Conference Day One: Tuesday 1 November 2011

08:30
Registration & Morning Coffee / Tea

09:00 Chairperson’s Opening Remarks

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)

09:10
A Global Outlook for the Generics Industry: from Commodity to Value Added Generics

• An overview of the investments in global generics and the future development opportunities in generic medicine
• Trends and the future market environment – what are the factors that will hinder or enhance growth and profitability?
• What are the main opportunities and/or threats which are pushing entry into this intensely competitive industry?
• How will the industry change with increased competition faced by new entrants?

Rajesh Kumar, Generics Director, South East Asia & Indochina, Sanofi-Aventis (Singapore)

09:45
Assessing Big Pharma Moves into Generics

• Analyzing why innovators are now showing active interest in the generics market
• Identifying common tactics used by Big Pharma in order to enter into the generics market to keep their market share

Graham Lewis, VP Europe, Global Pharma Strategy, IMS Health (UK)

10:20
How have the Competitive Entries of Originators Expedited the Development of Branded, Differentiated or Supergenerics?

• How are originators performing in the branded generics space?
• Generics are being reformulated and presented in improved delivery systems and packaging, has this had any effect on the market? If so, is this driving further development of differentiated or ‘Supergenerics’ or is it just hype?
• How are local generics players changing their strategies in response?
• What will be the next big moves by both originators and generics companies to preserve and grow their market share?

Moderator:
Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)

Panelists:
Tadashi Matsumoto, President, ReqMed (Japan)

Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Ltd, Former Chief Medical Officer, Teva (UK)

11:00
Morning Refreshments

11:30
Strategizing Entry into Asia’s High Value Economy, Japan

• The changing dynamics of the Japanese generics industry and its impact
• What are the main barriers of entry and how have partnerships eased this?
• What are the key areas of focus for M&A?

Osamu Sato, Chairman & Chief Executive Officer, Pharmex Japan Co., Ltd

12:05
India as Asia’s Generics Supplier

• An overview of the Indian generics industry and the movement from vanilla to value-added generics
• Analyzing India’s ability to support Asia in generics supply
• Looking beyond local markets and establishing partnerships with neighbouring companies to penetrate other Asian markets

Daara B. Patel, Secretary General, India Drug Manufacturers’ Association

12:40
Networking Lunch

14:00
Updates on ASEAN Harmonization and Regulations Governing Market Entry for Generics

• Analyzing ASEAN harmonization and its implementation around Asia
• What is the impact on the existing generic players as well as new entrants in pharmerging markets?
• What are the considerations for strategic entry into Asia’s emerging markets?

Dr Jang Kyung-Won, Director General, ASEAN Harmonization, KHIDI (South Korea)

14:35
Complying with Increased Local Government Protectionism

• Protectionism and what it means for entry into local Asian markets
• Assessing the role of healthcare cost reductions and how it translates to increased penetration of generics
• Understanding how the US Patient Protection and Affordable Care Act and its regional equivalents will affect generic drug manufacturers

Widya Buenastuti, Legal Director, Pfizer Indonesia

15:10
Drug Delivery and Reformulation: When is a Generic No Longer an Exact Copy?

• Distinguishing between exact copies and when a generic is “new” or improved
• How and when does drug delivery affect the application of an ANDA?
• To what extent is reformulation permissible before a generic drug requires an NDA?

Dr Thomas Leonard, Vice President & Chief Scientific Officer, Merrion Pharmaceuticals (USA)

15:45
Afternoon Refreshments

16:15
Generics’ Response to Big Pharma’s Defense Moves

• An overview & case studies of legal, regulatory and marketing tactics employed by originators
• Employing well strategized legal and marketing moves to keep out the competition
• Generic evergreening – how do generic companies compete in the evergreening race?

Dr Ron Tomer, Vice President, Unipharm (Israel)

16:50
Pre-emptive Launching vs the Legal Costs in Aggressively Pursuing Market Share

• Advantages of being first to market – balancing the benefits with expected legal challenges
• Examining this high risk strategy and assessing the potential payoffs in launching proactively
• How has this been applied successfully and under what conditions can risk be minimized?

