1. BO AN 20T BO
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“A thoroughly interesting and very informative conference with
excellent chairs and presenters. More of the same please.”
Biosimilars & Biobetters Europe 2013 Attendee
7th - 8th
Biosimilars & Biobetters USA APRIL
SMi present their inaugural conference on…
Creating an Innovate Plan for the USA
Biosimilars Market
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
2014
Chairperson
Dr Richard Dicicco, Chairman,
Harvest Moon Pharmaceuticals
Key Speakers Include:
• Dr John Pakulski, Senior Director, and Head US
Biopharmaceutical Regulatory Affairs, Sandoz
• Rodeina Challand, Executive Director, Biosimilars Development,
Scientific Affairs, PRA International
• Dr Stanley (SeungSuh) Hong, President, Research and
Development, Celltrion, Inc.
• Paul Ashton, President & CEO, pSivida
• Peter Pitts, President, Center for Medicine in the Public Interest
(Former FDA Associate Commissioner)
• Douglas M. Long, Vice President, Industry Relations, IMS Health
• and many more!
Benefits of attending:
• Gain up to date insight into the regulatory landscape and
how it is effecting the industry
• Evaluate commercialization and development strategies to
gain a competitive advantage
• Calculate possible revenue streams from biosimilar production
• Discover what lessons have been learned so far and what the
future holds
• Boost your industry knowledge and relationships by networking
and learning from key industry and academic leaders
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 9th April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
A: Differentiation Strategies for the
Generics Industry
Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0
8.30am - 12.30pm
B: Launching a Biosimilar in
an Innovator v. Generic World
Workshop Leader: Kristie Kuhl, JD, Executive Vice President, Health Practice, Makovsky
1.30pm - 5.30pm
Sponsored by
www.biosimilars-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUPS DISCOUNTS AVAILABLE

2. Biosimilars & Biobetters USA
www.biosimil
Day One I Monday 7th April 2014
8.30
9.00
COMMERCIALIZATION & PRODUCT DEVELOPMENT STRATEGIES
(PART 1)
Registration & Coffee
Chairman's Opening Remarks
Dr Richard Dicicco, Chairman, Harvest Moon
1.30
Pharmaceuticals
• Reviewing the European experience of biosimilar production
- barriers to entry
OPENING ADDRESS
- market opportunities
Biosimilars and specialty products: current status and future
- competitive response
• Understanding how the global pharmaceutical market is becoming
- differences in the biosimilars versus biobetter route
more specialized and precise
• Identifying what the experience on follow on biologics, generics
and biosimilars has been so far
Professor Joseph Fuhr, Professor of Economics, Widener University
2.10
• Assessing what role follow on biologics, generic biologics and
biosimilars play in the future
Insights into the structure function relationship of monoclonal
antibodies (mAbs) with respect to their evaluation of biosimilarity
• Ensuring quality CMC is in place before embarking on mAb
Douglas M. Long, Vice President, Industry Relations, IMS Health
9.50
• Examining the balance between innovation and competition
• Analysing potential entry into the USA market
REGULATORY AND MARKET REVIEW (PART 1)
9.10
Considering the impact of biosimilars on competition
production to achieve successful biosimilarity
• Considerations for building a pipeline of mab biosimilars
Ensuring that interchangeability does not thwart US innovation –
legislation at both federal and state level and FDA’s expectations
• Understanding why US mAbs will be an important target for the
• Understanding the basis for interchangeability at state and federal
Dr Magdalena Leszczyniecka, President and CEO, STC Biologics
development of biosimilar therapeutic products
• Assessing the risk of interchangeability to biologic innovation
level
• Analyzing the variations in state-level legislation governing biosimilar
substitution
2.50
Physician's perspective on biosimilars: the importance of
pharmacovigilance
• Understanding why patient safety is paramount
• Reaching a consensus on interchangeability - how and when should
this be permitted
• Realizing that information is power: the more doctor's have, the
• Determining whether physicians should be notified when
better it is for patients
pharmacies substitute biosimilar for brands
• Examining why manufacturers must be transparent for physician's to
considerations for interchangeable products
Dr Richard Dolinar, Chairman, Alliance for Safe Biologic Medicines
• Preparing for future FDA guidance regarding safety and quality
have confidence in the product
Dr John Pakulski, Senior Director and Head US Biopharmaceutical
Regulatory Affairs, Sandoz
10.30
10.50
3.30
PRICING & COST RETURNS
Morning Coffee
Biosimilars - the state of the union
3.50
• Reviewing current regulatory concerns
• An update on biobetters and biosimilars
• Profit margins in biosimilar production
Peter Pitts, President, Center for Medicine in the Public Interest (Former
• Evaluating biosimilar unit floor prices in a hyper-competitive market
FDA Associate Commissioner)
Ready, set, go! …… but watch out for IP hurdles along the way in an
• Reviewing the impact of patent laws on biosimilar production
• Identifying and overcoming the potential patent pitfalls biosimilar
applicants may encounter pertaining to:
- development
- marketing
- approval
production
• Presenting a biosimilar sales forecast from a manufacturing view
• Analysing cost versus quality
age of post-patent medicine!
