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Table of ContentsPresident’s Message from Patty Kiang, Ph.D.

Conference Chairperson’s Message from Li-Fen Lee Ph.D.

Organization and Advisors

Conference Agenda

Caring Begins with Prevention: Detecting, Preventing and Predicting Disease presented by Ethan Knowlden, Esq.

Medicine for Global Human Health presented by Tue H. Nguyen, Ph.D.

Your Value-added Partner in Biopharmaceutical Development & Manufacturing presented by Wei-Kuang Chi, Ph.D.

Strategic Partnering In China - Entering the Market Via Alliances, Joint Ventures & Other Strategic Collaborations presented by James Chapman, Esq.

RabMAbs, 10 years of Dedication to Scientific Discovery in Life Sciences presented by Guoliang Yu, Ph.D.

Key Events

Novel Therapeutic Approaches to Macular Degeneration & Multiple Sclerosis presented by John C. Lin, MD, Ph.D.

The Function of IL-22 in Skin Inflammation presented by Wenjun Ouyang, Ph.D.

OncoScan and QuantiGene: Two Powerful Technologies That Deliver From FFPE Tumor Samples presented by Yuker Wang, Ph.D.

Genome Regulation by Long Non-Coding RNAs presented by Howard Y. Chang, MD Ph.D.

Global Diagnostics and the Clinical Laboratory: An Evolving Relationship presented by Rose Romeo, Ph.D., DABCC, FACB

Development of Fidaxomicin, a New Antibiotic for C. Difficile Infection (CDI) presented by Youe-Kong Shue, Ph.D.

Meaning of the Globalization of the Biopharma Industry for Bay Area Entrepreneurs presented by James W. Larrick, MD, Ph.D.

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Patty Kiang, Ph.D.President’s MessageWelcome to the CBA Annual Conference

It has been a difficult year for many big pharma-ceutical companies as well as small biopharma compa-nies in the San Francisco Bay Area. Many down-sized or

re-organized and colleagues are laid-off in past months. Pharmaceutical corporations and life science companies are forming new types of partnerships. A new business model between manufacturing and development is collaborating worldwide. Biotech and pharmaceuticals are becoming global industries. Health care and biopharmaceutical technologies are closely built together. Medical devices have broader applications in diagnostics. Therapeutics are advanc-ing to cover more cancers and diseases. In this changing world, CBA plays a more impor-tant role than ever. As a professional society, we provide networking, mentoring and helping hands to each other. In 2011, CBA has organized various seminars regarding to entrepreneurship, finance, tax, and education to the public. CBA specially organized a delegation to Taiwan in support of the 2011 International Antibody Conference held in Taipei, Taiwan. CBA continues to spon-sor the Relay for Life for American Cancer Society and a scholarship for college students with AWIS (Association of Women in Science). CBA’s summer picnic provides an opportunity for members to connect with friends and family. This year, we especially selected the Li Ka Shing Learning and Knowledge Center at Stanford University as the venue of our annual conference. It has a special meaning for Chi-nese Americans. Mr. Li, a renowned business leader, donated this beautiful building to Stan-ford University School of Medicine. It has become a popular networking place for students and the public. As Chinese Americans, we are very proud of him and would follow his passion to give back to our society. Being the 2011 President of CBA, I had a most wonderful year with the CBA team. From the bottom of my heart, I would like to thank the CBA board members, Cindy, Cheng Chi, Julie, Cesar, Frank, Lifen, Jeng, Peiwen, Nicki and Patrick, and volunteers, Son and Syl-via for their dedication and contribution to the organization. I like to thank the 2010 President, Sydney, acting as board advisor, for her guidance and suggestions to CBA activities. I appre-ciate the friendship and fun time together with each team member. I also had the opportunity to work with many industry colleagues and friends through the collaborating activities with other organizations. Finally, it is my pleasure to welcome all of you to the 2011 Annual Conference. Truly, you will find an exciting, informative and visionary program that we have assembled for you.