Dr Mandar Kodgule, Associate Vice President & Head, Global IP & Strategic Planning, Wockhardt Ltd (India)

17:25
Legal Head to Head Debate: Legal Barriers to Market Entry: The Changing Role of Patents – Originators vs Generics

• Are generics becoming less generic?
• How are originators moving into branded generics?
• Generics getting more patents as they focus on super generics
• Are originators still succeeding with life cycle management or has it become a “never-greening” world of patents?
• Will generics doing more challenging and less designing around patents?
• How are originators doing more narrow patenting to build stronger, more enforceable patent portfolios?
• Determining if regulatory exclusivities or other barriers to market entry are more important than patents?
• Assessing if the hurdles of due diligence and freedom to operate are decreasing

Moderator:
Dr Janet M McNicholas, Partner, K&L Gates LLP (USA)

Panelists:
Dr Haitao Sun, Director, China and Asia Pacific Patents, Sanofi Aventis (China)

Dr Mandar Kodgule, Associate Vice President & Head, Global IP & Strategic Planning, Wockhardt Ltd (India)

18:05
Chairperson’s Remarks and End of Conference Day One

Conference Day Two: Wednesday 2 November 2011

09:00
Chairperson’s Opening Remarks

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)

09:10
Partnering with an Innovator: A Generics Point of View

• Are you giving away your market share?
• How can generics companies take advantage of their partnerships to improve their market share?
• Identifying the common challenges in a partnership
• What are the opportunities and advantages in the international markets through working with an international?
• How to deal with pricing issues between brand and generics

09:45
Establishing a Lucrative Relationship Between Innovators & Generic Companies – What is the Winning Formula?

• Identifying key elements in a successful partnership
• Advantageous business models for emerging market -based players and corresponding partner
• Compare the benefits and challenges of different partnership models: in-licensing, joint ventures, strategic alliances, venture capital
• Prediction of future trend of partnership between global and local companies

Panelists:
Song Jun, Business Development Manager, Strategy & Business Development, Pfizer Investment Co. Ltd (China)

Tadashi Matsumoto, President, ReqMed (Japan)

Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono (Switzerland)

10:25 Morning Refreshments

10:55 Flanking Generics: Successful Out-licensing Strategies

• Identifying licensing and collaboration opportunities in branded generics
• Working with local partners to launch as quickly as possible to establish market presence
• Case studies of successful risk-sharing relationships – lessons learnt

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)

11:30 Tapping into the Opportunities and Growth of Branded Generics in Asia

• The opportunities and challenges of selling branded generics in Asia’s developing markets
• Exploring therapeutic areas that are still untapped: Alzheimer’s, Pain, Inflammation, Diabetes
• Identifying successful steps to establishing a well recognized branded generic

Khalid Mahmood, Managing Director & Chief Executive Officer, Getz Pharma (Pvt) Limited (Pakistan)

12:05
Extending Big Pharma Market Profits through Branded Generics

• How and where are originators employing defensive pricing strategies to retain their market share?
• Practical applications to the Asian market
• Building brand awareness to encourage physician and patient loyalty
• Establishing a well-known brand
  

12:40
Networking Lunch

14:00
How Generic Companies can Play the Branded Game too

• Building upon local experience to reinforce branding and positioning in domestic markets
• Creating a successful business model for generic companies in pharmerging markets
• Fostering regional partnerships for expansion overseas – challenges and successes

Dr Abdullah Baaj, Chief Executive Officer, Boston Oncology (Syria)

14:35
A New Frontier: Commercialization of Super Generics

• What are super generics?
• What are the success stories?
• Strategic considerations for developing a value added generic
• Future potential for supergenerics

Dr Deepak Murpani, Vice President, Product Development, Genepharm Group (Greece)

15:10 Are Differentiated Generics the Next Pharma Bubble?

