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2010 CBA Annual Conference - A Sea Change: Advancement in Biotech & Pharmaceutical Industry
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2 0 1 0 A n n u a l C o n f e r e n c e
A S e a C h a n g e : A d v a n c e m e n t i n B i o t e c h & P h a r m a c e u t i c a l I n d u s t r y
P e r s o n a l i z e d M e d i c i n e
O c t o b e r 3 0 , 2 0 1 0 I 1 2 : 0 0 p m ~ 9 : 0 0 p m I D o u b l e T r e e H o t e l
T h e r a p e u t i c D r u g D e v e l o p m e n tB i o m a k e r s a n d D i a g n o s t i c s
B u s i n e s s a n d C a r e e r O p p o r t u n i t i e s
Abgenomics
Gold
www.abgenomics.com.tw
CITS Group www.citsgroup.com.cn
Genemed Inc www.genemed.com
QPS LLC www.qps.com
TECO sf.nsc.gov.tw
Primary Realty andFinance/Allison Yang [email protected]
ProtevoBio Inc www.protevobio.com
Julia Hsiao Insurance andFinancial Services www.calljulia.com
AB SCIEX
Si lver
www.absciex.com
AllCells www.allcells.com
Antagene, Inc. www.antageneinc.com
Cook Pharmica www.cookpharmica.com
Crown Biosciences www.crownbio.com
Hsinchu Science Park www.sipa.gov.tw
InvestHongKong www.investhk.gov.hk
ITRI www.itri.com
Shimazu www.shimazu.com
ThermoFisher www.thermofisher.com
Wisbiomed www.wisbiomed.com
Turning Leaf Financial www.TLPlanners.com
Sponsors
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Table of Contents
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Table of Contents President ‘s Message Organization and Advisors Conference Chairperson’s A Message Conference Agenda Perspectives on 30 years in Biotechnology Opportunities and Challenges in the Development of Novel Small Molecule Therapeutics for Oncology Obstacles to the Commercialization of the First Inhaled Insulin Product, Exubera Kaletra: a Second Generation Protease Inhibitor from Abbott Laboratories The Landscape and Trend of In Vitro Diagnostics Advances in Diagnostics and Biomarkers Translating Gene Expression Patterns into Commercialized Cancer Diagnostics Strategies for Developing Pharmacodynamic and Predictive Biomarkers to Target Cancer Stem Cell Agents Key Events RNAscope™, a Novel RNA In Situ Hybridization Platform for Personalized Medicine Introducing a Novel, Semiconductor Chip-Based Platform for DNA Biomarker Discovery and Personalized Medicine New Waves in Therapeutic Drug Development The Changing Ecology of 21st Century Pharmaceutical Research and Development Changing Business Model for Changing Times: The Rise of Virtual Innovation Conducting Personalized Medicine With The Assistance of Biostatisticians Next Generation Biology Through Next Generation DNA Sequencing Data-Driven Drug Discovery and Personalized Medicine ‘The Great Recession’ : How US Consumer Is Reacting to It and the Implications for International Trade
Copyright © 2010 Chinese Bioscience Association, San Francisco, California All right reserved.
President’s Message
Dr. Sydney S. Chen
Welcome to the 2010 Annual Conference. Thirty years since Genentech had the successful IPO in 1980 and became the first ever biotechnology company, Bay Area has the privilege of becoming the home of more than 1300 biotech companies of various sizes. One very important aspect why Bay Area became the Mecca of Biotechnology is the significant contributions by generations of outstanding Chinese Americans. Today, wherever you look in biotech, from labs to Board Rooms, Chinese Americans are there, conducting advanced
research, creating new markets, founding new companies, and in general helping to define the biotechnology for tomorrow. They helped to write the history of biotech in Bay Area and are crafting its future. CBA was founded in 1997 to provide a forum that helps all Chinese Americans in this industry to come together to know each other better, exchange information, and create new business opportunities. Every year, CBA hosts an annual conference and several seminars, organizes various activities, such as co-hosting job fairs and our extremely popular summer picnic/BBQ. With our unique identity, CBA has also established collaboration and communication with various organizations in the Asia Pacific region. With the continuously high interest in developing biotech and pharmaceutical industry in Asia, CBA has been invited to coordinate scientific and business meetings with delegations from China, Taiwan, as well as Hong Kong. As an active member of the community, CBA has a youth program in which we invite representatives from various biotech industry sectors to discuss and answer questions from high school and college students who are interested in pursuing career in bioscience field. For the past three years, CBA has awarded Fong-Yi Memorial Scholarship to junior college students who major in bioscience in the Silicon Valley. This year, CBA has also sponsored the American Cancer Society-Relay for Life event. Today CBA has close to 1000 members all over the Bay Area. As one of the Founding Board Members, I am extremely proud to be part of this fantastic organization. Of course, our Board of Directors and volunteers over the years are the true heroes who made it all possible. In particular, my utmost gratitude goes to my Board of Directors for 2010, specially our Web Master Frank, and the Publication Team, Peiwen, Cindy, Ming and Cesar. Without their talent, commitment, and countless hours of hard work, none of these events would have become reality. I would also like to thank our senior advisors and former presidents - Stella, Kelley, Betty, and Joshua, for their advice and their help in recruiting volunteers and fundraising. You are all welcome to join our exciting CBA family. CBA can help you not only to expand and enrich your professional network, but also to establish long-lasting friendship with a great group of people, allow you to demonstrate your talents beyond your work, and simply have some fun. Finally, I would like to thank you for attending our 2010 Annual Conference organized by our Conference Chair Dr. Patty Kiang and fellow Board Members. I sincerely hope you enjoy all the sessions as well as the evening presentation and live performance.