Conference Committee:Program Chair: Li-Fen LeeModerators: Peiwen Yu, Andrew Teng

Press Release Commititee:Webmaster: Frank LinNewspaper/media: Julie Yang

Publication Committee:Editor-in-Chief: Cesar Ho Review Editor: Son KuanLayout Editor: Kathleen ThurgateDesigner: Cindy Liu

Fundraising Committee:Patty Kiang (Lead), Cheng-Chi Chao, Sydney Chen, Li-Fen Lee, Peiwen Yu

Legal Consultants: Lin Sun-HoffmanCPA Consultant: Ying Wang

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Li-Fen Lee, Ph.D. Conference Chairperson’s MessageIt is with great pleasure that I welcome you to the 2011 Annual Conference. It has been three decades since the first ever biotech pat-ent, Cohen-Boyer patent, was granted in 1980. The same

year, Genentech, co-founded by Boyer, through an IPO, had become the first public biotech-nology company. Since then, many more biotech companies have been formed in the Silicon Valley. This has brought enormous changes and progress that include innovative drugs for different diseases, new technologies for clinical diagnostics and the in-depth understanding of biomarkers for precision medicine. During this period, changing business models present unprecedented challenges every day. With the current fragile economic situation and the 21st pharmaceutical ecology, it is essential to recognize new trends and adapt to the changes. Thus our program this year is designed to share with you the latest information on the busi-ness and market conditions between US and Asia, new ideas and innovative treatments on new drug research and new powerful platforms in diagnostic areas.

We have made a major change to the conference this year in which we extended the program from half-day to whole-day. In the morning, we have included a plenary session to cover the business opportunities between US and Asia and market status around the world. We have invited three Vice Presidents from Novartis, One World Health and DCB in Taiwan to share with us their success and insights. We have also added a lunch seminar. The CEO from Epi-tomics will share his story in developing the breakthrough monoclonal antibody technology.

In the afternoon, six leaders will be sharing their new findings. We will learn about innovative antibody drugs presented by two distinguished speakers from Pfizer and Genentech. Then two powerful platforms, OncoScan and Quantigene will be discussed by a leading researcher in Affymetrix. We also have the privilege to hear from an outstanding professor at Stanford, describing the very exciting work on a newly identified long intergenic noncoding RNAs that are involved in programming chromatin states. While reading his findings I was fascinated that the genome is pervasively transcribed to give rise to thousands of lincRNAs, which are likely to play key roles in the gene regulation of diverse biological states and disease.

We will close with a dynamic talk by a well-known venture manager who has worked on vari-ous aspects of therapeutic antibodies for the past 20 years and has had extensive experienc-es in founding many companies. We will hear his experience as a Silicon Valley biopharma entrepreneur.

Finally, I would like to thank the CBA President, Patty and all of the Board Members for their tireless devotion and full support to make this conference possible. I hope you will enjoy this meeting.

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Organization and Advisors

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Conference Agenda

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Ethan Knowlden, Esq.

Diagnostics for better treatment decisions. Patient-centered diagnostics solutions are an important pillar in disease prevention. Today, diagnostics comprise only a small fraction of total hospital costs, but may influence as much as 60-70% of healthcare decision-making. Through the development of novel diagnostics that help guide treatment decisions by detecting, preventing and predicting disease, we can create opportunities to increase the quality and efficiency of health services delivery and reduce downstream costs. Today’s presentation will provide an overview of diagnostics trends in the global market and various growth segments in diagnostics. The focus will then turn to opportunities in China, including Novartis Diagnostics’ efforts to initiate a NAT implementation program across China and in partnership with the Ministry of Health. I will highlight how China is advancing adoption of nucleic acid testing technology as a disease prevention strategy and how these efforts reflect a collaboration that joins industry with Chinese blood centers and the MOH. Novartis Diagnostics is proud to be collaborating with blood centers around the country to evaluate NAT technology as a method for safeguarding China’s 11 million annual blood donations.

