Day 1

CONFERENCE DAY ONE TUESDAY 12 JUNE 2012

08:30 Registration & Morning Coffee / Tea

09:00 Chairperson’s Opening Remarks

Pabel Delgado, Founder & Board Member, Asterism Healthcare Plus

THE JAPANESE PHARMA LANDSCAPE

09:10 Japan’s Growing Role in Global Pharma Markets

• The evolution and growth of Japan’s Pharma domestically and its emerging role in the global arena
• Keeping up with global demands – what more can be done to increase profitability at home and overseas?
• How can Japanese companies adopt strategic positions to enter new global markets?

Joshua Owide, Senior Analyst, PharmaVitae, Datamonitor

09:45    Keynote: The Changing Face of Japanese Pharma

• Major trends in priority shifts by Japan Pharma
• Increasing global emphasis and entering international/emerging overseas markets
• Investment and returns from biologics R&D
• Alliances, partnership and M&As to support innovation to late stage product portfolios

Norikazu Eiki, Chairman, Bayer Yakuhin

10:20      Morning Refreshments

10:50      Understanding Japan’s Unique Generics & Biosimilars Landscape

• A review of the global generics and biosimilars landscape and how is it applicable to Japan
• Understanding the market – why Japan’s uptake in generics and biosimilars has been slower than average and why foreign-entrants have not gained significant market share
• The potential of the Japanese generic market and general direction of government policy in generic promotion

Motoya Kohtani, Senior Analyst, Nomura

STRATEGIC PARTNERSHIPS FOR INCREASING GLOBAL MARKET ENTRY

11:25    Outsourcing Research & Development to India

• India as a market for Japanese companies to offshore R&D capabilities
• The opportunities and challenges of working in India
• The challenges of cross-cultural collaborations and how we worked around it

KB Sankara Rao, Independent Consultant, Dr Reddy’s

12:00 Networking Lunch

13:15 Facilitating Collaborations, In-licensing or Alliances to Expedite Global Drug Development

• An overview of the broad capabilities required for success in developing and commercializing innovative and approved drugs to overseas markets
• Identifying appropriate partners in the region / internationally and negotiating a win-win partnership
• Adopting comprehensive due diligence
• What are the criteria for selecting the right partners for the long term?

Dr Rami Suzuki, Senior Director, Head of Business Development Department, Eisai

13:50 Country Focus: China’s Biopharmaceutical Growth

• An overview of China’s pharmaceutical growth
• The evolution of China’s biopharma growth
• What are the opportunities and challenges that foreign companies might face in their attempt to enter into the Chinese market?

Dr Youling Wu, CEO, Zhejiang Teruisi

14:25 Partnering with Chinese Companies Successfully

• Case studies of dealings with local Chinese companies
• Understanding the local culture and playing in a competitive arena
• How can Japanese companies balance the opportunities with the risks?

Dr Binhui (Ben) Ni, Head of Scouting & Partnership, Sanofi-Aventis

15:00 Afternoon Refreshments

15:30 Leveraging Local Home Ground Advantages in Japan’s Domestic Markets

• Tapping into the increased interest from MNCs to enter into Japan
• How can local companies differentiate from each other and increase awareness to initiate relationships with prospective overseas counterparts?
• Weighing the advantages and disadvantages and deciding which path to choose? Eg Licensing? Partnership? Acquisition?

Dr Tadashi Matsumoto, President, ReqMed

16:05 Unique Challenges Japanese Biopharma Faces In The Global Phama Stage

Dr Nobuo Hanai, CEO, Kyowa Hakko Kirin

16:40 Panel Discussion: Innovative Approaches to Partnering with Japanese Pharma on a Global & Domestic Scale

• The various entry methods into Japan and the implications for each
• What are the social overlays needed to be understood before working with Japanese companies?
• Approaches to China, Korea and other Asian countries – assessing the best market entry strategies for Japanese companies to employ

Moderator:

Pabel Delgado , Founder & Board Member, Asterism Healthcare Plus

Panelists:

Ian Haydock, Asia Editor, SCRIP Intelligence

Yariv Hefez, Head, Business Development and Alliance Management Biosimilars, Merck Serono