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Conference Chairperson’s Message
Dr. Patty Kiang
Welcome to the Annual Conference.
There has been tremendous progress made in developing innovative technologies for clinical diagnostics and understanding the roles of biomarkers in personalized medicine. The completion of the human genome project, the rapid development of pharmacogenomic technologies and the proposal of the Genomics and Personalized Medicine Act of 2010 all call for changes in current practices and present unique challenges and opportunities. Additionally, the changing ecology of 21st century pharmaceutical research and development and
evolving business models during these difficult times also greatly impacted our industry. We all need to be aware of the trend and to adapt quickly to the changes. Therefore, our program is designed to share with you some of the latest information on emerging biotechnological, pharmaceutical development and business opportunities around the world.
We have expanded the program to include a plenary session to cover the broad spectrum of therapeutic and diagnostic developments summarizing industry review and new opportunities, followed by two concurrent sessions focused on the future development of both diagnostic and therapeutic areas.
In this session, five leaders from representative companies in the Bay area will share with us their success, their valuable lessons-learned and their insights on industry outlook.
In session A - Advances in Diagnostics and Biomarkers, leaders from these fields will share with us their experience, excitement, and vision, from tissue based diagnostics, DNA microarray, cancer stem cell biomarkers, to a novel RNA technology. In session B - New Waves in Therapeutic Drug Development, the generation of Customized Medicines through Molecular Profiling and next generation sequencing will be discussed. In addition, the new business model, especially with the globalization trend, and the investment aspects on drug discovery will be discussed.
A banquet dinner with live entertainment will take place in the evening. We also have the pleasure of Dr. David Robinson from Haas Business School, UC Berkeley, join us. He will discuss the hot topic of the recent financial crisis and its impacts on the industry.
This is going to be a very exciting, informative, and enjoyable conference. I am confident that you will gain new insights into our industry and may be inspired to have new ideas. You will expand your networking and make new friends.
Finally, I would like to take the opportunity to thank my committee members for their dedication and enthusiasm to make this conference possible.
Conference Committee: Program Chairperson: Patty Kiang Chairpersons: Cheng-Chi Chao, Michelle Chen, Stella Chang, Jeng Her, Andrew Teng Publication Committee: Editor-in-Chief: Peiwen Yu Art Editors: Cesar Ho, Ming Cheng Reviews Editors: Jessica Diao, Katherine Wang, Julie Yang Designer: Cindy Liu Press Release Committee: Webmaster: Frank Lin
President:
Organizat ion
Sei-Yu Chen
Vice Presidents: Patty KiangYong-Liang Zho
Directors: Cheng-Chi ChaoMichel le ChenJessica DiaoJeng HerPeiwen YuYeping Zhao
Secretary: Ta-Kai L i
Treasurer: Kather ine Wang
Community Relat ionship: Jul ie Yang
Market ing: Andrew Teng
Webmaster: Frank Lin
Member Database: Cindy Liu
Publ icat ion: Cesar Ho
Logo Designer: Candy Tang
Websi te powered by: Matchbin, Inc.
Websi te: www.cbasf.orgEmai l : [email protected]
Printer: E&T Pr int ing, San Jose, Cal i fornia
Senior Advisors
Dr. Jin-Long ChenFounder, President and Chief Scientific OfficerNGM Biopharma
Dr. David ChienChief Executive Officer and ChairpersonYingTech Bioscience Consulting Co.
Dr. Frank KungCo-founder & Managing partnerVivo Ventures
Dr. Rong-Hwa LinChief Executive Officer and Chairman of the BoardAbGenomics
Dr. Ching H. WangProfessor, Stanford University
Dr. Patrick YangExecutive VP, Genentech / Roche
AdvisorsDr. Betty ChangDirector, Pharmacyclics Inc.
Dr. Kelley LiuLead Expert, Biotechnology, CITS Group
Dr. Li-Chun HuangSenior Scientist, Genentech
Dr. Benjamin ChienPresident & CEO, Quest Pharmaceutical Services
Stella Chang, M.S.Senior Scientist, Juvaris BioTherapeutics
Dr. Joshua ChangVP of Business Development, RDD Lab Inc.
