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BIO China: Business Development Panel

Chinese Start-Ups

Thursday, October 13th, 11:00am - 12:15pm

A new wave of start-ups is moving forward pursuing innovative molecules.  These companies frequently feature officers with US/EU experience in drug development, and offices and operations in both the US and China.  The research being pursued has IP, as well as financing that is sourced in both the West and China.  These companies face numerous challenges and choices: where to locate discovery research or development operations? Which market should be primary for development? Where should financing be pursued?  What are investors looking for from these companies?  How to look at financing, given the health of the IPO market in China? This panel will feature a number of CEOs of these new companies, as well as venture capitalists who are seeking to finance new companies in China. 

Moderator:

  • Howard Liang, PhD, Managing Director, Biotechnology, Leerink Swann

Panelists:

  • Leon Chen, Partner, Fidelity Asia Growth Partners
  • James Li, Partner, KPCB China
  • Dajun Yang, MD, PhD, President & CEO, Ascentage Pharma Group Corporation

Who's Who


 

Leon Chen - Leon Chen joined Fidelity Growth Partners Asia in 2008 with over 15 years of experience as an accomplished scientist, management consultant and venture capitalist.

Prior to joining FGPA, Leon was a Managing Partner at BioVeda China and had led a number of investments in the life science sector in China including Cathay Industrial Biotechnology and CITIC Pharmaceuticals.

From 1997 to 2005, Leon was a management consultant and a business adviser to Pharmaceutical and Biotech companies. He worked as a management consultant with McKinsey & Company, Ernst & Young LLP, and as a co-founder and Managing Partner with Life Science Strategic Consulting in the San Francisco Bay Area.

From 1993 to 1997, Leon worked as a research scientist at Schering-Plough in New Jersey. He was a member of the discovery team of "VYTORIN"/"ZETIA" – now a multibillion dollar drug.

He received a BS degree from Peking University, a Ph.D. degree with top honor in Organic Chemistry from Catholic University of Louvain, and was a Post-Doc Fellow at the Massachusetts Institute of Technology. Leon holds 6 issued US Patents and co-authored the 14th and 15th Ernst & Young Biotechnology Report.

James Li - Dr. James Li is a partner of KPCB China. He joins in Oct 2009 to focus on fund’s life science practice. His main investment interests are in the space of bio-pharmaceuticals, vaccines, diagnostics and personalized medicine enabling tools, research services, medical devices and other life science opportunities in China.

James is also a member of Kleiner Perkins Caufield & Byers Pandemic Fund in which his interests are in the areas of the management of emerging infectious disease, specifically in bird flu and swine flu’s rapid diagnosis, prevention and treatment.

Prior to joining KPCB, James spent over 15 years with Merck Co. & Inc. where he held leadership positions with increasing responsibilities in clinical research, regulatory affairs, new product development and franchise management, both in the US and Asia Pacific/China. During his tenure, he was instrumental in obtaining regulatory approvals of Merck vaccines across Asia Pacific Region when the Vaccine Division started operations in the region, successfully built the foundations of Merck’s medical operations in China and drove the success of Merck’s largest product franchise in Asia.

James received his Medical Degree from Shanghai Medical University, completing an internship in Internal Medicine and a rotation in Oncology, followed by a Master of Science degree in Microbiology from the University of Montana.

James is currently involved with the following companies: BioCryst, GenScript, Kang Hui, Nexus Diagnostics, and Novavax.

Howard Liang - Dr. Liang was recognized by the Wall Street Journal's "Best on the Street" special report for stock picking in both biotechnology and pharmaceuticals in 2010, and in biotechnology in 2008.  In addition, he was named #2 Stock Picker for Biotechnology in the 2011 FT/StarMine Analyst Awards.

Dr. Liang was recognized by the Wall Street Journal's "Best on the Street" special report for stock picking in both biotechnology and pharmaceuticals in 2010, and in biotechnology in 2008.  Dr. Liang came to Leerink Swann from A.G. Edwards, where he was a senior biotechnology analyst.  His prior Wall Street experience includes JMP Securities as a senior biotechnology analyst and Prudential Securities, where he was an associate to an Institutional Investor-ranked major pharma analyst. 

Before that, Dr. Liang spent eight years at Abbott Laboratories, where he was a senior scientist and a member of one of the industry's leading structure-based drug discovery teams.  During his career as a scientist, Dr. Liang authored papers in prestigious journals including Nature, Science, and Proceedings of the National Academy of Sciences.  

Dr. Liang obtained his MBA and Ph.D. in Biochemistry and Molecular biology, both from the University of Chicago.  His undergraduate degree is a B.S. in Chemistry from Beijing University.

