SMi Group's 3rd annual Biosimilars North America 2016 conference returns to New Jersey this November

1. www.biosimilars-northamerica.com
Register online or fax your booking form to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
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#USABioSMi
Solving the Last Jigsaws to Minimize Risks,
Optimize Costs and Accelerate Commercialization
SMi Presents 3rd Annual Conference on…
Biosimilars
North America
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops:
15th
Conference:
16th - 17th
NOV 2016
A: Leveraging Successful Patient Recruitment
& Retention Strategies in Biosimilars Research
Workshop Leader:
Shazia Ahmad, Director, Patient & Physician Services,
UBC - An Express Scripts Company
08.00 – 12.30
B: Biosimilars: Considerations for
Optimizing Access and Price
Workshop Leader:
Mkaya Mwamburi, Vice President, HEOR/Evidence Generation,
MKTX Market Access Solutions, LLC
13.30 – 16.45
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Tuesday November 15th 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Highlights of 2016:
• Amgen to present on interchangeability’s impact on
biosimilars
• How to commercialize biosimilars? Case studies from
Vizient and Harvest Moon Pharmaceuticals USA, Inc.
• EMD Serono and Teva to discuss industry partnership and
corporate strategy for biosimilars
• Norwegian Medicine Agency enlightens how optimal
regulatory environment can encourage biosimilars uptake
• Pricing and reimbursement? Boehringer Ingelheim’s
thoughts on the best tactic in the US
Chairman:
• Richard Dicicco, Chairman, Harvest Moon
Pharmaceuticals USA, Inc.
Elite Speaker Panel 2016:
• Edric Engert, Senior Vice President, Biosimilars, Teva
Pharmaceuticals
• Gustavo Grampp, Ph.D., Director R&D Policy - Biosimilars,
Amgen Inc.
• Hillel Cohen, Executive Director, Scientific Affairs, Sandoz
• Andrew Simpson, Scientific Director, Orygen Biotechnologia S/A
• Dr. Jianguo Yang, CEO, Abpro-China; Vice President,
Abpro-US
• Daniel Alvarez, Senior Director, Asset Lead, Global
Established Pharma, Pfizer Inc.
Sponsored by

2. REGULATORY UPDATES ON BIOSIMILARS IN THE US
COMMERCIALIZATION (PART 1): LESSONS LEARNED IN BIOSIMILARS
TALK TO YOUR STAKEHOLDERS
Biosimilars North America
Day One | Wednesday November 16th 2016
08.00 Registration & Coffee
08.30 Chairman’s Opening Remarks
Richard Dicicco, Chairman,
Harvest Moon Pharmaceuticals USA, Inc.
08.40 OPENING ADDRESS:
What to Expect? Regulatory Agency’s Update
on Biosimilars Application
•Health authority perspectives on regulation
of biosimilars (US, EU, other regions)
- Totality of evidence
- Data expectations
- Naming
- Labeling
- Substitution and Interchangeability
•Extrapolation is a reality
•Are immunogenicity concerns about biosimilars
scientifically valid?
•Can a company develop a single global biosimilar application?
Hillel Cohen, Executive Director, Scientific Affairs, Sandoz
09.20 Regulatory Concerns for Interchangeability
– Time to Define and Clarify
•What’s in a name? Differentiating European and US terms
and policies
•What are the concerns? Medically-guided switching vs.
pharmacy substitution
•What’s the standard? Survey of perspectives from policy
makers and industry
•What’s next? Labelling, naming and pharmacy practice
Gustavo Grampp, Ph.D., Director R&D Policy - Biosimilars, Amgen Inc.
10.00 Put Aside Your Status as a Generic, Biosimilar,
Innovator or Sponsor? How Can You Beat the Big Guys?
•Barriers to market
- Difficulties and dead-ends of R&D to make a biological
- Patents
•How to overcome?
- Search and identify patents early – prepare in advance
of BPCIA
- Thorough evaluation of cost of bioequivalent work
vs new biological with full clinical data
•Almost blasphemy
- Make your products better
- Use sponsor/branded product and clinical data as guide
not as bioequivalent
- Better efficacy, better safety, lower immunogenicity
= ready government’s approval
•Get $/£/€/¥ benefits
- May not come from being bioequivalent/biosimilar
- Use IPR proactively to eliminate competitor patents and
as lessons for getting your own patents
- Gain exclusivity by patenting to achieve legal monopoly
•Do not be a Lemming and follow the herd off the cliff
Robin Chadwick, Principal, Schwegman Lundberg Woessner
Albin (Jim) Nelson, Ph.D., Senior Shareholder,
Schwegman Lundberg Woessner
10.50 Morning Coffee & Networking Break
11.20 Biosimilars – Lessons Learned in Europe
•What decides uptake in clinical practice?