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Organization and Advisors
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12:00 -1:00 Registration 1:00 - 1:10 Welcome & Opening Remarks
Dr. Sydney Chen, President CBA Plenary Session
(1:10 - 3:15)
Introduction Conference Chairperson: Dr. Patty Kiang , Vice President CBA Co-Chairperson: Dr. Cheng-Chi Chao
1:10 - 1:35
1:35 - 2:00
2:00 -2:25
2:25 - 2:50
2:50 - 3:15
Perspectives on 30 years in Biotechnology. Dr. Kevin Moore Opportunities and Challenges in the Development of Novel Small Molecule Therapeutics for Oncology. Dr. Peter Lamb Obstacles to the Commercialization of the First Inhaled Insulin Product, Exubera. Dr. John Patton Kaletra: a Second Generation Protease Inhibitor From Abbott Laboratories. Dr. Hing Sham The Landscape and Trend of In Vitro Diagnostics. Dr. Jimmy Zhang
3:15 - 3:40 Coffee Break Session A (3:40 - 5:45)
Advances in Diagnostics and Biomarkers Chairpersons: Dr. Michelle Chen and Ms. Stella Chang
3:40 - 3:50
3:50 - 4:10
4:10 - 4:30
4:30 - 4:50
4:50 - 5:10
5:10 - 5:45
Introduction and Overview. Dr. Michelle Chen Translating Gene Expression Patterns into Commercialized Cancer Diagnostics. Dr. Douglas Ross Strategies for Developing Pharmacodynamic and Predictive Biomarkers to Target Cancer Stem Cell Agents. Dr. Ann Kapoun RNAscope™, a Novel RNA In Situ Hybridization Platform for Personalized Medicine. Dr. Yuling Luo Introducing a Novel, Semiconductor Chip-Based Platform for DNA Biomarker Discovery and Personalized Medicine. Dr. Gary Zweiger Panel Discussion
Session B (3:40 - 5:45)
New Waves in Therapeutic Drug Development Chairpersons: Dr. Jeng Her and Mr. Andrew Teng
3:40 - 4:05
4:05 - 4:30
4:30 - 4:55
4:55 - 5:20
5:20 - 5:45
Capturing the Value of a Drug Before It Hits the Market The Changing Ecology of 21st Century Pharmaceutical Research and Development. Dr. Jim Larrick Changing Business Model for Changing Times: The Rise of Virtual Innovation. Dr. Yiyou Chen Generation of Customized Medicines through Molecular Profiling Conducting Personalized Medicine With The Assistance of Biostatisticians. Dr. Xiaowei Yang Next Generation Biology Through Next Generation DNA Sequencing. Dr. Dawei Lin Data-Driven Drug Discovery and Personalized Medicine. Mr. Joel Dudley
6:00 - 6:45 Networking Mixer and Exhibits Banquet Dinner
(6:45 - 9:00)
Live Entertainment: Sopranos - Lily Xu, Melody Wang and Remona Ji Keynote: ‘The Great Recession’: How US Consumer Is Reacting to It and the Implications for International Trade. Dr. David Robinson
Conference Agenda
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Perspectives on 30 Years in Biotechnology
Kevin W. Moore, Ph.D. Executive Director Research Protein Sciences Amgen
ABSTRACT My career in biotechnology began during the industry’s formative years. During the subsequent three decades pharmaceutical biotechnology has matured, with a few firms achieving “near-pharma” levels of success and growth. Nonetheless it retains an entrepreneurial tradition that, while suffering high failure rates, periodically creates innovations that spur progress. This presentation will discuss observations and lessons learned during my experiences in both the start-up and larger company environments. Biotechnology’s financial and regulatory challenges have never been greater, but 21st century advances in biolog y and technology offer astonishing opportunities for new therapies that will improve patients’ lives.
BIOGRAPHY Dr. Moore holds a Ph.D. in Chemistry and Chemical Engineering from the California Institute of Technology and an BA in Chemistry and a Certificate of Proficiency in Russian Studies from Princeton University. He served in various positions at DNAX Research, Inc. (1981-2003), and was a principal in the discovery of IL-10, IL-10 receptor, and IL-23 receptor, as well as a collaborator in the discovery of the cytokine IL-23. In addition his group made contributions to the molecular characterization of human Fc receptors for IgG and to the DNAX genomics-based discovery program in the 1990’s. He was leader of or key participant in several project teams for development and transition of major early discovery projects to the parent company Schering-Plough for development. During 2004, Dr. Moore was Visiting Distinguished Research Fellow at ChemoCentryx, Inc., a company focused on developing small molecule drugs that target the chemokine system. In November 2004, Dr. Moore joined Avidia, Inc. as Senior Director of Target Biology where he was responsible for the company’s assay development, in vitro pharmacology and preclinical safety/toxicology programs. After Avidia’s acquisition by Amgen in October 2006 he was retained as Executive Director and is now Site Head for Protein Sciences at Amgen South San Francisco. Dr. Moore is coauthor of more than 50 original research publications and 18 review articles, and coinventor on 20 issued patents. Among all authors in immunology, he was ranked 10th in number of citations and 18th in citation impact, 1990-1994 as reported by Science Watch (May 1995) and The Scientist (September 1995).
Opportunities and Challenges in the Development of Novel Small Molecule Therapeutics for Oncology
Peter Lamb, Ph.D. Chief Scientific Officer, Executive Vice President Discovery Exelixis, Inc.
ABSTRACT The last two decades have witnessed a major effort by the pharmaceutical industry to discover and develop novel, targeted small molecule therapies for the treatment of cancer. This work was based on increasing understanding of the pathways and proteins that regulate growth, survival and angiogenesis coupled with new insights into tumor genetics and has yielded an array of promising compounds. Much of this effort has been directed against kinases, since as a class they are involved in regulating key cellular processes, are often deregulated in tumor cells and are highly amenable to small molecule drug discovery. Current small molecule oncology discovery is based on both second generation approaches to known targets based on lessons from the clinical as well as de novo approaches based on novel areas of tumor biology. I will discuss these key areas and the opportunities and challenges they present as platforms for oncology drug discovery. BIOGRAPHY Peter Lamb, Ph.D., has served as Executive Vice President Discovery Research and Chief Scientific Officer since September 2009. Previously he served as Senior Vice President, Discovery Research and Chief Scientific Officer from January of 2007 until August 2009, Vice President, Discovery Pharmacology from December 2003 until January 2007 and Senior Director, Molecular Pharmacology and Structural Biology from October 2000 until December 2003. From June 1992 until September 2000 he held positions of increasing responsibility at Ligand Pharmaceuticals, most recently serving as Director of Transcription Research. Dr. Lamb has held post-doctoral research fellowships at the Carnegie Institution, Department of Embryology with Dr. S.L. McKnight and the University of Oxford with Dr. N.J. Proudfoot, working in the field of gene regulation. He has authored numerous articles in the fields of gene expression, signal transduction and oncology, and is an author on multiple issued and pending US patents. He has a Ph.D. in Molecular Biology from the ICRF/University of London and a B.A. in Biochemistry from the University of Cambridge.