Dajun Yang - Dr. Dajun Yang is the Managing Director for biotechnology and healthcare in the Morningside Ventures Group. Dr. Yang co-founded Ascenta Therapeutics in 2003 and is senior VP of research. In 2005, he established Ascenta Shanghai, the company's wholly-owned R&D Facility in the Pudong High-Tech Park in Shanghai, China. Prior to Ascenta, Dr. Yang was an associate professor of internal medicine and member of Comprehensive Cancer Center at the University of Michigan; an assistant professor in the Department of Biochemistry and Molecular Biology; and associate professor in the Department of Oncology and a senior investigator of the Lombardi Cancer Center at the Georgetown University Medical Center . Dr. Yang has more than 20 years of experience in cancer research and drug development. He is author and co-author of more than 60 papers, book chapters, patents and abstracts. Dr. Yang is the inventor of over ten national and international patents (issued/pending). He built the biology and pharmacology team for S*BIO Ltd Pte, a Singapore-Chiron Joint venture biopharmaceutical company where he served as the first VP of Biology.  Dr. Yang also holds an appointment currently as an Adjunct Professor in Department of Medicine at the University of Michigan, and a visiting professor at the Cancer Center of the Sun Yat-sen University in China.  Dr. Yang obtained his M.D. in 1983 from Sun Yat-sen University of Medical Sciences (SUMS), and his Master of Medicine degree in Oncology in 1986 from the SUMS Cancer Center. He received his Ph.D. in genetics from Michigan State University. Dr. Yang served as president of the Chinese Biopharmaceutical Association (CBA) from 2003-2004.

 
Conferences and Events: 

BIO China: Vaccines & Global Health Panel

Innovations in Prevention & Treatment: Global Trends in Vaccine Platform Development

Thursday, October 13th, 9:30am - 10:45am

This session will highlight global advances in technologies for new vaccines.  Advances in recombinant, cellular and protein sciences as well as the availability of adjuvants may allow for significant improvements in vaccine technology. These advances should lead to both new and improved preventive vaccines through their ability to elicit broad antigenic responses and streamline manufacturing techniques.  In addition, they may lead to the development of therapeutic vaccines to treat complex immune diseases such as cancer, Alzheimer’s and other chronic conditions.  Companies will present scientific and clinical data and discuss their approaches to and uses for these new platforms.

Moderator:

  • Phyllis Arthur, Senior Director, Vaccines, Immunotherapies and Diagnostics Policy, Biotechnology Industry Organization

Panelists:

  • Stephen W. Cook, PhD, Vice President, Head of Worldwide Vaccine Registration Management & Regulatory Operations, GlaxoSmithKline Biologicals
  • Stanley C. Erck, President & CEO, Novavax, Inc.
  • Peter Khoury, Vice President, Global Marketing, Baxter International 
  • Jueren Lou, Director of Technoogy, Shanghai Biological Product Research Institute
  • Dr. Jean-Denis Shu, Medical Director, Sanofi Pasteur China 

   Who's Who


 

Stephen W. Cook, PhD. - Dr. Cook is Vice President and Head of Worldwide Vaccine Registration Management & Regulatory Operations for GlaxoSmithKline Biologicals based in Belgium. In this role, he has responsibility for the definition and implementation of regulatory strategy to ensure that GlaxoSmithKline Beecham Biologicals assets are registered globally. He also has responsibility for operational support (eg, databases, eCTD) for the regulatory function. Prior to this, and from 2003 to end 2007, he was Vice President for Regulatory Affairs in the Asia Pacific area (based in Singapore) for GlaxoSmithKline with overall responsibility for all GSK regulatory activities in that region of the world. Dr Cook joined the pharmaceutical industry in 1986 working in the area of Active Pharmaceutical Ingredient (API) manufacture and Quality Assurance before moving into Regulatory Affairs in 1993. He is experienced in the registration of medicinal products and vaccines in Europe and has extensive first hand experience of regulatory affairs across the International region (ie, Asia, Africa, Central Eastern Europe, Latin America and the Middle East) for both pharmaceutical and biological products.Dr Cook is a graduate of the University of Strathclyde (Glasgow, UK) where he completed a BSc (Hons.) in Applied Chemistry and then an MSc followed by a PhD in Analytical Chemistry. He is a Member of the Royal Society of Chemistry and a Chartered Chemist. He was granted the designation of Chartered Scientist (CSci) in 2004 by the (UK) Science Council. He has been a Member of The Organisation of Professionals in Regulatory Affairs [previously the British Institute of Regulatory Affairs] since 1994. He has participated in various APEC LSIF activities, delivered training and lectures on ICH country regulatory requirements and presented at many conferences on subjects as diverse as the drug development process, quality control, electronic document management, BSE/TSE, batch release requirements for vaccines and the role of regulatory affairs in the pharmaceutical industry.

Stanley C. Erck. -  Mr. Erck was named President & Chief Executive Officer of Novavax, Inc. in April 2011. Until then, Mr. Erck was the Executive Chairman of the Board of Directors of Novavax since February, 2010. From 2000-2008, Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company, and through the development of a late-stage infectious disease product candidate. Prior to Iomai, Mr. Erck served as President and Chief Executive Officer of Procept, a publicly traded immunology company; as Vice President, Corporate Development at Integrated Genetics (now Genzyme), and in management positions within Baxter International. Mr. Erck currently sits on the Board of Directors of MacCyte and MdBio Foundation. He received his undergraduate degree from the University of Illinois and his Masters in Business Administration from the University of Chicago Graduate School of Business.