• Is it all a marketing gimmick and is it what the customer needs?
• Exploring the real opportunities of differentiated generics
• Finding the market gap and filling it with supergenerics

Moderator:
Ajay Rastogi, Vice President, Technology Catalysts International (USA)

Panelists:
Khalid Mahmood, Managing Director & Chief Executive Officer, Getz Pharma (Pvt) Limited (Pakistan)

Jamaludin Elis, Commercial Director, Pharmaniaga Marketing Sdn Bhd (Malaysia)

Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Ltd, Former Chief Medical Officer, Teva (UK)

Jaswinder Gill, Head of Sales and Marketing of International Branded Generics Business, Glenmark Pharmaceuticals (India)

15:50 Afternoon Refreshments

16:20
Leveraging Drug Delivery Systems as a Competitive Differentiator

• Understanding the strategic alliance between drugs and devices
• Determining the long term advantages for drug and delivery companies and their customers
• Assessing Asian acceptance of various alternatives in drug delivery

This is an opportunity for expert drug delivery system providers to present an interactive educational tutorial on differentiating generics. If you would like to host a tutorial, please contact us.

16:55
Winning Confidence and Brand Equity in the Minds of Asian Prescribers and Patients

• Key influencers and decision makers
• Understanding the Asian perspective and how it differs from the West
• Strategize your marketing strengths to gain the most market share as quickly as possible
• How can patients be sure of the quality of the drugs they obtain and ensure they are genuine?

Jamaludin Elis, Commercial Director, Pharmaniaga Marketing Sdn Bhd (Malaysia)

17:30
Closing Visionary Discussion: Will Asian Generics & Pharmerging Markets Eclipse those of the US & EU?

• What are the definitive success factors?
• How else can Asia compete in the global markets?
• Quality perception of Asian-made generics and what can they do to improve their image?
• Will pharmerging markets continue to outpace mature markets or will affordability affect growth?
• What are the opportunities for biosimilars in Asia?

Moderator:
Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)

Panelists:
Abdullah Baaj, Chief Executive Officer, Boston Oncology (Syria)

Daara B. Patel, Secretary General, India Drug Manufacturers’ Association

Rajesh Kumar, Generics Director, South East Asia & Indochina, Sanofi-Aventis (Singapore)

Dr Azizi Ayob, Corporate Technical Advisor, PT Dexa Medica Group (Indonesia)

18:10
Chairperson’s Closing Remarks and End of Conference

Briefing Facilitated by:

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals (USA)
Rich co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of products developed since 1984. HMP develops and licenses-out to the trade, worldwide, complex generic drug products, copy bio products and biosimilars. He is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics and biosimilars.

Dr Janet M McNicholas, Partner, K&L Gates LLP (USA)
Janet is noted for her achievements in the areas of biotechnology, pharmaceutical and medical products. She headed the biotechnology patent practice at McAndrew, Held and Malloy, headed the Life Sciences Patent Group of Cooley Godwardís Palo Alto Office and served as patent counsel for XOMA, a biotechnology company known as a leader in the development of therapeutic antibodies.

Prior to practicing law, Janet conducted research in immunology, molecular biology, biochemistry and genetics at Stanford University and at the California Institute of Technology through a post-doctoral fellowship.

About Your Workshop Leader:

Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Ltd, Former Chief Medical Officer, Teva (UK)

A physician for over 30 years, Sandy graduated from Cambridge University and studied clinical medicine at St Bartholomew’s Hospital Medical School in London. His postgraduate qualifications include Pharmaceutical Medicine and he has over 20 years’ experience in pharmaceutical regulation and pharmaceutical medicine.

Sandy has worked in several senior positions in both government and pharma, most recently as Chief Medical Officer for Teva Pharmaceuticals Europe for 5 years. In 2011, he set up his own company, providing independent advice on all aspects of pharmaceutical medicine and clinical research, covering innovative products, biosimilars and generics in all therapeutic areas.

About Your Workshop Leader:

Ajay Rastogi, VP, Technology Catalysts International (USA)

Ajay has a Bachelor of Science degree from the Indian Institute of Technology and an MBA from the Indian Institute of Management. He has over 30 years of experience in industry and consulting, including 25 years at Technology Catalysts.

At Technology Catalysts, Ajay is responsible for Business Development, Strategic and Technology Assessment Studies, and for sourcing hard-to-find information for large corporate clients in drug delivery systems, OTC, and ethical pharmaceuticals. He has managed several strategic planning studies, including technology audits to identify new business and diversification opportunities for large companies and due diligence studies leading to mergers and acquisitions, researched the FDA compliance aspects, current Good Manufacturing Practices, and other regulatory issues pertaining to the pharmaceutical and fine chemical industry.