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Obstacles to the Commercialization of the First Inhaled Insulin Product, Exubera
John S. Patton, Ph.D.
Founder and CEO Dance Pharmaceuticals
ABSTRACT The approval of the first inhaled insulin product in Europe and the US in January 2006 was hailed as a breakthrough in insulin delivery. However after only 15 months on the market, Pfizer decided to stop selling the product after disappointing initial sales, even though patient studies showed a high preference for inhaled insulin over injections. It was not a product recall and there were no safety signals that would have put patients at risk. A combination of poor marketing, perceived cumbersome delivery system, safety concerns, price above injections and impatience all conspired to kill the product. All of the issues are addressable today. BIOGRAPHY Dr. Patton is a biotechnologist and entrepreneur in the field of drug delivery, particularly pulmonary delivery and peptide and protein delivery. Prior to founding Dance in 2009, he was co-founder of Inhale Therapeutics (now Nektar), where he served as a Director, Head of Research and Chief Scientific Officer from 1990-2008. Before that he led the drug delivery group at Genentech (l985-1990), where he demonstrated the feasibility of systemic delivery of large molecules through the lungs. At Inhale/Nektar he initiated and helped lead the development and FDA approval of the first inhaled insulin product.
Prior to joining Genentech, Dr. Patton was a tenured professor at the University of Georgia. Dr. Patton received his Ph.D. in biology from the University of California, San Diego, and held post-doctoral positions in biomedicine at Harvard Medical School and the University of Lund, Sweden. He serves on scientific advisory boards for Penn State University, Scripps Institution of Oceanography and Aridis Pharmaceuticals as well as the executive boards of Dance, Halozyme, Activaero, and Pleiades Cardiotherapeutics. He is author or coauthor of >100 publications and inventor or coinventor of >38 patents.
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Kaletra: a Second Generation Protease Inhibitor From Abbott Laboratories
Hing Leung Sham, Ph.D.
Senior Vice President, Chemical Sciences
Elan Biopharmaceuticals
ABSTRACT Kaletra is the best in class HIV protease inhibitor that is discovered, developed and marketed by Abbott Laboratories, Inc. It is a combination of two HIV protease inhibitors: ritonavir (Abbott’s first generation HIV protease inhibitor) and lopinavir (Abbott’s advanced generation HIV protease inhibitor). This talk will discuss two key scientific discoveries that led to this unique combination: 1. The discovery of lopinavir that is 10-fold more potent than ritonavir, utilizing structure-based drug design (Abbott’s X-ray crystallography and molecular modeling group, a top-notch team in the industry, played an important role); 2. The concept of pharmacokinetics boosting using ritonavir (due to its reversible inhibition of CYP3A4, a major oxidative metabolizing enzyme) that is originally proposed and investigated by Dr. Daniel Norbeck, Dr. Dale Kempf and Dr. Kennan Marsh. The success of Kaletra is the result of team work in the broadest sense — the discovery of the potent drug, the rapid clinical development by a highly experienced development team led by Dr. John Leonard and Dr. Eugene Sun, the highly efficient commercial-scale synthesis developed by SPD and the successful marketing efforts of PPD and AI. BIOGRAPHY Hing Leung Sham, Ph.D., directed Abbott Laboratories’ medicinal chemistry research efforts in metabolic diseases, including diabetes and obesity, from 2002 until August 2006. He was the Distinguished Research Fellow at Abbott until 2006. He also has drug discovery experiences in cardiovascular, oncology and infectious diseases (1983-2002). Dr. Sham is the primary inventor of Kaletra® (lopinavir/ritonavir), Abbott's advanced-generation protease inhibitor for the treatment of HIV infection, and a co-inventor of Norvir® (ritonavir), Abbott's first generation protease inhibitor. An expert in medicinal chemistry and drug discovery, Dr. Sham is a named inventor on 75 issued US patents and multiple pending U.S. patents; he is author/co-author on more than 160 peer-reviewed publications. Currently, he is leading the Chemical Sciences Department at Elan Pharmaceuticals, Inc. in drug discovery efforts for Autoimmune, Alzheimer and Parkinson’s diseases and other neurodegenerative diseases.
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The Landscape and Trend of in vitro Diagnostics
Jimmy Zhang, Ph.D.
Senior Vice President Synergenics, LLC
ABSTRACT In vitro diagnostics are those reagents, instruments and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health in order to cure, mitigate, treat or prevent disease or its sequelae. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body. The IVD market is expected to grow significantly in the next five to six years. The entire market is expected to experience a 5% CAGR. Molecular diagnostics (MDx) is one of the fastest growing segments, which is expected to grow at 14% CAGR. MDx tests investigate the link between genes and function of metabolic pathways, drug metabolism and disease development with a primary focus on the study of DNA, RNA and proteins. Tests performed near patients or at home (point-of-care) are gaining significant progress in recent years. BIOGRAPHY Dr. Jimmy Zhang is a Senior Vice President at Synergenics, LLC, a professional service and investment company founded by Dr. Bill Rutter. Synergenics-invested companies cover areas such as therapeutic human mAb, gene therapy, cancer genomics, diabetes, diagnostics, and healthcare IT. Dr. Zhang is responsible for the business development of Synergenics and its portfolio companies, and their businesses in China. Dr. Zhang was previously a consultant at McKinsey traveling and working in China, US and Germany, a registered patent agent in Morrison & Foerster, and a project manager at Chiron Corporation. Dr. Zhang received his Ph.D. from the University of Texas Southwestern Medical Center at Dallas, where he worked closely with two Nobel Laureates, and his MBA from MIT Sloan. Dr. Zhang published in Cell, and Nature, and holds multiple patents. He’s a founding member and a Board Director of BayHelix Group. Dr. Zhang is a frequently invited speaker and panelist at bio-pharma conferences and hi-tech meetings. He is also often quoted in both US and Chinese news media.