Peter H. Khoury, PhD, MBA. - Dr. Khoury is Global Vice President for Baxter Vaccines. He obtained his doctorate in Microbiology from Syracuse University in 1991, studying the effects of heat shock proteins on the resistance of bacterial endospores. Dr. Khoury also holds a MBA from Cornell University's Johnson Graduate School of Management in marketing and general management. Peter has worked during the past seventeen years in various sales and marketing positions of increasing responsibility with Merck Vaccine Division, and Baxter Vaccines. His responsibilities have included Business Development, Promotion Management, Physician and Institutional Sales, Product Management, Database and Direct Marketing, International Marketing, and Global Market Strategic Development. He has been a key member of the launch teams for various pediatric and adult vaccine products. Dr. Khoury's current responsibilities in his position as Vice President, Global Marketing for Baxter International (BioScience Division) includes both vaccines sales and marketing for Latin America, North America, Asia, and the Pacific Region, government contracting, and business development.

Jean-Denis Shu - Medical Specialist qualified in France
Member of the Chinese Association of Biological Products
Member of the Reduction Committee of the Chinese Journal of Biologicals

Medical Director for Sanofi Pasteur China, Dr. Shu is widely recognized as a vaccine expert in China, with proven track-record in medical and marketing management and strong resource network in China. His past professional experiences also include Regional Director North Pacific for Chiron Vaccines (now Novartis Vaccines), Chief Representative China for Aventis Pasteur, and Medical and Regulatory Affairs Manager for Pasteur Merieux Connaught (based in Lyon, France). Dr Shu was the author of several articles and books on vaccinology and vaccines.
A French citizen born in Shanghai, Dr. Shu is bi-cultural and tri-lingual (English, French and Chinese). He earned a Certificate of Finance and Accounting from Wharton School, a MBA from the European School of Management (ESCP-EAP) in Paris, a Diploma of Specialization on Gynecology-Obstetrics from Medical and Pharmacy College of Besancon in France, and a Medical Degree, B. Med. from Medical University of Shanghai II, in China. Dr Shu spent five years as Foreign Physician in French hospitals.

Conferences and Events: 

BIO China: Health & Regulatory Issues Panel

A Bold Initiative To Support Biotechnology – China’s 12th 5 Year Plan

Thursday, October 13th, 9:30am - 10:45am

China’s recently announced 12th 5-Year Plan provides considerable support for biotechnology innovation.  This plan, which aims to support both the development and manufacture of new biotechnology products, holds substantial promise to elevate China’s position and leadership in the industry.  What does the government support for biotechnology portend for the sector? What are the various forms of support that will be created?  Which are the areas of greatest need?  This panel will discuss key aspects of China’s new initiative to support biotechnology.

Moderator:

  • Richard Davies, Vice President & General Manager, Japan & Asia Pacific, Amgen, Inc.

Panelist:

  • George Baeder, Vice President, Monitor Group Asia
  • Samantha Du, PhD, Chief Executive Officer, Hutchinson Medipharma
  • Kewen Jin, PhD - General Manager, Charles River Greater China
  • Song Ruilin, Exectuive President, SINO-PhIRDA

Who's Who


George Baeder - Mr. Baeder is a Partner and Vice President of Monitor Group Asia. He is also head of Monitor's Life Science practice in Asia. During his three decades living in Taiwan, Hong Kong and Singapore, Mr Baeder has focused on the region's emerging markets. He has spent his entire professional career in Asia, assisting major international firms to establish and expand their Asian businesses profitably and to meet the global competitive challenges originating in the region, covering ethical pharmaceuticals, OTC and medical devices. After studying economics and Chinese history in the US and Taiwan, he joined Business International Corp, a New York-based business advisory firm in 1973. In 1976 he moved to Hong Kong to build the company's Asian operations. After selling Business International in 1986, Mr Baeder founded the Pacific Rim Consulting Group, a strategy boutique, which he sold to AT Kearney in 1997.

Richard Davies - Richard is currently Amgen’s vice president of Japan and Asia Pacific and is responsible for driving the company’s expansion in this key growth region.  He began his career in the pharmaceutical industry in 1991 at Eli Lilly where he held a variety of positions in sales and business development.  From 1994 to 1996 Richard was the director of commercial and business development for the UK and played a key role in building the company’s capability in disease management.  Following this, he managed several regions for the group including Middle East and Poland, and for two years was the global team leader for Lilly’s Anti-infective Business based in Indianapolis.

Richard joined Amgen in 2003 as the general manager of Central and Eastern Europe.  In this position, he was responsible for commercial and R&D across the region and led the establishment of R&D operations in eight countries.  Three years later, Richard was promoted to run the company’s Australian operations where he successfully built market share for key products, transformed declining sales into sustained growth and represented the industry during Senate reform hearings.  From 2008, Richard was the vice president of sales for Amgen’s $3.3billion US immunology business. 

Immediately prior to his current role, Richard was vice president for Latin America, and led the acquisition and integration of Bergamo, a privately-held Brazilian pharmaceutical company specializing in hospital, oncology and generic products, as well as a deal with Mantecorp (a subsidiary of Hypermarcas) to regain the rights to key Amgen products in Brazil.

Richard has a BSc in applied chemistry from Portsmouth University and an MBA from Warwick Business School. 

Samantha Du - Dr. Du founded Hutchison MediPharma in 2002 and positioned the company for innovative drug discovery and development.  Under her leadership, HMP has established itself as a world class flagship biotechnology company in China, with more than 100 patents & patent applications worldwide, and a rich first-in-class and best-in-class potential pipeline, with its leading product entering global phase III trials.  HMP has achieved many precedent-setting milestones in China, and pioneered China’s drug development Green Channel.  HMP has also established multiple collaborations with multinational pharmaceutical companies with a “risk-sharing” strategy, and this unique business model has now been widely adopted by many other China-based pharmaceutical companies and research organizations.

