814 3460 be associated with them and see them as a key player
Jon Gwillim
Ed Schoonveld
Principal, Market Access & Pricing Practice Lead, Ian Talmage, VP Global Marketing, Bayer Healthcare
EMAIL register@eyeforpharma.com
ONLINE www.eyeforpharma.com/MACanada
6 VPs in delivering up-to-date intelligence to the industry.
VP North America ZS Associates Len Starnes, Head Of Digital Marketing & Sales, Bayer Schering
eyeforpharma Neelima Firth
Director, The Aequitas Group
PS. Sign up early and save CDN $300!
Visit www.eyeforpharma.com/MACanada For the latest information visit www.eyeforpharma.com/MACanada
Follow me on LinkedIn Supported by
PM 36O Global Sponsor Gold Sponsor Supporting Sponsor
www.linkedin.com/in/JonathanGwillim
THE FULL SPECTRUM OF PRODUCT MANAGEMENT
// 8 Presentations From VPs
Group Search: Reasons // 18 Senior Level Speakers Join eyefoprharma’s Market Access Canada
// 12+ Hours Worth of Networking LinkedIn group to be kept updated and to open
Market Access for Canadian Pharma
to Attend // The Premier Meeting Place for up your network to the key players in the space.
Search for ‘Market Access Canada’
Pharma & Regulators in Canada in the Group directory.