2008 SAPA Entrepreneurship


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2008 SAPA Entrepreneurship

  1. 1. 2008 SAPA Entrepreneurship & Investment Workshop In conjunction with Chinese New Year party 1:00 pm – 6:30pm, Saturday, February 9, 2008 Max Buffet, 1235B W. Chestnut St, Union, NJ 07083 (Tel 908-624-1158) On-line registration at http://sapaweb.org Registration fee: Workshop - SAPA member $10, non-SAPA member $25; Workshop & Party - SAPA member $20, non-SAPA member $35 Click here for driving direction Registration begins: 1:00 PM Introduction 1:15 PM Bill Wei, the Workshop Chair SAPA Update 1:20 PM Hancheng Zhang, President of SAPA or Mingde Xia, President Elect 1. 1:30 – 2:10 PM STARTUP: Perspectives from Founder and VC This presentation will provide real-life experiences of an entrepreneur. The speaker will discuss funding strategy for a startup regarding: Time to approach a VC, What to expect from a VC, Term-Sheet, and Patent evaluation. Through the presentation, the speaker will share his perspective whether or not you need VC to start a venture. The speaker will also address important issues in patent strategy, such as when and where to file a patent, PCT vs Paris Convention, defensive patenting and CIP. Eric Y. Shi, MD, PhD Chief and Director of Breast Cancer Research Long Island Jewish (LIJ) Medical Center eric@dieretech.com Beyond his academic appointment, Dr Shi is founder of DierePharma. The company is focusing on searching and developing novel therapeutic compounds for unmet medical needs. The company's leading compound is AKF-PD, a low toxic antifirotic drug candidate. AKF-PD has potential for all fibrotic diseases. Prior to his current role at LIJ, Dr Shi was Associate Professor in Radiation Oncology, Research Director in Hematology and Oncology at Albert Einstein College of Medicine. As principal investigator, he is recipient of many research grants from NIH, research foundations, and DOD. Dr. Shi published extensively in oncology area and received numerous academic awards for his contributions to cancer research. 2. 2:10 – 2:50 PM Building A Clinical CRO in US and Bridging With China
  2. 2.  Opportunities in drug clinical trials  Motivation to setup a clinical CRO  Defining position in the market place  Understanding strength and weakness  Factors of success  Long term goal and approaches  Challenges down the road Thomas (Tai) Xie, Ph.D. President Brightech International tomx@brightech-intl.com Dr. Xie has14 years of pharmaceutical experience in line of management and statistical analyses for Phase I-IV clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE) for new drug applications (NDA) in various therapeutic areas, especially in oncology. Prior to founding the Brightech, he held an Associate Director position of Biostatistics and Data Management at ImClone, heavily involved in Erbitux BLA submission. Before ImClone, he also held leadership positions at Wyeth (5 years, Assistant Director) and JNJ PRI (2 year, Sr. Statistician). Dr. Xie has extensive experience in design and writing clinical trial protocol, statistical analysis plan, and clinical and statistical report; and in the preparation of multiple NDA submissions. Since October 2004, Tai has led a team of statisticians and SAS programmers providing statistical/SAS programming services to 12 clients including Novartis Oncology, ImClone, Genta, Kyowa and MediWound and Target Health. He is an active researcher with number of research papers published in distinguished Journals with various topics including cancer prevention, two-stage adaptive design, survival analysis, etc. Dr. Xie is responsible for daily operation and hands-on statistical and SAS programming services to Brightech’s clients. 3. 2:50 – 3:30 PM Experience Learned to Build An Innovative Drug Discovery Company in China Egret Pharma (Shanghai) Limited is a pharmaceutical research and development company created to develop innovative medications for major diseases worldwide. Located in the Zhangjiang Hi-Tech Park in Shanghai, Egret is a majority Chinese-owned company established by a team of entrepreneurs and scientists with global experience from top academic centers and multinational pharmaceutical corporations. Our strategy is to be at the forefront of the development of leading edge practices for entrepreneurial innovation in China and to bring the best management principles of global drug development to bear on the challenges of the marketplace. In this presentation, the speaker will share with you the experience learned in the past three years to build a company from 1 person to current 50 employees and at the same time to bring compounds to clinical. Yuanwei Chen, PhD Chief Scientific