Vice President, Business Development & Licensing, Corporate Counsel, Novartis Diagnostics and Emeryville Site Head

Caring Begins with Prevention: Detecting, Preventing and Predicting Disease

Mr. Ethan Knowlden is Vice President, Business Development & Licensing, Corporate Counsel, Novartis Diagnostics and Novartis Emeryville Site Head. Mr. Knowlden has served Novartis Diagnostics and its predecessor, Chiron Corporation, in various capacities over the past ten years, including serving as legal counsel for its vaccines operations in London. Mr. Knowlden joined Chiron in February 2000. He has also held positions with Paging Network, Inc. and the law firms Gardere & Wynne, L.L.P., and Hughes & Luce, L.L.P. He began his professional career at The First Boston Corporation, based in New York. Mr. Knowlden has a law degree from the University of Virginia School of Law and a bachelor’s degree from Wesleyan University. ethan.knowlden@novartis.com

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Dr. Tue H. Nguyen is currently Vice President, Research and Pre-clinical Development, and Diarrhea and Artemisinin Program Leader at the Institute for One World Health (OWH), a non-profit pharmaceutical

Tue H. Nguyen, Ph.D.

The fact that “only 10% of global health R&D is devoted to conditions that account for 90% of the global disease burden” is often quoted to highlight the enormous gap in health care investment for people in the developing countries. In the last few years, starting with the WHO declaration of the Millenium Development Goals (MDG), several factors converged to push global health to the front agenda of governmental agencies, non-profit organizations, and even for-profit multinational pharmaceutical companies. For those of us who work in drug development, this represents a new opportunity to apply our skills, and to have a meaningful and satisfying career. The sciences and the processes of developing new treatments for neglected diseases are not unlike those involved in the development of any new drugs. However, developing new drugs in a resources constraint environment requires new approaches which will challenge us to think out of the box, take on new roles, and wear many hats at a time.

Vice PresidentInstitute for OneWorld Health.

Medicine for Global Human Health

company in San Francisco. He is responsible for directing R&D activities at OWH focusing on expanding the Diarrhea portfolio of projects, and leading the development of CFTR inhibitor as a treatment for acute secretory diarrhea. He is also OWH project team leader of the Artemisnin project. Dr. Tue H. Nguyen joined OWH in 2006 as a Vice President, Chemistry and Manufacturing to work on the semi synthetic Artemsinin project. Before joining OWH, he spent over twenty years at Genentech, a biotech pharmaceutical company in South San Francisco, progressing from scientist to Director of Pharmaceutical Research and Development where he was in charge of all product pre-formulation, formulation and drug delivery system development. He also served as Director of Analytical Sciences responsible for protein structure and activity characterization, as well as bio-analytical assays development for preclinical and clinical studies. Dr. Tue H Nguyen received his B.S. in Pharmacy from the School of Pharmacy, University of Saigon, VN, his M.S. in Industrial Pharmacy from St John University, New York, and his Ph.D. in Pharmaceutical Chemistry from the University of Kansas. He is a fellow of the American Association of Pharmaceutical Scientists. He was a member of the Board of Industrial Advisor for the Higuchi Bioscience Center, Kansas University, and adjunct associate professor at the Kansas University School of Pharmacy. He has also served as a member of the Pharmaceutical Development Steering Committee of PhRMA, the Pharmaceutical Manufacturer Association.

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Dr. Wei-Kuang Chi, obtained his M.S. in Engineering and Ph.D. in Chemical Engineering from the University of Pennsylvania. Dr. Chi has over 24 years of experience in biotechnology process development, including mammalian cell culture, recombinant yeast, recombinant Escherichia coli, online mass spectrometric off-gas analysis for fed-batch process control, and cell disruption bioseparation technology. He is responsible for the establishment of DCB’s new multi-product CGMP Biopharmaceutical Pilot Plant Facility, including design, equipment procurement/installation, validation, GMP quality system setup, analytical method validation, cleaning validation, process validation, and GMP production. This CGMP facility has been used to conduct bioprocess scale-up/development and to produce clinical trial material for protein drugs (monoclonal antibodies, recombinant proteins). At least five products have been produced under GMP for IND submissions for Phase I/II clinical trials. It has received four IND approvals from US FDA, Canadian health authority and Taiwan Department of Health. There are also over ten ongoing projects from US and Asia-Pacific clients on process development leading to GMP productions for recombinant proteins and monoclonal antibodies. The DCB CGMP BPPF has recently received Best CMO award on March 29, 2011.