•From biosimilar to biogeneric?
•The future of biosimilars
Dr. Steinar Madsen, Medical Director,
Norwegian Medicines Agency
12.00 The Engineering Scenario for Biosimilar Antibodies in Brazil
•Public sector vs private sector
•Local manufacturing
Andrew Simpson, Scientific Director,
Orygen Biotechnologia S/A
12.40 Networking Lunch
13.50 Overview of Biosimilars Industry in China
•Globalization of biosimilar from China to the rest
of the world
•Biosimilar development trend in China
•Challenges and opportunities in China
Dr. Jianguo Yang, CEO, Abpro-China; Vice President, Abpro-US
14.30 Development of Biosimilars in South Korea
•Overview and current trend of the biosimilars industry
in Korea
•Regulatory approval of biosimilars in Korea
•Patent disputes related to biosimilars in Korea
Kevin Kyumin Lee, Attorney, Kim & Change Intellectual Property
15.10 Afternoon Tea & Networking Break
15.40 Why Successful Commercialization of Biosimilars is Important to
Vizient
•What is Vizient and who do we represent (50% of the US Acute
Care Hospitals and 25% of Non-Acute Providers)
•The size of biological spend in Vizient hospitals and the
potential impact for biosimilar price reductions
•Vizient’s efforts to educate providers (hospitals and physicians)
regarding myths that must be overcome to ensure successful
commercialization of biosimilars
Ross Day, Director of Pharmacy & Sourcing Ops, Vizient
16.20 Panel Discussion: How to Capitalize on the
Market Growth of Biosimilars?
•What’s the best set-up of business unit
of biosimilars?
•Partnerships through M&A and support by VCs?
What is the potential return?
Panel joined by speakers of the day
17.00 Chairman’s Closing Remarks and Close of Day One
Proudly Sponsored By:
Abzena offers a suite of complementary services and technologies. Its range of technologies include immunogenicity assessment,
antibody drug conjugation, protein engineering, PEGylation, cell line development, GMP manufacturing and a range of bespoke
assays to enables the development of better biopharmaceuticals which will have a greater chance of reaching the market.
www.abzena.com
The Schwegman firm is dedicated to obtaining strong patents while innovating how IP law is practiced. Schwegman developed
proprietary systems, allowing us to deliver high quality work, remaining cost competitive. Schwegman attorneys have robust
backgrounds across a spectrum of technology areas, working with diverse clients, including corporations, universities, and start-ups.
www.slwip.com
Wyatt Health Management is Canada’s leader in Biosimilars. We provide database offerings, payer market research and
reimbursement consulting services in the Canadian market for pharmaceutical and non-drug technology firms. Established in
2002, we have developed a strong reputation for providing clients with customized, creative and practical solutions that address
their public and private market access and reimbursement objectives, whether related to products or policy. Contact us. We
would be pleased to help you succeed. www.wyatthealth.com
Official Media Partners:
Register online at www.biosimilars-northamerica.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you
wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

3. WORK WITH YOUR CUSTOMERS AND PROSPECTS
TECHNOLOGICAL DEVELOPMENTS IN BIOSIMILARS
COMMERCIALIZATION (PART 2): FORECAST AND LAUNCH
Biosimilars North America
Day Two | Thursday November 17th 2016
08.30 Registration and Coffee
09.00 Chairman’s Opening Remarks and Recap from Day 1
Richard Dicicco, Chairman,
Harvest Moon Pharmaceuticals USA, Inc.
09.10 OPENING ADDRESS:
Characterization of Innovator and Biosimilar Antibody Molecules
•Analytical characterization
•Novel methods to distinguish
•Clinical relevance of differences
T. Shantha Raju, Scientific Director, Janssen R&D, LLC
09.50 The Importance of Early Immunogenicity and Product
Quality Assessment (PQA) in Biosimilar Development
•Understanding the causes and variations of
immunogenicity between biosimilars and originators
•Case study: EPO vs infliximab switching experiences
•Methods for preclinical immunogenicity and PQA for early
comparative analysis
•De-risking approaches for biosimilars and biobetters
Laura Perry, Director of Scientific Affairs – Cell Line
Development, Abzena
10.30 Morning Coffee & Networking Break
11.00 Succeeding with Biosimilars in Canada
•Regulatory path at Health Canada
- Different from FDA and EMA
•Common drug review tailored review process
•Negotiations at the pan-Canadian pharmaceutical
alliance
•Public and private drug plan coverage
- New patients vs. switching
- Preferential listings, anyone?