Since returning to China, Dr. Du has worked closely with numerous government agencies, policy makers, and other stake holders to pave the way for drug innovation in China.  She also serves on numerous committees to help create and promote a better environment that nourishes innovative drug discovery and development in China, and a healthier ecosystem for the advancement of the overall industry.  In recent years, Samantha has received numerous awards and recognitions, including the 2010 Shanghai Magnolia Award from the Shanghai Municipality.

Kewen Jin, PhD - Kewen Jin is currently General Manager of Charles River Laboratories (CRL) China preclinical service company. He was founder/CEO of BioExplorer, a preclinical CRO which formed a JV with CRL in 2007. Kewen has co-founded and served as key executive (CEO, CBO, and founding partner) for three other companies in the R&D outsourcing, drug discovery, and consulting. He served as advisor to several MNC pharma and healthcare companies, major consulting and investment firms. Previously, he was a marketing and international operation executive with Wyeth, first five years in the U.S. , then two years in Beijing. He is a Senior Advisor to Shanghai Pudong Government. He was granted the 2005 Magnolia Award, which the Shanghai government grants to individuals making major contribution to the development of Shanghai. He is a member of the Board of Directors for Bayhelix and Sino American Pharmaceutical Association (SAPA), two leading Chinese life science professional organizations. He was trained in medicine (Shanghai Jiaotong University School of Medicine), biology (Rockefeller), finance (Columbia). 

Song Ruilin - Ever since the establishment of the Bureau of the Legislative Affairs under the State Council in April 1986, Mr. Song has been engaged in legislative review and research on public health and medicine. He is now an expert in legislation on public health and medicine, given his participation in almost all the legislative activities in public health in China since 1986.

Mr. Song was awarded the “Anti-SARS Medal” by Beijing municipal government in 2003. He played an important role in the organising of the drafting panel for Law on Prevention and Cure of Infectious Diseases approved by the State Council to be co-organised by the Council’s Legislative Affairs Office and the Ministry of Public Health in June of the same year. Now the Law on Prevention and Cure of Infectious Diseases has been enacted and implemented. In 2004, following the decision by the State Council to amend the Law on Food Hygiene, Mr. Song took the lead in the drafting panel.

Mr. Song is currently member of the National Committee on the Assessment of the Protected Traditional Chinese Medical Products, council member of China Pharmaceutical Association and Chinese Health Law Academy, and standing council member of China’s International Travelling Health Association and (Macao) International Association of Chinese Medicine.

Conferences and Events: 

BIO China: Keynote Session with Jörg Reinhardt CEO, Bayer HealthCare

Jörg Reinhardt
CEO, Bayer HealthCare 

Dr. Jörg Reinhardt has been Chairman of the Board of Management of Bayer HealthCare AG and Chairman of the Bayer HealthCare Executive Committee since August 15, 2010.

Dr. Jörg Reinhardt, born on March 11, 1956 in Homburg in the German state of Saarland, studied pharmaceutical sciences at Saarland University in Saarbrücken. After obtaining his doctorate in 1981, he started his career with Sandoz, a predecessor company of Novartis, in 1982, holding various managerial positions of increasing responsibility in research and development. He was appointed Head of Corporate Development in 1994.

After the formation of Novartis in 1996, he served as Head of Preclinical Development and Project Management before being appointed Global Head of Pharma Development in 1999. In November 2005 he was appointed CEO of the Vaccines & Diagnostics Division, Boston, United States. At the end of 2008, Reinhardt returned to Switzerland to become Chief Operating Officer (COO) of Novartis, a position he held until the end of January 2010. In this capacity Reinhardt was responsible for all four of the group’s divisions as well as for Human Resources, IT, Corporate Affairs and Communications. He was also a member of the company’s Executive Committee.

From 2000 until January 2010, Reinhardt also served as Chairman of the Board of Directors of the Genomics Institute of the Novartis Foundation in La Jolla, California. From 2001 through 2004 he was a member of the Supervisory Board of MorphoSys AG, Germany, which specializes in researching and developing monoclonal antibodies.

Jörg Reinhardt is married and has two grown-up children.

Conferences and Events: 

BIO China: Intellectual Property Panel

Encouraging Innovation through Robust Patent Enforcement

Wednesday, October 12th, 4:00pm - 5:15pm

A panel of experts will explore how enforcement of IP can support the goals of the 12th Five-Year plan in a competitive global economy.  The panel will explore the challenges to enforcement in face of limited resources and will compare and contrast enforcement in the US and China.

Moderator:

  •  Frank S. DiGiglio, Managing Partner, Scully Scott Murphy & Presser PC  

Panelists:

  • Brian P. Barrett, R.Ph., JD, Senior Director, Assistant General Patent Counsel, Eli Lilly
  • David Shen, Regional Legal Counsel, AstraZeneca
  • Tina Tai, Patent Attorney, Attorney at law, Assistant General Manager, China Patent Agent (H.K.) Ltd.