Wei-Kuang Chi, Ph.D.

In the presentation, the role of the Development Center for Biotechnology (DCB) in the promotion of biotechnology industry in Taiwan will be presented. DCB has established capabilities in biopharmaceutical development including small molecules and protein drugs to add value from lead to IND. International collaboration models and collaboration with China through ECFA will be shown, including pipelines from Taiwan biopharma research institutes and industries. CGMP biopharmaceutical pilot plant facilities (BPPF) including mammalian cell culture up to 500 L to provide clinical Phase I/II material has been in operation since December 2005, when the plant was first certified CGMP by Taiwan FDA and the DMF number was obtained on March 2006 from US FDA. The BPPF has entered a Production Alliance Network (PAN) with Boehringer Ingelheim (BI) since May 2007, case studies with BI on CHO/Mab process development and quality assessment will be presented, additional case studies with analytical characterization of monoclonal antibodies will be presented also.

Vice PresidentDirector, CGMP Biopharmaceutical Pilot Plant FacilityDevelopment Center for Biotechnology Taipei, Taiwan

Your Value-added Partner in Biopharmaceutical Development and Manufacturing

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Mr. James Chapman is a Partner in Foley & Lardner’s Silicon Valley office. His practice focuses on Mergers and Acquisitions, Venture Capital and Securities law. Mr. Chapman has been involved in over 200 Mergers, Acquisitions and financing transactions. He also has extensive experience in international business transactions. Mr. Chapman assists U.S. companies to acquire China-based companies, structure investments in China and complete technology transactions. He also represents Chinese companies in public and private securities offerings and investments in the U.S. Mr. Chapman is a frequent speaker at China-focused events and has published many articles on doing business in China including the two recent articles, “A Brave New World: Technology Transfer to China,” The Licensing Journal, August 2011 and “M&A in China-Anatomy of a Deal in the Middle Kingdom.” Corporate Finance Review, Sept.-Oct. 2011. jchapman@foley.com

James Chapman, Esq.

Entering the Chinese market alone is a risky proposition. The business culture, markets, competitive landscape and regulatory regime in China are complex and challenging. As a result, many companies operating in China have elected to do so by partnering with domestic Chinese companies. These strategic collaborations take a number of forms and entering into and prospering in these relationships is challenging. This presentation will discuss different types of partnering arrangements, the advantages and disadvantages of each, the best practices for entering into and maintaining these relationships and the critical success factors of each.

PartnerFoley & Lardner LLP

Strategic Partnering In China - Entering the Market via Alliances, Joint Ventures & other Strategic Collaborations

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Dr. Guo-Liang Yu is President and CEO, Epitomics Inc., an emerging biotech company with 250 employees dedicated to the development of innovative monoclonal antibodies for discovery, diagnostics and

Guoliang Yu, Ph.D.

RabMAbs are effective tools for highly sensitive and specific immuno-diagnostic assays that include identification and validation of biomarkers that either monitor and predict response to therapy or monitor and predict disease progression. In last 10 years, Epitomics has helped customers at hundreds organizations in the biopharmaceutical industry and academic community through out the world to achieve their research goals through the use of our high quality RabMAbs. The IHC community has identified RabMAbs as clearly superior antibodies for tissue staining and the RabMAb technology has emerged as the premiere choice for developing phosphorylation and other protein modification specific antibodies. Rabbits are well known to possess a strong immune system which generates high quality polyclonal antibodies even against targets that difficult in other systems. Epitomics has unique capabilities and intellectual property to develop rabbit monoclonal antibodies, also known as RabMAbs. The ability to generate a large and diverse repertoire of monoclonal antibodies that recognize a broad spectrum of epitopes is the key to the success of identifying best-in-class antibodies. RabMAbs also have extremely high affinities (100 fold higher than those of mouse MAbs), offering better sensitivities and specificities for diagnostics and high potency for therapeutics. We build a successful company based on the RabMAb technology. The entrepreneurial path and the experiences will be shared.