Chihiro Yokota, Global Head, Business Development and Licensing & Alliances, Astellas Pharma

Dr Kailash Sharma , President & Representative Director, Zydus Pharma Japan Co

17:25 Chairperson’s Remarks and End of Conference Day One

 

 

Day 2

CONFERENCE DAY TWO WEDNESDAY 13 JUNE 2012

09:00 Chairperson’s Opening Remarks

Dinesh Dua, CEO, Nectar Lifesciences

COLLABORATIONS FOR CROSS BORDER DRUG DEVELOPMENT

09:10 Country Focus: Assessing the Opportunities to Work with Indian Companies

• An overview of India’s pharmaceutical growth
• Working with two distinct cultures – how to make it work
• Case Study: Nectar’s collaborations in Japan – Challenges and lessons learnt

Dinesh Dua, CEO, Nectar Lifesciences

09:45 Encouraging Cross Border Innovations in Early Drug Discovery

• Analyzing the decline in research budgets and risk appetite targeting early drug discovery
• What are the new paradigms based on collaboration, networking and judicious use of research dollars needed to stimulate innovation?
• Case studies to further encourage cross border innovations

Swapan Bhattacharya, Managing Director, TCG Lifesciences

10:20 Morning Refreshments

10:50 Establishing a Commercially Viable Relationship with Institutions to Support and Enhance Vaccines R&D Pipeline

• Aligning goals between academics and main-stream pharma
• Fostering an environment of mutual beneficial relationship – balancing innovation with commercial expectations

Ralf Altmeyer, Director General, Institut Pasteur

11:25 Encouraging Cross-cultural Bio-innovations with Academia * delivered in Japanese and translated into English consecutively*

• Fostering academic research – how can the Pharma industry encourage this
• Current state of Japan’s pharma-academic relationships
• Case Study: Shionogi’s Science Programme in United Kingdom (UK) – Collaboration between a Japanese Pharma and UK researchers

Dr Tsuneaki Sakata, Head, Innovation Design Office, Global Development, Shionogi & Co Ltd

12:00 Networking Lunch

INNOVATIVE R&D AND BIO-DEVELOPMENTS IN JAPAN’S LABS

13:15 Innovative Research into EGFR-targeting Biobetters Monoclonal Antibody

• Defining biobetters – How are they different from biologics and biosimilars?
• The opportunities and potential of biobetters and the true cost of development
• Key issues which need to be addressed before entering a highly competitive, time and costsensitive industry

Dr Se-Ho Kim, Research Director, Green Cross Corp

13:50 Kyowa Hakko Kirin’s Partnership with Fujifilm - Understanding the Risks Before Jumping on the Biosimilars Bandwagon

• Moving past 1st gen molecules into mAbs
• How investments in biosimilars in the long-term will serve the domestic market
• What strategies can be employed to ensure speed to market and successful commercial launch?
• Working together towards a successful partnership

Hideaki Nomura, Deputy Director, Strategic Product Planning Department & Biosimilar Project Leader, Kyowa Hakko Kirin

14:25 Afternoon Refreshments

OPPORTUNITIES & CHALLENGES IN CLINICAL DEVELOPMENT

14:55 Clinical Innovations in Japan – How to Secure a Harmonized Pan-Asian Trial in Asia’s Clinical Framework

• An update on Asian trials led by Japan
• Fostering cooperation with China and Korea to achieve greater efficiency
• Identifying key challenges in data bridging and other issues
• Filling the gaps of speedy patient recruitment, high quality and optimal approval timelines
• Future opportunities and the priority-collaboration model in Asian trials

Hiroshi Sugii, Vice President, Clinical Development, Novo Nordisk

15:30 Conducting Successful Clinical Trials in Asia

• What’s the general pattern of the regulatory environment in Asia
• Identifying differences in clinical studies between Japan and the rest of Asia
• Developing an effective clinical management strategy

Shunsuke Izuka, Associate Manager, Clinical Development Group, Asia Development Department, Daiichi Sankyo

16:05 What is In Store for Japan’s Drug Development Future?\

• How is Japan’s pharma industry positioned compared with the rest of the world in terms of R&D?
• With greater focus on large molecule investments, are generics and small molecules no longer profitable?
• What is needed to drive creativity and innovation in Japan and globally?
• Identifying Japan’s current advantages and how can it be leveraged on the global stage
• How will the latest Health Technology Assessments (HTA) revisions affect Japan’s pharmaceutical landscape?