Evaluating the potential revenue streams achievable from biosimilar
• Biosimilar investing: what to expect for a return on investment (ROI)
• Discussing the EU experience
11.30
Afternoon Tea
Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
4.30
THE
TE
D EB A
What is the state of play! Highlighting what lessons have been learned
to date and where the industry is heading
• Discussing industry insights and what work you should be planning to do
• What opportunities are awaiting the market
• Deciding which models to use for successful biosimilar launch
• What benchmarks can be learned from biosimilar development in
Europe
• Evaluating how to challenge patents and potential patent
Rodeina Challand, Executive Director, Biosimilars Development,
Dominic Adair, Senior Associate, Patent Litigation, Bristows
Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Scientific Affairs, PRA International
extensions from innovator companies
12.10
Networking Lunch
Sponsored by
5.10
Chairman's Closing Remarks and Close of Day One
*Subject to final confirmation
As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational
expertise with local knowledge to serve clients across all phases of drug development. PRA’s dynamic services and forward-thinking approach are
making a difference to healthcare patients worldwide. www.prainternational.com
pSivida (PSDV, NASDAQ) is a leading provider of innovative sustained-release drug delivery products. Our proven proprietary technologies enable
us to achieve highly focused, long-term delivery of therapeutics. We have developed three of the only four products approved by either the US or
EU for the long-term, sustained-released delivery of drug to treat chronic eye disease. We are now working a long term sustained delivery system
(Tethadur®) for large molecules (including anti-bodies) for the eye. This fully bioerodible delivery system can be readily applied to virtually any site
in the body and can be used for systemically administered products. pSivida has a long history of successfully working with partners and with
licensing agreements with companies of various sizes such as Pfizer, Bausch and Lomb, Alimera Sciences. pSivida's intellectual property portfolio
consists of over 150 issued patents in countries including the U.S., Europe, Japan, China and Australia. www.psivida.com
Register online at: www.biosimilars-usa.com • Alternatively fax yo

3. Biosimilars & Biobetters USA
lars-usa.com
8.30
9.00
Day Two I Tuesday 8th April 2014
Registration & Coffee
• Identifying which products have significant potential for ‘biosuperior’
development
• Developing biosuperior protein therapeutics that address sub-optimal,
in-market characteristics of currently licensed biologics
• Examining current active projects in research and development of
biosimilar and novel biobetter/biosuperior therapeutic proteins
Dr Rakesh Dixit, Vice President, R & D Head, Global Biologics Safety
Assessment, MedImmune (AstraZeneca Biologics)
Chairman's Opening Remarks
Dr Richard Dicicco, Chairman, Harvest Moon
Pharmaceuticals
REGULATORY REVIEW - PART 2
9.10
9.50
10.30
10.50
11.30
12.10
1.30
OPENING ADDRESS
What is in a name! Reviewing the ongoing debate in the biosimilars
naming process to ensure appropriate pharmacovigilance!
• Presenting an update on the FDA’s naming preference - determining
their stand on distinctive International Nonproprietary Names (INNs) for
biosimilars
• Assesing the options for long-term biosimilar naming:
- Common non-proprietary name
- Shared root or prefix
- Distinct non-proprietary name
• Recognizing the need for clear naming principles to avoid patients
receiving the incorrect product and reduce confusion among
healthcare providers
Rodeina Challand, Executive Director, Biosimilars Development,
Scientific Affairs, PRA International
Exploring the European (EU) biosimilars landscape to determine what
lessons and ‘take homes’ the US market can employ
• Analyzing current regulatory requirements for biosimilar approval in
Europe and the future path of this legislation
• Reviewing the variations between the EU and US law and regulations
• Implementing strategies for harmonizing US and EU developments to
avoid program duplications
Liz Fuller, Partner, Bird & Bird
2.10
2.50
Morning Coffee
Essential infrastructure for successful mAb biosimilar development
• Introduction of biosimilars and how to secure the comparability to
reference products
• Highlighting key global opportunities of mAb biosimilars
• Understanding the key infrastructure for successful biosimilar
development
• Approval of world’s first mAb biosimilar from both developed and
emerging countries
• Utilizing bridging studies to enable the application of already
generated data
Dr Stanley (SeungSuh) Hong Ph.D. President, Research and
Development, Celltrion, Inc.
3.30
3.50
MARKET ACCESS FOR BIOBETTERS
Biosimilars vs. biobetters! Determining the implications for product
developers in the pharmaceutical industry
• Biobetters claim that they are a better product, but what evidence is
there to prove this?
• Discussing the regulatory status pertaining to production of biobetters
• Analyzing which features can be improved by utilizing biobetters
• Evaluating whether biobetters are better than biosimilars based on
efficacy, safety and delivery
Paul Ashton, President and CEO, pSivida
Networking Lunch
Can biobetters or biosuperiors meet the challenges of best in class
molecules and cheaper biosimilars
• Reviewing the challenges and opportunities in developing
relatively cost effective biosimilars
• Innovations in improving the existing biologics therapies in
diseases with unmet medical needs
• Making biobetters or biosuperiors successful and cost effective
through advances in protein engineering and pioneering
technologies - case studies of biosuperior vs. biosimilars
4.30
EL
PAN ION
USS
DISC
5.10
COMMERCIALIZATION AND PRODUCT DEVELOPMENT
STRATEGIES (PART 2)
Identifying how to create a truly marketable product! Assessing
commercialization considerations for biosimilars
• Understanding the role of partnerships in the development and
delivery of commercially successful biosimilars to secure specific
capabilities
• What are the various partnership models to consider in cocommercializing
• Providing relevant preclinical and clinical data for marketing
authorization
• Honing marketing tactics to achieve accelerated biosimilars sales
• Ensuring sufficient manufacturing capability and human capital to
produce and commercialize biosimilars
Dr Branimir Cvetkovic, Global Strategy Lead – Biosimilars, Novartis
Designing effective strategies to achieve excellence in clinical trials
• Identifying the key operational considerations for delivering high
quality trials on time and budget :
- What size should the trial be
- How many patients should be exposed to the drug
• What trial design should be used
• Developing strategies to optimize patient recruitment and retention in
clinical trials
• Examining the benefits of investigator/ patient education
• Implementing non clinical and clinical data to guarantee
pharmacovigilance for biosimilars
Session reserved for Pfizer further to final speaker confirmation *
Afternoon Tea
Creating effective strategies to control the manufacturing process and
address the unique challenges facing biosimilar producers
• Overcome challenges in developing biosimilars through formulated
testing strategies:
- analytical and bioanalytical method development
capabilities
- defined characterization programs
• Implementing procedures to prepare your manufacturing lifecycle for
each step of product development
• Applying the fundamentals of process analytical technology (PAT)
• Discovering how a small difference in the manufacturing process
may create a different product
• Understanding the importance of supply-chain expertise procurement
and quality assurance to speed up development
Dr Steve Flatman, Head Biosimilars Research and Development, Lonza
Biologics plc
The optimal manufacturing strategy! - Exploring what is shaping the
strategic biosimilar manufacturing plan of today's leading companies
• Discovering how to build or procure this manufacturing base in a cost
effective way
• Evaluating where should this manufacturing base be located and why
• Analysing how competition from new players is changing the
landscape
Kristopher Howard, Managing Director, Operational Excellence Leader,
NRL Enterprise Solutions
Chairman’s Closing Remarks and Close of Day Two
Supported by
our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
*Subject to final confirmation

4. HALF DAY POST CONFERENCE WORKSHOP A
Wednesday 9th April 2014 I 8.30am – 12.30pm
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Differentiation Strategies for the
Generics Industry
Workshop Leader:
Asa Cox, Founder & CEO, Generic Pharma 2.0
Overview of workshop:
This workshop will help to develop an expert
understanding of the differentiation strategies used in
worldwide markets, to explore new ideas and
opportunities for differentiation, plus possible
requirements demanded by industry evolution.
Why you should attend:
Gain insights into the future of the generic industry
and how differentiation might be the only option for
success.