 


Who's Who


 

Brian P. Barrett - Brian Barrett is Senior Director - Assistant General Patent Counsel at Eli Lilly and Company, Indianapolis, Indiana.  He practices patent prosecution and patent litigation strategy.  He joined Lilly in 1988.  He is a member of the Indiana Bar Association, American Intellectual Property Law Association, Intellectual Property Owners Association and the Biotechnology Industry Organization (BIO).  He is a former chairman of BIO’s Intellectual Property Counsels Committee and currently chairs BIO’s amicus committee.  Mr. Barrett has degrees in chemistry and pharmacy and graduated with honors from the Indiana University School of Law-Indianapolis in 1994.  He is admitted to the bars of Indiana and the Federal Circuit, and is admitted to practice before the U.S. Supreme Court.

Frank S. DiGiglio - Frank DiGiglio received his B.S. in Biology from Boston College in 1975 and his J.D. from St. John's University School of Law in 1982. He was admitted to the N.Y. State Bar in 1983, the U.S. District Court, Southern and Eastern Districts of N.Y., N.Y. State Court of Appeals for the Second Circuit and U.S. Court of Appeals, and Federal Circuit. Mr. DiGiglio is registered to practice before the U.S. Patent and Trademark Office and is a member of the N.Y.S. Biotechnology Association, NYIPA and AIPLA. Mr. DiGiglio is an Adjunct Professor at Benjamin N. Cardozo School of Law (Yeshiva University) in Pharmaceutical and Biotechnology Patent Law. Mr. DiGiglio is experienced in patent and trademark litigation; extensive interference practice; Federal Circuit appeal practice; with technical emphasis in biotechnology, biochemistry and pharmaceutical sciences.

Tina Tai - Ms. Tai received, from Peking University, her B.S. in Applied Chemistry in 1990 and M.S. in Polymer Chemistry in 1993. She joined CPA in 1993, and qualified as a patent attorney in 1994. Ms. Tai was admitted to practice law in 1999. She took the LLM program at the University of London from 2002 to 2003. She received further training at a famous company in Germany in 1997, and at other German and British law firms in 2001. She participated in the Research Project on the Third Amendment to the Chinese Patent Law in 2005. As a patent attorney, Ms. Tai has represented many of our important Chinese and foreign clients in renowned invalidation cases and lawsuits. She represented Pfizer. Inc. as the chief attorney in both invalidation proceedings and court procedure involving the “Viagra” case. Besides, she is skillful in drafting patent application documents in such fields of technology as polymer, pharmaceutical chemistry, organic chemistry, organic synthesis, and experienced in preparing responses to office actions in the substantive examination proceedings, in handling cases of patent reexamination, invalidation and patent-related administrative litigation and infringement lawsuits, and in making infringement analysis. Ms. Tai is a council member of the China Intellectual Property Society, a member of the Chinese Group of AIPPI, a member of the board of All-China Patent Agents Association and a member of LES China. Working language: Chinese, English, German and Japanese.

Conferences and Events: 

BIO China: Health & Regulatory Issues Panel

Navigating Changes in China's Registration & Regulatory Process

Wednesday, October 12th, 2:30pm - 3:45pm

To successfully introduce a new product in China requires in-depth knowledge of Chinese regulatory requirements.  At the same time, sponsors are increasingly looking to conduct trials simultaneously in multiple countries, putting a premium on a regulatory system that has strong standards that are similar among countries.  How are changes in China's regulatory structure supporting increased innovation?  How is the SFDA operating in a manner to foster both more rapid drug development to improve public health and internationally simultaneous trials?  Are there constraints that make changes to the registration and regulatory process more difficult to achieve?  In this session, experienced representatives from multi-national and local Chinese companies will discuss the registration process for products manufactured in China, import licensing issues for products exported to China, and the connotations of these processes for innovative global drug development.   

Moderator:

  • Romi Singh, Executive Director, Regulatory Affairs, Amgen, Inc.
     

Panelist:

  • He Bai, Official, Drug Registration Department, SFDA
  • Wassim Nashabeh, Ph.D, Global Head, Technical Regulatory Policy & Strategy, Genentech, a member of the Roche Group

Who's Who


 

Romi Singh - Dr. Romi Singh has over 14 years of extensive scientific and management experience in top-tier pharmaceutical and biotechnology companies such as Burroughs/GlaxoWellcome, Merck, and Amgen. His experience spans across the spectrum of drug development-basic research to regulatory/clinical sciences. He is well published and recognized in field of drug metabolism and is an expert on clinical trials and drug registrations in developing countries. Dr. Singh is currently an Executive Director of Global Regulatory & Safety heading the group that supports expansion into new emerging markets in Latin America, Asia, Central & Eastern Europe. He holds an undergraduate degree from St. Stephen’s College, doctorate from the University of Kansas, and has received postdoctoral training from the University of Washington.

Conferences and Events: 

BIO China: Opening Keynote Plenary Session

The Honorable Elaine Chao, Secretary, U.S. Department of Labor 2001-2009

Elaine L. Chao, the 24th U. S. Secretary of Labor, is the first American woman of Asian descent to be appointed to a President’s Cabinet in our nation’s history.  Having served from 2001-2009, she is the longest tenured Secretary of Labor since World War II, and the only member of President George W. Bush’s original cabinet to have served the entire eight years of his Administration.

An immigrant who arrived in America at the age of eight and speaking no English, Secretary Chao’s experience transitioning to a new country has motivated her to dedicate most of her professional life to ensuring that all people have the opportunity to build better lives.

