ChinaBio^® Partnering Forum 2013 Program Overview

Sanofi is a diversified global healthcare leader in areas ranging from orphan drugs to vaccines. Since 2009, Sanofi has invested more than EUR 26 billion in partnership and acquisition in order to broaden technology expertise, increase access to external innovations and deliver long-term sustainable growth.

Unlike many multinational companies, Sanofi applies a virtual model to its R&D business in the Asia Pacific, developing an open innovation structure with a variety of partners across regions, including specialized companies, leading scientific institutions, VCs and CROs. Flexible models such as option-for-collaboration, resource-sharing co-development and licensing will be discussed. The presentation will also provide strategic insight for successful drug development collaborations in China and beyond. Case studies and opportunities for out-licensing and co-development will also be announced in the meeting.

• Jian Li, PhD – Director, Partnering and External Innovation, Asia Pacific, Sanofi R&D

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• Greg B. Scott – President and Founder, ChinaBio^® LLC
• Carola Schropp, MBA, MTS – President, EBD Group

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On the first day of the Chinese New Year, Bloomberg News announced that China had surpassed the US to become the largest global trading partner in 2012. This trend is equally apparent in pharma, with the number of cross-border partnering deals up 48% in 2012, now representing 87% of all pharma partnering in China. This is being driven, to a great extent, by the China government. In addition to encouraging the importation and development of novel drugs to help improve the quality of healthcare in China, the government is also driving down prices on generics 20–30% per year, forcing China pharma to quickly move to higher margin Western drugs that offer better price protection. The big pharma are also changing their partnering models in China and are more willing to do regional deals for China-only rights and to partner shelved assets that may have a better chance of success in China. Our panel of global pharma and China company executives will discuss the trends and factors driving cross-border partnering in China, and the changes they see coming in the next few years, as China becomes the #2 global pharma market.

Moderator:
Greg B. Scott – President and Founder, ChinaBio^® LLC

• Eckhard Ottow, MD, PhD – Head Global Innovation Sourcing, Global Drug Discovery, Bayer Pharma AG
• Yongkui Sun, PhD – VP, Greater China Lead, External Scientific Affairs, Worldwide Licensing and Acquisitions, MSD R&D (China) Co., Ltd.
• Jinzi J. Wu, PhD – Founder, President and CEO, Ascletis, Inc.
• Steve Yang, PhD – VP, Head of Asia and Emerging Markets iMed, AstraZeneca

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Two years ago, China had only a handful of companies attempting to enter the biologics market, and most of those were struggling to deal with the complexities of biologics manufacturing and meeting global standards. Then, at the end 2012, the race was on. In a three-month period, China's first biologics facility intended to address the global market was opened in Wuxi; major VCs provided USD 25 million to a startup to develop biosimilars and a cGMP manufacturing facility in Suzhou; China government agencies created a VC fund specifically for biologics development; and a big pharma created a JV to develop a mAb in China. Of course, challenges abound, including the fact that China's regulatory policies have yet to adapt to the rapidly changing world of biologics and biosimilars. Executives who are leading the race to create the biologics industry in China examine the rapidly changing industry in China, factors for its success in the coming years and China's potential role as a global leader in biosimilars and biologics.

Moderator:
Joe Donahue – Senior VP Global Sales, Life Sciences, Thomson Reuters

• Hans-Peter Grau – VP Business Development and Key Account Management Asia, Contract Manufacturing Biopharmaceuticals, Boehringer Ingelheim Biopharmaceuticals GmbH
• Paul Grayson, MBA – President and CEO, RuiYi, Inc.
• Racho Jordanov – President and CEO, JHL Biotech
• Michael Yu, PhD – President and CEO, Innovent Biologics, Inc.

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These expert speakers will:

• Provide an updated summary of the Myriad Genetics case in the US challenging the patentability of isolated genes;
• Discuss how to protect trade secrets; and
• Review how to effectively negotiate and prepare licensing agreements.

• Barbara R. Rudolph, PhD, JD – Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP
• Ningling Wang, JD – Managing Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP

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Gain insights from the investor, corporate and legal perspectives on what types of pharma, device and diagnostic products and technologies are being in-licensed or acquired by Chinese entities, at what stages of development and regulatory approval, and at what up-front or staged cost. The panel will also discuss how these deals are being structured (e.g., JV or non-JV) and what structures are working and not working to achieve the parties' objectives and maximize exit values.