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Translating Gene Expression Patterns into Commercialized Cancer Diagnostics
Douglas T. Ross M.D., Ph.D. Chief Scientific Officer Clarient, Inc.
ABSTRACT Gene expression profiling experiments in the late 1990's revealed a novel biologic classification of carcinoma with the potential to impact management of patients. Through collaboration with scientists at Stanford University, Applied Genomics, Inc. (AGI) set out in 2000 to translate these insights into validated immunohistochemistry tests. We generated hundreds of novel antibody reagents and screened through commercially available reagents using thousands of tissue samples to identify the small subset that classified cancer in new ways. We then undertook association studies to nominate and ultimately validate single reagents or combinations of reagents useful in defined clinical situations. After acquisition of AGI by Clarient, Inc. in December of 2009, we launched Pulmotype for classification of non-small cell lung cancer and have plans to launch breast cancer classifiers later this year. This talk will review the science behind development and validation of cancer diagnostics and offer a perspective on the challenges of bringing technology out of academics with the goal of positively impacting patient care. BIOGRAPHY Douglas T. Ross M.D., Ph.D. has been Chief Scientific Officer of Clarient, Inc. since its acquisition of Applied Genomics Inc. in December of 2009. Dr. Ross obtained his M.D. and Ph.D. in Pathology from the University of Washington while studying at the Fred Hutchinson Cancer Research Center in Seattle. He completed two years of Clinical Pathology training including serving as Chief Resident at the University of California at San Francisco before doing genomics research as a Berry Fellowship Research Scholar at Stanford University beginning in 1996. He co-founded AGI in 2000 and has since led a research team translating insights from gene expression analysis of carcinoma into immunohistochemistry classifiers and clinically validated diagnostics. Together with his colleagues at Clarient and their academic collaborators, Dr. Ross has published numerous papers that translate insights from genomic scale analysis of cancer into clinical grade assays for managing cancer patients. He serves on the editorial board of BMC Genomics, and as adjunct visiting faculty at the University of Alabama at Huntsville and the Hudson-Alpha Institute of Biotechnology.
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Strategies for Developing Pharmacodynamic and Predictive Biomarkers to Target Cancer Stem Cell Agents
Ann Kapoun, Ph.D.
Sr. Director of Translational Medicine OncoMed Pharmaceuticals
ABSTRACT This talk will present an anti-DLL4 case study discussing how preclinical models can be used to identify pharmacodynamic and predictive biomarkers and how these markers can be implemented in clinical trials. • Use preclinical models to identify pharmacodynamic markers • Apply circulating tumor cells analysis and gene signatures as biomarkers • Integrate strategies for developing clinical biomarkers BIOGRAPHY Ann Kapoun, Ph.D., is Sr. Director of Translational Medicine at OncoMed Pharmaceuticals, Inc. in Redwood City, CA. She is responsible for developing clinical biomarker strategies and assays to demonstrate proof of principle in oncology trials. Ann leads the clinical execution and implementation of biomarkers and patient stratification approaches. Previously, she was Associate Director, Biomarker R&D, Clinical Pharmacology & Exp. Medicine, at ALZA, a Johnson & Johnson Company, in Mountain View, CA. Prior to that she was the Head of Biomarker R&D at Scios, Inc. in Fremont, CA. She received her Ph.D. in 1994 from Indiana University, Bloomington, IN.
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February 16 New Era of Drug Delivery: Microneedle Array Technology (CBA Seminar Series)
Apr i l 27 Chinese Bioscience Association and Ministry of Commerce Chinasigned a Collaboration Memorandum of Understanding (MOU)(CBA Event)
Apr i l 28 CBA Fong-Yi Memorial Scholarship Award to Millicnet Bogue,Foothill College by CBA and AWIS
June 26 Relay for Life, American Cancer Society(CBA sponsering American Cancer Society)
June 12 US-Taiwan Biomedical Engineering Forum(CBA Co-organized Event)
July 24 Six Pillars of Success for Life Science Products(CBA Seminar Series)
August 14 A Place to Go, a Time to Share(CBA Annual Summer Picnic and BBQ)
August 28 Tax Diversifying Your Retirement Income(CBA Seminar Series)
October 30 A Sea Change: Advancement in Biotech and Pharmaceutical Industry(CBA Annual Conference)
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RNAscope™, a Novel RNA In Situ Hybridization Platform for Personalized Medicine
Yuling Luo, Ph.D. Founder, President & CEO Advanced Cell Diagnostics, Inc.
ABSTRACT Companion diagnostics exploiting molecular biomarkers is a critical component of personalized medicine. In oncology, most companion diagnostic tests are based on in situ detection of protein or DNA biomarkers using IHC or FISH, respectively. However, in situ detection of RNA has not been recognized as a viable diagnostic platform due to low sensitivity and specificity of current methodologies. As a result, RNA biomarkers are currently analyzed by RT-PCR at the expense of destroying the tissue context, which is often highly heterogeneous in clinical specimens. ACD has developed RNAscope™, the first RNA in situ hybridization platform with single molecule detection sensitivity, enabling rapid development of RNA-based companion diagnostics. BIOGRAPHY Dr. Luo has spent his entire career in biotech start-ups. Before ACD, Dr. Luo was a founder of Panomics (previously named Genospectra before its acquisition of Panomics), a life science company that was acquired by Affymetrix in 2008. At Panomics, Dr. Luo served various roles including Vice President, Functional Genomics and Chief Scientific Officer and he led the development and launch of all of its flagship product lines. Prior to Panomics, Dr. Luo was one of the earliest senior scientists at Exelixis, where he led a team to identify and validate novel therapeutic targets. Dr. Luo received his doctorate in biochemistry from Case Western Reserve University and conducted post-doctoral research at the University of Pennsylvania.