President and CEO, Epitomics Inc, USA

RabMAbs, �0 years of Dedication to Scientific Discovery in Life Sciences

therapeutics. Epitomic is headquartered in the San Francisco Bay Area and has a wholly owned subsidiary in Hangzhou, China. Guo-Liang was Senior Vice-President of Research and Development at Mendel Biotechnology Inc. where his team analyzed the function of a complete set of plant transcription factors by knock-out and over-expression in planta. Dr. Yu was a Senior Scientist at Human Genome Sciences Inc. where he discovered the target Blys for the lupus drug belimumab. Dr. Yu was trained at Harvard Medical School as a postdoctoral fellow and earned a Ph.D. degree with Nobel Laureate Dr. Elizabeth Blackburn in Molecular Biology from the University of California, Berkeley and a B.S. degree in Biochemistry from Fudan University in Shanghai. Dr. Yu is a co-inventor of more than 150 patents and a co-author of 36 scientific articles. He is the founding president of Chinese Biopharmaceutical Association and serves on several professional organizations in the US and China as a member of the advisory board or board of directors.

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Key EventsJanuary 28 – Welcome Dinner for Taiwan Delegation (CBA Supported Event)

March 13 – How 2010 Tax Act Affects Your Estate Planning (CBA Seminar Series)

May 1 – Stanley Yen Seminar (CBA Co-organized Event)

May 13 – 2011 International Advanced Biotechnology Forum (CBA Co-organized Event)

May 25 – Entrepreneur Panel Discussion (CBA Seminar Series)

June 18 – US-Taiwan Medical Engineering Seminar (CBA Co-sponsored Event)

June 25 – Relay for Life, American Cancer Society (CBA Co-sponsored Event)

July 10 – Fong Yi Bih Memorial Scholarship Award to Lina Ma, Foothill College by CBA and AWIS (CBA Annual Event)

August 27 – Activities & Lunch at Marlin Park (CBA Annual Summer Picnic)

September 10 – Lunch with Director, Science & Technology Division, TECO in SF (CBA BOD Event)

October 1 – Dragon Parent Summit 2011 (CBA Seminar Series: Education)

October 29 – The World Is Flat: Glocalization of Biopharma Industry (CBA Annual Conference)

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Dr. Lin joined Rinat Neuroscience in 2002 as it started as a spin-off from Genentech. He has been with Pfizer

John C. Lin, MD. Ph.D.

Using two recent case studies, Dr. Lin will illustrate the approaches taken to create potential future therapies to address diseases associated with the ever expanding aging population.

Age-related macular degeneration (AMD) is a leading cause of blindness in the elderly,with no approved therapies for the dry form of the disease. We have implicated the deposition of amyloid β (Aβ) in AMD pathogenesis by demonstrating that administration of a new bispecific antibody targeting the two major forms of Aβ protects visual function and preserves the structure of the retinal pigmented epithelium in a mouse model that incorporates risk factors of dry AMD. These dose-dependent effects were correlated with reductions in the ocular deposits containing Aβ and activated complement components. Thus, independent of their clinical value for treating Alzheimer’s disease, Aβ-targeting drugs could be considered for preventing and treating AMD (Proc. Natl. Acad. Sci. USA 108, E279-E287, 2011).

The interleukin 7 receptor chain gene (IL-7R) was identified as a major non-MHC-linked risk locus for multiple sclerosis (MS). We have shown that while IL-7 signaling is neither necessary nor sufficient for the induction or expansion of TH17 cells, IL-7 alone is sufficient to induce human TH1 differentiation in the absence of IL-12 or other cytokine. Targeting IL7 / IL-7R is beneficial in experimental autoimmune encephalomyelitis (EAE). In patients with relapsing remitting MS, high serum levels of IL-7, particularly when coupled with low levels of IL-17F, predict responsiveness to IFN- and hence a TH1-driven subtype of MS. Therefore a serum profile of high IL-7 pathway activity may signify a TH1-driven disease and predict outcome in MS patients undergoing IFN- therapy. Blockade of IL-7 and IL-7R pathway may have therapeutic potential in MS and other autoimmune diseases (Science Transl. Med. 3, 93ra68, 2011).