As the first U. S. Secretary of Labor in the 21st century, Elaine L. Chao focused on improving the competitiveness of America’s workforce by restructuring departmental programs to empower workers and modernizing regulations to respond to the realities of the 21st century workplace.  Under her leadership, the U.S. Department of Labor achieved record results in protecting the health, safety, wages, and retirement security of the nation's workforce. These results included record low workplace injury, illness and fatality rates, recovering record levels of back wages for workers and monetary recoveries for workers’ pension plans, and obtaining record financial settlements for discrimination by federal contractors.

Secretary Chao successfully directed the Department to update the white collar overtime regulations under the Fair Labor Standards Act, which had been on the agenda of every Administration since 1977. The most significant regulatory tort reform of President Bush's first term, the new regulations provided millions of low-wage, vulnerable workers with strengthened overtime protections. For the first time in over 40 years, the Department updated the union financial disclosure regulations, giving rank and file members enhanced information on the financial condition of their unions.

The Department also launched comprehensive reform of the nation's publicly funded workforce training programs to better serve dislocated and unemployed workers. The Department spearheaded many of the reforms in the Pension Protection Act of 2006 to protect the retirement security of 44 million Americans with defined benefit plans. In record time, the Department processed disability compensation claims to energy workers, and implemented the requirements of the MINER Act, the first major legislation on mine safety in over 30 years.  In November 2008, the Department successfully updated the Family and Medical Leave Act for the first time in 15 years, implementing the first-ever job-protected leave rights that allowed America’s military families to care for our wounded warriors.  Under Secretary Chao’s leadership, the Department also made it a top priority to increase and protect our soldiers’ civilian re-employment rights, including issuing compliance regulations to fully implement the Uniformed Services Employment and Reemployment Rights Act (USERRA), which had been passed in 1994.

In the first successful use of the Taft-Hartley Act since 1971, the Department led the effort to resolve the West Coast ports labor dispute in 2002, which was costing the nation up to $1 billion a day in damages.

Secretary Chao's distinguished career spans the public, private and non-profit sectors. As President and Chief Executive Officer of United Way of America, she restored public trust and confidence in one of our nation's largest institutions of private charitable giving after it had been tarnished by financial mismanagement and abuse. As Director of the Peace Corps, she established the first programs in the newly liberated Baltic nations and the independent states of the former Soviet Union.  Her government service also includes serving as Deputy Secretary at the U.S. Department of Transportation, Chairman of the Federal Maritime Commission, Deputy Maritime Administrator, and White House Fellow.  Prior to her government service, she was Vice President of Syndications at BankAmerica Capital Markets Group and a banker with Citicorp.

Secretary Chao earned her MBA from the Harvard Business School and an economics degree from Mount Holyoke College.

Conferences and Events: 

BIO China: Intellectual Property Panel

Effective IP Mechanisms for Bringing Biopharmaceuticals to Market 

Wednesday, October 12th, 2:30pm - 3:45pm

China’s investment in its 12th Five-Year Plan has resulted in a significant boost in biotechnology R&D.  Innovative technologies and discoveries are resulting from investment in biotechnology.  China’s nascent innovative biopharmaceutical sector will be faced with challenges and opportunities for bringing their products to market.  A panel of experts will explore various IP mechanisms for protecting research data including trade secret and regulatory data protections as means for bringing discoveries to market.  The panel will also look to systems in the U.S. (Hatch Waxman) and in Europe (Biosimilars) as possible mechanisms for approval of biopharmaceuticals. 

Moderator:

  • Jonathan Z. Yuan, Managing Partner, US & European IP Practice, Shangcheng & Partners  

Panelists:

  • Haiyan Chen, PhD, JD, Senior Patent Counsel, GlaxoSmithKline R&D China
  • Jeffrey D. Hsi, Partner, Edwards Angell Palmer & Dodge, LLP
  • Joseph P. Taormino, Ph.D., Partner, Co-leader of Biotech Group, Hoffman Eitle
  • Yang Xu, PhD, JD, Chief Patent Counsel, Simcere Pharmaceuticals

Who's Who


Haian Chen - Haiyan Chen is senior patent counsel at GlaxoSmithKline R&D China.  Ms. Chen works on a variety of IP issues and her responsibilities include providing IP advices and opinions, developing and maintaining patent portfolios, developing IP strategy, and conducting IP due diligence.  Prior to joining GSK in 2009, Ms. Chen was a patent attorney at Fitzpatrick Cella in New York. Ms. Chen received her J.D. from Georgetown University and her Ph.D. in Biochemistry from Harvard University.

Jeffrey D. Hsi - Jeffrey's practice is devoted to corporate counseling, formation and execution of intellectual property strategy, and patent prosecution and opinion work in the areas of chemistry pharmaceuticals, biotechnology, agriculture, nutraceuticals, polymers, diagnostics, and medical devices.

Jeffrey's clients include multinational chemical and pharmaceutical companies, emerging biopharmaceutical companies, and academic and governmental research institutions throughout the world.

Jeffrey also served as Chair of the Firm's Intellectual Property Department for the past five years and serves on the Firm's Boston Office Teamwork and Diversity Strategic Committee.

Jeffrey has considerable experience in patent prosecution matters. He has prepared and prosecuted patent applications relating to pharmaceuticals (both approved and candidates in clinical trials), drug design/discovery technologies, nutraceuticals, medical diagnostics and biotechnology. Jeffrey also is experienced in specialty chemical and polymer technologies, medical devices, food and agricultural technologies and business methods.