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Introducing a Novel, Semiconductor Chip-Based Platform for DNA Biomarker Discovery and Personalized Medicine
Gary Zweiger, Ph.D. Vice President, Business Development BioNanomatrix, Inc.
ABSTRACT To realize the promise of personalized medicine we must be able to more rapidly and inexpensively identify, validate and routinely test for biomarkers in individuals. BioNanomatrix, Inc. has developed an automated, bench-top system for high-resolution, multi-color imaging and single-molecule analysis of DNA and other biopolymers. The system uses an electric field to concentrate, linearize, and flow DNA through disposable semiconductor-fabricated chips at rates of up to several gigabase pairs per hour. Laser excitation illuminates fluorescently labeled DNA in the nanochannels of the chip. An onboard CCD camera, coupled with an auto-focusing mechanism and control software, rapidly scans the nanochannels of the chip. Unamplified DNA fragments of up to >1Mb in length are thus imaged allowing an unprecedented view of native-state DNA, including biomarkers for DNA damage, genomic structure, or other sources of variation relevant to an individual’s health, response to therapies, and potential for therapy-related toxicities. Harnessing the drivers of innovation and growth in solid state electronics has been a long-sought dream within the biomedical research community and among those seeking to revolutionize healthcare. Here, we’ll consider one such example. BIOGRAPHY Dr. Zweiger joined BioNanomatrix in 2008. He has several decades of strategic business development experience with leading life sciences companies. Prior to joining BioNanomatrix, Dr. Zweiger led business development at Affymetrix. Previously, he led business development for Applied Biosystems' Cell and Molecular Biology division. Prior to Applied Biosystems, Dr. Zweiger held positions of increasing responsibility at Agilent Technologies. Earlier, he served as a strategic advisor and consultant to biotechnology and genomics companies and to the financial community. Dr. Zweiger received a Ph.D. in genetics and a B.S. in biological sciences from Stanford University and completed a post-doctoral fellowship in molecular oncology at Genentech, Inc. He has published a popular science book on sequencing the human genome, authored numerous scientific publications and holds seven patents.
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The Changing Ecology of 21st Century Pharmaceutical Research and Development
Jim Larrick, Ph.D. Managing director, Panorama Research Institute Director, Life Science Angels and Venture Partner, CMEA
ABSTRACT This meeting is being staged in Silicon Valley the birthplace of modern biotechnology, and a continuing greenhouse for many of the innovative solutions aimed to improve the human healthspan. We begin with a “grade card” of US health in the 20th century; in 1900 the average life expectancy was ~50 years; currently the US ranks 38th at 78 years. What are the prospects health and healthcare for the 21st century? We focus the discussion with a series of questions; Can this improvement in longevity continue? What problems and opportunities result from an aging population? How has biopharmaceutical R & D contributed to the improved human healthspan? How innovative has the pharmaceutical industry been over the past 50+ years? How will this innovation shape biomedicine in the 21st century? How will the risk profile and “block-buster” character of the pharmaceutical industry change? How have angel and venture investors adapted to these changes? As a witness to >25 years of this history, I will contrast the experiences of a Silicon Valley biopharma-entrepreneur with the perspectives of a 15 year angel investor and recent venture partner (at CMEA). BIOGRAPHY Dr. Jim Larrick has an international reputation in biotechnology in cytokines, therapeutic antibodies, molecular biology, pharmaceutical drug development having written or co-authored eight books, over 220 papers/chapters and fifteen patents. He serves on the editorial board of six journals. Dr. Larrick has worked on various aspects of therapeutic antibodies and other protein therapeutics for the past 20 years. Dr. Larrick received his MD and Ph.D. degrees from Duke University School of Medicine, Durham, NC. After house staff training in the Department of Medicine at Stanford University School of Medicine, he completed a post doctoral fellowship in the Stanford Cancer Biology Research Labs with Professor Henry S. Kaplan. In 1982, he joined Cetus Immune Research Labs, Palo Alto, CA, where he became Director of Research in 1986. While at Cetus he pioneered the use of PCR for the construction of recombinant antibodies. In 1988, he moved to Genelabs Inc., Redwood City, CA, as Director of Exploratory Research. In 1991, Dr. Larrick founded the Palo Alto Institute of Molecular Medicine, a non-profit research institute situated near Stanford University. Since then he has founded more than a dozen biopharmaceutical companies including: Panorama Research Inc., Planet Biotechnology Inc., Kalabios Inc., Nugen Technologies Inc., Medlogic Inc,, Panolife Products Inc., PanResearch Inc., Neuromolecular Inc., Absalus Inc., and Quality Clinical Labs Inc. are based in California. PanGenetics B.V. (merged with Tanox Inc.) and TargetQuest B.V. (merged with Dyax Inc.) are headquartered in The Netherlands. Currently he serves on the Boards of five early stage companies and continues to pursue entrepreneurial activities through TENEX Medical Investors in Silicon Valley and 7X, an investment fund he co-founded in The Netherlands.
