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Pre-conference workshop - 24 February 2009
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| Do generics have a future? |
Objectives
This practical and interactive session will give a unique perspective on the possible ways forward for the generics industry over the next ten years. They do not guarantee accuracy (crystal balls only guarantee results when used backwards) but they can promise a thought-provoking session that will allow you to take some original thinking back to your companies.
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09.00 | Registration and coffee
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09.30 | Main influences on the generics industry today
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10.30 | Morning tea
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11.00 | Current financial environment’s impact on generic companies
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11.30 | Is MA the answer, either financially or strategically?
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12.00 | Lunch
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13.00 | Best survival strategies for the future
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14.00 | A look to the future – industry in 2018
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14.30 | Afternoon tea
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15.00 | Big pharma friend or foe?
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16.00 | Close of workshop
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Day One - 25 February 2009
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08.00 | Registration & coffee
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08.50 | Opening remarks from the chair
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09.00 | Generic industry health check
- Financial performance
- Profitability
- M&A market
- Impact of innovator companies
- Nomura perspective
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| | Ms Francis Cloud, Director, Co-Head Healthcare Investment Banking, Nomura International plc, United Kingdom
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09.30 | Key note address: generics and healthcare provisions - opportunities in an international market
- Changing environment and it’s effect on the traditional business model
- Lessons to succeed for generics companies
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10.00 | Implications to generic companies of potential pharmacy ownership liberalisation in Europe
- Intervention by European Commission
- What could happen
- Implications of vertical integration
- Reimbursement problems for payers and their response
- Case studies from the Netherlands, Norway and the UK
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10.30 | Morning tea
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11.00 | Speed Networking
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11.30 | Keynote: wholesales and distribution environment for generic medicines in Europe
- Drivers of the changing environment
- The role of new distribution models like DTP in Europe
- When and how to outsource logistics as Gx industry
- Success factors for the cooperation with logistics providers
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12.00 | European Commission's findings on the pharma sector inquiry: Impact on generic medicines
- Patent strategies
- Litigation
- Settlements
- Other interventions
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| | Mr Sune Larsen, Pharmaceuticals Sector Inquiry Task Force, European Commision, Belgium
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12.30 | Keynote address: Operational realities of running a generic company in the CEE
- Presentation of the CEE/CIS region from the perspective of pharma industry,
- Perspective of the generics market growth,
- Sustainability of the branded generics model in the region,
- Key success factors/challenges today and tomorrow
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13.00 | Lunch
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14.00 | Future Intellectual Property Challenges for Generic Companies
- Enantiomer patents; what they reveal about variation in the standard for validity
- Patent extension provisions worldwide; inconsistencies and opportunities
- Ongoing impact of TRIPS and bilateral free trade agreements on the global IP landscape
- US Para IV filing strategies; how to protect your 180 day exclusivity
- Proposals for patent issues under pending US biologicals Bills
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| | Ms Julia Pike, Intellectual Prperty Director & Counsel, Hospira Global Pharma
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| IP strategy, legal issues and patent reform |
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14.30 | Litigation in Central / Eastern Europe
- What is the same and what is different
- What we have learned
- How to succeed
- Future development
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15.00 | Afternoon tea
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15.30 | Review of generic markets in Spain
- Market conditions for Generics in Spain in 2009 and assumptions for 2013
- The players: who is winning and why?
- Is the Spanish Government pushing the generics with political willing?
- The wholesaler structure in Spain: a key factor for Generics
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| Globalization in Southern Europe |
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16.00 | Review of generic markets in Italy
- Market conditions for Generics in Italy in 2009 and assumptions for 2013
- The players: who is winning and why?
- Is the Italian Government pushing the generics with political willing?
- The wholesaler structure in Italy: a key factor for Generics
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16.30 | Review of generic markets in Portugal
- Market conditions for Generics in Portugal in 2009 and assumptions for 2013
- The players: who is winning and why?
- Is the Portuguese Government pushing the generics with political willing?