Novel Therapeutic Approaches to Macular Degeneration and Multiple Sclerosis

Executive DirectorExperimental Medicine at Rinat, Pfizer Inc.

since Pfizer acquired Rinat Neuroscience in 2006. His main interest is on discovering and developing novel therapeutics for age-related health problems, including neural degeneration, inflammation and metabolic disorders. Dr. Lin earned his MD from the College of Medicine, National Taiwan University, his Ph.D. from Harvard University, and completed the postdoctoral fellowship at Genentech.

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Dr. Ouyang is currently a senior scientist and group leader in the immunology department, Genentech, Inc. His group is focused on identifying and developing novel therapies for the treatment of various autoimmune diseases. His group has brought several new therapeutic candidates, such as Rontalizumab, from early research into clinical trials. His research is interested in understanding the biology of T helper cells and their effector cytokines in autoimmune diseases. Before he joined Genentech, Inc. he had obtained his BS degree from Peking University (1991), and Ph.D. (1999) and post-doctorate training (2001) from Washington University, School of Medicine, in St. Louis.

Wenjun Ouyang Ph.D.

Psoriasis is an inflammatory skin disease characterized as epidermal keratinocytes hyperplasia and infiltration of leukocytes in both dermis and epidermis. We were interested in understanding the molecular mechanisms underlying the immune infiltration and the pathological phenotypes of keratinocytes in psoriasis. We identified that IL-22 is unregulated in lesional psoriatic skin. Its receptor is highly expressed on keratinocytes. By using both in vitro and in vivo models, we found that IL-22 is induced by IL-23 from various leukocyte subsets. IL-22 directly targets keratinocytes and induces many key pathological features from keratinocytes. Thus IL-22 is one of the key cytokines that mediate the crosstalk between the immune system and epidermal keratinocytes, and the pathogenesis of psoriasis. Interestingly, in the intestinal tract, IL-22 exerts protect functions during inflammation. We used both infection and DSS induced colitis model to mimic human inflammatory bowel disease. IL-22 induces various antimicrobial responses from intestinal epithelial cells and promotes epithelial healing and homeostasis.

Senior Scientist and group leader,Genentech, Inc.

The Function of IL-�� in Skin Inflammation

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Yuker is currently a Director in Product Development at Affymetrix. The main focus of his efforts in the past few years is to develop a robust SNP-based copy number platform for cancer discovery and diagnosis. Yuker was a senior scientist at a start-up company ParAllele before it was acquired by Affymetrix in 2005. He received a Ph.D. degree in Chemistry from New York University and did postdoctoral research at the Genetics Department of Stanford University, School of Medicine.

Yuker Wang, Ph.D.

Dr. Wang will describe OncoScan, a unique array based platform which delivers allelic copy number for more than 300,000 SNPs, plus cancer relevant somatic mutations. With only 75ng genomic input, OncoScan has been applied to more than 7000 FFPE (Formalin Fixed Paraffin Embedded) tumor samples from around the world with an impressive 88% pass rate. Background, technology and applications to translational research and clinical diagnosis will be discussed. Another platform that will also be discussed is QuantiGene, a hybridization based detection method that works at single cell level for both RNA and DNA.

OncoScan and QuantiGene: Two Powerful Technologies that Deliver from FFPE Tumor Samples

DirectorAffymetrix

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Howard Y. Chang M.D., Ph.D. is Associate Professor of Dermatology at Stanford University School of Medicine and Early Career Investigator of the Howard Hughes Medical Institute. Dr. Chang received his A.B. degree from Harvard College, his Ph.D. in Biology from MIT (with Prof. David Baltimore), and his M.D. from Harvard Medical School. He completed Dermatology residency at Stanford University and postdoctoral fellowship with Professor Patrick Brown, and joined the faculty in 2004. His research addresses how individual cells know where they are located in the human body, which is important in normal development and in cancer metastasis. Chang discovered that a new class of genes, termed long non-coding RNAs, can control gene activity throughout the genome, illuminating a new layer of biological regulation. Chang’s honors include the Damon Runyon Scholar Award, American Cancer Society Research Scholar Award, California Institute for Regenerative Medicine New Faculty Award, elected membership to the American Society for Clinical Investigation, the Vilcek Prize for Creative Promise, the CERIES Award, and the Alfred Marchionini Research Prize.