Changing Business Model for Changing Times: the Rise of Virtual Innovation
Yiyou Chen, Ph.D. Chief Scientific Officer and Co-founder Crown Bioscience
ABSTRACT The rate of new drug approval has not kept in pace with the rate of R&D spending by pharmaceutical companies. The massive patent expiration in the next 3-5 years further exacerbated the challenges faced by the industry. Reducing the innovation effort simply will not be an option, as the pharmaceutical industry depends heavily on innovation to deliver product pipeline, just as patients depend on innovation to access breakthrough medicines. The “virtual innovation model” was adopted by the semi-conductor industry decades ago, where highly specialized chip designer firms utilize external capability and capacity to tackle complex chip design and manufacturing process. Similar concept may also help to significantly increase the efficiency of drug discovery and development. Many Contract Research Organizations (CROs) have recently emerged to provide high quality and cost-effective services to global biotech and pharmaceutical companies. The main driving force for the outsourcing industry has been the major pharmaceutical companies, who can benefit, at least in the short-term, from the quick cost saving generated from labor arbitrage between western countries and developing countries such as China and India. Paradoxically, there has been relatively less adoption of outsourcing by small to medium sized companies, which are in much weaker financial position than the large pharmaceutical companies. The presentation will focus on the dynamics of the industry, and argue the validity of the “Virtual Innovation Model”, especially for small and medium sized companies. I will also discuss near term market opportunities in emerging markets such as China and India. BIOGRAPHY Dr. Yiyou Chen is the Chief Scientific Officer and Co-founder of Crown Bioscience Inc., a leading biology outsourcing company with expertise in oncology and cardio-metabolic disease. The company leverages its strength in translational research and structure based drug design to provide value-added, Target-to-Candidate solutions. Before CrownBio, Dr. Chen was CSO and co-founder of Starvax Inc., an R&D driven bio-pharmaceutical company based in Beijing. Prior to that, Dr. Chen was a senior scientist at Genencor. Dr. Chen obtained his B.S. in Biochemistry from Peking University, and his Ph.D. in Experimental Pathology from University of Utah School of Medicine.
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Conducting Personalized Medicine With The Assistance of Biostatisticians
Xiaowei Yang, Ph. D. CEO BayesSoft
ABSTRACT From the perspective of biostatistician, personalized medicine is defined within two contexts. In drug development, it refers to design clinical trials and analyze data to verify the efficacy of a therapeutic product that responses differentially to subpopulations with distinct genotypes. Within the context of healthcare, it refers to personalized diagnosis and tailored treatment or therapy that reflects the heterogeneity between patients. In this talk, we illustrate how Biostatistical methods are used for personalized medicine in the latter context. Focusing on chronic disease management, we illustrate how Bayesian statistical methods and web-based tele-monitoring technologies are jointly applied to improve the quality of chronic disease management. By allowing self-measurement of biometric data (e.g., blood pressures, glucose level, and body weight), and self-report of psycho-behaviors (e.g., smoking, eating disorder, and depression level), we dynamically collect personal health records (PHRs) using mobile phones with Bluetooth-enabled devices. Then, dynamic Bayesian analysis could be used to make personalized clinical decisions (e.g., to modify lifestyle or accept certain interventions). This PHRs-based Bayesian solution has the potential to reduce healthcare cost while improve the quality of care. We also briefly discuss how Bayesian adaptive trials can be designed to meet the needs of personalized medicine within the context drug development. BIOGRAPHY Dr. Yang is the CEO of the Bayesoft Inc., which is a provider of telehealth solutions to medical researchers, healthcare providers, and individual consumers. He is an expert in the Bayesian methods specialized in Bayesian variable selection in generalized linear models and MCMC algorithms for incomplete longitudinal data analysis with nonignorable missing data. After his graduation from UCLA-school of Public Health with Ph.D. in 2002, he has successfully applied these methods to hierarchical modeling in profiling health providers and developed biostatistical solutions to enhance the quality of healthcare and disease control, providing an ultimate solution to challenges in the coming era of healthcare that emphasizes personalized medicine, patient-centered care, and prevention-oriented management.
Next Generation Biology Through Next Generation DNA Sequencing
Dawei Lin, Ph. D. Director Bioinformatics Core UC Davis
ABSTRACT Next generation DNA sequencing technology (NGS) is touted as enabling the next wave of the genomics revolution. Massively-parallel generation of DNA nucleotide sequences makes it possible to map out entire genomes the size of the human genome, within days and for a few thousands dollars. Importantly, it allows small laboratories even individuals to do research which was previously only possible at large genome centers. The widespread availability of this technology is stimulating the development of a large array of innovative approaches to genome-wide investigations. This presentation will discuss through examples on what the new capability of the NGS technologies has changed not only the way to conduct biological and medical studies but also the mindset to think about biological problems. The discussion will cover new areas that have been created by the NGS technologies including personalized medicine, molecular breeding as well as some innovative uses of the technologies in fields used to be unrelated to DNA sequencing. BIOGRAPHY Dr. Dawei Lin received his Ph.D. from Peking University, China in Computational and Structural Biology. He created the China’s first Bioinformatics server in 1995. He started his career at the Protein Data Bank (PDB) at Brookhaven National Laboratory, a worldwide repository for macromolecular structures. He is currently the Bioinformatics Core Director at the UC Davis Genome Center. In his current position, he is leading his team to provide expertise and infrastructure to carry out acquisition, curation, and distribution of complex data sets as well as to develop and perform computations, analyses, and simulations addressing a wide variety of biological questions from genomics to network biology.