Officer Egret Pharma (Shanghai) Ltd yuanweichen@egretpharma.com Dr. Chen has over 13 years of experiences in pharmaceutical research in various therapeutic areas. Joined Egret Pharma (Shanghai) Ltd. in 2005 as the Chief Scientific Officer, Dr. Chen has led the company and established Egret as a leading innovative drug discovery company in China with 6 US patents applied and INDs to be filed with FDA and SFDA in 2008. In his current position, Dr. Chen is responsible for the establishment of drug discovery platform, implementation of company and research strategy, and management of business and drug discovery programs. From 1999 to 2005, he worked at the Bayer Corporation on various projects in oncology, during which time he also acted as project coordinator. Prior to his tenure with Bayer, Dr. Chen spent 4 years at Abbott Laboratories where he was involved in combinatorial chemistry and medicinal chemistry program for discovery of influenza neuraminidase inhibitors. Through his career, Dr. Chen has published more than 30 research papers, co-invented 30 patents, and developed several clinical candidate compounds. He received his PhD from University of Lausanne, Switzerland and conducted postdoctoral research at Scripps Research Institute. Break 3:30 – 3:40 PM
  3. 3. 4. 3:40 – 4:20 PM Path to be An Entrepreneur - One of Many Ways to Do It In this presentation, the speaker will share with SAPA members how he gained pharmaceutical development and regulatory affairs experience by initially working for large pharmaceutical companies for 8-9 years: broad exposure in wide range scientific and management settings; in-depth understanding of challenges in drug development and regulatory approval, and successfully obtaining FDA approval of several pharmaceutical products. Applying large pharma experience plus entrepreneur spirit working for several startup pharmaceutical companies, this presentation will illustrate in details some startups’ success or failure, his engagement as an independent consultant providing regulatory affairs support to start up companies while functioning as a Vice President for a startup pharmaceutical company; and his endeavor as an adjunct professor teaching class at a local University which not only balances industrial experience with academic thinking but also gains access to an alternate network of resources and information. Furthermore, the academic appointment also provides prestige when interacting with regulatory authorities and professionals in the US, Europe and other countries due to respect for professorship. King C. Lee, PhD, RAC Vice President, Regulatory and Clinical Affairs Cornerstone Pharmaceuticals king.lee@comcast.net Dr Lee has been with Cornerstone, which develops novel anti-cancer agents, since 2004. Dr. Lee is also a consultant to ExSAR Corporation, providing regulatory consultant services for the development of new products for the treatment of metabolic diseases such as Tay-Sachs disease, and an adjunct professor at Quinnipiac University since 2005, teaching Advanced Pharmacology course to graduate nursing students. Previously, he was the Vice President, Regulatory Affairs, for Acorda Therapeutics, Inc. Prior to Acorda, Dr. Lee was Executive Director of Regulatory Affairs/Quality Assurance with ATON Pharma, Inc. (acquired by Merck in 2003). Prior to ATON, Dr. Lee was the Director of Regulatory Affairs/Quality Assurance for VION Pharmaceuticals, Inc. with responsibilities in Regulatory Affairs, preclincal and clinical assessments of oncology products leading to five successful INDs. He was the Manager of Regulatory Affairs/Clinical Affairs for IBEX Technologies, Inc. from 1993 to 1996, responsible for an IND and clinical development of hematological products. Prior to IBEX, Dr. Lee was a Research Investigator and later a Senior Pharmacologist at Sterling- Winthrop from 1987 to1993, where he involved in two INDs submission which led to two NDAs of a cardiovascular product and a MRI contrast agent. Dr. Lee began his pharmaceutical industrial career as a Research Supervisor at Wyeth from 1985 to 1986. He was a part-time academic faculty member of Eastern Kentucky University from 1982 to 1983. He has been a guest speaker at several professional meetings, including the Biotechnology Program at Stony Brook SUNY, the Annual Meeting and Workshop of the Society of Cardiovascular Anesthesiologists, the annual meeting of the Drug Information Association, and the Annual Workshop at the Southern Connecticut State University. Dr. Lee is a member of several professional societies including the Regulatory Affairs Professional Society and Drug Information Association. He has authored over 40 full publications and numerous scientific abstracts. Dr. Lee received his PhD in Pharmacology from the University of Kentucky in 1983 and was certified by the Regulatory Affairs Professionals Board in 1994. 