Howard Y. Chang, M.D. Ph.D.

An organizing principle of the diverse cell types in multicellular organisms is their anatomic location. In turn, anatomic location is patterned by the positional identities of cells along developmental axes. Recent progress in functional genomics and chromatin biology illustrates how cells use specific gene expression programs to encode location. Dynamic chromatin states of key genes, notably the Hox loci, serve as the internal representation in cells of their positional identity within the animal. The same regulators are also involved in cancer development and progression. New findings on long non-coding RNAs (lincRNAs) that are involved in programming chromatin states will be presented. Some lincRNAs interact with the Polycomb repressive complexes, while other lincRNAs physically interact with the MLL/trithorax complexes and position MLL binding on chromatin, thereby influencing histone H3 lysine 4 methylation and transcription. Analysis of genomic location, non-coding transcription, and chromatin states provides an integrated view of how the genome is configured to encode diverse positional identities.

Associate ProfessorHHMI and Program in Epithelial Biology,

Stanford University School of Medicine

Genome Regulation by Long Non-coding RNAs

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Rose Romeo is a board certified clinical chemist who has worked in both the medical device and clinical laboratory industries for over 20 years. Her areas of expertise include strategic and logistical laboratory operations, clinical trial planning and implementation, quality systems implementation and regulatory submissions. Past positions have included UCSF/San Francisco General Hospital, SurroMed, XDx and Roche Molecular Systems.

Dr. Romeo is currently the Laboratory Director at Hunter Laboratories, a reference clinical laboratory located in Campbell, CA. Her duties include working closely with both the Medical Director and Chief Operating Officer to ensure alignment of laboratory quality operations with the strategic and logistical objectives of Hunter Laboratories. Dr. Romeo received her graduate degree in pathology & molecular biology from Albany Medical College (Albany, NY) and is board certified by the American Board of Clinical Chemistry and the National Registry of Clinical Chemistry. She is also licensed as a clinical chemist by the State of California. She is an active member of the American Association for Clinical Chemistry and the National Academy of Clinical Biochemists and is also a member of the Regulatory Affairs Professional Society.

Rose Romeo, Ph.D. DABCC, FACB

A key aspect of any global diagnostic and therapeutic market is to understand the needs of the customer. Expectations for diagnostics, companion diagnostics and laboratory-developed tests continue to evolve in response to new technologies, expanding competition, changing regulations, laws and evolving standards of clinical practice. This presentation will focus on the impact of these factors on clinical laboratories looking to expand or revise their test menu when engaging diagnostic and therapeutic providers.. Key drivers in decisions to expand the test menu via laboratory developed tests versus FDA cleared in vitro diagnostic devices will be discussed.

Global Diagnostics and the Clinical Laboratory: An Evolving Relationship

Senior DirectorHunter Laboratories Inc.

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Dr. Youe-Kong Shue joined Optimer Pharmaceuticals, Inc. in June 2000 as Senior Director of Chemistry and has served as Vice President, Clinical Development

Youe-Kong Shue, Ph.D.

Clostridium difficile infection (CDI) has become a significant medical problem in hospitals, long term care facilities, and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile, which produces toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal flora, and thus allowing C. difficile to flourish.

Current therapeutic options for CDI include metronidazole and oral vancomycin. However, ~25% of patients who initially respond to these treatments experience a recurrence following cessation of antibiotic administration. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.

Fidaxomicin is a new class of antibiotics called macrocycles. It eradicates C. difficile selectively with minimal disruption to the normal intestinal flora that facilitates the early return of normal physiological conditions in the colon which resulted in reducing CDI recurrence.

The two Fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects. Subjects with confirmed CDI received either Fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h). These studies were designed to evaluate safety and compare the response to treatment in subjects during and after a 10-day course of therapy. Combined data from the two Phase 3 trials will be presented.