George Wyatt, Managing Director,
Wyatt Health Management
11.40 How to Build a Convincing Business Case and Sustainable
Model for Biosimilar mAbs
•mAb development and manufacturing cost drivers are
declining
•How to price and how low can you go: Case study of
mAb development cost 2007 – present
•Market access strategy and lifecycle: Case study of
post-approval launch mistakes
•Can biosimilars be a sustainable business at current
variable costs?
Richard Dicicco, Chairman,
Harvest Moon Pharmaceuticals USA, Inc.
12.20 Industry Partnerships: Key Success Factors in Biosimilar
Space
•Stand-alone situation: High R&D costs, unclear regulatory
pathways, uncertain business model, incomplete portfolios
•We will win together through innovative partnership models
•Case study: Airline industry – high fixed costs but low
marginal costs
•Translation to the biosimilar space
Catherine Godrecka-Bareau, Director Strategy & Portfolio
Management, Biosimilars, EMD Serono
13.00 Networking Lunch
14.00 Biosimilars – From Aspiration to Operations
•Corporate strategy
•Portfolio strategy
•Organizational implications
Edric Engert, Senior Vice President, Biosimilars,
Teva Pharmaceuticals
14.40 Considerations for Commercial Success
•Engaging key stakeholders to drive biosimilar adoption
•The big question of reimbursement of biosimilars in the US –
what’s the future and challenges?
Molly Burich, Associate Director, Public Policy
- Biosimilars, Pipeline, Reimbursement,
Boehringer Ingelheim Pharmaceuticals, Inc
15.20 Afternoon Tea & Networking Break
15.50 Addressing the Clinical Risks of Switching
•Types of switching, let’s talk the same language
•Considerations when switching to biosimilars – what are the
risks?
•How to transition from reference product to biosimilars?
Daniel Alvarez, Senior Director, Asset Lead, Global
Established Pharma, Pfizer Inc.
16.30 Panel Discussion: Marketing and Distribution
– Keys to Success
•How to market your biosimilars?
•National and international distribution channels
– working with hospitals and pharmacies
•Competing with originators – challenges and solutions
Panel to be joined by speakers of the day
17.00 Chairman’s Closing Remarks and Close of Day Two
Attendees by industry sector –
Biosimilars USA 2015
■ Strategy 29%
■ Marketing and
Business Development 26%
■ R&D 26%
■ Regulatory Affairs 19%
Attendees by geo location –
Biosimilars USA 2015
■ USA 85%
■ Canada 2%
■ Europe 8%
■ UK 5%
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved?
Interested in promoting your services to this market?
Contact Anna Serazetdinova, Marketing Executive,
email: aserazetdinova@smi-online.co.uk, or telephone: +44 20 7827 6180
Supported by

4. Leveraging Successful Patient
Recruitment & Retention Strategies
in Biosimilars Research
Workshop Leader:
Shazia Ahmad, Director, Patient & Physician Services,
UBC - An Express Scripts Company
HALF-DAY PRE-CONFERENCE WORKSHOP A
Tuesday November 15th 2016
08.00 – 12.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Overview of Workshop:
There are many challenges in identifying and recruiting patients
for biosimilar studies. This workshop will focus on addressing
challenges with patient recruitment and retention for biosimilars,
howtoovercomethemandincorporateasuccessfulrecruitment
strategy that includes considerations around patient compliance
and retention. Discussion items include: communication
strategies with key stakeholders and local communities, synergies
with rare diseases/orphan drugs and how to adopt successful
communication strategies around patient participation.
This workshop will also include open dialogue amongst
participants.
Program:
8.00 Registration & Coffee
8.30 Workshop Leader’s Opening Remarks
8.40 How to Plan a Successful Clinical Trial for Biosimilars?
• Challenges with patient recruitment
• Best practice for patient retention and compliance
considerations
• Case study reference
9.30 Talk to Your Stakeholders
• Communication strategies with advocacy group
and public
• How to engage?
• Mini exercise - delegates will be grouped to work
on a scenario-based case study to devise on a
communication program
10.30 Morning Coffee
11.00 Understanding and Executing Key Strategies for A
Successful Biosimilars Clinical Trials
• Being compliant and avoid regulation pitfalls
• What if? What are the risks that could delay your
clinical trials?
