English 英文:

公司背景

總裁、總經理：

龔曉嘉，博士，工商管理碩士，美國毒理學會認證毒理專家

龔曉嘉博士於2008創立國際捷效醫藥研發技術諮詢公司, 專精於臨床前製藥發展。在這期間龔博士也擔任了一家台灣小分子製藥公司的副總及另一家台灣幹細胞公司的執行長。

龔 曉嘉博士是博際醫藥研發有限公司（現稱中國北京Pharmaron公司）的創始人之一，從2006年初開始擔任博際公司的總經理。作為機構的最高負責人， 她在建立中國首家通過AAALAC認證、符合美國GLP規範並且雙語（英語和漢語）運作的非臨床實驗室的過程中起到了關鍵的作用。

龔博士 全權負責人員的招聘和培訓以及確保機構符合美國GLP規範（其中包括軟件和硬體的認證）。由此可見，她不僅僅招聘、培養了100多個員工，而且建立了毒 理、病理、藥理、動物疾病模型、藥物代謝動力學、生物分析和免疫學等方面的技術部門。她也建立了質量保證體系，計算機信息技術和電子數據採集系統，實驗動 物設施和獸醫部門。同時機構運營機制、財務、法務和人力資源等系統的成立也在她的帶領下完成。

從2004到2008年，她同時也是博際在美國馬裡蘭州總公司的首席技術官，運營和藥品開發資深副總裁。在職期間，她為多個客戶提供了法規、藥品開發及藥物代謝動力學方面的諮詢。

龔 博士致力於藥理學（動物模型和藥物代謝動力學）、毒理學研究多年，是通過美國毒理學學會認證的毒理專家。在小分子藥物、疫苗、肽類物質、蛋白質藥品的研發 領域，她擁有資深的經驗。龔博士在法規和質量體系方面也有淵博的知識和豐富的經驗，代表醫藥和生物技術公司與美國FDA進行聯繫。她還擅長美國FDA和中 國CFDA的IND與NDA申請。龔博士也是少數同時精通中美藥物研發的人才之一。

加入博際之前，龔博士擔任過多個製藥公司的高層管理人員，最近的是Gryphon Therapeutics公司的藥品研發和項目管理副總裁，SRI International公司的藥品研發和項目管理總監。

龔博士是《蛋白質藥品：藥物代謝和藥物動力學》一書的作者，也是多篇文獻的作者。她多次受邀參加國際醫藥界會議並發表了眾多演講。

龔博士擁有美國俄亥俄州大學的博士學位。

諮詢顧問團

Marc Better. Ph.D.

Dr. Better is currently Executive Director, Process Development at Amgen in Fremont, CA. Dr. Better joined Amgen through the acquisition of Abgenix in April 2006. At Abgenix, he served as the Vice President, Process Sciences and led a group of approximately 70 scientists working on process development for panitumumab (Vectibix®) and other products in the Abgenix portfolio. Prior to joining Abgenix in May 2005, Dr. Better served as the Vice President, Technical Development at XOMA (US) LLC where he was responsible for process development and clinical manufacturing operations. During his sixteen-year tenure at XOMA, Dr. Better made significant contributions to various technology platforms for product development, including gene cloning and expression in bacterial, fungal and mammalian cell systems. He also developed protein and peptide recovery and purification systems. From 1984 to 1989, Dr. Better held various research positions at International Genetic Engineering, Inc. (INGENE), in Santa Monica, CA.

Dr. Better is named as the inventor of more than 20 patents issued in the U.S. and Europe. He published extensively in many peer-reviewed journals and served as invited speaker in numerous international conferences.

He earned a Ph.D. in biochemistry from Brandeis University.

David J. Brusick, Ph.D., ATS

Dr. Brusick is currently a consultant to chemical and pharmaceutical companies as well as contract research organizations (CRO) worldwide.

Dr. Brusick served as Vice President of Global Resource Management for Covance Labs, one of the largest preclinical CRO’s in the world; supervised more than 1000 professional and technical staff members. He developed and implemented a Resource Management system that supported the global toxicology infrastructure across Covance toxicology that included metric- based costing and scheduling systems. He was also responsible for the development of Covance’s automated system giving clients full-time secure access to toxicology study data (Study/Tracker™).