Development of Fidaxomicin, a New Antibiotic for C. difficile Infection (CDI)

President and CEOOptimer Biotechnology, Inc.

since 2006. In 2009, he assumed additional responsibility as the President and Chief Executive Officer of Optimer Biotechnology, Inc, in Taiwan, of which Optimer is a majority owner. Dr. Shue started his career in 1983 at Abbott Laboratories, where he conducted neuroscience research. From 1993 to 1996, he worked for Cubist Pharmaceuticals. In 1996, he moved to AstraZeneca, where he led a drug development program to identify novel therapies to treat H. pylori infection. Dr. Shue received his Ph.D. in organic chemistry from the University of Pittsburgh and did his post-doctoral training at the Massachusetts Institute of Technology.

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of Life Science Angels and several early stage companies, and as managing director and Chief Medical Officer at Velocity Pharmaceutical Development LLC. Dr. Larrick received his M.D. and Ph.D. from Duke University, and housestaff and post-doctoral training at Stanford University. He was a founding scientist at Cetus Immune Research Labs, where he became Director of Research. He pioneered the use of PCR for the construction of recombinant antibodies, which was critical to the development of antibody library cloning and recombinant antibodies as a new class of biotherapeutics. In 1991, Dr. Larrick founded Panorama Institute of Molecular Medicine (PAIMM) and Panorama Research Inc (PRI). Based on PRI team’s work in cancer, infectious, autoimmune, cardiovascular, neurological and metabolic diseases, he has co-founded more than a dozen companies. Among these are Planet Biotechnology, Kalobios, and NuGen Technology. To date, PRI-initiated projects and/or companies have led to 5 IPOs/exits. Dr. Larrick has led the biopharma screening committees of various Bay Area angel investment groups and was a venture partner at CMEA Capital. He has organized and led a number of biomedical expeditions to Ecuador, Peru, Guatemala, Nepal, India, Tibet and China. Presently he helps fund and serves on the Boards of two non-profits focused on education, delivery of technology, and diagnosis and therapy to less developed countries.

James W. Larrick, MD. Ph.D.

Silicon Valley has been the birthplace of several successive waves of history’s most meaningful and valuable technologies: silicon-based computer technology, biotechnology, the internet and search technology and most recently social network technology. Presently, the pharma industry is in crisis, the market caps of the top 20 pharmas have dropped by >30% in the past decade. Revenues are threatened by expirations of significant patents. Investors are cautious. Investment models are changing. Healthcare costs for our aging population provides a huge challenge. The “global village” has forced rapid and monumental changes in conduct of research and intellectual property. My experience as a participant-entrepreneur as well as an investor in a diverse set of biopharma projects and companies will serve as the basis for reflections on future changes of the biopharma industry. Although our human nervous system was selected to recognize patterns, with respect to biomedicine and biotechnology, the patterns of the past have not always been a good guide to the future. Perhaps the Chinese Book of Changes, the I Ching can guide us!

Founder, CEO, Scientific DirectorPanorama Research Institute

Meaning of the Globalization of the Biopharma Industry for Bay Area Entrepreneurs

Dr. James Larrick is a biomedical entrepreneur, having written or co authored 8 books, over 250 papers/chapters and 30 patents. He has served on the editorial board of 6 journals and currently serves on the boards

Company Overview AbGenomics International Inc., incorporated in Delaware with principal office in California, is a biopharmaceutical company integrated globally and virtually to develop targeted antibody therapeutics 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 on the 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 with Boehringer Ingelheim in June 2005.

Currently, AbGenomics has several potential therapeutic antibodies targeting against autoimmune diseases, colorectal cancer, multiple myeloma, lung cancer, lymphoma, and other solid tumors in various development stages.

To increase the efficacy and success rates, diagnostic methods specific for those therapeutics are also being developed. We intend to build a diversified product portfolio through our R&D and partnerships.

Job Opportunity

About Us AbGenomics is looking for innovative scientists of different levels to join our rapidly expanding R&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 to creating new technologies and products through our proprietary platform technologies and alliances 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 have a Ph.D. or M.D. degree with solid background in molecular biology/cell biology /immunology and extensive research experience in the relevant fields. Experience with animal models is preferred but 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/cell biology /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 three letters of recommendation to: Department of Human Resource, 2F, No. 32, Lane 358, Juikuang Road, Neihu, Taipei, Taiwan or e-mail to abbylin@abgenomics.com