- The wholesaler structure in Portugal: a key factor for Generics
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17.00 | Panel discussion: The generics business in Southern Europe
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17.30 | Closing remarks from the chair
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17.45 | Drinks reception
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20.00 | Networking dinner
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Day Two - 26 February 2009
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08.00 | Registration & coffee
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08.50 | Opening remarks from the chair
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09.00 | Keynote: globalisation and integration
- Understanding the impact of culture in large scale acquisitions and mergers
- improve integration process in future, with specific focus on “people“ and culture issues
- important dimensions: the clarity of business direction, trust, motivation, values, loyalty, results and vision as critical, both at local level and global level for Actavis integration process
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| | Mr Milan Todorovic, Executive Vice President, Chief Operating Officer, Actavis Central Eastern Europe, Iceland
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09.30 | Panel discussion: authorised generics and delayed entry pacts
- Authorised generics and delayed entry pacts – current status
- Impact on the introduction of other generic pharmaceuticals
- Further considerations
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| | Ms Julia Pike, Intellectual Prperty Director & Counsel, Hospira Global Pharma
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10.00 | Morning tea
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10.30 | Market opportunities for generics in South Africa and Sub Saharan Africa
- Sociopolitical and Macroeconomic overview
- Market dynamics
- Market entry strategies
- Growth Opportunities
- Challenges of doing business in South Africa (and Sub Saharan Africa) and the Role of Affordable Medicines
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| | Dr Vikash Salig, Chief Executive Officer, Dr Reddy's Laboratories (Pty) Ltd, South Africa
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11.00 | China – new trends and opportunities for the generic pharmaceutical industry
- Key growth and market drivers for China’s pharmaceutical industry
- Pharmaceutical consolidation in China
- Business strategy for China’s pharmaceuticals
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| | Dr Wei Huacheng, Chairman, Beijing Pharmaceutical Group Co. / Beijing Double Crane Pharmaceutical Co, China
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11.30 | Big pharma’s reaction to growth of generic drugs
• Big pharmaceutical companies reactions to the growth of generic drugs
• Redefining the value proposition hurdle
• Identifying sustainable options to extend brand life cycle
• Looking for synergies with generics
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| | Mr Tony Ellery, Formerly Head of Lifecycle Management, Ellery pharma Consultants, Switzerland
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12.00 | Lunch
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13.00 | U turn
U Turn is your turn. Because your knowledge and experience is important to us, this is where you select the topic and the presenters for a session.
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13.30 | Injectable generics in Europe
- Operating landscape for injectable generics in Europe
- Market entry strategies for speciality injectables in niche areas
- Growth opportunities for injectable generics in Europe
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| BIOSIMILARS |
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14.00 | Biosimilars - succeeding in the market of the future: the pioneer's perspective
- Biosimilar regulatory pathway: What is the difference? Why does it matter?
- Ensuring quality by design: The story of the first two biosimilars (development, approval, marketing)
- From dream to reality: The real-life battle for recognition of therapeutic equivalence
- What next? The growing demand for affordable biopharmaceuticals and the need for harmonized global pathways
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| | Ms Mateja Urlep, Former Global Head of Marketing and Medical, Sandoz Biopharmaceuticals, TikhePharma, Slovenia
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14.30 | keynote address: congressional update and Q&A on Hatch-Waxman reforms
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15.00 | Clinical development strategy of biosimilars
- Creating the clinical development plan
- Minimising financial exposure whilst getting the right answers
- How to cope with regulatory requirements
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| | Partha Ghosh, Director & Service Lead, Early Stage Drug Development, Parexel, United Kingdom
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15.30 | Afternoon tea
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16.00 | US legal and legislative update: diversifying into generic biologics
- Update on the current legislation surrounding the development, registration and marketing of biosimilars in the US
- What are the differences with the process in Europe
- Modelling the cost of litigation and structuring the financial benefits
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16.30 | Case study: bringing a biosimilar to market in the US
- Dual path strategy for entry into follow on biologics arena
- Trial data for replication of biologic product
- Financial savings for healthcare
- U.S. Congress biologic approval pathway
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17.00 | Chair’s closing summary
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Post-conference workshop - 27 September 2009
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| Regulatory strategy for generic pharmaceuticals |
Objectives
Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This one day seminar will address and clarify the latest regulatory changes and challenges. It will focus on the major strategic issues facing your generic drug submissions helping you to improve speed to market for your generic drugs.
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09.00 | Registration and coffee
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09.30 | Review of mutual recognition and decentralised procedure for generic medicines
- The DCP and agency expectations
- What is the effect of the DCP on MRP submissions?
- Experienced gained and common pitfalls
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10.00 | Current guidelines and expectations for eCTD submission
- European implementation status
- NeeS - Guidance as a training for transition
- eCTD - Guidance as the future submission format
- Recommendation how to submit electronically
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10.30 | Morning tea
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11.00 | Regulatory perspective: review of European biosimilar regulatory submissions
- Clinical data required to register a biosimilar product
- Tips to overcome hurdles in biosimilar registration
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11.30 | Industry case study: Pioneer's perspective for regulatory submissions
- Review of biosimilar regulatory pathway
- Submitting bioequivalence tests
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12.00 | Lunch
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13.00 | Regulatory review of inhaled products, design and models
- Changes in the regulations
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13.30 | Lifecycle management techniques applied to generics
- 505 (B)2 – supergenerics and ANDA
- Europe and US strategy for global development
- Clinical requirements for supergenerics / global considerations
- Practical experience
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14.00 | Afternoon tea
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14.30 | Panel discussion: regulatory environment for generics
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15.30 | Close of workshop
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