Moderator:
Dr Osamu Sato, Senior Director, R&D Planning Department, Daiichi Sankyo

Panellists:
Dr Kentaro Yoshimatsu, Senior Scientific Advisor, Eisai

Dr Tadashi Matsumoto, President, ReqMed

Tadashi Fujisawa, CEO, Mebiopharm Co Ltd

Dr Hisafumi Okabe, Vice President, General Manager, Research Division, Chugai Pharmaceutical

16:50 Chairperson’s Closing Remarks and End of Conference

 

 

Pre-Conference Workshop

Pre-Conference Half-day Workshop A | 11 June 2012

Strategies and Tactics for the Development of Novel Biologics and Biosimilars

Workshop Objectives:
Entry into the world of research and development of biological products including innovative biologics and biosimilars is relatively new in Asia as more companies are exploring recombinant protein products in order to expand their product pipeline. The commercialization of biologics in emerging markets of Asia presents unique opportunities and challenges. This workshop will explore strategies and tactics to take advantage of opportunities and overcome challenges in the ever-evolving world of biopharmaceuticals and biosimilars.

Workshop Agenda:

• How has the West successfully commercialized a number of important biological products and what lessons can be applied in Asia?
• How is the patenting of biologics different than the patenting of small molecule drugs and what are the consequences of those differences?
• How will partnering and collaboration strategies impact the success of Asian companies to compete in local or global markets?
• How can Asian companies innovate to develop the next generation of biologics?
• How can Asian companies compete in local or global markets with the development of biosimilars?

Led By:

Dr Janet M McNicholas, Partner, K&L Gates LLP
Janet has headed the biotechnology patent practice at McAndrew, Held and Malloy, the Life Sciences Patent Group of Cooley Godward in Palo Alto 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.

 

Post-Conference Workshop

Post-Conference Full-day Workshop B | 14 June 2012

Understanding and Developing a Strategic Approach to China

Workshop Objectives:
The workshop is designed to assist key decision makers and front line managers of multinational pharmaceutical companies that are considering or already doing business in China to establish and execute on a winning strategy for China. Participants will be engaged in a highly interactive learning environment, with plenty of opportunities to raise questions, consider possible solutions and apply newly enhanced knowledge after the workshop.

Workshop Agenda:

A. Market and business considerations

• An overview of China’s pharma landscape
• Opportunities and challenges in the major therapeutic areas and classes of drugs
• Who are the leaders and what are their portfolios?
• Launching in China – what are the considerations?
• A look into Japanese presence in China and how this can still be grown

B. Legal and regulatory considerations

• Types of legal entity or collaboration relationship to establish in China
• How to protect your intellectual property?
• Meeting the regulatory requirements on major business activities
  ~ clinical trial
  ~ marketing authorization
  ~ manufacturing
  ~ sales and marketing

About Your Workshop Leaders:

Guang Yang, Senior Principal, Management Consulting, IMS Health China
Guang over 10 years’experience in management consulting serving Fortune 500 as well as China domestic fast-growth companies with a broad leadership role in strategy planning, product development, organization change management, portfolio management, business development, and M&A strategy and execution support on pharmaceutical company buyout. He has led government policy makers in formulating policies, as well as helping municipal government on bio-pharmaceutical economic development planning. Before IMS Health, Guang served as Principal with Booz & Co. and VP of ROMIT Health.

Shaoyu Chen, Managing Director, China Food and Drug Practice, Covington & Burling LLP
Shaoyu has over 10 years experience in food and drug law, including serving as assistant chief counsel at the U.S. Food and Drug Administration Office of Chief Counsel, as senior counsel at California-based Amgen Inc., and as chief compliance counsel for GE Healthcare China. He currently represents pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic companies in matters involving China SFDA, U.S. FDA, and other government agencies.