• Delivering clinical trials on-time and on-budget
• Mini exercise - delegates will be grouped to work on
a scenario-based exercise to devise on an execution
plan for clinical trials
12.00 Round Up Q&A
12.30 Workshop Leader Closing Remarks
and End of Workshop
About the Workshop Leader:
Shazia Ahmad serves as the Director on UBC’s Patient &
Physician Services team. She brings to this role 20 years
of experience in the healthcare industry. Shazia provides
oversight and strategy on patient recruitment and
retention as well as site feasibility and recruitment for clinical, late
stage, safety and risk management programs.
Before joining UBC, she served as a study coordinator at the
National Institutes of Health (NIH). While there, Shazia coordinated
NIH-sponsored studies within various institutes at the NIH (NINDS,
NCI, NIAID). Her work included direct parent/patient family
interaction in various rare diseases. Shazia also served as a study
coordinatorforClinSearch,aprivateresearchcenter.Sheworked
on protocols from various sponsors and therapeutic areas.
Shazia has experience in many therapeutic areas, such as
cardiology, endocrinology, gastroenterology, nephrology,
neurology, infectious disease, pulmonology, rheumatology,
weight management, rare disease and oncology.
Shazia earned a B.S. in Physiology and Neurobiology from the
University of Maryland.
About the Organization:
United BioSource Corporation (UBC) is
a leading provider of pharmaceutical
support services, partnering with life
science companies to make medicine
and medical products safer and more accessible.
With the strength of our parent company, Express Scripts, one of
the nation’s largest healthcare companies, UBC leads the market
in providing integrated, comprehensive clinical, safety and
commercialization services.
UBC’s Patient & Physician Services (PPS) team delivers global
solutions that meet the needs of pharmaceutical, government
and biotech sponsors. But PPS does not just provide patient
recruitment for clinical trials. As part of Express Scripts, one of the
largest healthcare organizations in the U.S., UCB offers HIPAA-
compliant solutions for patient recruitment, patient retention and
site selection for clinical research. PPS can identify the patients
and the healthcare providers (HCP) who treat them, giving our
clients a distinct advantage as we implement clinical studies.

5. HALF-DAY PRE-CONFERENCE WORKSHOP B
Tuesday November 15th 2016
13.30 – 16.45
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Biosimilars:
Considerations for Optimizing
Access and Price
Workshop Leader:
Mkaya Mwamburi, Vice President, HEOR/Evidence
Generation, MKTX Market Access Solutions, LLC
Overview of Workshop:
This interactive workshop will address, in a deliberative
and interactive manner, factors to consider when:
1. A biosimilar is entering an original biologic’s space
2. Evaluation process for biosimilars
3. Legal aspects around biosimilars and competitive pricing
4. Evaluating price-points for biosimilars
5. Defensive considerations and when to start
6. Hedging outcomes between biologics and biosimilars
Program:
13.30 Registration & Coffee
14.00 Workshop Leader Introduction
14.10 How Much Should We Charge?
• Pricing for biosimilars - how to be competitive
while maintaining a good profit margin?
• Discounts and incentives from government/
payers?
• Marketing strategy - bundled services?
• Value demonstration options
15.15 Afternoon Tea
15.45 Case Study & Exercise:
Developing a Sustainable Business Model
• How to draw up a business plan?
• Life cycle of biosimilars?
• Managing your distribution and market
access strategy
• Where’s the growth? US vs LATAM
• What if? Risk mitigation strategy and ensure
business integrity against the originator
16.30 Round Up Q&A
16.45 Workshop Leader Closing Remarks and
End of Workshop
About the Workshop Leader:
Mkaya Mwamburi MD, PhD, MA (Econ), is Vice
President of Health Economics & Outcomes
Research and heads the HEOR practice area.
Mkaya is an HEOR specialist and evidence strategist
with extensive experience in consulting for pharmaceutical
industry leading health economic modeling, systematic
reviews, and value determination and communication
projects among others. He also has experience in the
clinical trial analysis of oncology and immunology products
and has published extensively in this space.
About the Organization:
MKTXS Market Access Solutions, LLC
is a boutique consultancy that helps
pharmaceutical and biotechnology
companies with integrated evidence generation and
market access and price optimization strategies. MKTXS
helps clients identify and align product value with unmet
needs to optimize access and price through robust
evidence generation and values demonstration and
communication.

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BIOSIMILARS NORTH AMERICA
Conference: Wednesday 16th & Thursday 17th November 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops: Tuesday 15th November 2016, New Jersey, USA
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www.biosimilars-northamerica.com
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