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Data-Driven Drug Discovery and Personalized Medicine
Mr. Joel Dudley Bioinformatics Specialist Butte Lab, Stanford University
ABSTRACT The expanding wealth and diversity of publicly available high-throughput molecular measurements is creating opportunities to develop and apply novel informatics-oriented approaches to translate fundamental discoveries in molecular biology and genetics into improved clinical therapies and diagnostics. Despite the availability of these data, we are faced with enormous challenges in mining, organizing, and integrating these data towards establishing and testing novel translational hypotheses. In this talk I describe how our group is leveraging informatics approaches and public data on a large scale to gain novel insights into disease biology and also to discover novel therapeutic opportunities to reposition approved drugs for novel indications. Additionally, I will discuss our group's efforts to organizing public genetic association and environmental exposure data to enable clinical assessment of personal genomes. BIOGRAPHY Joel Dudley is a Bioinformatics Specialist in the laboratory of Atul J. Butte MD, Ph.D. in the Department of Pediatrics at the Stanford University School of Medicine. His work involves the development of a genomics-based classification of human disease, known as the Genomic Nosology, and other projects leveraging translational bioinformatics for genomic and personalized medicine and drug discovery. He has authored a number of peer-reviewed publications on topics related to genomics, bioinformatics, molecular evolution, drug discovery, and personalized medicine. Prior to joining Stanford, Joel was the Chief Technical Officer at the Center for Evolutionary Functional Genomics where he participated in the development of the popular Molecular Evolutionary Genetics Analysis (MEGA) software package among other bioinformatics projects.
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‘The Great Recession’: How US Consumer is Reacting to It and the Implications for International Trade
David Robinson, Ph.D. Haas Business School, UC Berkeley Santa Clara University
ABSTRACT What has been called the Great Recession is the biggest downturn in the US economy—and in global trade — since the Great Depression of the 1920s and 30s. But this is an odd recession, perhaps best called the “patchwork recession”. This talk will describe how US consumers have reacted to current economic difficulties and why the good times won’t be rolling again soon. BIOGRAPHY David Robinson is Senior Lecturer in Marketing at the Haas School of Business where more than 10,000 Berkeley students have taken his Principles of Business over the last 15 years. In addition to the introductory business course he teaches the core undergraduate courses in marketing and business communication. He has traveled and taught extensively in Asia. At Santa Clara University he teaches the core MBA courses in Marketing and an MBA elective in Pricing Strategy. After studying in England for four years, he earned his Ph.D. in Psychology from Brown and his MBA at UNC Chapel Hill. Live Entertainment and Sopranos
Solo: My Beloved Northern Winter and Ma Yi La by Lily Xu Duet: You Are My Sunshine and La Paloma by Remona Ji and Melody Wang Trio: The Flowering Red Berries and My Grand Mother’s Peng Hu Bay by Lily Xu, Remona Ji and
Melody Wang
BIOGRAPHY Lily Xu came to the US in 1996. She works in a bio-science research company. She is a lyric soprano and has studied singing for many years in pursuit of musical knowledge and vocal skill. She believes that constant study and hard work are necessary to keep improving. She currently takes vocal lessons with Manhua Gao. Melody Wang is a senior program manager at Cisco, and her daughter, Remona Ji, is a student at UC Berkeley. They share a profound love of classical music and opera. In the past few years, through charity fundraising and choir performances they have shared their coaxing harmony and mixed repertoire with the Bay Area.
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Company Overview AbGenomics International Inc., incorporated in Delaware with principal office in California, is a biopharmaceutical company integrated globally and virtually to develop targeted antibodytherapeutics for the treatment of cancer and immune related inflammatory diseases.
With its R&D foundation in Taipei Taiwan since June 2000, AbGenomics has been focusing onthe discovery and development of novel therapeutics for the unmet medical needs.
Our R&D scientists built an efficient discovery platform to identify and validate novel antibody therapeutics.
Our lead therapeutic antibody, designed for autoimmune diseases has been collaborated withBoehringer Ingelheim in June 2005.
Currently, AbGenomics has several potential therapeutic antibodies targeting againstautoimmune diseases, colorectal cancer, multiple myeloma, lung cancer, lymphoma, and othersolid tumors in various development stages.
To increase the efficacy and success rates, diagnostic methods specific for those therapeuticsare also being developed. We intend to build a diversified product portfolio through our R&D andpartnerships.
Job Opportunity
About Us AbGenomics is looking for innovative scientists of different levels to join our rapidly expandingR&D teams. AbGenomics Research Unit is located in Neihu Technology Park, Taipei, Taiwan on a 20,000 sq. ft, state-of-the-art facility in a highly interactive environment. We are dedicated tocreating new technologies and products through our proprietary platform technologies andalliances with universities, research institutions and other biotech companies worldwide.
About the Positions Scientist or Associate Scientist --- The ideal candidate should be able to lead a research team in studying immune response disorders, oncology and metabolic diseases. The person should havea Ph.D. or M.D. degree with solid background in molecular biology/cell biology /immunology andextensive research experience in the relevant fields. Experience with animal models is preferredbut not a must.
Assistant Scientist --- He or She should be able to work in a cooperative environment. The candidate should have a M.S. or a B.S. degree with solid background in molecular biology/cellbiology /immunology and research experience in the relevant fields. Experience with animal models is preferred but not a must.
Salary and Benefits AbGenomics offers an excellent salary and benefits package, including pension, group life insurance, and stock options.
To Join Us Interested individuals are encouraged to send curriculum vitae, list of publications and threeletters of recommendation to: Department of Human Resource, 2F, No. 32, Lane 358, JuikuangRoad, Neihu, Taipei, Taiwan or e-mail to [email protected]
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