5. 4:20 – 5:00 PM How to Protect An Idea This presentation will cover following topics:  Patent basics. (Right to exclude, not right to use; requirements in the U.S.: useful, novel, non- obvious, enabled and sufficiently described; patent examination procedure; patent term);  Should you file a patent application? (Did you invent the idea? Do you own the idea? Is the idea potentially commercially valuable? Have you done a prior art search? Are you willing to pay the cost associated with a patent application?);  How should you file a patent application? (Provisional or nonprovisional? CIP or new application? Initial filing in China or U.S.? PCT or individual countries?);  What can you do with a patent? (Exclusive or non-exclusive license, assignment, develop and commercialize it yourself);  How do you enforce your patent right? (Patent litigation) Weihong Hsing Patent attorney
  4. 4. Panitch Law Firm whsing@panitchlaw.com Dr. Weihong Hsing’s practice focuses on the preparation and prosecution of patent applications related to the biotechnology and pharmaceutical arts, as well as rights to operate, due diligence, patentability analyses, litigation support and opinion work on patent validity and infringement. Prior to joining Panitch Schwarze Belisario & Nadel LLP, Dr. Hsing was an associate with the Life Science Transactions Group of Reed Smith LLP., where she practiced law on both intellectual property and transactional issues of life science. Dr. Hsing also worked as a patent agent at Johnson & Johnson Law Department, where she drafted and prosecuted patent applications, undertook patent and prior art analysis, and assisted in strategic counseling and patent portfolio development and management. Before starting her legal career, Dr. Hsing had been a research scientist at Princeton University and a biotech start-up company. Dr. Hsing received her B.S. in biology from the University of Science and Technology of China and her Ph.D. in microbiology from the University of Massachusetts. She also had four years postdoctoral training in genetics and molecular biology from Princeton University, where she was granted the Damon-Runyon Cancer Research Postdoctoral Fellowship. Dr. Hsing received her J.D. Cum Laude from Temple University, where she was a member of the Giles S. Rich Intellectual Property Moot Court Team winning second place in briefs at the regional competition, and where she also won the John J. Mackiewicz Memorial Scholarship in Intellectual Property. Dr. Hsing is a member of the Pennsylvania and New Jersey Bars and is admitted to practice before the U.S. Patent and Trademark Office. Dr. Hsing is an inventor of biotechnology inventions. She also published various research papers on leading scientific journals including Science and Nature. 6. 5:00 – 5:40 PM Venture Investing Process and VC Valuation of Opportunities This discussion/presentation will focus on helping you understand how a typical venture investment term sheet is structured. You'll have an opportunity to hear this directly from the perspective of an investor. For entrepreneurs without a finance background, this discussion will shed some lights on key angles to compare the offers you'll receive from multiple investors. Perry Chui, MBA Senior Associate Rho Ventures pchui@rho.com Perry Chui joined Rho Ventures in 2005 after a stint at Microsoft as a senior marketing manager. Previously, he was a Channel Strategist at AT&T Wireless, and Director of Business Development and M&A at Perkin Elmer. Perry started his business career as a management consultant with McKinsey & Co. after receiving his MBA from Cornell in 2000. Before business school, Perry spent four years as a design architect for Lucent Technologies. While at Rho Ventures, Perry has been primarily involved in Rho's investments in media, communications and mobile technology. Aside from leading due diligence activities, he also board observing some portfolio companies. Panel Discussion 5:40 – 6:20 PM Chinese New Year Party: 6:30 PM – 9:30 PM (Dinner, Raffle Prize, Karaoke, Dancing, etc)
  5. 5. Organization Committee: Chair: Bill Wei Members: Jisong Cui, Haixia Fen, Handan He, Bo Liang, Wenseng Pan, Tsang-Bin Tzeng, Mingde Xia, Yan Xia, Haishan Xiong, Ning Yan, Hancheng Zhang, Xiaoying Zhang, Marlon Zhong, Jian Zhu
  6. 6. Organization Committee: Chair: Bill Wei Members: Jisong Cui, Haixia Fen, Handan He, Bo Liang, Wenseng Pan, Tsang-Bin Tzeng, Mingde Xia, Yan Xia, Haishan Xiong, Ning Yan, Hancheng Zhang, Xiaoying Zhang, Marlon Zhong, Jian Zhu