Dr. Brusick is an internationally recognized expert in genetic toxicology and has published extensively in peer-reviewed journals. He has authored many book chapters and three books on the subject. He is also active and served as advisor and contractor to a variety of different government agencies including US FDA, USEPA, NIEHS, NIOSH, and DOD. Dr. Brusick served on the editorial board for different scientific journals, including Toxicological Sciences and Mutation Research. He has been an invited speaker at many US and international conferences.

Dr. Brusick received his Ph. D. from Illinois State University.

Vera S. Byers, MD, Ph.D.

Dr. Byers is currently the president of Immunology Inc. and acts as consultant to various pharmaceutical companies since 1993. In her role as a pharmaceutical consultant, Dr. Byers is responsible for the design of clinical protocols, selection of clinical sites and principal investigators for pharmaceutical clinical trials in autoimmune diseases, allergic diseases, and oncology indications. She also authored clinical reports in the development of biologic drugs in autoimmune diseases, allergic diseases and cancer. She has been responsible for over 40 INDs often defending before the FDA, and was part of the teams responsible for the approval of Enbrel for Rheumatoid Arthritis, Cialis for erectile dysfunction, and the monoclonal antibody based immunosuppressant H-65-RTA for autoimmune diseases.

Dr. Byers co-founded Allergen Corporation and held positions in the clinical development at XOMA Corp., and Abbott Laboratories. Dr. Byers is an Adjunct Assistant Professor at University of California, San Francisco. Since 1993 Dr. Byers served as a reviewer for NIH study sections in autoimmune diseases and oncology. She has published extensively in peer-reviewed journals in immunology related areas and served on the editorial board of Cancer Immunology and Immunotherapy for 20 years. She holds 7 patents in pharmaceuticals.

Dr. Byers received her MD from University of California at San Francisco and is a Fellow in the American Academy of Asthma Allergy and Immunology. She is also certified by American Board of Internal Medicine. She has a Ph.D. in Immunology from the University of California at Los Angeles and a fellowship in clinical immunology from UCSF, and was a Special Lecturer at the Cancer Campaign Research Laboratories, Univ. Nottingham in the UK in Oncology for 15 years.

Charlene Chen, Ph.D.

Dr. Charlene Chen is currently the senior director of CTPS (Center of Toxicology and Preclinical Services) at QPS Taiwan, an integrated CRO for preclinical, analytical/bioanalytical and clinical services. Dr. Chen is an expert in the REACH program and responsible in conducting studies to support REACH.

Dr. Chen was the General Manager of Development Center for Biotechnology (DCB) at Taiwan. DCB is the first and largest preclinical CRO in Taiwan with over 20 years of history in the preclinical testing. During her tenure as the General Manager, Dr. Chen was instrumental in obtaining the Department of Health (DOH) GLP compliance inspection approval and the certification of OECD GLP national compliance monitoring system. Dr. Chen has held this position since 2006. Prior to that, she was the head of general/reproductive toxicology at DCB. From 2000 and 2003, Dr. Chen was a distinguished postdoctoral scholar at Academia Sinica, Institute of Biomedical Sciences.

Dr. Chen has served as lecturer for many of GLP and toxicology training courses and programs in Taiwan and published in peer-reviewed journals. She was the editor of the first edition of Chinese version of globally harmonized system for classification and labeling of chemicals (GHS) in 2006. Dr. Chen is well-versed in the submission of IND and studies to support clinical trial to Taiwan DOH.

Dr. Chen received her Ph.D. from Tulane University, New Orleans, LA, USA.

Richard Chin, M.D., J.D.

Dr. Chin is a physician with extensive expertise in drug and biologics development. He has overseen multiple investigational new drug applications and new drug applications/biologic license applications, and has authored several textbooks on clinical trial medicine.

 

From 2008 until 2011, Dr. Chin served as a director and CEO of OneWorld Health, a nonprofit pharmaceutical company largely funded by the Bill and Melinda Gates Foundation. OneWorld Health is engaged in developing drugs for neglected diseases in impoverished countries.

 

From 2006 to 2008, he was the CEO and President of OXiGENE, Inc., and served on its board of directors from 2004 to 2008.

 

From 2004 to 2006, Dr. Chin was employed by Elan Corporation, where he served, among other roles, as Senior Vice President of Global Development.

 

Dr. Chin also held various clinical and scientific roles for Genentech, Inc. between 1999 and 2004, including Head of Clinical Research for the Biotherapeutics Unit, overseeing approximately half of the clinical programs at Genentech. Dr. Chin began his career at Procter and Gamble Pharmaceuticals, where he served as Associate Medical Director.

 

He received a B.A. in Biology, magna cum laude, from Harvard University and the equivalent of a J.D. with honors from Oxford University in England under a Rhodes Scholarship. Dr. Chin holds a Medical Degree from Harvard Medical School and is licensed to practice medicine in California. He currently serves on the Adjunct Faculty of the University of California, San Francisco School of Medicine, and serves on the Boards of Directors of Genmedica Therapeutics S.L., Balance Therapeutics, Inc., and Galena Biopharma, Inc.

James S. Chu, MBA Ph.D.

Dr. James Chu is currently an independent consultant for consulting services in formulation design, process optimization, cGMP compliance and regulatory application for drug substance or product programs in the US, Taiwan and China. Before mid 2010, Dr. Chu tenured as Vice President of Product Development in PharmTak Inc. responsible for product development and CMC management in development of generics for US ANDA regulatory applications. He orchestrated development strategies including prototype assessment, patent reviews, competitive evaluations and clinical supply planning and hands-on managed development programs in formulation design, process optimization and manufacturing of registration batches for generic products including controlled-release, delayed-release and fast-melt dosage forms. From mid 2007 to early 2009, Dr. Chu serves as Head of Formulation Development, Pharmaceutical Development Division in KV Pharmaceutical Inc., Saint Louis, MO and was responsible for overall formulation development and clinical supplies manufacture of solid, liquid and semi-solid dosage products towards US IND, ANDA and 505b(2) regulatory applications. He managed more than 50 technical personnel with multiple projects at various stages of formulation and process development to ensure corporate milestones for clinical studies and regulatory submissions were completed on time and within budget.

Prior to his service in KV Pharmaceuticals, Dr. Chu served as Vice President and Asia Operations Officer of Bridge Pharmaceuticals, Menlo Park, CA since February 2005 and was responsible for establishing Bridge’s business operations and drug development infrastructures in Asia Pacific regions. He involved developing a network of manufacturing facilities in China and Taiwan focused on providing lower cost, FDA compliant drug development services for US and EU based clients. He engaged numerous site visits and audits of manufacturing facilities throughout China and Taiwan to ensure maximum efficiency, operating time, and compliance to GLP and cGMP regulations. Prior to joining Bridge, Dr. Chu served as Vice President of Technology and Product Development for Yamanouchi Pharma Technologies, Inc., USA (currently known as Astellas Pharma after merging with Fujisawa) with responsibility for all scientific activities for product development including feasibility, dosage form design, analytical method development and validation, process scale-up development, clinical material manufacturing, and technology transfer.

Dr. Chu has also held previous roles in scientific, quality assurance, and product development with Industrial Technology Research Institute (ITRI) and Syntex Research, California. He has over 20 years of pharmaceutical development experience in all aspects of technology-driven product development from drug discovery, preclinical, proof of concept, preformulation, bench scale formulation through scale-up development to commercialization, including pharmacokinetic BA/BE studies, animal models, cGMP pilot scale manufacturing and release testing for clinical trial materials to fulfill CMC submissions for IND/NDA/ANDA.

Dr. Chu holds a Ph.D. in Pharmaceutical Sciences from the University of Utah and a MBA from San Jose State University. He was a postdoctoral research fellow in the University of Michigan and is a certified RAC Regulatory Affairs professional.

Eita Kitayama, M.S.

Mr. Kitayama is currently Director of Preclinical Development at Synta Pharmaceuticals Corp. in Lexington, Mass. He is the strategic and tactical leader for preclinical development programs. In this role Mr. Kitayama is responsible for the planning, budgeting, and execution of Synta drug development programs coordinating all preclinical/nonclinical activities in toxicology and ADME/PK/PD with bioanalysis and API & drug product development and manufacturing as well as formulation development to support discovery, IND, clinical development, and NDA filings. Mr. Kitayama has extensive experiences in identifying partnering CRO’s and CMO’s and executing projects/studies via external partners. He has been in this position since 2003.

From 2001 to 2003, Mr. Kitayama was Senior Program Manager for early drug development at Covance Laboratories, Inc. in Madison, Wis. In this role he assisted biotechnology and pharmaceutical companies in the preclinical drug development of their products. He served as a liaison between Covance and the companies and coordinated all preclinical activities for the clients and served as an adviser for the client companies’ drug development programs. During his tenure Mr. Kitayama also served as the Program Manager for Japanese programs at Covance.

Prior to coming to the U.S., Mr. Kitayama established himself as a toxicologist and the chief of GLP office at Nippon Shinyaku Co, Ltd. in Kyoto, Japan (1984 – 2001). Mr. Kitayama has unique combined experiences in the preclinical drug development across three different countries, U.S., Japan, and China.

Mr. Kitayama published extensively in toxicology and was an invited speaker in the international conferences specifically on the subject of Asian outsourcing. Mr. Kitayama received his M.S. from Kwansei Gakuin University in Hyogo, Japan in 1984.

Alan S. Levin, MD, JD

Dr. Levin is currently an attending physician at the Department of Medicine, Mt. Zion/University of California San Francisco Hospital and he has held this position since 1971. He had a full time medical practice in medicine in clinical immunology and allergy, and tumor immunology for over 30 years, and has been practicing law since 1995. His expertise includes autoimmune diseases and cancer, pathology and immunopathology, general law and patent law.

Throughout Dr. Levin’s medical career he has worked as a clinical pathologist, holding posts as the director of laboratory of immunology at University of California and Kaiser Foundation Research Institute (1971-1974), director of immunology at Western Laboratories, (1974-1977), medical director of MML/Solano Laboratories (1977-1979), and medical director at Levin Clinical Laboratories (1979-1981) He was the Chief Medical Director of Positive Action Health Care, one of the largest HIV clinics in the United States between 1990 and 1992.

Dr. Levin received his M.D. degree from University of Illinois at Chicago Medical Center and served a pre-doctoral fellowship, an internship and a post doctoral fellowship in Pediatric Immunology at Harvard Medical School. He is certified by American Board of Allergy and Immunology and American Board of Pathology. In addition, Dr. Levin received his J.D. from Golden Gate University and is admitted to practice law in California, Texas, Nevada and the U.S. Patent and Trademark Office (USPTO). Dr. Levin has published extensively in various peer-reviewed journals.

Xavier Paliard, Ph.D., Pharm. D.

Dr. Paliard has over 20 years of experience in Translational Sciences in the field of biologics, small molecules and vaccines. He has led several drug R&D projects and collaborations across a variety of therapeutic areas including immune-inflammation, anti-infective, oncology, cardiovascular and metabolic diseases. With his integrative view of R&D, his expertise spans target selection, portfolio management, planning and executing on plans from late stage discovery through clinical development and defining clear differentiation for assets based on high quality science to ensure successful clinical and commercial opportunities.

Dr. Paliard currently serves as Vice President of Translational Research at Anaphore. Before this, he held positions of increasing responsibility in the pharmaceutical and biotechnology industry including ARYx, Gryphon, Merck, Chiron / Novartis, ImmuLogics and DNAX Research Institute.

Dr. Paliard is a named-inventor in more than 15 patents, including two as sole inventor, and has numerous publications in peer-reviewed professional journals, including Nature and Science.

Dr. Paliard holds a Pharm.D. and a Ph.D. in human immunology from the Claude Bernard University in Lyon, France and received his postdoctoral training from the HHMI laboratory of Dr. Philippa Marrack and Dr. John Kappler in Denver CO.

William W.Y. Pang, D.V.M., M.S., Ph.D.

Dr. Pang is currently the Director of Veterinary Services at Charles River Laboratories Preclinical Services Shanghai, China. Prior to this, Dr. Pang was the associate director of Laboratory Animal Medicine Department at Bridge Laboratories, Beijing, China. While in Bridge he played a key role in acquiring the AAALAC accreditation for the Bridge Beijing lab which was the first Western standard GLP laboratory with multi-species from rodent, dogs to Non-human primates. He is well-versed in generating the AAALAC program descriptions and is experienced in AAALAC site evaluations. During his tenure with Bridge lab he constructed most of the veterinary care related SOP’s and served as the attending veterinarian as well as a member of Institutional Animal Care and Use Committee (IACUC) and the Occupational Health and Safety Committee. He had held this position since mid 2006 to June 2008.

Dr. Pang was a research scientist at the Department of Animal Health and Welfare of Grange Research Centre, Teagasc in Co. Meath, Ireland while pursuing his Ph.D. degree in veterinary medicine with University College Dublin, Ireland. Prior to that Dr. Pang served as veterinary pathologist for animal disease diagnosis, prevention and control from 1997 to 2006 at a variety of different China Research Institutes.

Dr. Pang received both his veterinary degree and Masters degree in veterinary pathology from College of Veterinary Medicine, China Agricultural University, Beijing, China. In addition, Dr. Pang earned his Ph.D. from the University College Dublin in Ireland.

Ramachandran (TR) Thirucote, Ph.D.

Dr. Thirucote is currently Vice President of Pharmaceutical Sciences at ROXRO Pharma, Inc., a Strategic Product Development company based in Menlo Park, CA.

Since 2001 Dr. Thirucote is a member of the Executive Team and responsible for directing all of the pharmaceutical operations for ROXRO. He is responsible for the coordination of development on three continents, the synthesis and procurement of drug substance, developing and implementing strategies for alternative sourcing, and formulation and development of company products.

Dr. Thirucote has established the corporate regulatory systems for regulatory compliance and responsible for the compilation of all chemistry, manufacturing and controls (CMC) reports. He in charge of drug product development, from Phase I development to NDA submission and subsequent commercial scale production.

Prior to joining ROXRO Dr. Thirucote established from ground-up the drug product manufacturing facility at SRI International from 1995 to 2001. He has designed and built a GMP compliant multi-functional manufacturing facility for small molecule and protein/peptide drugs, characterization, evaluation and development of clinical trial materials.

From 1992 to 1995, Dr. Thirucote was senior scientist and project leader in Pharmaceutical Development at Agouron Pharmaceuticals, Inc., in San Diego, CA. In this role, Dr. Thirucote was responsible for preformulation research, analytical method development, and the product development of oncology drugs.

Prior to the post with Agouron, Dr. Thirucote held different positions in companies in the US and India.

Dr. Thirucote received his Ph.D. in Industrial Pharmacy from Massachusetts College of Pharmacy in 1991.

Alan G.E. Wilson, Ph.D., ATS

Alan G. E. Wilson, PhD, ATS, is currently Vice President of Drug Metabolism, Pharmacokinetics, and Toxicology and Pathology at Lexicon Pharmaceuticals. He is internationally recognized in drug metabolism, pharmacokinetics and toxicology and has over 25 years of experience working on product discovery and development for both small molecules and biotherapeutics. He has significant hands-on experience with the regulatory and GLP requirements for the conduct of ADME, PK, CMC and safety assessment studies to support regulatory submissions and clinical studies.

Prior to Lexicon, Dr. Wilson held senior management positions with Pharmacia/Pfizer where he was Senior Director and Senior Science Fellow in Preclinical Development, with Searle Pharmaceutical Company where he was Director and Senior Science Fellow of ADME/PK and Investigative Toxicology. In addition, he has had significant experience in Regulatory Affairs and Product Registration while at Monsanto Agricultural Company. He has been involved in the global regulatory submission, approval and registration of a number of successful pharmaceutical and agricultural products. Alan has extensive experience in the application of computational modeling approaches (i.e. in silico, PK, PK/PD) to support product discovery and development and clinical PK studies. As a Board Certified in Toxicologist he has extensive experience working with regulatory agencies in the U.S., Europe, Asia and Asia Pacific on ADME, PK, Toxicology and registration issues. He has Board of Director and Scientific Advisory experience with several companies. He has chaired several Scientific Committees including AIHC’s Dosimetry and Risk Assessment, SOT’s Biological Modeling Subcommittee; in addition he chaired SOCMA’s Pharmacokinetics committee which worked closely with the EPA on the establishment of the EPA Metabolism and Pharmacokinetic Guidelines. He is on the Editorial Board of several scientific journals and has over 120 publications including numerous invited speaker, and session chair, presentations at international conferences.

Dr. Wilson received his PhD in Drug Metabolism from the University of Surrey in England and followed this with a Visiting Science Fellowship in the Laboratory of Pharmacology and Pharmacokinetics at the NIEHS in North Carolina.