Moderator:
Christina Zhang, JD – Partner, Cooley LLP, Shanghai

• Lifei Cheng, PhD, MBA – Senior Director, Business Development and Strategy, Medtronic
• Lila Hope, PhD, JD – Partner, Cooley LLP, Palo Alto/Shanghai
• Shiang Huang, MD – President and CEO, Kindstar Globalgene Technology, Inc.
• Ching Zhu, PhD, EMBA – Partner, Frontline BioVentures

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VCs were on the hunt in China in 2012, with life science investments up 72% while US and European investment fell precipitously. Pharmaceutical and biotech companies are still reaping the majority of the funding, but diagnostics and medical devices are on the rise, representing nearly 30% of the deals last year. Many of the active VCs in China have roots in the US, Europe or Japan, and many of the companies receiving funds are utilizing Western-developed technology or are focused on Western markets, making VC investment in China a truly global game. Hear venture capitalists actively investing in life science in China describe how their investment focus is evolving as the China market rapidly expands and if they will continue to seek their fortunes here as the market matures.

Moderator:
Greg B. Scott – President and Founder, ChinaBio^® LLC

• Francine Fang, MD, PhD – Venture Partner, TusPark Ventures
• Nisa Leung, MBA – Partner, Qiming Venture Partners
• Yi Shi, MBA, PhD – Managing Director, Lilly Asia Ventures
• Jonathan Wang, MBA, PhD – Senior Managing Director, OrbiMed Asia

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• Gangfeng Xu, PhD, MBA – VP, Divisional Vice President, Licensing & Acquisitions, Abbott

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• Augustine Yee – Asia Pacific Head of Regional and Corporate Business Development; China, AstraZeneca

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• Nicolas Becker – Head, Business Development and Licensing, Bayer HealthCare China

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• Zheng Li, PhD – General Manager, Lundbeck Research China

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• Jimmy Z. Zhang, PhD, MBA – Managing Director, MSD Early Investments, Greater China

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• Tomas Landh, PhD – Director, Strategy and Innovation Sourcing, Diabetes Research Unit, Novo Nordisk

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China's life science industry continues to grow, and significant deals between Western and Chinese entities are taking shape. Getting the deal done is a complex procedure that involves in-depth analyses of the status quo of both partners as well as the goals of the collaboration. This panel will take a behind-the-scenes look at the drivers, options and strategies it takes to form a successful partnership. Join dealmakers from these major players for a strategic look inside recent deals.

Moderators:
Lester Ross, PhD, JD – Partner, WilmerHale
Kenneth Zhou – Partner, WilmerHale

• David Deperthes, PhD – VP Business Development and Licensing, Debiopharm
• Darren Ji, MD, PhD, MBA – Global Head of Roche Partnering, Asia and Emerging Markets, Roche
• Shan Jiang, PhD – CEO and Founder, Ascepion Pharmaceuticals, Inc.
• Jinzi J. Wu, PhD – Founder, President and CEO, Ascletis, Inc.

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Any drug or device company wanting to do business in China must deal with the China FDA (CFDA). This can be a slow and arduous process, especially for the uninitiated, and the wrong approach can lead to delays and even ultimate rejection. But there are a variety of strategies and approaches that can be used to smooth and speed the process and help ensure success. Special paths including the Green Channel and Fast Track are now available for products that address a significant medical need. And bringing a product in as an imported vs. domestic product can speed the approval process, but may have other consequences, such as pricing and reimbursement. Learn what works—and what doesn't—from our panel of experts who have successfully brought hundreds of products to market through the CFDA.

Moderator:
Katherine Wang, LLM – Chief China Life Sciences Advisor, Ropes & Gray LLP

• John Gong, PhD, MD – VP, Drug Development and Regulatory Affairs, BeiGene (Beijing) Co., Ltd.
• Dan Zhang, MD, MPH – Chairman and CEO, Fountain Medical Development Ltd.
• Jenny Zhang, MD – Director of Business Development, Hangzhou Tigermed Consulting Co., Ltd.

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The road to China can take many paths. This year we will explore two China startups that have several similarities...and some distinct differences. Both are focused on drug development in China. Both were founded by Westerners and funded by Western investors. Both were started in 2010 and are based in Shanghai. But that is where the similarities end. Luqa is a specialty pharma focused on rapid commercialization of products for the China market that recently launched their first product. RuiYi is focused on the discovery and development of novel biologics for the global market. This session will probe the very different paths our two entrepreneurs have taken to conquer China, and the lessons learned during their journeys.

Interviewees:
Robert Braithwaite – CEO and Co-Founder, Luqa Pharmaceuticals
Paul Grayson, MBA – President and CEO, RuiYi, Inc.

Interviewed by:
Debra Yu, MD – Managing Director, Labrador Advisors

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