Jeffrey also has experience in transactional matters including negotiation and establishment of licensing and R&D collaboration agreements, manufacturing and supply agreements, due diligence studies, venture capital funding, merger and acquisition, and technology acquisitions.

As in-house counsel to a biopharmaceutical start-up company, Jeffrey established and guided the company's patent law department, including formation of worldwide corporate intellectual property strategy and internal intellectual property policies.

Jeffrey also advised on aspects of corporate and business development activities. The start-up was ultimately acquired by a major U.S. biotechnology company.

Jeffrey is an invited speaker internationally on various intellectual property issues and has lectured at the Harvard Extension School and at MIT Sloan School of Management. Jeffrey is a co-author of written materials and lectured for the "Biotechnology: Patents, Licensing & FDA Practice" course for the Patent Resources Group.

Jeffrey is a co-inventor on two U.S. Patents and co-author of numerous scientific publications and presentations.

Joseph P. Taormino - Joseph Taormino studied chemistry at Cornell University, Ithaca, NY/USA, B.A. in 1985; Ph.D. in 1992 from The Johns Hopkins University in the area of biochemistry, cell and molecular biology and genetics. Dissertation on the transcriptional and post-transcriptional regulation of gene expression in animal cells. Lecture at JHU on human genetics 1992; Alexander v. Humboldt Postdoctoral Fellowship at the University of Cologne in the field of transgenic animal models in 1994. With Hoffmann Eitle since 1994; European Patent Attorney since 1998. Co-leader of Biotech Group since 2002.

Opposition and appeal proceedings before the European Patent Office; legal opinions and litigation in the fields of biotechnology, food chemistry and pharmaceuticals. Particular experience with patents/applications relating to genes, proteins, transformed eukaryotic and prokaryotic cells, transgenic animals and plants and in vitro screening and diagnostic methods. Involved in opposition/appeal proceedings on erythropoietin (T412/93), antisense RNA (T994/95), reach-through claims (T609/02) among others; cross-border litigation on alpha-interferon and involvement in several due diligence evaluations on the IP assets of established biotech firms and start-ups

Jonathan Z. Yuan - Jonathan is a managing partner for US & European IP Practice at Shangcheng & Partners, an intellectual property law firm located in Beijing with a branch office in Shanghai. Jonathan is a U.S. patent attorney registered to practice before the United States Patent and Trademark Office. He is also an attorney at law admitted in New York and Connecticut. Jonathan's practice focuses on patent counseling, strategies, search and analysis, opinion, procurement, patent litigation/ITC 337 actions and licensing in technology fields including life sciences, pharmaceuticals, material sciences, medical devices and electronics. He counsels various clients, most of which are based in US and Europe, ranging from multinational pharmaceutical companies to start-ups and academic institutions

Jonathan obtained his B.S. in biology from Peking University, China. He was later trained in a master of medicine program at Peking Union Medical College in Beijing and a Ph.D. program on cell and molecular biology in City University of New York. He earned his master’s degree in biology from City College of New York and his J.D. from St. John’s University School of Law in New York. Prior to pursuing his legal career, Jonathan conducted research in molecular and developmental biology at Cold Spring Harbor Laboratory.

Before joining Shangcheng, Jonathan was a partner at one the largest IP law firms in China as well as the head of the firm’s Shanghai office. Before that, Jonathan was an attorney with a large international law firm based in US and a representative/visiting attorney at the firm’s Shanghai and Beijing offices. Jonathan started his legal career at a well-known IP boutique in New York.

Jonathan is frequently invited to speak in international IP conferences and was interviewed by major media in US and China on various IP issues. He was one of the key organizers behind several high-profile IP forums in China. Jonathan is an author/a co-author of numerous scientific and legal publications, including an article featured on cover of China Law and Practice (2010), Chapter of “Patent Law” in the book Doing Business in China (2010), and a research article featured on cover of Cell (1998) as well as other peer-reviewed articles on journals Development, Proc Natl Acad Sci USA, and Genes & Development. Jonathan is a co-inventor on a PCT application filed in the US.

Jonathan is a member of AIPLA, INTA and AUTM.

 



Conferences and Events: 

BIO China: Intellectual Property Panel

Protection of Biotechnology Inventions in China, US and Europe: A Comparative Perspective

Wednesday, October 12th, 1:00pm - 2:15pm

The panel will compare what can be patented and the scope of protection in China, EU and the US including protections that are afforded to plants (utility, PVP, etc.). The panel will also explore the impact of changes in patent laws or regulations in each of these jurisdictions on biotechnology patenting.  The panel will consider aspects of the Third Patent Law Amendments in China, patent reform in the US, and the European Directive and other related policies and their impact on biotechnology patenting.

Moderator:

  • Thomas T. Moga, Of Counsel, Shook, Hardy and Bacon

Panelists:

  • Francisco Fernandez y Branas, Director Biotechnology, European Patent Office
  • Jasemine Chambers, Deputy Administrator for Policy and External Affairs, United States Patent and Trademark Office (USPTO)
  • Zhang Qingkui, Director General, Pharmaceutical and Biotech Examination Department, State of Intellectual Property Office, People's Republic of China
  • Chris Sappenfield, Senior Counsel, Ibis Biosciences, Inc.

