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Health Network Communications, The Hilton London Paddington
22 - 25 February 2011
Pre conference multi speaker day, Tuesday 22 February 2011
9am Strategic planning in the generics industryOutline:
The past few years have seen tremendous change in the
generic pharmaceutical industry. M&A, new legislation
and pricing pressures have all raised questions on where
the industry is headed and how companies should be
positioning themselves for the future.
Objectives:
This practical and interactive session will examine
strategies for surviving and thriving over the next 5
years. The speakers will provide structured content with
attendees having the opportunity to discuss and add
their own contributions.
Registration opens at 9:00 with the meeting beginning
at 9:30. The meeting will end at 16:30. Lunch and
refreshments will be provided.
MORNING SESSION
Mergers and Acquisitions
• Examining the changing landscape of the generics
industry
• Key industry challenges and strategic considerations
• Analysis of some recent M&A transactions
• Exploring the future landscape of mergers and
acquisitions
Hurdles and opportunities for the generic
pharmaceutical industry
• Factors influencing the generic pharmaceutical
business
• The changing dynamics of the industry and it’s
impact
• Commercial opportunities of combining Gx
entrepreneurship with brand pharma expertise
• Assessing what the innovator pipeline crisis will
mean for generics. How should the generics
industry be preparing for this?
Lunch
AFTERNOON SESSION
Business models for becoming a successful generic
player
• Building a major international business – getting a
foot hold in most attractive markets
• Generic differentiation strategies
Multi national operations
• Globalization and integration – overcoming cultural
barriers
Q&A and closeMalcolm Ross,Managing Director, Generapharm Consultancy
Jesus Carrasco abad,Director Healthcare Investment Banking, RBS
Pascal Brenneisen,Chief Executive Officer, Sandoz UKSaxen van Coller,Chief Executive Officer, Ranbaxy SA
Dr Ullrich Hanstein, General Manager, HELP S.A. Conference Day One, Wednesday 23rd February 2011
8.30am Registration and coffee
8.50am Opening remarks from the chair
Guy Clark,Business Development Director, Goldshield Group Limited
STRATEGIC OVERVIEW
9am Generic medicines health check – view from the investment community
· Key trends driving consolidation
· Who are the key acquirors in the sector and how has this changed?
· What are the key areas of focus for M&A?
Tommy Erdei,Healthcare Investment Banking, Jefferies International
9.30am The sustainability of healthcare in Europe
· Trends and future market environment
· Current steps to generic entry
· Reducing complexity and increasing harmonization
· Originator companies marketing through generic arms
Gerard van Odijk,President and Chief Executive Officer, Teva Pharmaceutical Europe
10am Market trends and opportunities for generic medicines
• Governments are cutting costs - increased penetration of generics
• Tenders are becoming more prominent – opportunities and threats for generics
• Emerging markets – the greatest opportunities in the next few years
• Biosimilars – will they become a success?
Gudbjorg Edda Eggertsdottir,Deputy Chief Executive Officer, Actavis Group
10.30am Speed Networking and morning refreshments
11.15am Generic medicines: rethinking the future
• Why the current business model in the generic industry may not be sustainable
• The next generic generation companies & future trendscess?
Robert Wessman,Executive Chairman, Alvogen
11.45am Building scale, market share and value in today's global market
• Providing affordable medicines in a fiercely competitive environment
• The changing dynamics of the industry and it’s impact
• Thinking small and winning big
Dr György Thaler,Director of Development, Gedeon Richter
POLICY REVIEW
12.15pm European industrial policy for generic medicines
• Enforcement of the competition rules
• Compatibility of patent settlements
• European competition law
Paul Csiszar,Competition Directorate General Director, Basic Industries, Manufacturing and Agriculture, European Commission
12.45pm Lunch
1.45pm Congressional update and Q&A session on Hatch-Waxman Reforms
The Honorable Henry Waxman,Member of Congress, United States of America
2.15pm New U.S. healthcare law: impact on generics
• Discussion of how the Patient Protection and Affordable Care Act will impact generic drug manufacturers
• Status of the Administration's implementation efforts
• Outlook for health care legislation moving forward
Julia Reed,Vice President, Government Affairs, Hospira Inc.
2.45pm Cost containment and generic prescribing in Germany – a purchaser's perspective
• What´s the mission of spectrum|K ?
• Purchaser´s interest: Competition in the generic market
• Cost containment requires rebate contracts
• Tendering procedures: New method of contracting
• Impact on pharmaceutical supply chain and on European patients
Ingo Werner,General Manager, Specktrum K
3.15pm Afternoon refreshments
3.45pm Market dynamics in Europe – opportunities and risks
• The changing dynamics in Europe and their impact
• Building a sustainable generic business
• Access strategies for new markets
Andrew Macaulay,Executive Vice President Europe, Lupin
4.15pm Pharma differentiation and drug delivery systems
• Strategic considerations for developing a value added generic
• Differentiated drug delivery e.g. ready to use syringes,
PVC-premixes, unit doses
• Competitive dynamics
Joe Talanges,European Generic Injectables, Hospira
4.45pm International IP Developments
• Topical IP cases
• EU, patents and SPCs
• Review of other jurisdictions around the world
Howard Rosenberg,Scientific Advisor, Frommer, Lawrence and Haug, LLP
5.15pm Closing remarks from the chair
5.30pm Networking drinks reception sponsored by Pharmanet
7pm Gala dinnerConference
Day Two, Thursday 24 February 2011
8am Registration and refreshments
8.50am Opening remarks from PharmaNet chair
BIG PHARMA AND GENERICS
9am Big pharma strategy in generics
• Why AstraZeneca is turning to multi-source markets for future growth
• Contributing to affordable healthcare
• Competing in the challenging multi-source space
Renaud Savary,Head of Branded Generics Unit, AstraZeneca
BIOSIMILARS
9.30am The age of biosimilars: opportunities and challenges
• Market opportunity
• Potential challenges
• Implications for the future
Ameet Mallik,Global Head, Sandoz Biopharmaceuticals, Sandoz International GmbH
10am The Impact of biosimilars on Global Healthcare
The Impact of biosimilars on Global Healthcare
• The geographic availability of follow-on biologics and their affect on overall healthcare (from a treating/curing disease standpoint)
• Regulatory pathways: EU / US – navigating and learning from recent approvals
• Pfizer's commitment to FOBs
- Experience in development, manufacturing, and commercialization
- Successful collaborations to date
Petra Danielsohn-Weil,European President, Establish Brands, Pfizer AG
10.30am Morning refreshments
11am Clinical Trial Requirements for Biosimilars
• Comparability requirements: taking advantage of known
product/disease knowledge
• Statistical design discussions: seeking innovative approaches
• How much safety data are required and for how long?
• The preclinical requirement for comparability. How does that
differ from non-biological generics?
• What are the regulatory hurdles for biosimilars in Europe and
the US?
Dr Pablo Fernandez,Senior Vice President, Medical Affairs, PharmaNet Ltd
11.30am Entering the biosimilars market through acquisitions and partnerships
• Current biosimilars landscape and how companies are utilizing acquisitions to enter the lucrative field
• Survey of various licensing & partnership deals for development and marketing
• Ranbaxy’s entry into biosimilars and vaccine space through acquisitions and partnership
Dr Shyam Bishen,Vice President, Corporate Development, Ranbaxy
12pm Building a global biosimilar development strategy
• The growing demand for affordable biopharmaceuticals
• Alliancing as a key strategic driver
• Dr Reddy’s biosimilar development approaches
Dr Anshuman Patwardhan,Senior Director, Portfolio Strategy & Licensing Biologics, Dr. Reddy's Laboratories, Inc.
12.30pm Lunch
INTERNATIONAL MARKET FOCUS
1.30pm Indian generics on a world stage
• Indian generic companies: globalisation and growth
• Comparing requirements for market entry in key markets
• Analysing future changes of the global environment and
resulting market opportunities
Mr Murtaza Khorakiwala,Managing Director, Wockhardt
2pm Exploring how smaller generic companies are competing in challenging EU countries
• How are companies managing key challenges?
• The future of healthcare expenditure
• Strategic options for small-sized companies: the key challenges
Dr Ullrich Hanstein,General Manager, HELP S.A.
2.30pm Opportunities and challenges for generics in Brazil
• Changing market structure and present landscape in Brazil
• Regulatory and patent environment
• Competitive dynamics in generic launches
• Opportunities and challenges for new entrants
Vinzenz Plorer,Vice President , Operations, EMS Brazil
3pm Afternoon refreshments
3.30pm Review of market dynamics in South America
• What´s in a name? The said & the unsaid
• Changing dynamics of generic space
• Challenges & opportunities for generic players
• M&A activity including big pharma
• Evolution…way forward
Srinivas Komala,Country Manager, Glenmark Generics Argentina
4pm Market Dynamics in Southern Africa; The Good, The bad and The Ugly'
• The good; significant market size, virtually unexploited (high potential for generics vs. brands)
• The bad; market access barriers and challenges
• The ugly; mistakes made by generic companies
George Proctor,Chief Executive Officer, Gemi Pharmacure
4.30pm Closing remarks from the chair
Post conference workshop, Friday 25 February 2011
9am Registration and refreshments
9.30am Overview – Biosimilars? Biogenerics? Follow on biologicals?
• Is biosimilars a viable market?
• Summary of issues affecting Biosimilars – regulatory/legal commercial
• Interchangeability – what is the issue?
Peter Wittner,Managing Director, Interpharm Consultancy11amMorning refreshments
11.30am The regulatory process and pitfalls
• Europe
- EMA guidelines and overview
- Case studies of successful and failed
applications
• The USA
- How will the legislation work?
• Japan
• Situation in other parts of the world
1pm Lunch
2pm Biosimilars – the commercial reality
• Biologicals market and prospects
• What has happened so far?
• Patents, IP and other issues
• Where do biosimilars go from here?
3pm Discussion session
3.30pm Close of workshop and afternoon refreshments
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Organized by:
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Health Network Communications |
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Invited Speakers:
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Vice President, Corporate Development, Ranbaxy Chief Executive Officer, Sandoz UK » Jesus Carrasco abad, Director Healthcare Investment Banking, RBS Business Development Director, Goldshield Group Limited Competition Directorate General Director, Basic Industries, Manufacturing and Agriculture, European Commission European President, Establish Brands, Pfizer AG Deputy Chief Executive Officer, Actavis Group Healthcare Investment Banking, Jefferies International » Dr Pablo Fernandez, Senior Vice President, Medical Affairs, PharmaNet Ltd » Dr Ullrich Hanstein, General Manager, HELP S.A. » Mr Murtaza Khorakiwala, Managing Director, Wockhardt » Srinivas Komala, Country Manager, Glenmark Generics Argentina » Andrew Macaulay, Executive Vice President Europe, Lupin Global Head, Sandoz Biopharmaceuticals, Sandoz International GmbH » Dr Anshuman Patwardhan, Senior Director, Portfolio Strategy & Licensing Biologics, Dr. Reddy's Laboratories, Inc. Vice President , Operations, EMS Brazil » George Proctor, Chief Executive Officer, Gemi Pharmacure Vice President, Government Affairs, Hospira Inc. » Howard Rosenberg, Scientific Advisor, Frommer, Lawrence and Haug, LLP Managing Director, Generapharm Consultancy Head of Branded Generics Unit, AstraZeneca » Joe Talanges, European Generic Injectables, Hospira Director of Development, Gedeon Richter » Saxen van Coller, Chief Executive Officer, Ranbaxy SA President and Chief Executive Officer, Teva Pharmaceutical Europe Member of Congress, United States of America General Manager, Specktrum K Executive Chairman, Alvogen » Peter Wittner, Managing Director, Interpharm Consultancy |
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Deadline for Abstracts:
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N/A
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Registration:
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Register online at: https://secure.terrapinn.com/V5/rCalc.aspx?E=3827 or call Sabrina on +44 (0)207 608 7055
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E-mail:
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skhamissa@healthnetworkcommunications.com
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