Programme:
8.30
Registration & Coffee
9.10
Session 1: Current differentiation tactics
9.50
Session 2: The challenges that
10.30
Coffee Break
9.00
Introductions and opening remarks
in global markets
differentiation brings
11.00
11.40
Session 3: Ideas for differentiation
Session 4: The future of the industry and
why differentiation is needed
12.20
12.30
Closing remarks
Workshop ends
About the workshop host:
Asa has been involved in the generic pharma sector
for over 16 years; covering all aspects of the industry,
both commercial and technical. Asa launched
genericlicensing.com in 2008. The platform now
manages more than 9000 products and is used by
generic companies the world over. Asa created
Generic Pharma 2.0 in 2010 as a vehicle to convert
substantial market intelligence into a dedicated
consulting company. The firm now consults with
clients on portfolio strategy, international market
entry and pharmagination models.
About Generic Pharma 2.0
Generic Pharma 2.0 are ‘masters of business
development & marketing’. Established in 2008,
Generic Pharma 2.0 has built a global network of
30,000 companies; achieved by combining ferocious
business development and the latest web
technologies. It offers clients both access to a
network and the intelligence gained from a unique
perspective. We work with companies of all sizes,
locations and product categories. We partner with
clients. We create together. We have a lot of fun.
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, Director on+44 (0) 20 7827 6168
or email: amalick@smi-online.co.uk
Want to know how you can get involved?
Interested in promoting your services to this market?
Contact Julia Rotar, SMi Marketing on
+44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk

5. HALF DAY POST CONFERENCE WORKSHOP B
Wednesday 9th April 2014 I 1.30pm – 5.30pm
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Launching a Biosimilar in an
Innovator v. Generic World
Workshop Leader:
Kristie Kuhl, JD, Executive Vice President,
Health Practice, Makovsky
Overview of workshop:
This interactive workshop will discuss the unique
aspects of successfully launching a biosimilar in the
United States. Topics to be discussed include:
• Filing a BLA or sBLA – when to determine the path
to approval
• Government affairs – likely allies and foes of
biosimilars, what regulations to expect
• Marketing – what level of support will biosimilars
need
• Revenue discussion – what will reimbursement
look like. How will the major biologics be
impacted and when
Why you should attend:
Attendees of this interactive workshop will have the
opportunity to learn the pluses and minuses of
various approaches about new products that fall
between an innovator and a generic.
Programme:
1.30
Registration and coffee
2.10
Session 1: BLA v sBLA
2.00
2.50
3.30
4.00
4.40
5.20
5.30
Introductions and opening remarks
Session 2: USA regulation & substitution
update – friends and foes
Coffee Break
Session 3: Marketing
Session 4: Revenue and reimbursement
Closing remarks
Workshop ends
About the workshop hosts:
Kristie Kuhl, JD is Executive Vice President and Deputy
Practice Head at Makovsky Integrated Communications.
Her experience as a regulatory communications attorney
and counselor on biosimilar challenges started in 2005. She
is a sought-after expert on biosimilars, and has served as a
panelist and/or session leader at more than 10 biosimilars
conferences since 2006. She was instrumental in creating
and executing the Pfizer Genotropin communications
strategy when the company feared biosimilar entry in
Europe would collapse the growth hormone market. Kristie
has been hailed for her knowledge of legal
communications, media strategy and account-team
management. She bridges the divide between public
relations and public affairs. Utilizing her legal and public
relations background, Kristie is a counselor on
communications strategy.
About Makovsky
Makovsky is a leading healthcare communications
company in its ongoing mission to improve the lives of
patients served by biotech, pharmaceutical and device
manufacturing companies. Through giving voice to
patients in advocacy programs, brand communications
and disease education, Makovsky connects audiences via
social media, news coverage and engagement at thought
leader events such as TEDMED, Prix Galien and medical
congresses such as ACOG, ASCO and AHA. The Makovsky
team lives with intent; fostering deep knowledge of the
underlying science, a profound understanding of the
regulatory space, and a sensitivity to the complex
interactions between patients, physicians, researchers and
regulatory agencies. In 2013 alone, Makovsky received 11
healthcare communications industry awards, including
“Best in Healthcare,” “Best Education/Public Service
Campaign,” and “Best of the Best” across other industry
sectors.

6. BIOSIMILARS & BIOBETTERS USA
Fee
$2997.00
$2398.00
$1799.00
$1198.00
$599.00
$999.00
Conference: Monday 7th April & Tuesday 8th April, 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA I Workshops: Wednesday 9th April 2014, New Jersey
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ONLINE www.biosimilars-usa.com
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