Who's Who


 

Jasemine Chambers - As the Deputy Administrator for Policy and External Affairs at the United States Patent and Trademark Office (USPTO), Dr. Chambers assists the Administrator for Policy and External Affairs in providing policy advice to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on matters relating to intellectual property (IP) protection and enforcement, and IP-related trade issues, including proposed legislation and international activities.  She also has responsibility for overseeing the day to day operations of the Office of Policy and External Affairs that comprises Policy and Administration Support, the Office of Governmental Affairs, the Global IP Academy, the IP Attaché Program, and the Office of the Chief Economist.

Prior to assuming her current position, Dr. Chambers was Director of Technology Center 2900.  She oversaw a 120-member organization responsible for the examination of industrial design patent applications.  Dr. Chambers also participated in the review and analysis of pending legislative proposals on industrial design protection and the implementation of the Geneva Act of the Hague Agreement, as well as represented the USPTO in Trilateral Meetings on Industrial Designs.

Dr. Chambers began her career at the USPTO in 1988 as a Patent Examiner in biotechnology.  She became a Supervisory Patent Examiner in 1996, and was appointed Director of Technology Center 1600 in 2000 to oversee the examination of biotechnology, pharmaceutical, and organic chemistry patent applications.  Dr. Chambers was instrumental in developing policy and practice related to the examination of stem cells, animals and gene therapies, as well as in developing examination guidelines and examiner training materials on the utility, written description and enablement requirements for biotechnological inventions.  She represented the USPTO in meetings of the Trilateral Biotechnology Working Group and worked on harmonizing examination practices.  Dr. Chambers also served as the USPTO's project coordinator in the creation of the Patent Cooperation Treaty Search and Examination Guidelines that was subsequently adopted by the World Intellectual Property Organization in 2004. 

A former law clerk to Chief Judge Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit, Dr. Chambers also has served on detail assignments at the White House Office of Science and Technology Policy, the Department of State’s Office of Intellectual Property Enforcement, and the USPTO’s Office of Intellectual Property Policy and Enforcement.  Prior to joining the USPTO, Dr. Chambers was a Postdoctoral Research Fellow at the Duke University Medical Center, and a Senior Staff Fellow at the National Institutes of Health.

Dr. Chambers is the recipient of a Commerce, Science and Technology Fellowship, a Department of Commerce Team Gold Medal for work on the Patent Cooperation Treaty Search and Examination Guidelines, a Department of Commerce Team Silver Medal for work on China intellectual property issues, two individual Bronze Medals for sustained outstanding performance, and a USPTO Exceptional Career Award. 

Dr. Chambers received a B.A. with high honors in Biology from Agnes Scott College, a Ph.D. in Molecular Biophysics from the Florida State University, and a J.D. with honors from the George Washington University Law School.  She is a member of the Maryland state bar and the District of Columbia bar, and is admitted to practice before the U.S. Supreme Court and the Court of Appeals for the Federal Circuit. 

Thomas T. Moga - Thomas T. Moga is a patent attorney with the Washington DC office of Shook, Hardy & Bacon where he focuses on patent preparation and prosecution as well as on licensing, litigation and dispute resolution. His primary experience is in development and enforcement of domestic and foreign patent portfolios for US pharmaceutical and chemical companies.  Mr. Moga holds a BS degree in biochemistry and a degree in law.  He is an experienced patent prosecutor in the chemical, biochemical and pharmaceutical arts and has been qualified and has testified as an expert witness in patent disputes.   Mr. Moga is the author of a multi-volume treatise on patent law in Asia.

Mr. Moga has been involved in intellectual property training programs both at home and abroad. He spent part of 1997 as a Fulbright Scholar in China where he taught patent law at Jilin University and acted as an instructor for patent examiners at China’s State Intellectual Property Office.  Mr. Moga was a visiting foreign expert in law at Xiamen University, China. He is an adjunct professor of law at the University of Toledo School of Law and is on the Board of Advisors for the Cooley School of Law’s LLM program in intellectual property.

Conferences and Events: 

BIO China: Zhangjiang Session

Innovation in Zhangjiang

 Wednesday, October 12th, 1:00pm - 2:15pm

As a passport to China innovation, ZJ High-Tech Park played a pivotal role in leading biotech and pharmaceutical development in China.  In this session you will meet leaders from the different sectors in Zhangjiang who have contributed to the establishment of the innovation ecosystem in Shanghai.  While it is important for you to hear their successful experiences and lessons learned in our session, you can expect more;  they will collectively address the frequently asked Big Question " When can China become a leader in drug discovery innovation and what does it take to make China discovery far more productive than what we have done in the last two decades in the western world?"  

Moderator:

Dr. Li Chen, President and CEO, Hua Medicine Co., Ltd.

Panelists:

  • Mr. George Baeder, Monitor Group Company
  • Mr. Kevin Chen, President & COO, ShangPharma Group
  • Mr. Leon Chen, Partner, Fidelity Asia Growth Partners
  • Dr. Samantha Du, CEO, Hutchison MediPharma Limited (HMPL)
  • Lingshi Tan, General Manager (China) R&D Center and VIP, Worldwide Development Operations, Pfizer, Inc.
  • Mr. Tony Zhang, Vice Presdient of Global R&D, Asia, Eli Lilly and Company
Conferences and Events: